What Does the FDA Say about Sunscreen Labels?

Spending time in the sun represents one of the most enjoyable parts of summer, but the risk of sunburn, early aging and skin cancer do not. To mitigate these risks while keeping individuals more comfortable all season long, numerous sunscreens exist.

In the past, these products have made claims on their packaging that have failed to bear out in regular use. Those believing they were providing themselves with superior sun protection often put stock in misleading claims, leading users to purchase products less effective than advertised and use them less liberally than intended.

To combat widespread misunderstanding about the nature and efficacy regarding sunscreen, the FDA recently released new labeling guidelines to reduce the ambiguity of packaging claims. These new restrictions include:

1.    Cancer risk statements.
On products providing SPF below 15, the FDA now requires companies to provide a disclaimer stating they do not provide sufficient protection from early skin aging or cancer.

2.    Water resistance clarifications.
To reflect the inability of any sun protection product to provide “all day protection” or “sweat-proof” or “waterproof” qualities, sunscreens may now designate themselves only as “Water Resistant (40 Minutes)” or “Water Resistant (80 Minutes).”

3.    Limits on SPF levels. Although sunscreens once designated themselves as high as SPF 100, few products offer more than SPF 50 protection, which blocks close to 100 percent of the sun’s rays. Most highly-rated sunscreens will now advertise as “SPF 50+.”

4.    Tighter restrictions on broad-spectrum.
The term “broad-spectrum” refers to products providing protection from UVA as well as UVB rays. Companies must now pass a wavelength test to ascertain their protection from UVA rays.

5.    Elimination of “sunblock.” This previously used term misled many consumers into believing a product provided full protection from UV rays, leading the FDA to designate all sun protection products as sunscreen.

The FDA’s new regulations have provided additional oversight in an industry prone to ambiguous claims.

When manufacturers use dishonest advertising to sell products, significant injuries and illnesses may result. DC product liability attorneys help those affected by such claims hold companies accountable for their actions.

Are the products you use living up to the claims they make?

Do you need to go to the hospital for a skin condition or sunburn? Read these 10 tips to stay safe.

Posted In Product Liability , U.S. Food and Drug Administration Warnings
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Compounding Pharmacy Report Reveals Limited Regulation

Posted by Salvatore J. Zambri, founding member and partner

 

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

 

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

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

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

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

Do you have any questions about this post?

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Another Compounding Pharmacy Recalls All Products

 Posted by Salvatore J. Zambri, founding member and partner

 

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

 "Recall -- Firm Press Release

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

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

Contact
Consumer:
732-493-3390

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

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

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

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

Included in the recall are the following product list:

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

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

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

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

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

Do you have any questions about this post?

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Controversy Continues Regarding Compounding Pharmacy Regulation

Posted by Salvatore J. Zambri, founding member and partner

 

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

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

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

Do you have any questions about this post? 

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FDA Recall: DePuy Orthopaedics Class I Recall for LPS Diaphyseal Sleeve

Posted by Salvatore J. Zambri, founding member and partner

 

The FDA recently announced a Class 1 Recall for DePuy Orthopedics.  We are reproducing the recall notice below for our readers in its entirety.  If you anticipate or have recently had knee replacement surgery, please consult with your surgeon regarding the type of implant and possible symptoms or issues related to it.

"DePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall - Taper Connection May  Not Accommodate Physiologic Loads

[Posted 02/22/2013]

AUDIENCE: Orthopedics, Surgery, Risk Manager

ISSUE: FDA notified healthcare professionals of a Class I recall of the LPS Diaphyseal Sleeve. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death.

The FDA has received a total of 10 reports (6 fractures and 4 reports of loosening that may or may not be attributed to the same device design issue) of incidents in which the device has malfunctioned.

The affected devices were manufactured from 2008 to July 20, 2012. See the Recall notice for a list of affected product codes and lot numbers.

BACKGROUND: The LPS Diaphyseal Sleeve is intended for use with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.

RECOMMENDATION: On Jan. 4, 2013, DePuy issued an Urgent Medical Device Recall informing hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots. If a medical facility has the affected product in stock, it should be returned to DePuy.

DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device. However, DePuy is encouraging surgeons to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing symptoms.


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


[02/22/2013 - Recall Notice - FDA]"

 Do you have any questions about this post?

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Should Compounding Pharmacies Be Required to Follow FDA Safety Regulations?

Posted by Salvatore J. Zambri, founding member and partner

 

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

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

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

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

Continue Reading Posted In Medications , Patient Safety , Product Liability , Public Health
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Why Are Compounding Pharmacies So Dangerous?

Posted by Salvatore J. Zambri, founding member and partner

 

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

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

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

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

Do you have any questions about this post?

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Anticlotting Drug Pradaxa Allegedly Causing Deaths

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

 

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

Please consult with your doctor before taking any medication.

Do you have questions about this post?

About the author:

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

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

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

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

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


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

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

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

Do you have questions about this post?

About the author:

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

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

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

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

By Catherine Bertram, partner

                                                                                                             

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

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

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

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Doctor Contends 15 Dead in NECC Medication Contamination was Preventible and Predictable

By Catherine Bertram

                                                                                                            

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

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

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

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

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

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

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So You Think Your Medical Device Was Safety Tested? Think Again.

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

Medical devices such as artificial joints, heart defibrillators and surgical mesh have become an integral part of the healthcare industry.  As consumers, we would naturally expect that those devices have been tested for safety and effectiveness. In reality, many implants and other high-risk devices on the market have not undergone any safety testing.  Rather, the manufacturers have frequently only  filed paperwork and paid the mandatory FDA user fee to market those items. 

In 2011, the Institute of Medicine of the National Academies, an independent, non-profit organization that works outside of the government to provide unbiased and authoritative advice to decision-makers and the public, released a consensus report concluding that "the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle." In summary, they recommended that the FDA completely overhaul its system that regulates medical devices because presently it doesn't ensure patient safety either before or after products are on the market.  Surprisingly, Congress is currently working on a new law that neither addresses the failures of the current FDA process nor forces manufacturers to sufficiently safety test devices. Rather, its goal is to allow them to market devices even faster.  That's a shame.

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

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


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

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

Be safe.

Do you have questions about this post?

About the author:

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

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

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

Posted In Medications , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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Stryker Recalls Modular Neck-Stem Devices Attaching to Artificial Hips

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


The Boston Business Journal (7/10, Donnelly, Subscription Publication) reported, "Stryker Orthopaedics has voluntarily recalled two brands of devices used in conjunction with artificial hips in hip replacement surgeries, according to the US Food and Drug Administration website." To date, "there have been at least 45 adverse event reports from patients who say the devices caused pain and/or tissue swelling." This week, Stryker said that "it would remove Rejuvenate and ABG II modular-neck stems, which attach to artificial hips, from the market and cease global distribution."

The modular neck-stem devices were recalled "because of postmarketing data showing fretting and corrosion at the modular neck junction, according to an alert from the US Food and Drug Administration (FDA)," Medscape (7/11, Hitt) reports. "The FDA posted the company's press release, dated July 6." Stryker "states that patients who already have the implanted modular-neck stems should contact their surgeon only if they experience pain and/or swelling of the hip and should undergo revision surgery only if symptoms of pain and swelling at the local joint site are not attributable to other conditions such as aseptic loosening and periprosthetic sepsis."

If you have had a hip replacement, or if you are thinking of getting one, please speak with your doctor about product safety.  I have many clients who have been victims of faulty hip replacements, and they are left with a lifetime of pain and suffering.

Do you have questions about this post?

About the author:

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

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

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

Posted In Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Article Suggests Merck Hid Evidence of Vioxx's Harmful Effects

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

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

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

Do you have questions about this post?

About the author:

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

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

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

 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Women's Health Issues
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Some NSAIDS May Increase Risk of Birth Defects

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


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

Do you have any questions about this post?

About the author:

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

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

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

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Hip Replacement: Safety Problems and Questions Continue

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

Hip replacement is one of the most common surgical procedures in the United States. It is estimated that 250,000 replacements are performed each year. Since the beginning of 2011, the Food and Drug Administration (FDA) has received over 5,000 complaints about metal-on-metal hips, more than the previous four years combined.  Some experts believe that this rise in complaints is an indication of  the "biggest and most costly medical implant since Medtronic recalled a widely used heart device component in 2007."  In May, the FDA ordered producers of metal hips to submit proposals to the FDA with plans for studying how frequently the devices were failing and to examine the threat to patients.  The agency is expected to determine the adequacy of those plans by  November, 2011.   Even the chief scientist at the FDA who oversees medical devices acknowledges that finding answers to the complaints could take several years.

As more problems are uncovered, some surgeons have abandoned installing all-metal hips, and they are looking for safer alternatives, usually those which combine metal and plastic components.  Many surgeons are also dealing with questions related to replacing the all-metal hips in their patients who don't seem to to have obvious problems.  For some patients, crippling injuries have resulted from the tiny particles of cobalt and chromium that shed into the patient's body.  Debris-caused tissue damage is very extensive in those cases.  Some researchers believe that many all-metal hip implants have an inherent flaw.  Numerous unanswered questions remain about their safety, whether from the the device itself, or its interactions with human tissue.

According to the FDA, "Many all-metal devices were sold without testing in patients or without a requirement that producers track their performance."  According to a recent report in the New York Times, the FDA is now intervening and ordering producers to study how frequently the devices were failing and to examine the threat to patients.  There are currently "no standard protocols for a uniform procedure to measure metallic ions in a patient's blood or how to calibrate diagnostic equipment to best detect tissue damage."

To date, almost 75% of the hip implant device complaints received by the FDA have been regarding the Articular Surface Replacement (A.S.R.), which was recalled by the DePuy Division of Johnson & Johnson in 2010.  Another Johnson and Johnson product receiving complaints was the Pinnacle.  Still another model receiving complaints is the Durom Cup, manufactured by Zimmer Holdings.  Along with DePuy and Zimmer, other companies submitting study proposals to the FDA include Wright Medical and Biomet.

If you have received a hip replacement, please consult with your surgeon to determine whether the model you received is subject to recall.  As the safety of hip replacement devices is further investigated, other models and brands of all-metal implants may be recalled in the future.

Do you have any questions about this post?

Continue Reading Posted In Medical Malpractice , Men's Health Issues , Patient Safety , Product Liability , Public Health , Women's Health Issues
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Experts Say Cell Phones Are "Possibly Carcinogenic"

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


ABC World News (5/31, lead story, 3:10, Sawyer) reported, "An important new alert about the safety of cell phones and the possible risk of cancer, brain cancer in particular...comes from the World Health Organization." NBC Nightly News (5/31, lead story, 3:10, Williams) reported, the WHO "statement labeling cell phones as a possible carcinogenic hazard comes from a panel of 31 scientists."      

According to the AP (6/1, Cheng), the statement was "issued in Lyon, France, on Tuesday by the International Agency for Research on Cancer" (IARC) after a "weeklong meeting" during which experts reviewed "possible links between cancer and the type of electromagnetic radiation found in cellphones, microwaves and radar." The IARC classified cellphones in "category 2B, meaning they are possibly carcinogenic" to humans. The assessment now "goes to WHO and national health agencies for possible guidance on cellphone use."

The Wall Street Journal (6/1, Martin, Hobson, Subscription Publication) reports that the IARC working group did not conduct new research. Instead, the panel reviewed existing literature that focused on the health effects of radio frequency magnetic fields. Its findings are slated to be published July 1 in Lancet Oncology.

The New York Times (5/31, Parker-Pope, Barringer, Subscription Publication) "Well" blog noted that the panel's decision to "classify cellphones as 'possibly carcinogenic' was based largely on epidemiological data showing an increased risk among heavy cellphone users of a rare type of brain tumor called a glioma." Most "major medical groups," including the National Cancer Institute, have "said the existing data on cellphones and health has been reassuring." Earlier this year, the Journal of the American Medical Association "reported on research from the National Institutes of Health, which found that less than an hour of cellphone use can speed up brain activity in the area closest to the phone antenna."

