The U.S. Supreme Court today agreed to consider a Third Circuit ruling that revived litigation over Merck’s alleged failure to warn about a risk of femoral fractures from its osteoporosis drug Fosamax.  The precise question presented on appeal is “whether a state-law failure-to-warn claim is pre-empted when the Food and Drug Administration rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data, or whether such a case must go to a jury for conjecture as to why the FDA rejected the proposed warning.”

Multiple plaintiffs filed personal injury lawsuits consolidated in the New Jersey District Court under state law against Merck alleging that the osteoporosis drug Fosamax caused them to suffer serious thigh bone fractures and that Merck failed to provide adequate warning of that risk.  The MDL judge granted Merck’s motion for summary judgment based on preemption, finding that state law warning claims are preempted when there is “clear evidence” that the FDA would not have approved the proposed warning.  Following dismissal, last year, the Third Circuit revived the patients’ claims, saying the issue presented was a factual one requiring Merck to prove to a jury that federal regulators blocked the warning. The panel specifically found that it was feasible that Merck could have received approval to include the contested warning had it described the fractures differently.

Merck asks the high court to affirm the district court decision dismissing the case, saying it had to accept the FDA’s decision to remove the warning.  It argues that under Supreme Court precedent set in Wyeth v. Levine, pharmaceutical companies cannot be sued for a failure to warn where there is “clear evidence” that the FDA considered a proposed warning but rejected it for inadequate data.

The resolution of this question could have broad implications for the medical device and pharmaceutical industries, which necessarily rely upon FDA approvals of product warnings and labels.  As it stands, lower courts are sharply divided over the meaning of Wyeth’s reference to “clear evidence”.

The Supreme Court granted certiori today, the end of the term.  The case is likely to be argued later this year and a decision is expected the first quarter of 2019.  Cozen O’Connor is closely monitoring this appeal and will provide updates as it proceeds.

The case is Merck Sharp & Dohme Corp. v. Doris Albrecht et al., case number 17-290, before the Supreme Court of the United States.