Court Applies Strong Presumption Against Impossibility Preemption in ‘In re Fosamax’

Types : Alerts

On September 20, 2024, the Third Circuit issued a published opinion in In re Fosamax Products Liability Litig., No. 22-3412, __ F.4th __, 2024 WL 4247311 (3d Cir. Sept. 20, 2024). In this longstanding drug label MDL, the Plaintiffs-Appellants—who brought over 500 state law tort actions—alleged that Merck failed to sufficiently warn that its osteoporosis drug, Fosamax, increased the risk of femur fractures. The central question on appeal concerned a narrow federal preemption defense called impossibility preemption, which applies when it is impossible for a party to comply with both federal and state law requirements.

Merck argued that it could not be liable under any state laws because the Food and Drug Administration (FDA) had rejected a label change Merck itself had proposed that would have communicated the femure-fracture risk. The district court agreed and dismissed all 500+ litigations against Merck on that basis. But the Third Circuit reversed, concluding the Plaintiffs’ state law claims were not preempted. Plaintiffs’ cases, in other words, are back on.

The court’s analysis relied on the strong presumption in the law against impossibility preemption. The court explained that Merck had to prove that “the FDA, acting with the force of law, … clearly rejected Merck’s label in a manner that made it evident that no label about atypical femoral fractures would have been appropriate.” Merck could not do so here, because the FDA’s letter rejecting the label was ambiguous. It was not “abundantly clear,” in other words, “that the FDA would have rejected any and all labels that would have satisfied state law.” The district court saw the ambiguity, but resolved it in Merck’s favor. That was where it erred as a matter of law. Applying the correct presumption against impossibility preemption, the court should have rejected the defense.

Appellate practitioners should take note of the compound standard of review the Third Circuit applied, which was one of the contested issues on appeal. The panel noted that preemption cases often present a legal question that cannot be decided without making various intricate factual findings. It thus rejected the Plaintiffs’ argument that de novo review should apply across the board. Instead, drawing from the similarly “mongrel practice” of claim construction in the patent context, the court held that courts should apply de novo review to the ultimate legal question (i.e., are these state law claims preempted?), but clear-error deference to the factual findings necessary to reach that conclusion.