The lesson here is simple:  Don't blindly believe what the cell-phone companies are saying. their products may in fact cause cancer, according to international experts.  Consequently, be safe.  Use a cell phone only when necessary, and use an earpiece if possible. 

Let's hope the cell phone companies do the right thing by both testing their products sufficiently and revealing the true results of the tests, so customers can make proper decisions to protect their 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. 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 products, medication errors, medical malpractice litigation, and safety improvements.

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

Posted In Cancer Misdiagnosis , Men's Health Issues , Patient Safety , Product Liability , Public Health , Women's Health Issues
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Pfizer Under-Reported Side Effects of Smoking-Cessation Drug, Says Report

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


ABC News reports that a new analysis by the Institute for Safe Medication Practices "says that there were 150 instances" where users of the smoking-cessation drug Chantix committed suicide "out of the nearly 600 delayed reports of severe issues noted in the study."  As a result, the FDA "wants the drug maker to resubmit thousands of records to get a clearer idea of just how widespread severe reactions to Chantix are, which also include vivid nightmares, depression and violent outbursts."

I applaud the FDA in demanding Pfizer to release its records.  Decisions to market drugs should be based principally on patient safety and health, not on profits.  It would be a shame if people lost their lives as a result of using a drug after side-effects were concealed.

Do you have any questions about this post?

About the author:

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

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

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

Posted In Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Issues New Guidelines for CT Scanning

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

As reported in a recent article by the New York Times, "the Food and Drug Administration has concluded that manufacturers of CT scanners should do a better job of training and educating those who use their equipment, and that the machines themselves could be made safer by warning operators that a dangerously high radiation dose is about to be administered.

These two conclusions . . . are the result of a yearlong investigation by the F.D.A. into hundreds of radiation overdoses in 2008 and 2009 that occurred during a specific diagnostic test for a stroke, called a CT brain perfusion scan."

Over-radiation can be very dangerous.  Manufacturers of scanners and physicians must work together to maximize patient safety.

Do you have any questions about this post?

About the author:

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

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

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

 

 

 

Posted In Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Litigation Over DePuy Hip Replacements Rising

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

An August recall of DePuy ASR hip implants had led to lawsuits.  The suits claim that the manufacturer knew its product was failing, but nevertheless continued to sell it for profit without informing consumers.

The problem seems to be with the metal-on-metal design of the device, which does not appear to adhere well in the hip joint.  Consequently, the failed replacements have to be re-done, often at a terrible cost both financially and physically. Some patients have suffered metal poisoning, and others are having a hard time ambulating.

My firm regularly represents victims of product defects.  It is a shame when you see companies put profits over people.  Bad things--tragic things--happen when that business model is used.

Do you have any questions about this post?

About the author:

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

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

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

Posted In Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Candy and Candy-like Tablet Recalled

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

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

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

Enjoy Halloween, but please put safety first.

Do you have any questions about this post?

About the author:

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

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

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

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

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

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

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

Do you have any questions about this post?

About the author:

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

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

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

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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AstraZeneca Pays $198Mill To Settle 17,500 Lawsuits

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

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

Do you have any questions about this post?

About the author:

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

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

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

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

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

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

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

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

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

Do you have any questions about this post?

About the author:

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

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

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


 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Wants Tougher Medical Device Regulation

Posted by: Salvatore J. Zambri, founding member     

The AP (8/4, Perrone) reports that "makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year." The FDA "released recommendations Monday night designed to improve oversight of the US device industry, including the government's ability to recall products that prove unsafe or ineffective." At "the center of the overhaul" is the so-called 510(k) system the FDA "uses to grant speedy approval to devices that are deemed similar to products already on the market." FDA critics "say that high-risk devices, such as heart pacemakers, are increasingly slipping through the 510(k) process without thorough testing and scrutiny."

The Minneapolis Star Tribune (8/4, Moore) reports among the recommendations released is the creation of "a new class of devices that would require clinical evidence before gaining 510K approval." The designation "would streamline the process for a 'small subset' of devices by telling applicants up-front what will be required to gain marketing clearance, thus avoiding delays." As it stands, "only 8 to 10 percent of the devices approved under the 510(k) moniker require clinical studies," said Jeffrey Shuren, director of the FDA's device center.

Increased oversight is needed, so that patients' health and lives are not put at risk.  Safety must be put 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 acknowledged as one of "The Best Lawyers in America" by Best Lawyers (2011 edition), and has been repeatedly named a "Super Lawyer" by Super Lawyer magazine (March/April 2010)-- national publications that honor the top lawyers in America.

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

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


 

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

Posted by: Salvatore J. Zambri, founding partner     

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

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

Do you have any questions about this post?

About the author:

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner     

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

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

Do you have any questions about this post?

About the author:

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner     

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

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

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

Do you have any questions about this post?

About the author:

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner     

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

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

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

Do you have any questions about this post?

About the author:

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

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

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

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

                                                                       

By Catherine Bertram

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

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

About the author:

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

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

Posted by: Salvatore J. Zambri, founding partner     

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

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

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

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

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

Do you have any questions about this post?

About the author:

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner     

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

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

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

Do you have any questions about this post?

About the author:

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner     

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

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

Do you have any questions about this post?

About the author:

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner     

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

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

Do you have any questions about this post?

About the author:

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

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

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

Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA to Conduct Formal Safety Review of ARBs

Posted by: Salvatore J. Zambri, founding partner     


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

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

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

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

Do you have any questions about this post?

About the author:

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner     

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

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

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

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

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

Do you have any questions about this post?

About the author:

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

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

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

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Tech at VA Dental Center in St. Louis warned officials about poor sterilization

By Catherine D. Bertram

Earlene Johnson worked as a medical supply technician at the St. Louis Veterans Affairs Medical Center, where almost 2,000 veterans may have been exposed to Hepatitis B and C and HIV due to poor sterilization practices.  She testified, before the House Committee on Veterans Affairs, that she warned her superiors that the dental equipment wasn't being adequately sterilized, but they ignored her and eventually fired her.

After her warnings, a year passed before the VA notified the veterans who had potentially been exposed.

Rather than use a special sterilizing machine, technicians evidently washed the dental instruments by hand, which does not clean the instruments as fully as the sterilizing machine.  The improper sterilization took place over thirteen months, from February of 2009 to March 2010.

Earlier this year, the VA had to inform 3,000 colonoscopy patients of San Diego's Palomar Hospital that reused medical equipment might have exposed them to infection.

Posted In Medical Malpractice , Men's Health Issues , Product Liability , Public Health , Women's Health Issues
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Elan agrees to settle Zonegran probe for $203.5 Million

Posted by: Salvatore J. Zambri, founding partner     

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

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

 

Do you have any questions about this post?

About the author:

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner     

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

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

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

Do you have any questions about this post?

About the author:

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner     

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

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

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

Please call your legislators and support this bill.

Do you have any questions about this post?

About the author:

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner     

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

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

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Medical Errors Cause More Deaths In DC Than Car Accidents

Posted by: Salvatore J. Zambri, founding partner     

The DC Department of Health recently released a report, making clear that medical errors are killing more DC residents than all types of car and truck accidents combined.  Per the February, 2010 report, "The leading causes of preventable death in the District of Columbia...were tobacco use (estimated 860 deaths; 16.6 percent of total DC resident deaths), poor diet and physical inactivity (estimated 780 deaths; 15.1 percent), microbial (infectious) agents—excluding HIV—(estimated 240 deaths; 4.6 percent), alcohol consumption (estimated 150 deaths; 2.9 percent), firearms (estimated 140; 2.7 percent), and medical errors (estimated 140 deaths; 2.7 percent). 

According to the comprehensive study and report, motor vehicle accidents account for .6% of the overall deaths in DC--that's 4.5 times less than the deaths caused by preventable medical errors.

The complete report can be viewed by clicking here.

There is a lot of discussion in politics about "tort reform".  The term--"tort reform"--is actually a misnomer, and is better understood as "tort deform".   Some powerful business groups and industries wish to strip Americans of their rights and their access to justice when injured due to medical errors.  Instead of robbing Americans of their fundamental rights and compensating them for the devastating damages they incur as a result of medical negligence, the focus should be on preventing the medical errors in the first place.  That's true reform.

About the author:

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

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

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

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

Posted In Patient Safety , Product Liability , Public Health , Tort Reform
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FDA WARNING: QUE SHE WEIGHT LOSS SUPPLEMENT CONTAINS DRUGS

 By Catherine Bertram

 

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

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

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

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

 

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

Posted by: Salvatore J. Zambri, founding partner     


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

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

Do you have any questions about this post?  

About the author:

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

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

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

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

 Posted by: Salvatore J. Zambri, founding partner     


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

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

 

Do you have any questions about this post?  

About the author:

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

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

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

 


 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Unaware of Companies' Foreign Drug Trials

Posted by: Salvatore J. Zambri, founding partner

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

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

 

 

Do you have any questions or comments about this post?  

About the author:

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner

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

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

Do you have any questions or comments about this post?  

About the author:

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

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

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

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

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

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

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

Continue Reading Posted In Medical Malpractice , Medications , Product Liability , U.S. Food and Drug Administration Warnings
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FDA Warns Pfizer on failure to report drug complaints.

Posted by: Salvatore J. Zambri, founding partner

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

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

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

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

 

Do you have any questions or comments about this post?  

About the author:

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

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

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

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Proton Pump Inhibitors Can Cause Bone Fractures

Posted by: Salvatore J. Zambri, founding partner

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

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

 

Do you have any questions or comments about this post?  

About the author:

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner        

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

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

Be safe.

Do you have any questions about this post?  

About the author:

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

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

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

Posted In Medications , Men's Health Issues , Product Liability , Public Health , Women's Health Issues
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Sedative Vials Too Large, Doctor Testifies

Posted by: Salvatore J. Zambri, founding partner               

                                                                                                        

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

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

 

Do you have any questions or comments about this post?  

About the author:

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner               

                                                                                                        

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

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

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

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

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

Do you have any questions about this post?  

About the author:

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

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

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

Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Antidepressants May Similarly Affect Suicide Risk In Children, Adolescents

Posted by: Salvatore J. Zambri, founding partner               

                                                                                                        

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

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

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

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

do you have any questions about this post?  

About the author:

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

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

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

Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Stalevo May Increase Prostate Cancer Risk, Says FDA

Posted by: Salvatore J. Zambri, founding partner               

CONTACT US  

                                                                                                        

Bloomberg News reported that "Novartis AG and Orion Oyj's Stalevo treatment for Parkinson's disease may be linked to an increased risk of prostate cancer, US health regulators said." In a statement found on its website, the FDA states that its "review of Stalevo is ongoing, and no new conclusions or recommendations about the use of this drug have been made." The agency "is reviewing a clinical trial that showed that prostate cancer was more common among patients taking Stalevo than in those taking only a combination of carbidopa and levodopa."

If you have been prescribed Stalevo, we encourage you to speak to your doctor promptly about all potential risks and benefits.  Your doctor is obligated to provide this information to you so that you can make the best, most informed, decisions possible concerning your health. 

I'll report back once we learn more about the FDA's review of the clinical trial.  In the meantime, if you have any questions at all, please feel free to contact me.

CONTACT ME  

About the author:

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner

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

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

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

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

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

CONTACT ME  

About the author:

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

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner

CONTACT US      

                                                                                                        

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

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

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

About the author:

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

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner     

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

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

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

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

About the author:

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

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner     


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

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

 

About the author:

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

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

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

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

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Class I Recall of Baxter In-Home Dialysis Device Announced

Posted by: Salvatore J. Zambri, founding partner     

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

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

Dow Jones Newswire reported on the recall as well.

