November 8, 2011
Jeremy Taylor, Senior Attorney, National Legal Research Group
The U.S. Supreme Court recently decided a case involving the issue of federal preemption of state law warning claims against manufacturers of the generic drug metoclopramide. See Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011). The plaintiffs were users of the drug who filed state court actions alleging that their long-term use of metoclopramide had caused them to suffer tardive dyskinesia. In the first case, the U.S. District Court for the Eastern District of Louisiana granted in part and denied in part the manufacturer's motion to dismiss, and the manufacturer appealed. The U.S. Court of Appeals for the Fifth Circuit affirmed. In the second case, the U.S. District Court for the District of Minnesota granted the manufacturers' motions for summary judgment, and the consumer appealed. The U.S. Court of Appeals for the Eighth Circuit reversed in part. The Supreme Court granted certiorari, and the cases were consolidated. The Court ruled that federal law preempts state laws imposing a duty on generic drug manufacturers to change a drug's label.
Following approval by the Food and Drug Administration ("FDA") of the sale of metoclopramide under a brand name, generic manufacturers began producing the drug, which is used to treat digestive disorders. The plaintiffs had been prescribed the brand-name drug but had received generic metoclopramide from their pharmacists. After having used the drug for several years, both plaintiffs developed tardive dyskinesia, a severe neurological disorder. They sued the manufacturers in state court for failing to provide adequate warnings of the dangers of the drug. The manufacturers argued that federal statutes and the FDA regulations preempted the state products liability causes of action, and they asserted that because federal law required them to use the same safety and efficacy labeling as was used in their brand-name equivalents while state law required the use of a different label, it was therefore impossible for them simultaneously to comply with both federal law and state law. The Court noted that evidence has mounted that metoclopramide can cause tardive dyskinesia. As a result, warning labels for the drug have been strengthened and amended several times. In 2004, the brand-name manufacturer requested, and the FDA approved, a label change to provide that therapy with the drug should not exceed 12 weeks. In 2009, the warning was intensified to caution that treatment with the drug can cause tardive dyskinesia, an often irreversible movement disorder.