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# High Court Rules that Judges, Not Juries, Determine Preemption
- URL: https://www.fdaweb.com/high-court-rules-that-judges-not-juries-determine-preemption/
- Published: 2019-05-20T12:00:00.000Z
- Updated: 2026-09-15T01:27:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144144

The U.S. Supreme Court has unanimously ruled that FDA preemption questions are for a judge to decide, not a jury. In a [5/20 opinion](https://www.supremecourt.gov/opinions/18pdf/17-290%5Fi425.pdf?ref=fdaweb.com) in a Merck product liability lawsuit involving osteoporosis drug Fosamax, the high court reiterated that “clear evidence that the FDA would not have approved a change to the drug’s label preempts a claim, grounded in state law, that a drug manufacturer failed to warn consumers of the change-related risks associated with using the drug.”

The opinion is in line with a U.S. Solicitor General *amicus* [brief](https://www.druganddevicelawblog.com/wp-content/uploads/sites/30/2018/05/Albrecht-SG-brief-on-petition.pdf?ref=fdaweb.com) that said the 3rd Circuit Court of Appeals erred in holding that a jury must determine whether an FDA 5/2009 decision declining to approve a Merck proposal to revise Fosamax’ Warnings and Precautions labeling sections to warn against low-energy fractures of the subtrochanteric and proximal femoral shaft preempted later failure-to-warn claims arising from the same type of injury.

The Solicitor General brief asserted that when FDA declines to approve a drug labeling change, the interpretation of that administrative decision and its significance for a failure-to-warn claim are legal questions for a court to resolve and not factual questions for a jury. “Moreover,” the Solicitor General said, “because FDA’s decision here prevented petitioner from modifying the relevant labeling before late 2010, the court of appeals erred in rejecting petitioner’s impossibility-preemption defense.”

The Supreme Court opinion said the 3rd Circuit Court of Appeals treated the pre-emption question as one of fact, and not law. It remanded the case to the appeals court for further proceedings consistent with the opinion.