On September 20, 2018, WLF filed a brief with the U.S. Supreme Court urging it to decide that federal law preempts a plaintiff’s state-law failure-to-warn claim in cases where it can be shown that the Food and Drug Administration (FDA) rejected the drug manufacturer’s request to alter its label to include the very warning needed to avoid liability. The case arises from a multi-district litigation (MDL) combining lawsuits by more than 1,200 users of Fosamax, an FDA-approved prescription drug for treating osteoporosis in older women. Merck, the manufacturer of Fosamax, successfully argued in the MDL that the plaintiffs’ claims were preempted, as the only way it could avoid liability under state law was to violate federal law by misbranding Fosamax with an FDA-rejected label. But on appeal, the Third Circuit disagreed. WLF’s brief contends that by focusing on what the FDA might have done rather than on what the FDA did, the appeals court’s decision would render the Supremacy Clause a dead letter. WLF’s brief also argues against the so-called presumption against preemption.

Documents:

WLF Amicus Brief