Pharmaceutical Compounds: Investigating and Regulating Their Use (Part 2)

In our last post, we discussed how pharmaceutical companies have begun to profit from the proliferation of compound drugs, as reported by the New York Times. Today, we will examine the measures various entities have taken to investigate and regulate these products.

Catamaran, a pharmacy benefits manager, discovered their spending on compounded drugs had increased fourfold over the past two years. The company is now making a concerted effort to examine such claims to determine their validity. Similar companies – including Blue Cross Blue Shield, Harvard Pilgrim, and state workers’ compensation plans – are now doing the same.

Express Scripts, meanwhile, recently decided to stop payments for over 1,000 of the ingredients compounders commonly use. This 95 percent reduction in spending has saved money for consumers, health plans, and employers alike, while cutting into the profit margins of compounding pharmacies.

According to Dr. Sumit Dutta, Catamaran’s chief medical officer, such measures remove the “profit motive” driving these companies to produce more complex and expensive medications.

In Southern California in June, 15 individuals -- including financial brokers, doctors, chiropractors, and pharmacists -- were indicted for participating in a “kickback scheme” targeting workers’ compensation plans. Kareen Ahmed of Landmark Medical Management allegedly helped to purchase accounts receivable from health providers awaiting payment for workers’ compensation related services.

Some states have responded to the compounding pharmacy problem by imposing payment limits (Ohio) and limits on the number of ingredients payable per prescription (Georgia).

However, the compounding industry refuses to go down without a fight. The new Patients and Physicians for Rx Access, founded in June, advocates for compounding pharmacies, claiming that patients need compound drugs -- that standard medications often do not meet their health needs.

Have you or a loved one experienced negative effects as a result of a contaminated or incorrectly formulated compounded drug? Call a D.C. medical malpractice attorney today to discuss your legal options.
 

Want to learn more? Check out: Compounding Pharmacy Report Reveals Limited Regulation

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Pharmaceutical Compounds: What They Are and How They Cost Consumers (Part 1)

The rising costs of health care in the United States are no secret to doctors, patients, or pharmacists. Lifesaving drugs, procedures, and equipment continue to place a high cost burden on consumers and their insurers.

Among the fastest-growing and most expensive treatments patients received as of late are compounded drugs, according to a recent article by the New York Times. These formulations consist of custom ingredients to meet the unique needs of patients, from diaper rash to pain and scarring.

Created by compounding pharmacies, these drugs present alternative treatments for individuals unable to take mass-produced drugs due to ingredient intolerances, an inability to take oral doses, or other complications. Pharmaceutical compounds frequently cost exponentially more than their standard counterparts, reaching into hundreds or thousands of dollars.

Compounding companies claim the prices of their products have increased due to rising oversight of their international chemical suppliers. However, a change in 2012 to how pharmacists bill insurers for compound medications likely points to a more compelling reason.

Whereas pharmacists used to submit claims based on the price of the main ingredient in a compound, they now bill based on each ingredient in a compound. Incidentally, the number of ingredients in each compound has begun to increase.

Not only are insurance companies and patients bearing the brunt of these excessive costs – the safety of pharmaceutical compounds has also recently been called into question. A recent high-profile example was a steroid injection that sickened 750 and killed 64 after being tainted with a fungus at the New England Compounding Center.

This troubling news comes as pharmacy benefit managers note compounded drugs often yield no more benefits to patients than their mass-marketed equivalents. In addition, compounds require no FDA approval, putting their safety and efficacy further into question.

In Part 2, we will discuss how the medical and legal communities have reacted to the high costs of compound drugs.

If you or a loved one have experienced injury or illness due to faulty pharmaceuticals, contact a D.C. medical malpractice attorney today.
 

Want to read more? Check out this article: Senate Drafts Bill to Regulate Compounding Pharmacies



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New Research Casts Doubts on Benefits of Niacin for Heart Health

Although many physicians have prescribed niacin, or vitamin B3, to treat high cholesterol levels, a recent study shows the compound may cause more problems than it prevents.

In its July 17 issue, the New England Journal of Medicine details a major clinical trial scientists conducted to explore the benefits of niacin in patients with hardened arteries. Researchers found it did slightly raise HDL (“good”) cholesterol in subjects but presented no apparent cardiovascular benefits.

In the study, researchers at Oxford gave half of the 26,000 study participants a pill composed of niacin and laropiprant, while providing the other half with a placebo.

According to Jane Armitage, senior author of the study and professor of clinical trials and epidemiology at Oxford, niacin intake also heightened the risk of dangerous side effects, such as increased blood sugar in diabetics, higher numbers of new diabetes diagnoses, and a proliferation of skin problems, gout, infections, diarrhea, excess bleeding and liver problems. These side effects led to several hospitalizations.

More notably, 9 percent more patients died when taking niacin compared to the control group. Although researchers note this percentage is not statistically significant, it represents a “deal breaker” to Dr. Donald Lloyd-Jones, who penned the editorial accompanying the study.

Researchers concluded niacin use is unlikely to create the effects for which doctors have prescribed it, such as increasing HDL cholesterol and reducing stroke and heart attack. They recommend any individuals currently taking niacin contact their physicians to discuss switching to statins, which have proven safer and more effective.

Constant discoveries in the medical field often uncover complications and dangers presented by commonly-prescribed medications. Although medical professionals do their best to provide the best care based on the information available to them, they must be held accountable when their recommendations lead to negative effects in their patients.

If you or a loved one have suffered as a result of an inappropriately prescribed medication, contact a DC medical malpractice attorney today to discuss legal options.

Have you talked with your doctor regarding the safety of your medications?


 

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Senate Drafts Bill to Regulate Compounding Pharmacies

Posted by Salvatore J. Zambri, founding member and partner

 

Following the recent debates over how to regulate the compounding pharmacy business, the Health, Education, Labor and Pensions Committee of the U.S. Senate has drafted a bill aimed to "make clear oversight responsibilities for pharmaceutical compounding and ensure safety for consumers." According to the news as posted on the Committee's Senate.gov website:

 "Draft legislation preserves the states’ primary role in traditional pharmacy regulation and clarifies FDA authority over those making sterile products without prescriptions and shipping across state borders."

As I have noted in earlier posts, the most challenging problem with compounding pharmacies has been determining who is in charge of regulating them. FDA Commissioner Margaret Hamburg indicated that the conflicting patchwork of state and federal laws regarding pharmacies has resulted in a lack of aggressive policing by the FDA.  The new bipartisan Senate bill requires compounding manufacturers to register with the FDA, report the drugs they make, and meet standards similar to those of drug manufacturers.

The International Academy of Compounding Pharmacists has criticized the bill for creating "more confusion and blurring the jurisdiction authority of regulators."  Its position continues to be that states should license and oversee compounding pharmacies and that the FDA should oversee and regulate pharmaceutical manufacturers.

Public Citizen, a consumer advocate and nonprofit organization has also weighed in on the proposed Senate bill to regulate compounding pharmacies. In its press room release on May 1, 2013, "Public Citizen to Congress: Proposed Compounding Pharmacy Legislation Would Be a Major Step Backward for U.S. Drug Safety", Public Citizen criticizes the bill for actually weakening  existing FDA control and creating more ambiguity defining compounding pharmacies. An alternative suggested by Public Citizen proposes legislation that would:

"- Draw a single, clear line between traditional compounding and drug manufacturing, with no newly created category of second-tier, substandard drug manufacturers, called “compounding manufactures”;

- Provide adequate funding to the FDA to aggressively enforce existing laws against “compounding pharmacies” that cross the line into manufacturing;

- Strengthen the FDA’s authority to police the line between traditional compounding and drug manufacturing by requiring registration and granting the FDA authority to inspect for traditional compounding pharmacies, regardless of whether they engage in drug manufacturing activities; and

- Require clear, standardized warning labels to communicate to providers and patients who purchase traditional compounded products that the safety, efficacy and the accuracy of the product’s labeling have not been assessed by the FDA."

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Compounding Pharmacy Report Reveals Limited Regulation

Posted by Salvatore J. Zambri, founding member and partner

 

The push to regulate compounding pharmacies is beginning to gain more attention on the national front. According to a congressional report released on April 15, 2013, the state-by-state examination last fall into the safety issues surrounding the common practices among compounding pharmacies demonstrates that states do not adequately track, regulate or inspect these pharmacies, exposing patients to unsafe drugs, disease and death.

 

The Markey Report, "State of Disarray," findings and conclusions:

  • "State boards of pharmacy generally do not know which pharmacies engage in compounding, do not know whether pharmacies ship compounded drugs across state
    lines, and do not know which pharmacies manufacture large quantities of compounded
    drugs.
  • Only thirteen state boards of pharmacy know which pharmacies are providing sterile compounding services and only five of these states have inspectors that are trained to identify problems with sterile compounding.
  • States typically do not maintain pharmacy inspection records that enable them to identify systemic and repeated compounding pharmacy safety problems that originate either in-state or out-of-state.
  • States are unable to effectively police compounding pharmacy activities in other states. Moreover, when issues arise with out-of-state pharmacies, states do not consistently inform the origination state or the FDA.
  • Despite general increases in state board of pharmacy budgets, the number of pharmacy inspectors has remained consistently low. Furthermore, states usually do not distinguish between inspections of traditional and compounding pharmacies."

Congressman Markey is among those who support legislation to give the Food and Drug Administration more authority over compounding pharmacies.  A scheduled hearing of a House Energy and Commerce subcommittee will be held on Tuesday, April 16, 2013 to focus on this issue.

I will continue to update our readers on this critical consumer issue as more attention is given to the safety problems of compounding pharmacies. 

Do you have any questions about this post?

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Clinical Specialties Compounding Pharmacy Recalls All Sterile Products

Posted by Salvatore J. Zambri, founding member and partner

 

The FDA has announced that Clinical Specialties Compounding Pharmacy is recalling all sterile products due to lack of sterility assurance.  We have reproduced the FDA notice in its entirity for our readers.

 "Clinical Specialties Compounding Pharmacy Products: Recall - All Sterile Products Recalled Due To Lack of Sterility Assurance

 [Posted 03/21/2013]

AUDIENCE: Health Professional, Pharmacy, Patient

ISSUE: Clinical Specialties is voluntarily recalling all lots of all sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance. The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site which cannot assure the sterility of the products.

BACKGROUND: This expanded recall follows the firm’s initial recall of Avastin on March 18, 2013, due to reports of five patients who have been diagnosed with serious eye infections associated with the use of the product. The Center for Disease Control and Prevention (CDC) notified the FDA of these endophthalmitis infections, which occur inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision. Clinical Specialties Compounding sterile products covered under this recall were distributed nationwide between October 19, 2012 and March 19, 2013.

RECOMMENDATION: Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company. Consumers or Health Care providers with questions regarding this recall may contact Clinical Specialties by phone at 866.880.1915 Monday through Friday between the hours of 10 am to 5 pm EST, or e-mail at clinicalrx@bellsouth.net. Patients who have received any product distributed by Clinical Specialties Compounding and have concerns should contact their healthcare provider.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[03/21/2013 - News Release - FDA]

[03/20/2013 - Press Release - Clinical Specialties ]

Related MedWatch Alert

[03/18/2013 - Press Release - Clinical Specialties ]"

As I have been following the compounding pharmacy investigations, I will continue to share with our readers what I learn regarding this very important consumer safety issue.

Do you have any questions about this post?

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Another Compounding Pharmacy Recalls All Products

 Posted by Salvatore J. Zambri, founding member and partner

 

 A recent U.S. Food and Drug Administration (FDA) press release announced the voluntary recall of all compounded products by Medprep Consulting, Inc. due to potential mold contamination.  We are including the complete FDA press release along with a listing of all the products in the recall.

 "Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination

Contact
Consumer:
732-493-3390

Media:
Angelo J. Cifaldi, Esq., R.Ph.
Satish V. Poondi, Esq., R.Ph.
Counsel for Med Prep Consulting Inc.
(732)855-6096

FOR IMMEDIATE RELEASE – March 17, 2013 – Tinton Falls, NJ., Med Prep Consulting, Inc. is voluntarily recalling all lots of all products compounded at its facility. The level of recall is to the user, that is, regional hospital pharmacies and related departments, and physician’s office practices. The recall resulted from the pharmacy being notified by a Connecticut hospital, that it observed visible particulate contaminants in 50 ml bags of MAGNESIUM SULFATE 2GM IN DEXTROSE 5% IN WATER, 50ML FOR INJECTION intravenous solution confirmed to be mold. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital. At this time a total of five (5) contaminated bags were discovered. In an abundance of caution, the pharmacy included all compounded products in the voluntary recall due to lack of sterility assurance.

Administration of an intravenous product found to be contaminated with mold, could result in a fatal infection in a broad array of patients. To date, no injuries or illnesses have been reported.

The products are used for a wide range of therapeutic uses for hospitalized inpatients and outpatients, and, patients directly treated by a health care professional at a physician’s office practice facility or clinic. None of these products are dispensed directly to patients from retail pharmacies or to home care patients for either self-administration or nursing administration. All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials. Products packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials were distributed directly to regional hospital pharmacies located in New Jersey, Pennsylvania, Connecticut, and Delaware. Products packaged in plastic syringes only, were distributed nationwide to physician’s office practice facilities and clinics. All of these products were distributed to the described users through March 13, 2013, from Tinton Falls, New Jersey to both regional and nationwide locations.

Included in the recall are the following product list:

  • Acetylcystiene vials
  • Adenosine Bags
  • Alteplase syringe
  • Atropine syringe
  • Avastin syringe
  • Aztreonam syringe
  • Bacitracin vials
  • Bupivacaine Bag
  • Bupivacaine
  • Epinephrine Bag
  • Bupivacaine Syringe
  • Bupivacaine OnQ Pump
  • Calcium Gluconate Bag
  • Calcium Gluconate syringe
  • Cefazolin syringe
  • Cefazolin Bag
  • Cefepime syringe
  • Cefepime Bag
  • Cefotaxime syringe
  • Cefotetan syringe
  • Cefoxitin syringe
  • Ceftazidime syringe
  • Ceftazidime Bag
  • Ceftriaxone syringe
  • Ceftriaxone Bag
  • Cefuroxime syringe
  • Cefuroxime Bag
  • Clindamycin syringe
  • Darboepoetin (Aranesp) syringe
  • Denusumab Syringe
  • Dexamethasone Bag
  • Diltiazem Bag
  • Diphenhydramine Bags
  • Dobutamine Bag
  • Dobutamine syringe
  • Ephedrine syringes
  • Epinephrine Bag
  • Epinephrine Bag
  • Epinephrine syringe
  • Epoetin Alfa syringe
  • Esmolol syringes
  • Famotidine syringe
  • Fentanyl Citrate Bag
  • Fentanyl Citrate with Bupivacaine HCL Bag
  • Gentamicin syringe
  • Gentamicin Bag
  • Glycopyrrolate syringes
  • Granisetron syringe
  • Hectoral syringe
  • Heparin syringe
  • Heparin bag
  • Hydromorphone syringe
  • Hydromorphone Bag
  • Hydromorphone PCA syringe
  • LET Gel syringe
  • LET Soln syringe
  • Leukine syringe
  • Magnesium Sulfate bag
  • Meperidine Bag
  • Methadone Syringe
  • Midazolam Bag
  • Midazolam syringe
  • Morphine Sulfate Bag
  • Morphine Sulfate syringe
  • Norepinephrine bag
  • Norepinephrine Syringe
  • Ondansetron Bag
  • Ondansetron – Dexamethasone Bag
  • Ondansetron syringe
  • Oxacillin syringe
  • Oxacillin Bag
  • Oxytocin bag
  • Palanosetron (Aloxi) syringe
  • Penicillin syringe
  • Penicillin Bag
  • Phenylephrine Bags
  • Phenylephrine syringes
  • Potassium Chloride Bag
  • Potassium Phosphate l bag
  • Ranitidine syringe
  • Rituxan syringe
  • Ropivacaine Bag
  • Ropivacaine OnQ Pump
  • Sodium Citrate syringe
  • Sodium Phosphate bag
  • Succinylcholine syringes
  • Sufentanil with Bupivacaine Bag
  • Timentin syringe
  • Tobramycin syringe
  • Vancomycin Bags
  • Zometa syringe

All facilities that received any product compounded by Med Prep Consulting, Inc. have been notified by telephone fax, electronic mail and regular mail of the recall and have been instructed to remove and return the product to the pharmacy. Facilities with questions may contact the company at 732-493-3390, Monday through Friday, between 10:00 a.m. and 5:00 p.m. EST.

Product complaints related to this recall should be reported to 732-493-3390, Monday through Friday, between 10:00 a.m. and 5:00 p.m. EST.

Adverse events that may be related to the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

As I have been following the compounding pharmacy investigations, I will continue to share with our readers what I learn regarding this very important consumer safety issue.

Do you have any questions about this post?

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Controversy Continues Regarding Compounding Pharmacy Regulation

Posted by Salvatore J. Zambri, founding member and partner

 

In a move prompted by pressure from Congress and health-care watchdogs, the FDA launched a series of aggressive surprise inspections of large compounding pharmacies last week. Among their findings so far: contaminated drugs, medications without expiration dates, and drug containers "not clean and sterilized." The inspections of about 30 facilities are expected to continue for the next two months and could result in fines and possible suspensions of their licenses. This new program of aggressive inspections is aimed at regulating the multibillion-dollar industry that custom mixes medications for individual patients, hospitals and clinics. As I have posted previously, the compounding pharmacy industry has fallen between the regulatory cracks.

According to Howard Sklamberg, director of compliance for the FDA's Center for Drug Evaluation and Research, inspectors do not know exactly what they may find during these inspections, since compounding pharmacies currently do not have to register with the FDA, nor tell them what medications they produce. "A lot of these firms are behaving like manufacturers and producing like manufacturers, yet they are trying to operate under the law as if they were a small pharmacy."  According to the Washington Post's investigative series, "The FDA is seeking authority from Congress to require registration, which would allow the agency to demand that firms release detailed information about operations and give it greater authority to require that safety problems be fixed."

Patient safety should be the ultimate goal for compounding pharmacies instead of making as much profit as possible and resisting oversight by the FDA or other regulatory agencies.  Profit should never be put ahead of patient safety.

Do you have any questions about this post? 

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Should Compounding Pharmacies Be Required to Follow FDA Safety Regulations?

Posted by Salvatore J. Zambri, founding member and partner

 

The International Academy of Compounding Pharmacies has traditionally fought against FDA oversight for compounding pharmacies and has argued that state pharmacy board registration and control was sufficient. Under the current laws, pharmacies must register with and are licensed by the state boards of pharmacy, not the FDA.  For drug manufacturers, FDA registration is required and their products must have FDA approval.  

Following a recent investigative research article by the Washington Post about the lack of safety regulation for compounding pharmacies, the executive vice president of the organization now endorses, "FDA registration for what he describes as compounding manufacturers and supports giving the agency the power to enforce safety standards for these firms."  As the FDA commissioner argued before Congress several months ago, "non-traditional" compounders need a special category for stepped-up enforcements, but left open recommending whether the FDA or state pharmacy boards should be responsible for the enforcement. 

This new position by the International Academy of Compounding Pharmacies seems to acknowledge the need for more control by the FDA. Creation of a way to regulate "non-traditional" drug manufacturing is currently being debated on Capitol Hill. Compounding firms frequently use non-FDA-approved drugs as key ingredients and many of their drugs are not dispensed in pill form, creating a difficult regulation scenario. According to Sarah Sellers, executive director of the Center for Pharmaceutical Safety, her concern is that a new enforcement system would be set up for compounders that assumes they are using FDA-approved ingredients. “When people use FDA-approved ingredients, built into that are good manufacturing practices. But there is an entire group of compounding pharmacies that are not using FDA-approved drugs. I’m concerned they will end up creating a ‘good manufacturing practices light.' ”

As I posted previously, the safety problems with compounding pharmacies have been known for years. Finding a way to police the industry effectively is important for patient safety.

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Why Are Compounding Pharmacies So Dangerous?

Posted by Salvatore J. Zambri, founding member and partner

 

After so many cases and deaths related to the New England Compounding Center's tainted steroid shots, new inspections have resulted in a report about conditions and practices that violated federal law aimed at maintaining sterile environments.  Sarah Sellers, a former FDA official who is now a consultant on quality and sterility issues, also reviewed the report. “The entire pharmacy was an incubator for bacteria and fungus,” she said. “The pharmacy knew about the contamination and did nothing.”

However, a more recent review of compounding pharmacy practices shows that these organizations have been tied to deaths and illnesses over the past decade and that those pharmacies have experienced safety problems for years. According to a recent Washington Post article, compounding pharmacies "mass-produce medications and ship them across state lines, often without individual patient prescriptions." Compound pharmacies supply about 40% of all intravenous medications used in hospitals and are not required to follow the safety rules that apply to commercial drugmakers. With such a lightly-regulated industry, neither state nor federal authorities did much to "systematically inspect and correct hazards posed by specialty pharmacies," resulting in practically no punishment for the pharmacies, even when their mistakes caused deaths. 

As further indication that this problem has been known for some time: "In 2007, a team of investigators from the Centers for Disease Control and Prevention issued an unusually blunt warning to hospitals and doctors: Compounded drugs had a higher risk of contamination than commercially manufactured drugs, and compounding pharmacies had 'generally lower quality-control standards than pharmaceutical manufacturers.' ”

The FDA has pressed Congress for more authority to regulate compounding pharmacies. FDA Commissioner Margaret Hamburg said, "Legislation is needed that would allow the FDA to routinely inspect 'non-traditional' compounding pharmacies, hold them to higher production standards and see records about the volume of drugs being made, as well as require compounders to report adverse events associated with their products."  State pharmacy boards have the primary responsibility for policing the compounding pharmacies, but they have an uneven record of enforcement. In addition, the regulatory standards that do exist for the compounding pharmacy industry has not kept pace with the rapid expansion pace of that business. By relying on gaps in laws and conflicting court rulings, these companies have fought enforcement orders and kept the FDA out of their facilities.

Do you have any questions about this post?

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Anticlotting Drug Pradaxa Allegedly Causing Deaths

Posted by: Salvatore J. Zambri, founding member and partner

 

Please read the front-page of the Business Day section of the New York Times (11/3, B1, Thomas, Subscription Publication, 1.23M), which reported that blockbuster anticlotting drug Pradaxa is producing deaths from unstoppable bleeding, and critics are taking aim at the FDA "because it allowed a potentially dangerous drug to be sold without an option for reversing its effects." Unlike warfarin, Pradaxa - or dabigatran - has no antidote to stop its blood-thinning ability. The Times adds, "Pradaxa is an example, some critics say, of what can happen when a drug that performs well in tightly controlled trials is released into the messy world of real-life medicine. Boehringer Ingelheim said it was working on developing an antidote but that even without one, patients in a large clinical trial died at roughly the same rate as those who were taking warfarin."

Please consult with your doctor before taking any medication.

Do you have questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2012 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2012)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Merck to Settle Rofecoxib Class-Action Suit

Posted by: Salvatore J. Zambri, founding member and partner


The AP (11/2) reported Merck & Co. Inc. announced Nov. 1 that it has "agreed to settle a class action lawsuit filed on behalf of Missouri consumers" over its prescription painkiller Vioxx (rofecoxib). The FDA "approved Vioxx as a painkiller in May 1999," but the Justice Department "said Merck began marketing it almost immediately" off-label as a rheumatoid arthritis treatment, an indication for which the FDA did not grant approval "until 2002." The proposed agreement would settle "claims that New Jersey-based Merck violated the Missouri Merchandising Practices Act by promoting and selling Vioxx, which Merck pulled from the shelves eight years ago because of evidence that it doubled users' chances of suffering a heart attack or stroke."

According to the Philadelphia Inquirer (11/4, Sell, 346K), the agreement "calls for Merck to pay $39 million to $220 million, depending on how many members of the class are certified." Notably, the proposed settlement offers consumers the choice of two options: Based on a "one-month drug cost of $90," they could obtain a "onetime payment of $180 if they submit a claim with a declaration under oath, but provide no proof." Or, by "declaring under oath and providing proof of payment," consumers could claim "$90 for each month" they purchased Vioxx.

The St. Louis Business Journal (11/2, Weiderman, Subscription Publication) noted that the "case, which has been pending since 2004, was moved to federal court before the 8th US Circuit Court of Appeals moved it to plaintiff-friendly Jackson County." The proposed settlement "must be approved by the Jackson County Circuit Court before it becomes final."
 

Do you have questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2012 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2012)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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A Family Impacted by Compounding Pharmacy's Tainted Medications Seeks to Transfer all Related Cases to A Minnesota Court

By Catherine Bertram, partner

                                                                                                             

A family that filed a contaminated steroid case against New England Compounding Pharmacy asked the the Judicial Panel on Multidistrict Litigation to transfer all federal compounding pharmacy cases to the U.S. District of Minnesota for consolidated pretrial proceedings.

It is reported that attorneys for Brenda and Robert Bansale made this request in a filing earlier this week.  They argue all the compounding pharmacy cases should be combined for motion practice, discovery and damage issues because it  will involve the same evidence and arguments and therefore consolidation is appropriate under the federal code.

We are investigating several cases of tainted medication for families and our firm participates in these class actions, commonly referred to as MDLs (multi-district litigation)  across the country for clients from various states.  If you have questions about this litigation feel free to call me.  202-822-1875.

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10 Tips Patients Can Do to Make Your Hospital Stay Safer

By Catherine Bertram

According to the Centers for Disease Control and the Agency for Healthcare Research and Quality, these ten tips are actions patients and their families can do during hospital stays to try to make their hospital stay safer:

  1. "SPEAK UP"
    Talk to your doctor about any worries you have about your safety and ask them what they are doing to protect you.
  2. "KEEP YOUR HANDS CLEAN"
    If you do not see your healthcare providers wash their hands, please ask them to do so. Also remind your loved ones and visitors. Washing hands can prevent the spread of germs.
  3. Ask if you still need a central line Adobe PDF file [PDF - 191KB] catheter or urinary Adobe PDF file [PDF - 226KB] catheter. Leaving a catheter in place too long increases the chances of getting an infection. Let your doctor or nurse know if the area around the central line becomes sore or red, or if the bandage falls off or looks wet or dirty.
  4. ASK YOUR HEALTH CARE PROVIDER "Will there be a new needle, new syringe, and a new vial for this procedure or injection?" Healthcare providers should never reuse a needle or syringe on more than one patient.
  5. BE CAREFUL WITH MEDICATIONS
    Avoid taking too much medicine by following package directions. Also, to avoid harmful drug interactions, tell your doctor about all the medicines you are taking.
  6. Photo: A healthcare professional preparing to vaccinate a patient.GET SMART WITH ANTIBIOTICS
    Help prevent antibiotic resistance by taking all your antibiotics as prescribed, and not sharing your antibiotics with other people. Remember that antibiotics don't work against viruses like the ones that cause the common cold.
  7. Prepare for surgery Adobe PDF file [PDF - 207KB].
    There are things you can do to reduce your risk of getting a surgical site infection. Talk to your doctor to learn what you should do to prepare for surgery. Let your doctor know about other medical problems you have.
  8. Watch out for C. diff. Adobe PDF file [PDF - 179KB] (aka Clostridium difficile)
    Tell your doctor if you have severe diarrhea, especially if you are also taking an antibiotic.
  9. Know the signs and symptoms of infection.
    Some skin infections, such as MRSA, appear as redness, pain, or drainage at an IV catheter site or surgical incision site. Often these symptoms come with a fever. Tell your doctor if you have these symptoms.
  10. GET YOUR FLU SHOT
    Protect yourself against the flu and other complications by getting vaccinated."

By following these 10 steps, you can help make healthcare safer and help prevent healthcare-associated infections.

Continue Reading Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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Doctor Contends 15 Dead in NECC Medication Contamination was Preventible and Predictable

By Catherine Bertram

                                                                                                            

According to Dr. Michael Carome, of Public Citizen, the fungal meningitis outbreak associated with 15 recent deaths and over 200 serious illnesses was completely preventable.  In an article released by CNN, Dr. Carome contends that,  "(T)he injectable steroid medication produced at the center was never approved by the FDA and was not manufactured in accordance with the FDA's rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed.

As a result, as many as 14,000 patients in 23 states were exposed to potentially contaminated steroids and need to be monitored for signs of fungal meningitis or other infections."

Dr. Carome contends that many entities are responsible for this preventable deadly outbreak, "(W)hile numerous probes and investigations are just getting under way and litigation targeting the producer of the tainted drug and health care providers who used it will certainly take years to resolve, blame for this disaster will undoubtedly rest with many parties. Among them are the compounding pharmacy that produced the contaminated steroid drugs, health care facilities and providers who chose to use a dangerous drug lacking approval by the FDA and evidence that the products were sterile, trade associations and professional groups representing compounding pharmacies that have vigorously resisted federal regulatory oversight of their members, state and federal regulators, and Congress."

On October 4, the Federal Drug Administration (FDA) advised health care providers not to use any New England Compounding Center (NECC) products after a patient was diagnosed with meningitis that was possibly associated with an epidural injection of a steroid medication.   On October 6, NECC announced a recall of all of its products.  Click here for a complete list of the  products subject to this recall.  

The FDA is advising healthcare professionals to follow up with patients who were administered any injectible medication from or produced by NECC after May 12, 2012.  

We are currently investigating cases involving tainted medication such as this. If you or a family member has questions about this please call me for a free consultation.  202-822-1875.

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Sedona Labs Recalls iFlora Children's Supplements

Posted by: Salvatore J. Zambri, founding member and senior partner


Reuters (7/11, Simpson) reports that Atrium Innovations Inc.'s Sedona Labs unit is recalling its iFlora 4-Kids Powder, sold by healthcare professionals, and its iFlora Kids Multi-Probiotic, sold online and in US health food stores, due to possible contamination of a galactooligosaccharide component with salmonella. To date, no salmonella-related incidents have been reported. According to a company statement, the products involved have a distribution date range from March 16 through May 3. The recall affects the following lot numbers: 1074711, 1479611, 1640811 and 1734411.

