GlaxoSmithKline scores a big win in Zofran litigation after FDA repeatedly rejects pregnancy warning

A judge just upended years of litigation against GlaxoSmithKline and its Zofran drug only months before a key trial was set to begin this fall.

GSK has been defending against claims that Zofran, a nausea drug, can cause birth defects if used during pregnancy and that the company failed to warn about the risks.

But because GSK and Novartis, which bought Zofran rights in 2015, submitted safety data to the FDA several times over the years—and the FDA decided against adding a pregnancy warning each time—the plaintiffs' state-law claims are preempted by federal law, a judge ruled Tuesday.