California Avandia Lawsuit Seeks Billions in Compensation

An Avandia lawsuit has been filed by California’s Santa Clara County, charging GlaxoSmithKline with false advertising, and seeking billions in compensation for Californians who took the controversial diabetes drug. According to the, the lawsuit was spurred by a recent Senate report on <"">Avandia that accused Glaxo of withholding information about the drug’s heart risks.

Avandia’s cardiovascular problems have been the subject of concern since May 2007, when a meta- analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. In November 2007, a black box warning – the Food & Drug Administration (FDA’s) strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling.

The Senate Finance Committee report was the result of a two-year investigation, and drew on 250,000 pages of documents, including emails from GlaxoSmithKline officials, as well as interviews with Glaxo and FDA officials and anonymous whistleblowers. According to the report, in July 2007 the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks. Two of the FDA’s own doctors wrote in an October 2008 memo that Avandia should be removed from the market because it poses serious heart-related dangers to patients, the report said.

The Senate report also claimed that Glaxo tried to undermine criticism of the drug: “GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” the report says. Since the release of the Senate report, calls have increased for the FDA to pull Avandia off the market. Earlier this week, the FDA said it would again review Avandia for heart risks, and has scheduled an advisory panel meeting for July.

According to the, Santa Clara County’s lawsuit is the first governmental lawsuit claiming the drug maker falsely advertised Avandia’s benefits and concealed its risks. It was filed on behalf of all patients in California in U.S. District Court in San Jose.

The Avandia lawsuit alleges that Santa Clara County spent $2 million on Avandia from 1999 to mid-2007 for indigent patients and also absorbed the cost of treating heart patients whose problems could have been avoided had GlaxoSmithKline warned of the risks of its drug. It seeks to recover costs incurred by anyone who purchased Avandia, including hospitals, clinics and counties, the said.

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