Background
Elissa Warner sued Amgen over the death of her son, Lucas Warner, after he received one dose of Aimovig, a migraine-prevention biologic. Lucas had a history of seizures, arteriovenous malformation, cerebrovascular disease, and related procedures. Warner alleged that Aimovig caused seizures and severe brain injury that contributed to his death.
Her original state-law failure-to-warn theory alleged that Amgen should have proposed, during FDA approval, a label disclosing that clinical trials excluded people with histories of seizures or cerebrovascular disease or surgery. After Amgen moved to dismiss on federal-preemption grounds, Warner sought leave to amend based on articles that she contended gave Amgen newly acquired information permitting a post-approval label change through the Changes Being Effected procedure.
The Court’s Holding
The First Circuit affirmed dismissal of the original complaint. A manufacturer’s ability to ask the FDA to approve a different initial label does not constitute the unilateral authority necessary to defeat impossibility preemption. Independently, the FDA had considered the relevant trial exclusions and theoretical cerebrovascular risks, rejected proposed risk language, and approved a label without the warning Warner claimed state law required.
The court reversed the denial of leave to amend in a limited respect. At the pleading stage, Amgen had not conclusively shown that four articles—the Rehni, Liu, Sorby-Adams, and Zhai articles—could not constitute newly acquired information supporting a CBE label change concerning CGRP’s potentially protective cerebral mechanisms during brain injury. The court remanded for further proceedings on that limited post-approval theory.
Key Takeaways
- A claim that a manufacturer should have proposed a different FDA-approved label is preempted when the manufacturer lacked unilateral authority to impose that label.
- FDA approval can show that the agency would have rejected a proposed warning when it considered and declined materially similar risk language.
- Preemption did not conclusively bar Warner’s narrow CBE theory based on potentially new information about cerebral risks associated with CGRP inhibition.
Why It Matters
The decision distinguishes pre-approval labeling theories, which depend on FDA permission, from post-approval CBE theories, under which a manufacturer may in some circumstances strengthen a warning without prior FDA approval. It also underscores the demanding standard for disposing of a proposed amended complaint based on an affirmative preemption defense at the pleading stage.