GSK Zofran Birth Injury Suits Preempted by Federal Labeling Law

GlaxoSmithKline LLC won judgment in nearly 500 Zofran birth defect suits, as a Massachusetts federal court said federal drug labeling law preempts claims that the drugmaker failed to adequately warn about use of the anti-nausea medication during pregnancy.

The drugmaker met its burden on its preemption defense, presenting “clear evidence” that the Food and Drug Administration would have rejected the warning the families sought, Chief Judge F. Dennis Saylor IV of the U.S. District Court for the District of Massachusetts said Tuesday.

Plaintiffs alleged Zofran, approved to treat nausea associated with chemotherapy, was illegally promoted to treat pregnancy-related sickness—an off-label ...