Shire U.S., Inc., et al. v. Mark Blackburn

This Court’s preemption cases have long drawn a critical distinction when it comes to state-law claims implicating prescription-drug labels that have been approved by the Food and Drug Administration (FDA): While there may be room for such claims in circumstances where the manufacturer had the ability to unilaterally change the label, those claims cannot proceed when they are premised on the notion that the manufacturer was required as matter of state law to make a change that federal law prohibits it from making without the prior approval of the FDA. See PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011). Respondent brought a state-law claim positing that petitioners should have unilaterally changed language that appears in the “Highlights” section of the label for one of their drugs. But petitioners were precluded as a matter of federal law from doing so, as the governing FDA regulations expressly state— twice—that the procedure that allows manufacturers to make certain changes to other aspects of their labels does not apply to changes implicating the Highlights section, which always require FDA preapproval. Yet the Eleventh Circuit nevertheless concluded that respondent’s claim could go forward, while simply ignoring unambiguous regulatory text that prohibited petitioners from unilaterally making the changes that respondent insists they should have made. The question presented is: Whether a state-law claim is preempted if it places a duty on a drug manufacturer to unilaterally change FDA-approved language that appears in the Highlights section of a drug label.