28 F. Supp. 3d 164
W.D.N.Y.2014Background
- Amos, widow of Andrea Amos, administers her estate in a wrongful‑death action against Biogen Idec and Elan over Tysabri.
- Amos allegedly died from a fatal brain infection (PML) linked to Tysabri use.
- Amos took Tysabri from Sept 2006 to mid‑2011; diagnosed with PML August 2011; death Sept 20, 2011.
- Plaintiff asserts nine causes of action including negligence, strict liability, design defect, failure to warn, negligent misrepresentation, fraud, breach of implied warranty, NY GBL §349, and wrongful death.
- Defendants move to dismiss five claims (design defect, strict liability–failure to warn, negligent misrepresentation, fraud, NY GBL §349); court grants some with prejudice and others without prejudice.
- Court dismissed design defect and NY GBL §349 with prejudice; dismissed fraud without prejudice; denied dismissal of strict liability for failure to warn and negligent misrepresentation.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Design defect preemption feasibility | Amos’s design defect claims are not preempted. | Mutual preemption bars state design‑defect claims for FDA‑approved drugs. | Design defect claims dismissed with prejudice; preempted. |
| Strict liability failure to warn viability | Failure to warn supports strict liability. | Warning claims insufficiently pled as strict liability. | Court denies dismissal of strict‑liability failure‑to‑warn claim. |
| Negligent misrepresentation pleading | Special relationship supports misrepresentation claim; adequately plead. | Rule 9(b) applies; insufficient particularity. | Negligent misrepresentation claim sustained; Rule 9(b) not applied here. |
| Fraud specificity under Rule 9(b) | Claims detail misrepresentations and concealment. | Lack of particularity; information‑and‑belief pleadings insufficient. | Fraud claim dismissed without prejudice for lack of particularity. |
| NY General Business Law §349 consumer‑oriented | Deceptive practices directed at consumers due to drug warnings. | Duty runs to prescribers; warnings not consumer‑directed. | Section 349 claim dismissed; not consumer‑oriented; may proceed on warnings to doctors. |
Key Cases Cited
- Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013) (preemption of state design‑defect claims for FDA‑approved drugs)
- Lindsay v. Ortho Pharm. Corp., 637 F.2d 87 (2d Cir. 1980) (duty to warn extends to doctor, not patient (inform intermediary))
- Bee v. Novartis Pharm. Corp., 18 F. Supp. 3d 268 (E.D.N.Y. 2014) (manufacturer duty to warn patients via doctor; informed intermediary doctrine)
- Rezulin Prods. Liab. Litig., 133 F. Supp. 2d 272 (S.D.N.Y. 2001) (Rule 9(b) applicability to negligent misrepresentation not per se)
- Oswego Laborers’ Local 214 Pension Fund v. Marine Midland Bank N.A., 85 N.Y.2d 20 (1995) (Section 349 consumer‑oriented requirement; drug warnings to doctors)