Oral argument: Mar. 30, 2011
Appealed from: United States Court of Appeals for the Eighth Circuit (Nov. 27, 2009); United States Court of Appeals for the Fifth Circuit (Jan. 8, 2010)
DRUGS, FAILURE-TO-WARN, FOOD, DRUG, AND COSMETIC ACT, FEDERAL PREEMPTION, HATCH-WAXMAN ACT
Doctors prescribed both Gladys Mensing and Julie Demahy the drug Reglan. They each had their prescriptions filled with the generic equivalent of the name brand drug. After long-term use of this generic drug, Mensing and Demahy developed severe neurologic disorders. The women separately sued Pliva and Actavis, the generic drug manufacturers, making state law failure-to-warn claims, alleging that the drug’s warning label failed to adequately warn them of the risks. Pliva and Actavis argue that the federal Food, Drug, and Cosmetic Act, along with Food and Drug Administration regulations that govern the entire drug approval and labeling process, preempt Mensing and Demahy’s state law claims because it was impossible for Pliva and Actavis to comply with both federal and state law. The companies argue that they could not provide additional warnings beyond what the brand manufacturer provided on its label. In deciding this case, the Supreme Court will ultimately have to weigh the costs born by generic drug manufacturers and the public against the benefits of incentivizing manufacturers to create safer drugs with more complete warnings.