Fosamax is a drug manufactured by Merck that belongs to a class of drugs known as bisphosphonates. Both Merck and the FDA have long been aware that antiresorptive drugs like Fosamax could theoretically increase the risk of atypical femoral fractures. The question that both Merck and the FDA faced in the years following the drug’s approval was whether the developing evidence of a causal link between Fosamax and atypical fractures was strong enough to require adding a warning to the Fosamax drug label. The specific question, for the purposes of the litigation, was whether, prior to September 2010, the FDA would have rejected an attempt by Merck to unilaterally amend the Fosamax label (via a CBE submission) to include a warning about the risk of atypical femoral fractures.
The District Court held that the failure-to-warn claims were preempted. Applying the Supreme Court’s decision in Wyeth, the court stated that state-law failure-to-warn claims are preempted when “there is ‘clear evidence that the FDA would not have approved a change’ to the prescription drug’s label.” The District Court concluded that the claims were preempted because the FDA’s May 2009 denial of Merck’s request to add language about atypical femur fractures to the Warnings and Precautions section of the label was “clear evidence that the FDA would not have approved a label change to the Precautions section of the label….”
On appeal, the U.S. Third Circuit, reversing, concluded that (1) the term “clear evidence” refers solely to the applicable standard of proof, and (2) the ultimate question of whether the FDA would have rejected a label change is a question of fact for the jury rather than for the court.
“By describing the ultimate question as one of fact for the jury, we do not mean to suggest that summary judgment is categorically unavailable to a manufacturer asserting a preemption defense. When there is no genuine issue of material fact — that is, when no reasonable jury applying the clear-evidence standard of proof could conclude that the FDA would have approved a label change — the manufacturer will be entitled to judgment as a matter of law. We simply hold that, at the summary judgment stage, the court cannot decide for itself whether the FDA would have rejected a change, but must instead ask whether a reasonable jury could find that the FDA would have approved the change.”
In re Fosamax Products Liab. Lit., No.14-1900, 2017 WL 1075047 (3rd Cir. March 22, 2017).