Articles Posted in Product Liability

Donna Scroggin had a hormone replacement product liability suit against Wyeth and Upjohn and at the spring 2008 trial her claim that the drug companies failed to warn of the increased risk of breast cancer resulting from their estrogen and progestin products, a federal district court jury awarded the breast cancer survivor $2.75 million in compensatory damages. In the second phase of trial, the jury hit Upjohn with about $8 million in punitive damages, and Wyeth with $19 million.

After post-trial motions, the judge upheld the jury’s liability finding and $2.75 million compensatory damages verdict against Wyeth and Upjohn. But he struck the testimony of Scroggin’s punitive damages expert and vacated the punitive damages awards against the drug companies.

Read the opinion here.

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Amylin Pharmaceuticals Inc. and Eli Lilly & Co. said safety warnings were strengthened for their diabetes drug Byetta relating to the risks of pancreatitis and the medicine’s use by patients with severe kidney disease.

Patients with “severe kidney problems” shouldn’t take Byetta and the treatment should be “used with caution” in people who have had a kidney transplant, San Diego-based Amylin and Indianapolis-based Lilly said in a statement. The companies also said U.S. regulators approved the use of the drug as a stand-alone medication for adults with Type 2 diabetes.

Six patients taking Byetta died in August 2008 from pancreatitis, an inflamed pancreas. A safety alert was issued by the Food and Drug Administration though Amylin said no evidence directly linked the drug to the deaths. The revised language reflects the concerns raised by the FDA a year ago, according to Amylin’s medical director.

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A drug designed to fight anemia appears to double the risk of stroke in patients with diabetes and kidney disease without substantially improving their quality of life, a new study finds.

Darbepoetin alfa, marketed as Aranesp and known as an erythropoiesis-stimulating agent (ESA), is often prescribed for diabetic patients with chronic kidney disease and mild anemia.

“The benefits we assumed we would have by treating anemia were less striking and the risks were more striking,” said lead researcher Dr. Marc A. Pfeffer, a professor of medicine in the cardiovascular division of Brigham and Women’s Hospital in Boston.

“This provides new data for doctors and patients to make their own risk-benefit assessment,” he said. “There was a perception that treating anemia would make people feel so much better that we’ll take risks, but the benefit in quality of life was not as great as we thought, and there was a clear doubling of your risk for a stroke.”

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A Pfizer Inc. unit must pay an undisclosed amount of punitive damages to an Illinois woman who developed breast cancer after taking one of the drugmaker’s menopause treatments, according to a Philadelphia jury.

Jurors deliberated 25 minutes before finding Pfizer’s Wyeth subsidiary was responsible for paying an award to Connie Barton. The specific amount of the award was sealed by the trial judge immediately after it was returned.

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The state’s high court said that cigarette maker Philip Morris USA may have to pay for diagnostic chest exams so smokers can get early warning they have developed lung cancer, possibly opening a new front in tobacco liability lawsuits.

In a unanimous ruling, the Supreme Judicial Court said Massachusetts law has an antiquated definition of negligence. Historically, plaintiffs had to show explicit injury, such as a broken leg, before the other party can be ordered to pay for diagnostic tests.

Writing for the court, Justice Spina said that such legal thinking must change. “We must adapt to the growing recognition that exposure to toxic substances and radiation may cause substantial injury, which should be compensable, even if the full effects are not immediately apparent,’’ he wrote.

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