The United States Court of Appeals for the Third Circuit stated in its precedential Opinion filed on September 20, 2024, “Drug manufacturers have the primary responsibility to ensure that the labels on their products comply with federal and state law. In this case, hundreds of Plaintiffs accuse drug manufacturer Merck Sharp & Dohme (“Merck” or the
“Company”) of failing to comply with drug labeling requirements under state law. According to the Plaintiffs, they
were injured by the drug Fosamax and would not have taken it had they been properly warned. The District Court concluded at the summary judgment stage that the Plaintiffs’ state law claims are preempted because Merck in fact proposed a label change that would have addressed the risk with Fosamax that the Plaintiffs complain of, but the Food and Drug Administration (the “FDA” or the “Agency”) rejected the proposed change as lacking sufficient scientific support.”
Presumption Against Pre-emption
“With real respect for the thorough and thoughtful work the District Court did in this complex case, we nonetheless
conclude that it erred in its pre-emption analysis by giving too little weight to the required presumption against pre-emption. Applying that presumption, and considering the record here, we conclude that Plaintiffs’ state law claims are not preempted. Accordingly, we will vacate the District Court’s judgment for Merck and remand for further proceedings.”
While the federal appellate court held “the District Court did not err in finding that Merck fully informed the FDA of the
justifications for adding to the Fosamax label a warning about atypical femoral fractures,” the federal appellate court further stated, “Undertaking our own review of the Complete Response Letter in the context of the pre-emption question presented here, we conclude that the District Court erred by placing too much weight on informal FDA communications and the Agency’s amicus brief to decide that the Letter preempted the Plaintiffs’ state law claims. We acknowledge that this is a close case, but, in a close case, the strong presumption that the Supreme Court has established will likely be determinative. The “difficult” and “demanding” clear-evidence standard is one that “a drug manufacturer will not ordinarily be able to show[.]” Albrecht, 587 U.S. at 313, 315. Congress’s intent to preserve state law claims in the drug labeling context would be undermined, and the presumption against pre-emption that exists in that context would have diminished effect, if the kinds of informal communications the District Court relied on here could readily serve as the determinative evidence in answering the pre-emption question.”
“We are not unsympathetic to the pressures Merck faced from the competing demands of a possible state law requirement and FDA action, but there is no escaping the consequences of Albrecht. The Supreme Court has established a very high bar to show impossibility pre-emption in drug labeling cases. It is Merck’s burden to show that “federal law (including appropriate FDA actions) prohibited the drug manufacturer from adding any and all warnings to the drug label that would satisfy state law.” Albrecht, 587 U.S. at 313-14 (emphasis added). And because “federal law – the FDA’s CBE regulation – permits drug manufacturers to change a label … without prior approval from the FDA[,]” “a drug manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law such that it was impossible to comply with both.” 26 Id. at 314-15. Merck must show that the “federal and state laws irreconcilably conflict.” Id. at 315 (internal quotation marks omitted) (emphasis added). In short, we are bound to consider the “presumption against pre-emption” when analyzing the particular Complete Response Letter in this case. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449 (2005). We actually “have a duty to accept the reading that disfavors pre-emption.””
“To support the conclusion that there was pre-emption, the FDA, acting with the force of law, must have clearly rejected Merck’s label in a manner that made it evident that no label about atypical femoral fractures would have been appropriate at the time of Merck’s Prior Approval Supplement. That did not happen here. For that reason, Merck has not shown that the FDA would have rejected any and all labels that would have satisfied state law. In addition, the availability of a label change via a CBE supplement is problematic for Merck, as will very often be the case for pharmaceutical companies raising an impossibility defense. The bar set by Albrecht is high indeed. Therefore, Merck has not shown that federal and state law irreconcilably conflict.”
Source In re: FOSAMAX (ALENDRONATE SODIUM) PRODUCTS LIABILITY LITIGATION, No. 22-3412.
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