Cases & Deals

Organon defeats failure-to-warn claims in Fosamax® litigation

Clients Organon & Co.

Organon & Co., represented by Jones Day, recently prevailed against hundreds of plaintiffs claiming that Merck, Sharp & Dohme Corp. (Organon's predecessor in interest) failed to warn them about the risk of developing so-called "atypical femoral fractures" when using Fosamax® to prevent and treat osteoporosis. The district court initially held that these claims were preempted. Under Wyeth v. Levine, 555 U.S. 555 (2009), failure-to-warn claims are preempted if there is "clear evidence" that the FDA would have rejected the requested warning, and here Merck did try to warn patients about atypical femoral fractures, but the FDA said no. On appeal, however, the Third Circuit held that whether there is clear evidence must be determined by a jury, not a judge, with proof by clear and convincing evidence.

Jones Day represented Merck in successfully seeking the Supreme Court's review of the Third Circuit's decision. In Merck, Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019), it held that the judge, not the jury, should assess whether the FDA would have approved a change, and should do so under ordinary evidentiary standards. It remanded for the lower courts to consider its clarification of Wyeth in the first instance. In a painstaking 87-page opinion, the district court agreed with Merck that plaintiffs' claims were preempted: contrary to the plaintiffs' contentions, Merck had fully informed the FDA of the justification for its proposed warning, and the FDA had made clear it would approve no such warning. The court therefore granted summary judgment on those claims, by far the most important ones in the decade-old litigation.

In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., __ F. Supp. 3d __, 2022 WL 855853 (D.N.J. Mar. 23, 2022)