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PLIVA, Inc. v. Mensing - 564 U.S. 604, 131 S. Ct. 2567 (2011)


21 U.S.C.S. § 352(f)(2) provides that a drug is misbranded unless its labeling bears adequate warnings against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users. By regulation, the Food and Drug Administration (FDA) has interpreted that statute to require that labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug. 21 C.F.R. § 201.57(e). According to the FDA, these requirements apply to generic drugs. As it explains, a central premise of federal drug regulation is that the manufacturer bears responsibility for the content of its label at all times. The FDA reconciles this duty to have adequate and accurate labeling with the duty of sameness in the following way: Generic drug manufacturers that become aware of safety problems must ask the agency to work toward strengthening the label that applies to both the generic and brand-name equivalent drug.


Five years after the Food and Drug Administration (FDA) first approved metoclopramide, a drug commonly used to treat digestive tract problems, under the brand name Reglan, generic manufacturers such as petitioners also began producing the drug. Because of accumulating evidence that long-term metoclopramide use can cause tardive dyskinesia, a severe neurological disorder, warning labels for the drug have been strengthened and clarified several times, most recently in 2009. Respondents were prescribed Reglan in 2001 and 2002, but both received the generic drug from their pharmacists. After taking the drug as prescribed for several years, both developed tardive dyskinesia. In separate state-court tort actions, they sued petitioners, the generic drug manufacturers that produced the metoclopramide they took (Manufacturers). Each respondent alleged, inter alia, that long-term metoclopramide use caused her disorder and that the Manufacturers were liable under state tort law for failing to provide adequate warning labels. In both suits, the Manufacturers urged that federal statutes and FDA regulations pre-empted the state tort claims by requiring the same safety and efficacy labeling for generic metoclopramide as was mandated at the time for Reglan. The Fifth and Eighth Circuits rejected these arguments, holding that respondents' claims were not pre-empted.


Did the federal statutes and FDA regulations pre-empt the respondents’ state tort claims?




The Court held that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state claims. Under the federal drug regulations, as interpreted by the FDA, the Manufacturers were prevented from independently changing their generic drugs' safety labels; as such, manufacturers were not permitted to issue additional warnings through Dear Doctor letters. The Court found it was not lawful under federal law for the manufacturers to do what state law required. According to the Court, where state and federal law directly conflict, state law must give way.

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