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

 

About the author:

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

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

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

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

Posted by: Salvatore J. Zambri, founding partner     

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

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

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

About the author:

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

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

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

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

 Posted by: Salvatore J. Zambri, founding partner     


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

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

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

About the author:

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

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

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

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Avandia Linked to Heart Attacks, Death Per Senate Report

 Posted by: Salvatore J. Zambri, founding partner     

The front page of the New York Times reported that "Hundreds of people taking Avandia [rosiglitazone], a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports." A Senate Finance Committee review cites internal FDA documents that highlight a dispute among regulators that "has been brewing for years but has been brought to a head by disagreement over a new clinical trial."

The Wall Street Journal reports that the Senate committee concluded that Glaxo was aware of the risks, but minimized the issue and attempted to suppress concerned physicians. The FDA's documents also indicate that agency scientists said the drug should be pulled from the market in 2008, but FDA chiefs rejected the recommendations. Now, agency commissioner Margaret Hamburg is expected to meet "with FDA scientists and outside experts to gain a full understanding...of all of the data and issues involved," a spokeswoman said.

The AP reported that the Senate committee is asking the FDA "why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007." Glaxo agreed to an FDA request for "a six-year study between its drug and" the Pfizer diabetes drug Actos [pioglitazone] "to give a definitive picture of Avandia's safety."

If the senate report proves to be accurate, this once again smacks of a company putting profits over patient safety, leading to serious injuries and death.

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

About the author:

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

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

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

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

 Posted by: Salvatore J. Zambri, founding partner     


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

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

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

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

About the author:

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

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

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

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Trailblazer Support Catheter Recalled, Dangerous

 Posted by: Salvatore J. Zambri, founding partner     

ev3 Endovascular, Inc. and FDA notified healthcare professionals of a Class I Recall of the Trailblazer Support Catheter. According to the recall, "This device may crack near the radiopaque marker band. This may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death."

If using a catheter, please contact your doctor immediately to be sure it is not part of the recall.  If you know you are using a Trailblazer Support Catheter, please stop using it right away, and obtain an alternative product.

About the author:

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

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

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

Posted In Medical Malpractice , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA WARNING: NZU, A MORNING SICKENESS "REMEDY" MAY CONTAIN HIGH LEVELS OF LEAD/ARSENIC

Posted by Catherine D. Bertram                                                        

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

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

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

About the author:

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

 

 

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

 Posted by: Salvatore J. Zambri, founding partner     


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

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

About the author:

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

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

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

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

 Posted by: Salvatore J. Zambri, founding partner     


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

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

About the author:

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

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

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

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

 

 Posted by: Salvatore J. Zambri, founding partner     


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

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

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

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

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

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

About the author:

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

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

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

Posted In Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Radiation Exposure from CT Scans Worse Than Previously Estimated

 Posted by: Salvatore J. Zambri, founding partner     

The CBS Evening News reported, "The problem of too much radiation during CT scans may be more widespread than anyone thought." CBS further confirmed that "new research...found a wide variation in radiation dose for the most common CT scan like abdomen, pelvis, and chest. A survey of four hospitals found some patients received 13 times more radiation than others for the same type of scan."   Over-radiation can be very dangerous.

NBC Nightly News, referring to a study, stated that "researchers calculated that 72 million CT scans are performed in this country a year and concluded that could lead to 29,000 excess cancers and 15,000 excess deaths a year in the future."  The study NBC cited was published in the Archives of Internal Medicine. 

A second study, in the same journal, of over 1,000 patients at four hospitals, showed that 1 out of 270 women and 1 out of 600 men suffer from cancer as a result of undergoing a single heart scan at age 40, the Wall Street Journal reports. According to the report, researchers who performed the study noted that the differences in radiation doses may be a result of the difference in technology from one medical provider to another as well as a lack of standardized settings.

Bloomberg News reports that in the National Cancer Institute study, "the authors predicted that lung cancer will be the most common radiation-related cancer followed by colon cancer and leukemia." In response to these study, the FDA has "issued interim regulations Dec. 7 requiring closer monitoring of CT scans after more than 250 cases of exposure to excess radiation were reported since October."

Before undergoing a CT scan, you should get sound medical advice from an experienced physician who is familiar with the risks and benefits of the procedure.  If undergoing a scan, be sure the facility has technologically advanced equipment, so your exposure to radiation is minimized to the extent possible.  Your doctors should be advising you of all risks associated with the procedure, as well as all options available to you, so you can make the best health decision you can.  Your doctors should also be using equipment that is safe and in excellent working condition.

I wish you good health and happiness.

About the author:

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

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

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


 

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , Women's Health Issues
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Glaxo Announces Payouts From Paxil Cases

 Posted by: Salvatore J. Zambri, founding partner     

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

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

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

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

About the author:

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

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

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

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

 Posted by: Salvatore J. Zambri, founding partner     

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

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

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

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

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

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

About the author:

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

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

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

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

 

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

 Posted by: Salvatore J. Zambri, founding partner     

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

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

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

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

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

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

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

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

About the author:

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

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

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

 

 

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

 

 Posted by: Salvatore J. Zambri, founding partner     

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

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

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

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

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

About the author:

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

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

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

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

 Posted by: Salvatore J. Zambri, founding partner     


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

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

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

A few things the law requires:

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

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

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

About the author:

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

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

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

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

 Posted by: Salvatore J. Zambri, founding partner     

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

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

About the author:

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

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

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

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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American Associate for Justice Publishes Primer on Medical Negligence Debate: A Must Read

 

 Posted by: Salvatore J. Zambri, founding partner     

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

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

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

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

To read the publication, please click here.

About the author:

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

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

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

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

 

 Posted by: Salvatore J. Zambri, founding partner     

 

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

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

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

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

We wish you good health.

About the author:

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

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

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

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

 Posted by: Salvatore J. Zambri, founding partner     

 

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

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

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

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

About the author:

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

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

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

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


 Posted by: Salvatore J. Zambri, founding partner     

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

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

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

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

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

  • Myth #3: Doctors are fleeing.

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

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

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

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

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

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

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

About the author:

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

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

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

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

 Posted by: Salvatore J. Zambri, founding senior partner     

 

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

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

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

About the author:

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

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

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

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Warning: Excessive Radiation from CT Brain Perfusion Scans

By Catherine D. Bertram, Esquire                                

The U.S. Food and Drug Administration, FDA, issued an updated warning to health care professionals today regarding excessive radiation exposure for an additional 50 patients during CT brain perfusion scans.  The warning is as follows:

"The FDA, working with state and local health authorities, has identified at least 50 additional patients who were exposed to excess radiation of up to eight times the expected level during their CT perfusion scans. These cases so far involve more than one manufacturer of CT scanners. Some of these patients reported hair loss or skin redness following their scans. High doses of radiation can cause cataracts and increase the risk of some forms of cancer.
On the basis of its investigation to date, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure.

These recommendations include:
•    Facilities assess whether patients who underwent CT perfusion scans received excess radiation.
•    Facilities review their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study.
•    Facilities implement quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered.
•    Radiologic technologists check the CT scanner display panel before performing a study to make sure the amount of radiation to be delivered is at the appropriate level for the individual patient.
•    If more than one study is performed on a patient during one imaging session, practitioners should adjust the dose of radiation so it is appropriate for each study."


You can review the MedWatch safety summary, including a link tlo the FDA News Release, by clicking here.

About the author:

Catherine Bertram is board certified in civil trials.  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 can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875. 

 

 


 

Posted In Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings
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Drug Warning: Vials of Genzyme Drugs Potentially Contaminated

Posted by: Salvatore J. Zambri, Esquire

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

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

 About the author:

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

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


 

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

Posted by: Salvatore J. Zambri, Esquire

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

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

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

About the author:

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

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

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Drugmaker Hid Dangers of Drug from Public to Pad Profits

Posted by: Salvatore J. Zambri, Esquire

According to a Bloomberg report, a former GlaxoSmithKline executive testified under oath that the drug company knew as early as 2001 that its anti-depressant drug--Paxil--could cause birth defects in the fetuses of pregnant women.  It has been alleged that this information was withheld from the public so the company could maximize profits at teh expense of public health.  The reports notes that in a videotaped deposition, former Glaxo drug-safety executive Jane Nieman stated that the company was “almost certain” by 2001 that Paxil was to blame for a certain heart defect that caused women to abort their fetuses. 

The drug generated about $942 million in sales last year alone.   We have no problem with companies making money--that's America.  What's un-American is putting profits over people.  No company should ever risk public health in a greedy effort to pad profits.  Many lawsuits against the drug manufacturer are pending, and we expect that the truth will be revealed and that the victims' suits will help protect all Americans from corporate greed. 

 About the author:

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

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

 


 

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

Posted by: Salvatore J. Zambri, Esquire

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

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

About the author:

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

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

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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American Association of Justice Rightly Defends Access to Justice

Posted by: Salvatore J. Zambri, Esquire


In a segment on CNN's "Anderson Cooper 360" (9/15), the immediate past-president of the American Association of Justice, Les Weisbrod, and another past-president, Todd Smith, addressed the notion of placing artificial caps on medical malpractice claims.  Weisbrod declared such a cap to be unconstitutional and made the well-known point that there is no evidence to show that such a cap would lower health-care spending.  Smith countered the notion that frivolous cases are brought by trial attorneys by stating the obvious--that lawyers have no logical reason whatsoever to take a case with no chance of winning.

Medical malpractice cases are extraordinarily expenses to litigate.  As a medical malpractice lawyer, I routinely advance hundreds of thousands of dollars on my clients' behalf, knowing that if the case fails, I lose all of that money since I never allow my clients to pay me back my advanced expenses in the absence of a favorable resolution.  To bring a frivolous suit would not only lead to financial ruin, but it exposes a lawyer to serious sanctions that can be imposed by the presiding judge and the Office of Bar Counsel that oversees attorney conduct.  Simply put, the idea that doctors face a barrage of frivolous suits is a myth.

Those with special interests need to recognize that too many Americans are killed or severely and permanently injured as a result of medical errors every year.  We need to focus on reducing medical mistakes.  The rights of victims of wrongdoing, often the most vulnerable in our nation, should never be stripped or capped.

About the author:

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

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


 

Posted In Medical Malpractice , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , Women's Health Issues
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Pfizer Subsidiary Pleads Guilty to Illegally Promoting Pain Killer

Posted by: Salvatore J. Zambri, Esquire

According to an AP (9/16) report, Pharmacia and Upjohn, a subsidiary of Pfizer, "has pleaded guilty to illegally promoting the pain killer Bextra [valdecoxib]" as part of "a settlement agreement announced earlier this month, when prosecutors slapped" Pfizer "with a record-breaking $2.3 billion in fines for illegal drug promotions."  In addition, Bloomberg News (9/16, O'Reilly) reports that, according to the United States Department of Justice, "US District Judge Douglas P. Woodlock in Boston took the plea...but deferred a decision on formally accepting it until a sentencing hearing on Oct. 16."

All too often we hear about drug companies, insurers, and other entities that put profits over people.  Innovation is essential, but no company should ever seek money at the expense of public health and well-being.  Such conduct is reprehensible and dangerous.  Access to justice through the civil jury system is what allows for proper checks and balances.  If gives people a fair voice to speak out against corporate corruption, and it allows the innocent victims of corporate greed to obtain fair and just compensation for all of their harms and losses.

About the author:

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

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

Posted In Medical Malpractice , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , Women's Health Issues
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Study Suggests Hormone Therapy Increases Risk of Ovarian Cancer

Posted by: Salvatore J. Zambri, Esquire

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

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

About the author:

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

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

 

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

Posted by: Salvatore J. Zambri, Esquire

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

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

About the author:

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

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

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

Posted by: Salvatore J. Zambri, Esquire

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

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

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

To read the entire warning, click here.

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

About the author:

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

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

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Doctors Fail to Report Abnormal Test Results At Alarming Rate

Posted by: Salvatore J. Zambri, Esquire

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

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

About the author:

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

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

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

Posted by: Salvatore J. Zambri, Esquire

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

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

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

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

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

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

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

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

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

Posted by: Salvatore J. Zambri, Esquire 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Antidepressants May Cause Breast Cancer

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

According to a recent Bloomberg report, 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", states the article. 

