Products Liability Law Daily Wrap Up, PREEMPTION—DRUGS—D. Mass.: Amgen migraine medicine wrongful death suit dismissed due to preemption, (Feb 21, 2025)

By Donielle Tigay Stutland, J.D.

Wrongful death claim is preempted by the FDCA, because it would have been impossible for Amgen to comply with federal regulations governing prescription drug labeling and any state-law duty to provide warnings beyond those already included in Aimovig’s label.

A federal district court in Massachusetts dismissed a wrongful death suit brought by the estate of a young man who passed away alleging that Amgen Inc. and Amgen USA Inc. failed to provide adequate warnings on its injectable migraine medicine Aimovig. The court dismissed the suit, finding that the estate’s claims were preempted to the extent they alleged that Amgen had a state-law duty to submit a stronger warning label to the FDA in its pre-approval review of Aimovig. The estate argued that Amgen’s warnings should have included that individuals with a history of seizures and cerebrovascular disease or surgery were excluded from the clinical testing done to obtain FDA approval. The estate asserted that its claims were not preempted by the Food, Drug, and Cosmetic Act (FDCA), because the drug maker could have included such a warning pre-approval in its new drug application or defendant could have changed the warning post-approval under the Changes Being Effected (CBE) regulations. The court disagreed and found the pre- and post-approval failure to warn claims were preempted (Warner v. Amgen Inc., No. 1:24-cv-10632-JEK (D. Mass. Feb. 13, 2025)).

Background. Aimovig, which is marketed by Amgen, is an injectable drug approved for the preventive treatment of migraine headaches in adults. The FDA approved Aimovig on May 17, 2018. Certain individuals, including those who had been diagnosed with a seizure disorder or cerebrovascular disease, were excluded from Aimovig’s clinical trials based on their medical histories and conditions.

The patient was diagnosed with an arteriovenous malformation following an unrelenting headache. In June 2018, a physician, who was unaware that individuals with a history of seizures or cerebrovascular disease or surgery had been excluded from Aimovig’s clinical trials, prescribed the patient Aimovig. On June 17, 2018—exactly one month after Aimovig received FDA approval—the patient took his first and only injection of Aimovig. Two days later, the patient suffered a seizure and was found near death by a friend. After performing multiple tests to ascertain the cause of his ailment, doctors concluded that Aimovig had crossed the patient’s blood-brain barrier and caused the seizures. The patient passed away on November 17, 2020 and his death was attributed to complications from Aimovig.

The estate filed a lawsuit asserting a single failure-to-warn wrongful death claim under Massachusetts law.

Preemption. The court began its analysis by noting that it did not even need to look at whether or not Massachusetts law requires such warnings, as the estate’s wrongful death claim was preempted by the FDCA under Supreme Court and First Circuit precedent. Wrote the court, “Insofar as [the estate] seeks to hold Amgen liable for failing to propose a stronger warning label to the FDA before Aimovig’s approval, [the] claim is preempted because the FDA considered the exclusion criteria used in Aimovig’s clinical trials and the theoretical risks associated with CGRP antagonism. To the extent [the estate] seeks to hold Amgen liable for failing to strengthen its warning label after obtaining FDA approval, [the] claim is also preempted because there is no reasonable basis to find that Amgen possessed newly acquired information of a causal association between Aimovig and an adverse event or risk, such that it could have unilaterally strengthened the label warnings via the CBE regulation in the month after the drug’s approval.”

The estate’s first argument was that Amgen was liable for failing to submit, before Aimovig’s approval, a warning label that listed all of the patient populations excluded from Aimovig’s clinical trials. The court stressed that it was undisputed that, during the FDA’s pre-approval review of Aimovig, the FDA knew that individuals who had ever been diagnosed with a seizure disorder or cerebrovascular disease were excluded from Aimovig’s clinical trials. And it is further undisputed that, despite having this knowledge, the FDA approved a label that did not warn consumers that people who had experienced seizures or cerebrovascular disease during their lifetimes were excluded from Aimovig’s clinical trials. The court pointed out that caselaw “forecloses” this argument. In Celexa, the First Circuit held that the FDA is “the exclusive judge of safety and efficacy based on information available at the commencement of marketing, while allowing the states to reach contrary conclusions when new information not considered by the FDA develops.” The courts have interpreted this as, “when the FDA has considered the safety and efficacy information required by state law in the course of approving a prescription drug’s label, there exists clear evidence that the FDA would not have approved the warning required by state law.” The court concluded that the estate’s claim based on the pre-approval theory was preempted because the FDA was fully aware of the exclusion criteria used in Aimovig’s clinical trials before it approved the Aimovig label in May 2018.

The estate’s second argument was that after Aimovig’s approval, Amgen had a duty under Massachusetts law to strengthen the drug’s label with a warning that people with a history of seizure disorders or cerebrovascular disease were excluded from the clinical trials. The estate alleged a post-approval failure to warn claim that Amgen could have strengthened the label warnings through the CBE process. The estate also asked to amend the complaint to make further allegations that Amgen was liable for failing to warn, post-approval, that Aimovig poses “cerebral risks.” While the estate offered “articles” as evidence, the court found that none of the estate’s evidence plausibly showed any “causal association” between Aimovig and a “contraindication, warning, precaution, or adverse reaction” that “satisfies the standard for inclusion in [Aimovig’s] labeling.” Additionally, the court noted that “the articles do not plausibly constitute newly acquired information, because they do not contain information that was unknown to the FDA when it approved Aimovig.” The court concluded that the articles offered by the estate to show newly acquired information did not show a causal association between Aimovig and an adverse event or risk. As such, the court concluded that Amgen could not have used the CBE regulation to unilaterally modify the Aimovig label between May 17, 2018, when it received FDA approval, and June 17, 2018, when the patient received his injection. The court concluded that the estate’s post-approval claim against Amgen, like the pre-approval claim, was preempted and dismissed the suit.

The case is No. 1:24-cv-10632-JEK.

Judge: Kobick, J.

Attorneys: Abbye R. K. Ognibene (Hagens Berman Sobol Shapiro LLP) for Elissa M. Warner. Lauren S. Colton (Hogan Lovells US LLP) for Amgen Inc.

Companies: Amgen Inc.

Cases: CourtDecisions PreemptionNews DrugsNews WarningsNews MassachusettsNews