The U.S. Supreme Court is considering whether a generic drug maker can be held liable under state law for failing to include on its drug label safety information not yet used by name brand manufacturers or required by the Food and Drug Administration (FDA). PLIVA, Inc. v. Mensing, No. 09-993 (U.S., oral argument, March 30, 2011). The product at issue was the generic bioequivalent of a drug prescribed to treat the plaintiff’s diabetic gastroparesis. She took the generic drug for four years and then allegedly developed tardive dyskinesia. Generic drug makers generally label their products with the warnings that FDA approves for the name brand versions, and when the plaintiff was taking metoclopramide, no manufacturer had taken steps to change the label warnings despite mounting evidence that long-term use carries a purported tardive dyskinesia risk.
The Eighth Circuit Court of Appeals reversed a lower court’s grant of the generic drug makers’ motion for summary judgment, finding that the plaintiff had stated a viable claim that was not preempted by federal law. According to the court, the regulatory framework “does not permit generic manufacturers passively to accept the inadequacy of their drug’s label as they market and profit from it.” The Eighth Circuit rejected the defendants’ efforts to establish that it would be impossible for them to comply with both federal law and the state laws the plaintiff sought to enforce. The defendants argued that they are prohibited from implementing a unilateral label change without prior FDA approval, but the court observed that they “could have at least proposed a label change that the FDA could receive and impose uniformly on all metoclopramide manufacturers if approved.”
Numerous amicus briefs were filed, nearly all of them on behalf of the plaintiff, who is the respondent before the U.S. Supreme Court. Among those supporting her are 42 states and the District of Columbia; various medical societies, including the American Medical Association; the U.S. government; Representative Henry Waxman (D-Calif.); and a number of legal scholars. A decision could be handed down before the Court concludes its term in June 2011.