Notably, the study revealed that tumors were more than twice as likely to return after two years in women taking the antidepressants cited above while on the anti-cancer drug tamoxifen, as compared with those taking tamoxifen alone. The research was conducted by Medco Health Solutions Inc., and was presented at a meeting of researchers at the American Society of Clinical Oncology in Orlando.

To read the entire article, please click here.

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

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

Posted In Cancer Misdiagnosis , Medical Malpractice , Men's Health Issues , Patient Safety , Product Liability , Public Health , Women's Health Issues
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Congress To Question VA Hospital Regarding Exposure to HIV

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

The Washington Post reports that Congress plans to question officials with the Department of Veteran Affairs concerning events that have potentially exposed more than 10,000 former VA patients to blood borne illnesses, including HIV.  The purpose of the U.S. House Committee on Veterans' Affairs' investigation is to determine whether the exposure came from improper medical procedures and, if so, what the VA has done to address the problems.  

To date, 5 people have been diagnosed with HIV and 43 have been infected by hepatitis. Last week,  U.S.  Rep. Harry Mitchell D-Arizona, the subcommittee chairman, said that veterans who are testing positive, "whether it came from these improper procedures or not, the VA has a responsibility to take care of these patients."

Our firm has experience pursing cases for patients that involve tragic medical errors.  If you think you have been injured as a result of medical negligence, we encourage you to read an article regarding medical malpractices cases authored by senior partner Salvatore Zambri.

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

 

 



 

Posted In Medical Malpractice , Men's Health Issues , Patient Safety , Product Liability , Public Health , Women's Health Issues
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Maryland Rejects Link Between Vaccinations and Autism

By Victor E. Long, Esq. 

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

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

 

 

Posted In Medications , Patient Safety , Product Liability , Public Health
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Former Surgeon at VA Hospital May Have Falsified Study Data

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

The Wall Street Journal (WSJ) reports that an "investigation by Walter Reed Army Medical Center in Washington found 'a number of serious questions' about a study by a former surgeon at the hospital evaluating the use of a bone-growth protein in soldiers with leg fractures."  The product at the center of the study, Infuse, is a bone-growth drug that is widely used in hospitals and by physicians to treat broken bones. The report goes on to state that the former Walter Reed surgeon "forged his purported co-authors' signatures on the study and that the number of injured soldiers differs from the Army's records of its wartime casualties. Hospital officials said the study was based on 'falsified information.'"

WSJ was not the only periodical to challenge the study by Timothy R. Kuklo. The St. Louis Post Dispatch reported that  the surgeon "published a study that reported a bone growth drug sold by Medtronic Inc. had a higher success rate than Walter Reed doctors could verify."  Medtronic has confirmed that he "was a paid consultant, but that Medtronic did not review or finance the study."

If the study was indeed falsified, it woul dbe another example of putting profits over people.  Patients rely on drug and device manufacturers conducting ethical and reliable studies.  Pushing drugs and devices into teh marketplace and disseminating promotional materials that are false or misleading can cause serious and potentially deadly consequences.  

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

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

 

Posted In Medical Malpractice , Men's Health Issues , Patient Safety , Product Liability , Public Health , Women's Health Issues
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Taxotere Promotional Materials Misleading

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

Dow Jones Newswires  reports that the Food and Drug Administration (FDA) has urged Sanofi-Aventis SA, a drug manufacturer, "to stop distributing certain promotional material for its breast cancer drug, Taxotere [docetaxel], saying the material misleadingly claims the medicine is more effective than proven."  According to the report, the FDA has indicated that "binders with reprinted medical studies claim Sanofi's Taxotere is better than other medicines to treat patients with breast cancer after prior chemotherapy treatments failed," yet the "FDA is unaware of substantial evidence to support these claims."

We encourage our readers to be very careful when reading or listening to promotional materials disseminated by drug companies.  All too often these materials are misleading and are driven by the drug companies' desire to maximize its profits.   We believe that people should be above profits and that promotional materials must be accurate and properly informative.  If profits are put above people, public health will be compromised.

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

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

 

Posted In Cancer Misdiagnosis , Medical Malpractice , Men's Health Issues , Patient Safety , Product Liability , Public Health , Women's Health Issues
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Tarceva Warnings Added

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

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

To read the entire FDA report, please click here.

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

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

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

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Recalls Biosite'sTriage Cardiac Panel

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

The Food and Drug Administration (FDA) reports that Biosite and the FDA have notified medical professionals of a Class 1 recall of the Biosite-brand Triage Cardiac Panel.  This particular panel is a test used by healthcare specialists to diagnose a heart attack (myocardial infarction).  However, according to the FDA, the "use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, with CK-MB, and with myoglobin, possibly resulting in missed or incorrect diagnosis. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have."

All Biosite customers must stop using all Biosite-brand Triage Cardiac Panels immediately.  Reliance upon these defective tests can lead to mistreatment of people with otherwise treatable heart conditions.

To read the entire recall, please click here.

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

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

Posted In Medical Malpractice , Men's Health Issues , Obstetrics , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Tainted Equipment at VA Hospitals Cause HIV Infections

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

Former patients at several Veterans Administration Hospitals have been tested positive for HIV or hepatitis following exposure to dirty medical equipment.  According to a recent report at Chron.com, "[f]ive patients have tested positive for HIV and 33 have tested positive for hepatitis since February, when the VA started notifying more than 11,000 people treated at three VA medical centers to get follow-up blood checks because they could have been exposed to infectious body fluids." The specific VA hospitals involved are located in Miami, Fla., Murfreesboro, Tenn., and Augusta, Ga.

The VA determined last December that its equipment used for colonoscopies and ear, nose and throat procedures "was either not properly cleaned or set up", states the report.  Despite the medical errors, Dr. Jim Bagian, the VA's chief patient safety officer, boldly proclaimed that patients will never be able to prove that they were infected by the tainted equipment, the report comments. Congress is not satisfied with this statement and wants more information.

Senior partner Salvatore Zambri has handled many cases involving patients becoming infected with HIV as a result of medical errors.  There are clear standards that apply to hospitals governing the sterilization of medical devices and products.  If these procedures are not followed, the consequences can be severe.

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

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

Posted In Medical Malpractice , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Women's Health Issues
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Hearing Tomorrow On Medical Device Safety Act of 2009

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

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

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

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

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

The New York Times has also endorsed the bill.

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

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

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

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , Tort Reform , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Too Lenient On Device Approval

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

An editorial from yesterday's New York Times challenges the Food and Drug Administration (FDA) , suggesting that the agency has been too lenient in approving medical devices.  The article notes that a “vaginal sling,” used to control urinary leaks, that was previously sold by the Mentor Corporation,  a company that was acquired by Johnson & Johnson, has caused serious medical problems for many women throughout the country. In one instance, a woman's "surgeon inserted a strip of synthetic mesh — Mentor’s ObTape vaginal sling — under her urethra. It stopped the leakage but soon caused pain and bleeding as pieces of the sling worked their way through her vaginal wall. The woman has had five operations to remove bits of the sling, and another is scheduled."

Last year, the FDA received more than 1,000 reports directly from manufacturers about complications with "vaginal-sling"-like devices, according to the report.  About one-fourth of the complaints concerned "ObTape" specifically.  "The injuries may stem from the fact that far too many medical devices are cleared for sale without undergoing rigorous clinical trials for safety and efficacy."

To read the entire article, please click here.

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

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

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

Posted In Medical Malpractice , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Weight-Loss Products Spiked With Illegal Drugs

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

The Food and Drug Administration (FDA) has found that more than 70 weight-loss products contain prescription drugs, including four illegal drugs that have not approved by the FDA for sale in the United States, according to Public Citizen, citing its Worst Pills, Best Pills News article released last week on WorstPills.org, the organization’s drug safety website.

The FDA has announced what is obvious--that adding active prescription drug ingredients to otherwise ineffective weight-loss supplements is not only illegal, but can be extremely dangerous.  "For instance, sibutramine (brand name Meridia, an appetite suppressant available by prescription only and a controlled substance) and fluoxetine (brand names Prozac and Serafem, an antidepressant available by prescription only) were among the drugs found in the supplements", states Public Citizen. 

Although the FDA is seeking a voluntary recall of the illegal products, some say the FDA is not acting strong enough.  "The FDA’s response has been inadequate,” said Sidney M. Wolfe, M.D., director of Public Citizen’s Health Research Group and acting Public Citizen president. “Some of the drugs found in these supplements are dangerous and are putting people at an unacceptable risk of injury. To protect citizens, the agency needs to go further and seize these products.”

To read the entire article, please click here.

We encourage our readers to be very careful about what medications they ingest.  All medications should be supervised by a physician.  Don't become a victim of others' greed.

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

Posted In Medical Malpractice , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Beware of Fraudulent Swine Flu Products

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

Both the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have warned the public to be wary of entities selling products through the internet "that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus"--the swine flu.  According to the FDA, many of the products are fraudulently advertised, and officials are going after the perpetrators, who face serious consequences if found guilty of fraud.

“The last thing any consumer needs right now is to be conned by someone selling fraudulent flu remedies,” said FTC Chairman Jon Leibowitz.  “The FTC will act swiftly against companies that resort to deceptive advertising.”

To read the FDA press release, please click here.

We encourage our readers to be very careful about what medications they ingest.  All medications should be supervised by a physician.  Don't become a victim of others' greed.

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

Posted In Medical Malpractice , Men's Health Issues , Patient Safety , Product Liability , Public Health , Women's Health Issues
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Revelations on Genetic Risks of IVF

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

For nearly thirty years, in-vitro fertilization (IVF) has been consider relatively safe.  A recent report in the New York Times, however, reports that new epidemiological studies and scientific techniques have revealed findings that suggest that "there may be some abnormal patterns of gene expression associated with IVF and a possible increase in rare but devastating genetic disorders that appear to be directly linked to those unusual gene expression patterns."  The report also states that, with IVF, there "appears to be an increased risk of premature birth and of babies with low birth weight for their gestational age."

To read the entire article, please click here.

If you are considering an IVF procedure, we encourage you to speak with your doctors about all potential risks and benefits, so that you can make fully informed decisions.

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

Posted In Cerebral Palsy , Medical Malpractice , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Product Liability , Public Health , Women's Health Issues
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Health Care Delayed in Ailing Economy

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

The economy is forcing twenty percent (20%) of Americans to delay or avoid needed medical care, according to a recent Thomson Reuters survey. The survey also reports that more than 20% of Americans believe they will have difficulty paying for health insurance or health services over the next three months.

"We are seeing a positive correlation between Americans losing their access to employer-sponsored health insurance and deferral of healthcare," said Gary Pickens, of Reuters' health-care division, who led the study.  "if this trend continues, it will ultimately have an impact on our collective well-being."

If you are having difficulty affording health coverage, we urge you to contact local and state agencies to see if you qualify for Medicaid or other benefits.  Certain private companies, like Walgreens, provide programs for the unemployed and uninsured, as well.

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

Posted In Medical Malpractice , Men's Health Issues , Patient Safety , Product Liability , Public Health , Women's Health Issues
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Hospital Devices Infected by "Conficker" Worm Virus

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

According to MercuryNews.com, technologists monitoring the threat have determined that hundreds of medical devices used at hospitals throughout the country are infected by the computer worm known as "Conficker".  The infected devices include MRI machines and hundreds, if not thousands, of other medical devices.  Manufacturer of the devices told investigators that "none of the machines were supposed to be connected to the Internet — and yet they were. And because the machines were running an unpatched version of Microsoft's operating system used in embedded devices they were vulnerable," states the report.

The report explains that "Conficker spreads by copying itself onto machines running Microsoft's Windows operating system that lack the security patch from October. Conficker installs itself and periodically reaches out for directions from its maker that cause it to rewrite its code, increasing its capabilities for malicious action and decreasing its chance of detection."  Apparently, patients have not yet been harmed, but it is clear that these infected devices place patients at risk.

