On January 8, 2010, the United States Court of Appeals for the Fifth Circuit held that state law failure to warn claims against generic drug manufacturers are not preempted by federal regulation. Demahy v. Actavis, Inc., 2010 WL 46513 (C.A. 5 (La.).
This decision is consistent with that of the Eighth Circuit in Mensing v. Wyeth, 588 F.3d 603 (8th Cir. 2009) and was guided by the Supreme Court's decision in Wyeth v. Levine, 129 S. Ct. 1187 (2009), holding that such a claim is not preempted against name brand drug manufacturers.
In Demahy, the drug was the generic form of Reglan (metoclopramide) manufactured by Actavis. Demahy claimed that her long-term ingestion of the drug caused her to develop a neurological movement disorder called tardive dyskinesia. She asserted personal injury claims under the Louisiana Products Liability Act for, among other things, failure to warn of the risks of the drug's long-term use.
The Fifth Circuit rejected the argument that compliance with state duties to warn would burden generic manufacturers with duplicative drug trials, noting that clinical studies are not prerequisites to labeling changes and reports of adverse drug reactions can substantiate the need for a heightened warning. The Fifth Circuit's decision was grounded in the belief that a central premise of federal drug regulation is that the manufacturer bears responsibility for the content of its label at all times.
Here's the opinion: Here.
