A federal appeals court on Oct. 9 reopened a narrow part of a Massachusetts wrongful-death lawsuit against Amgen over its migraine drug Aimovig. Elissa E. Warner may amend her complaint to argue that the company could have strengthened the drug's warning after federal approval, the First Circuit ruled.
The court upheld dismissal of Warner's original challenge to the label the Food and Drug Administration first approved. The part of the case allowed to continue concerns four scientific articles that she argues gave Amgen grounds to change the warning before her son received the drug.
Lucas Joseph Warner was 23 when he took one dose of Aimovig on June 17, 2018, according to the opinion. Less than 48 hours later he suffered seizures and was placed in a coma. He died Nov. 17, 2020, at 25. His mother sued Amgen Inc. and Amgen USA Inc. on behalf of his estate.
Warner alleges the label failed to disclose that clinical trials excluded people with a history of seizures or neurological disorders. Her son had both, according to the opinion. At this stage, the appeals court treated the facts alleged in Warner's complaint as true to decide whether her case could proceed. It did not determine whether Aimovig caused his injuries.
Federal law generally requires FDA permission before a drugmaker changes an approved label. An exception permits some stronger warnings based on newly acquired information. That exception matters because federal law can otherwise block a state lawsuit demanding a different warning.
U.S. Circuit Judge William J. Kayatta Jr., writing for the panel, said Amgen had not conclusively shown that four articles Warner cited could not qualify. The articles concern CGRP, a signaling molecule whose activity Aimovig inhibits, and its possible protective effects during brain injury.
The revived claim is limited to whether those articles permitted a warning that Aimovig could reduce CGRP's protective effects in the brain after an injury. U.S. District Judge Julia E. Kobick had dismissed the original complaint in February 2025 and refused to allow an amendment. The case returns to the district court; its other rulings remain in place.
Amgen can still argue that the FDA would have rejected the proposed warning. The company did not rely on that defense at this stage, the appeals court said.