US Supreme Court Issues Opinion in PLIVA, Inc. v. Mensing

In a trilogy of closely watched cases, PLIVA, Inc. v. Mensing, No. 09-993, Activas Elizabeth, LLC v. Mensing, No. 09-1039, and Activas, Inc. v. Demahy, No. 09-1501, the Supreme Court held that the federal statutes and regulations governing the labeling of generic drugs preempt state-law failure-to-warn claims against generic drug manufacturers. The Court had previously held, in Wyeth v. Levine, 129 S. Ct. 1187 (2009), that failure-to-warn claims against brand-name drug manufacturers generally are not preempted.

Manufacturers seeking to market generic forms of a previously approved drug must demonstrate, among other things, that the generic drug’s labeling will be identical to that approved by the FDA for its brand-name equivalent. Slip op. 6. In the decision, the Court concluded that generic manufacturers would violate federal labeling requirements if they unilaterally changed their warning labels to satisfy the state-law tort duties that a failure-to-warn claim necessarily would impose. Invoking the rubric of “impossibility” preemption, the Court held that state law had to give way in favor of the directly conflicting federal law. Slip op. 11-12.

The plaintiffs here—echoing similar arguments advanced by the plaintiffs in Wyeth and adopted by the Wyeth Court in concluding that preemption did not apply in the brand-name-drug context—asserted that there was no true conflict because, in their view, “federal law provided several avenues through which the [generic drug manufacturers] could have altered their . . . labels.” Slip op. 6. The Court was not persuaded. Writing for the majority, Justice Thomas discerned a crucial difference between the federal regulatory regime applicable to brand-name manufacturers and that applicable to generic manufacturers.

Brand-name manufacturers have a continuing responsibility “for the accuracy and adequacy” of labeling and are specifically permitted to “change their labels” to add additional warnings. Slip op. 6-7, 9. Impossibility preemption thus was rejected in Wyeth on the ground that “the federal regulations applicable to [a brand-name manufacturer] allow[] the company, of its own volition, to strengthen its label in compliance with its state tort duty.” Slip op. 18.

Generic manufacturers, on the other hand, “have an ongoing federal duty of ‘sameness.’” Slip op. 6. Deferring to the FDA’s interpretation of its own regulations, the Court concluded that federal law did not permit generic manufacturers to unilaterally strengthen their warning labels. In particular, generic manufacturers are forbidden from adding warnings through the FDA’s “changes-being-effected” process or by sending “Dear Doctor” letters. Slip op. 7-9. 

The Court also rejected the plaintiffs’ remaining suggestion that impossibility preemption does not apply because generic manufacturers could ask the FDA for help in strengthening the brand-name drug’s label, in turn allowing the generic drug’s label to be updated. Slip op. 10, 13. The Court concluded “[t]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.” Slip op. 13 (emphasis added). To hold otherwise, the Court explained, would “render conflict pre-emption largely meaningless,” since a private party could always, in principle, try to persuade “the Federal Government . . . [to] do something that makes it lawful for a private party to accomplish under federal law what state law requires of it.” Slip op. 14.

Justice Thomas, writing for himself and three other justices, would have clarified that no presumption against preemption applies in conflict preemption cases. Slip op. 15-17. Justice Kennedy did not join that section of the majority opinion.

Justice Sotomayor dissented, joined by Justices Ginsburg, Breyer, and Kagan. The dissent would have required the generic manufacturers to prove that the FDA would not have accepted a requested labeling change. “Until today, the mere possibility of impossibility had not been enough to establish pre-emption.” Dissent at 1. The dissent invoked the presumption against preemption, which, according to the dissent, “has particular force when the Federal Government has afforded defendants a mechanism for complying with state law, even when that mechanism requires federal agency action.” Dissent at 13. The dissent also pointed out the anomaly in finding preemption here, but not in Wyeth—namely, that a patient injured by a generic drug might be left without a remedy at the same time that a patient injured by its brand-name equivalent could bring a failure-to-warn claim.

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