Please do not consume this potentially contaminated product or provide it to your children.  I advise you to speak to a physician about what alternatives can be provided.

Be safe.

Do you have questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2012 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2012)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Medications , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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Article Suggests Merck Hid Evidence of Vioxx's Harmful Effects

Posted by: Salvatore J. Zambri, founding member and senior partner

Our health is so important.  For some, it's the most important thing in life.  So we need companies to manufacture medicines to maintain health and cure illness.  It is never acceptable, however, for a company to put profits over people.

Pharmalot (7/11, Silverman) reports that almost eight years after Merck removed Vioxx from the market "over links to heart attacks and strokes," a new paper suggests that "the drugmaker hid evidence that Vioxx tripled the risk of cardiovascular death for more than three years before taking the pill off the market in 2004." The authors of the paper say that instead of using an "intent-to-treat analysis" of the control studies, Merck instead relied on an "on-treatment analysis," which is "not the preferred method for ferreting out potentially harmful side effects that may occur in a clinical trial." Jerry Avorn, one of the co-authors, says "Intention-to-treat is the gold standard for evaluating clinical trial results" and "the information was never presented publicly and there was no oversight because none of the three Alzheimer's trials had a Data Safety Monitoring Board that have might persuaded the drug-maker to include this information." Merck has declined to respond specifically to the paper.

Do you have questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2012 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2012)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Women's Health Issues
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FDA Links Cholesterol-Reducing Medications to Other Medical Issues

Posted by: Salvatore J. Zambri, founding member and partner

The Food and Drug Administration (FDA) has now officially linked cholesterol-reducing drugs to cognitive problems, diabetes and muscle pain.  Some important safety labeling changes are now to be included on these drugs, generally known as statins, including Lipitor, Lescol, Mevacor, Altoprev, Livalo, Pravachol, Crestor, and Zocor, as well as several combination products.

According to the director for the Division of Metabolism and Endocrinology Products in the Office of Drug Evaluation II in FDA's Center for Drug Evaluation and Research, “We want health care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol." 

Currently, more than 20 million Americans take some form of statin medication.  While the benefits of these drugs are certainly not disputed, the FDA's ongoing review of medical literature, clinical trial data and reports of adverse events prompted the new cautions. 

Listed below are the specific labeling changes that will be required:

  • "The drug labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. FDA now recommends that liver enzyme tests should be performed before starting statin therapy, and as clinically indicated thereafter. FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect. Patients should notify their health care professional immediately if they have the following symptoms of liver problems: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; yellowing of the skin or the whites of the eyes.
  • Certain cognitive (brain-related) effects have been reported with statin use. Statin labels will now include information about some patients experiencing memory loss and confusion. These reports generally have not been serious and the patients’ symptoms were reversed by stopping the statin. However, patients should still alert their health care professional if these symptoms occur.
  • Increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus. The labels will now warn healthcare professionals and patients of this potential risk.
  • Health care professionals should take note of the new recommendations in the lovastatin label. Some medicines may interact with lovastatin, increasing the risk for muscle injury (myopathy/rhabdomyolysis). For example, certain medicines should never be taken (are contraindicated) with Mevacor (lovastatin) including drugs used to treat HIV (protease inhibitors) and drugs used to treat certain bacterial and fungal infections."

If you or a member of your family are currently taking any of the listed statin medications for the reduction of cholesterol, please consult with your personal physician to determine the potential risks of these drugs. Patients should report any side-effects to their physician. As with any medications, do not attempt to quit taking your prescriptions without consulting a medical professional first.  Doing so often causes unintended medical complications.    

Do you have questions abut this post?

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DECODING MEDICAL RECORDS IN MALPRACTICE CASES


By Catherine Bertram, partner (cbertram@reganfirm.com)


One of the key tasks we initially perform when investigating a case involving malpractice or abuse at a health care facility is a thorough review of the medical records.  At our firm we have two attorney who have both worked in hospital settings so we are quite familiar with medical records.  Catherine(“Katie”) Bertram is a partner at the firm and was previously the Director of Risk Management at Georgetown Hospital.  Jackie Colclough is a nurse-attorney with the firm who has a wealth of experience including work as labor and delivery nurse in a local hospital.

Here are a few basic tips to keep in mind when looking at records:

COMPLETE  CHART

The first task is to review the records and try to make sure you have a complete set.  Often, the records are incomplete.  We check to make sure we have an initial History & Physical, Orders, Physician Progress Notes, Nursing Notes, Laboratory Data, Radiology Reports, Operative Notes, Operative Records/Consent Forms, Pathology, and a Discharge Summary.

Medical Records for pregnant patients are quite different.  We have extensive experience with these types of cases as well.  In childbirth cases you will also have to review the prenatal records from the mother’s office visits before the delivery. It is key to obtain the Fetal Monitor Strips (FMS) or Fetal Heartrate Strips (FHR) which demonstrate the baby’s heart rate relative to the mother’s contractions.  This is often critical in determining if the doctor acted promptly to deliver the child and avoid injury to the child.  You will also need the child’s chart and the operative delivery records.

INITIAL HISTORY & PHYSICAL


Doctors are required to write a detailed note within 24 hours of a patient’s admission. This note is often referred to as the “H&P.”  This is a good place to start in your review since it usually provides a history of the patient’s present condition and symptoms, past medical and surgical history and any significant labs or imaging results.  The note also usually includes a detailed plan for the patient.

ORDERS

Physicians have the responsibility and authority to order medication, labs, imaging and other services that the patient or nursing home residents need.  We check these orders to see what medication or services or consults have been ordered for the patient.  The orders should have a time and date and should be legible.  It should also have some indication that the R.N. acknowledged receipt and review of the order and that it has been carried out.  Some special order sheets may also be included like a patient controlled analgesia record (“PCA”) which is utilized if the patient has a pain pump which allows medication to be self-administered at regular intervals.

PROGRESS NOTES


There is another section of the medical record that includes entries by doctors and nurses, and sometimes others like consultants, physical therapists, pharmacists and medical residents.  This section often looks like a diary or a log.  Most doctors were trained to write their notes in a SOAP format. The first section should detail the “subjective” concerns of the patient.  The “objective” section follows and this  is where the physician performs a physical examination of the patient and records the findings.  The doctor usually goes through each system of the body and records the important findings or any changes.   The third section is “assessment” - which is the where the doctor records his or her thoughts about what is going on with the patient after considering the subjective complaints and the findings on physical examination along with any test results or images.  The final section is the “plan.”   Here, the doctor writes out the plan of action which should address the concerning findings and include a plan consultations by other specialists, medication changes, labs or imaging that is necessary and other follow up.

NURSING NOTES

In some facilities the nurses also write in the progress notes along with the doctors, but in many hospitals the nurses have their own checklists and flow sheets where they record their nursing assessments and interventions from their shift.  There may also be other specialized forms for medication administration (MAR) and for treatment (TAR).    

In long term care facilities (nursing homes) we check the skin sheet to verify if the patient is being turned and the skin integrity is being checked.  *Families are reminded that you must also check your loved one’s skin yourself.  It is key not to let any concerning new “hot spots” progress.  If you see a red spot or a pressure point that is concerning you need to ask questions and get the staff to act on it right away.

If a patient has a fall or any other abnormal event, the facts and circumstances should be clearly documented in the progress notes along with a plan.   In most cases, a fall requires prompt physician assessment.  

LABORATORY REPORTS

The laboratory report can also give you clues about what is happening with the patient and what needs to be addressed.  A high white blood cell count (WBC) can be a sign of an infection.  The lab usually provides the normal range for each value on the report so that you can compare the patient’s value to the normal population.   In most labs the patient’s value will be followed by an “H” or an “L” if the value is abnormally HIGH or LOW.   For lab values that are critical, or an emergency, the lab also usually includes documentation that the result was called into either the physician or the nurse assigned to the patient and the time of that conversation.   It is often the case that you can have the facility print out a laboratory summary report for the patient  that shows the results of the lab data over many days, an entire hospital stay or over the course of many hospital stays. This can be quite helpful in terms of tracking trends.  

RADIOLOGY REPORTS

Many patients also have x-rays, CT scans, MRIs, mammograms, sonograms or other diagnostic imaging performed as a part of their hospital stay. The written reports from these tests should also be included in the hospital chart.  You can often determine the date and time the image was obtained, which physician read the image and also if the image is very concerning, the radiologist often documents that the results were called into the patient’s doctor or nurse directly and the time of such a call.   The written reports may also suggest additional follow up testing or imaging that may be required for the patient given the clinical circumstances.  You also need to be careful because occasionally there are initial preliminary reports of the results and then final reports. If this is the case, you want to carefully compare the two for any significant differences.  

Sometimes imaging is obtained before, during or after surgery while the patient remains in the operating room so it is important to  make sure you obtain all of that imaging and those reports as well.  

OPERATIVE RECORDS

If the patient has had a surgical procedure, as an in-patient or in a same day setting, there are certain required records that will be present.  First, the pre-operative assessments, including anesthesia assessment and the consent form for the procedure. In some circumstances the patient will have had an x-ray, a cardiac clearance or certain blood work performed to make sure it is safe for the surgery.  The anesthesia provider will meet with the patient and obtain a history and assess the patient for anesthesia risks.   Also, the surgeon will talk to the patient about the surgery and obtain a written consent from the patient.

During the surgery, the healthcare team documents many things.  The nursing staff  document on records often called “perioperative” records that include safety checklists performed prior to surgery, including patient placement, verification of the surgery to be performed including which side and which surgery and other safety factors.  The nursing team keeps track of which surgical instruments are used during the surgery and must account for all instruments at the end of the surgery before the patient is closed to make sure no instruments or sponges are left in the patient.   The nurse also documents which nurses are in the operating room and when they leave. At some hospitals the doctor’s entrance and exit are also noted.

The anesthesia providers keep a very detailed log of the patient’s vital signs during surgery, the medication that are given and any response the patient has to medications.

The surgeon does not take notes during the surgery but is required to dictate a detailed operative note following the surgery.

The patient is moved to the post anesthesia care unit (PACU) following most surgeries. This used to be called the recovery room.  In most hospitals the patient is monitored by nurses and the anesthesia team in this area for a certain amount of time until the anesthetic wears off and the patient is either ready to leave based on certain discharge criteria or the patient is transferred to the hospital floor if it is a more involved surgery.   

PATHOLOGY

If a patient has cultures take, a biopsy or a surgery that involves removal of tissue, the patient should have a pathology report.   If the report involves growth results of a culture it can take a few days or several weeks for the final report to be issued.  Oftentimes we have to call and obtain those final reports as they may not make it to the final paper version of the hospital record.

DISCHARGE SUMMARY/AUTOPSY RESULTS

Once a patient leaves the hospital, the attending physician is required to dictate a discharge summary. Most hospitals require the discharge summary be completed and signed within 30 days of the date the patient leaves the hospital. This is also true if a patient dies in the hospital. In that case, you will also want to request any autopsy report or findings.   There are certain circumstances involving patient deaths where the facility is required to conduct an autopsy based on state law.  In other circumstances a physician may ask for an autopsy or a family may request one.  Again, certain testing may be done as part of an autopsy and the results may take a few days or have to be sent to a separate lab so make sure you obtain all of the results that accompany the autopsy.   In a medical case, we often request the entire autopsy file which may include photographs, tissue blocks and/or pathology slides with special staining.  


About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a Top Lawyer for Washingtonian Magazine. Ms. Bertram has over 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes a majority of her practice to the representation of patients and families who have been injured or lost due to medical errors.  Ms. Bertram lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Women's Health Issues
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Stevens-Johnson Syndrome Can Be Deadly if Not Diagnosed Promptly

 

By Catherine Bertram

Stevens-Johnson Syndrome (SJS) is a serious disorder in which your skin and mucous membranes react severely to a medication or infection. Often, Stevens-Johnson syndrome begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed. It  is important that physicians keep this diagnosis in their differential so that it can be diagnosed and treated promptly and properly.

SJS usually begins with fever, sore throat, and fatigue, which can be initially misdiagnosed. Ulcers and other lesions begin to appear in the mucous membranes, almost always in the mouth and lips but also in the genital and anal regions. Those in the mouth are usually extremely painful and reduce the patient's ability to eat or drink.

SJS is most often caused by  of medication. The leading cause appears to be use of antibiotics and sulfa drugs.    Although SJS can be caused by viral infections.

Medication causes

Drugs commonly associated with Stevens-Johnson syndrome include:

  • Anti-gout medications, such as allopurinol
  • Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Sulfonamides and penicillins, which are used to treat infections
  • Anticonvulsants, which are used to treat seizures

Allopurinol currently has warnings about the potential risk of severe skin side effects, and prescribing physicians should be on the lookout for the possible development of SJS. A multinational study published in the Journal of the American Academy of Dermatology in January 2008 indicated that Allopurinol was the most common cause of SJS and TEN in Europe and Israel, constituting about 18% of all cases.   Allopurinol is the generic name for Zyloprim, made by Prometheus Laboratories, Inc. There are also several generic manufacturers. 

RESOURCES

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2012 Washingtonian Best Lawyers. She lives and practices in Washington, D.C.  Ms. Bertram was formerly Director of Risk Management at Georgetown Hospital.  She lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

 

Posted In Medical Malpractice , Medications
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Some NSAIDS May Increase Risk of Birth Defects

Posted by: Salvatore J. Zambri, founding member and partner


Reuters (12/13, Thrasybule) reported a study in the American Journal of Obstetrics and Gynecology suggesting that some over-the-counter painkillers, when taken during early pregnancy, may slightly increase the risk of rare birth defects. For instance, aspirin and naproxen have been linked to babies with either anophthalmia or microphthalmia. Other conditions that saw a rise in risk with painkiller use included amniotic band syndrome, cleft palate, and spina bifida. However, the researchers noted that the majority of NSAIDs were not tied to birth defects, and emphasized that the study does not prove that the painkillers caused the increased risk. An expert not involved with the study suggested avoiding ibuprofen, aspirin or naproxen altogether and using acetaminophen for pain relief instead.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Alert Issued Regarding Avastin

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.

According to a recent alert issued by the U.S. Food and Drug Administration (FDA), health care professionals are being cautioned as a result of recent serious eye infections resulting from Avastin injections.  Several recent incidents of patients losing all remaining vision after Avastin injections prompted the FDA alert.  Although Avastin is approved for treatment of some cancers, it has not been approved, but is frequently-prescribed treatment for wet age-related macular degeneration (AMD). Regulators and manufacturers warn against unapproved use of Avastin, citing infection and loss of vision as examples of the risks associated with doing so. It is believed that the tainted injections were from a pharmacy that repackaged the preservative-free vials into smaller single-use syringes.  The investigation continues.

The FDA alert states: "Health care professionals should be aware that repacking sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections.  Healthcare professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered.  Avastin solution for intravenous infusion is approved for the treatment of various types of cancers.  Some physicians also prescribe Avastin off-label for the treatment of wet age-related macular degeneration, although Avastin is not currently approved for this indication."

Genentech, the division of Roche that manufactures Avastin, maintains that caution against unapproved use was always advised.  According to a Genentech spokesman, "Avastin is not manufactured or approved and to date has not been proven safe for use in the eye."  Many ophthalmologists argue that Avastin is a much cheaper alternative treatment of wet AMD and that the infection and vision-loss incidents are due to carelessness instead.  The safety debate regarding off-label use continues.

Please check with your doctor if you have been prescribed any off-label medications.  Although some off-label prescribing of medication has existed for an extended period of time, the fact that serious infections and even blindness can occur when a cancer medication to treat eye disease reveals that it is a risky practice. 

Do you have questions about this post?

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AMA Predicts Errors With Electronic Medical Records

Posted by: Salvatore J. Zambri, founding member and senior trial attorney     

American Medical News (1/3, Dolan) reports, "Medical liability insurers once said electronic medical records would let physicians earn discounts on their premiums, because the potential benefits of the technology included improving patient safety." But "those discounts haven't materialized" and "the reason, a study says, is that liability insurers are betting that claims will rise during a so-called adjustment period, when practices new to the technology are working out the kinks in their systems." The study found that "in the short term, 'as systems are tested, errors with coding data input and software-interoperability failures may occur."

The movement to electronic medical records is a very positive change. So long as information is inputted correctly and timely, errors should not occur.  If they do occur, patients could be seriously injured.  Sometimes change is difficult for people, but failing to make appropriate entries in electronic medical records should not be excused.  Too much--the health of patients--is at risk.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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Nurses Union States Understaffing At DC Hospital Jeopardizes Patient Care

Posted by: Salvatore J. Zambri, founding member and senior attorney     

The nation's largest nurses union has asked the D.C. Health Department on Monday to investigate nurse under-staffing at Washington Hospital Center.  According to the union, under-staffing is jeopardizing patient care.

The National Nurses United union filed a 19-page report with the D.C. Health Department, which documents 50 separate instances of what it describes as unsafe patient care across all departments in the hospital this year.

As the Washington Post reported, the union filing describes "instances of patients not receiving medication on time, newborn infants not being fed promptly and a patient who was rushed back to the operating room after the patient had stopped breathing and suffered cardiac arrest. The union did not know whether the patient survived."  The full Post article can be read by clicking here.

Under-staffing is a major issue that plagued hospitals across the country.  It is important for hospitals to put safety above profits and staff their facilities appropriately.  If they don't, patients will be seriously injured and killed.  I represent victims of medical malpractice and their families every day.  All too often the harms caused to patients could have been easily avoided if sufficient competent staff was in place to monitor and treat patients. 

I hope the union report spurs positive change.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Public Health , U.S. Food and Drug Administration Warnings
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Candy and Candy-like Tablet Recalled

Posted by: Salvatore J. Zambri, founding member and senior attorney     

With Halloween approaching, it is appropriate to consider which candies children should and should not eat.  CQ HealthBeat (10/26) reports, "The Food and Drug Administration on Monday put out a warning that Hyland's Teething Tablets may pose a risk to children and the company has agreed to a voluntary recall. The agency also passed along recall information about two candy products in this week before Halloween." Notably, the "teething relief product, manufactured by the Standard Homeopathic Company, contains a small amount of belladonna, a substance that can cause serious harm at larger doses."

In addition, "Nestlé USA's Confections & Snacks Division has voluntarily recalled its Raisinets Fun Size Bags, which the company says may contain peanuts even though there is nothing on the label to indicate that" peanuts are included in the snacks.  Also, "Colombina, S.A., which manufacturers Mega Pops brand lollipops, is recalling specific lots of the candy" since "certain packages may contain 'traces of foreign particles.'"

Enjoy Halloween, but please put safety first.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Sulindac Caused Blindness, Scarring

Posted by: Salvatore J. Zambri, founding member and senior attorney     

The AP (9/9, Tuohy) reports, "A federal jury in New Hampshire has awarded $21 million to a woman blinded and scarred by a prescription drug she took for shoulder pain. Karen Bartlett, 51, of Plaistow suffered extreme burns to her skin, mucus membranes and eyes after taking the anti-inflammatory drug Sulindac." After taking the medication for two weeks, Bartlett "was admitted to the hospital" and "was diagnosed as having Stevens-Johnson Syndrome and toxic epidermal necrolysis (SJS/TEN)." The jury concluded "that Philadelphia-based Mutual Pharmaceutical Co. was liable for her injuries and should have known the drug was unreasonably dangerous to consumers."

If you have been taking the drug, please stop ingesting it and speak to your doctor. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Hospitals Failing To Protect Patients From Drug-Induced Bacteria

Posted by: Salvatore J. Zambri, founding member and senior attorney     

It is commonly acknowledged that hospitals should do all they can to protect patients from drug-resistant bacteria.  But far too many hospitals are not, leading to serious injuries, and even death of patients.

The Las Vegas Sun (8/8) editorialized that recently published articles detailing patients' experiences with "lethal drug-resistant bacteria during" their hospital stays "should serve as a wake-up call to those medical facilities that more needs to be done to improve patient safety." Between 2008 and 2009, the "rate of patients who contracted the contagious bacteria known in shorthand as MRSA rose by 34 percent in area hospitals," even though some hospitals have "said they adhere to national standards intended to prevent the spread of bacteria among patients." But, "this is troubling, because it tells us either that the national standards are deficient or that hospitals have not been as careful as they say they have been."

Hospital-induced MRSA infections are all-too-common and can be prevented by creating a sanitary environment by washing hands, wearing clean clothing, and by taking other steps to protect patients. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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AstraZeneca Pays $198Mill To Settle 17,500 Lawsuits

Posted by: Salvatore J. Zambri, founding member and senior attorney     

Bloomberg News (8/9, Feeley, Kelley) reports, "AstraZeneca Plc will pay about $198 million to settle 17,500 lawsuits, or about two-thirds of the total, alleging its antipsychotic drug Seroquel causes diabetes in some users." As I mentioned in an earlier blog, AstraZeneca "previously agreed to pay at least $55 million to resolve more than 5,500 cases alleging the company knew Seroquel could cause diabetes and failed to adequately warn patients, people familiar with those settlements said. These earlier agreements are part of the 17,500 settlements, the company said." The Financial Times (8/9, Jacobs) reports that the settlement stems from court-ordered mediation, a process where the parties meet together, discuss the issues, and work to come to a fair resolution. The Wall Street Journal (8/9, Zekaria) reported that analysts called the settlement figure relatively small, given the alleged defect of the product at issue. The AP (8/9) also covered the story.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Dietary Supplements Have Unsafe Ingredients, Says Consumer Reports

Posted by: Salvatore J. Zambri, founding member and senior attorney     

ABC World News (8/3, story 8, 1:50, Sawyer) reported, "Dietary supplements are a $27 billion a year business in this country, but Consumer Reports has an alert" on "supplements the magazine says can be dangerous to your health." Consumer Reports' Nancy Metcalf said, "With the dozen supplements that we've identified, we think it's all risk and no benefit."

The Los Angeles Times (8/4, Stein) notes that the list of those that are unsafe include "aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe." The report also "argues that the FDA has not fully used its limited authority granted by the Dietary Supplement Health and Education Act to ban supplement ingredients that may be dangerous."

The Washington Post (8/4) adds that supplement manufacturers "routinely, and legally, sell their products without first having to demonstrate that they are safe and effective."

Before taking any dietary supplement, or any medication for that matter, please consult with your doctor.  Be safe.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been acknowledged as one of "The Best Lawyers in America" by Best Lawyers (2011 edition), and has been repeatedly named a "Super Lawyer" by Super Lawyer magazine (March/April 2010)-- national publications that honor the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.


 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Senate Bill Introduced To Increase FDA Safety Oversight

Posted by: Salvatore J. Zambri, founding partner     

The Hill 's (8/4, Lillis) "Healthwatch" blog reports, "citing a recent spike in pharmaceutical recalls, Sen. Michael Bennet on Tuesday introduced legislation to bolster consumer protections governing the nation's drug supply." The "Colorado Democrat says his proposal," which would "greatly expand the FDA enforcement powers while holding drug companies more accountable for the products they sell," is "vital in a globalized age when more and more drug ingredients originate overseas."

I applaud this introduction of this important legislation.  The lack of oversight has allowed drug and other product manufacturers to push products into the market for profit without proper safety considerations.  Let's hope Congress will do the right thing and make this bill law.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been acknowledged as one of "The Best Lawyers in America" by Best Lawyers (2011 edition), and has been repeatedly named a "Super Lawyer" by Super Lawyer magazine (March/April 2010)-- national publications that honor the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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AstraZeneca To Pay $55Mill To Resolve Seroquel Lawsuits

Posted by: Salvatore J. Zambri, founding partner     

As Bloomberg News (8/5, Feeley, Milford) reports, "AstraZeneca Plc, the UK's second-biggest drugmaker, agreed to pay about $55 million to settle around 5,500 lawsuits related to side effects of the antipsychotic Seroquel [quetiapine]." AstraZeneca's "5,500 settlements include 4,000 that AstraZeneca acknowledged in a July 29 regulatory filing." The company "is moving to resolve Seroquel claims as it faces expiring patents on the drug and the ulcer treatment Nexium [esomeprazole] in the next four years."

We hope that these settlements effect how drug companies decide to do business.  They must put patient safety above profits.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Are Drug Studies Reliable or Tainted?

Posted by: Salvatore J. Zambri, founding partner     

A recent analysis of the outcomes of pre-market drug-trials raised some great concerns.  The Los Angeles Times (8/2, Roan) "Booster Shots" blog reported, "According to an analysis of drug trials published Monday, studies were much more likely to be positive -- that is, showing the drug worked -- in trials that were funded by the pharmaceutical industry." A review of 546 drug trials "found that industry-funded trials reported positive outcomes 85% of the time, compared with 50% of the time for government-funded trials and 72% of the time for trials funded by nonprofits or non-federal organizations." But, among "the nonprofit or non-federal studies, those that received industry contributions were more likely to be positive (85%), compared with those that did not have any industry support (61%)."

I'm concerned that drug companies are not sufficiently testing their drugs before pushing them on the market for a profit.  The vast difference in the trial outcomes conducted by teh drug companies and the federal government suggests that the pharmaceutical industry needs to do more to protect consumers.  Safety must be put above profits.

And the non-profit and non-federal organizations involved in performing drug studies need to be careful not to take a blind eye to negative effects of drugs just because drug companies make financial contributions to the entities. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Exposure To Evamist Dangerous For Children And Pets

Posted by: Salvatore J. Zambri, founding partner     

The FDA has warned that "inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets. Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. The drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm. The FDA currently is reviewing reports of adverse events in children and pets who were inadvertently exposed to this topical estrogen product."

According to the announcement, the FDA has received several post-marketing cases of unintended exposure to Evamist in children ages 3 years to 5 years during the period July 2007 through June 2010. "Adverse events reported in unintentionally exposed children include premature puberty, nipple swelling and breast development in females, and breast enlargement in males. Since 2007, two reports of secondary exposure to Evamist in dogs also have been received by FDA’s Center for Veterinary Medicine. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling."

Please keep your children and pets away from the drug. If you have experienced any adverse side effects from the use of Evamist, please contact the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Glaxo to Pay $1 Billion to Children with Birth Defects from Mothers who took Paxil

                                                                       

By Catherine Bertram

Bloomberg News reported that GlaxoSmithKline P.L.C.  has agreed to pay $1 billion to injured consumers to resolve more than 800 cases involving the antidepressant Paxil.  The medication has been in use in the U.S. since 1992.   Paxil generated about $793 million in sales in 2009 alone which was about 1.8 percent of Glaxo’s total revenue.  Glaxo reported U.S. sales exceeding $11 billion since 1997. 

Not all of the pending birth defect cases are resolved, according to the report, about  100 Paxil claims are not included in this settlement.   Glaxo confirmed that it settled some Paxil cases citing the reason as avoiding costs and uncertainties of litigation, but would not comment on the terms of the settlement.  A Philadelphia jury awarded a 3 year old boy $2.5 million finding that Paxil caused severe heart defects in a trial in October of last year.

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital.  Ms. Bertram is a member of the bar for the U.S. Supreme Court.  She is a partner with the firm and lectures regularly to lawyers and health care providers, nationally and locally, regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a surgical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

Posted In Medications , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Drinking Miracle Mineral Solution (MMS) Can Cause Serious Harm

Posted by: Salvatore J. Zambri, founding partner     

The U.S. Food and Drug Administration is warning consumers not to take Miracle Mineral Solution, an oral liquid also known as “Miracle Mineral Supplement” or “MMS.”  The product, when used as directed, produces an industrial bleach that can cause serious harm to health.

According to the FDA's website, "The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.

Consumers who have MMS should stop using it immediately and throw it away."

MMS claims to treat many illnesses and disease, including HIV,  the H1N1 flu virus, common colds, hepatitis, acne, cancer, and other conditions. However, the FDA is not aware of any studies that prove that MMS effectivey treats any of these conditions.

If you have experienced any negative side effects from MMS, please contact your doctor or visit an emergency room as soon as possible.  Do not use the product any longer, and keep it away from others, especially children. Adverse events can be reported to the FDA’s MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Shoulder Pain Pumps Destroy Shoulder Joints

Posted by Catherine Bertram   

   
Recognized medical studies show that pain pumps that inject pain medicine right into shoulder joints after surgical procedures are a very likely cause of severe cartilage damage.  The FDA, in November 2009 and again in February 2010 issued a warning about this device.  At the heart of the shoulder pain pump litigation is the fact that continuous infusion pumps were not approved by the FDA for this use.   The pain medication essentially eats away the cartilage in the shoulder joint which is critical to allowing the shoulder to move smoothly without pain and grinding.   The research shows that this permanent injury occurs when an intra-articular pain pump catheter is inserted into the shoulder joint by the surgeon in an effort to reduce the patient's pain, usually after a shoulder surgery.  The catheter then pumps pain medication right into that key joint for several days.    The medical studies show the damage can be inflicted in 2-3 days.  This is a permanent injury and is extremely painful and limiting for the patient. Symptoms include increased pain and stiffness, a clicking or popping or grinding in the shoulder and less motion and loss of strength.  The condition is known as Postarthroscopic Glenohumeral Chrondrolysis (PAGCL).

If you or a family member has this condition and a pain pump was used you may want to consider having the records reviewed and the matter investigated. 
                                                                                       

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Whistleblower Suits Likely To Increase Given Healthcare Reform

Posted by: Salvatore J. Zambri, founding partner     

Bloomberg News (7/28, Bass) reported, "Federal fraud cases begun by private citizens against drugmakers, insurers and hospitals will probably surge . . .driven by incentives in the new health law." The "health overhaul makes it easier for citizens to be rewarded for uncovering swindles" and reduces the time "before medical providers can be accused of withholding overpayments from Medicare and Medicaid."

