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."

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?

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?

 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:

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:

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at:
  www.fda.gov/MedWatch/getforms.htm.
• Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD  20852-9787
• Fax: 1-800-FDA-0178"

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?

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? 

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.

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?

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 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.

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.

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  [PDF - 191KB] catheter or urinary  [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. 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  [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.  [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.

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.

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 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 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?

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 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 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. 

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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 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 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 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 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 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 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 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 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 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 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.

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 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 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.                                                                                         

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 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 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.

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 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 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 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 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 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 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.

 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.

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:

 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:

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

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 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.

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.

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 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. 

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.

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 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.

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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.

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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 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.

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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.

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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.

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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  

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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.

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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.

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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.

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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.

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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.

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 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.

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 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."

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 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.

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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 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.

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 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."

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 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:

 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:

 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:

 Posted by: Salvatore J. Zambri, founding partner     

 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:

 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:

 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:

 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:

 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:

 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:

 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:

 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:

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:

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:

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:

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:

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:

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:

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:

Posted by: Salvatore J. Zambri, Esquire

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:

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 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 contact Mr. Zambri at 202-822-1899 or email him at szambri@reganfirm.com.

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 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 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 us at Regan Zambri & Long, PLLC at 202-463-3030. 

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 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 us at Regan Zambri & Long, PLLC at 202-463-3030.

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 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 us at Regan Zambri & Long, PLLC at 202-463-3030.

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 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 us at Regan Zambri & Long, PLLC at 202-463-3030.

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 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 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 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 us at Regan Zambri & Long, PLLC at 202-463-3030.

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 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 us at Regan Zambri & Long, PLLC at 202-463-3030.

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 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 us at Regan Zambri & Long, PLLC at 202-463-3030.

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)."

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 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 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 us at Regan Zambri & Long, PLLC at 202-463-3030.

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.

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.

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. 

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," 

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.

"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.

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.

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 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.

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.

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:  

• FDA to Require Black Box Warning on Avandia, Actos
• FDA Adds [New] Black Box Warning to Actos, Avandia
• Older Diabetes Drugs Rival New, More Advanced Ones: New Study

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.

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.

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.

  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.

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

              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.

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.

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.

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.

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.

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).

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.

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. 

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.

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.

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. 

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.

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.

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.

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:

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:

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.

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.

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.

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. 

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.

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.

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.

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.

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.

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.

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.

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.

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.

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. 

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.

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).

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.

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. "
  

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.

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.

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.

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.

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)."

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. 

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:

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.

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:

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. 

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:

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.

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.

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:

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.

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.

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:

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.

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.

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.

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. 

• 2007-2008 immunization requirements for metro area school districts
• Action by local lawmakers regarding mandatory HPV vaccinations
• HPV vaccine prevents cervical cancer
• Adult immunization guidelines updated