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When Congress enacted the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.S. § 301 et seq., it charged the Food and Drug Administration (FDA) with ensuring that prescription drugs are safe for use under the conditions prescribed, recommended, or suggested in the drug’s labeling. 21 U.S.C.S. § 355(d). When the FDA exercises this authority, it makes careful judgments about what warnings should appear on a drug’s label for the safety of consumers. The U.S. Supreme Court has held that “clear evidence” that the FDA would not have approved a change to the drug’s label preempts a claim, grounded in state law, that a drug manufacturer failed to warn consumers of the change-related risks associated with using the drug. This question of preemption is one for a judge to decide, not a jury. “Clear evidence” is evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.
Petitioner Merck Sharp & Dohme Corp. manufactures Fosamax, a drug that treats and prevents osteoporosis in postmenopausal women. However, the mechanism through which Fosamax treats and prevents osteoporosis may increase the risk that patients will suffer “atypical femoral fractures,” that is, a rare type of complete, low-energy fracture that affects the thigh bone. When the Food and Drug Administration first approved of the manufacture and sale of Fosamax in 1995, the Fosamax label did not warn of the then-speculative risk of atypical femoral fractures associated with the drug. But stronger evidence connecting Fosamax to atypical femoral fractures developed after 1995. And the FDA ultimately ordered Merck to add a warning about atypical femoral fractures to the Fosamax label in 2011. Respondents are more than 500 individuals who took Fosamax and suffered atypical femoral fractures between 1999 and 2010. Respondents sued Merck seeking tort damages on the ground that state law imposed upon Merck a legal duty to warn respondents and their doctors about the risk of atypical femoral fractures associated with using Fosamax. Merck, in defense, argued that respondents' state-law failure-to-warn claims should be dismissed as preempted by federal law. Merck conceded that the FDA regulations would have permitted Merck to try to change the label to add a warning before 2010, but Merck asserted that the FDA would have rejected that attempt. In particular, Merck claimed that the FDA's rejection of Merck's 2008 attempt to warn of a risk of “stress fractures” showed that the FDA would also have rejected any attempt by Merck to warn of the risk of atypical femoral fractures associated with the drug. The District Court agreed with Merck's preemption argument and granted summary judgment to Merck, but the Third Circuit vacated and remanded. The Court of Appeals recognized that its pre-emption analysis was controlled by this Court's decision in Wyeth v. Levine, which held that a state-law failure-to-warn claim is preempted where there is “clear evidence” that the FDA would not have approved a change to the label. The Court of Appeals, however, suggested that the “clear evidence” standard had led to varying lower court applications and that it would be helpful for this Court to “clarif[y] or buil[d] out the doctrine.”
Were failure to warn claims preempted by the FDA when there was no clear evidence that the FDA would not have approved the warning state law required?
The court held that the consumers' failure to warn claims were preempted by the FDA only when there was clear evidence that the FDA would not have approved the warning state law required. A judge, not the jury, had to decide the preemption question. Clear evidence of federal impossibility preemption required showing that the manufacturer fully informed the FDA of the justifications for the state law warning and that the FDA informed the manufacturer that the FDA would not approve a change to the drug's label to include that warning.