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Constitutional Law — federal preemption — drug labels

U.S. Supreme Court


Constitutional Law — federal preemption — drug labels

State-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law.

To assess whether a product’s design is “unreasonably dangerous to the user,” Vautour v. Body Masters Sports Industries, Inc., 147 N. H. 150, 153, 784 A. 2d 1178, 1181, the New Hampshire Supreme Court employs a “risk-utility approach,” which asks whether the danger’s magnitude outweighs the product’s utility, id., at 154, 784 A. 2d, at 1182. The court has repeatedly identified three factors as germane to that inquiry: “the usefulness and desirability of the product to the public as a whole, whether the risk of danger could have been reduced without significantly affecting either the product’s effectiveness or manufacturing cost, and the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses.” Ibid. Increasing a drug’s “usefulness” or reducing its “risk of danger” would require redesigning the drug, since those factors are direct results of a drug’s chemical design and active ingredients. Here, however, redesign was not possible for two reasons. First, the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as its brand-name drug equivalent. Second, because of sulindac’s simple composition, the drug is chemically incapable of being redesigned. Accordingly, because redesign was impossible, Mutual could only ameliorate sulindac’s “risk-utility” profile by strengthening its warnings. Thus, New Hampshire’s law ultimately required Mutual to change sulindac’s labeling.

But PLIVA makes clear that federal law prevents generic drug manufacturers from changing their labels. See 564 U. S., at ___. Accordingly, Mutual was prohibited from taking the remedial action required to avoid liability under New Hampshire law.

678 F. 3d 30, reversed.

12-142 Mutual Pharmaceutical Co., Inc., v. Bartless


Alito, J.; Breyer, J., dissenting; Sotomayor, J., dissenting.

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