Litigation Advisory – Generic Drug Preemption – Mutual Pharmaceutical Co., Inc. v. Bartlett, No. 12-142 (June 24, 2013)

Product Liability Preemption—Pursuing the Possibility of Impossibility

On June 24, 2013, the Supreme Court issued one of its more lucid product liability preemption decisions of the past twenty years. The Court held 5-4 in Mutual Pharmaceutical Co., Inc. v. Bartlett, No. 12-142, that state-law design-defect claims are federally preempted if they would impose liability upon a generic drug manufacturer for failing to provide label warnings that the federal regulatory scheme for prescription drugs did not allow the manufacturer to add to its label. To avoid liability, New Hampshire tort law effectively required Mutual, a generic drug manufacturer, to independently change its product labeling to provide warnings stronger than those approved by the Food and Drug Administration (FDA)—something that the Court held in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), a generic drug manufacturer (unlike a brand name drug manufacturer) cannot do.

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