GSK Can't Escape MDL Alleging Zofran Caused Birth Defects

By Rick Archer (February 5, 2019, 6:49 PM EST) -- A Massachusetts federal judge on Tuesday denied GlaxoSmithKline a quick win in multidistrict litigation claiming its anti-nausea drug Zofran led to birth defects, saying GSK has not proven the U.S. Food and Drug Administration would have rejected a stricter warning label.

U.S. District Judge F. Dennis Saylor IV denied the drugmaker's motion for summary judgment, saying there remain questions of fact about whether GSK fully disclosed material data about Zofran to the FDA and whether the allegedly withheld data would have swayed the agency's decision on the drug's warning label.

"In other words, GSK must essentially show that the FDA either...

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