Feds Back Merck in Fosamax Warning Case

The federal government has filed an amicus brief supporting Merck’s position before the Supreme Court that a state failure-to-warn suit is preempted if it involves labeling changes that were rejected by FDA. The government filing notes that a federal district court had ruled that the state suits over inadequate Fosamax warnings were preempted, and that decision was reversed by the 3^rd Circuit Court of Appeals.

The appeals court held that a jury should determine whether FDA would have rejected Merck’s request for labeling changes. The government brief tells the Supreme Court that “petitioner (Merck) provided FDA with the relevant scientific data about Fosamax’ risks and, in 5/2009, FDA rejected petitioner’s proposal to add a warning about atypical femoral fractures in the Warnings and Precautions section of Fosamax’ labeling. The court of appeal erroneously rejected petitioner’s impossibility-preemption defense to respondents’ state law failure-to-warn claims, based on its determination that preemption required petitioner to establish by ‘clear and convincing’ evidence that FDA would have denied a Changes Being Effected supplement, which the court deemed to be a factual question for a jury to decide. The proper focus here is on whether FDA’s 5/2009 decision embodied a determination by FDA that insufficient causal evidence existed to warrant strengthening the Warnings and Precautions section of the Fosamax labeling to address atypical femoral fractures. That is a question of law for a court to resolve, not a question of fact for a jury.”