Whistleblower actions empower private citizens to come forward and stop companies from breaking the law.  These courageous citizens are protected by the law and may be entitled to compensation for their efforts that, in end, make our communities safer.

My firm accepts whistleblower cases, and if you have any questions about these cases, please do not hesitate to contact me.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , Women's Health Issues
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Families of Nearly 3,500 Deceased Vioxx Users Receive Payments From Merck

Posted by: Salvatore J. Zambri, founding partner     

Bloomberg News (7/28, Voreacos, Johnson) reports "Merck & Co. paid claims to the families of 3,468 users of its Vioxx painkiller who died of heart attacks or strokes," a court-appointed administrator told a judge Tuesday. "A $4.85 billion settlement fund made payments to the families of 2,878 Vioxx users who died of heart attacks and 590 who died of strokes," according to the report. Merck "pulled Vioxx from the market in 2004 after a study showed it doubled the risk of heart attacks and strokes."

Well, it is nice to see families of victims obtain justice, but it is nevertheless a shame that so many lives had to have been lost before the dangerous drug was pulled from the market.  Hopefully, the tragic results regarding Vioxx will compel drug companies to focus on safety above profits in the future.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Zinc nasal gels could cause some patients to lose sense of smell.

Posted by: Salvatore J. Zambri, founding partner     

The New York Times (7/26, D6, Rabin) reports "a new analysis has concluded that controversial zinc nasal gel products can cause some patients to lose their sense of smell," according to a study in the Archives of Otolaryngology - Head & Neck Surgery. There is no danger "from taking zinc gluconate orally" but that "when sniffed through the nose it can burn olfactory tissue." The FDA "last year warned consumers to stop using Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Nasal Swabs," popular "homeopathic remedies that contain zinc." Arizona-based Matrixx Initiatives, which markets them, "has denied the zinc gels cause anosmia and called the conclusions 'scientifically unfounded and misleading.'"

It seems to me that we all should heed the FDA warning.  As with any drug, do not take the zinc gels without first speaking with your doctor.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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DUI for Prescription Drugs

A recent report from the New York Times reveals that some patients are being arrested for driving under the influence (DUI) after taking medications that have been prescribed to them. What has been surprising to most is that a DUI can be issued to a driver who is impaired from any substance while operating any vehicle such as a car, boat, or bicycle.

Statistics relating to impaired driving don't breakout the causes, so it is not known how many drivers, arrested for DUI, are actually impaired from prescription drugs or from alcohol. To avoid this potential problem, it is recommended that patients talk to their doctor, follow the directions on their prescription, and inquire about any possible interaction between medications.

 

Posted In Medications
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FDA to Conduct Formal Safety Review of ARBs

Posted by: Salvatore J. Zambri, founding partner     


The New Jersey Star-Ledger (7/16, Todd) reports that spurred by a "recently published study," the "Food and Drug Administration is investigating whether some of the most commonly used blood pressure medicines may increase the risks of cancer."

According to the report, the "agency said it began a review of a class of drugs known as angiotensin receptor blockers after a recently published study suggested the medicines could be associated with a slight increased risk of cancer, according to a notice posted on the FDA’s website."

The group of drugs under concern include some of the top-selling blood pressure drugs, such as  Cozaar, which is manufactured by Merck, and Avapro, a Bristol-Myers Squibb drug.

Before taking any medication, please speak with your doctor, who is obligated to inform you of all risks and benefits of the drug prescribes so you can make the best--most informed--decision about your health.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Panel Votes To Keep Avandia On Market With More Restrictions

Posted by: Salvatore J. Zambri, founding partner     

The FDA has not yet removed Avandia from the market, although it is still considering its options.
The New York Times (7/15, A1, Harris) reports on its front page that the 33 panelists "took six votes on a variety of issues" and when asked what the FDA should do, "12 voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug's label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label's present heart warnings." Dr. Janet Woodcock, director of the FDA's drug center, "said that the agency took the panel's advice seriously and that it would consider its regulatory options."

The Washington Post (7/15, Stein) reports that a "majority" of the panel urged to keep the drug "available, perhaps with tough new restrictions and warnings." The votes "came after the panel concluded that there was sufficient evidence to be concerned that Avandia increases the risk of heart attacks and strokes but insufficient evidence that the drug increases the risk of death." The panel "also voted to recommend that the FDA allow a large new international study by GlaxoSmithKline, the maker of Avandia, to proceed." Still, the final, "mixed vote illustrated the intensity of the debate over the drug. Critics...argued that the drug was clearly dangerous and unnecessary. Others expressed concern about pulling a drug that might be useful to some diabetics, who frequently need to try more than one medication."

USA Today (7/15, Rubin) also reports that the panel "voted 18-6 that the data raise significant concerns that Avandia carries a higher risk of those heart problems than does Actos [pioglitazone], the only other drug in its class. Nine were undecided."

The Hill 's (7/15, Lillis) Healthwatch blog reports, "Sen. Tom Harkin (D-Iowa), chairman of the Senate Health Committee, is calling on the Food and Drug Administration (FDA) to reach a quick verdict on the fate of Avandia." The Hill also notes that the panel's "mixed verdict puts the ultimate decision in the hands of Margaret Hamburg, who heads the FDA."

Given the serious risks of dangerous drugs, we urge you to speak with your doctor before ingesting any drug.  Be safe.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Elan agrees to settle Zonegran probe for $203.5 Million

Posted by: Salvatore J. Zambri, founding partner     

The AP (7/16) reports, "Irish drug maker Elan Corp. PLC said Thursday it agreed to pay $203.5 million to settle investigations into sales and marketing practices related to the epilepsy drug Zonegran [zonisamide]." Elan's US division Elan Pharmaceuticals Inc. "expects to plead guilty to a misdemeanor violation of the Food, Drug and Cosmetic Act," the company said. If the settlement is approved, Elan "said it would resolve all federal and state Medicaid claims into the marketing of Zonegran."

Patients with epilepsy need drugs, but they deserve to know that the marketing and sales practices of the drug-makers are fair, accurate, and properly informative.  Safety and health must be put above profits.  It's a matter of life and death.

 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Should Avandia Stay On The Market?

Posted by: Salvatore J. Zambri, founding partner     

There is a great debate over whether Avandia should stay on the market in light of its risks.  The Wall Street Journal urges FDA to keep Avandia on the market. In an editorial, the Wall Street Journal (7/16) says that people who want GlaxoSmithKline's Avandia (rosiglitazone) to be removed from the market, as well those who maintain that it should still be available to patients with type 2 diabetes, were frustrated this week by an FDA advisory panel that voted to keep the drug on the market with tougher restrictions. The Journal notes that the FDA is under immense pressure to remove Avandia from the market, especially from FDA Commissioner Margaret Hamburg's deputy chief Dr. Joshua Sharfstein, but the paper says that, hopefully, Hamburg will keep Avandia available, even just as a backup treatment.

Not everyone shares that view.  One columnist says the collusion between the government and  drugmakers is allowing Avandia to remain on the market.  Jon Carroll wrote in his San Francisco Chronicle (7/14, F8) column that if patients were offered two drugs, one which "has been linked to an increased risk of heart attacks and the other [which] hasn't," they would prefer the latter. He added, "My conclusion is that patients were not given that information by their doctors. My conclusion is that the clammy hand of GSK has urged the doctors to ignore the, ahem, 'flawed and preliminary data' and keep on pushing the Avandia." Carroll argued that despite data suggesting that Avandia may be unsafe, the government is allowing it to remain on the market. He called this "lunacy," and said that there was a "happy collusion between the government, drug companies and (some) private doctors."

Before taking Avandia or any drug, speak to your doctor.  Your doctor is obligated to explain all risks and benefits of drugs he or she prescribes.  If safer drugs are available, they should be considered.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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New Law Would Empower FDA To Recall Dangerous Drugs

Posted by: Salvatore J. Zambri, founding partner     

Did you know that the FDA has limited power to recall dangerous drugs?  That's not good, and something needs to be done about it.  Perhaps the time is now.

"[S]purred by questions about Johnson & Johnson's voluntary recall of millions of bottles of children's medicine this spring, a House committee chairman has introduced legislation to give federal regulators the authority to recall drugs that pose health threats," CQ Today (7/16, Ethridge) reports.  House Oversight and Government Reform Chairman Edolphus Towns (D-NY) said Thursday that the bill would give the FDA "the authority to order a recall when a drug has been adulterated or misbranded, or when exposure to the drug would cause serious health consequences or death to humans and animals."

Currently, the FDA can only ask companies to recall their drugs, although it "has the authority to mandate recalls of some products it regulates." This legislation is desperately needed, and has the potential to save lives and keep people from being harmed by defective and dangerous drugs.

Please call your legislators and support this bill.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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New Evidence that Avandia Manufacturer Hid Test Results

Posted by: Salvatore J. Zambri, founding partner     

Last week, I posted a blog entry about the controversy surrounding Avandia after recent studies revealed the cardiovascular dangers surrounding it and advised readers to contact their doctor immediately regarding possible alternative medication. 

A new article in the New York Times provides more insight into the known problems with Avandia at SmithKline Beecham.  According to studies conducted by the manufacturer in 1999, signs were evident that Avandia was riskier to the heart; however, the company chose not to publish those studies, instead spending 11 years trying to cover them up.  "The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law."  Following the May, 2007 lawsuit that forced SmithKline (successor to SmithKline Beecham) to post some documents on its website, it has become more obvious that the company aggressively attempted to prevent the public from learning of the cardiovascular safety risks to protect their sales numbers.

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA WARNING: QUE SHE WEIGHT LOSS SUPPLEMENT CONTAINS DRUGS

 By Catherine Bertram

 

The FDA warned consumers and healthcare professionals today that "Que She, marketed as an herbal weight loss supplement, contains unlisted and active pharmaceutical ingredients that could harm consumers, especially those with cardiovascular conditions. These active pharmaceutical ingredients also may interact with other medications and result in a serious adverse event.

Que She, advertised as “Slimming Factor Capsule” and as “an all-natural blend of Chinese herbs,” has been widely distributed on Internet sites such as the Bouncing Bear Botanicals website, and at retail outlets, including Sacred Journey in Lawrence, Kansas."

FDA analysis of Que She found that it contains:
   
o    fenfluramine – a stimulant drug withdrawn from the U.S. market in 1997 after studies demonstrated that it caused serious heart valve damage
o    propranolol – a prescription beta blocker drug that can pose a risk to people with bronchial asthma and certain heart conditions
o    sibutramine – a controlled substance and prescription weight loss drug, sibutramine was the subject of a recent study whose preliminary findings showed an association between sibutramine use and increased risk of heart attack and stroke in patients who have a history of heart disease
o    ephedrine – a stimulant drug that is legally marketed over-the-counter for temporary relief of asthma but can pose a risk to people with certain cardiovascular conditions.

The FDA recommends that people who have purchased Que She should stop taking the product immediately and consult a health care professional.

 

Continue Reading Posted In Medications , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Should Patients Seek Alternatives To Avandia?

Posted by: Salvatore J. Zambri, founding partner     


The New York Times (7/5) editorialized that the recent controversy over the diabetes drug Avandia -- with "two major studies" saying it "raises the risk of cardiovascular ailments" and the third yet-to-be-published study that "seemed to exonerate" the drug -- should probably lead patients to ask their doctors about alternatives. The paper said that as expert advisers to the Food and Drug Administration work to deliver a more definitive judgment, it would throw its lot with the views of safety specialists, who focus solely on risks emerging after the drug is in use, rather than the opinions of those "who approved the drug as safe and effective in the first place.

If you or a loved one uses Avandia, you are encouraged to speak to your doctor immediately.  Your doctor should inform you of all risks associated with any drug he or she prescribes, so that you can make fully informed health decisions.

Do you have any questions about this post?  

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Claims Cornerstone Withheld Risks of Asthma Drug

 Posted by: Salvatore J. Zambri, founding partner     


The AP (7/7) reports, "The Food and Drug Administration said Tuesday it sent a warning letter to Cornerstone Therapeutics Inc. alleging that Cornerstone's promotional materials withheld information about the risks of its asthma drug Zyflo CR [zileuton]." The FDA "said the materials violated the Food, Drug, and Cosmetic Act" by using "outdated labeling" and suggesting "Zyflo CR is more effective than competing drugs like Singulair [montelukast]." In addition, the agency "said a Cornerstone visual aid did not include warnings about the most serious side effects or the most common ones."

While I appreciate the desire to sell products, it is critically important for drug companies to inform customers and the public generally of the risks associated with the use of their drugs. It is often a matter of life and death.  Safety and people should always trump profits.

 

Do you have any questions about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

 


 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

By Catherine Bertram

Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are serious disorders in which your skin and mucous membranes react severely to a medication or infection. Often, Stevens-Johnson syndrome begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed.

SJS usually begins with fever, sore throat, and fatigue, which can be initially misdiagnosed. Ulcers and other lesions begin to appear in the mucous membranes, almost always in the mouth and lips but also in the genital and anal regions. Those in the mouth are usually extremely painful and reduce the patient's ability to eat or drink.

SJS is most often caused by  of medication. The leading cause appears to be use of antibiotics and sulfa drugs.    Although SJS can be caused by viral infections.

Medication causes

Drugs commonly associated with Stevens-Johnson syndrome include:

  • Anti-gout medications, such as allopurinol
  • Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Sulfonamides and penicillins, which are used to treat infections
  • Anticonvulsants, which are used to treat seizures
Continue Reading Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Unaware of Companies' Foreign Drug Trials

Posted by: Salvatore J. Zambri, founding partner

In a story appearing on over 100 news websites, the AP (6/23, Perrone) reports that the FDA "is reviewing only a fraction of foreign drug trials, as companies increasingly move drug testing overseas to reduce costs." According to a report issued Tuesday by the Inspector General for HHS, the FDA "inspected about one percent of foreign drug testing sites in fiscal year 2008," and is "often unaware" of "early-stage trials conducted in developing countries" in "South and Central America." The report also makes several recommendations to help the FDA oversee foreign studies, including developing "better coordination with foreign governments to monitor drug trials abroad," and requiring drugmakers "to submit trial data in a standardized electronic format, to help the FDA identify sites for inspection."

If companies are going to rely on foreign drug trials, they must alert the FDA about such trials and afford the agency the time and access to inspect and evaluate the trials.  The FDA, for their part, must diligently inspect the foreign sites.  Of course, drug companies are ultimately responsible for their drugs, not the FDA, although the FDA does have its obligations.  No drug should enter the marketplace unless it is safe and sufficiently tested.  Safety must always trump profits. 

 

 

Do you have any questions or comments about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, serious automobile accident claims, and other personal injury actions.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Pfizer Withdraws Mylotarg From US Market

Posted by: Salvatore J. Zambri, founding partner

The Wall Street Journal (6/22, Dooren) reports that the FDA has announced that Pfizer Inc. has withdrawn Mylotarg (gemtuzumab ozogamicin) from the US market following research indicating that the medication was not effective and was linked to safety issues. The AP (6/22, Perrone) reports that the drug "carries a warning label about a sometimes fatal liver condition called veno-occlusive disease. The FDA said the rate of reports of the disease associated with the drug increased during its time on the market."

If you are taking this drug, please contact your doctor immediately.  Your physician is obligated to inform you of all known risks and benefits of a drug so you can make the best--most informed--health decisions.

Do you have any questions or comments about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, serious automobile accident claims, and other personal injury actions.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Warning: Counterfeit Tamiflu

The Food and Drug Administration (FDA) has released a report about the sale of Generic Tamiflu over the internet. Tamiflu, a drug used for the treatment of patients with illness due to influenza that contains the active ingredient oseltamivir, has been sold through websites claiming to be online drug stores.  The Generic Tamiflu that is being sold through these websites has cloxacillin as its active ingredient, which belongs to the same class of antibiotics as penicillin.  Patients who are allergic to penicillin will possibly see a similar life-threatening anaphylactic reaction to cloxacillin, including the following symptoms:

  • Labored/Difficult breathing
  • Chest tightness
  • Swelling of the throat/tongue
  • Dizziness
  • Hives
  • Loss of consciousness
  • Rapid or weak pulse

The FDA advises patients that possess or come across the counterfeit Tamiflu to discontinue use and contact the FDA's Office of Criminal Investigations.

Continue Reading Posted In Medical Malpractice , Medications , Product Liability , U.S. Food and Drug Administration Warnings
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FDA Tylenol & Benadryl Recall Update

Yesterday, Johnson & Johnson announced the recall of five additional lots of over-the-counter medications that were inadvertently omitted from a January 15, 2010 recall of similar products. The latest recall involves four lots of BENADRYL® Allergy ULTRATAB™ 100 COUNT pills and one lot of TYLENOL® EXTRA STRENGTH RAPID RELEASE GELCAP 50CT, both manufactured by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson.

If you have purchased any of the products involved, you are advised to stop using them immediately.

Find detailed information about the recall and how to obtain a refund HERE, or for information on all McNeil recalls, see their product recall homepage.

For related information on recalls and medication disposal, please feel free to read the DC Area Medical Malpractice Law Blog's posting on recent McNeil recalls.

Posted In Medications , Patient Safety , U.S. Food and Drug Administration Warnings
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FDA Warns Pfizer on failure to report drug complaints.

Posted by: Salvatore J. Zambri, founding partner

According to an AP report, the Food and Drug Administration issued a warning letter to "Pfizer Inc. for failing to promptly report complaints with its drugs that may have involved serious injury." In the 12-page letter, dated May 26, the FDA "cites a number of product complaints which were not reported to government regulators within the required 15 days." The letter also "demands that Pfizer submit a plan for correcting the problems within 15 business days."

The Wall Street Journal also reports that this FDA warning letter to Pfizer is the second one this year. Two months ago, the company received an agency warning regarding pediatric clinical trials of the antipsychotic Geodon (ziprasidone). The Journal points out that the latest warning results from a 2009 inspection of Pfizer's headquarters, an inspection which the agency said was to ascertain Pfizer's compliance with reporting rules regarding adverse events after drugs are allowed on the market. Specifically, the letter said the agency discovered that some adverse-event reports were not actually reported until after its inspection was conducted. The drugs involved were Lyrica (pregabalin) and Lipitor (atorvastatin).

Per a Reuters report, the Food and Drug Administration has asked to meet with Pfizer to discuss the violations. For its part, Pfizer promised to work with the FDA to address and remedy the problems.

Obviously, we need medication to maintain and promote health.  However, it is critically important for pharmaceutical companies to accurately and timely report the dangers of the drugs they make and sell, so that doctors and patients can properly evaluate the risks and benefits of the drugs.  Safety must always trump profits.

 

Do you have any questions or comments about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, serious automobile accident claims, and other personal injury actions.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Recalls and Medicine Safety

Over the weekend, four PediaCare brands of children's medicines became the most recent additions to a string of recalls stemming from Johnson & Johnson's McNeil plant in Fort Washington, Pennsylvania. Four PediaCare products joined the long list of child and infant liquid formulations of Tylenol, Motrin, Zyrtec, and Benadryl that had previously been recalled.

According to WebMD, the newly recalled PediaCare brands are as follows:
    * PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9
    * PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7
    * PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8
    * PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4

To see the complete list of Tylenol, Motrin, Zyrtec, and Benadryl products involved in the original recall, or to request a refund online, see McNeil’s recall page. The Food and Drug Administration’s (FDA’s) explanation of the recall can be found here, or in a helpful PDF brochure.

Continue Reading Posted In Medications , Pediatrics , U.S. Food and Drug Administration Warnings
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Proton Pump Inhibitors Can Cause Bone Fractures

Posted by: Salvatore J. Zambri, founding partner

The FDA has warned that Proton Pump Inhibitors can cause bones to fracture when used for more than one year or prescribed in higher doses.  According to ABC World News, as reported by CBS Evening News , "high doses or long-term use of what are called proton pump inhibitors can lead to an increased risk of bone fractures." This is especially true in patients "over the age of 50," and for "people on the high dose," says NBC Nightly News.

Before taking any medication, please speak with your doctor to be sure the benefits of the drug outweigh the risks.  Your doctor is obligated to explain all risks and benefits to you so that you can make the most informed decision possible about your health.  If not monitored appropriately, certain medications can cause serious, even life-threatening, consequences.

 

Do you have any questions or comments about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, serious automobile accident claims, and other personal injury actions.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Battery, Software Errors Lead to Recall of Infusion Pumps

Posted by: Salvatore J. Zambri, founding partner        

Recently, Baxter International issued a voluntary recall of their Colleague infusion pumps, which are used in hospitals to deliver various forms of medications and nutrients to patients.  According to the New York Times,  the FDA said that the pumps have contributed to more than 56,000 complaints of injuries and deaths between 2005 and 2009. The injuries and fatalies are attributed to battery failures and software errors.

There are approximately 200,000 infusion pumps in use in American hospitals. Baxter officials have said they will exchange the Colleague pumps with their Sigma Spectrum infusion pumps.  If you are using an infusion pump, please contact your physician immediately and  you are encouraged to swap the potentially defective pump with a reliable one.

Be safe.

Do you have any questions about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Product Liability , Public Health , Women's Health Issues
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Nurse Interruptions, Distractions Lead To Medical Errors

Posted by: Salvatore J. Zambri, founding partner 

As reported recently by a HealthDay report, Patient Safety and Quality Healthcare article and Archives of Internal Medicine abstract, distractions and interruptions for nurses during medication preparation and administration lead to a higher rate of procedural failures and clinical errors.  Although patient safety experts have warned about these dangers for a number of years, this is the first research to actually confirm that relationship. Common distractions include staff inquiries, stopping to search for missing drugs or supplies, and responding to phone calls or pages.  According to Patient Safety and Quality Healthcare Reports, nurses view these types of interruptions as part of the daily work and don't seek to control them--a scary thing.

Following are significant observations from the study:

  • "Errors were classified as either "procedural failures," such as failing to read the medication label, or "clinical errors," such as giving the wrong drug or wrong dose.
  • Only one in five drug administrations (19.8 percent) was completely error-free, the study found.
  • Interruptions occurred during more than half (53.1 percent) of all administrations, and each interruption was associated with a 12.1 percent increase, on average, in procedural failures and a 12.7 percent increase in clinical errors.
  • Most errors (79.3 percent) were minor, having little or no impact on patients, according to the study. However, 115 errors (2.7 percent) were considered major errors, and all of them were clinical errors.
  • Failing to check a patient's identification against his or her medication chart and administering medication at the wrong time were the most common procedural and clinical glitches, respectively, the study reported."

"Nurses reported that study observations were made during a comparatively non-chaotic days when they had not been working extremely busy shifts. Investigators felt that if the nurses had been observed during a more intensely busy shift, more errors would have been seen."  The value of this new study "lends important evidence to identifying the contributing factors and circumstances that can lead to a medication error," said Carol Keohane, Program Director for the Center of Excellence for Patient Safety Research and Practice at Brigham and Women's Hospital in Boston.

Several hospitals have recommended possible means to avoid excessive interruptions, such as "no interruption zones," "do not disturb vests," "medication pass time-out," or "protected hour" for medication administration.  This issue must be taken seriously by hospitals and other medical facilities otherwise serious medical errors will continue to occur.  According to the reputed Institutes of Medicine, approximately 98,000 Americans are killed every year as a result of medical errors.  Patient safety needs to be a priority.

Do you have any questions about this post?  

 

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Nursing Home Negligence , Patient Safety , Pediatrics , Public Health , U.S. Food and Drug Administration Warnings
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Sedative Vials Too Large, Doctor Testifies

Posted by: Salvatore J. Zambri, founding partner               

                                                                                                        

The Las Vegas Review-Journal reports that an anesthesiologist testified that "the 50-milliliter vials of anesthetic linked to a hepatitis C outbreak would have been enough to knock out a 600 pound gorilla during a colonoscopy," in the trial of Henry Chanin who was infected with hepatitis C during a 2006 colonoscopy in a Southern Nevada clinic. Chanin is suing Teva Parenteral Medicine and Baxter Healthcare Services on product liability issues claiming that "the companies made and sold vials of propofol that were much larger than needed for colonoscopies, which tempted medical workers to reuse vials among patients instead of throwing away unused anesthetic."

Hospitals and doctors should never reuse vials.  Doing so clearly and seriously threatens the health of patients.  We hope a lesson is learned here, although for many Americans it is too late, as they have suffered terrible health problems from the apparent misuse of the vials.

 

Do you have any questions or comments about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Warns Pfizer About Insufficient Oversight During Clinical Trial Involving Children

Posted by: Salvatore J. Zambri, founding partner               

                                                                                                        

The AP reports that in a warning letter dated April 9 and posted online April 20, the Food and Drug Administration said that Pfizer "has failed to correct problems with its testing procedures that resulted in overdoses of several children during a company trial" of "an experimental medication, which the agency did not name." However, a company spokeswoman said that medicine "is Geodon [ziprasidone], which the company was studying for children with bipolar disorder."

Bloomberg News reports that the letter posted to the agency's website outlined "'significant violations' discovered during an inspection of a Pfizer clinical trial site from May 4 to June 3." In 2005, the FDA warned Pfizer about the "lack of study monitoring that led to widespread overdoses," and "follow-up inspections in 2006 and 2007 also found dosing errors, the FDA said." The FDA has ordered Pfizer "to respond within 15 days with a plan to ensure that its studies comply with federal regulations."

The Wall Street Journal/Dow Jones Newswire reports that Pfizer is currently seeking agency approval of Geodon to treat bipolar disorder in patients ranging in age from 10 to 17 years old, which the FDA declined to do six months ago, citing a need for more information. The medication is currently approved for the treatment of schizophrenia and bipolar disorder in adult patients, however. Meanwhile, the Journal quotes Pfizer as stating that it "recognizes the seriousness of the issues cited by the FDA and is committed to fully addressing FDA's concerns."

Reuters reports that even though 13 children suffered from overdosing during the clinical trial, none was injured or subjected to ongoing side effects, and only two youngsters had to be taken out of the clinical trial. Since the overdosing incidents, seven found by the FDA and six documented in the pharmaceutical company's own internal memoranda, Pfizer said it "has instituted several new measures designed to improve monitoring and execution of clinical trials, including our oversight of clinical investigators."

Medications for children are necessary.  But so is safety.  In an effort to create effectove drugs, companies should never risk the health of those utilized in a clinical trial.  Safety over profit must be the goal.

Do you have any questions about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Actor Quaid Is Advocate For Hospital Safety

Posted by: Salvatore J. Zambri, founding partner               

                                                                                                        

USA Today reports that according to actor Dennis Quaid, "When a crash happens, it's so public. ... No one is going to fly on their airplanes unless they have that trust." Yet, "when a mistake occurs in a hospital, the public might never hear about it. Although an estimated 100,000 Americans die each year because of medical errors, their deaths are scattered over thousands of hospitals, 'where people die anyway,' Quaid said. 'It doesn't get the same type of attention.'"

USA Today says that since "Quaid's 10-day-old twins were twice given an adult dose of the blood thinner heparin," he "has become the self-described 'frontman' for a campaign to improve patient care with the implementation of 'safe practices' as simple as hand-washing and the use of technologies such as bar codes to match medications to patients."

It's wonderful that Mr. Quiad is speaking out for hospital safety and patients.  The best way to keep costs down is to improve health care.  By avoiding medical errors, people will be healthier.  It's sound business, and more especially, it's the ethical thing to do.

Do you have any questions about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Nursing Home Negligence , Patient Safety , Public Health , Women's Health Issues
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Antidepressants May Similarly Affect Suicide Risk In Children, Adolescents

Posted by: Salvatore J. Zambri, founding partner               

                                                                                                        

HealthDay reported that, according to a study published in the journal Pediatrics, "there appears to be no difference among antidepressants in raising a kid's risk of suicidal thoughts." Harvard School of Public Health researchers "collected data on 20,906 children aged 10 to 18 who had been diagnosed with depression in British Columbia," after following the children for nine years. The young participants "were on a variety of commonly prescribed antidepressants called selective serotonin reuptake inhibitors (SSRIs), including citalopram (Celexa), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft)."

Medscape reported, "During the first 12 months of treatment, the researchers identified 266 attempted and three completed suicides -- an event rate of 27.04 suicidal acts per 1000 person-years (95% confidence interval [CI], 23.9 – 30.5 suicidal acts per 1,000 person-years)." However, "they failed to see any significant differences in rate ratios (RRs) in analyses comparing fluoxetine with citalopram (RR, 0.97; 95% CI, 0.54 – 1.76), fluvoxamine (RR, 1.05; 95% CI, 0.46 – 2.43), paroxetine (RR, 0.80; 95% CI, 0.47 – 1.37), and sertraline (RR, 1.02; 95% CI, 0.56 – 1.84)."

Reuters interviewed Thomas Laughren, MD, director of the FDA's Division of Psychiatry Products, who pointed out that clinicians need to closely follow young people on antidepressants due to the increased risk for suicide.

These reports underscore the importance of carefully monitoring people, especially young people, who are prescribed antidepressants.  Doctors must be aware of all risks and benefits attendant to the drugs they prescribe, and must explain those risks and benefits to patients and, when appropriate, parents and guardians, so that the best medical decisions can be made.

do you have any questions about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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"Experts" Supporting Avandia Drug Had Financial Ties To Drugmaker

Posted by: Salvatore J. Zambri, founding partner

CONTACT US      

                                                                                                        


Bloomberg News (BN) recently reported that, according to the Mayo Clinic, "Most scientists who published articles supporting GlaxoSmithKline Plc's diabetes drug Avandia [rosiglitazone] after it was linked to heart disease in 2007 had financial ties to the company."  

