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Pharmaceuticals / Commercial Operations

Third Circuit Says Merck Deserves Trial on Failure-to-Warn

April 5, 2017
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Reversing a district court, the Third Circuit ruled that a case consolidating about 5,000 state-court lawsuits alleging Merck’s osteoporosis drug Fosamax caused thigh fractures should proceed to trial.

The plaintiffs, all Fosamax users, claimed Merck failed to add an adequate warning of the risk of thigh fractures to the FDA-approved drug label. The U.S. District court for the District of New Jersey granted Merck’s motion for summary judgment and dismissed the claims. According to the district court, state-law failure-to-warn claims are preempted when there is “clear evidence” that the FDA would not have approved the requested warning.

However, the Third Circuit held that a reasonable jury could conclude that the FDA would have approved a properly worded warning about thigh fractures. As a result, the case was sent back to the district court for a trial on that issue.

The case is In re Fosamax, Nos. 14-1900 et al. 3rd Cir. 2016.

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