Product Liability

November 7, 2009

CPSC finds Chinese Drywall has High Levels of Sulfur and Strontium.

Federal investigators reported that imported Chinese drywall that homeowners have linked to health problems and odors had higher levels of some chemicals than its domestic counterparts.

The investigators, however, were unable to link the chemicals, sulfur and strontium, to the health problems and smells in thousands of homes built during the recent housing boom, and said further testing was under way to determine any possible connection.

The preliminary findings are part of a larger study by federal agencies, including the Consumer Product Safety Commission and the Environmental Protection Agency, into complaints from nearly 2,000 homeowners that their recently built homes emit odors and cause nosebleeds and respiratory problems. The owners also say their electrical appliances have failed and their wiring has corroded. It has been estimated that more than 60,000 homes could have the imported drywall. Large amounts of Chinese drywall were imported over the last few years when domestic supplies ran short. An estimated seven million sheets made in China were used as a substitute. Most of the complaints come from Florida, Virginia and Louisiana, where the widespread destruction after hurricanes lead to rapid rebuilding of damaged homes.

November 6, 2009

Pfizer Jury to Award $75 M Prempro Verdict to Woman

by Dr. Shezad Malik

Pfizer Inc. must pay about $75 million in punitive damages to an Illinois woman who developed cancer after taking one of the drugmaker’s menopause treatments.

A Philadelphia jury ordered Pfizer’s Wyeth unit on Oct. 26 to pay the bad-conduct award, which is about 20 times larger than the $3.7 million in actual damages the panel awarded to Connie Barton over her use of Wyeth’s Prempro menopause drug, according to people with direct knowledge of the verdict.

A judge ordered Barton’s punitive-damage award sealed at Wyeth’s request until the trial of another Prempro lawsuit in the same courthouse is completed. Lawyers in that case say jurors won’t start deliberating on that suit’s claims for another three weeks.

November 5, 2009

Wyeth to Face New Trial on Punitive Damages in Prempro Hormone Replacement Case

by Dr. Shezad Malik

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.

November 3, 2009

Rapid Weight Gain Associated With Antipsychotic Drugs

by Dr. Shezad Malik

Young children and adolescents who take the newest generation of antipsychotic medications risk rapid weight gain and metabolic changes that could lead to diabetes, hypertension and other illnesses, according to the biggest study yet of first-time users of the drugs.

The study, to be published in The Journal of the American Medical Association, found that 257 young children and adolescents in New York City and on Long Island added 8 to 15 percent to their weight after taking the pills for less than 12 weeks.

November 3, 2009

Amylin, Lilly’s Byetta Gets Stronger Safety Warning

by Dr. Shezad Malik

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.

November 2, 2009

Anemia Drug Raises Stroke Risk in Kidney Patients

by Dr. Shezad Malik

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.”

November 2, 2009

AstraZeneca Pays $520 M to Settle Seroquel Whistle Blower Cases

by Dr. Shezad Malik

The pharmaceutical company AstraZeneca said that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.

One of the investigations related to “selected physicians who participated in clinical trials involving Seroquel,” AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug.

As a result of aggressive marketing, Seroquel has been increasingly used for children and elderly people for indications not approved by the Food and Drug Administration. Doctors are permitted to prescribe any approved drug for off-label uses.

Seroquel was the top-selling antipsychotic drug in America. It had $17 billion in sales in the United States since 2004, according to IMS Health, a research firm.

October 30, 2009

Appeals Court Reverses $24.2 M Verdict in Asbestos Mesothelioma Case

by Dr. Shezad Malik

The 3rd District Court of Appeal reversed a $24.2 million verdict Wednesday, striking a Miami-Dade jury award to a Weston, Fla., surgeon who claimed asbestos exposure caused his terminal cancer.

In a unanimous unsigned opinion, the three-judge panel remanded the products liability lawsuit by Dr. Stephen Guilder against Honeywell International and ordered a new trial.

Guilder won one of the highest compensatory damage awards against a single defendant in a mesothelioma case in April 2008. He died before the appeal was decided.

He claimed he developed the rare peritoneal mesothelioma from exposure to asbestos by remodeling an attic, working in road construction and repairing cars in the 1970s and 1980s.

October 27, 2009

Pfizer Unit’s Prempro Punitive Damages Verdict Remains Secret

by Dr. Shezad Malik

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.

October 27, 2009

Philip Morris Has to Fund Medical Monitoring Tests for Smokers

by Dr. Shezad Malik

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.