The United Kingdom's Independent reported, "Researchers from the Mayo Clinic in Minnesota -- one of the few US research organizations that does not rely on commercial sponsorship -- analyzed more than 200 articles published in scientific journals, including original papers, editorials, and letters, which commented on the heart attack risk associated with Avandia after 2007. " The investigators "found almost half (47 percent) of the study authors had financial conflicts of interest, but almost a quarter (23 percent) did not disclose it. They were discovered by searching other publications by the same author or on the Internet."

In February, internal documents and findings from the Food and Drug Administration, released by US Senators, made the recommendation that Avandia should be removed from the American market. The agency now plans to conduct a July meeting to weigh the pros and cons of the drug.

I blogged about the Avandia drug earlier this year.  To read that blog and learn more about the risks of Avandia, please click here.

If prescribed Avandia, please contact your doctor immediately.  Your doctor should not prescribe any medication without first warning you of all known risks, and only if the benefits of the medication outweigh the risks.

CONTACT ME  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Drug Company Alpharma Pays $42.5Mill To Settle Suit Alleging Misrepresentation

Posted by: Salvatore J. Zambri, founding partner

CONTACT US      

                                                                                                        

According to the Wall Street Journal, the Justice Department has announced that Alpharma, Inc. has agreed to pay a whopping $42.5 Million to settle a claim in which the government alleged that the drug company improperly paid physicians to prescribe and promote a particular morphine drug--Kadian.  The settlement follows a whistle-blower suit.

Whistle-blower suits allow people who work for companies to come to the government with evidence that the companies are violating the law.  These kinds of suits are important as they provide protection to the whistle-blower while the government intervenes and remedies an injustice.

People who are aware of corporate wrongdoing understandably feel like they have a moral and ethical obligation to come forward in an effort to stop the injustice.  They often don't, however, fearing that they will be retaliated against.  These whistle-blowers are protected by the law, however.  If you are aware of corporate misfeasance, feel free to contact me to discuss your rights.  Never feel powerless.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Forces Drugmakers to Stop Selling Unapproved Nitrogylcerin Tablets

Posted by: Salvatore J. Zambri, founding partner     

New Jersey's Star-Ledger reports that the FDA on Tuesday ordered "Glenmark Generics to stop selling unapproved nitroglycerin tablets for relief from chest pain." The unapproved drugs "are different from approved nitroglycerin tablets in some ways, such as formulation and labeling, but the FDA said it has seen quality and efficacy problems with the unapproved versions." The FDA also "advised consumers that Pfizer sells a version of the product that has been approved by regulators." Kotec Inc. of Arizona also received a warning.

According to the Los Angeles Times' "Booster Shots" blog, the FDA gave the two drugmakers "90 days to stop making and selling nitroglycerin tablets for use by heart patients and 180 days to stop shipping those they have made." Reuters also covers the story.

There is great danger in selling unapproved drugs.  Drug companies must always put the safety of people over profits.  If they don't, their greed will seriously injure and even kill Americans. 

Before taking any medication, be sure to consult with your doctor, who is obligated to provide you with all risks and benefits of the drug before prescribing the medication.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  
 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Similar Drug Names and Bottles Cause Major Mistakes

Posted by: Salvatore J. Zambri, founding partner     


ABC World News recently reported on how some drug bottles look alike and how the United States Food and Drug Administration (FDA) "said it gets thousands of reports of such mix-ups every year." The FDA's Dr. Gerald Pan said, "Today's near-miss, today's medication error that doesn't cause harm to somebody could cause harm to someone tomorrow." ABC noted the name-change for Kapidex (dexlansoprazole) last week, but "that still leaves several hundred sound-alike and lookalike drug combinations to go."

Many scholars believe drug companies mirror other companies' products in an effort to fool customers into purchasing their products.  Here's what is important:  never buy a drug unless you are absolutely sure you know what you are purchasing.  Also, doctors and medical staff should never provide drugs to patients without understanding all risks and benefits of the drug and without first confirming that the drug provided to the patient is what the doctor has in fact prescribed.

 

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
Comments / Questions (0) | Permalink

Class I Recall of Baxter In-Home Dialysis Device Announced

Posted by: Salvatore J. Zambri, founding partner     

According to the Chicago Tribune, Baxter International Inc. announced a recall of its "in-home dialysis device that has been linked to serious injury reports and at least one death in the last two years." In addition, the "Food and Drug Administration has classified the action as a Class I recall, the agency's most serious, for the Baxter's HomeChoice and HomeChoice Pro peritoneal dialysis cyclers, because the device is causing an 'overfill' of fluid in the patient's stomach," states the Tribune report.

A Class I recall applies to problems that can cause serious adverse health consequences or death. According to an AP report, "Baxter said it is still investigating the source of the problems and is working on changes to labeling and software to prevent patient errors."  The company nevertheless claims that the "machines do not need to be physically returned to the company and can still be used."

Dow Jones Newswire reported on the recall as well.

If using a Baxter device, we urge you to speak with your doctor immediately to determine if it is safe for you to continue using it.  Your doctor should be aware of the problems and the consequential risks to be able to provide you with the information you need to make the best decision possible for your health.

 

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also described him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , Women's Health Issues
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Congress Deals With Radiation Safety, Doctor Kick-Backs

Posted by: Salvatore J. Zambri, founding partner     

The New York Times, in a front-page report, announced, "To help ensure that medical radiation is safe, Medicare insists that certain highly technical cancer treatments be administered only when a patient's radiation oncologist is present or nearby." Federal officials say physicians who fail to adequately supervise technicians during radiotherapy risk patient safety. But, the issue also "raises questions about financial incentives and the overuse of high-tech, and highly reimbursed, treatments" when "less advanced and cheaper ones would have served just as well."

As a result, "Congress passed an antikickback law designed to stop doctors from" unnecessarily ordering "tests or procedures in which they have a financial interest," according to the report.  In addition, "radiation safety will be the subject of a Congressional hearing Friday." For its part, "the American College of Radiology has said that self-referral endangers patients because doctors tend to order more tests."

Before undergoing any diagnostic test or invasive procedure, your doctor should describe all benefits and  risks of the procedure and he or she should explain all alternative options as well.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Women's Health Issues
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KV Pharmaceutical reaches $27 million settlement with Justice Department

 Posted by: Salvatore J. Zambri, founding partner     


The AP reported that "Drugmaker KV Pharmaceutical Co. says it will shut down its Ethex generic division, plead guilty to criminal charges" that the company failed to immediately notify "regulators of safety hazards."  The embattled company will "pay $27.6 million to resolve government investigations," according to the report.

The settlement requires Ethex to "plead guilty to two felony counts for failing to file 'field alerts' for two drugs, dextroamphetamine and propafenone," the St. Louis Post-Dispatch reports. In addition, "KV was ordered to stop making some time-release cough, cold, and gastrointestinal drugs in 2008," but despite that order, "the FDA said KV continued to make the drugs."

This smacks as another instance in which a big company decided to mock the law and put profits over safety.  There is no place for such greed in this country.  I hope the criminal consequences send a message to all greedy executives that they better change the way they do business and start putting people over profits.  Americans shouldn't be seriously injured or killed just so executives can pad their pockets.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Two Million Defective Huber Needles Recalled by Nipro

 Posted by: Salvatore J. Zambri, founding partner     


The AP (1/27, Perrone) reports, "Federal health officials announced the recall of two million medical needles Tuesday because of a risk they can push bits of silicone into patients' bodies." The FDA "said Japanese manufacturer Nipro Medical Corp. has voluntarily recalled its Exel/Exelint Huber needles manufactured between January 2007 and August 2009."   Doctors, nurses, and patients should not be using these needles under any circumstances.

Bloomberg News (1/27, Peterson) reports that the "defect...might lead to fatal blockages of the main artery of the lung, the [FDA] said." The needles, which are intended "to give food and medicine to chronically ill patients," can "dislodge 'cores,' or slivers of silicon, from 'ports' under the skin and release the material into the bloodstream, FDA officials said." Jon Casamento, deputy director of the Solid and Fluid Mechanics Division at the FDA's Center for Devices and Radiological Health, said the "defective needles...may cause tissue damage and inadequate drug delivery."

Regulators have not received reports that the needles released silicon or other foreign chemicals into patients, but the defect is difficult for doctors to detect, Dow Jones Newswire (1/27, Favole) reports.

CNN (1/27, Young) reports that the FDA "said anyone using the products should stop immediately and return any unused needles to Exelint." The agency indicated that it is conducting investigations "of needles from 20 companies," of which 10 have already been completed. "The FDA said it has sent letters to all Huber manufacturers asking them to address any design or manufacturing problems."

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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States Without Damage Caps Have More Doctors

 Posted by: Salvatore J. Zambri, founding partner     

In a blog at the California Progress Report (1/6), J.G. Preston wrote, "One of the arguments the 'tort reform' crowd uses to justify putting a cap on the amount of money a jury can award to a victim of medical negligence is their assertion that increases in the cost of malpractice insurance are driving doctors out of the business." But "there are more doctors per capita in states that don't limit the amount that can be awarded to victims of negligence than there are in states that have implemented caps. The American Association for Justice broke down the numbers and found there are 21% more doctors per capita in states that don't restrict compensation that there are in states with caps." 

And there are more doctors than ever in America.   Take a look at the most recent data published by the American Medical Association, which confirms this fact.  The publication considers data through 2008.  There were 309 doctors for every 100,000 people that year.   Compared to the 1960s, that's twice as many.  So, not only are there more doctors per capita in states without damages caps, there are also more doctors everywhere in this nation.

The lesson:  Don't let the corporate greed of certain special interest groups convince you that you need to abandon your constitutional rights to pad their pockets.  Victims of the carelessness of others need their rights. 

Be safe, and don't be fooled by well-worn rhetoric.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice, product liability, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (2010)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding civil litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

 

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Public Health , Tort Reform , Women's Health Issues
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FDA WARNING: NZU, A MORNING SICKENESS "REMEDY" MAY CONTAIN HIGH LEVELS OF LEAD/ARSENIC

Posted by Catherine D. Bertram                                                        

On December 31, 2009, the FDA issued a warning to consumers and medical professionals, "especially pregnant or breastfeeding women, to avoid consuming a product called “Nzu”, taken as a traditional remedy for morning sickness,because of the potential health risks from high levels of lead and arsenic, noted on laboratory analysis by Texas DSHS. Exposure to lead can result in a number of harmful effects, and a developing child is particularly at risk of effects on the brain and nervous system. Arsenic is a carcinogen, and excessive long-term exposure to it has been associated with a range of adverse health effects, including cancers of the urinary bladder, lung and skin. Nzu, which is sold at African specialty stores is also called Calabash clay, Calabar stone, Mabele, Argile and La Craie. It generally resembles balls of clay or mud and is usually sold in small plastic bags with a handwritten label identifying it as “Nzu” or “Salted Nzu.” Anyone who has been ingesting the product should contact their health care provider."

Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online by clicking here or by phone at 1-800-332-1088.

 If you have any questions about injuries related to this medication, or any other medication, you can call our firm for more information about your legal rights.  Click here to contact us online or call us at 202-463-3030.

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes her practice to the representation of patients and families of loved ones who have been injured or lost due to medical errors.  Ms. Bertram lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

 

 

Posted In Medical Malpractice , Medications , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Issues Warning For Hypertension Drug

 Posted by: Salvatore J. Zambri, founding partner     


The AP reports that officials with the Food and Drug Administration warned doctors recently that "about 11 recalled lots of an intravenous hypertension drug made by the Medicines Co. are contaminated with bits of steel." According to the agency, the particles "could potentially disrupt blood flow to the brain, kidney, liver heart and lungs." Medicines Co. recalled the affected lots of Cleviprex (clevidipine butyrate).

If you believe you have been prescribed this drug, contact your doctor immediately.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Pfizer Wants Prempro Internet Video Removed

 Posted by: Salvatore J. Zambri, founding partner     


Bloomberg News (12/16, O'Reilly, Feeley) reports, "Pfizer Inc. asked a judge to order the removal of an Internet video about its menopause medicines that the company says is misleading and aimed at swaying potential jurors in future trials over the pills." The video, called "Prempro News Segment," was posted on YouTube.com by "plaintiffs' lawyers who recently won more than $78 million in damages in a Pennsylvania trial over Pfizer's Prempro hormone-replacement drug."

At issue in that case was whether the "menopause drugs helped cause" the plaintiff's breast cancer. In the video, "breast-cancer victims discuss their cases," while the attorneys "accuse Wyeth of minimizing the risks of Prempro." According to Pfizer's lawyers, "Pennsylvania rules governing lawyer ethics prohibit lawyers from making pre-trial statements to the press that could 'prejudice' an upcoming case."

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   
 

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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800,000 Swine Flu Vaccine Doses Recalled

 

 Posted by: Salvatore J. Zambri, founding partner     


A massive recall of swine flu vaccine doses drew national attention recently when it was announced by the Center for Disease Control.  ABC World News (12/15, story 6, 0:20, Gibson) reports that federal health officials "are recalling 800,000 children doses of swine flu vaccine...made by Sanofi Pasteur." NBC Nightly News (12/15, story 2, 0:35, Williams) reported that the doses "are less potent than they should have been."

The Los Angeles Times (12/16, Maugh) reports that Centers for Disease Control and Prevention director Dr. Anne Schuchat said the recall was "non-safety-related," and was "part of a routine quality assurance program." Schuchat emphasized that "children who received the vaccine do not need to be re-immunized," but the agency "wanted to make sure that doses that weren't already given won't be." The Washington Post (12/16, Stein, Laris) reports that "most of the vaccine, which was distributed nationwide in November, has probably already been used."

Bloomberg News (12/16, Randall) reports that Sanofi "began delivering swine flu vaccine in the US in September, with the bulk of deliveries expected in the fourth quarter." The United States "has ordered 75 million doses from the Paris- based company." CQ HealthBeat (12/16, Norman) reports that the problem was identified during "ongoing quality assessments" made by the drugmaker. The New York Times (12/16, A28, Mcneil) reports that Dr. Schuchat "said the vaccine was fully potent at release but dropped by about 12 percent in follow-up tests." In a story appearing in some form on over 320 news websites, the AP (12/16, Stobbe) reports that Jesse Goodman, the FDA's deputy commissioner for science and public health, said the problem may be related to the antigen sticking to the walls of children's pre-filled syringes.

USA Today (12/16, Sternberg) reports that the affected vaccine, "packaged in half-dose amounts meant for children 6 months to nearly 3 years old, represents about 1% of the nation's H1N1 vaccine supply." Sanofi spokesman Len Lavenda said the doses comprise roughly "18% of the 4.5 million doses in prefilled syringes made by Sanofi for children in that age group." Lavenda commented that officials were "baffled" by the weakened vaccine, adding "we can't remember a time when flu vaccine lost potency." The Wall Street Journal (12/16, Dooren) reports that Sanofi will be notifying providers to return any unused doses.

Reuters (12/16, Fox) also reported on this story, while Time (12/16, O'Callaghan) mentioned the recall in their "Wellness" blog.

Please be careful when taking a vaccine or allowing a loved one to be injected.  We urge you to speak with your doctor about all pros and cons of any drug before ingesting it.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.   

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Glaxo Announces Payouts From Paxil Cases

 Posted by: Salvatore J. Zambri, founding partner     

Bloomberg.com reports that GlaxoSmithKline "has settled 450 suicide cases for about $390 million and 600 birth defect cases for unspecified amounts." According to the report, "The company has also paid out about $400 million in antitrust cases since 2003."

Many people who have taken Paxil have been subjected to an increased risk for suicide and birth defects.  The extent of the increased risk has never been disclosed. 

I represent victims of dangerous products.  Far too often companies put profits over people, placing into the marketplace drugs that have not been properly tested.  We hope that companies will put people over profits and be sure their products are safe before they are sold.

Before taking any medication, be sure to consult with a physician.  Your physician should also inform you of all risks and benefits of a medication before you ingest it, so that you can make the best health decisions you can.

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including product liability, medical malpractice, and automobile accident claims.  Mr. Zambri has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.    

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Cartons of Berries & Balsamic Salad Recalled

 Posted by: Salvatore J. Zambri, founding partner     

The FDA has announced that a California-based company--organicgirl produce--has recalled 120 cartons of its 5.75 oz Berries & Balsamic Salad "because it may contain an incorrect condiment packet with an unlabeled allergen for walnuts."

"The product is packaged in plastic trays in a 6-count carton, UPC 895203-001332, product lot number 31B073830, with Use-By Date of December 16, 2009."  If you have an allergy to walnuts, do not eat this product.  Doing so would "run the risk of serious or life-threatening allergic reaction," says the FDA.

If you purchased the recalled product, you are urged to return it to the place you bought it from for a full refund. If you have any questions, you may also contact organicgirl produce at 1-831-758-7810.

It is common for people to have allergic reactions to all kinds of foods.  That is why it is critically important for all food suppliers to carefully label what the product contains.  Without appropriate warnings, public health is compromised. 

Many people die every year as a result of food allergies.  If you have an allergy to a food product, read labels carefully.  If eating at a restaurant, ask your server to confirm the absence of the product you are allergic to when ordering.

Enjoy your meals, but please be careful to ingest only what you know is safe.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and business professionals concerning product defects, product liability litigation, and safety improvements.

Mr. Zambri was sought after to publish a chapter regarding product liability litigation in Aspatore Books - a company that is touted as "the largest and most exclusive publisher of C-1 Level executives (CEO, CFO, CTO, CMO, Partner) from the world's most respected companies and law firms."  To read Mr. Zambri's publication, entitled "Constantly Preparing To Win", please click here.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

 

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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State Tort "Reforms" Don't Lower Insurance Premiums

 Posted by: Salvatore J. Zambri, founding partner     

The American Association for Justice has published an article that establishes what we have known now for some time--that state tort "reforms" have provided a boon to insurance companies, while physician and patient premiums continue to skyrocket.  The winner:  insurnace companies, whose profits have hit record levels.  The losers:  doctors and, especially, patients, whose fundamental rights have been taken from them.

"An analysis of data from the National Association of Insurance Commissioners (NAIC) and company annual statements shows malpractice insurer profits are 24 percent higher in states with caps.  In these cap states, insurers took in 3.5 times more in premiums than they paid out in 2008.  In contrast, insurers in states without caps took in just over twice what they paid in claims."

98,000 people die every year from preventable medical errors, yet the insurnace industry and the chamber of commerce want o place nonsensical limits on patients' rights simply to pad insurance companies' profits.  This profits-over-people model is anti-American and unethical.

The report establishes that the "medical malpractice insurance industry has seen a 47 percent increase in profitability in the last 10 years. Overblown 'reported' losses were used by the insurance industry to justify new measures restricting the rights of those injured by medical negligence."

Americans need to fight back against the myths spread by special interest group.  Over 30 states have been fooled into thinking caps on daages will help pemiums.  They haven't. In the meantime, though, "the average profit of the 10 largest medical malpractice insurers was higher than 99 percent of Fortune 500 companies and 35 times higher than the Fortune 500 average."

To view a copy of Insurance Company Handout: How the Industry Used Tort Reform to Increase Profits While Americans' Premiums Soared, visit http://www.justice.org/clips/Insurance_Company_Handout.pdf.

As I mentioned, It is widely accepted that approximately 98,000 Americans die every year as a result of medical errors.  That's like two 747 airplanes full of passengers crashing to the ground every day for a year.  Yet, some legislators want to strip innocent victims of their constitutional rights, including limiting their recoveries, instead of focusing on preventing future errors. 

Our leaders should be fighting for safer drugs, safer hospitals, better medical practices, and a safer American health system.  We must put people over profits.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" whose practice is dedicated to handling catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

 

 

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Medical Malpractice Accounts for Far less than 1% of Overall Healthcare Costs

 

 Posted by: Salvatore J. Zambri, founding partner     

According to a study from Public Citizen,  medical malpractice payments to patients who have been injured due to medical errors declined for the third year in a row.  The study further shows that the payouts total between merely 0.18% and 0.6% of the overall medical costs in this country. 

Is this decline the result of better medical care?  Unfortunately, no, according to the study.   Instead, fewer injured patients are being compensated.  Approximately 98,000 people are killed every year in this country due to medical mistakes, but payouts only go to about 11,000 of them.  If there is a medical malpractice crisis in this country, the core of the crisis is sloppy medicine, not frivolous lawsuits, notes the study:

More than 80 percent of the money paid out for medical malpractice in 2008 was for cases involving "significant permanent injuries"; "major permanent injuries"; injuries resulting in quadriplegia, brain damage or the need for permanent care; or death, according to NPDB [National Practitioner Data Bank] reporting.

Despite the hysteria surrounding debates over medical malpractice litigation, experts have repeatedly concluded that several times as many patients suffer avoidable injuries as those who sue. The best known such finding was included in the Institute of Medicine’s (IOM) seminal 1999 study, "To Err Is Human," which concluded that between 44,000 and 98,000 Americans die every year because of avoidable medical errors. Fewer than 15,000 people (including those with non-fatal outcomes) received compensation for medical malpractice that year, and in 2008, the number receiving compensation fell to just over 11,000.

Patient safety needs to become a priority in this country.  Unless it does, thousands upon thousands of Americans will be needlessly killed or seriously injured each year. 

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" whose practice is dedicated to handling catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (2009-2010)--a national publication that honors the top lawyers in America. 

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Medical Errors Should Be Reported to Improve Safety

 Posted by: Salvatore J. Zambri, founding partner     


The AP (12/11, Tanner) reports that "in 2005, Illinois legislators...passed a measure requiring hospitals to report the deadliest kind" of medical errors, but "the law has yet to be implemented -- and it likely won't be for at least another year." Illinois "budget woes and foot-dragging by special interests are among reasons cited for the long delay." However, "there are finally glimmers of progress. That includes the recent launch of a related state website that tracks hospital infection rates and staff levels, and the imminent start of a search for a vendor to help put the law in place."

Ten years ago, a landmark report proved that medical mistakes kill up to 98,000 Americans yearly. Only a handful of states have decided to do something about it, Minnesota being the first in 2003.  In 2005, Illinois modeled a law after Minnesota's.  Four years later, the law has still not been implemented.  Why?  Foot-dragging by special interest groups.  Finally, though, some progress is being made, including " the recent launch of a related state Web site that tracks hospital infection rates and staff levels, and the imminent start of a search for a vendor to help put the law in place."

According to the AP report, "The law will require hospitals to publicly report so-called "never" mistakes. These are mostly preventable errors with potentially life-threatening consequences -- like the wrong-knee surgery Krzysztof Kordes says Chicago-area doctors performed on him last year or the forgotten sponge left inside a Plainfield woman during breast tumor surgery."

A few things the law requires:

  • hospitals required to report major medical errors within 30 days to the state's public health department
  • list of hospitals and mistakes will be posted online
  • hospitals required to determine cause of errors and to develop corrective plan

These kinds of laws should be in every state in our country.  Medical providers should not bow to special interest groups.  Sharing more, not less, following an adverse event is the only way to truly minimize future medical errors. 

Encourage your legislators to work hard to implement strong laws that clearly work to open communication and spur better, safer health practices.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" whose practice is dedicated to handling catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (2009-2010)--a national publication that honors the top lawyers in America. 

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , Women's Health Issues
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WARNING LABELS FOR ANTIPSYCHOTICS MAY BE STRENGTHENED

 Posted by: Salvatore J. Zambri, founding partner     

Dow Jones Newswires (12/8, Dooren) reported that Thomas Laughren, the director of FDA's division of psychiatric products, said Tuesday that the agency is weighing tougher warning labels for antipsychotics that might cause weight gain and diabetes.  According to the report, "the agency has asked manufacturers of drugs like Seroquel, Abilify and Zyprexa for all of the information they have on metabolic side effects such as increases in blood glucose" to determine whether warnings need to be improved.  This comes in the wake of concerns of how antipsychotic medication has been effecting children in particular.

Like all drugs, antipsychotic medication should never be taken without a doctor's prescription, and a physician should never prescribe this medication unless it is in the best interest of the patient and only after the patient has been fully informed of all of the risks and benefits of the drug. 

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" whose practice is dedicated to handling catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America. 

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Evaluating a Medical Malpractice Case

 Posted by: Salvatore J. Zambri, founding partner     

As a consumer justice attorney, I have the privilege of representing and helping people through difficult times every day. Oftentimes, my clients are horrifically and permanently injured due to no fault of their own. Other times, I represent families of those who have died as a result of someone else's carelessness.

This may surprise you, but it is widely accepted that approximately 98,000 Americans die each year as a result of medical negligence, more than deaths caused by guns and automobile collisions.  The yearly death toll from medical errors equates to the number of deaths that would result from two 747 airplanes crashing to the ground every day.  This alarming statistic does not even include those who have not died, but have nevertheless suffered serious permanent injuries due to a lack of appropriate medical care.

I have published a paper that addresses some fundamental, but extraordinarily important, steps necessary to properly and thoroughly evaluate a potential medical malpractice claim. By no means does the article include all investigative efforts required to analyze a case, as every claim is different and deserves special attention. 

To read my article, entitled "Evaluating a Medical Malpractice Case", please click here.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" whose practice is dedicated to handling catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America. 

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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American Associate for Justice Publishes Primer on Medical Negligence Debate: A Must Read

 

 Posted by: Salvatore J. Zambri, founding partner     

The American Association for Justice has published a primer on the medical malpractice debate.  It comprehensively shows how special interest groups have perpetuated myths in an effort to strip Americans of their rights in order to pad their profits.  Here are some of the findings:

  • Myth #1: There are too many “frivolous” malpractice lawsuits
  • Myth #2: Malpractice claims drive up health care costs.
  • Myth #3: Doctors are fleeing.
  • Myth #4: Malpractice claims drive up doctors’ premiums.
  • Myth #5: Tort reform will lower insurance rates.

It is widely accepted that approximately 98,000 Americans die every year as a result of medical errors.  That's like two 747 airplanes full of passengers crashing to the ground every day for a year.  Yet, some legislators want to strip innocent victims of their constitutional rights, including limiting their recoveries, instead of focusing on preventing future errors. 

Our leaders should be fighting for safer drugs, safer hospitals, better medical practices, and a safer American health system.  We must put people over profits.

To read the publication, please click here.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" whose practice is dedicated to handling catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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GAO Says FDA Lacking in Developing Drug Surveillance Office

 

 Posted by: Salvatore J. Zambri, founding partner     

 

The Associated Press has reported today that the Food and Drug Administration (FDA) "still hasn't restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal."  According to the report, the Government Accountability Office (GAO) will release a report today indicating that FDA officials "have made some changes to drug oversight," although the agency "continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market."  Consequently, the GAO "calls on the FDA to set a timetable for transferring new responsibilities to the surveillance office."

In response, the FDA "said major decisions about drug safety are delegated to the new drugs division because that is 'where staff with the broadest expertise and experience' on product safety issues reside," according to the AP report.

We urge the FDA to ramp up its surveillance of drugs, and we implore pharmaceutical companies to be sure their products are safe before placing them into the marketplace.  Drugs are obviously important, but manufacturers need to put people over profits.  No drug should enter the marketplace until it has been thoroughly tested and until its side-effects are fully understood.

Before taking any medication, please confer with your doctor.  Know all risks and benefits of a drug before taking it.

We wish you good health.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who dedicates his practice to catastrophic personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Alka-Seltzer Cold Capsules Recalled

 Posted by: Salvatore J. Zambri, founding partner     

 

The Los Angeles Times reports that "Bayer Healthcare is recalling 100,000 packages of Alka-Seltzer cold capsules because some do not properly display warning information about drowsiness."  The recalls pertains to packages of Alka-Seltzer Plus Day & Night Liquid Gels, according to the report.

"Company spokeswoman Tricia McKernan said the problem was caused by human error during the printing process. McKernan said the machinery used to make the labeling had to be shut down and manually restarted during the production for the affected lot."

If you have purchased these medications from lot 296939L--a lot that was distributed nationwide--please stop using the product and contact Bayer .  The manufacturer's phone number is (800) 986-3307, and they will provide a refund.

Be sure never to operate heavy machinery, drive a car, or engage in any dangerous activity while taking medication that has the potential to make you drowsy.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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New Paper Debunks Medical Malpractice Myths


 Posted by: Salvatore J. Zambri, founding partner     

The American Association for Justice has published a paper that concisely and clearly debunked the myths about medical malpractice which has been spread by business interest groups aimed at putting profits over people.  In the first of a series of papers, Public Citizen debunks the following "five myths: 

  • Myth #1: There are too many “frivolous” malpractice lawsuits.

Fact: There’s an epidemic of medical negligence, not lawsuits.  Only one in eight people injured by medical negligence ever file suit.  Civil filings have declined eight percent over the last decade, and are less than one percent of the whole civil docket.  A 2006 Harvard study found that 97 percent of claims were meritorious, stating, “portraits of a malpractice system that is stricken with frivolous litigation are overblown.”

  • Myth #2: Malpractice claims drive up health care costs.

Fact: According to the National Association of Insurance Commissioners, the total spent defending claims and compensating victims of medical negligence was just 0.3% of health care costs, and the Congressional Budget Office and Government Accountability Office have made similar findings.

  • Myth #3: Doctors are fleeing.

Fact: Then where are they going?  According to the American Medical Association’s own data, the number of practicing physicians in the United States has been growing steadily for decades. Not only are there more doctors, but the number of doctors is increasing faster than population growth.  Despite the cries of physicians fleeing multiple states, the number of physicians increased in every state, and only four states saw growth slower than population growth; these four states all have medical malpractice caps.

  • Myth #4: Malpractice claims drive up doctors’ premiums.

Fact: Empirical research has found that there is little correlation between malpractice payouts and malpractice premiums paid by doctors. A study of the leading medical malpractice insurance companies’ financial statements by former Missouri Insurance Commissioner Jay Angoff found that these insurers artificially raised doctors’ premiums and misled the public about the nature of medical negligence claims.  A previous AAJ report on malpractice insurers found they had earnings higher than 99% of Fortune 500 companies.

