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Appelate Court Upholds AstraZeneca Ruling

By Drug Discovery Trends Editor | April 7, 2010

TRENTON, N.J. (AP) – A federal appellate court has upheld a lower court ruling dismissing the first product liability lawsuit among thousands alleging British drugmaker AstraZeneca PLC’s antipsychotic drug Seroquel triggered a patient’s diabetes.

A three-judge panel of the 11th Circuit Court of Appeals ruled Tuesday that the U.S. District Court for the Middle District of Florida had correctly dismissed the case brought by Linda Guinn, a former legal secretary from Palm Bay, Fla., in her early 60s.

Before that case was to go to trial, AstraZeneca successfully argued in January 2009, before District Judge Anne Conway, that Guinn’s doctor did not qualify as an expert under federal court rules and so her testimony should be excluded. The drugmaker also persuaded the judge to grant a summary judgment motion in its favor, arguing that Guinn failed to establish that Seroquel caused her diabetes.

The 11th Circuit Court, based in Atlanta, upheld those decisions.

“The appeals court decision echoes earlier federal and state court opinions that found Seroquel could not be proven to be responsible for plaintiffs’ alleged injuries,” AstraZeneca spokesman Tony Jewell said in a statement.

Guinn’s physician, Dr. Jennifer Marks, had given the district court an expert opinion stating that her patient gained about 40 pounds over five years while taking Seroquel, which is linked to significant weight gain in many patients, and, as a result, Guinn developed diabetes. AstraZeneca countered that the woman had a strong family history of diabetes and had other risk factors for the blood sugar disorder, including a sedentary lifestyle and high blood pressure and cholesterol.

AstraZeneca, which has its U.S. headquarters in Wilmington, Del., faces more than 25,000 product liability lawsuits over Seroquel, with most alleging that the drug caused diabetes.

The drugmaker has used a similar strategy – questioning expert witness’ qualifications and whether plaintiffs have strong evidence that Seroquel caused their diabetes – to get numerous other lawsuits over the drug dismissed.

Seroquel is approved for treating schizophrenia and bipolar disorder, but is widely prescribed for unapproved uses, including other psychiatric conditions and insomnia. Partly because of all that so-called off-label use, the drug brought in $4.9 billion last year, making it Astra Zeneca’s second-best seller. It’s been on the market since 1997.

Last fall, the company said it had reached a $520 million settlement in principle to end a federal investigation of alleged improper marketing of Seroquel, including promoting it for unapproved uses.

Date: April 6, 2010
Source: Associated Press


Filed Under: Drug Discovery

 

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