In re Fosamax (alendronate sodium) Products Liability Litigation

Overview

(U.S. Court of Appeals for the 3rd Circuit, September 20, 2024): The U.S. Court of Appeals for the Third Circuit found that the federal Food, Drug, and Cosmetic Act (FDCA) that gives the Food and Drug Administration (FDA) power to regulate the labeling of drugs does not preempt failure-to-warn claims made under state law. Nationally more than 3,000 cases have been filed against Merck, the manufacturer of Fosamax, an osteoporosis drug. Plaintiffs allege that Merck was aware that the drug created a risk of thigh bone fractures but failed to warn about that risk. Merck claimed that the warnings on the drug were approved by the FDA, that the company sought but was denied approval for relevant changes to the FDA-approved warnings, and that this federal process preempts any failure-to-warn claims based on state law. The parties have litigated this issue for more than 10 years, with several court decisions and reversals over that time. Although Fosamax now carries the thigh bone fracture warning, as a result of the Court’s decision, those injured prior to the warnings are able to proceed to trial on their state law claims. Read the full Opinion here.

View all cases in the Judicial Trends in Public Health – November 18, 2024.

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