  • Myth #5: Tort reform will lower insurance rates.

Fact:  Tort reforms are passed under the guise that they will lower physicians’ liability premiums. This does not happen. While insurers do pay out less money when damages awards are capped, they do not pass the savings along to doctors by lowering premiums. Even the most ardent tort reformers have been caught stating that tort reform will have no effect on insurance rates."

It is widely accepted that approximately 98,000 Americans die every year as a result of medical errors.  That's like two 747 airplanes full of passengers crashing to the ground every day for a year.  Yet, some legislators want to strip innocent victims of their constitutional rights, including limitibg their recoveries, instead of focusing on preventing future errors. 

Don't let your legislative representatives takes your rights away just so some special interest groups can pad their profits.  Fight for safer hospitals, better medical practices, and a safer American health system.  We must put people over profits.

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications and medical errors.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Reputable Consumer Group Petitions For Ban of Drug Meridia

 Posted by: Salvatore J. Zambri, founding senior partner     

 

The AP recently reported,  "A consumer advocacy group is petitioning the government to ban the weight loss pill Meridia [sibutramine] because a recent study suggests it increases the risk of heart attack, stroke, and death." In a letter to the Food and Drug Administration (FDA), the consumer watch-dog--Public Citizen--calls on the agency "to pull Abbott Laboratories' drug from the US market," citing results from "a 10,000-patient study" that "showed a slightly higher risk of heart-related problems in patients taking Meridia...compared with a dummy pill."

The FDA, however, "said it was 'making no conclusions about the preliminary findings' when they were released last month." The agency "previously rejected a 2002 petition from Public Citizen to withdraw Meridia," saying "it wanted to wait for the findings of the 10,000-patient study."

We will soon see how the FDA responds to the study. In the meantime, please be very careful when taking any medication.  You should always get competent, expert medical advice for ingesting any medication.  Be sure, too, that your doctor fully explains all risks associated with certain medications so that you can make a wise decision about what's best for you and your body.
      

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Task Force Study Regarding Effectiveness of Mammograms Sparks Political Debate

Posted by: Salvatore J. Zambri, Esquire

A recent federal task force's study that discourages routine mammograms for most women below the age of 50 has sparked a major political debate.  As a Washington Post article puts it, "The findings underscore a decades-long debate in the medical community about the benefits and risks of routine breast cancer screening for younger women."

In response to the study, Rep. Frank Pallone Jr. (D-N.J.) "announced that his House health subcommittee will hold hearings on the mammogram issue next month," according to the Post report.  And legislators from both political parties are suggesting that "the task force had been swayed by insurance companies that stand to save money if fewer screenings are performed."

Certainly, insurance companies' greed should not dictate what treatments are best for patients.  Those decisions should be left to medical experts who know what they are talking about, who are responsible for making sound decisions and informing their patients of all attendant risks and benefits.  As it stands, the  American Cancer Society has reiterated that it will continue to recommend regular mammograms for women age 40 and above. 

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from misdiagnosed cancer and dangerous drugs.  He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Drug Warning: Vials of Genzyme Drugs Potentially Contaminated

Posted by: Salvatore J. Zambri, Esquire

The New York Times reported that according to the US Food and Drug Administration (FDA), "Vials of five different Genzyme drugs for rare diseases may be contaminated with tiny particles of steel, rubber or fiber that could potentially harm patients."  However, "the FDA and Genzyme said that there had been no reports of patients being harmed by particles and that the problem affected less than one percent of the vials."  Although Dr. Jason Woo, an FDA official, stated, "We do not believe this is a wide-scale problem, but we do not have information that fully defines the scope," patients and doctors are concerned.

According to the report, the FDA has confirmed that "the products would remain on the market, because there are few alternative treatments," the AP (11/14, Perrone) reported. The agency has strongly advised physicians to "closely inspect vials for particles before injecting them into patients."  If exposed to contaminated vials, patients may experience "potential allergic reactions, blood clots, and other problems," states the report. 

 About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.


 

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Multiple Sclerosis Drug Tysabri Linked to Lethal Brain Inflammation

Posted by: Salvatore J. Zambri, Esquire

The Associated Press (AP) recently reported that the Food and Drug Administration (FDA) "says it confirmed three new cases of a potentially lethal brain inflammation linked to the multiple sclerosis drug Tysabri [natalizumab]."  According to the FDA, the reports "are the first confirmed new cases since June."  The condition is known as progressive multifocal leukoencephalopathy, or PML.  The report states that the FDA has confirmed that since mid-2006 there have been 13 reported cases of PML.  The AP adds that "the FDA says the risk appears to increase as patients remain on Tysabri" and all "the PML cases are linked to its use in multiple sclerosis," although the drug is also marketed to treat Chron's disease as well.

According to the AP report, Tysabri  "was approved in November 2004 and pulled from the market the next year due to PML reports. It was reintroduced in July 2006, and Biogen said it is used by 43,000 patients."

Like all drugs, Tysabri, which is marketed by Biogen Idec Inc. and Elan Corp. PLC, should never be taken without a doctor's prescription, and a physician should never prescribe this medication unless it is in the best interest of the patient and only after the patient has been fully informed of all of the risks and benefits of the drug.
 

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Mandates "Black Box" Warning for Promethazine

Posted by: Salvatore J. Zambri, Esquire

The AP (9/17, Johnson) reports that the FDA has determined that "[m]akers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation." FDA regulators said that "makers of generic promethazine will have to put a 'black box' warning at the top of the detailed package insert explaining that when the drug is administered incorrectly, it can damage skin severely, including causing gangrene."

We urge our readers to be very careful when taking this drug.  It is vitally important that you refrain from using it unless directed by a doctor, who is responsible for understanding all of the risks and benefits of the drug.  The risks should be communicated to you by your doctor before the physician prescribes the medication.
 

About the author:

Mr. Zambri is Past-President of the Trial Lawyers Association of Metropolitan Washington, DC and has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions stemming from defective or dangerous medications.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Study Suggests Hormone Therapy Increases Risk of Ovarian Cancer

Posted by: Salvatore J. Zambri, Esquire

According to a recent Danish study, women who undergo hormone replacement therapy after menopause are at a meaningfully higher risk of developing ovarian cancer.  A Reuters report states that the study, published in the Journal of the American Medical Association, comments that women who took hormone replacements were 38 percent more likely to develop ovarian cancer than those who did not.  This follows a study that was conducted ion 2002 by the Women’s Health Initiative, which produced similar findings.

We encourage our readers to be very careful when taking any medication.  No women should undergo hormone replacement therapy or other kind of therapy without first seeking the advice of medical experts.  Doctors should warn patients of potential side-effects and should not prescribe drugs unless it is proper to do so in light of all risks and benefits.

About the author:

Mr. Zambri has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  Our firm has experience pursing cases for patients that involve dangerous medical products, as well as claims involving inappropriately prescribed medications.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

 

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Bayer Sued Over Its Oral Contraceptive--Yaz

Posted by: Salvatore J. Zambri, Esquire

Bayer reached an agreement with the Food and Drug Administration (FDA) in 2008, forcing the company to pay for a $20 million ad campaign to correct the company's history of overstating the benefits of its oral contraceptive--Yaz--and downplaying its risks.  The FDA determined that Yaz carries additional risks as compared to other contraceptives because the drug contains drospirenone, a progestin, which can increase a woman's potassium to dangerous levels.  Increased levels of potassium can lead to many adverse side-effects including blot clots, which can then lead to stroke, heart attack, or other serious condition. 

Before taking any drug, please be sure to consult with your doctor and pharmacist.  Physicians must take affirmative steps to be aware of all side-effects of the medications they prescribe so their patients do not suffer adverse, otherwise avoidable, consequences.

About the author:

Mr. Zambri has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  Our firm has experience pursing cases for patients that involve dangerous medical products.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medical Malpractice , Medications , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Warning: Don't Purchase or Use New Whey Liquid Products or Hardcore Energize Bullet

Posted by: Salvatore J. Zambri, Esquire

The FDA has warned consumers not to buy or use Hardcore Energize Bullet or New Whey liquid products sold in test tube-like vials, as a result of suspected product tampering. The products are being recalled.

According to the FDA, "The suspected tampering involved a utility knife blade found in one vial of Hardcore Energize Bullet drink, manufactured in the United States and sold in Canada, and another blade in one vial of New Whey liquid products, manufactured and sold in the United States."

Both of the products--Hardcore Energize Bullet and New Whey liquid products--are manufactured by Protica Inc., of Whitehall, Pa. The company is investigating this incident.

To read the entire warning, click here.

Do not use or purchase these items.  To do so would expose you to serious health risks.  Be safe.

About the author:

Mr. Zambri has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, including medical malpractice actions.   He has also been named a "DC Super Lawyer" by Super Lawyer magazine (March/April 2009)--a national publication that honors the top lawyers in America.  Our firm has experience pursing cases for patients that involve tragic medical errors, including the failure to properly inform patients of abnormal test results.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Surgery Technician Exposes Thousands of Patients to Hep-C

Posted by: Salvatore J. Zambri, Esquire

According to a Colorado Springs Gazette report, and other reports, a surgery technician, who worked at Rose Medical Center in Denver and Audubon Ambulatory Surgery Center in Colorado Springs, gave patients dirty syringes filled with saline solution and stole clean ones filled with Fentanyl to feed her drug addiction.  Fentanyl is a morphine-based drug that is used as a surgical anesthetic.  Since the technician stole the drugs, the patients were left to suffer.  The technician has been recently charged in a federal criminal complaint.

4,700 patients at Rose and 1,000 patients at Audubon are receiving letters from the medical facilities, advising them of the horrific conduct of the technician and further urging them to get tested for Hepatitis-C. The testing is necessary because the technician was later tested positive for the virus.  Unfortunately, according to reports, several patients have tested positive.

Hepatitis-C is terrible virus that can lead to serious liver problems and even liver cancer. There is no known cure for Hep-C.

Not very long ago, a rogue technician did the same sort of thing at a local, reputable hospital here in the District of Columbia.  Several patients who contracted Hep-C retained me to represent them in an action against the hospital, which I proudly advanced for them.  The technician in the case I pursued should never have been hired, was improperly trained and supervised, and was able to swap syringes for a protracted period of time.  Regrettably, lives were greatly impacted by the technician's wrongful conduct and the hospital's carelessness.

 About the author:

Mr. Zambri has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters, inlcusing medical malpractice actions.   He has also been named a "Super Lawyer" by Super Lawyer magazine (March/April 2009).  Our firm has experience pursing cases for patients that involve tragic medical errors.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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Doctors Fail to Report Abnormal Test Results At Alarming Rate

Posted by: Salvatore J. Zambri, Esquire

Doctors fail to report clinically significant findings to their patients in more than seven percent (7%) of the cases, according to the Associated Press, relying on a new study published Monday in the Archives of Internal Medicine.  Physicians' use of electronic medical records tended to lower instances of failures to inform.  The frequency of errors is higher in practices that used a combination of electronic and paper records, as opposed to practices that relied on only paper or only electronic records, reports Nicholas Bakalar of the New York Times.    

We encourage doctors to utilize the electronic technology now available to better communicate with patients and other physicians regarding a patient's symptoms and conditions.  Reckless record-keeping leads to needless deaths and injuries.  There is a crisis in this country--too many Americans die each year as a result of hospital and doctor errors.  Nearly 100,000 people die every year as a result of hospital mistakes alone.  Safety needs to be a priority as we move forward.

About the author:

Mr. Zambri has been rated by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all lawyers in the Washington metropolitan area.  The magazine also describes him as "one of Washington's best--most honest and effective lawyers" who specializes in personal injury matters.  He has successfully litigated multiple cases against Metro and other automobile owners.  He has also been named a "Super Lawyer" by Super Lawyer magazine.  Our firm has experience pursing cases for patients that involve tragic medical errors, including the failure to properly inform patients of abnormal test results.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

If you want more information about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Matrixx Withheld Consumer Complaints

Posted by: Salvatore J. Zambri, Esquire

Shannon Pettypiece reports for Bloomberg that Matrixx Initiatives Inc. announced that it failed to turn over to U.S. regulators about 800 consumer complaints concerning serious side-effects linked to its Zicam nasal spray and swabs, which have been withdrawn.

According to the report, "Matrixx, based in Scottsdale, Arizona, stopped selling the cold remedies on June 16 after the Food and Drug Administration warned consumers the treatments may cause a loss of smell. Matrixx today defended its products and called the FDA warning 'a surprise,' during a conference call with analysts."

The 800 complaints were unearthed only after the FDA performed a routine inspection found 800 reports of consumer concerns this past May.  William Hemelt, acting president and chief operating officer of Matrixx, said that he was informed that  his compnay did not need to report the complaints despite a 2007 regulation requiring companies to turn over reports of serious side effects, arguing that the regulation didn't apply. 

“We have complaints but we weren’t required to send them,” Hemelt said. “At least we didn’t believe we were required to send them and we based that on an opinion of counsel who looked at the FDA regulation and said no, it doesn’t fit.”

The FDA reported that doctors and consumers have linked a permanent loss of smell to the us of the medications.

When companies withhold critically important information it smacks of putting profits over people.  Safety and public health should always be the paramount concern of drug companies. 

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please contact Mr. Zambri at 202-822-1899 or email him at szambri@reganfirm.com.

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Medical Device Oversight Required

Posted by: Salvatore J. Zambri, Esquire 

According to a Reuters article, reported by James Pethkoukis, experts have determined that the FDA's approval process needs to be improved to better protect patients from dangerous risks.

At a congressional hearing, Representative Frank Pallone, who chairs a House Energy and Commerce subcommittee, stated, "There is evidence of an approval system that is broken -- that its standards, its procedures and its rules don't meet modern needs of getting medical devices to those in need with confidence in their safety." The article further comments that "Marcia Crosse, healthcare director for the nonpartisan Government Accountability Office, said various shortcomings 'raise concerns' about the FDA's pre-approval reviews and post-approval monitoring 'that are necessary for ensuring the safety and effectiveness of medical devices.'"

Although Americans benefit greatly from new products, the FDA must do more to protect those who will be using the products in the end--the patients. Without serious oversight, great harm can result.

Our firm has experience pursing cases for patients that involve tragic medication errors, pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability  authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact Mr. Zambri at 202-822-1899.

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , U.S. Food and Drug Administration Warnings
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FDA Warns of Dangers of Sirolimus (Rapamune) for Liver Transplant Patients

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Recently, MedPage Today reported that "The FDA issued an alert regarding the risk of increased mortality in stable liver transplant patients who switch from a calcineurin inhibitor-based (CNI) immunosuppressive regimen to sirolimus (Rapamune)."  It was noted, however, "that a causal relationship has not been established and that" the FDA "is not recommending discontinuation of the drug, which is indicated for prevention of organ rejection in kidney transplant recipients older than 12."

The label for the drug "already carries a boxed warning of excess mortality and graft loss associated with the use of" sirolimus "in combination with tacrolimus (Prograf) in de novo liver and lung transplant recipients."  And it also warns that it is not clear that the drug is safe for liver or lung transplant patients.  Doctors, therefore, should heed those warnings, comments the FDA.  Prescribing medication in a way that is contrary to the labeling may lead to serious permanent injury or death.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030. 

Posted In Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Cholesterol-type Not Usually Screened May Cause Heart Attack

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Medical News Today recently reported that a certain kind of cholesterol--known as lipoprotein (a)--may increase the risk of heart attack (medically referred to as myocardial infarction, or MI).  This type of cholesterol, says the article, has been screened little.  Historically, doctors ahve been screening patients for low-denisty lipoproteins, commonly called "bad protein".  Nevertheless, MI has continued to be a leading cause of death.  As a result, scientists have been looking at other caused of heart disease.

The theory about lipoprotein (a) leading to heart disease stems from a study of people living in Denmark, who had higher levels of lipoprotein (a) due to genetic reasons, and who were at a higher risk of heart attack.  The article comments that the "researchers suggested that although their findings were strong enough to support the idea that higher levels of lipoprotein (a) due to genetic reasons very probably cause higher risk of heart attack, only randomized clinical trials that show fewer heart attacks occur when lipoprotein (a) is reduced through therapy can prove it."  So, expect more studies.

According to the report, representatives of "the National Heart, Lung and Blood Institute's Framingham Heart Study commented that although Kamstrup and colleagues revealed some 'interesting mechanistic insights' into the biological link between lipoprotein (a) and MI, and put forward evidence that there might be potential benefit in reducing lipoprotein (a) early in life, the 'clinical implications are quite limited.'"

Before taking any medication, we encourage you to seek the advice of competent physicians. 

Our firm has experience pursing cases for patients that involvee tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Issues Warnings About Clarcon Skin Products

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The AP recently reported that  "The Food and Drug Administration warned consumers Monday not to use skin products made by Clarcon." This warning followed a recent inspection which revealed high levels of disease-causing bacteria in the products.  According to the report, the FDA has said that the findings are "particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds and damaged skin and protect against various infectious diseases."  Yet, according to the report, some of the bacteria found in the products "can cause opportunistic infections of the skin and underlying tissues and could result in medical or surgical attention as well as permanent damage," the report comments.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.


 

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Merck & Co., Schering-Plough Accused of Fraud

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Bloomberg News reports that "Merck & Co. and Schering-Plough Corp. were sued by a Pennsylvania fund for active and retired state employees over claims they misled consumers into paying too much for prescriptions of Zetia [ezetimibe] and Vytorin cholesterol pills."  The Pennsylvania Employees Benefit Trust Fund alleges in a complaint that "the companies have known for years -- and failed to make public -- that Zetia doesn't reduce fatty arterial plaques that can cause heart attacks and strokes."  The reports commenst that two studies last year showed that "the pills may work no better at unclogging arteries than does an older, cheaper medicine called simvastatin." Nevertheless, the companies allegedly withheld the the finding and "used false and deceptive marketing techniques claiming Vytorin was more efficacious than and just as safe as the much cheaper generic," according to the report.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Dirty Syringes From Plant Kill and Injure: FDA Could Have Intervened

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Natalie Fullerton's father feels like he is responsible for the death of his child, but he's not.  After a successful lung transplant, Natalie was thriving.  Her loving father tirelessly cared for her post-surgery, administering medication with the use of syringes.  The syringes, however, were manufactured at a factory owned by a Lake Zurich businessman.  And they were contaminated.  Natalie died.  She was 2 1/2 years old.

The tainted syringes from the plant are now "linked to four deaths and 162 illnesses nationwide, including 22 in Illinois", according to ChicagoTribune.com.  The report comments that "an examination of inspection reports and other documents shows that the U.S. Food and Drug Administration missed several chances to stop the tainted syringes from being used by patients."

According to the article, just three months before the contaminated syringes were shipped (in October 2007), "an FDA inspector visited the plant in North Carolina where they were made. She investigated reports of red, brown and black particles in syringes and reported that managers had a plan to deal with rust."  Those plans were either faulty or non-existent, and teh FDA did not follow-up sufficiently it is suggested.

"A week later, when the FDA learned a distributor was recalling 1.3 million of the syringes, the agency should have launched a thorough inspection, according to its operations manual. That didn't happen, an FDA spokeswoman now says, because the agency is so understaffed it no longer follows the policy unless the recalled product poses a reasonable probability of serious injuries or deaths."

The bacteria on the syringes never should have entered the marketplace.  And, unfortunately, there is plenty of blame to go around.  The owner of the plant is now a fugitive of law.  He fled the country and is trying to evade charges that could land him 95 years on prison.

When dispensing medical devices, medical providers must be sure they are sterilized.  Manufacturers and distributors must do the same.  Natalie may not be the last victim of corporate greed and carelessness, but the FDA must do more to protect Americans of all ages.  That's what we pay them to do.

Our firm has experience pursing cases for patients that involve tragic medication or other medical errors.   If you think your providers have ignored your symptoms, we encourage you to read an article regarding medical malpractice authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

 

 

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Window for Clot-Busting Drug tPA Opened

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The American Heart Association/American Stroke Association has established a new guideline, based on European studies,  concerning when a clot-busting drug known as tPA can be given intravenously to stroke victims. Previously, the guideline in America was to provide the drug only within three hours of the onset of symptoms,; otherwise, it could do more harm than good.  This posed a problem to patients who, for one reason or another, could not get to a hospital quickly enough following the start of stroke symptoms.  The new guideline extends the time in which the drug can be administered to four and one-half hours after symptoms begin.

It is important, however, to recognize that the widening of the window does not mean that doctors should act slowly when treating patients with stroke symptoms. The faster the clot in the brain is relieved, thereby restoring normal blood flow, the greater the likelihood of recovery.

The following is the American Stroke Association's list of "warning signs of stroke:

  • Sudden numbness or weakness of the face, arm or leg, especially on one side of the body
  • Sudden confusion, trouble speaking or understanding
  • Sudden trouble seeing in one or both eyes
  • Sudden trouble walking, dizziness, loss of balance or coordination
  • Sudden, severe headache with no known cause"

If experiencing any of the warning signs of stroke, seek immediate medical attention, as time is of the essence.

Our firm has experience pursing cases for patients that involve tragic medication or other medical errors.   If you think your providers have ignored your symptoms, we encourage you to read an article regarding medical malpractice authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Women's Health Issues
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Atypical Antipsychotic Medications Effective But Risky for Children

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

According to the The Wall Street Journal, staff from the Food and Drug Administration (FDA) indicate that three medications "currently approved to treat bipolar disorder and schizophrenia in adults were effective at treating the disorders in children and adolescents, but carry significant risks." As a result, the FDA is now "considering applications for AstraZeneca PLC's Seroquel [quetiapine] and Eli Lilly and Co.'s Zyprexa [olanzapine] to treat bipolar disorder and schizophrenia in children and adolescents, and Pfizer, Inc.'s Geodon [ziprasidone] to treat bipolar disorder in children 10 to 17," comments the report.  In fact, "an FDA panel of outside medical experts is scheduled to meet to discuss" these atypical antipsychotic medications, and will be "asked to vote on whether each product is safe and effective for children ages 10 to 17."  The report goes on the add that the FDA and the drug-makers announced that "studies showed the products were effective at treating the symptoms of bipolar and schizophrenia," but also warned that "all had side effects."  These sides effects include "sedation and weight gain."

We encourage our readers to speak with their doctors before taking any medication.  Mixing drugs can be particularly dangerous.  Some drugs pose greater health risks than others.  Relying, too, on what the FDA reports and what the drug-makers themselves state about their own medications may not be sufficient.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Propylthiouracil Poses Serious Liver Injury

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

An U.S. Department of Health and Human Services (HHS) report confirms that, two days ago, the U.S. Food and Drug Administration (FDA) "warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil for the treatment of Graves' disease."  Citing the FDA, HHS reports that: "After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves' disease. If propylthiouracil therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy."

Graves' disease is an autoimmune disorder which causes the thyroid gland to be overactive. The thyroid gland releases hormones that regulate the rate of the body’s metabolism.  These hormones "are critical for body temperature control, energy, weight, mood, and blood calcium levels."

Medications can have serious side-effects, especially if warnings and precautions are not taken seriously. Doctors should fully inform patients of all risks associated with prescribed medications and patients should never hesitate to ask their doctors for more information if they are confused about the risks of certian medications.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA May Require More Warnings on Tamoxifen Label

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

We recently posted a blog informing our readers that a Bloomberg report announced that  researches have determined that certain antidepressants may increase the recurrence  of breast cancer among women who have already survived the disease.  The study reports that drugs including Prozac, Paxil and Zoloft "significantly decrease the effectiveness of a drug [tamoxifen] used to reduce the chances of breast cancer recurrence". 

A new Bloomberg report of yesterday confirms that "US regulators may warn patients taking tamoxifen, a breast cancer medicine...not to use certain types of antidepressants because they block the tumor-fighting drug's effectiveness." Karen Riley, a spokeswoman for the Food and Drug Administration, commented that the agency is considering "'adding new information to the tamoxifen label to advise women taking the cancer drug against using some antidepressants."

Ms. Riley's comments are welcomed, but action is what is needed.  The public must be warned of the harmful effects of mixing these drugs.  It could be a matter of life and death.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Acid-Suppressive Medications Linked to Increased Risk for Hospital-Acquired Pneumonia

According to a recent study summarized in the Journal of the American Medical Association, use of acid-suppressive medications is associated with increased risk for hospital-acquired pneumonia.  For this study, researchers examined electronic medical data for nearly 64,000 adults hospitalized at one medical center for at least three days over a four-year period.  About half of the patients were prescribed proton-pump inhibitors or histamine-2-receptor antagonists during their hospital stays.  Their conclusion was that "further scrutiny is warranted regarding inpatient prescribing practices" of acid-suppressive drugs.

Below is an abstract of the research, as it appeared in the Journal of the American Medical Association:

"Authors: Shoshana J. Herzig, MD; Michael D. Howell, MD, MPH; Long H. Ngo, PhD; Edward R. Marcantonio, MD, SM

JAMA. 2009;301(20):2120-2128.

Context: The use of acid-suppressive medication has been steadily increasing, particularly in the inpatient setting, despite lack of an accepted indication in the majority of these patients.

Objective: To examine the association between acid-suppressive medication and hospital-acquired pneumonia.

Design, Setting, and Patients: Prospective pharmacoepidemiologic cohort study. All patients who were admitted to a large, urban, academic medical center in Boston, Massachusetts, from January 2004 through December 2007; at least 18 years of age; and hospitalized for 3 or more days were eligible for inclusion. Admissions with time spent in the intensive care unit were excluded. Acid-suppressive medication use was defined as any order for a proton-pump inhibitor or histamine2 receptor antagonist. Traditional and propensity-matched multivariable logistic regression were used to control for confounders.

Main Outcome Measure: Incidence of hospital-acquired pneumonia, defined via codes from the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), in patients exposed and unexposed to acid-suppressive medication.

Results: The final cohort comprised 63 878 admissions. Acid-suppressive medication was ordered in 52% of admissions and hospital-acquired pneumonia occurred in 2219 admissions (3.5%). The unadjusted incidence of hospital-acquired pneumonia was higher in the group exposed to acid-suppressive medication than in the unexposed group (4.9% vs 2.0%; odds ratio [OR], 2.6; 95% confidence interval [CI], 2.3-2.8). Using multivariable logistic regression, the adjusted OR of hospital-acquired pneumonia in the group exposed to acid-suppressive medication was 1.3 (95% CI, 1.1-1.4). The matched propensity-score analyses yielded identical results. The association was significant for proton-pump inhibitors (OR, 1.3; 95% CI, 1.1-1.4) but not for histamine2 receptor antagonists (OR, 1.2; 95% CI, 0.98-1.4).

Conclusions: In this large, hospital-based pharmacoepidemiologic cohort, acid-suppressive medication use was associated with 30% increased odds of hospital-acquired pneumonia. In subset analyses, statistically significant risk was demonstrated only for proton-pump inhibitor use.

Author Affiliations: Divisions of General Medicine and Primary Care (Drs Herzig, Ngo, and Marcantonio), Pulmonary and Critical Care (Dr Howell), and Gerontology (Dr Marcantonio), Beth Israel Deaconess Medical Center, Boston, Massachusetts; and Harvard Medical School, Boston (Drs Herzig, Howell, Ngo, and Marcantonio)."

Posted In Medications , Men's Health Issues , Women's Health Issues
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Maryland Rejects Link Between Vaccinations and Autism

By Victor E. Long, Esq. 

The Maryland Court of Appeals upheld the dismissal of  a case which sought to  draw a link between the  Thimerosal and Autism.   The high court affirmed a ruling, the first in the nation, subjecting the thimerosal/autism link to a  difficult evidentiary test.  The defendant's moved to disqualify five potential experts on the grounds that the experts were not qualified in epidemiology, the study of the distribution of diseases in populations.  The motion led to a ten day evidentiary hearing.  The CDC has concluded that the evidence favors rejection of a causal relationship.  Many vaccines contain thimerosal.

Blackwell et al v. Wyeth ,CA No. 112 Sept. Term 2008 Filed May 7, 2008.

 

 

Posted In Medications , Patient Safety , Product Liability , Public Health
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Tarceva Warnings Added

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Food and Drug Administration (FDA), along with manufacturers OSI and Genentech, notified healthcare professionals of new safety information that has been added to the " WARNINGS AND PRECAUTIONS" sections of the prescribing information for Tarceva.  The FDA reports that "[g]astrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva." (emphasis added).  Tarceva has been used to treat patients with certain kinds of lung cancer after at least one prior chemotherapy regimen proved to be unsuccessful.  It has also been prescribed to treat patients with pancreatic cancer.

To read the entire FDA report, please click here.

Medications can have serious side-effects, especially if warnings and precautions are not taken seriously. Doctors should fully inform patients of all risks associated with prescribed medications and patients should never hesitate to ask their doctors for more information if they are confused about the risks of certian medications.

Our firm has experience pursing cases for patients that involve tragic medication errorspharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Two Delaware Patients Die from Taking Heparin

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The Wall Street Journal reports, "Two Delaware patients died last weekend after taking heparin, a widely used blood thinner made by Baxter International Inc., sparking concerns about a repeat of fatal heparin contamination in 2008." Baxter is quoted in the article as stating that "the heparin involved in the cases of the two patients who died is from North American-derived bulk material supplied by Pfizer Inc. In the heparin deaths last year, the bulk material came from China."  According to the press statements, the FDA has "sent medical teams to Delaware, and an FDA agent drove samples of the heparin bags directly to an agency laboratory in Queens, New York."

