In cases stretching back to 2008, Merck has argued that Federal Preemption takes out State Law claims, but the U.S. Third Circuit has most recently disagreed. Initially, a District Court granted summary judgment in favor of Merck. The U.S. Third Circuit then overturned that ruling in 2017, concluding that the issue should have been decided by a jury. However, in 2019, the U.S. Supreme Court held that it was a legal issue to be decided by the judge. In 2022, the Third Circuit sided with Merck. But the Court now reverses that decision:

With respect to Prong 1, 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 Prong 2, the Court found that Merck has not shown that the FDA would have rejected any and all warnings that satisfied State Law.

The outcome of the case largely depends on the interpretation of the Complete Response Letter the FDA issued to deny Merck’s Prior Approval Supplement, in which the Agency stated as follows: “While the Division agrees that atypical and subtrochanteric fractures should be added to the ADVERSE REACTIONS, Post-Marketing Experience subsections of the Fosamax labels, your justification for the proposed PRECAUTIONS section language is inadequate. Identification of ‘stress fractures’ may not be clearly related to the atypical subtrochanteric fractures that have been reported in the literature. Discussion of the risk factors for stress fractures is not warranted and is not adequately supported by the available literature and post-marketing adverse event reporting.”

“At oral argument, the Plaintiffs conceded that complete responses letters may have preemptive effect, but they contend that the Letter in this case did not have such effect because it invited further action and because other FDA communications confirm its provisional nature. Merck, at oral argument, conceded that not every complete response letter has preemptive effect, but it argues that the Letter in this case did. Thus, on appeal, the parties are in accord that the particular language of a complete response letter governs its preemptive effect. We too agree….

“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.  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….

The undisputed facts indicate that, when the FDA issued the Complete Response Letter in May of 2009, it had not yet determined whether a change to the Precautions section of the label was warranted. It was not until the Task Force report issued in September 2010 that the FDA decided 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. So, while §355(o)(4)(A) is relevant to the pre-emption analysis when the FDA has fully considered the information submitted by a drug manufacturer, it does not change our analysis in this case because the FDA was in the process of deciding whether a change to the Precautions section of the label was needed at the time it issued the Complete Response Letter. Whether it seems fair or not, the FDA can take its time, but Merck is responsible for the content of its label at all times. Practical considerations are a factor in laying that continuing responsibility on the drug manufacturer. The FDA has limited resources to monitor the drugs on the market, and manufacturers have superior access to information about their drugs, especially as new risks emerge. State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. In short, failure-to-warn actions, like this case, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times. Thus, since the FDA had not formalized a decision on whether to include atypical femoral fracture language in the Precautions section of Fosamax’s label, it is not dispositive that the Agency did not invoke its power under §355(o)(4)(A) to require manufacturers to change its label.”

 

In re Fosamax, No.22-3412, 2024 WL 4247311 (3rd Cir. Sept. 20, 2024).