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# U.S. Asks Supreme Court to Hear Fosamax Case
- URL: https://www.fdaweb.com/u-s-asks-supreme-court-to-hear-fosamax-case/
- Published: 2018-05-23T12:00:00.000Z
- Updated: 2026-09-15T00:07:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141520

The U.S. Solicitor General says the Supreme Court should hear Merck’s appeal of an appeals court ruling in a failure-to-warn case involving its Fosamax. In an *amicus* [brief](https://www.druganddevicelawblog.com/wp-content/uploads/sites/30/2018/05/Albrecht-SG-brief-on-petition.pdf?ref=fdaweb.com), the government says 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 brief asserts 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 says, “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 government says the underlying issue of whether the meaning and effect of an FDA labeling decision present a question of law for courts to resolve or a question of fact for juries to determine is significant. “The petition clearly presents that issue in a context in which hundreds of separate cases asserting similar failure-to-warn claims turn on its proper resolution,” it says. “No circuit conflict yet exists, however, and further percolation in the courts of appeal could potentially refine the issue for review. Although the question is close, the government concludes that, on balance, review is warranted at this time.”