According to the Chicago Tribune (5/12, Japsen) the hospital where the incidents occurred, the Beebe Medical Center has suspended the use of heparin. "Adverse reactions were reported in five patients who had problems that included internal bleeding in the brain."  It was reported that the new complications involve premixed intravenous bags of heparin. Last year's problems involved bulk supplies, vials of the medicine and drug-coated medical devices.

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Hearing Tomorrow On Medical Device Safety Act of 2009

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Subcommittee on Health will hold a hearing tomorrow regarding The Medical Device Safety Act of 2009.   This is an important piece of legislation that should become law.  We encourage our readers to contact their representatives in Congress and urge them to vote in favor of the bill.

The Medical Device Safety Act of 2009 is important for two principal reasons.  First, it will allow every American patient to hold manufacturers of defective medical devices accountable for injuries and deaths caused by unsafe products.  It will also prevent the manufacturers of defective devices from receiving total immunity from any claims simply because the devices were previously approved by the Food and Drug Administration (FDA). 

On March 19, 2009, the editors of the New England Journal of Medicine endorsed the Medical Device Safety Act. They stated:

"Patients and physicians deserve to be fully informed about the benefits and risks of medical devices, and the companies making the devices should be held accountable if they fail to achieve this standard. We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts."

The New York Times has also endorsed the bill.

Medical devices can be extremely dangerous, and the FDA often does a poor job screening defective products from the public.  If your doctor wants to insert a medical device into your body, ask questions to be sure your physician has sufficiently investigated the device's safety and effectiveness.

If you think you have been injured by a defective device, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Warning About Insulin Box Mix Ups - Can be Deadly for Patients

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The Institute for Safe Medication Practices (ISMP) issued a warning to health care providers that storing insulin vials inside their cardboard cartons after the packages have been opened can be a medical emergency waiting to happen.

The warning explains, that "if the vial is accidentally returned to the wrong carton after being used, that sets the stage for a serious insulin mix-up.   That is because the next person looking for a particular insulin product could read the label on the carton, assume that it accurately reflects what is inside, and end up administering the wrong product."

ISMP recommends that the cartons be thrown out, either in the pharmacy before the medication is dispensed, or when at the nursing station. The bottom line? Do not dispense or store insulin vials in their cartons on patient care units.

Medication errors by health care providers and hospital personnel can be life threatening.  In most instances these tragic errors should have been prevented.  If you have questions about a medication error that caused permanent injury or contributed to the death of a patient you speak with an experienced medical malpractice attorney about the circumstances or call us (202 463-3030. 

 

Posted In Medications , Patient Safety , U.S. Food and Drug Administration Warnings
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FDA Issues Guidelines for Drug Disposal

By Victor E. Long, Esq.

The FDA has issued guidelines on the disposal of prescription drugs.  The Kaiser Family Foundation states that the average American takes more than 12 prescription drugs annually, with more than 3.8 billion prescriptions purchased each year,

Previously, three federal agencies--the White House Office of National Drug Control Policy, Department of Health and Human Services and Environmental Protection Agency--jointly released new guidelines in February designed to help people safely trash their prescription  drugs.   According to an Enviromental Protection Agency spokesperson  "Flushing medication down the toilet is probably the least desirable of the alternatives," 

Continue Reading Posted In Medications , U.S. Food and Drug Administration Warnings
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Massage and Accupuncture Relieve Pain after Cancer Surgery

By Victor E. Long, Esq.

Studies show that practices such as meditation or guided imagery and visualization can be calming. Yoga and tai chi also may be helpful. Acupuncture has been shown to provide relief for some kinds of pain. Herbs, such as peppermint and ginger, may help ease the nausea and vomiting associated with chemotherapy. 

 According to a recent study reported in the Journal of Pain and Symptom Management , massage and acupuncture relieved pain and depression in surgery patients more than traditional postoperative care alone.  In the study, both massage and acupuncture were given for 10-30 minutes at the bedsides of 138 people who underwent surgery for intestinal and other cancers. Swedish massage was used along with an acupressure foot massage. Acupuncture was given at points related to the patients' symptoms, which included pain and nausea.

Continue Reading Posted In Medical Malpractice , Medications , Public Health
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Transdermal Drug Patch Users Advised to Remove Patch Before MRI

"The U.S. Food and Drug Administration (FDA) has issued a public health advisory recommending that individuals who use transdermal drug patches that contain aluminum or other metal backing remove these patches before undergoing MRI (magnetic resonance imaging) scans. These patches may cause skin burns during the scan.

Transdermal patches, which contain a time-release dose of medication that is absorbed through the skin and into the blood stream, are used for delivery of several types of drugs; these include nicotine for smoking cessation, estrogen for management of menopausal symptoms, nitroglycerin for angina (chest pain), and several forms of pain medication. Some of these patches contain aluminum and other metals, which are used as backing.

Even though this metal backing is not in contact with the skin, it can overheat during an MRI and cause a painful burn on the patient’s skin. In an effort to avoid such injury, the FDA advises that patches containing metal are removed prior to an MRI and individuals who use transdermal patches look for warning labels about risk of burns. And, because not all patches containing metal currently have warning labels, it’s recommended that any patch containing metal is removed before an MRI scan.

In order to avoid a burn during an MRI scan due to metal backing on a transdermal patch, patients are advised to talk to their physician about removing and discarding the patch before undergoing the scan. Physicians will also advise patients about replacing the patch after the scan. As well, when an MRI is scheduled, patients should notify the facility performing the scan that they use a patch. This will help ensure that the correct procedures are followed to remove the patch before the scan and replace it with a new one following the MRI.

The risk of burning associated with transdermal patches during an MRI is avoidable. By consulting with physicians, being aware of this potential complication, and following correct safety procedures, patients can get the most benefit from transdermal medications and MRIs, safely and comfortably."

Reference: Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings [FDA Public Health Advisory]. US Food and Drug Administration Web site.

April 16, 2009.

Posted In Medications
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FDA Recalls 34 Dietary Supplement Products

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The Food and Drug Administration ("FDA ") notified consumers and health care professionals of a recall of 34 dietary supplement products. The FDA lab identified undeclared sibutramine, which is more commonly known as "Meridia",  an FDA-approved drug, used as an appetite suppressant for weight loss. FDA advises that the products listed below pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

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Is the FDA ignoring realities of Internet marketing?

In the New York Times advertising column, Stephanie Clifford writes that "the Food and Drug Administration sent letters to 14 major pharmaceutical companies late last month, "warning them that their "search advertisements...had to start including risk information about each drug or else be rewritten or removed."

The companies, however, argued that "there was no way to include all the required information" within the "95 characters...allowed for search ads." According to Arnie Friede, counsel at McDermott, Will & Emery, "Until these letters were sent, pharmaceutical and media companies had assumed that there was a one-click rule" under which they would be "in compliance" if they "provided risk information within one click of their search ads." In changing the ads, industry executives now claim they "are even more confusing and misleading" and that "the agency is ignoring the realities of Internet marketing." Furthermore, the drug industry argues that the FDA "is not issuing clear rules about compliance."

Posted In Medications , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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Attention-Deficit Drugs May be Harmful

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Nearly forty million prescriptions were written in 2008 in an effort to treat Attention Deficit Hyperactivity Disorder (ADHD). A recent study, however, warns that many of these widely prescribed drugs may cause more harm than good, especially if taken for more than two years. According to the study, prolonged use of ADHD medications can lead to significantly stunted growth.

To read the study, which was published in the Washington Post, please click here.

One lesson to take from the study is that it is critically important for parents to communicate well and often with their children's physicians and to question any prolonged prescription plan recommended by a physician. The more informed you are as parents, they better you are able to make decisions in your children's best interest.

For information about your legal rights, please click here or call the law firm of Regan Zambri & Long, PLLC at 202-463-3030.

 

 


 

Posted In Medications , Patient Safety , Pediatrics
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FDA Warning: Psoriasis Medication Raptiva Withdrawn from Market

On April 8, 2009, Genetech and the US Food & Drug Administration (FDA) announced a voluntary phased withdrawal of Raptiva (efalizumab) from the U.S. market.  We have reproduced the FDA  statement for our readers in its entirety.

FDA Statement

 FOR IMMEDIATE RELEASE
Statement
April 8, 2009

Media Inquiries:
Rita Chappelle, 301-796-4672
Consumer Inquiries:
888-INFO-FDA

FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market

Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States.

Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to other alternative therapies for psoriasis.

The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML. On Oct. 16, 2008, FDA updated the FDA-approved labeling for Raptiva to warn of the risk of life-threatening infections, including PML. On Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva's labeling regarding PML.

Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis.

Prescribers should continue to monitor patients on Raptiva for neurologic symptoms that might represent PML. Prescribers and patients may report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

More information about the withdrawal of Raptiva is available on the Genentech Web site: www.gene.com/gene/products. Prescribers with questions about Raptiva may contact Genentech Medical Communications at (800) 821-8590.

Additional Information
Efalizumab (marketed as Raptiva) Information

For information about your legal rights, please click here or call
the law firm of Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medications , Patient Safety , U.S. Food and Drug Administration Warnings
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Avandia: More Evidence that Risks Outweigh Potential Benefits

During the past several years, researchers have discovered that Avandia, used to treat Type 2 diabetes, increases patient risks for a variety of problems, including, but not limited to:

  • 43% increase for heart attack risk
  • 64% increased risk of death from heart disease
  • double risk for bone fractures
  • increased risk of anemia
  • increased risk of vision loss from macular edema

Recent research conclusions published in the America Diabetes Association's (ADA) Diabetes Care advises against use of Avandia because of an increase in life-threatening liver toxicity.  Both the American Diabetes Association and the European Association for the Study of Diabetes released a consensus statement concluding  "given that other [treatment] options are now recommended, the consensus group members unanimously advised against using rosiglitazone (generic name for Avandia)."

Public Citizen, a national non-profit public interest organization requested that FDA ban Avandia in its petition.  Earlier, the FDA included black-box warnings for Avandia, which later were strengthened as more dangers were documented.  The DC Metro Area Medical Malpractice Blog provided summaries and links for earlier FDA notices:  

Although Avandia prescriptions have decreased sharply since the first warnings were revealed, there are still approximately 10,000 prescriptions being filled every day for it.  If you have been prescribed Avandia, consult your physician to determine whether you are a candidate for an alternative medication. 

If you or a family member believe that you have a case involving a medication or medical care please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.

 

 

 

 

Posted In Medications , Patient Safety
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Supreme Court Ruling in Wyeth v. Levine: Victory for Justice

The Supreme Court of the United States recently announced its ruling in the Wyeth v. Levine case. The principal question before the Court was whether FDA approval of a drug's label overrides (or preempts) state-law claims of inadequate warning. The argument made by the drug company was that it would be impossible to comply with both state and federal laws if the state's law provides for a stronger warning label than the FDA labeling regulation. The Supreme Court rightly rejected that argument, finding that "Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness." By issuing this ruling, the Court will allow consumers more protection from drug injuries that could have been prevented if the drug label had included proper warnings.

In this case, Diane Levine, a professional musician being treated for migraine headaches was injected with Phenergan, a drug manufactured by Wyeth. Because of the direct IV administration (IV push) of the drug, Ms. Levine's artery in her arm died, ultimately resulting in amputation of that arm. Wyeth was aware of the dangers of the IV push method for administering Phenergan, but never included any warnings to prohibit IV push administration on the label. The FDA had not determined whether the label should have included the warning. However, the FDA's labeling rules require that a prescription drug manufacturer change warning labels as soon as there is reasonable evidence that the drug causes adverse reactions without waiting for FDA approval of the label change.

Government regulations are intended to set minimum safety standards, but cannot guarantee safety. The preamble of regulations was intended to define the agency's interpretation. Beginning in 2005, Federal agencies started adding to the preamble of regulations without Congressional approval. With these additions, the agencies claimed that federal standards overrule any state safety standards and that state tort claims should be discarded. By adding preemption language to the agency preamble, the agencies bypassed Congress in determining if or when state law should be overruled. In 2007, however, Congress passed the Food and Drug Administration Act of 2007 (FDAAA), forcing the FDA to require drug manufacturers to update their labels when the manufacturers become aware of potential hazards.

If you or a family member has been injured as a result of a drug error or other product defect, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.

 

Posted In Medications , Patient Safety , Product Liability
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FDA Reevaluates Standards and Rules for Children's Cold Medicine in Response to Mounting Evidence of Hazardous Effects

New FDA-regulated modifications to over the counter cold and cough medicines should be observed by parents of young children. The following is the FDA statement regarding the new regulations applied to over-the-counter cough and cold medicine. Links have been added to the original statement for the readers' convenience.

Continue Reading Posted In Medications , Patient Safety , Pediatrics , U.S. Food and Drug Administration Warnings
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FDA Warns Websites: Cease Sales of Fraudulent Cancer Remedies

  According to a report on medicalnewstoday.com, consumer complaints and Internet searches conducted by members of the Mexico-US-Canada Fraud working group lead the Federal Drug Administration (FDA) to find that 125 products sold online, that are boasting prevention, treatment, and/or cures for cancer, are fraudulent. Government officials are concerned that these products will interfere with legitimate cancer treatment and/or be independently harmful to individuals. Furthermore, it is worrisome that cancer patients may rely on these false claims and not seek appropriate medical care.

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FDA Warns Consumers About Two Baltimore Pharmacies

The FDA has issued a warning to consumers regarding expired and suspected counterfeit drugs for two Baltimore pharmacies.   The FDA News Release is reproduced below in its entirety.  

                            FDA News

FOR IMMEDIATE RELEASE
August 8, 2008

Media Inquiries:
Rita Chappelle, 240-753-8603
Consumer Inquiries:
888-INFO-FDA

 

              FDA Warns Consumers About Potential Problems

                                at Two Baltimore Pharmacies

Expired and suspected counterfeit prescription drugs

found at pharmacies

The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.

The products in question include: 

  • Lisinopril (20 milligrams)
  • Guaifenesin/Dextromethorphan (600 mg and 1000 mg)
  • Gabapentin (100 mg, 300 mg and 400 mg)
  • Metoprolol (50 mg)
  • Nifedipine (30 mg)
  • Diclofenac Sodium (30 mg)
  • Glucophage (500 mg Extended Release)
  • Glucovance (125 mg and 500 mg)
  • Glipizide/Metformin (2.50 mg/250 mg)
  • Furosemide (20 mg)
  • Tamoxifen Citrate (10 mg)
  • Metformin HCl ER (500 mg)
  • Calcitrol (0.25 micrograms)

The FDA has no evidence that any other Medicine Shoppe pharmacies outside of the 8035A Liberty Road and 5900 Reisterstown Road facilities are involved.

Because the safety and efficacy of the listed drugs has not been established, the FDA is strongly advising consumers who filled prescriptions for these drugs at these two pharmacies to contact their prescribing physician immediately for new prescriptions. Additionally, consumers in possession of the above listed prescription drugs from these pharmacies should call FDA at 800-521-5783 for further information on how to dispose of the drugs.

Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.

 

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Sound-Alike Drug Names Increase the Risk of Medication Errors

Whether the drug names are Celexa and Celebrex, Losec and Lasix, or even Prilosec and Prozac, sound-alike drug names pose dangers to patients.  Those dangers are compounded by the multi-ethnic and geographic diversity of the U.S. healthcare system, where strong accents combined with ordinary mispronunciation of complex pharmaceutical terms can lead to catastrophic outcomes if the wrong medication is accidentally dispensed.  Medication errors and sound-alike drug names are the topics of a recent article featured on HealthDay News.

Continue Reading Posted In Medical Malpractice , Medications , Patient Safety , Product Liability
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Back-to-School Safety: Make Certain Your Children Are Fully Vaccinated

Making certain that young children receive their recommended vaccinations is particularly important for their long-term health ― as well as for the health of their friends and classmates. Vaccines protect children against common seasonal diseases like the flu, but they also help prevent much rarer, more serious diseases.

All parents can determine what vaccines their children need and when the doses should be administered by consulting the nationally recommended Childhood Immunization Schedules, available on the web site of the U.S. Centers for Disease Control and Prevention (CDC).

If a child falls behind schedule on his or her vaccinations, it can sometimes be difficult to determine the best way to catch up. To help, the CDC has developed a Catch-Up Immunization Scheduler -- an online tool that shows parents and healthcare providers the best options for getting children six years of age and younger back on schedule.

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Rates of Accidental Medication Overdoses in the Home Rapidly Increasing

The number of fatal medication errors occuring in people's homes has risen dramatically in recent years, particularly in those situations where alcohol or street drugs are also involved.  The finding is the result of research published in a recent edition of the Archives of Internal Medicine.  Authors of the study note that the number of years of potential life lost due to these home-based medication errors is likely greater than the number of years of life lost from all other accidents combined -- including falls and automobile accidents.

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Guinea-Pigging: Drug Safety Trial Testing for a Living?

Guinea-Pigging, a drug safety-testing method increasingly used by pharmaceuticals, was recently reviewed by bioethicis professor Carl Elliott.  His article discusses the trend of participating in drug trials and testing and making a living off the income.  Professor Elliot cites many concerns regarding "guinea-pigging," which may affect the safety and welfare of the subject as well as the validity of the study.

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Fewer Pediatric Rotavirus Cases Reported this Season

Rotavirus cases in the current 2007-2008 season showed up much later than usual and have been less severe, overall, than during any previous season on record, according to an interim report issued by the U.S. Centers for Disease Control and Prevention (CDC).

Continue Reading Posted In Medications , Men's Health Issues , Pediatrics , Public Health , Women's Health Issues
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Few Physicians Adopt Electronic Medical Record Technology: New Study

Electronic medical record systems have been touted as the wave of the future in healthcare and research has demonstrated their value in preventing medical errors.  According to new data published in the New England Journal of Medicine, however, only 4% of physicians have extensive, fully-functioning electronic systems, and only 13% have even a basic system.

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FDA to Require Boxed Warnings on Older Antipsychotic Drugs

The U.S. Food and Drug Administration (FDA) utilized its new authority this month under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of older or "conventional" antipsychotic drugs to make safety-related changes to prescription information and labeling.  The required changes are to warn of an increased risk of death linked to the off-label use of these drugs to treat behavioral problems in older people suffering with dementia

Continue Reading Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Patient Safety , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Darvon and Darvocet: Too Risky to Prescribe?

Public Citizen, a consumer advocacy group, has recently sued the FDA over the organization's failure to respond to a petition addressing the risks of prescribing Darvon, Darvocet, and other medications containing propoxyphene.  Public Citizen filed a lawsuit in the U.S. District Court in Washington, DC alleging the FDA's failure to respond to their petition to ban the drug within the six months mandated by law. Continue Reading Posted In Medications , Patient Safety , Public Health
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FDA Takes Action to Eliminate Sham Cancer "Cures"

According to the U.S. Food and Drug Administration, 23 U.S. companies and two international manufacturers have been warned to cease their production and marketing of fraudulent cancer remedies.  The agency is also warning consumers not to purchase the products, which include ingredients such as bloodroot, coral calcium, cesium, shark cartilage and Cat's Claw, among others.  Continue Reading Posted In Medications , Patient Safety , Public Health , U.S. Food and Drug Administration Warnings
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Whole Milk Safer Than Barium for GI Scans: New Study

Whole milk is as effective as diluted barium when used as an oral contrast agent for patients undergoing a gastrointestinal CT scan.  It's cheaper and safer for patients, according to a new study published in a recent edition of the American Journal of Roentgenology.

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Complementary and Alternative Medicine: It's Time to Talk

The National Center for Complementary and Alternative Medicine (NCCAM) -- a division of the National Institutes of Health (NIH), recently launched an educational campaign to encourage patients (particularly those 50 years of age or older) to speak openly with their primary care providers about complementary and alternative medicines.  The campaign, known as Time to Talk, focuses on medical practices and products that aren't presently considered to be conventional medicine -- items such as herbal supplements, meditation and acupuncture.

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Post-Stroke Care Should Include Antidepressants: New Study

The Houston Chronicle reports that more than 700,000 Americans suffer strokes each year and more than one-third will develop depression in the next two years.  Previous research indicates that stroke patients with depression recover more slowly and are more likely to die.  However, new research suggests that doctors may want to give stroke victims antidepressants right away instead of waiting until they develop depression. 

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FDA's New System to Track Approved Drugs' Effectiveness

The New York Times reported on the Food and Drug Administration's announcement last week of a new system to track already-released drugs' effectiveness. Called the Sentinel Initiative, many bodies such as the Institute of Medicine have recommended such a system for years. Additionally, the Sentinel Initiative is supported by recently-released research showing fast-tracked approval of new drugs leads to problems down the road. However, there are also many criticisms regarding the system's method of collecting data and its accuracy.

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CDC Recommends Shingles Vaccine for Most Adults Over 60 Years of Age

According to statistics reported by the U.S. Centers for Disease Control and Prevention (CDC), almost one in three Americans will develop shingles (herpes zoster) during their lifetime.  The disease is particularly dangerous to people over age 60 and those who are immunocompromised.  Fortunately, there is a way to reduce the risk of developing shingles and the long-term pain that often follows an outbreak of the disease.

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Heart Surgery Drug Trasylol Confirmed Deadly

A new study has confirmed that hospital patients given Trasylol (aprotinin), a drug used to reduce bleeding during heart surgery, are 53% more likely to die than patients who are given other anti-bleeding drugs.  The drug's manufacturer, Bayer AG, has informed the U.S. Food and Drug Administration (FDA) that it has begun removing all remaining stock of Trasylol from all pharmacies and health care facilities in the U.S.

The latest Trasylol study was released Wednesday is slated to appear in print in the May 29 issue of the New England Journal of Medicine.

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CDC Posts Updated Immunization Recommendations for People 18 Years of Age and Younger

The 2008 edition of the schedule of recommended immunizations for people 18 years of age and younger has been posted by the Advisory Committee on Immunization Practices (ACIP) -- a division of the U.S. Centers for Disease Control and Prevention (CDC).  The advisory committee releases new recommendations annually to reflect changes in vaccine formulations and current recommendations for the use of licensed vaccines. 

This summer, don't wait until the last few busy weeks before fall school registration begins to make your child's vaccination appointment -- schedule an appointment now, and enjoy a safer summer. 

Changes from the 2007 immunization schedule are as follows:

Continue Reading Posted In Medications , Men's Health Issues , Pediatrics , Public Health , Women's Health Issues
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Allergy Management Tips for Summer Travel

Despite the rising costs of fuel this year, millions of Americans will be hitting the nation's roads and airports for a summer vacation -- and for those who suffer from seasonal allergies, summer traveling can pose some unique challenges.  The American Academy of Allergy, Asthma & Immunology (AAAAI), reminds travelers that the climate of your destination, rather than your home, determines the pollens and molds to which you'll be exposed on vacation, and that all seasonal allergy sufferers should take time to plan their clothing and needed medications appropriately. 

The academy offers the following additional allergy management tips for summer vacationers:

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Experimental Blood Substitutes Linked to Heart Attack, Death: New Study

New hemoglobin-based artificial blood -- still unapproved for use in the U.S., but heavily studied -- appears to raise a patient's risk of heart attack and death according to an exhaustive review of clinical research data.  This latest research was published in a recent edition of the Journal of the American Medical Association (JAMA).  The findings have spurred critics to allege that the U.S. Food and Drug Administration (FDA) put clinical trial participants in imminent danger by failing to detect or act on research data illustrating significant increases in the rates of heart attack and death reported in trials of these blood substitutes.

Continue Reading Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , Women's Health Issues
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Cardiologists Recommend Heart Screening for Children Taking ADHD Stimulants

The American Heart Association has issued new pediatric recommendations that call for heart fitness screenings prior to stimulant treatment for all children diagnosed with attention-deficit hyperactivity disorder (ADHD).  The new patient safety guidelines were published in a recent issue of the journal Circulation -- official journal of the American Heart Association -- and they address growing fears that stimulant medications can cause serious heart complications in children with underlying, undiagnosed heart disease.

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Head and Neck Cancers in Young Men Traced to HPV Infection

Human Papillomavirus (HPV) -- the sexually-transmitted virus responsible for cervical cancer in thousands of women -- has now been implicated in a rapidly increasing rate of mouth and throat cancers among young men.  Researchers are hoping that a recently-approved HPV vaccine will soon be approved for boys, and tested for its effectiveness in preventing head and neck cancers.  A news article in a recent edition of the Baltimore Sun features Dr. Maura Gillison, an oncologist at Johns Hopkins University's Sidney Kimmel Comprehensive Cancer Center, whose research has been credited with linking the virus and tumors.

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Dietary Supplements Recalled: Toxic Levels of Selenium

The U.S. Food and Drug Administration (FDA) has announced that some flavors of the dietary supplements "Total Body Formula" and "Total Body Mega Formula" have been found to contain dangerously high levels of selenium -- a naturally-occurring mineral that is toxic in high doses.  The sole distributer of the product, Total Body Essential Nutrition, Inc., has issued a voluntary recall. 

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CDC: Poor Vaccine to Blame for Worst Flu Season in Three Years

This year's flu season was worse that the previous three, partly because the flu vaccine didn't effectively defend people against the viruses that made them sick, according to the U.S. Centers for Disease Control and Prevention (CDC).  The flu season started slowly this year, peaked in February, and seems to finally be declining. Continue Reading Posted In Medications , Men's Health Issues , Pediatrics , Public Health , Women's Health Issues
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Mumps: Childhood Disease Makes Comeback on College Campuses

A Mumps comeback in the U.S. in 2006 was alarming in its severity, and the disease may now take several years to completely eradicate, according to federal public health experts.  Interestingly, the viral outbreak occurred despite the routine administration of a second dose of a mumps vaccine throughout the early 1990s.  These findings were reported in a recent edition of the New England Journal of Medicine (NEJM).  Among other data presented in the article is the fact that 84% of people between 18 and 24 years of age who contracted Mumps during the outbreak had already been given the second recommended dose of MMR vaccine -- a dose that should have protected them from Mumps.

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Medical Expert Criticizes FDA Over Dangerous Proposed Relaxation of Prescribing Rules

New U.S. Food and Drug Administration (FDA) guidelines for oversight of "off-label" drug use -- still in draft form and unfinalized -- could allow pharmaceutical companies to market more drugs for unapproved uses.  The proposed guidelines are a step in the wrong direction according to Dr. Randall Stafford, an associate professor of medicine at the Stanford Prevention Research Center.  His concern for patient safety was articulated in a recent edition of the New England Journal of Medicine.

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Medical Errors Add Billions of Dollars to U.S. Healthcare Costs: New Study

Patient safety errors resulted in 238,337 potentially preventable deaths of U.S. Medicare patients and drove up the cost of the Medicare program by $8.8 billion from 2004 to 2006, according to the 5th Annual Patient Safety in American Hospitals Study. Continue Reading Posted In Medical Malpractice , Medications , Patient Safety
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Early Communication From FDA Regarding Potential Singulair Reactions

The U.S. Food and Drug Administration (FDA) has announced that it is working with Merck, Inc., the pharmaceutical company, to explore a possible link between the popular asthma and allergy drug Singulair (known generically as montelukast) and behavioral changes, mood changes, and increased rates of suicide among users.  The investigation could take nine months, and although the agency is not yet recommending that anyone stop taking the drug, it is asking health care professionals to monitor Singulair patients for changes in condition that may indicate a suicide risk.

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Pediatric Journal Details Medication Errors for Hospitalized Children: New Study

Adverse drug events affect about 7% of U.S. children in hospitals -- adverse events such as getting the wrong medication, the wrong doses of medication, and dangerous, preventable reactions.  The percentage is much higher than previous estimates, too, underscoring growing concerns about medical errors involving hospitalized children, according to new research published in the journal Pediatrics.

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Neupro: Transdermal Patch for Early Parkinson's Disease Recalled

Neupro (rotigotine), the first skin patch approved to treat symptoms of Parkinson's disease in the U.S. in 2007, is being recalled by the FDA.   Physicians have been advised to not start  new patients on the transdermal patch and to begin tapering down patients who are currently using the patch.  After the end of April, Neupro will not be available in the United States.   Neupro is being recalled because of formation of rotigotine crystals that can form on the patches, thus altering the amount of medication that can be absorbed through the skin.  

For further details, please call the company's toll-free information number: 800-477-7877.

Please contact your doctor for further advice regarding Neupro's recall.

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How Safe Is Your Drinking Water? AP Investigation Reveals Pharmaceutical Drugs Contaminate Many Public Water Systems

A complex assortment of pharmaceutical drugs has been found in the drinking water supplies of tens of millions of Americans, according to a recent Associated Press investigation.  The contamination affects the drinking water supplies of at least 24 major metropolitan areas across the U.S., including the DC Metro area.

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Spiriva May Contribute to Stroke Risk: FDA Warning

Spiriva, a pulmonary drug marketed by Pfizer and Boehringer Ingelheim Pharmaceutical, appears to increase the risk of stroke, according to a public warning from the the  U.S. Food and Drug Administration (FDA).  Though a comprehensive assessment of the drug's safety is not yet complete, a potential for adverse events has prompted the agency to issue a warning, to assist patients and physicians in identifying any potential problems immediately.

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Anti-Malaria Drug May Be Unsafe for U.S. Troops: New Study

Nearly 10% of U.S. military personnel deployed to Afghanistan are not suitable candidates for mefloquine, an anti-malaria drug commonly administered by the military.  The drug is also known by its trade name Lariam.  The finding is the result of research published in a recent edition of Malaria JournalContinue Reading Posted In Medications , Patient Safety , Public Health
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Baxter Healthcare Corp. Recalls All Remaining Heparin Vials and Hep-Lock Products

According to the U.S. Food and Drug Administration (FDA), Baxter Healthcare Corp. has announced that it is recalling all remaining multi-dose vials of their heparin, as well as single-dose vials and Hep-Lock heparin flush products, which prevent blood clots in intravenous (IV) lines.  Baxter widened its initial recall after another manufacturer of multi-dose heparin vials -- APP Pharmaceuticals of Schaumburg, Ill. -- was able to assure the FDA that it could meet the demand for the entire supply of the blood thinner in the United States.  Several U.S. manufacturers produce items similar to Baxter's Hep-Lock.

