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# SCOTUS to Hear Merck Fosamax Appeal Arguments
- URL: https://www.fdaweb.com/scotus-to-hear-merck-fosamax-appeal-arguments/
- Published: 2019-01-03T12:00:00.000Z
- Updated: 2026-09-15T00:52:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143078

The Supreme Court will hear oral arguments 1/7 as part of Merck’s [appeal](https://www.fdaweb.com/scotus-will-hear-preemption-case-appeal/) of a 3rd Circuit Court of Appeals ruling that allowed hundreds of state-based liability claims involving alleged failure to adequately warn of fracture risk associated with Fosamax (alendronate sodium) to go to trial.

*Chemical & Engineering News* [reports](https://cen.acs.org/policy/regulation/US-high-court-hear-Merck/97/i1?ref=fdaweb.com) that in 2008 Merck gave FDA data suggesting that Fosamax might be linked to certain bone fractures, but the agency rejected the company’s proposal to add a Warning to the labeling. FDA reversed field in 2010 after reviewing new research and ordered the company to add the Warning. But more than 500 patients said their injuries occurred before 2010 and Merck should have warned them sooner.

The company says the FDA 2008 rejection of a labeling change should preempt the suits. A New Jersey federal court agreed with Merck, but was overturned by the 3rd Circuit, which said that a “reasonable jury” could conclude that FDA had objected only to Merck’s wording of the proposed labeling change and might have approved a properly worded Warning.