November 8, 2011
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.
The Court began its analysis by noting that under Louisiana and Minnesota tort law, a product manufacturer has a duty to warn about dangers in its product of which it knew or should have known. The Court then observed that the FDA's "changes being effected" ("CBE") rules permit a generic drug manufacturer to change a drug's label only when the change is made to match an updated brand-name label or to follow the FDA's instructions. The Court thus framed the potential conflict between the state tort law principles urged by the plaintiffs and the FDA regulations pertaining to manufacturers of generic drugs. The Court summarized the problem in these terms: State tort law places a duty on all drug manufacturers to label their products adequately and safely, such that the defendant manufacturers were required to use a different, stronger label than they had actually used, while federal drug regulations, as interpreted by the FDA, prevented the manufacturers from unilaterally changing their generic drugs' safety labeling. The Court further posited that federal law required the generic manufacturers to request FDA assistance in urging the brand-name manufacturer to adopt a stronger label so that the generic manufacturers of the drug could change their labels to match the stronger warning.
The Court noted that under the doctrine of conflict preemption, when state and federal law directly conflict, state law must yield. The Court observed that although an express statement on preemption in a federal law is always preferable, the lack of such a statement does not end the inquiry, and the absence of express preemption furnishes no reason not to find conflict preemption. Conflict preemption may exist when it is impossible for a private party to comply with both state and federal requirements. With the issues thus stated, the Court proceeded to find impossibility in the case at hand. According to the Court, it was not lawful under federal law for the defendant manufacturers to do what state law required of them. If they had independently changed their labels to satisfy their state law duty, they would have violated federal law, which proscribes a generic drug manufacturer from making unilateral changes to its label which cause that label to differ from that of the brand-name analog. According to the plaintiffs, however, by allowing the manufacturers' labels to remain unchanged, the manufacturers violated their state tort duties. Consequently, in the Court's view, it was impossible for the manufacturers to satisfy both state and federal law, and the state law requirements thus had to give way.
Interestingly, the Court explained that its holding did not conflict with that of Wyeth v. Levine, 555 U.S. 555 (2009), in which the Court had held that state law failure-to-warn claims against a drug manufacturer were not preempted by federal law under the theory that the manufacturer could not have modified its warning label once it had been approved by the FDA and that it was therefore impossible for the manufacturer to comply with both state law warning duties and its federal labeling duties. The Wyeth Court concluded that pursuant to FDA regulations, the manufacturer could have, without waiting for FDA approval, modified its label to add to or strengthen its warning. Despite the apparent conflict with the holding in Wyeth, the Pliva Court said that due to the different treatment given to brand-name and generic manufacturers by the FDA regulations, Wyeth was not contrary. According to the Court, the CBE regulation permitted a brand-name manufacturer, as in Wyeth, to strengthen its label unilaterally, without prior FDA approval. Accordingly, it was not impossible for the manufacturer in Wyeth to comply with both its state tort duty and the federal regulations. The Court sympathized with the Pliva plaintiffs, recognizing that from their perspective, finding preemption in the case at hand but not in Wyeth "makes little sense." The Court noted that had the plaintiffs taken the brand-name metoclopramide, their state actions would not have been preempted, while the mere fortuity of their having taken the generic equivalent foreclosed their state law remedies. According to the Court, the "unfortunate hand" dealt to consumers in the position of the plaintiffs can be remedied only by Congress and the FDA.