Product Liability

April 28, 2009

Bayer Settles Gadolinium Contrast Agent Injury Lawsuits

Bayer AG has begun the process of settling medical injury lawsuits regarding its Magnevist contrast agent; Magnevist contains gadolinium.

The company is one among several, including General Electric Company and Tyco International Limited, being sued over complaints that the gadolinium-containing contrast agent was responsible for causing a potentially fatal organ hardening disease, called Nephrogenic Systemic Fibrosis (NSF). Since May 2007, the U.S. Food and Drug Administration (FDA) has required that gadolinium-containing contrast agents carry a black box warning.

April 28, 2009

Wyeth Must Face Woman’s Prempro Lawsuit, Appeals Court Rules

by Dr. Shezad Malik

Wyeth, the drugmaker being acquired by Pfizer Inc., must face a lawsuit by a woman who claims her breast cancer was caused by the menopause medicine Prempro, a Texas appeals court ruled.

The state appeals court in Houston said that Susan Brockert’s “failure-to-warn” claims aren’t preempted by federal drug-labeling regulations, overturning a district judge’s finding from February 2007. The case was sent back to the lower court for further proceedings.

The appeals panel cited last month’s U.S. Supreme Court decision upholding a $7 million award to a musician who lost her arm after being injected with Wyeth’s Phenergan nausea treatment. The high court said patients can sue drugmakers for failing to provide adequate safety warnings, even when a treatment and its packaging are approved by the U.S. Food and Drug Administration.

April 14, 2009

Reglan Lawsuits

by Dr. Shezad Malik

Reglan side effects have been associated with the development of tardive dyskinesia, a syndrome that causes involuntary movements in the body extremities, particularly the lower face. In February 2009, the FDA required that a “black box” warning about the tardive dyskinesia problems be added to Reglan and other gastrointestinal drugs containing metoclopramide.

REGLAN LAWSUIT STATUS: Lawyers are reviewing potential claims for individuals who may be entitled to compensation through a Reglan lawsuit as a result of developing tardive dyskinesia.

April 3, 2009

3rd Circuit: Kids Hurt by Vaccines Cannot Pursue Design Defect Claims

by Dr. Shezad Malik

The 3rd Circuit has ruled that children allegedly injured by vaccines are barred from pursuing any design defect claims because Congress expressly prohibited such suits in an effort to guarantee immunity to manufacturers.

By rejecting the analysis of a recent ruling from the Georgia Supreme Court, the 3rd Circuit’s ruling in Bruesewitz v. Wyeth Inc. creates a direct split between the federal courts and a state’s highest court on the question of how broadly courts should read the pre-emption clause in the National Childhood Vaccine Injury Act.

April 1, 2009

Pfizer Settles Rezulin Product Liabilty Cases

by Dr. Shezad Malik

Pfizer Inc. resolved all but three of 35,000 claims over its withdrawn diabetes drug Rezulin for a total of about $750 million.

Pfizer, which is acquiring rival Wyeth for almost $64 billion, paid about $500 million to settle Rezulin cases consolidated in federal court in New York, according to court filings. The company also paid as much as $250 million to resolve state-court suits.

March 21, 2009

Diacetyl Popcorn Workers Lung Victim, Wife Awarded $7.5 Million

by Dr. Shezad Malik

A jury has ruled in favor of a plaintiff in a Popcorn Workers Lung lawsuit. According to The Associated Press, the federal jury in Iowa yesterday ordered a flavorings manufacturer to pay the victim – who died just a day before of complications from Popcorn Workers Lung – and his wife $7.5 million for causing his injuries.

Popcorn Workers Lung is a potentially life threatening ailment, for which the only cure is a lung transplant. The disease – also known as bronchiolitis obliterans – has been linked to diacetyl, a chemical used to give microwave popcorn and other snack foods a buttery flavor.

March 16, 2009

Medtronic Links Device for Heart to 13 Deaths

by Dr. Shezad Malik

Medtronic said that at least 13 people might have died in connection with a heart device that it recalled in 2007 but was still in widespread use, including four patients whose deaths were related to efforts by doctors to surgically remove the product.

The new data reflect the first fatality update by Medtronic since October 2007, when it recalled the device — a thin electrical cable that connects an implanted defibrillator to a patient’s heart. The company cited five deaths when it recalled the product, saying fractures in the cable could cause a defibrillator to fail to deliver a lifesaving shock to an erratically beating heart, or to fire for no reason.

Separately, a previously undisclosed Food and Drug Administration report indicates that Medtronic began receiving reports soon after the device reached the market in late 2004 that the cable, known as the Sprint Fidelis, was fracturing. The company also revised its manufacturing process in the months before withdrawing the Sprint Fidelis from the market, according to the F.D.A. report.

March 12, 2009

FDA issues peanut safety guidelines for foodmakers

by Dr. Shezad Malik

The U.S. Food and Drug Administration issued safety guidelines for companies that use peanut products today and said it may seize products that test positive for salmonella bacteria.

While heat-sensitive, salmonella bacteria become heat-resistant in high-fat environments such as peanut butter, according to the FDA guidance.

The U.S. Centers for Disease Control and Prevention government said 683 people in 46 states have been sickened in the outbreak linked to foods that used peanut ingredients made by the now-bankrupt Peanut Corp of America.

March 11, 2009

New Questions About Seroquel And Diabetes

by Dr. Shezad Malik

Shortly after new antipsychotic drugs came on the market in the late 1990s, the Food and Drug Administration started to worry that they might trigger diabetes in some patients.

So in 2000, the FDA asked AstraZeneca P.L.C. and other pharmaceutical companies to share data on cases of new-onset diabetes and related illnesses in patients taking the drugs. AstraZeneca, told the FDA that patients and doctors had reported 12 new cases of diabetes and five cases of related illnesses among the 623,000 who had taken its antipsychotic drug Seroquel.

But internally, the company had reported the number as 27 cases of diabetes and two of hyperglycemia, according to court documents recently released.

March 9, 2009

Peanut Processor Has No Money For Injuries

by Dr. Shezad Malik

Sickened consumers who sued the peanut processor blamed for a national salmonella outbreak could have trouble recovering damages from company accounts because assets listed in a bankruptcy filing will likely go to other businesses that bought its products.

Lynchburg-based Peanut Corp. of America filed documents listing nearly $11.4 M in assets and debts of $4.8 M in U.S. Bankruptcy court. However, more than $7 M listed as assets was in insurance that covers the company’s products and will not be used for claims by consumers. Among the uses for that money would be compensating businesses that had bought Peanut Corp. products that were recalled, trustee Roy V. Creasy said.