Claims Against Generic Manufacturer are Not Preempted, Court Affirms

NEW ORLEANS - Generic drug manufacturers can strengthen their warning labels after the initial approval process without violating FDA rules, the 5th Circuit U.S. Court of Appeals has affirmed, rejecting Actavis Inc.'s argument that claims against it are preempted by federal law. Demahy v. Actavis Inc., No. 08-31204 (5th Cir.).

On Jan. 8, the appellate court, led by Judge Patrick E. Higginbotham, ruled that federal regulations did not preempt a consumer's state law failure-to-warn claims based on alleged inadequacy of generic drug labels.

Julie Demahy was prescribed Reglan to treat her gastroesophageal reflux and for the next four years, …