Janssen Pharmaceuticals, Inc., et al. v. A. Y., et al.

Off-label use of prescription drugs is an accepted and beneficial feature of medical practice, but federal law bars drug manufacturers from—and imposes significant civil and criminal penalties for—promoting their drugs for off-label use. 21 U.S.C. §§331(a), 333(a), 352(a) & (f). The FDA accordingly prohibits manufacturers from making unsolicited statements— including warnings in their FDA-approved labeling— about off-label uses, which impliedly promote such uses as safe and effective. By law, only the FDA may impose such a warning: a “specific warning relating to a use not provided for under the [product’s labeling] may be required by Food and Drug Administration,” but only after it determines the “drug is commonly prescribed” off-label and such “usage is associated with a clinically significant risk or hazard.” 21 C.F.R. §201.57(e) (2003) (emphasis added). Petitioner Janssen Pharmaceuticals markets Risperdal, a highly effective treatment for psychotic disorders that, until 2006, was approved only for adults but also prescribed off-label for children. The court below misapplied this Court’s decision in Wyeth v. Levine, 555 U.S. 555 (2009)—which concerned warnings for on-label uses—to hold Petitioners liable under state tort laws for failing to unilaterally add warnings about Risperdal’s off-label use in children. The decision below exposes Petitioners (and every drug manufacturer) to unendurable liability for failing to do precisely what federal law prohibits. This is the paradigm of impossibility preemption. The question presented is: Whether federal law preempts state-law claims