FDA Never Saw Birth-Defect Tests On GSK Drug, Families Say

Law360, Boston (September 13, 2018, 6:04 PM EDT) -- Families suing GlaxoSmithKline who claim the anti-nausea medication Zofran led to birth defects argued Thursday in Massachusetts federal court that crucial tests were not shown to the U.S. Food and Drug Administration when it rejected a correlation between the drug and defects as the families tried to beat the company's motion for summary judgment.

During a hearing Thursday morning in a Boston courtroom, the families said a group of Japanese studies done on animals showed that the medication, in higher doses, resulted in a higher rate of birth defects. GSK has moved for a win in the multidistrict litigation, which was...

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