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Some Dietary Supplements Contain Hormonal Components that May Promote Prostate Cancer: New Study

Some over-the-counter dietary supplements have been found to contain hormonal ingredients that speed up the development of colon cancer and also make important cancer-treating drugs less effective.  The finding is the result of recent research conducted at the University of Texas Southwestern Medical Center and published in a recent edition of Clinical Cancer Research.

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Risky Pharmacy Practices Increase Medication Errors

An industry-wide culture of long hours, speedy service and staffing shortages contributes to millions of potentially serious medication errors in pharmacies across the United States, according to a recent investigative article by USA Today. Continue Reading Posted In Medications , Patient Safety , Pediatrics , Public Health
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Scientists Recommend New Hospital Policies for Pediatric Flu Vaccination

A new study conducted at Seattle Children's Hospital indicates that many children hosptalized with influenza have had a recent prior hospitalization that would have provided an opportunity to receive the flu vaccine.  Complete results of the study appear in a recent issue of Pediatrics, the official journal of the American Academy of Pediatrics.

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FDA Mix-Up Results in Unapproved, Dangerous Heparin Ingredients, 350 Adverse Medication Reactions

According to a recent article in the Washington Post, an error at the U.S. Food and Drug Administration (FDA) has resulted in the approval of the wrong Chinese drug manufacturing facility.  That error may be partly to blame for approximately 350 adverse reactions and 4 potential fatalities which have been linked to Heparin manufactured by Baxter Healthcare Corporation.  Heparin is a powerful blood thinner.  According to the Post, it now appears that the corporation manufactured its product with pharmaceutical ingredients imported from a Chinese manufacturer that accidentally escaped FDA inspection and approval. Continue Reading Posted In Medications
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Botox Linked to Respiratory Failure and Death: FDA Warning

The U.S. Food and Drug Administration (FDA) is warning that three products:  Botox, Botox Cosmetic (Botulinum toxin Type A), and Myobloc (Botulinum toxin Type B) have been linked to fatal adverse reactions including respiratory failure.  The most severe adverse reactions have occurred in children with cerebral palsy, who rely on the drug for treatment of limb spasticity.  The FDA warns that it has not approved any Botulinum toxins for treatment of spasticity in either children or adults, though it is not advising healthcare professionals to stop prescribing the products at this time. 

Continue Reading Posted In Cerebral Palsy , Medications , Patient Safety , Pediatrics , Product Liability , U.S. Food and Drug Administration Warnings
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Nursing Education Doesn't Prepare Nurses to Question Pharmaceutical Industry Bias: New Study

The pharmaceutical industry has made nurses "soft targets" for drug marketing purposes, but nursing education still does little to teach nurses to recognize and question pharmaceutical industry bias in marketing literature or sales tactics.  The finding is the result of a scientific review of nursing literature recently published in PLoS Medicine, a peer-reviewed medical journal published by the Public Library of Science. Continue Reading Posted In Medications , Patient Safety
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Thousands of Pediatric ER Visits Linked to Cough and Cold Medications Each Year: New Study

Each year more than 7,000 children 11 years of age or younger visit hospital emergency rooms due to incidents involving over-the-counter cough and cold medications.  Two-thirds of those incidents involve kids taking the medications without adult supervision.  The findings are the result of recent research published in the journal Pediatrics, the official journal of the American Academy of Pediatrics.

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25% of Elderly Patients Receive Incorrect or Less-Effective Prescription Medicines: New Study

According to a recent study of more than 800,000 seniors, patients receiving care from a geriatrician are much more likely to have safe and positive prescription drug outcomes than those receiving care from non-geriatrician specialists or general practitioners.  The study appears in the latest issue of the journal Medical Care, an official journal of the American Public Health Association. Continue Reading Posted In Medical Malpractice , Medications , Nursing Home Negligence , Patient Safety
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Many Physicians Prescribe Inappropriate Flu Drugs: New Study

Approximately 36,000 U.S. deaths are attributed to the flu annually, but seeing your physician at the first signs of flu may not be as beneficial as you think -- last year, thousands of primary care physicians prescribed flu drugs that were known to be ineffective.  Furthermore, 88% of the influenza lab tests ordered last year produced false positive results nearly 30% of the time.  The findings are the result of research recently published in the Morbidity and Mortality Weekly Report (MMWR) -- a publication of the U.S. Centers for Disease Control and Prevention (CDC).

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Pharmacy Drive-Through Windows May Offer Convenience at the Expense of Safety

A study examining pharmacists' perceptions of drug dispensing errors and their abilities to communicate critical medication information at drive-through windows indicates that many worry about the safety of window service.  This new study was conducted by researchers at Ohio State University and published in the International Journal for Quality in Health Care. Continue Reading Posted In Medications , Patient Safety
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Many Uninsured Asthmatic Children Receive No Medical Care: Physicians Concerned

Hundreds of thousands of children in the U.S. face the prospect of a life-threatening asthma attack at a time when they have no health insurance, according to a new study recently published in the journal Ambulatory Pediatrics. Continue Reading Posted In Medications , Patient Safety , Pediatrics , Public Health
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Chewing Some Medications Can Be Fatal: Patient Safety Organization Issues Warning

The Institute for Safe Medication Practices (ISMP), a non-profit patient safety organization, has issued an alert that some medications should never be chewed, cut, crushed, or diluted. The group advises all patients to read medication label instructions carefully and to ask pharmacists or physicians specifically how each drug should be taken. The group reports that unfortunately, not all patients read pharmaceutical directions or receive and follow the advice of health providers.

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Non-White Patients Less Likely to Receive Strong Pain Relievers in Emergency Rooms: New Study

Black and Hispanic patients who make pain-related ER visits are significantly less likely than white patients to receive strong opiate pain medication, according to new research published in the most recent edition of the Journal of the American Medical Association (JAMA). Continue Reading Posted In Medical Malpractice , Medications , Patient Safety , Public Health
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Over-The-Counter Medication Abuse Common for Adolescents: New Study

More than 3 million U.S. adolescents have used over-the-counter cough and cold medications to get high -- a number comparable to those who have used LSD, and higher than the number who have experimented with methamphetamines.  The finding is the result of recent research sponsored by the U.S. Substance Abuse & Mental Health Services Administration (SAMHSA). Continue Reading Posted In Medications , Patient Safety , Public Health
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FDA Health Advisory: Don't Use ANY Over-the-Counter Cough and Cold Medicine for Children Under 2 Years of Age

The FDA recently announced that no OTC cough and cold products are safe for children under the age of two years.   Studies are on-going for children between the ages of two and eleven.   The FDA announcement is reproduced in its entirety below. 
Public Health Advisory
Nonprescription Cough and Cold Medicine Use in Children
FDA Recommends that Over-the-Counter (OTC) Cough and Cold Productsnot be used for Infants and Children under 2 Years of Age


"FDA has completed its review of information about the safety of over-the-counter (OTC) cough and cold medicines in infants and children under 2 years of age.  FDA is recommending that these drugs not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur.

FDA’s recommendation is based on both the review of the information we received about serious side effects in children and the discussion and recommendations made at the October 18–19, 2007, public advisory committee meeting at which this issue was discussed.  FDA strongly supports the actions taken by many pharmaceutical manufacturers to voluntarily withdraw cough and cold medicines that were being sold for use in this age group. 

FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age.  We are aware of reports of serious side effects from cough and cold medicines in children 2 years of age and older.  FDA is committed to completing its comprehensive and thorough review of the safety of OTC cough and cold medicines in children 2 years of age and older as quickly as possible and expects to communicate our recommendations to the public in the near future. 

Pending completion of FDA’s ongoing review, if parents and caregivers use OTC cough and cold medicines in children 2 years of age and older, FDA recommends:

  • Checking the “active ingredients” section of the DRUG FACTS label.  This will help you understand what “active ingredients” are in the medicine and what symptoms each active ingredient is intended to treat. Cough and cold medicines often have more than one “active ingredient” (such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever/fever reducer).

  • Being very careful if you are giving more than one OTC cough and cold medicine to a child.  Many OTC cough and cold medicines have more than one “active ingredient.”  If you use two medicines that have the same or similar “active ingredients” a child could get too much of an ingredient which may hurt your child. For example, do not give a child more than one medicine that has an antihistamine.

  • Carefully following the directions in the DRUG FACTS part of the label.  These directions tell you how much medicine to give and how often you can give it.
  • Only using the measuring spoons or cups that come with the medicine or those made specially for measuring drugs. Do not use common household spoons to measure medicines for children since household spoons come in different sizes and are not meant for measuring medicines.

  • Choosing OTC cough and cold medicines with childproof safety caps, when available, and store the medicines out of the reach of children.

  • Understanding that using OTC cough and cold medicines are intended only to treat your child’s symptom(s).  OTC cough and cold medicines do not treat the cause of the symptoms or shorten the length of time your child is sick.  They only relieve symptoms and make your child feel more comfortable.

  • Not using these products to sedate your child or make children sleepy.

  • Calling a physician, pharmacist, or other healthcare professional if you have any questions about using cough or cold medicines in children 2 years of age and older. "
Posted In Medications , Patient Safety , Pediatrics , U.S. Food and Drug Administration Warnings
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Pharmaceutical Companies Spend More on Advertising Than on Research and Development: New Study

Wonder why drug costs are so high?  Contrary to industry claims, U.S. pharmaceutical companies spend almost twice as much on advertising as they do researching and developing new drugs.  The finding is one result of recent research conducted at York University and published in PLoS Medicine -- the peer-reviewed official journal of the Public Library of Science.

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Does Your Child Have Upper Respiratory Symptoms? Perhaps Honey Will Help: New Study

Buckwheat honey appears to give children more relief from the symptoms of upper respiratory infection than does the once-popular over-the-counter medication dextromethorphan (DM), or no treatment at all, according to a recent study published in the Archives of Pediatric & Adolescent Medicine.

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Hib Vaccine Recalled, Shortage Looming

Merck & Co., Inc. has announced a voluntary recall of two of its Haemophilus influenza type b (Hib) vaccines, PedvaxHIB® (monovalent Hib vaccine) and COMVAX® (Hib/hepatitis B vaccine), and won't resume distribution until the fourth quarter of 2008.  The U.S. Centers for Disease Control (CDC) is warning that as a result, pharmaceutical manufacturers likely will not be able to provide adequate Hib vaccine to inoculate all children for whom the vaccine is recommended during the following year.

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Medical Schools Influence the Way Physicians Interact with Drug Companies: New Study

Pharmaceutical companies spend an average of $21 billion per year advertising prescription drugs, and most of that is directed at physicians, physicians-in-training and medical students.  Whether medical schools facilitate or discourage their students' exposure to pharmaceutical advertising significantly impacts the way physicians will later view drug companies, according to a new study published in the Journal Pediatrics, the official journal of the American Academy of Pediatrics (AAP). Continue Reading Posted In Medical Malpractice , Medications , Patient Safety , Public Health , U.S. Food and Drug Administration Warnings
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Cardiologists Concerned Over Unexplained Two-Year Delay in Drug Study Results

Cardiologists are growing increasingly suspicious over the hesitation of drug makers to release the results of clinical trials for the cholesterol-lowering drugs Vytorin and Zetia, according to a recent New York Times article.  The two drugs are prescribed for an estimated 800,000 Americans every week, generating sales of $4 billion in 2007 alone.  Clinical trials of the drugs ended two years ago, but manufacturers Merck and Schering-Plough have yet to release those research results.

Continue Reading Posted In Medications , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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Tamiflu & Relenza: FDA Experts Recommend New Label Warnings for Children's Flu Medications

According to a safety review by FDA experts, the flu drugs Tamiflu and Relenza should carry a package warning label about possible dangerous psychiatric side effects in children. Tamiflu was approved by the FDA for pediatric use for children under 12 in 2005.  

Safety concerns became evident two years ago after Japanese reports of 25 deaths and 32 incidents of psychiatric problems in children after taking Tamiflu.  Following reports of children experiencing "neuropsychiatric events," to include delirium, delusions, hallucinations, impulsive behavior and self-injury, new studies of the drug were initiated. Tamiflu is available in pill and syrup form, and is used to treat symptoms of seasonal influenza. 

On Tuesday, November 27, 2007, the FDA's Pediatric Advisory Panel will review the data and determine whether to issue new warning labels for Tamiflu and Relenza.  According to the FDA documents, the problems usually occur within 24 hours of first taking the medication, and usually among patients younger than 21.  FDA documents indicate, "In the remaining reports of delirium with impulsive behavior and self-injury, patients were attempting to flee or escape from windows or balconies and were unsuccessful in their efforts. In addition, there were a few patients who became aggressive or violent and/or performed acts that were injurious to themselves (e.g. banging head against wall) or others (e.g. child tried to strangle mother)."

Continue Reading Posted In Medications , Patient Safety , Pediatrics , U.S. Food and Drug Administration Warnings
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Nine Percent of U.S. Kids Fit ADHD Diagnosis Criteria

Almost 9% of all U.S. kids between the ages of 8 and 15 fit the diagnostic criteria for Attention Deficit Hyperactivity Disorder (ADHD), according to a study recently published in the Archives of Pediatrics & Adolescent Medicine.  The study was designed, in part, to establish a national baseline for the incidence of ADHD, so that changes or fluctuations in the number of diagnoses would not go unnoticed. Continue Reading Posted In Medications , Pediatrics , Public Health
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FDA Seizes Cosmetic Eye Product Over Eye Injury Concerns

At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals recently seized  more than 12,000 tubes of cosmetic eyelash product worth approximately $2 million, because the product contained undeclared bimatoprost -- a prescription drug ingredient used in the treatment of increased eye pressure. Continue Reading Posted In Medications , Product Liability , U.S. Food and Drug Administration Warnings
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Exercise Benefits Women with Fibromyalgia: New Study

Walking, stretching and simple strength training can significantly reduce the symptoms and improve the functional status of women with fibromyalgia, according to a recent study published in the Archives of Internal Medicine.  The benefits of exercise also seem to be significantly enhanced when paired with disease management education.  Continue Reading Posted In Medications , Patient Safety , Women's Health Issues
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Traysol Heart Surgery Drug: FDA Announces Suspension of Marketing Until Review Completed

Bayer Schering Pharma, the manufacturer of popular heart surgery drug Trasylol, will suspend all marketing of the drug until a review can be conducted of recent Canadian research which has implicated the drug in a higher risk of death for cardiac patients. 

Continue Reading Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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New Parents' Guide to ADHD Presents Treatment Options Without Drug Company Bias

According to the American Academy of Child and Adolescent Psychiatry and the American Psychiatric Association, 3% - 7% of school-age children suffer from Attention Deficit Hyperactive Disorder (ADHD) -- a disease that often leads to failure in school, difficulty in relationships and employment, and even to alcohol and drug abuse.  Still, finding unbiased, dependable literature regarding ADHD treatment options and medications can be difficult. 


The new ADHD Parents Medication Guide is a free, comprehensive reference and treatment guide published by a network of medical professionals and parent advocacy groups with no pharmaceutical funding or editorial support.  The guide can be downloaded at:  www.ParentsMedGuide.org, and is sponsored in part by each of the following organizations:

Continue Reading Posted In Medications , Patient Safety , Pediatrics
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Evaluating the Trustworthiness of Medical Websites

There is an abundance of medical information on the Internet, but unfortunately, not all of it is accurate.  Previously on the DC Metro Area Medical Malpractice Law Blog, we've highlighted trustworthy sources of medical information on the web.  Distributors of drugs and dietary supplements sometimes use deliberately misleading marketing ploys to sell their products, though, and in those cases, knowing how to evaluate a website, itself, is a good way to safeguard against fraud.

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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Poor Judgment, Lack of Teamwork, Insufficient Skills Cause Most Trainee Medical Errors: New Study

Most medical errors made by young physicians can be blamed on poor judgment, teamwork breakdown, and / or inadequate technical skill, according to a new study recently published in the Archives of Internal Medicine.  The study involved a comprehensive review of the closed medical malpractice claims of 5 major insurance companies, collected from 1984 to 2004.  Continue Reading Posted In Medical Malpractice , Medications , Obstetrics , Patient Safety , Pediatrics , Women's Health Issues
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Flu Vaccine Questions & Answers from the CDC

The single best way to prevent the flu, according to the U.S. Centers for Disease Control, is to be vaccinated each year.  For those who wonder just how effective the flu vaccine is, however, the agency offers the following questions and answers related to its effectiveness in preventing the flu:

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FDA Issues Warning Update on "Stay-Awake" Drug, Provigil

The U.S. Food and Drug Administration (FDA) and pharmaceutical manufacturer, Cephalon, have notified physicians of a change to the warning which accompanies Provigil -- a drug used in the treatment of narcolepsy and obstructive sleep apnea.  The drug has recently been linked to life-threatening skin infections and other serious hypersensitivity reactions, as well as to adverse psychiatric symptoms, such as anxiety, mania, hallucinations, and suicidal ideation. 

Continue Reading Posted In Medications , Patient Safety , U.S. Food and Drug Administration Warnings
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AHRQ Announces 10 Patient Safety Tips for Hospitals

The Agency for Healthcare Research and Quality (AHRQ), a division of the U.S. Department of Health and Human Services (HHS), recently issued a 10-item advisory for hospitals and healthcare facilities designed to improve patient safety and reduce medical errors.  Though AHRQ primarily supports research designed to assist health administrators and medical personnel, this knowledge of best practices in patient safety can also benefit the public by enabling patients and their families to advocate for safer medical care.  Following are the 10 recommendations, re-posted in their entirety:

Continue Reading Posted In Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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Dietary Supplement Safety Tips: Natural and Herbal Labels Don't Guarantee Safety

U.S. Marshals recently seized $71,000 worth of dietary supplements at the request of the U.S. Food and Drug Administration (FDA).  The supplements, marketed and distributed by FulLife Natural Options, Inc., of Boca Raton, Florida, had been promoted for the treatment of diabetes, anemia and hypertension, but had never been approved by the FDA, making them unapproved new drugs.  The agency moved to have the supplements seized by federal agents after conducting multiple investigations of FulLife's business practices and issuing warnings regarding the unproven health claims.

Continue Reading Posted In Medications , Patient Safety , Public Health , U.S. Food and Drug Administration Warnings
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Undeclared Gluten in Many Drugs Poses Dangers to Patients with Celiac Disease

Unlabeled gluten in prescription medications can pose critical health risks for patients with celiac disease, yet many patients and healthcare workers are unaware of the potential for harm.  The National Foundation for Celiac Awareness (NFCA) has partnered with the American Society of Health-System Pharmacists (ASHSP) to raise awareness of the issue within the medical community.  According to the NFCA, an estimated 3 million Americans have celiac disease, but only 100,000 are correctly diagnosed.  Celiac disease is an autoimmune digestive disease and the only treatment is a life-long, gluten-free diet -- one containing no wheat, barley, or rye.

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MRSA Cases Increasing, DC-Area Schools Affected

Deadly infections caused by MRSA (methicillin-resistant staphylococcus aureus) are more prevalent than has previously been understood, according to a study recently published in the Journal of the American Medical Association.  The virulent, treatment-resistant bacteria has become the most frequent cause of skin and soft tissue infections among patients who visit U.S. hospital emergency rooms, and infection rates are highest among senior citizens, black people, and men.  Previously associated with hospitals and health care centers, authors of the study note that the bacteria is increasing in prevalence in U.S. prisons and schools.  According to a recent Washington Post article, the following DC-area schools have identified school-based cases of MRSA:

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New Ear Infection "Superbug" Resists All Pediatric Antibiotics

A strain of bacteria responsible for ear infections in children has been discovered to be resistant to all eighteen antibiotics approved for pediatric use, according to a recent article in the Journal of the American Medical Association.  Pediatricians discovered the strain by performing a procedure known as tympanocentesis (or an "ear tap"), and analyzing the fluid.  The strain, known by scientists as 19A, can be eradicated only with levofloxacin, an antibiotic approved for use in adults, but which specifically carries a warning against use in children. Continue Reading Posted In Medications , Patient Safety , Pediatrics , Public Health , U.S. Food and Drug Administration Warnings
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FDA Links Heart Imaging Drugs to Serious Risks, Fatalities

The U.S. Food and Drug Administration (FDA) has warned that a type of drug used in heart testing can cause serious cardiopulmonary reactions, and has advised that a Black Box warning should warn against the risk.  Marketed as Definity and Optison, the drugs, classified as micro-bubble ultrasound contrast agents, are used by physicians to get a clearer image of the heart during electrocardiography.  The FDA has warned that these drugs have caused as many as 11 deaths and nearly 200 dangerous adverse reactions, mainly in patients with severe heart conditions.  Adverse reactions typically occur between 1 and 12 hours after administration of the injectable drug.

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Pediatric Cold Remedies Removed From Market Over Safety Concerns

More than a dozen children's cough and cold medications have been voluntarily recalled by their manufacturers this week in response to mounting safety concerns, according to a Washington Post report.  Fourteen branded, over-the-counter (OTC) cold remedies marketed for use in children under 2 years of age have been pulled from store shelves so far.  The popular drugs have never been approved by the United States Food and Drug Administration (FDA) for use in children. Continue Reading Posted In Medications , Patient Safety , Pediatrics , U.S. Food and Drug Administration Warnings
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FDA Issues Advisory on Fentora Following Overdoses, Deaths

Fentora, a cancer pain medication, is too frequently misused and improperly prescribed, according to a Public Health Advisory recently issued by the U.S. Food and Drug Administration (FDA).  Manufactured by Cephalon, Inc., Fentora is most commonly prescribed to treat breakthrough pain in terminal cancer patients who have already developed a tolerance to opioid pain medications.  According to the FDA, Fentora-associated deaths have recently occurred in non-cancer patients, and in patients who lacked opioid tolerance, indicating that the drug has been prescribed incorrectly.  Some patients have suffered adverse reactions following a dosage of Fentora that was too high, and some adverse events have occurred after patients took too many doses of the drug.

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FDA to Scrutinize Children's Cold Medicine

The U.S. Food and Drug Administration (FDA) has warned that children's cold medicines can be deadly if over-used.  According to a recent Public Health Advisory,  serious adverse events recently reported in conjunction with the use of many common, over-the-counter cold remedies appear to be the result of over-medication.  The agency has announced that its Nonprescription Drugs Advisory Committee will meet to discuss the safety and effectiveness of these drugs in October.  In the interim, the agency recommends that parents who administer over-the-counter cold remedies to their children adhere to the following safety guidelines:

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Experts Suggest High Physician Reimbursement Contributes to U.S. Health Care Woes

Public policy debates concerning rising pharmaceutical costs and the profitability of insurance companies neglect a large part of the U.S. health care problem, according to a recent article in The New York Times.  According to the article, not only are U.S. physicians paid an average of $200,000 to $300,000 per year ($400,000+ for specialists), their pay is based on the number of procedures they perform, with little incentive to actually keep anyone healthy.  The practices stand in stark contrast to those of similar countries, where physicians typically work on a salary basis ($60,000 to $120,000 in Europe), within health systems that incentivize preventive care in order to avoid more serious, more expensive treatments.  The article notes that though pharmaceutical costs in the U.S. are notoriously high, they are only 30% - 50% higher than those in many other countries, whereas physician salaries are often 200% - 300% higher here, despite our lackluster health outcomes.  Continue Reading Posted In Medical Malpractice , Medications , Patient Safety , Public Health
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Nursing Mothers Should Use Codeine with Caution: FDA Warning

Women who are ultra-rapid metabolizers of codeine may inadvertently expose their babies to lethal levels of morphine if they take the drug while breastfeeding.  At least one infant has recently died from a morphine overdose linked to contaminated breast milk -- the mother had been taking codeine for episiotomy pain.  The U.S. Food and Drug Administration (FDA) recently issued a warning related to the potential dangers of the drug for nursing mothers and babies. Continue Reading Posted In Medical Malpractice , Medications , Obstetrics , Patient Safety , Pediatrics , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Diabetes Supplement Found to Cause Diabetes: New Study

Selenium, an antioxidant trace mineral marketed as a nutritional supplement for the prevention of Type 2 diabetes actually increases the risk of developing the disease, according to a new study published in the Archives of Internal Medicine.  In a randomized clinical trial using 200mg of selenium alone, researchers determined that Type 2 diabetes developed 55% more frequently in patients taking the supplement than in patients who took a placebo.  Patients with the highest selenium levels had the highest incidence of Type 2 diabetes, the researchers report.  The 7-year study followed more than 1,200 patients who enrolled as non-diabetics, and increased risks associated with age, sex, smoking status and body mass were controlled for statistically.  Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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Risk of Blood Clots Goes Unaddressed in Discharged Patients: New Study

Dangerous blood clots typically form within three months of a hospital stay, but fewer than 43% of discharged patients leave the hospital with orders for clot-preventing treatment or medications according to a recent study published in the Archives of Internal Medicine.  Based on a review of the medical records of patients in the Worcester, Massachusetts area who were diagnosed with blood clots in 1999, 2001 and 2003, researchers determined that 73.7% of all patients with clots developed them at home, and that 59.1% occurred in patients who had recently been hospitalized.  Only 59.7% of those patients ever received anticoagulant therapies in the hospital, however, and fewer than 50% received orders for those therapies or medications upon their discharge. 
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Physicians Disregard Ear Ache Treatment Guidelines: New Study

Most physicians don't follow professional standards for treating ear aches in children, according to a new study published in the journal Pediatrics.  New treatment guidelines were jointly established by the American Academy of Pediatrics and the American Academy of Family Physicians in 2004, endorsing a non-antibiotic "observation option" for all children older than two who lack severe infection symptoms.

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Children Receive Insomnia Drugs at High Rates: New Study

Although no sleeping pills are currently approved for use in children, 80% of children who visit their doctor for help with insomnia wind up with a prescription for sleeping pills, according to a new study published in the journal SLEEP.  The findings dovetail with a 2004 poll by the National Sleep Foundation suggesting that sleeping problems are a common problem among U.S. children.  Continue Reading Posted In Medications , Patient Safety , Pediatrics
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Many Americans Taking Medications Incorrectly, or Not at All: New Study

Millions of Americans do not take the drugs they are prescribed, or do not take them correctly, according to a new report by the National Council on Patient Information and Education.  The report sheds light on a lesser-acknowledged aspect of the nation's health care conundrum:  even when Americans have access health care services, they may not get the treatment they need to actually improve their health. Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Women's Health Issues
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FDA: Antipsychotic Drug Approved for Children, But Critics Disagree

The U.S. Food and Drug Administration (FDA) recently announced its approval of the antipsychotic drug Risperidone (marketed as Risperdal) for the treatment of schizophrenia in adolescents between 13 and 17 years of age, and for the treatment of bipolar I disorder in children and adolescents between the ages of 10 and 17.  It is the first atypical psychiatric drug ever approved to treat these disorders in children, and at least one human interest organization is concerned that the drug's approval came too easily.

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Skincare Tips for Preventing, Treating Acne

Stress has been shown to worsen acne in teenagers, and what could be more stressful than starting a new year of school following a summer vacation?  According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, a division of the National Institutes of Health, there are several standard treatments for acne that your family physician or dermatologist might employ to help resolve an acne flare-up.  These treatments may include: Continue Reading Posted In Medications , Men's Health Issues , Pediatrics , Women's Health Issues
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Drugs for Stomach Acid May Cause Cognitive Decline: New Study

Common acid reflux and ulcer drugs appear to cause cognitive impairment in older African-American adults, according to a new study in the Journal of the American Geriatrics Society.  Histamine 2 receptor antagonist (H2A) drugs -- more commonly known as acid blockers -- are among the most frequently prescribed drugs in the U.S., and some varieties are also available without prescription.  Axid, Pepcid, Tagament and Zantac are a few examples.  A five-year observational study of more than 1,500 African-American seniors, however, has indicated that the drugs might be responsible for the significant cognitive decline of almost one-fifth of the study participants.  Data from the study suggests older African-American patients are 2.5 times as likely to suffer cognitive impairment if they use the drugs on a long-term basis.  Conducted by Indiana University School of Medicine and the Regenstrief Institute, the study demonstrates the need for further research into the safety and efficacy of these drugs for all patients.  Continue Reading Posted In Medications , Men's Health Issues , Nursing Home Negligence , Patient Safety , Women's Health Issues
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Low LDL Cholesterol Linked to Incidence of Cancer: New Study

Cholesterol-lowering drugs have long been employed to reduce the risk of heart disease, but they may also pose a risk of cancer, according to a new study in the Journal of the American College of Cardiology.  According to research based on an evaluation of more than 41,000 cases, low levels of low-density lipoprotein (LDL) cholesterol have been associated with an increased incidence of cancer, as well as liver and muscle toxicity.  The findings give rise to new concerns regarding the relative necessity and benefits of pharmaceutical cholesterol treatment.  Researchers note that the study is not definitive, and further research is warranted.  Specifically, it is not clearly understood whether the perceived cancer risk is related primarily to low LDL cholesterol levels, or to the statins prescribed in order to lower the LDL levels. 

You should always consult your physician before beginning or discontinuing any medical treatment. 

Previously on the D.C. Metro Area Medical Malpractice Law Blog, we posted an article concerning public health interventions that have lowered heart disease rates.

For information about your legal rights, please click here or call the law firm of Regan Zambri & Long, PLLC at 202-463-3030.

