The US Supreme Court [official website] on Thursday voted 5-4 to reverse [opinion, PDF] the lower court in PLIVA, Inc. v. Mensing [Cornell LII backgrounder; JURIST report], holding that since generic drugs and their warnings are managed by the Food and Drug Administration (FDA) [official website], their federal regulations on warning labels preempt state law on warning labels. Justice Clarence Thomas delivered the opinion of the court, except for Part III-B-2, which only Chief Justice John Roberts, Justice Samuel Alito and Justice Antonin Scalia join. The court found impossibility in meeting both the state's higher standard and the FDA's standard of identical labels between brand name and generic drugs and denied plaintiffs' claim under their respective states' tort laws. Justice Sonia Sotomayor wrote a dissent decrying the broadening of the impossibility standard.
We have traditionally held defendants claiming impossibility to a demanding standard: Until today, the mere possibility of impossibility had not been enough to establish pre-emption. The Food and Drug Administration (FDA) permits—and, the Court assumes, requires—generic-drug manufacturers to propose a label change to the FDA when they believe that their labels are inadequate. If it agrees that the labels are inadequate, the FDA can initiate a change to the brand-name label, triggering a corresponding change to the generic labels. Once that occurs, a generic manufacturer is in full compliance with both federal law and a state-law duty to warn. Although generic manufacturers may be able to show impossibility in some cases, petitioners, generic manufacturers of metoclopramide (Manufacturers), have shown only that they might have been unable to comply with both federal law and their state-law duties to warn respondents Gladys Mensing and Julie Demahy. This, I would hold, is insufficient to sustain their burden.She went on that the opinion is dangerous and holds a multitude of consequences for current tort law surrounding drugs. Justice Thomas responded in a footnote that the situation is too rare to impact the drug industry significantly.
PLIVA, Inc. v. Mensing was a consolidated case with Actavis Elizabeth, LLC v. Mensing and Actavis v. Demahy. In all the cases, petitioners were prescribed a brand name drug and instead received the generic version. The drugs, created to treat digestive tract disorder, sometimes caused a severe nervous system disorder with continued use. At the time, in 2001, this did not appear on the brand name label, and thus, due to FDA regulations that require generic drugs to match the brand name, did not appear on the generic label. The manufacturers claims this prevented them from creating more accurate warnings. Petitioners took the generic drug manufacturers to court, citing a higher standard in their state laws.