Lauren Farrugia is a Litigation Clerk at Washington Legal Foundation and is a Juris Doctor candidate at the George Washington University School of Law.

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When the Food and Drug Administration (FDA) approves a prescription drug as safe and effective for its intended use, no one asks a state-court jury to re-litigate the science. Congress did not design the federal regulatory regime to allow twelve laypeople to substitute their own judgments for that of the FDA by conducting an impromptu review of pharmacology, running pseudo-clinical trials and rewriting a drug label in hindsight. Yet that is effectively what’s happening in Merck Sharp and Dohme Corp. v. Albrecht, where the Third Circuit has twice rejected Merck’s straightforward preemption defense in a failure-to-warn lawsuit.

At issue is a simple question: Does federal law preempt a state-law claim against a drug manufacturer for failing to include a warning that the FDA has already reviewed and formally rejected? As WLF’s amicus brief urging the Supreme Court to review the Third Circuit opinion explains, the answer is yes. Merck submitted all the relevant data to the FDA and proposed a stronger warning label for its osteoporosis drug Fosamax in 2008. The FDA rejected a warning in 2009 and offered no alternative. Yet Merck is still being sued under New Jersey law for not issuing that very warning. That scenario presents the clearest possible case of impossibility preemption.

The Third Circuit’s decision rests largely on a “presumption against preemption.” This is a concept that, as WLF’s brief discuses, has no grounding in the Constitution, no meaningful support in legal history and no place in a case where it is impossible to comply with both federal and state law. The Supremacy Clause makes clear that when federal and state obligations collide, federal law prevails. The Supreme Court made that point unequivocally clear in Albrecht I (2019), yet the Third Circuit has, once again, veered off course, imposing a misguided evidentiary burden that the Supreme Court has already rejected.

If the Third Circuit’s approach is allowed to stand, the consequences could be far-reaching. Pharmaceutical companies would face conflicting mandates from the FDA to use one label and from state juries to use another. That legal uncertainty not only threatens innovation but also weakens the national uniformity that underpins the FDA’s regulatory authority. Manufacturers complying fully with federal laws should not be penalized for failing to do what federal laws prohibit.

The Supreme Court should grant review, reaffirm the primacy of federal law, and bring this 17-year litigation saga to a close. The stakes extend far beyond this case. The Court now has an opportunity to clarify preemption doctrine, curb judicial overreach, and restore predictability to an area of law that demands it.