Pliva, Inc. v. Mensing
United States Supreme Court
131 S. Ct. 2567 (2011)
Gladys Mensing (plaintiff) and Julie Demahy (plaintiff) were each prescribed Reglan, the brand name for metoclopramide, in 2001 and 2002. After its release in 1980, metoclopramide became associated over time with the development of tardive dyskinesia, a serious neurological disorder. As evidence mounted, the drug’s warning label was altered in 1985, 2004, and 2009. The 2009 label instructed that use of the drug beyond 12 weeks “be avoided in all but rare cases.” The prescriptions of Mensing and Demahy were filled not for Reglan but for generic metoclopramide. After using the drug for several years, each woman developed tardive dyskinesia. Each sued the manufacturers of the generic drugs they had taken (collectively, Manufacturers) (defendants). Plaintiffs alleged that Manufacturers were liable under state tort law for failing to provide adequate warnings. Manufacturers pleaded preemption as an affirmative defense, contending that because federal law required them to use the same label as Reglan, it was impossible to comply with a state-law duty requiring a different label. The Courts of Appeals for the Fifth and Eighth Circuits rejected Manufacturers’ defense. Manufacturers petitioned the Supreme Court for certiorari.
Rule of Law
Holding and Reasoning (Thomas, J.)
Dissent (Sotomayor, J.)
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