First Avandia Trial Underway in Philadelphia

The litigation surrounding <"">Avandia is finally underway. The first federal trial involving an Avandia heart attack lawsuit began yesterday. According to a Daily Finance report, GlaxoSmithKline, the maker of Avandia, has already settled around 10,000 such claims, but it could face as many as 50,000 more.

Earlier this year, the US Food & Drug Administration (FDA) restricted sales of Avandia, as well as two related drugs called Avandamet and Avandaryl, after concluding their association with an increased risk of heart attacks and strokes outweighed the drugs’ benefits for most patients. At the same time, regulators in Europe announced that sales of Avandia and related drugs would be suspended.

Since November 2007, Avandia’s US label has included a black box warning – the FDA’s strongest safety alert – detailing its association with myocardial ischemia. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack. Since the addition of the black box, evidence linking Avandia to an increased risk of heart attacks has continued to accumulate.

According to Daily Finance, at least 1,600 Avandia lawsuits are pending in the multidistrict litigation underway in federal court in Philadelphia. This first trial in the litigation involves an Avandia lawsuit that was filed by James Buford, who died at age 49 from a heart attack in 2006, after taking Avandia for about a year. The lawsuit alleges that Glaxo failed to adequately research Avandia or warn users about its association with heart problems.

According to Daily Finance, at least 50,000 Avandia lawsuits have yet to be filed. They’re on hold until the Buford lawsuit and other bellwether cases are tried.

In addition to the cases pending in the multidistrict litigation, thousands of Avandia lawsuits are also pending in state courts around the country.

Last week, Glaxo announced that it expects to record a legal charge for the fourth quarter of 2010 ($3.4 billion). According to a press release from the company, the charge primarily relates to additional provisioning in respect of the investigation by the U.S. Attorney’s Office for the District of Colorado into sales and promotional practices and for product liability cases regarding Avandia.

In July 2010, the company took a provision for product liability cases relating to Avandia that had been settled or received at that time. Glaxo has continued to receive substantial numbers of new product liability cases regarding Avandia in the U.S., the statement said.

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