Appeals Court Rejects Preemption for Generic-Drug Labeling

Generic-drug makers’ legal defense against product liability lawsuits related to labeling took another hit as a second federal appeals court has ruled that the suits are not preempted by federal regulations. The U.S. Court of Appeals for the Fifth Circuit made the ruling in a liability case over generic-drug maker Actavis’ Reglan (metoclopramide HCl), according to court documents. The ruling, coupled with one last month by the U.S. Court of Appeals for the Eighth Circuit, may presage a judicial trend against favoring federal preemption for generic-drug makers.
Washington Drug Letter