Monday, February 22, 2016

GSK Ruling Raises Bar For Pharma On Brand Label Warnings - Law360

GSK Ruling Raises Bar For Pharma On Brand Label Warnings - Law360

 By Sindhu SundarLaw360, New York (February 19, 2016, 4:42 PM ET) 

-- An Illinois federal court's finding thatGlaxoSmithKline 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 LLPpartner Stewart Dolin, committed suicide in 2010 after taking a generic version of the drug.

Judge Zagel's ruling, which paves the way for the case to go to trial in September, rejected GSK's argument that Wendy Dolin's claims are preempted by the U.S. Food and Drug Administration's oversight of pharmaceuticals. He ruled that under the Supreme Court's landmark 2009 ruling in Wyeth v. Levine, drugmakers must show "clear evidence" that the FDA would have rejected a heightened warning sought by a plaintiff. In this case, Dolin claimed GSK should have warned on Paxil's label that the drug had posed a risk of suicidality among adult patients.

Judge Zagel's ruling raises the bar for "clear evidence" under Wyeth by essentially requiring branded-drug makers to actually show that the FDA rejected — even if only informally — a heightened warning, attorneys say.
The case is Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403, in the U.S. District Court for the Northern District of Illinois

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