Supreme Court Grants Review in Generic Drug Preemption Case

By Brian Wolfman

In 2009, the Supreme Court held 6-3 in Wyeth v. Levine that, in general, FDA approval of a brand-name prescription drug and its labeling does not preempt a state-law damages claim premised on the drug manufacturer's failure to warn of the drug's hazards. I wrote an article on the implications of that decision. Then, in 2011, the Court held 5-4 in PLIVA v. Mensing that FDA approval of a generic prescription drug and its labeling generally does preempt a state-law damages claim premised on a failure to warn of the drug's hazards. Dena Feldman and I wrote an article on the implications of that decision.

Last Friday, the Supreme Court granted review in Mutual Pharmaceutical Co. v. Bartlett, which presents the question whether FDA approval of a generic prescription drug preempts a state-law damages claim premised on a drug's design defect. Here is how the drug company characterized the issue in its cert petition:

Whether the First Circuit erred when it created a circuit split and held—in clear conflict with this
Court’s decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)—that federal law does not preempt state law design-defect claims targeting generic pharmaceutical products because the conceded conflict between such claims and the federal laws governing generic pharmaceutical design allegedly can be avoided if the makers of generic pharmaceuticals simply stop making their products.

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