Warner v. Amgen Inc.
1:24-cv-10632
| D. Mass. | Feb 13, 2025Background
- Plaintiff, Elissa Warner, as personal representative of Lucas Warner’s estate, filed a wrongful death claim against Amgen Inc., related to the use of Amgen’s migraine drug Aimovig.
- Lucas Warner, with a history of arteriovenous malformation, suffered a fatal seizure after taking Aimovig, which had been prescribed shortly after FDA approval in May 2018.
- Plaintiff alleges Aimovig’s labeling was inadequate, failing to warn that individuals with seizure or cerebrovascular history were excluded from clinical trials and to disclose relevant risks.
- Amgen sought dismissal, arguing the claim was preempted by the Federal Food, Drug, and Cosmetic Act (FDCA) since FDA regulations controlled labeling, and no new information post-approval allowed unilateral label changes.
- The court reviewed the adequacy of warnings, the timing of possible label changes under FDA’s “changes being effected” (CBE) regulation, and whether state law claims could survive federal preemption.
- On February 13, 2025, the court granted Amgen’s motion to dismiss, finding Warner’s claim preempted by federal law and denying leave to amend.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption of pre-approval label claim | Amgen should have warned pre-approval about trial exclusions and risks | FDA fully considered exclusion/risk before approval; label change impossible | Claim preempted—FDA was aware of and considered exclusion criteria/risk before approving label |
| Preemption of post-approval label claim | Newly acquired information permitted label strengthening via CBE regulation | No newly acquired information or plausible causal link allowing label change | Claim preempted—no plausible new information to trigger CBE; label change not permitted by law |
| Adequacy of proposed amendment | Articles submitted support newly acquired information of risk | Articles do not show causal association or new risk beyond FDA’s prior review | Amendment futile—articles did not meet standard for newly acquired info or necessitate new warning |
| Massachusetts law duty to warn and learned intermediary doctrine | Amgen owed a duty to warn per state law | FDA regime preempts any such state duty, plus learned intermediary doctrine | Did not reach state law/learned intermediary issues since claim dismissed on preemption grounds |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (FDA’s approval of drug labeling does not automatically preempt state law claims unless compliance is impossible)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (impossibility preemption applies where manufacturer cannot independently comply with state and federal label requirements)
- Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019) (clear evidence standard for FDA’s would-not-have-approved determination in preemption context)
- Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (2013) (state law failure-to-warn claims preempted where compliance with both state and federal law is impossible)
- In re Celexa and Lexapro Mktg. & Sales Pracs. Litig., 779 F.3d 34 (1st Cir. 2015) (states cannot impose warnings based on info considered by FDA at time of approval)
- In re Zofran (Ondansetron) Prods. Liab. Litig., 57 F.4th 327 (1st Cir. 2023) (FDA aims to prevent overwarning and considered relevant evidence at label approval)