Product Liability

May 29, 2009

March 2009 Drug Safety Update Newsletter Raises Emerging Safety Issue Of Kidney-Related Side Effects From Byetta Use

We reported on Byetta (exenatide) in August 2008, when the FDA issued a MedWatch email alert about six new cases of hemorrhagic pancreatitis and necrotizing pancreatitis that had been reported to FDA since an October 2007 “Dear Doctor” letter about Byetta and acute pancreatitis was sent to doctors in the U.S.

The March 2009 Drug Safety Update newsletter — from drug regulators in the United Kingdom (UK) — included this article, “Exenatide (Byetta): risk of severe pancreatitis and renal failure”. We get some new information about two types of serious side effects associated with Byetta, pancreatitis and renal, or kidney, impairment.

May 28, 2009

Quadriplegic Musician Wins $18 M Verdict Against Ford Motor Co.

by Dr. Shezad Malik

An Oakland musician who was made a quadriplegic in a rollover crash four years ago won an $18.3 million verdict against Ford Motor Co. in federal court.

Dax Pierson, 38, suffered severe spinal injuries when a Ford passenger van that the band was traveling in ran off an icy highway in Iowa and rolled over in a ditch on Feb. 24, 2005.

Pierson sued Ford for creating a defective seat-latching mechanism that caused his seat to come loose, resulting in his head hitting the roof of the rolled-over van.

The $18.3 million jury award came after three weeks of trial in the court of U.S. District Judge Phyllis Hamilton. It includes $12.3 million for past and future medical expenses and lost earnings plus $6 million for pain and suffering.

May 24, 2009

Dangerous Drugs: Hydroxycut Class Actions Filed

by Dr. Shezad Malik

Two class action lawsuits have been filed in the wake of the recall of Hydroxycut, a popular weight-loss supplement that has been linked to liver damage and other life-threatening side effects.

The suits, filed in Canada and Tennessee, accuse Iovate Health Sciences, which manufactures Hydroxycut, of failing to warn of the drug’s dangers or take proper precautions to protect its users.

May 23, 2009

Land Rover Maker Ordered to Pay $21.1 M in Rollover Case

by Dr. Shezad Malik

A Los Angeles judge has ordered automaker Jaguar Land Rover to pay $21.1 million to a Simi Valley man who was paralyzed in 2003 when his Land Rover Discovery sport utility vehicle rolled over several times after a collision on the 118 Freeway.

L.A. County Superior Court Judge Robert H. O’Brien cited two key reasons for his decision: The vehicle’s high center of gravity made it susceptible to rolling over, and its roof collapsed too easily, causing Sukhsagar Pannu to suffer a debilitating spinal cord injury.

May 15, 2009

Avandia Class Action Lawsuits Continuing

by Dr. Shezad Malik

GlaxoSmithKline, maker of Avandia, faces more lawsuits alleging that patients suffered from serious Avandia side effects. Among the more severe side effects is the reported link between Avandia and heart attacks. Some critics say the risk of a heart problem is too high, while patients file lawsuits alleging they were harmed by the use of Avandia.

One such lawsuit was filed in Texas, alleging the plaintiff, Frank Casteel, took Avandia for 5 years and then underwent heart bypass surgery. According to the Southeast Texas Record, the suit was filed against Smithkline Beecham Corp., doing business as GlaxoSmithKline. The plaintiff claims that GlaxoSmithKline knew its drug was unreasonably dangerous, knew that patients were not informed about the risks associated with Avandia and still marketed and distributed the drug. Furthermore, the suit alleges that the pharmaceutical maker disclosed positive information about Avandia, but concealed or withheld any negative information about the drug’s safety.

May 11, 2009

Texan Awarded $2.19M In Nissan Lawsuit

by Dr. Shezad Malik

A 63-year-old Tyler woman who sued Nissan after she was seriously injured in a 2006 car accident has been awarded $2.19 million by a federal jury.

Rebecca Perdue filed a lawsuit against Nissan Motor Co., LTD, claiming her 1995 Nissan Pathfinder failed to protect her during a Nov. 28, 2006 collision in Tyler. A seven-person Marshall jury in U.S. District Court returned its verdict, finding Nissan was responsible for her injuries.

May 9, 2009

Hydroxycut Diet Aids Recalled After FDA Warning

by Dr. Shezad Malik

Federal drug regulators warned consumers to stop using the popular Hydroxycut line of weight-loss products, citing reports of a death due to liver failure and other instances of serious health problems.

In all, the Food and Drug Administration said it had received 23 reports of significant adverse health effects in people who used Hydroxycut, including one person who required a liver transplant. Other complications included heart problems and a kind of muscle damage that could lead to kidney failure, the agency said.

May 5, 2009

Wyeth Supreme Court Loss Restarts Drug Lawsuits

by Dr. Shezad Malik

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 March 4 decision in a case on Wyeth’s nausea treatment Phenergan broke a logjam of cases in state and federal courts. Federal regulatory approval of a medicine and information about side effects does not shield drugmakers from claims that patients and doctors were not adequately warned, the high court ruled. The decision already affected more than 250 lawsuits involving at least 10 companies that were in limbo before the ruling.

May 4, 2009

The U.S. Supreme Court cleared the way for a suit by a New Jersey woman who claims to have suffered mercury poisoning from Chicken of the Sea canned tuna.

by Dr. Shezad Malik

The U.S. Supreme Court cleared the way for a suit by a New Jersey woman who claims to have suffered mercury poisoning from Chicken of the Sea canned tuna.

The denial of certiorari sets the stage for a federal court trial in Newark, N.J., in a putative class action suit, filed under New Jersey’s Product Liability Act, that faults a cannery company with not putting mercury warnings on the label.

The justices without opinion let stand a 3rd U.S. Circuit Court of Appeals ruling last September that the claim is not pre-empted by the Food and Drug Administration’s “pervasive regulatory scheme.” The appeals court said this is a case where state tort law complements federal regulations, which often lack a compensatory apparatus or a process for gathering information about potential claims.

April 30, 2009

Accutane Injury Results in $10.5 Million Judgment

by Dr. Shezad Malik

A woman who said she developed ulcerative colitis from taking Accutane was awarded $10.5 million by a New Jersey jury. It was the third of 425 lawsuits alleging that Accutane caused inflammatory bowel disease in some users to go to trial. All three cases have resulted in multi-million dollar judgments against Hoffman-LaRoche, Inc., the maker of Accutane.

Approved by the Food & Drug Administration (FDA) in 1982, Accutane has been the subject of controversy for years. In addition to inflammatory bowel disease, the drug has been associated with myriad other serious side effects.

It was known in the late eighties for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to 266 cases of suicide in the United States.

In addition to inflammatory bowel disease, Accutane has also been associated with problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems.