GSK Tells First Circuit Zofran Birth Defect Suits Preempted

GlaxoSmithKline LLC told the First Circuit that hundreds of families’ Zofran birth injury suits were properly dismissed as preempted because federal regulators have consistently rejected stronger warnings about use of the drug during pregnancy.

The Food and Drug Administration has repeatedly maintained that evidence doesn’t show an association between the anti-nausea drug and birth defects, and that the warnings sought by the families would mislead patients, GSK said in a brief docketed May 27.

The FDA has rejected proposals three times to add enhanced warnings against use of Zofran during pregnancy, making this an “open-and-shut case for preemption,” the drugmaker ...