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# Appeals Court Sends Fosamax Case Back to Lower Court
- URL: https://www.fdaweb.com/appeals-court-sends-fosamax-case-back-to-lower-court/
- Published: 2017-03-28T12:00:00.000Z
- Updated: 2026-09-14T22:14:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138308

The 3rd Circuit Court of Appeals has vacated a New Jersey federal court decision that failure-to-warn and other claims against Merck involving thigh bone fractures caused by its Fosamax (alendronate sodium) were preempted by federal law. The appeals court [remanded](http://www2.ca3.uscourts.gov/opinarch/141900p.pdf?ref=fdaweb.com) the case to the lower court for further consideration consistent with its ruling.

Hundreds of plaintiff suits against Merck were consolidated in multi-district litigation that was assigned to the New Jersey federal court. That court presided over a bellwether trial in which a jury found in favor of Merck, and then ruled that all of the plaintiffs’ claims should be dismissed because they were preempted by federal law.

“Preemption is an affirmative defense, and Merck has not carried its burden to prove that it is entitled to that defense as a matter of law,” a three-judge 3rd Circuit panel ruled. “The *Wyeth* ‘clear evidence’ standard is demanding and fact-sensitive. It requires the factfinder to predict a highly probable outcome in a counterfactual world and, therefore, requires a court sitting in summary judgment to anticipate both the range of conclusions that a reasonable juror might reach and the certainty with which the juror would reach them. Here, plaintiffs have produced sufficient evidence for a reasonable jury to conclude that FDA would have approved a properly-worded warning about the risk of thigh fractures — or, at the very least, to conclude that the odds of FDA rejection were less than highly probable.”

The appeals court divided the plaintiffs’ claims into three groups — failure-to-warn, adverse reactions, and non-warning claims. While the district court found that all three types of claims hinged on the preempted failure-to-warn claim, the appeals court concluded that **(1)** the Warnings and Precautions claims are not preempted as a matter of law because a reasonable jury could find it less than highly probable that FDA would have rejected Merck’s proposed Warning; **(2)** Merck is not entitled to summary judgment on the adverse reactions claims; and **(3)** the non-warning claims are not preempted as a matter of law.