The plaintiffs in this case are hundreds of women who experienced severe femoral fractures attributable to the drug Fosamax. When they sued the manufacturer, Merck, for failure to warn that the drug posed a risk of causing this injury, Merck moved to dismiss the cases on the ground of preemption. Merck argues that the Food and Drug Administration would not permit it to provide a warning prior to 2010 and, therefore, that compliance with any state law duty to warn would have been impossible.
In Wyeth v. Levine (2009), the Supreme Court held that, absent clear evidence that the FDA would not have approved a change to a drug’s label, the manufacturer could not prevail on its defense that compliance with both federal and state requirements was impossible. In the Fosamax litigation, Merck argues both that the Wyeth standard is met and, in addition, that 2007 amendments to the Food, Drug, and Cosmetic Act should alter the standard to make it more favorable to manufacturers. Public Citizen filed an amicus brief in the Supreme Court explaining that the standard set forth in Wyeth applies in this case and continues to reflect both the legal and practical reality of prescription drug regulation by the FDA.
In a decision issued on May 20, 2019, the Supreme Court held that the question whether the FDA would have not have approved a labeling change is for a judge, not a jury, to decide. Although in a separate opinion three justices expressed agreement with Merck’s argument that the 2007 amendments altered the standard for assessing preemption, the six justices who joined the majority opinion did not adopt it.
See the complete Supreme Court docket for this case here.