Last year, the Food and Drug Administration (FDA) placed significant restrictions on the use of Avandia in response to studies linking the use of the drug to an increased risk of heart attacks and stroke. According to BizJournals, the Britain-based drug maker just reached an Avandia settlement for 5,000 U.S. product liability lawsuits totaling $250 million, which averages out to about $46,000 each.
Last week, we wrote about an Avandia Lawsuit that was expected to be a test case for the thousands of similar claims that are pending nationwide. This case was settled on the eve of trial. GlaxoSmithKline, the maker of Avandia, had already settled around 10,000 Avandia heart attack and stroke claims, but could face as many as 50,000 more.
As we’ve reported previously, at least 1,600 defective drug lawsuits are pending in an Avandia multidistrict litigation underway in federal court in Philadelphia, Pennsylvania. The recently settled test case, which was scheduled to be the first trial in the litigation, involved an Avandia lawsuit that was filed by the family of James Buford. Buford died at age 49 from an Avandia heart attack in 2006, after taking the defective drug for about one year. His family’s lawsuit, like many other claims, alleged that Glaxo failed to adequately research Avandia or warn users about its association with heart problems.
According to a Reuters report, no one from Glaxo would comment on the terms of the settlement.
Although a drug recall has not been implemented, the 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 Defective Drugs benefits for most patients. The restriction took place late last year. At the same time, regulators in Europe announced that sales of Avandia and related drugs would be suspended.
Since November 2007, Avandia’s U.S. 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.
Last month, Glaxo announced that it expected 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 to the investigation by the U.S. Attorney’s Office for the District of Colorado into sales and promotional practices and for Product Liability Lawsuits regarding Avandia. That was in addition to a $2.36 billion charge the company took last year related to Avandia and Paxil litigation.
As we reported previously, at least 50,000 Avandia lawsuits have yet to be filed. They were placed on hold until other bellwether cases including the Buford lawsuit could be tried.
In addition to the cases filed in the multidistrict litigation, thousands of Avandia Lawsuits are also pending in state courts around the country concerning not just Avandia heart attacks, but Avandia strokes, as well.