Brief Fact Summary.
Plaintiffs were injured by a drug who’s warning label was updated several times.
Synopsis of Rule of Law.
Federal statutes (FDA regulations) preempt the plaintiff’s state tort claims.
The FDA, however, has limited resources and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge.View Full Point of Law
The FDA approved a drug, and it was sold under both a brand name and a generic name. Plaintiffs took the generic version in 2001 and 2002, but in subsequent years the FDA required that the warning label be updated to reflect new scientific information regarding the potential harm of the drug. The plaintiffs sustained injuries as a result of taking the drug. The question is whether, given that the plaintiffs took the drug before the additional warnings were required, the FDA regulations preempt the plaintiff’s state tort claims.
Do the federal statutes (FDA regulations) preempt the plaintiff’s state tort claims?
Yes, the federal statutes (FDA regulations) preempt the plaintiff’s state tort claims.
Justice Sotomayor, J. (joined by Ginsberg, Breyer, and Kagan, JJ.)
The justices dissent on the grounds that the ruling of the majority will result in unfavorable future outcomes. They opine that there are additional steps the defendant could have taken to minimize harm to the plaintiffs, and other drug consumers who are in similar situations, and that the ruling of the majority will lead to additional (through similar) negative effects.
The majority finds in favor of the defendant, and rules that the FDA regulations preempt the plaintiff’s state tort claims, because under the FDA regulations, the defendant was not permitted to unilaterally change the warnings. This legal inability to update the warning, the court reasons, should prevent them from being successfully sued for failing to update it.