To read the entire article, please click here.

Many Americans are injured or killed each year due to defective products.  For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030. 

Posted In Medical Malpractice , Men's Health Issues , Nursing Home Negligence , Patient Safety , Pediatrics , Product Liability , Public Health , Women's Health Issues
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Stalled Suits Against Drug Companies Now Proceeding

Posted by Patrick Regan and Paul Cornoni

Bloomberg News (4/30 Fisk, Feeley) reports, "Just two months after the U.S. Supreme Court decided patients can sue drugmakers over injuries from medicines approved by the government, long-stalled lawsuits against GlaxoSmithKline Plc and Bristol-Myers Squibb Co. are again moving toward trials."

The Supreme Court's decision in Wyeth essentially states that federal regulatory approval (FDA) of a medicine or drug doesn't shield drugmakers from claims that patients were not adequately warned of potential side effects and other harms.  The Wyeth decision has already affected more than 250 lawsuits involving at least ten different drug companies. 

As the article explains: "Glaxo this month settled two cases on claims its antidepressant Paxil can make patients suicidal, after judges set trials citing the Wyeth decision. A Barr Pharmaceuticals hyperactivity-drug case is to be tried in August in federal court in Tallahassee, Florida. And a group of Bristol-Myers lawsuits over the blood-thinner Plavix may now proceed to trial in federal court in Trenton, New Jersey."

Posted In Product Liability , Tort Reform
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Crib Safety: Changes in Store for Parents

Posted by Patrick M. Regan

Parents shopping for baby cribs are going to notice some significant changes in the types of cribs offered for sale.  Toys "R" Us has recently announced that it will stop selling drop down cribs because of a concern for the safety of infants.  In a blog on the Wall Street Journal's (4/22) website, Rachel Silverman wrote, "Concerns about the safety of popular crib designs have led to 21 recalls of 4.2 million cribs over the past two years because of hazardous defects" and the "products involved in the recalls have been linked to at least five infant deaths and 16 cases in which babies were trapped by parts of a crib, said the Consumer Product Safety Commission."

Continue Reading Posted In Product Liability , Public Health
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Botox Uses Increase

Posted by:  Salvatore J. Zambri and Catherine Bertram

Not even the inventors of Botox could have anticipated how widely used the drug has become.  Once thought to be the answer to wrinkles, Botox is now being administered to treat all kinds of  ailments, including,  migraines, speech impediments, skin disorders, muscle and gland problems, and much more, according to a recent publication in the New York Times. 

The Times report quotes Dr. Mitchell F. Brin, a neurologist who is the chief scientific officer for Botox at Allergan, the drug’s maker, who stated, “We see it as a molecule that keeps on giving.  As we understand it more, it gives us new ideas of how to use it." But not everyone agrees.  “It’s trial and error with a nerve poison,” says Dr. Sidney M. Wolfe, the director of the health research group at Public Citizen, a consumer advocacy group. 

To read the entire Times article, please click here.

Botox is a nerve poison produced by the bacteria that cause botulism, a disease that paralyzes muscles and can be fatal. Before taking any medication, please be sure you are evaluated by your physician.  The wrongful administration of medication can cause serious permanent injury or death. 

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

Posted In Medical Malpractice , Men's Health Issues , Product Liability , Public Health , Women's Health Issues
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Epilepsy Drug May Harm Unborn Children

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

According to the New York Times, a new study found that pregnant women who took a popular epilepsy drug-- valproate, sold generically and under the brand name Depakote-- to treat migraines, pain and psychiatric disorders had children whose I.Q. scores were significantly lower than similar children who were not exposed to the drug.  Valporate remains the second-most-popular antiseizure medication used for epilepsy, says the report, but users must fully appreciate  its risks.

“My thought is that if I make a mistake and the patient has a breakthrough seizure, I can change the medication and switch the patient to valproate,” said Dr. Kimford J. Meador, professor of neurology at Emory University School of Medicine in Atlanta, and the first author of the new study. “If I put the patient on valproate as a first choice and the baby has cognitive impairment or a malformation, I can’t repair that.”

To read the full Times report, please click here.

Before taking any medication, please be sure you are evaluated by your physician.  The consequences of mixing medications and taking them while pregnant can be devastating. 

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

Posted In Medical Malpractice , Patient Safety , Product Liability , Public Health , Women's Health Issues
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FDA Approval of Seroquel

The American Association for Justice is following a developing story involving FDA approval of uses of the anti-psychotic drug Seroquel.  The FDA has approved the drug for schizophrenia and bipolar disorder, but AstraZeneca has been marketing the drug to patients suffering from depression and anxiety.  AstraZeneca is currently under review by the FDA to have the drug’s use expanded to include patients of depression and anxiety.  However, many believe that sealed documents with the court could shed some light on the side effects of Seroquel.   

Ted Baker, 60, of Bastrop, La., a Vietnam veteran who suffers from post-traumatic stress disorder and major depressive disorder, was prescribed Seroquel in 2001 as an antidepressant and continued to take it until 2006.  Due to his Seroquel use, he was diagnosed with Type II diabetes in March 2004.

Many people fear that the expanded use of this drug could expose others to diabetes.   Please review AAJ's press release for more details concerning this story. 

Posted In Patient Safety , Product Liability , Public Health
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Is the FDA ignoring realities of Internet marketing?

In the New York Times advertising column, Stephanie Clifford writes that "the Food and Drug Administration sent letters to 14 major pharmaceutical companies late last month, "warning them that their "search advertisements...had to start including risk information about each drug or else be rewritten or removed."

The companies, however, argued that "there was no way to include all the required information" within the "95 characters...allowed for search ads." According to Arnie Friede, counsel at McDermott, Will & Emery, "Until these letters were sent, pharmaceutical and media companies had assumed that there was a one-click rule" under which they would be "in compliance" if they "provided risk information within one click of their search ads." In changing the ads, industry executives now claim they "are even more confusing and misleading" and that "the agency is ignoring the realities of Internet marketing." Furthermore, the drug industry argues that the FDA "is not issuing clear rules about compliance."

Posted In Medications , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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FDA Warning: Class 1 Recall of Electronic Infusion Pumps Used for Medications and Fluids

The FDA has issued a Class 1 Recall for electronic infusion pumps that deliver IV medications and fluids to patients.   Class 1 recalls, the most serious category, are made when there is a reasonable probability that use of the product will cause injury or death.  We have reproduced the FDA Warning Notice in its entirety for our readers. 

Class 1 Recall: Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps

Date Recall Initiated: January 23, 2009
Product:  Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps

Model numbers: Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163

These products were manufactured and distributed from February, 1997 through December, 2008.


Use:  Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.


Recalling Firm:
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd.
Round Lake, Illinois 60073


Reason for Recall:

The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death.


Public Contact:
Customers may call Baxter Healthcare Corp. at 1-800-843-7867


FDA District:
Chicago


FDA Comment:

On January 23, 2009, the company sent a correction letter to all of its customers about failures that could lead to:

* interruption of therapy
* damaged battery messages
* smoke and fire hazards
* serious injury and/or death

The letter also:

* advised institutions to have contingency plans to verify that back-up pumps are available
* provided new steps for addressing an interruption of therapy with any failure code
* provided instructions for addressing damaged battery messages
* provided instructions for proper device cleaning

For more information about this recall, please see the company’s press release at: http://www.baxter.com/about_baxter/news_room/ news_releases/2009/03_11_09_colleague.html

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the 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 5600 Fishers Lane, Rockville, MD 20852-9787
* FAX: 1-800-FDA-0178

Updated March 11, 2009

Continue Reading Posted In Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings
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Supreme Court Ruling in Wyeth v. Levine: Victory for Justice

The Supreme Court of the United States recently announced its ruling in the Wyeth v. Levine case. The principal question before the Court was whether FDA approval of a drug's label overrides (or preempts) state-law claims of inadequate warning. The argument made by the drug company was that it would be impossible to comply with both state and federal laws if the state's law provides for a stronger warning label than the FDA labeling regulation. The Supreme Court rightly rejected that argument, finding that "Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness." By issuing this ruling, the Court will allow consumers more protection from drug injuries that could have been prevented if the drug label had included proper warnings.

In this case, Diane Levine, a professional musician being treated for migraine headaches was injected with Phenergan, a drug manufactured by Wyeth. Because of the direct IV administration (IV push) of the drug, Ms. Levine's artery in her arm died, ultimately resulting in amputation of that arm. Wyeth was aware of the dangers of the IV push method for administering Phenergan, but never included any warnings to prohibit IV push administration on the label. The FDA had not determined whether the label should have included the warning. However, the FDA's labeling rules require that a prescription drug manufacturer change warning labels as soon as there is reasonable evidence that the drug causes adverse reactions without waiting for FDA approval of the label change.

Government regulations are intended to set minimum safety standards, but cannot guarantee safety. The preamble of regulations was intended to define the agency's interpretation. Beginning in 2005, Federal agencies started adding to the preamble of regulations without Congressional approval. With these additions, the agencies claimed that federal standards overrule any state safety standards and that state tort claims should be discarded. By adding preemption language to the agency preamble, the agencies bypassed Congress in determining if or when state law should be overruled. In 2007, however, Congress passed the Food and Drug Administration Act of 2007 (FDAAA), forcing the FDA to require drug manufacturers to update their labels when the manufacturers become aware of potential hazards.

If you or a family member has been injured as a result of a drug error or other product defect, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.

 

Posted In Medications , Patient Safety , Product Liability
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Sound-Alike Drug Names Increase the Risk of Medication Errors

Whether the drug names are Celexa and Celebrex, Losec and Lasix, or even Prilosec and Prozac, sound-alike drug names pose dangers to patients.  Those dangers are compounded by the multi-ethnic and geographic diversity of the U.S. healthcare system, where strong accents combined with ordinary mispronunciation of complex pharmaceutical terms can lead to catastrophic outcomes if the wrong medication is accidentally dispensed.  Medication errors and sound-alike drug names are the topics of a recent article featured on HealthDay News.

Continue Reading Posted In Medical Malpractice , Medications , Patient Safety , Product Liability
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Heart Surgery Drug Trasylol Confirmed Deadly

A new study has confirmed that hospital patients given Trasylol (aprotinin), a drug used to reduce bleeding during heart surgery, are 53% more likely to die than patients who are given other anti-bleeding drugs.  The drug's manufacturer, Bayer AG, has informed the U.S. Food and Drug Administration (FDA) that it has begun removing all remaining stock of Trasylol from all pharmacies and health care facilities in the U.S.

The latest Trasylol study was released Wednesday is slated to appear in print in the May 29 issue of the New England Journal of Medicine.

Continue Reading Posted In Medical Malpractice , Medications , Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings
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Experimental Blood Substitutes Linked to Heart Attack, Death: New Study

New hemoglobin-based artificial blood -- still unapproved for use in the U.S., but heavily studied -- appears to raise a patient's risk of heart attack and death according to an exhaustive review of clinical research data.  This latest research was published in a recent edition of the Journal of the American Medical Association (JAMA).  The findings have spurred critics to allege that the U.S. Food and Drug Administration (FDA) put clinical trial participants in imminent danger by failing to detect or act on research data illustrating significant increases in the rates of heart attack and death reported in trials of these blood substitutes.

Continue Reading Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , Women's Health Issues
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Crowns and Other Dental Fixtures Produced Abroad May Contain Lead

Though patients and even dentists are often unaware, crowns, bridges and other dental devices produced by foreign manufacturers contain dangerous levels of lead in many instances, according to an investigative report by WBNS-10 TV  -- an Ohio television station that has captured the attention of the American Dental Association (ADA) and millions of concerned patients.

