Glaxo May Mediate More Avandia Settlements

Last week, we wrote that GlaxoSmithKline Plc agreed to pay $3 billion to resolve federal investigations into how it marketed some of its drugs, including its controversial type 2 diabetes drug, Avandia. Now, a judge is urging the drug maker to resolve most of its pending <"">Avandia lawsuits.

U.S. District Judge Cynthia Rufe said she appointed a mediator to “preside over settlement negotiations” for an unspecified amount of Avandia cases that were consolidated before her in Philadelphia, said Bloomberg Businessweek. Judge Rufe imposed a 75-day deadline to resolve the majority—85 percent—of the remaining cases, said court filings. If unresolved, the cases face fast tracking, said Businessweek.

According to Businessweek, Glaxo is working to resolve legal issues that go back more than 10 years. “GSK welcomes the court’s mediation order and looks forward to constructive discussions with the special master,” Bernadette King, a U.S.-based Glaxo spokeswoman, said via emailed statement, Businessweek reported.

Glaxo also previously agreed to pay over $700 million to settle over 10,000 patient claims that Avandia caused heart attacks and strokes, said people close to that issue, wrote Businessweek. About 20,000 Avandia claims remain open and include those consolidated before Judge Rufe, as well as cases filed in state courts and lawsuits that were stayed subject to Glaxo-plaintiff attorney agreements, said Businessweek.

Judge Rufe named Patrick A. Juneau, of Louisiana, the mediator, said Businessweek, which pointed out that Juneau has mediated over 2,000 cases. But, if 85 percent of the cases cannot be resolved in 75 days, Judge Rufe said she will put 100 of the oldest into a trial pool for presentation to jurors within the following 60 days, said Businessweek, citing court filings.

We previously wrote that a prior report from The Wall Street Journal said that the $3 million settlement relates, in part, to an eight-year-old probe into how Glaxo marketed several of its top-selling drugs, including the antidepressants Paxil and Wellbutrin, between 1997 and 2004. The settlement also resolves a Justice Department investigation into the development and marketing of Avandia.

According to The New York Times, Glaxo whistle-blowers and federal prosecutors said the company paid doctors and manipulated medical research to promote the drug. In addition, the $3 billion covers a Justice Department investigation into whether Glaxo manipulated Medicaid rules to squeeze more money out of the state-financed program, which provides health care for low-income Americans, the Journal said. Also, Bloomberg previously wrote that Glaxo reportedly paid $250 million to resolve about 5,500 claims related to Avandia heart attack and stroke lawsuits.

We also recently explained that since November 2007, Avandia’s U.S. label has included a black box warning detailing its heart attack link. The black box was added after Dr. Steven Nissen of the Cleveland Clinic published a study showing that patients taking Avandia had a 40 percent increased risk for cardiovascular disease. Since, more evidence of Avandia’s heart risks has accumulated and, last year, the U.S. Food & Drug Administration (FDA) placed severe restrictions on Avandia sales, after determining its heart risks outweighed its benefits.

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