Posted In Medications , Men's Health Issues , Patient Safety , Women's Health Issues
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FDA Re-Approves Zelnorm for Limited Use

Zelnorm (tegaserod maleate), a constipation drug removed from the market earlier this year by the U.S. Food and Drug Administration (FDA) will be made available once again under restricted access guidelines.  Patients and physicians who were left with no alternative treatment options following the agency's ban had appealed to the FDA earlier this year, requesting that it reconsider its position.  The agency banned the marketing and sale of the drug in the U.S. after it was associated with an unacceptably high risk of heart attack, stroke and unstable angina in patients.
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D.C. Students Will Be Allowed to Carry Asthma Inhalers for School Year 2007-2008

Students in D.C. public schools will be allowed to carry and use asthma inhalers throughout the school day and at school-sponsored events following the recent passage of the Student Access to Treatment Emergency Act of 2007 by the D.C. City Council.   According to a press release hosted on the website of Council Member David A. Catania, the act passed unanimously and will be in effect for the 2007-2008 school year. 

As a group, the release notes, D.C. students have one of the highest rates of asthma in the nation.  Previously, they had not been allowed to self-administer their asthma medication.  Of 8,400 asthma-related visits to school health departments last year, almost 900 resulted in trips to the hospital.  Forty-seven other states allow school children to carry and administer their own inhalers.  To learn more about the new rule, contact the office of Council Member David Catania at (202) 724-7772.

For information about your legal rights, please click here or call the law firm of Regan Zambri & Long, PLLC at 202-463-3030.
Posted In Medications , Patient Safety , Pediatrics , Public Health
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FDA Adds Black Box Warning to Actos, Avandia

The U.S. Food and Drug Administration (FDA) has announced that a black box warning has been placed on the popular diabetes drugs Avandia and Actos (pioglitazone hydrochloride), regarding an increased risk of heart failure among some patients taking the medications.  The drugs treat Type 2 diabetes by decreasing insulin resistance. The warnings will be aimed at physicians who prescribe the drugs, urging them to monitor their patients for dangerous cardiac symptoms.  The drugs had previously been labeled as increasing the risk of heart failure, but a stronger warning label was agreed upon when it became evident that physicians were still prescribing the drug too frequently. 

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Back-to-School: Prince Georges County Students Lack Immunizations

Approximately 1,000 students in Prince Georges County, Maryland won't be able to return to school when the doors re-open on Monday, because they lack proper immunizations, according to a Local NBC4.com news report.  The new academic year begins soon in most area school districts.

Previously on the D.C. Metro Area Medical Malpractice Law Blog, we have posted articles related to:
For information about your legal rights, please click here or call the law firm of Regan Zambri & Long, PLLC at 202-463-3030. Posted In Medications , Public Health
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54 Prescription Drugs Get Safety Label Updates

Safety labels on fifty-four prescription drugs have recently undergone changes that may merit your attention, according to the U.S. Food and Drug Administration (FDA).  Flagged as part of the agency's Safety Information and Adverse Event Reporting Program, the latest labeling changes could alert many patients to health hazards or dangerous situations before they become critical.  The following drugs made changes to the "contraindications" or "warnings" sections of their labeling: Continue Reading Posted In Medications , U.S. Food and Drug Administration Warnings
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Clinical Trial Results Should Be Made Public, Says Public Interest Organization

A recent report by Public Citizen, the non-profit public interest organization, demonstrates that clinical trial registries  -- and databases of the trial outcomes -- need to be made available to the public, in the interest of patient safety.  The recommendation comes in the wake of growing evidence that the pharmaceutical industry acts to suppress unfavorable clinical trial results.  The Public Citizen news release announcing the report is reproduced below in its entirety:

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Back-to-School: Immunization Requirements

They're less popular than designer clothes or backpacks, but immunizations are still among the more important things your child should acquire before returning to school this fall.  Laws and guidelines regarding immunizations vary by jurisdiction.

Following are the 2007-2008 metro area student immunization requirements by state:

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Infection Rates of Antibiotic-Related Bacteria Increase Dramatically: New Study

The rate of infection of Clostridium difficile (C. diff.) more than doubled between 1993 and 2003, according to a new study published in the journal Archives of Surgery.  According to researchers, serious C. diff. infections, which often accompany prolonged antibiotic use, are becoming more prevalent in hospitals and nursing homes.  In 1993, the C. diff. death rate was 20.3 deaths per 100,000 cases.  By 2003, it had risen to 50.2 deaths per 100,000.  The number of surgeries performed to contain the damage of C. diff. also tripled in that same length of time; when untreated infection damages the colon, segments of the intestine have to be surgically removed.  Continue Reading Posted In Medications , Nursing Home Negligence , Patient Safety , Public Health
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Infants Taking Antibiotics Face Greater Risk of Asthma: New Study

Children who take antibiotics in their first year of life are significantly more likely to develop asthma by age 7, according to a new study published in Chest, the official journal of the American College of Chest Physicians.  The study, which controlled for well-known asthma risk factors, detected the association between antibiotics and asthma in cases of non-respiratory tract infections.  The children at the highest risk of developing asthma were those who had completed more than four courses of antibiotics.  The association was particularly pronounced in populations of children who were likely to be prescribed broad-spectrum (BS) cephalosporins -- a category of antibiotics that clinicians typically differentiate from narrow-spectrum varieties.  Researchers advise that the risk of asthma can be reduced by avoiding BS cephalosporins in infancy. 

For information about your legal rights, please click here or call the law firm of Regan Zambri & Long, PLLC at 202-463-3030.
Posted In Medications , Patient Safety , Pediatrics
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Some Red Yeast Rice Products Contain Undeclared Prescription Drugs: FDA Warning

Red yeast rice and red yeast rice supplements are often marketed as cholesterol-lowering alternatives to medication.  The U.S. Food and Drug Administration (FDA) has announced, however, that some red yeast rice products may lower peoples' cholesterol because manufacturers have been illegally lacing them with lovastatin -- the active ingredient in Mevacor, a prescription cholesterol drug.  The FDA has issued warnings related to the following specific red yeast rice products:

  • Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively
  • Cholestrix, sold by Sunburst Biorganics.
Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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Low LDL Cholesterol Linked to Incidence of Cancer: New Study

Cholesterol-lowering drugs have long been employed to reduce the risk of heart disease, but they may also increase your risk of cancer, according to a new study in the Journal of the American College of Cardiology.  According to research based on an evaluation of more than 41,000 cases, low levels of low-density lipoprotein (LDL) cholesterol are associated with an increased incidence of cancer, as well as liver and muscle toxicity.

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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Prescription Drug Use Among Teens Rising: New Study

Prescription drug abuse by teens is on the rise, according to a recent report from the U.S. Office of National Drug Control Policy (ONDCP).  According to the report, among adolescents age 12-17, prescription drugs are the second most frequently abused drugs, ranking just behind marijuana.  The drugs are popular, in part, because they are perceived to be safe.  OxyContin and Vicodin, both potent painkillers, are the most frequently abused.   In addition to using the drugs  to get high, teens report that they also use various prescription drugs illegally to relieve anxiety, regulate their sleeping patterns, and also to increase their alertness.  Continue Reading Posted In Medications , Pediatrics
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Federal Jury Awards $5.5 Million in Damages in Duragesic Patch Case

A federal jury in Florida has awarded $5.5 million to the estate of a 28-year-old man who died of an accidental overdose of pain medication because his Duragesic narcotic patches were defective.  The single-use patches which deliver fentanyl, a narcotic, via skin absorption, are manufactured by two Johnson & Johnson subsidiaries.  A jury found the manufacturers guilty of negligence in the manufacture of the patch, and of failing to adequately warn people about its dangers. 

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Aggressive MRSA Protocol Meets with Success in VA Hospital

Despite the increasing prevalence of Methicillin-resistant Staphylococcus aureus (MRSA), a surgical unit of one U.S. hospital has managed to halt its spread.  According to a recent article in The New York Times, a surgery unit of the Veterans Affairs hospital in Pittsburgh reduced its average caseload from 60 MRSA infections per year to only 17, using aggressive detection and containment  protocols that require diagnostic nasal swabs of all new patients, and the isolation of those infected behind red painted lines that warn caregivers to don gloves and gowns before entering.  According to the article, similar campaigns in the Netherlands and Finland have met with success, as well.

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Some Medications Increase the Risk of Heat Illness

Summer heat can jeopardize anyone's health, but according to the U.S. Centers for Disease Control, taking certain medications can actually increase your risk of heat-related illness. The agency advises that the following types of drugs can make you more vulnerable to the heat: 
  • "Psychotropic drugs which affect behavior, experience, or psychic function (i.e., anti-depressants, anti-psychotics, mood stabilizers, etc.). 
  • Medications for Parkinson's Disease, as they can keep you from sweating.
  • Tranquilizers (i.e., Haldol, etc.)
  • Diuretics (or "water pills") that affect your body's fluid balance"
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Older Diabetes Drugs Rival Newer, More Advanced Ones: New Study

Some of the oldest oral medications for type-2 diabetes perform better than newer, more expensive varieties, according to a study published in the Annals of Internal Medicine.  Researchers from Johns Hopkins University School of Medicine report that according to their research, the drug metformin (sold as Glucophage, Riomet and Fortamet) was a consistent top-performer, controlling blood sugar effectively and posing no additional danger of weight gain, high cholesterol, or heart disease among patients.  Those dangers are often associated with the "second generation" diabetes drugs.

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Health Literacy Levels Predict Length of Life: New Study

Seniors who can't understand medical information are significantly more likely to die at a younger age than their health-literate peers, according to a new study published in the Archives of Internal Medicine.  Researchers say the inability to understand medical information typically leads to difficulties in the management of chronic conditions, and ultimately to declining health.  Continue Reading Posted In Medications , Patient Safety
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Area Lawmakers Take Action on HPV Vaccine

Lawmakers in each jurisdiction of the D.C. metro area have taken action on Human Papillomavirus (HPV) and school immunization requirements in recent months.  

If you have questions about the HPV vaccine, or whether it is required as an immunization in your school district this year, consult your child's pediatrician or school guidance counselor.

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Drug Companies Still Romancing Physicians: New Evidence

Two medical journals this spring have reported that pharmaceutical companies continue to make questionable payments to physicians as incentives to boost drug sales. 
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Drugs with the Same or Similar Names Pose Dangers: FDA Advisory

Drugs with identical brand names may contain completely different chemicals -- and treat completely different illnesses -- depending on the country in which they are sold, according to the U.S. Food and Drug Administration (FDA).  The FDA has issued an advisory that although a registry of drug names is maintained in the U.S., and proposed new drug names are compared against it, no organization provides such a safeguard internationally.  As a result, drugs like Flomax, if bought from a U.S. pharmacy, will always treat an enlarged prostate.  Buy Flomax at a pharmacy in Italy, however, and you'll get a pain reliever. 

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Antibiotics Ineffective, Problematic in Kids with Urinary Tract Infections: New Study

Antibiotic treatment for kids with urinary tract infections (UTIs) appears not only to be ineffective, but potentially harmful, according to a new study published in the Journal of the American Medical Association (JAMA).  Though recurrent UTIs can lead to potentially dangerous kidney problems in children, the most popular current treatment -- daily antibiotics -- appears to be ineffective.  Worse, the regular dose of antibiotics can give rise to antibiotic-resistant infections, which pose more difficult medical challenges in later years.  The ineffectiveness of the drug treatment was observed even in kids with bladder reflux (a condition in which urine occasionally flows backwards to the kidneys).  In a second finding, researchers determined that kids with bladder reflux were no more prone to UTIs than other children; a finding that contradicts longstanding medical belief.  Continue Reading Posted In Medications , Patient Safety , Pediatrics , Public Health
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Safe Ways to Buy Drugs Online: FDA Tips

Do you need to fill a prescription?  Do you want to save money by on-line ordering?  Rising drug and health care costs have prompted many to fill their prescription drug orders through Internet pharmacies.  Not all Internet pharmacies are equal, however.  The government's General Accounting Office (GAO) reported to Congress in 2004 that prescription drugs purchased online by their investigators were in many instances unsafe.  Often, they were unaccompanied by important instructions, some temperature-sensitive drugs were shipped in regular envelopes, and sometimes the chemical composition of the drugs was not at all what it should have been -- the drugs were counterfeit.

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FDA: Absent for Many Drug Committee Hearings

Public Citizen, a non-profit public interest organization, has petitioned the U.S. Food and Drug Administration (FDA) to give oral presentations at all advisory committee meetings that involve the presentation of specific products.  According to a recent article published in The Lancet, of the 275 public meetings of the FDA's Human Drug Advisory Committee occurring between 1997 and 2006, 49 included no oral scientific presentation by the agency.  In contrast, drug company representatives made presentations at every meeting but one. 

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FDA Issues New Rule for Dietary Supplements

The U.S. Food and Drug Administration (FDA) has issued a final rule for current good manufacturing processes (CGMPs) for dietary supplements.  The new rule is aimed at ensuring that supplements are free of undeclared active ingredients and impurities.  According to the FDA, if a supplement is now found by inspectors to not contain the exact ingredients claimed by its manufacturer, the agency could officially deem the product adulterated or misbranded, and compel the producer to change its labeling or remove an ingredient.  Alternatively, the agency could seize the product and file a lawsuit, or seek criminal charges against its manufacturer.  The dietary supplement industry has historically faced little regulation.  Some critics maintain that even this new rule doesn't go far enough to protect consumer safety.

For information about your legal rights, please click here or call the law firm of Regan Zambri & Long, PLLC at 202-463-3030.  

Posted In Medications , Men's Health Issues , Patient Safety , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Anti-psychotics Unsafe for Elderly with Dementia: New Study

Anti-psychotic drugs can be fatal for some elderly patients, according to a new study published in the Annals of Internal Medicine.  The study included more than 27,000 patients over age 66 who suffered from dementia, and revealed that the use of the drugs in these patients contributes to an increased risk of death. 

An advisory issued by the FDA in 2005 warned that patients who suffered from dementia and who also took atypical anti-psychotics such as Zyprexa, Seroquel, Risperdal, suffered a rate of death 1.6 to 1.7 times higher than similar patients who only took a placebo.  Most of those deaths seemed to be heart-related or linked to infections.  The FDA subsequently requested that manufacturers label these anti-psychotic drugs with appropriate warnings and note that they were not approved for the behavioral treatment of elderly patients with dementia.  Many physicians continue to prescribe them, however.  This new study lends more scientific weight to the idea that these drugs are not appropriate for many elderly patients.  The FDA advises that elderly patients taking the drugs for behavioral reasons should have their treatment plans reviewed by health care professionals. 

The Alzheimer’s Association, a nonprofit voluntary organization addressing Alzheimer’s Disease, notes that the range of appropriate behavioral treatments for dementia consists of both non-drug interventions and prescription medications, and the organization recommends that non-drug interventions be tried first.  The group has also designed the internet-based “Alzheimer’s Association Care Finder,” an interactive guide to educate consumers about recognizing quality Alzheimer’s care, choosing the best care options, and advocating for quality care in residential facilities. 

Posted In Medications , U.S. Food and Drug Administration Warnings
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FDA to Require Black Box Warning on Avandia, Actos

The U.S. Food and Drug Administration (FDA) recently announced in congressional testimony that it intends to compel manufacturers of Avandia and Actos, similarly-acting anti-diabetes drugs, to place black box consumer warnings on those drugs, because of their tendency to worsen heart failure in patients whose hearts are compromised.

It is something of a confusing move for consumers, coming as Avandia’s manufacturer, GlaxoSmithKline, is investigated concerning allegations that silenced dissenting researchers during a period of drug testing. Though the new black box warning will address the drug’s potential to worsen heart failure, it does not address current concerns before Congress and the FDA that the drug may also cause heart attacks and increase rates of cardiac death in patients – concerns which officials say have yet to be settled scientifically.

According to 21 C.F.R. § 201.80 (2007), the FDA can compel a manufacturer to label drugs with a black box warning in cases where their use may result in serious risks or hazards (such as death or serious injury). These warnings are generally based on clinical data or, alternatively, on demonstrated animal toxicity.

If you are taking Avandia or Actos, consult your physician about whether these recent cardiac concerns affect your suitability for treatment with these drugs.        

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FDA Warns of Counterfeit Weight-Loss Drug

"FDA informed consumers and healthcare professionals regarding the dangers associated with buying prescription drugs over the internet.  FDA received information showing that 24 apparently related websites may be involved in the distribution of counterfeit prescription drugs.  The website appear to be operated from outside the United States.  

On three occasions during recent months, consumers obtained counterfeit versions of Xenical 120 mg Capsules, a drug used to help obese individuals who meet certain weight and height requirements to lose and maintain weight loss, from two different websites.  Instead of receiving Xenical, a product manufactured by Hoffmann-LaRoche Inc, consumers received sibutramine, the active ingredient in Meridia.  Although Meridia is also used to lose and maintain weight loss, the drug should not be used in certain patient populations and is not a substitute for other weight loss products.  Consumers should be wary if there is no way to contact the website pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from their doctor is required.  Additionally, consumers are urged to review the FDA web page at www.fda.gov/buyonline for additional information prior to making purchases of prescription drugs over the internet.  See FDA press release for the list of the 24 web site that may be involved in the distribution of counterfeit prescription drugs. "

Read the complete 2007 MedWatch 2007 Safety summary, including a link to the FDA Press Release regarding this issue at the MedWatch section of FDA's website.


Posted In Medications , Patient Safety , U.S. Food and Drug Administration Warnings
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Pediatric Study: 80% of Hospitalized Children Receive Medications Approved Only for Adults

According to a recent study by the Pediatric Health Information Systems Research Group, almost 80% of hospitalized children receive drugs that have been tested and approved only for adults.  The study revealed that the drugs most frequently used off-label for children were painkillers, nutrients and gastrointestinal agents. Children were more likely to receive off-label drugs if they underwent surgery, were older than 28 days and had more severe illnesses.  Least likely drugs to be used in this manner were anti-cancer drugs.

 "Using drugs that have been insufficiently studied in children has contributed to adverse outcomes, which have been documented in the medical literature," said Samir Shah of The Children's Hospital of Philadelphia. "We hope that by better defining the magnitude of off-label drug use, our study may help encourage greater cooperation among industry, academia, and government in carrying out studies to better protect children."

The study focused on patient records from 31 major U.S. children's hospitals for the year 2004 and involved 90 drugs that were either frequently administered to children or had been recommended for further pediatric study by the Food and Drug Administration.

Researchers in the Pediatric Health Information Systems Research Group, representing various medical centers, analyzed patient records from 31 major U.S. children's hospitals for the entire year of 2004. At least one drug was used off-label in 79 percent of the more than 355,000 children requiring hospitalization. Off-label use accounted for $270 million, some 40 percent, of the total dollars spent on children's medication in the study, which appears in the March issue of the Archives of Pediatrics and Adolescent Medicine.

Although off-label prescribing is relatively common among adult patients, it has long been recognized that many of the drugs used in pediatrics have never been tested in children. In recent years, federal regulations providing financial incentives to pharmaceutical companies have helped increase the number of drugs tested and approved for children. However, said Dr. Shah, "there was little information on the extent of off-label use among children, the types of drugs used off-label, and the characteristics of hospitalized children receiving those drugs."

All previous studies of off-label drug use in hospitalized children were performed outside the United States and were often limited to specific conditions or other restrictions. The current study focused on 90 drugs that were either administered frequently to children or were recommended for further pediatric study by the FDA.

Senior study author Anthony Slonim noted that, once the FDA approves a drug for use, physicians may legally prescribe it for different conditions and patients in other age groups. The practice is called prescribing "off-label."

The study was published in the March issue of the Archives of Pediatrics and Adolescent Medicine. Posted In Medications , Patient Safety , Pediatrics
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Study Finds That Hospital Efforts To Reduce Costs Put Patients At Risk Of Adverse Events

According to a study published in the May issue of Medical Care, the Boston Herald reports, hospital efforts to streamline operations and reduce costs place patients at risk for preventable mistakes.  Researchers at Brigham and Women's Hospital and Massachusetts General Hospital reviewed 6,841 patient records at four hospitals over 12 months.  Two of the hospitals were urban teaching hospitals, and two were suburban hospitals in two states.  The analysis revealed 1,530 adverse events that were not caused by the patient's medical condition at the time of admission. Preventable mistakes included medication errors, nerve injuries and infections.  According to the study, a 0.1% increase in the patient-to-nurse ratio at one hospital, for instance, caused a 28% increase in preventable adverse events. David Bates, M.D., senior author of the report and Chief of the Division of General Medicine and Primary Care at Brigham and Women's Hospital, said hospitals' goals of cutting costs and increasing the quality of patient care are "working against each other," adding that "hospitals are clearly stressed." Linda Kenney, director of Medically-Induced Trauma Support Services in Massachusetts, who did not take part in the study, said, "This is not due to individuals not being caring. It's due to systems that aren't set up to do the best job possible. When you have a nurse who has to take care of 10 patients, instead of six, things are going to be overlooked."

To view an abstract of the study, please click here.  If you or a family member has suffered injuries in connection with a preventable medical mistake, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.  If you would like to receive our electronic newsletter, please click here.

Posted In Medical Malpractice , Medications , Patient Safety , Public Health
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New Federal Guidelines: Safe Prescription Drug Disposal

According to a February 20, 2007 joint press release by the White House Office of National Drug Control Policy (ONDCP), the Department of Health and Human Services (HHS) and the Environmental Protection Agency (EPA), new prescription drug disposal guidelines go into effect immediately.  The new guidelines are designed to reduce the diversion of prescription drugs and protect the environment.

"The new Federal prescription drug disposal guidelines urge Americans to:

  • Take unused, unneeded, or expired prescription drugs out of their original containers
  • Mix the prescription drugs with an undesirable substance, like used coffee grounds or kitty litter, and put them in impermeable, non-descript containers, such as empty cans or sealable bags, further ensuring that the drugs are not diverted or accidentally ingested by children or pets
  • Throw these containers in the trash
  • Flush prescription drugs down the toilet only if the accompanying patient information specifically instructs it is safe to do so
  • Return unused, unneeded, or expired prescription drugs to pharmaceutical take-back locations that allow the public to bring unused drugs to a central location for safe disposal"

Posted In Medications , Patient Safety , Public Health
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FDA Warning: Buying Prescriptions Online

"FDA informed consumers and healthcare professionals regarding the possible dangers of buying prescription medications online.  Individuals who ordered Ambien, Xanax, Lexapro, and Ativan over the internet received a product that contained haloperidol, a powerful anti-psychotic drug.  Several consumers experienced difficulty in breathing, muscle spasms and muscle stiffness after ingesting the suspect product and had to seek emergency medical treatment. Haloperiodol can cause muscle stiffness, spasms, agitation and sedation.  Taking medication that contains an active ingredient other than what is prescribed by qualified healthcare professionals is generally unsafe.  FDA urges consumers to review the FDA website for additional information prior to making purchases of medications over the internet."

To review the complete MedWatch 2007 Safety summary, please see the FDA press release regarding this issue.




Posted In Medications , Patient Safety , U.S. Food and Drug Administration Warnings
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Benefits of Medications Overstated

The drug industry says that ads arm consumers with information.  According to NPR Radio researchers found that ad information is technically accurate, but the tone is misleading.  A study in the Annals of Family Medicine raises questions about the message the ads promote.

"Typically, what we would see with these ads is that before taking a particular prescription drug, the character's life is out of control and the loss of control extended beyond the impact of their health condition," says UCLA psychologist Dominick Frosch, who headed the study.  None of the adds mentioned that life style changes could have similar benefits to the prescribed drug. 

Dr. David Kessler, dean of the school of medicine at the University of California, San Francisco, headed the FDA for seven years, under the first President Bush and then President Clinton. He opposed TV advertising for drugs.  Kessler says a complete ban on TV ads for prescription drugs is unlikely, now that ads has been approved. But he says regulation can — and should — be tightened.
Posted In Medications , Patient Safety
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American Cancer Society Releases Guidelines On HPV Vaccine


In the January 19, 2007 issue of its journal CA: A Cancer Journal for Clinicians, the American Cancer Society has recommended that girls ages 11 and 12 receive Merck's human papillomavirus (HPV) vaccine, Gardasil, which reportedly has been shown to be 100% effective in preventing infection with HPV strains 16 and 18.  It is believed that these strains together cause approximately 70% of all cervical cancer cases. In June 2006, the U.S. Food and Drug Administration approved Gardasil for sale and marketing to girls and women ages nine to 26, and the U.S. Center for Disease Prevention and Control’s Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine.  

Continue Reading Posted In Cancer Misdiagnosis , Medications , Public Health , Women's Health Issues
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FDA WARNING: Counterfeit Drugs Enter the Supply Chain

In a Fall 2006 release, the FDA urged consumers not to buy drugs on line from Canadian pharmacies.  The FDA’s 2005 crackdown found that 85% of drugs intercepted from “Canadian pharmacies,”  actually came from 27 other countries.

In particular, the FDA is urging consumers not to purchase any medications from websites that have orders filled by Mediplan Prescription Plus Pharmacy or Mediplan Global Health in Manitoba, Canada. The FDA is currently investigating reports that these companies are involved in the distribution of counterfeit drugs to US consumers.

Continue Reading Posted In Medications , Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings
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Medication Safety: Educated Patients Are Safer

A report issued by the Institute of Medicine, stated that 1.5 million Americans are negatively affected by mistakes in the prescribing and administration of medication. The report suggests that implementation of electronic prescribing programs which are capable of cross checking  the myriad of factors that can determine a patient’s reaction to a drug will decrease those negative outcomes. Furthermore, the report recommends measures to increase the amount of drug information accessible to the public.  Most importantly, the report called for an enhanced dialog between patient and physician in order educate patients regarding to their medications. 

Continue Reading Posted In Medications , Nursing Home Negligence , Patient Safety
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Institute of Medicine Suggests Changes to FDA Processes

The Institute of Medicine recommends major changes in the FDA’s regulatory process to help increase public health and safety with respect to pharmaceuticals, according to a statement by the IOM in the New England Journal of Medicine. The changes include:

  • Giving the FDA greater access to administrative databases;
  • Limiting conflicts of interest for members of advisory committees;
  • Requiring reports of all clinical trials’ summary results;
  • Increase in general appropriations to the FDA.
Posted In Medications , Patient Safety
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Antibiotic Prescriptions by Phone: Is It Safe for Patients?

According to a recent study by healthcare information firm Thomson Medstat, 40 percent of patients refilling an antibiotic prescription had not seen a doctor in at least a month.  Researchers in this study analyzed 1.5 million claims for antibiotic prescriptions made in 2004 for children and adults under 65.  Although some of these prescriptions were for already-diagnosed infections, many of them were for viral infections which would not have responded to any antibiotic.   The researchers noted that prescribing antibiotics in this way is a factor in the growth of antibiotic-resistant infections.  However, the research ultimately uncovered a more disturbing issue of increased reliance on Internet and phone-based communication between patient and healthcare provider.  Thomson Medstat's analysis of prescribing without more contact between patient and healthcare provider concludes that medical societies need to establish new standards for this type of medical care and prescribing practice. 
Posted In Medications , Patient Safety
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Government Goes After Fake Diabetes Treatments

The U.S. Food and Drug Administration and Federal Trade Commission have begun a campaign to stop Web sites selling pills that they claim cure diabetes, according to the FTC Web site. The FDA has already sent out over 180 warning letters to the sites.

The FTC also recommends that patients “be smart, be skeptical” when considering diabetes treatments and always ask their doctor before starting any new treatments.

If you or a family member believes that you have a case involving improper false drug marketing, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.  If you would like to receive our complimentary electronic newsletter, please click here.

Posted In Medications
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Use of Pfizer Drug in Children Is Backed

According to a recent story by the Associated Press, federal advisers recommended that Pfizer be allowed to market the painkiller Celebrex as a treatment for children with a severe form of arthritis, even though they were split on whether it was safe. 

In a 15-1 vote, the advisers said that the benefits of the drug outweighed its risks for juvenile rheumatoid arthritis patients 2 years old and older. They also strongly recommended that its safety be monitored for years.

The Food and Drug Administration must now weigh the panel’s recommendation that it expand approval of Celebrex. The agency is not required to follow the advice of its expert panels, but it usually does.   To find out more, please review the full articlePosted In Medications , Public Health
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Doctors Fail to Communicate Information Concerning Prescription Drugs

Many doctors often fail to provide patients with the necessary information when writing a new prescription, according to a story published by the Archives of Internal Medicine.

The study in question, conducted in 1999 at two Sacramento hospitals, found that doctors advised patients on the length of time the patients were to take the medication only 34% of the time, and described possible negative side effects of the medication only 35% of the time.


 

Continue Reading Posted In Medical Malpractice , Medications
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Frozen Flu Vaccine Ineffective: Recalled

As reported by the Houston Chronicle, Novartis has recalled 500,000 doses of its influenza vaccine. Distributed under the "Chiron" name, two shipments headed for New York were found frozen.
Freezing the vaccine renders it completely ineffective. The vaccine froze while in the possession of one of the distributors, thus none of that shipment was administered to anyone.

Continue Reading Posted In Medications , Patient Safety
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Beta-Blocker Eye Drops Can Be Dangerous

Beta-Blocker eye drops are used to treat glaucoma.  A recent study by Public Citizen, a consumer advocacy organization, suggests that the eye drops can cause very serious side-effects, including drops in blood pressure, fainting spells, heart attack, and even death. Details of the study can be found at the organization’s November posting on its WorstPills.org website.

Continue Reading Posted In Medications
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Cutting Edge Diabetic Treatment: Physician's Dilemma

As reported by Medical News Today, a recent Duke University report has found that diabetics are not receiving cutting edge treatment due to physician resistance to them.

The researchers found that empirical evidence supports several new treatments on the market such as, insulin pumps and blood glucose monitoring devices allow diabetics to better manage their disease and stick with prescribed treatment regimens. These treatments not only result in lesser pain than older treatments but also prevent or delay the complications to diabetes, including, hypertension, blindness, and end-stage renal disease, among other debilitating outcomes.