GSK Ruling Raises Bar For Pharma On Brand Label Warnings

Law360, New York (February 19, 2016, 4:42 PM EST) -- An Illinois federal court's finding that GlaxoSmithKline PLC didn't show that federal regulators would have rejected a warning that its antidepressant Paxil could make adult patients suicidal sets a high bar of proof for branded-drug makers under evidence standards outlined by the Supreme Court's landmark Wyeth ruling, attorneys say.

The Feb. 11 ruling by U.S. District Judge James Zagel denied GSK's summary judgment motions against a negligence suit by plaintiff Wendy Dolin, whose husband, Reed Smith LLP partner Stewart Dolin, committed suicide in 2010 after taking a generic version of the drug.

Judge Zagel's ruling, which paves the way for the...

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