Continue Reading Posted In Patient Safety , Product Liability
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Baxter Healthcare Corp. Recalls All Remaining Heparin Vials and Hep-Lock Products

According to the U.S. Food and Drug Administration (FDA), Baxter Healthcare Corp. has announced that it is recalling all remaining multi-dose vials of their heparin, as well as single-dose vials and Hep-Lock heparin flush products, which prevent blood clots in intravenous (IV) lines.  Baxter widened its initial recall after another manufacturer of multi-dose heparin vials -- APP Pharmaceuticals of Schaumburg, Ill. -- was able to assure the FDA that it could meet the demand for the entire supply of the blood thinner in the United States.  Several U.S. manufacturers produce items similar to Baxter's Hep-Lock.

Continue Reading Posted In Medications , Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings
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Botox Linked to Respiratory Failure and Death: FDA Warning

The U.S. Food and Drug Administration (FDA) is warning that three products:  Botox, Botox Cosmetic (Botulinum toxin Type A), and Myobloc (Botulinum toxin Type B) have been linked to fatal adverse reactions including respiratory failure.  The most severe adverse reactions have occurred in children with cerebral palsy, who rely on the drug for treatment of limb spasticity.  The FDA warns that it has not approved any Botulinum toxins for treatment of spasticity in either children or adults, though it is not advising healthcare professionals to stop prescribing the products at this time. 

Continue Reading Posted In Cerebral Palsy , Medications , Patient Safety , Pediatrics , Product Liability , U.S. Food and Drug Administration Warnings
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Surgical Site Infections Common Following Breast Reconstruction Surgery: New Study

Breast cancer patients who elect reconstruction surgery immediately following a mastectomy suffer substantially higher rates of surgical infection when they choose to use surgical implants, rather than their own abdominal fat, to shape their breasts.  The finding is the result of new research published in the journal Archives of Surgery

Continue Reading Posted In Medical Malpractice , Patient Safety , Product Liability , Women's Health Issues
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Low Lead Levels In Blood Linked to ADHD: New Research

Levels of lead in childrens' blood which were previously thought to be safe could actually be contributing to Attention Deficit Hyperactivity Disorder (ADHD), according to researchers at Michigan State University.  Their research findings will appear in the March issue of Biological Psychiatry, the official journal of the Society of Biological Psychiatry

Continue Reading Posted In Pediatrics , Product Liability , Public Health
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Cardiologists Concerned Over Unexplained Two-Year Delay in Drug Study Results

Cardiologists are growing increasingly suspicious over the hesitation of drug makers to release the results of clinical trials for the cholesterol-lowering drugs Vytorin and Zetia, according to a recent New York Times article.  The two drugs are prescribed for an estimated 800,000 Americans every week, generating sales of $4 billion in 2007 alone.  Clinical trials of the drugs ended two years ago, but manufacturers Merck and Schering-Plough have yet to release those research results.

Continue Reading Posted In Medications , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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FDA Seizes Cosmetic Eye Product Over Eye Injury Concerns

At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals recently seized  more than 12,000 tubes of cosmetic eyelash product worth approximately $2 million, because the product contained undeclared bimatoprost -- a prescription drug ingredient used in the treatment of increased eye pressure. Continue Reading Posted In Medications , Product Liability , U.S. Food and Drug Administration Warnings
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Traysol Heart Surgery Drug: FDA Announces Suspension of Marketing Until Review Completed

Bayer Schering Pharma, the manufacturer of popular heart surgery drug Trasylol, will suspend all marketing of the drug until a review can be conducted of recent Canadian research which has implicated the drug in a higher risk of death for cardiac patients. 

Continue Reading Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Mattel, Inc. Expands Toy Recall Over Lead Paint, Magnet Concerns

Mattel, Inc. has announced an expanded recall of 9 million toys due to health threats posed by powerful magnets and toxic lead paint.  Approximately 1.5 million toys were recalled on August 1st, all of which had been manufactured in China.  These latest additions were also manufactured in China.  Among those magnetic toys most recently recalled are Polly Pocket toys, Barbie and Tanner sets, Doggie Daycare sets and Batman figurinesSarge characters from the movie Cars are being recalled due to toxic surface paint.

Continue Reading Posted In Pediatrics , Product Liability
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Some Red Yeast Rice Products Contain Undeclared Prescription Drugs: FDA Warning

Red yeast rice and red yeast rice supplements are often marketed as cholesterol-lowering alternatives to medication.  The U.S. Food and Drug Administration (FDA) has announced, however, that some red yeast rice products may lower peoples' cholesterol because manufacturers have been illegally lacing them with lovastatin -- the active ingredient in Mevacor, a prescription cholesterol drug.  The FDA has issued warnings related to the following specific red yeast rice products:

  • Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively
  • Cholestrix, sold by Sunburst Biorganics.
Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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Federal Jury Awards $5.5 Million in Damages in Duragesic Patch Case

A federal jury in Florida has awarded $5.5 million to the estate of a 28-year-old man who died of an accidental overdose of pain medication because his Duragesic narcotic patches were defective.  The single-use patches which deliver fentanyl, a narcotic, via skin absorption, are manufactured by two Johnson & Johnson subsidiaries.  A jury found the manufacturers guilty of negligence in the manufacture of the patch, and of failing to adequately warn people about its dangers. 

Continue Reading Posted In Medications , Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings
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Supreme Court to Hear Major Medical Device Liability Case

The U.S. Supreme Court recently agreed to hear a product liability case with significant implications for the medical device industry and for any patient treated with medical devices.  The Public Citizen Litigation Group is representing Charles Riegel, in the case Riegel v. Medtronic; a case stemming from an incident in which Mr. Riegel was seriously injured by a defective cardiac catheter.  Medtronic asserts that the Food, Drug, and Cosmetic Act preempts state laws damages actions brought by injured patients in cases where the injury resulted from a device permanently approved by the U.S. Food and Drug AdministrationContinue Reading Posted In Patient Safety , Product Liability
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Toy Recall Alert: Fisher-Price, Mattel Issue Toy Recall Over Lead Paint Concerns

Fisher-Price and its parent company, Mattel, Inc., are recalling 83 kinds of children's toys, including Sesame Street, Sponge Bob and Dora the Explorer figures among others, because surface paint on the toys contains high levels of lead.  The U.S. Consumer Product Safety Commission (CPSC) has stated that the toys were available in most major retail stores between May 2007 and August 2007, for prices between $5 and $40.  The recall is the first ever for Fisher-Price or Mattel, Inc. involving lead paint, and the largest recall for Mattel, Inc. in nearly a decade.  No injuries have yet been attributed to the toys, which were manufactured in Chinese facilities.

Continue Reading Posted In Product Liability , Public Health
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Davol, Inc. Warned By FDA Over Defective Kugel Hernia Patches

Following an expanded recall of the Kugel hernia patch, The U.S. Food and Drug Administration (FDA) has inspected the headquarters of its manufacturer, Davol, Inc., and issued the company a warning, citing serious quality control problems related to the manufacture of its surgical patch and an associated fixation device.  The inspection was completed in March, 2007. 

Continue Reading Posted In Medical Malpractice , Patient Safety , Product Liability
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Fake "Colgate" Toothpaste Recalled

Discount store toothpaste labeled "Colgate" and sold in 5-ounce tubes is being recalled after it was found to contain diethylene glycol, an ingredient used to make anti-freeze, according to a bulletin issued by the U.S. Food and Drug Administration (FDA).  The product was also found not to contain fluoride. 

The Colgate-Palmolive company denies responsibility for the contamination, noting that the affected toothpaste is counterfeit and that the boxes are marked "Manufactured in South Africa," and feature a number of misspelled words.  Colgate does not import its product from South Africa, and is working closely with the FDA to identify the source of the contaminated product. 

If you suspect you have purchased counterfeit Colgate toothpaste, you are urged to call the Colgate-Palmolive at (800) 468-6502.

If you or a family member believes that you have a case involving a dangerous product, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.  If you would like to receive our complimentary electronic newsletter, please click here. 

Posted In Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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Contact Lens Solution Recall: Serious Eye Infection Risk

Contact lens wearers should immediately stop using Complete MoisturePlus Multi Purpose Solution and discard all partially-used or unopened bottles.  Reports of a rare and extremely serious eye infection have been linked to the solution.  The infection, Acanthamoeba keratitis, is caused by a parasite and may lead to vision loss with some patients requiring a corneal transplant.  Normally healthy people who wear contact lenses may be affected by the parasite.  During a recent investigation by the Centers for Disease Control (CDC), users of the Complete MoisturePlus Multi Purpose Solution were at least seven times more likely to develop Acanthamoeba keratitis than those who used another brand.

According to an announcement by the director of the Center for Devices and Radiological Health of U.S. Food and Drug Administration(FDA), the manufacturer of the product, Advanced Medical Optics,  "acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public health.  FDA and CDC are working closely with the company to collect additional information and we will continue to  alert consumers and advise them as more information becomes available."

Consumers should consult with their doctors about alternative cleansing/disinfecting products.  If they have any symptoms of eye infection, they should seek immediate medical attention.  Early detection is critical for effective treatment of Acanthamoeba keratitis.

Continue Reading Posted In Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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FDA WARNING: Counterfeit Drugs Enter the Supply Chain

In a Fall 2006 release, the FDA urged consumers not to buy drugs on line from Canadian pharmacies.  The FDA’s 2005 crackdown found that 85% of drugs intercepted from “Canadian pharmacies,”  actually came from 27 other countries.

In particular, the FDA is urging consumers not to purchase any medications from websites that have orders filled by Mediplan Prescription Plus Pharmacy or Mediplan Global Health in Manitoba, Canada. The FDA is currently investigating reports that these companies are involved in the distribution of counterfeit drugs to US consumers.

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Defective Drugs: Major Victory for Consumers---Court rejects federal preemption

Victims of pharmaceutical company misconduct won a major victory in U.S. District Court in Philadelphia Oct. 17 when Judge Stewart Dalzell rejected Novartis Pharmaceutical Corp.'s claim that the Federal Food, Drug and Cosmetic Act and FDA regulations preempt state failure-to-warn tort claims. The issue of FDA preemption has been a hot one since the FDA issued a new drug labeling regulation in January 2006. At that time, the agency claimed in the preamble to the rule that federal drug labeling regulations preempt most state failure-to-warn claims against pharmaceutical manufacturers. This new language on preemption was added to the notice of final rulemaking, even though it was never included in--and directly contradicted--the notice of proposed rulemaking. The case, Perry v. Novartis, claims use of the prescription drug Elidel for the treatment of a two-year-old's eczema caused lymphoma. Novartis argued the suit should be dismissed because the claim was preempted by FDA labeling requirements for the product, which at the time did not require a warning about the risk of cancer. Plaintiffs' counsel vigorously opposed the motion and argued that the claims should be heard by a judge and jury. Judge Dalzell agreed with much of plaintiffs' counsel's argument in his landmark ruling. While recognizing that an administrative agency is entitled to great deference in its interpretation of ambiguities in its governing statute and regulations, he concluded that the FDA was not entitled to such deference when it attempts "to supply on Congress's behalf, the clear legislative statement of intent required to overcome the presumption against preemption." Dalzell rejected the FDA position--advanced in an amicus brief--that the appropriate test is whether the warning sought by the plaintiffs "would have rendered the drug misbranded" or "would have been rejected by the agency as unsubstantiated." Instead, he adopted a far narrower rule: "to allow state law to require the addition of warnings so long as there has been no specific FDA determination as to the sufficiency of the scientific evidence to support a particular warning." Dalzell went on to reject the policy argument that the claim might disturb the delicate balance of the FDA regulatory scheme, noting, "given the recent concerns about the effectiveness of the FDA's safety monitoring of recently approved drugs, the availability of state tort suits provides an important backstop to the federal regulatory scheme." Posted In Product Liability , Public Health
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Magnetic Toys Need Effective Warning Labels

In a November 21, 2006 release, the U.S. Public Interest Research Group (U.S. PIRG) has called for warning labels on toys with magnets after more than 4 million Mattel, Inc. play sets were recalled due to injuries to several children who swallowed magnets that fell off.  The U.S. Consumer Product Safety Commission (CPSC), which announced the recall of magnetic Polly Pocket sets as the holiday gift-buying season begins, urged shoppers to avoid buying toy sets with small magnets for children under 6. The recall does not include Polly Pocket play sets now on store shelves, which were redesigned to make them safer, according to CPSC spokesperson, Scott Wolfson.  The CPSC received nearly 200 reports of the small magnets falling from Polly Pocket dolls and accessories. Three children swallowed more than one magnet and suffered intestinal perforation that required surgery.  U.S. PIRG said the CPSC should require labels on all magnetic toys warning parents to seek immediate medical help if their child has swallowed a magnet. Continue Reading Posted In Patient Safety , Pediatrics , Product Liability
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FDA Approves Marketing of Silicone Gel-Filled Breast Implants

On November 17, 2006, after “rigorous” scientific review, the U.S. Food and Drug Administration (FDA) approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older.  The products are manufactured by Allergan Corp., Irvine, California, and Mentor Corp., Santa Barbara, California.  The approval has been highly criticized by consumer groups, including Public Citizen, which labeled them the "most defective medical device ever approved by the FDA" as well as a “terrible reminder of the double standard for women versus men” since the FDA has not approved silicone gel testicular implants because of the inadequacy of clinical trials.

