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Pharmaceuticals / Commercial Operations

Court Axes Lawsuit Claiming Insufficient Warning of Heart Attack Risk From GSK Drug

Dec. 19, 2017

A federal judge threw out a case against GlaxoSmithKline that was part of multidistrict litigation over the labeling of its diabetes drug Avandia.

Judge Cynthia M. Rufe of the Eastern District of Pennsylvania granted the company’s motion for summary judgment in the case of John Siddoway, who alleged Avandia contributed to his two heart attacks in 2003.

The judge ruled Siddoway failed to prove his primary care doctor would not have prescribed the drug if the labeling had included a warning of heart attack risk.

GSK had added a warning following an FDA alert in 2007 but removed it in 2014 after the agency concluded the drug did not in fact pose any increased cardiovascular risk.

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