Fosamax Cases Allowed to Proceed: Herman Examines U.S. Third Circuit’s Rejection of Merck’s Preemption Claims

Special counsel Steve Herman recently published an article examining the Third Circuit’s reversal of its decision In re Fosamax. Continue reading below or click here to read on JD Supra.

In 2022, over 500 plaintiffs filed a case alleging that Merck Sharp & Dohme Corp., a drug manufacturing company, failed to provide adequate warnings that one of their drugs increased the risk of atypical femoral fractures.[i] The drug in question is Fosamax, an alendronic acid commonly used to treat or prevent postmenopausal or steroid-induced osteoporosis. The plaintiffs argue that, had they been properly informed of this risk, they would not have taken the medication. Merck maintains that it proposed a label change to the Food and Drug Administration (FDA) to address this risk, but that the FDA rejected the proposed change due to insufficient scientific support.

Procedural History

In cases stretching back to 2008, Merck has argued that Federal Preemption eliminates State Law product liability claims, but—most recently—the U.S. Third Circuit Court of Appeals has disagreed. Initially, the United States District Court for the District of New Jersey granted summary judgment in favor of Merck. On appeal in 2017, the Third Circuit overturned that ruling, concluding that the issue should have been decided by a jury. However, the U.S. Supreme Court held in 2019 that this was a legal issue to be decided by the judge.

The Supreme Court’s 2019 analysis[ii] was far narrower than any preemption argument proposed by drug manufacturers and much stricter than the clear evidence tests used by many lower courts prior. In this decision, a two-pronged test was established, requiring courts to determine whether it would be impossible for the drug manufacturer to satisfy state tort law requirements while also complying with the directives of the FDA. First, the manufacturer is required to show that they “fully informed” the FDA by providing both all “material” safety information and an “evaluation or analysis concerning the specific dangers” raised by the plaintiff. Second, the branded drug manufacturer must show that the FDA took action, “carrying the force of law,” to disapprove the warning that the plaintiff contends should have been provided.

In 2022, the Third Circuit sided with Merck; however, the Court has since reversed that decision.

Reasoning

With respect to the first prong, the Court of Appeals found that the District Court did not err in concluding that Merck fully informed the FDA about the risks of atypical femoral fractures. However, on the second prong, the Third Circuit found that Merck had not shown that the FDA would have rejected any and all warnings that would have satisfied state law.

The outcome of the case largely depends on the interpretation of a Complete Response Letter the FDA issued to deny Merck’s Prior Approval Supplement, in which the Agency states that while they agree that atypical and subtrochanteric fractures should be added to Fosamax warning labels, Merck’s “justifications for the proposed PRECAUTIONS section language is inadequate.” Specifically, they determined Merck’s mention of stress fractures to be unwarranted as there is no clear evidence from literature and post-marketing adverse event reporting linking them to the Fosamax-related fractures – atypical subtrochanteric fractures.

Plaintiffs conceded at oral argument that while complete response letters may have a preemptive effect, the Letter in this case “did not have such effects because it invited further action and because other FDA communications confirm its provisional nature.” Merck also conceded that not all complete response letters have preemptive effects but argued that—in this case—the Letter did. The Appeals Court found that they, as well as both parties, were all “in accord that the particular language of a complete response letter governs its preemptive effect.”

In their review of the question of preemption determined by the Complete Response Letter, the Third Circuit found that the FDA’s amicus brief and informal communications were given too much importance by the District Court in their decision that the Letter preempted state law claims by the Plaintiffs. The Court continued that because this is a close case, “the strong presumption that the Supreme Court has established will likely be determinative.” Additionally, if the kinds of informal communications the District Court relied on are accepted as determinative evidence in questions of preemption, then “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.”

The facts of the case, according to the Third Circuit, indicate that the FDA had not yet determined whether a warning about atypical femoral fractures should be added to the label of Fosamax when it issued its Complete Response Letter to Merck in May 2009. It was not until the Task Force report in September of 2010 that the FDA felt it had “enough information to use its authority under §355(o)(4)(A) to require Merck and other bisphosphonate manufacturers to include a warning about atypical femoral fractures in the Precautions section of the label.” Despite this, it was emphasized that Merck, not the FDA, was responsible for the content of the drug label at all times, due to the FDA’s limited resources.  The Court further highlighted that “state tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly,” reinforcing the idea that manufacturers should act swiftly to protect consumers.

Since the FDA had not yet made a formal decision about including the proposed warning, the Court found that Merck did not meet the demanding standard of showing that federal law prohibited it from adding any and all warnings that could satisfy state law. Thus, Merck could still be held responsible for not adding the warning sooner. The Third Circuit unanimously vacated the District Court’s judgment and remanded the case for further proceedings.

Conclusion

The Third Circuit Court’s decision underscores the evolving complexities at the intersection of federal regulatory authority, state tort law, and pharmaceutical litigation. By reaffirming the high standard required to establish federal preemption and emphasizing the limited weight of informal regulatory communications, the Third Circuit has reinforced the importance of state law protections in drug labeling cases.

This case serves as a reference for both plaintiffs and defendants, highlighting the evidentiary and strategic challenges inherent in asserting and overcoming preemption defenses. For legal practitioners, it reinforces the necessity of a meticulous approach to regulatory analysis and evidentiary presentation in failure-to-warn litigation, while simultaneously affirming the judiciary’s critical role in safeguarding to the presumption for preserving a tort victim’s state law claims.

Steve Herman is special counsel in Fishman Haygood’s Litigation Section and represents both plaintiffs and defendants in commercial, class action, and professional liability cases. Steve teaches class actions at both Tulane and Loyola Law Schools and is often asked to provide expert testimony in such matters.

[i] In re Fosamax, 118 F.4th 322 (3d Cir. 2024).

[ii] Merck v. Albrecht (In re Fosamax), 587 U.S. 299, 139 S.Ct. 1668, 203 L.Ed.2d 822 (2029).