Continue Reading Posted In Patient Safety , Product Liability , Public Health , Women's Health Issues
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Recall of 500 mg Acetaminophen (Tylenol) Caplets: Metal Fragments Found in Caplets


The Federal Drug Administration (FDA)  and Perrigo Company notified the public of a voluntary recall of 383 lots of acetaminophen 500 mg caplets manufactured and distributed under various store-brands.  The concern is that small metal fragments were found in some of these caplets. The FDA has a list of stores that carry store-brands potentially affected by this recall, as well as batch numbers affected, on the their website (referenced above). 

According to the FDA, there have been no injuries reported yet and no consumer complaints have been reported to the FDA. Based on limited information available, the FDA believes the probability of serious adverse health consequences is remote; however, they do warn that if a consumer were to swallow an affected caplet, it could result in possible cuts to the mouth or throat. 

Consumers should consult their physician immediately if they suspect they may have been injured by this product.  You should save the entire bottle and the contents as well.

Posted In Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings
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Use of Stents to Prevent Stroke Questioned

According to the Seattle Times, “the increasingly common practice of preventing strokes by using wire-mesh stents to prop open neck arteries is much riskier than the traditional method of surgically removing plaque and should be curtailed, according to two large European studies.”  The American studies, however, seem to suggest that stents are safer than surgery. 

Continue Reading Posted In Medical Malpractice , Men's Health Issues , Patient Safety , Product Liability , Women's Health Issues
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Spinach Update: Lab Links E. coli to Infant's Death

The Idaho Department of Health and Welfare has confirmed that the toddler who died of kidney failure was infected by the same E. coli strand found in tainted spinach from the Salinas Valley, according to the Centers for Disease Control and Prevention’s latest update on the E. coli outbreak.

The child’s death is the third confirmed death associated with the E. coli outbreak. Meanwhile, the U.S. Attorney, the FBI, and the FDA are investigating allegations that spinach suppliers failed to take the necessary steps to ensure the spinach was safe, according to a statement from the U.S Attorney’s office. Posted In Product Liability , Public Health
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Guidant Settlement In Defibrillator Fraud Suit

Just days before trial was scheduled to begin, Guidant Corporation, a subsidiary of Boston Scientific, settled a fraud suit for an undisclosed amount, according to The New York Times.  The plaintiffs claimed that the company failed to warn them that their implanted defibrillators might malfunction and knowingly chose to sell off a defective inventory.  Guidant has recalled thousands of implantable defibrillators since June 2005.  

The settlement comes following a meeting between the U.S. Food and Drug Administration (FDA) and Guidant to discuss the removal of several models of pacemakers and implantable defibrillators from hospital inventories due to defectiveness.  The defect in these devices involves a component that controls how the device holds its power supply.  The defect may cause the device to lose power and malfunction, causing intermittent or permanent loss of therapy, premature battery depletion or other malfunctions.  Earlier this year, Guidant issued a press release regarding its XIENCE V Everolimus Eluting Coronary Stent, a device that is not classified as an implantable defibrillator, stating that a small percentage of the inventory "was not manufactured with strict adherence to its quality standards." 
   

Continue Reading Posted In Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings
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Patients Not Informed When Hospitals Reuse Single Use Medical Devices

Debate continues over the safety of reusing surgical blades, forceps and other medical devices.  The practice is called "reprocessing" single use devices.  It cuts the cost of the device by half but is often done without the patient's knowledge or consent.

A federal law taking effect this fall requires companies that reprocess medical devices to put their name on the reprocessed devices.  This could help determine who is at fault when a problem occurs.

There are also concerns about infections and whether these single use devices can be safely and completely cleaned for re-use.  Reprocessed devices are soaked in sterilized solutions, disassembled and then reassembled, inspected and packaged and resealed.  According to some reports, the devices originally marked as "single use" by the manufacturer, are reused on average three to six times. Continue Reading Posted In Medical Malpractice , Patient Safety , Product Liability
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Deaths Following Medical Abortion: April 10, 2006 Update

It is remarkable how quickly pharmaceutical products can move through the regulatory approval process, so much so that one might question the effectiveness of research and development by manufacturers. Since the approval of mifepristone (marketed as Mifiprex) in September 2000, the U.S. Food and Drug Administration (FDA) has received reports of six deaths in the United States following medical abortion with mifepristone and misoprostol. Of the two most recent deaths reported to FDA in March 2006 (see DC Metro Area Medical Malpractice Law Blog, Deaths Following Administration of Medical Abortion), one has been determined to be unrelated to an abortion or to the use of these medications, while the other, with symptoms of infection, continues to be under investigation. According to previous FDA reports, four women in the United States have died from sepsis (severe illness caused by infection of the bloodstream) after medical abortion with mifepristone and misoprostol. All four women were infected by the same type of bacteria. While sepsis is a known risk of abortion in general, the symptoms in these four cases were not typical of sepsis. FDA has tested batches of mifepristone and misoprostol and has not found any contamination with the type of bacteria involved in the four cases. FDA recommends that women who have taken these medications for medical abortion contact a healthcare professional immediately if they develop stomach pain or discomfort, or have weakness, nausea, vomiting, or diarrhea with or without fever, more than 24 hours after taking the misoprostol.

Posted In Medications , Obstetrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Internal Documents Reveal Deception by the U.S. Centers for Disease Control and Prevention Regarding the Role of Vaccines in Autism

All too often, we find that clients have not been provided with complete information and, as a result, have not been given the opportunity to make informed decisions with regard to their own care or the care of a loved one. According to Generation Rescue, a nonprofit organization formed by parents of children diagnosed with autism and other developmental disorders, the U.S. Centers for Disease Control and Prevention (CDC) has minimized or attempted to conceal the association between childhood vaccines and autism. On April 6, 2006, Generation Rescue launched a website, www.PutChildrenFirst.org, and placed a full page advertisement in USA Today with regard to its allegations and the basis for them. Many parents and scientists believe that autism and other neurological disorders, including Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder (ADD/ADHD) and sensory integration disorder, are caused by the toxic metal mercury, a key ingredient in a vaccine preservative called thimerosal. Through the Freedom of Information Act, parents of autistic children obtained numerous internal documents from CDC, the U.S. Food and Drug Administration, the Institute of Medicine, and the U.S. Congress regarding this connection between vaccines and autism. According to Generation Rescue, one such document is an email and spreadsheet from a CDC epidemiologist showing an extremely high correlation between mercury received through vaccines and autism, with the researcher writing that the correlation "just won't go away." Another is a transcript from a meeting held by CDC during which health officials reported that "the number of dose-related relationships [between thimerosal and autism] are linear and statistically significant" and that CDC's data should be kept out of "less responsible hands."

During the last decade, CDC, as the agency responsible for the National Immunization Program, dramatically increased the number of recommended immunizations for children, nearly tripling the amount of mercury injected into children and grossly exceeding federal safety standards. During this period, rates of autism also dramatically increased, and Generation Rescue reports that more than 1 in 150 children are currently diagnosed with autism, as compared to 1 in 10,000 in the 1970s.

Continue Reading Posted In Medications , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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Recall of ACCU-CHEK Ultraflex Infusion Sets

FDA MedWatch announced a voluntary recall of all ACCU-CHEK Ultraflex Infusion Sets by the manufacturer, Disetronic Medical Systems, Inc. on April 4, 2006. The tubing for the units has a potenial to fully or partially separate at the luer lock-tubing connection, allowing insulin to leak and causing an interruption of insulin delivery. Hyperglycemia could result. Symptoms of hyperglycemia include:
- nausea/vomiting,
- blurred vision,
- excessive thirst or hunger,
- fatigue/tiredness/sleepiness,
- headache,
- fruity acetone breath,
- abdominal pain.
Patients with these symptoms should check their blood glucose level and follow the medical advice of their healthcare professional if the blood glucose level is not within the acceptable range.

Under this recall, customers may replace their ACCU-CHEK Ultraflex Infusion Set with ACCU-CHEK Tender of ACCU-CHEK Rapid-D infusion sets.

The complete MedWatch summary and press release is available at the FDA website.

For further information, contact ACCU-CHECK Customer Care Center or call 1-800-858-8072.

Posted In Medications , Product Liability , U.S. Food and Drug Administration Warnings
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Public Health Advisory: Telithromycin and Liver Toxicity

As recently reported in the Annals of Internal Medicine, there have been three cases of serious liver toxicity in individuals taking telithromycin (also known as Ketek). Telithromycin is an antibiotic of the ketolide class and was the first of this class to be approved by the U.S. Food and Drug Administration (FDA) in April 2004 for the treatment of respiratory infections in adults caused by the microorganisms Streptococcus pneumoniae and Haemophilus influenzae. These cases have been reported to MedWatch, the FDA's voluntary reporting system.

Telithromycin is marketed and used extensively in many other countries, including Japan and countries in Europe. FDA is continuing to evaluate the issue of liver problems in association with the use of telithromycin in order to determine if labeling changes or other actions are warranted. Moreover, FDA is exploring the frequency of liver-related adverse events reported for approved antibiotics in general in addition to telithromycin.

Continue Reading Posted In Medications , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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Ambien: Doctors and Patients Alerted

A recent series of articles in the New York Times reported strange new side effects in patients taking Ambien, one of the oldest and most prescribed sleep medications. "The articles cite recent studies by Carlos H. Schenck, MD, and colleagues at the Minnesota Regional Sleep Disorders Center. Schenck told the Times that he thinks thousands of U.S. Ambien users experience sleep-related eating disorders." Sleep eating disorders were first reported in 2002 by Michael H. Silber, MD, co-director of the Mayo Clinic Sleep Disorder Center and president-elect of the American Academy of Sleep Medicine. During these episodes, patients prepare and eat food, but have no memory of it the following day. Other less common reported side effects include sleepwalking and sleep driving. The complete summary appears in WebMD.

Continue Reading Posted In Medications , Product Liability
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Deaths Following Administration of Medical Abortion

The Food and Drug Administration (FDA) recently received verbal notification of two deaths in the United States following medical abortion with mifepristone and misoprostol. The notification was given by the drug's manufacturer, Danco Laboratories. While the FDA investigation is ongoing and the causes of these deaths have not been confirmed, the FDA has recommended that all providers of medical abortion and their patients be aware of the specific circumstances and directions for use of the drug as well as all attendant risks, including sepsis. In particular, providers and their patients should fully discuss early signs and symptoms that may warrant immediate medical evaluation, such as nausea, vomiting, or diarrhea, weakness with or without abdominal pain, all without fever or other signs of infection more than 24 hours after taking misoprostol.

