In a major victory for generic drug manufacturers, the U.S. Supreme Court ruled 5-4 last week that federal law directly conflicts with, and therefore preempts, state-law failure-to-warn claims against manufacturers of generic drug products. As the Court explained in two consolidated appeals, PLIVA, Inc. v. Mensing and Actavis, Inc. v. Demahy, Nos. 09-993, 09-1039, 09-1501, it is “impossible” for a generic drug manufacturer to comply with both the federal mandate that a generic drug must bear a label that is “the same as” the brand-name equivalent, and any duty under state law to provide a different, stronger warning. This result was different from that reached by the Court in Wyeth v. Levine, 555 U. S. 555 (2009), which held that federal law does not preempt state failure-to-warn claims against manufacturers of brand-name drugs. Citing basic differences relating to how the Hatch-Waxman Act treats brands and generics, the Court held that largely identical claims against the manufacturer of a generic drug are preempted.

The plaintiffs in the PLIVA cases developed tardive dyskinesia, a neurological disorder, after long-term use of generic versions of the drug metoclopramide. At the time, the FDA-approved label for the brand-name product, Reglan, warned of that very risk. And, as required by federal law, the generic products used by the plaintiffs carried an identical warning. (The warning has since been further strengthened. In 2009, the FDA ordered that Reglan and generic metoclopramide products carry a “black box” warning about the risk of tardive dyskinesia and long-term use of metoclopramide.) The plaintiffs nonetheless filed suit, claiming that the manufacturers violated Louisiana and Minnesota law because they knew or should have known that their labels provided an inadequate warning of the risks of metoclopramide.

The manufacturers argued that the claims were preempted because federal law precluded them from providing any warning that was not “the same as” the label that the FDA had approved for the brand-name product. The Fifth and Eighth Circuits disagreed, holding that the claims were not preempted because (in the view of those courts) federal law allowed generic manufacturers to make unilateral label changes, and because the manufacturers could have asked the FDA for permission to make a label change.  

The Supreme Court reversed. Writing for the majority (comprising himself, the Chief Justice, and Justices Scalia, Kennedy, and Alito), Justice Thomas first agreed with the FDA’s position that federal law does not allow generic manufacturers to make unilateral label changes—not by adding or changing warnings provided with the product, and not by sending “Dear Doctor” letters, which are also “labeling” as a matter of federal law and thus subject to the same mandate that generic product labeling at all times match that of the name-brand equivalent. This, the majority explained, is the critical difference from the Court’s prior decision in Levine: FDA regulations permit brand-name drug manufacturers to unilaterally strengthen a warning; the FDA has authority to rescind such changes, but pre-approval is not necessary. Generic drug manufacturers, by contrast, have an “ongoing federal duty of ‘sameness’” that precludes any unilateral label change.

Second, assuming without deciding that federal law requires generic manufacturers to ask the FDA for a “safer label” if they become aware of a new safety issue, the majority concluded that any such duty does not defeat preemption: “State law demanded a safer label; it did not instruct the Manufacturers to communicate with the FDA about the possibility of a safer label.” This is the heart of the decision— that conflict preemption does not take into account actions third-parties might or could be asked to take. “The question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.” (Emphasis added).

The Plaintiffs argued that the manufacturers should be required to prove that they tried and failed to get FDA-approval for a warning that would have complied with state law. The majority rejected the argument. “In these cases,” the Court explained, “it is certainly possible that, had the Manufacturers asked the FDA for help, they might have eventually been able to strengthen their warning label.” It is also “possible” that the manufacturers could have convinced the FDA to reinterpret its regulations to allow unilateral label changes, or that, “by asking, the Manufacturers could have persuaded the FDA to rewrite its generic drug regulations entirely or talked Congress into amending the Hatch- Waxman Amendments.” But such “conjectures,” the majority concluded, cannot be sufficient or else the Supremacy Clause would have no effect outside of express preemption—rendering “conflict preemption all but meaningless.”

PLIVA is also significant in that the Court’s majority nowhere cites the so-called “presumption against preemption.” Instead, the Court simply determined whether federal and state law “directly conflict” such that compliance with both would be an “impossibility.” In a section of Justice Thomas’s opinion that Justice Kennedy declined to join, a plurality of Justices added a textual analysis of the Supremacy Clause: The phrase, “any [state law] to the Contrary notwithstanding,” the plurality explains, is a “non obstante provision.” It “suggests that federal law should be understood to impliedly repeal conflicting state law,” and, moreover, that “courts should not strain to find ways to reconcile federal law with seemingly conflicting state law.” Instead, courts “need look no further than the ordinary meaning of federal law, and should not distort federal law to accommodate conflicting state law.” (Internal quotation and alteration marks omitted).

Justice Sotomayor’s dissent (which was joined by Justices Ginsburg, Breyer, and Kagan) took issue with this “novel theory.” In particular, the dissent insisted that precedent and respect for “the historic police powers of the States” require not only starting with a heavy presumption against preemption, but also making every effort to interpret federal law to avoid conflict with state law. Indeed, the dissent went so far as to contest the proposition that preemption questions should be resolved based on the “ordinary meaning” of federal law.

The majority and dissenting opinions both remarked on the different treatment for generic and name brand drugs under Levine and PLIVA. Justice Sotomayor’s dissent concluded by marshalling a parade of “absurd consequences” to show why this could not have been Congress’s intent. For its part, the majority conceded that, from the perspective of consumers, it “makes little sense” that they have a state-law claim if they take the name-brand, but not if they take a generic product. The majority concluded, however, that the federal law governing generic manufacturers is “meaningfully different” (adding that the differences are what allowed the market for generic drugs to explode in the first place). “As always,” the majority pointed out, “Congress and the FDA retain the authority to change the law and regulations if they so desire.”

Winston & Strawn filed an amicus brief in support of the petitioners in this case. A copy of that brief is available here.