In re: Fosamax (Alendronate Sodium) Products Liability Litigation, Nos. 14-1900 et al. (3d Cir. March 22, 2017).
In a precedential decision issued on March 22, 2017, the United States Court of Appeals for the Third Circuit reversed the District of New Jersey’s entry of summary judgment in favor of Merck Sharp & Dohme in multidistrict litigation by plaintiffs alleging injury related to the Merck drug Fosamax. The decision is obviously important for the plaintiffs, who claim that Merck failed to warn them that taking Fosamax to treat their osteoporosis might actually increase their risk of femur fractures. The Merck decision is also significant for federal jurisprudence, because it offers further development of the federal preemption doctrine as applied to state law failure-to-warn claims.
The legal theory behind the preemption defense in failure-to-warn cases is that where the FDA has approved a specific drug label, a state law judgment requiring a different label is preempted because it would be impossible for the manufacturer to comply with both federal and state law requirements. In Wyeth v. Levine, 555 U.S. 555 (2009), the United States Supreme Court rejected this “impossibility preemption” defense as applied to that case. The Court noted, however, that a drug manufacturer may strengthen the warnings on an FDA-approved label without going through a formal approval process – subject to the FDA’s authority to reject the label change. Accordingly, the Court left room for the possibility that a state law tort claim of failure to warn could be preempted if there was “clear evidence” that the FDA would have rejected the drug label warning the plaintiff alleged was lacking. The Court did not define what would constitute “clear evidence.” In Merck, the Third Circuit concluded the Supreme Court did intend to announce “clear evidence” as a standard of proof, and that it is synonymous with the “clear and convincing evidence” standard.
Applying its interpretation of that standard, the Third Circuit held that Merck had not proven it was entitled to the affirmative defense of preemption as a matter of law, and therefore was not entitled to summary judgment. Rejecting Merck’s argument that its preemption defense presented a pure question of law, the Third Circuit described the “clear evidence” standard articulated in Wyeth as “demanding and fact-sensitive” because it forces a factfinder “to predict a highly probable outcome in a counterfactual world.” Thus, a summary judgment motion depending on the Wyeth standard requires the trial court to “anticipate both the range of conclusions that a reasonable juror might reach and the certainty with which the juror would reach them.” The Third Circuit found that to defeat summary judgment, the plaintiffs only needed to produce sufficient evidence to allow a reasonable jury to conclude that it was “less than highly probable” the FDA would have rejected the proposed warning.
Since the Supreme Court decided Wyeth, federal courts in various circuits have applied differing analyses to the “clear evidence” preemption standard. The Third Circuit, weighing in on the issue in Merck, discussed the varying analyses and rejected those approaches suggesting the preemption issue was one of law. In light of the emerging split among the circuits, the issue may be ripe for additional clarification from the Supreme Court, either in Merck or in some future case.
