U.S. Supreme Court Holds That State-Law-Based Failure-to-Warn Claims Are Federally Preempted Against Generic Drug Manufacturers


On June 23, 2011, the U.S. Supreme Court issued a decision in Pliva, Inc. v. Mensing,1 holding that state-law claims against generic drug manufacturers are federally preempted pursuant to the Supremacy Clause of the U.S. Constitution. The case evaluated the tension between state-law-based duty-to-warn claims of risks inherent in medications and the Hatch-Waxman amendments to the federal Food, Drug, and Cosmetic Act (FDCA), which require generic drug warnings to mirror those of their bioequivalent branded pharmaceutical products. The Court found conflict preemption existed insofar as it was impossible for the defendant generic drug manufacturers to simultaneously comply with federal law and state-law duties.

The Court framed the issue as "whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt. . . state-law claims." In the underlying lawsuits, the plaintiffs alleged that the defendant generic drug manufacturers failed to provide adequate warning labels and were thus liable under state tort law. Conversely, the defendant generic drug manufacturers contended that federal statutes and U.S. Food and Drug Administration (FDA) regulations required their labels to be the "same as" brand drug manufacturers' labeling.

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