On March 23, 2022, the Honorable Freda L. Wolfson, Chief Judge for the United States District Court for the District of New Jersey, issued a comprehensive opinion granting summary judgment to Merck in In re Fosamax (Alendronate Sodium) Products Liability Litigation. Chief Judge Wolfson’s decision ends about 500 lawsuits filed over the last fourteen years. 

In re Fosamax involved more than 500 individual plaintiffs who took Fosamax, a drug manufactured by Merck. The plaintiffs claimed that they suffered atypical femoral fractures between 1999 and 2010 and that Merck failed to warn them of this alleged side effect. The plaintiffs’ claims were based on state-law failure-to-warn theory. 

This case previously went to the Supreme Court of the United States on the issue of whether the judge or jury decides whether federal law preempts the plaintiffs’ state-law failure-to-warn claims. The Supreme Court ruled that the trial judge decides the preemption issue. The case was remanded to the District Court to decide if communications between Merck and the Food and Drug Administration (“FDA”) were sufficient to give rise to preemption. Specifically, the FDA issued a Complete Response Letter (“CRL”) that rejected a warning concerning atypical femoral fractures that Merck proposed. 

Chief Judge Wolfson’s opinion evaluated whether the CRL rejecting Merck’s proposed warning preempts the plaintiffs’ state-law failure-to-warn claims. The plaintiffs argued that the CRL was not “clear evidence” that the FDA would have rejected any and all warnings. Chief Judge Wolfson disagreed, finding that Merck fully informed the FDA of the justification for its proposed warning, which would have been adequate under New Jersey law, and that the FDA did not approve changing the Fosamax label to include a warning about atypical femoral fractures. Further, the FDA based its rejection on insufficient evidence of a causal link between Fosamax and atypical femoral fractures, so Chief Judge Wolfson also found that the FDA would not have approved a differently worded warning about that risk. Thus, Chief Judge Wolfson concluded that the state-law failure-to-warn claims were preempted by the FDA’s rejection of the proposed warnings. 

NJCJI applauds this decision as an appropriate application of the doctrine of preemption. Read Chief Judge Wolfson’s thoughtful opinion here.