As previously reported in its July 19, 2005 Public Health Advisory, updated on November 4, 2005, the FDA is aware of four previous confirmed deaths from sepsis in the United States, from September 2003 to June 2005, in women following medical abortion with mifepristone and misoprostol.

Information pertaining to these medications can be found at the FDA's Drug Information Page. For additional information regarding medication warnings in general, please visit the FDA's Medwatch site.

Posted In Medications , Obstetrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Steroid Warning: Dietary Supplements

Recent news articles have discussed the ongoing investigation into the use of performance enhancing steroids by major league baseball players. This investigation has led to the FDA's heightened awareness of the dangers associated with steroids and their widespread use. Steroid use extends beyond professional athletes and includes high school and recreational athletes as well as dieters.

"The Food and Drug Administration (FDA) warned several manufacturers and distributors of unapproved drugs containing steroids that are marketed as dietary supplements and promoted for building muscle and increasing strength that the products may cause serious long-term adverse health consequences in men, women, and children. These products claim to be anabolic and problems associated with anabolic steroids include: liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, and short stature in children. Anabolic steroids are also associated with causing adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke.

Consumers who have any of the following products should stop taking them and return them to their place of purchase:

Anabolic Xtreme Superdrol- manufactured for Anabolic Resources LLC, Gilbert, Arizona
Methyl-1-P, manufactured for Legal Gear, Brighton, MI

Read the complete MedWatch 2006 Safety summary, including links to the FDA Press release and Warning Letters to manufacturers and distributors of illegal steroid products sold as dietary supplements at:

http://www.fda.gov/medwatch/safety/2006/safety06.htm#steroids"

Posted In Medications , Product Liability , U.S. Food and Drug Administration Warnings
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Recall of Gentlease Baby Formula - Found to Contain Metal Particles

"Mead Johnson and FDA notified the public of a recall of one lot, lot # BMJ19, of GENTLEASE powdered infant formula, found to contain metal particles up to 2.7 millimeter in size. If an infant were to inhale the infant formula into the lungs, the presence of these particles could present a serious risk to the infant's respiratory system and throat.

There were approximately 41,464 24-ounce cans of this lot of recalled product distributed, beginning on December 16, 2005, through many major retail stores across the country, so the consumer should concentrate on the code on the can rather than on the place of purchase. The affected products can be identified by the lot number and expiration/use by date embossed on the bottom of the can of BMJ19, use by 1 Jul 07. Consumers who have a can of this batch of GENTLEASE powdered infant formula should not use the product and should contact Mead Johnson at 888-587-7275 immediately."

To read the complete recall notice please go to:

http://www.fda.gov/medwatch/safety/2006/safety06.htm#gentlease

Posted In Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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Pregnancy and Paxil: Not in the First Trimester

According to The Center for Drug Evaluation and Research of the U.S Food and Drug Administration, preliminary results of two important studies indicate that the popular antidepressant Paxil (also known as Pexeva or paroxetine) increases the risk of congenital defects, particularly cardiovascular malformations, when taken during the first trimester of pregnancy. Based on these findings, Paxil's pregnancy category has been changed from "C" to "D," indicating that studies show that its use in pregnant women have demonstrated an associated risk to the fetus. For these reasons, Paxil should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant. Women already taking Paxil who become pregnant or who are currently in their first trimester of pregnancy should be alerted to the potential risk to the fetus and counseled regarding whether Paxil should be discontinued and possibly replaced by another antidepressant. For certain women, however, the benefits of continuing Paxil may outweigh the potential risk to the fetus. The FDA is currently awaiting the final results of the recent studies and accruing additional data pertaining to the use of Paxil in pregnancy in order to better characterize its associated risks. The FDA will provide updates as new information becomes available.

Posted In Medications , Obstetrics , Product Liability , U.S. Food and Drug Administration Warnings
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Warning: Miracle II Neutralizer and Neutralizer Gel Products

The U.S. Food and Drug Administration issued a December 6, 2005, warning from MedWatch, the FDA's safety information and adverse event reporting program. According to the FDA warning, consumers are advised not to use the Miracle II Neutralizer and Neutralizer Gel products. These products are bacterially contaminated and have not been proven to be safe and effective. They are marketed as cleaners, deodorizers, natural insecticides and antibacterial agents. Despite the FDA notification, the manufacturer, Tedco, Inc., has declined to voluntarily remove the products from the market. The FDA's MedWatch program requests that any adverse events related to Miracle II products be reported by phone at 1-800-FDA-1088 or by using the FDA MedWatch online reporting form.

Tedco's promotional health claims for the Miracle II Neutralizer products were categorized by the FDA as "deceptive and untruthful." Although Miracle II naturalizer products have been promoted for treatment of cataracts and pinkeye, as well as an eyewash, FDA investigations revealed bacterial contamination and poor manufacturing conditions. Consumers are advised to discontinue using the products and dispose of them.

Posted In Product Liability , U.S. Food and Drug Administration Warnings
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Space Heater Recall

On January 26, 2006, the U.S. Consumer Product Safety Commission (CPSC) issued a warning to consumers to immediately stop using and unplug the Maxi-Heat Dream Tower Heater. The model recalled is CH920 and was sold at Wal-Mart stores from August to December 2005. The wires in the oscillating heater may short-circuit and spark, creating a fire hazard. Consumers may return the heaters directly to Wal-Mart for a full refund. For additional information, call King of Fans, Inc. at (866) 443-1291 or visit http://www.kingoffans.com/.

Posted In Product Liability
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Drug Safety News

"As the world's largest trial bar, the Association of Trial Lawyers of America (ATLA) promotes justice and fairness for injured persons, safeguards victims' rights--particularly the right to trial by jury--and strengthens the civil justice system through education and disclosure of information critical to public health and safety." Their website includes a useful resource for consumers regarding drug safety.

* Drug Safety News;
* Press Releases & Statements on Drug Safety;
* Fact Sheets on Drug Safety;
* Consumer News;
* Research on Drug Safety.

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Medical Device Maker Forced to Settle Antitrust Lawsuit

Defendant medical device maker Hillenbrand Industries Inc. reached a $337.5 million settlement in the antitrust lawsuit brought against it by plainitff Spartanburg Regional Healthcare System. Hillenbrand, which makes healthcare equipment and caskets, settled this suit which stems from a June 2003 complaint that the company's Hill-Rom unit's discounting practices harmed competition in the healthcare industry and resulted in higher prices for hospital beds and in-room products.

The settlement agreement has been approved by the United States District Court for the District of South Carolina. The settlement covers all of the plaintiff's claims as well as those of U.S. and Canadian purchasers or renters of Hill-Rom products from 1990 through the date of the agreement on February 3, 2006. All told, it is expected that this settlement will have a beneficial impact for healthcare consumers, who ultimately bear the brunt of costs that are passed along by healthcare providers such as Spartanburg.

Posted In Product Liability
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Infant Teether Recall

On January, 27, 2006, the FDA and The First Years announced a voluntary recall of liquid-filled teethers. The fluid inside the teethers may possibly contain bacterial contamination, which could cause serious illness in children if the teether is punctured.

Consumers should immediately stop using the following products:
* Disney Days of Hunny Soft Cool Ring Teether--Style# Y1447
* Disney Soft Cool Ring Teether--Style# Y1470
* Disney Soft Cool Ring Teether--Style# Y1490
* The First Years® Cool Animal Teether/Fish, Zebra and Dinosaur designs--Style# Y1473
* The First Years® Floating Friends Teether-- Style# Y1474
* Sesame Beginnings™ Chill & Chew Teether-- Style# Y3095

Continue Reading Posted In Pediatrics , Product Liability , U.S. Food and Drug Administration Warnings
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U.S. Consumer Product Safety Commission (CPSC)

The U.S. Consumer Product Safety Commission (CPSC) is the government agency responsible for informing consumers about dangerous products. The introduction to the USPC website states:

"The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of serious injury or death from more than 15,000 types of consumer products under the agency's jurisdiction. Deaths, injuries and property damage from consumer product incidents cost the nation more than $700 billion annually. The CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard or can injure children. The CPSC's work to ensure the safety of consumer products - such as toys, cribs, power tools, cigarette lighters, and household chemicals - contributed significantly to the 30 percent decline in the rate of deaths and injuries associated with consumer products over the past 30 years."

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Pemoline Withdrawn as Approved Drug for ADHD

Attention Deficit Hyperactivity Disorder (ADHD) has become a prevalent diagnosis among children in recent years. Consequently, numerous drugs have been developed and prescribed to children to treat this disorder. In October, the U.S. Food and Drug Administration withdrew approval for pemoline, a drug used to treat ADHD, because it has been associated with liver problems, including death. The drug was sold under the name Cylert and originally developed by Abbott Laboratories. Earlier this year, Abbott discontinued production of Cylert, but generic versions continued to be produced and remain available. Even though pemoline or Cylert has been associated with liver problems and death, the FDA did not recall the drug. Public Citizen, a consumer advocacy group, criticized the FDA's failure to issue a recall of the drug calling it "reckless and insensitive to the health and lives of children and adults using this drug . . .." For an additional story about Cyclert, also see the October 24, 2005 online edition of MSN Health & Fitness - Health Highlights .

Posted In Medications , Pediatrics , Product Liability , U.S. Food and Drug Administration Warnings
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Landmark Study to Evaluate Drug Safety

The Cleveland Clinic, recently ranked by U.S. News & World Report as the best cardiac care center in the nation, will lead a massive international study to evaluate whether painkillers taken by millions of Americans for arthritis are safe for those who are also at risk for cardiovascular problems. The study will be led by Steven Nissen, M.D., who, incidentally, called for studies on the cardiovascular risks of Celebrex and Vioxx in a 2001 report. It is anticipated that it may take 18 months to enroll all of the 20,000 study participants, who will then be monitored for two years. The study will be funded by Pfizer Inc., the maker of Celebrex, a popular arthritis medication.

With an unusual mix of industry, academic researchers, and government oversight, the study aims to restore public confidence in pharmaceutical products. The credibility of research and drug safety assurances in particular has been called in to question by American consumers over the years. Public concerns have been amplified more recently, however, since products such as Vioxx and Bextra were withdrawn from the market due to evidence that they can raise the risk of a heart attack or stroke. "Since so many arthritis patients are at risk for heart disease, it is critically important to understand the cardiovascular safety of these drugs,'' said Dr. Nissen. "Currently available information is insufficient to determine whether typical dosages of celecoxib [Celebrex] and other popular pain relievers are linked to an increased risk of heart disease."

Continue Reading Posted In Product Liability , U.S. Food and Drug Administration Warnings
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MedWatch: FDA Safety Information and Adverse Event Reporting Program

MedWatch is the safety information and adverse event reporting program for the U.S. Food and Drug Administration. According to FDA guidelines, consumers and healthcare professionals may use this website for timely safety information on drugs and other regulated medical products. In addition, consumers may register to receive notices of new warnings and complete online reporting forms for medical products and/or medications.

Posted In Medications , Product Liability , U.S. Food and Drug Administration Warnings
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Recalls of Medication Infusion Pumps

Baxter International Inc. recently announced its withdrawal of a medication delivery pump from the market over the next 12 months as it continues to struggle with problems in its pump business. The withdrawal of the 6060 Multi-Therapy Infusion pump follows Baxter's much larger recall in early 2005 of its Colleague Infusion and Syndeo PCA Syringe pumps, which are used to administer medication in hospitals.

For more information about this and other recalls of Baxter products, see the July 2005 Food and Drug Administration news release.

Posted In Medical Malpractice , Product Liability
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Ortho Evra Birth Control Patch Found Dangerous

The U.S. Food and Drug Administration (FDA) recently acknowledged what experts have been saying for months: Ortho Evra (manufactured by Ortho-McNeil) birth control patches are dangerous. The agency warned that "women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill." Increased estrogen means increased risks, including the increased risk of life-threatening blood clots.

Continue Reading Posted In Medications , Obstetrics , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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