249 F. Supp. 3d 690
W.D.N.Y.2017Background
- Andrea Amos (decedent) had aggressive relapsing MS and was treated with Tysabri (natalizumab) from Sept. 2006 until May–June 2011; she developed PML in July 2011 and died in Sept. 2011.
- Tysabri was initially approved in 2004; after reports of PML in 2005 it was withdrawn and relabeled with an FDA-required black box warning when reapproved in 2006 and subject to the TOUCH restricted-prescribing program.
- Early on, the relationship between JC virus antibody status, prior immunosuppressant use, treatment duration, and PML risk was uncertain; FDA rejected Biogen’s 2010 proposals to add JCV-antibody–based guidance until further validation; label changes addressing JCV antibody testing were approved in 2012.
- Plaintiff (decedent’s widower and estate administrator) sued Biogen and Elan for wrongful death, alleging Tysabri caused PML and that warnings failed to disclose risk factors (JC virus antibody status, duration, prior immunosuppressants).
- Defendants moved for summary judgment arguing (1) warnings were adequate as a matter of law, (2) plaintiff lacked competent evidence on inadequacy/proximate cause, and (3) state-law claims were preempted because FDA would have rejected earlier label changes; the court granted summary judgment for defendants.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Adequacy of warnings | Warnings were inadequate for failing to disclose JCV-antibody correlation and specific risk factors (duration, prior immunosuppressants) | Label (including FDA black box) adequately and clearly warned of increased PML risk; details were scientifically uncertain in relevant period | Warnings were adequate as a matter of law |
| Scope of related claims (negligence, strict liability, negligent misrepresentation, breach of warranty) | Those claims can proceed independently of failure-to-warn theory | Under NY law, adequacy of warnings controls related product-liability and misrepresentation claims; learned intermediary rule bars direct-to-patient misrepresentation reliance | All related claims fail if warning adequate; negligent misrepresentation also barred by learned intermediary rule |
| Federal preemption | State-law labeling-based claims are permissible | Claims are conflict-preempted: defendants either could not unilaterally change FDA-approved labeling or FDA would have rejected the proposed earlier changes | Claims preempted: FDA had rejected Biogen proposals in 2010; evidence shows FDA would not have approved earlier label changes |
| Liability of distributor Elan | Elan should be liable for failure to warn | Elan (non-NDA holder/distributor) lacked authority to change FDA labeling; state law cannot impose such duty | Claims against Elan preempted; distributor cannot lawfully change NDA labeling |
Key Cases Cited
- Tolan v. Cotton, 134 S. Ct. 1861 (court must view facts in light most favorable to nonmoving party)
- Scott v. Harris, 550 U.S. 372 (granting summary judgment when no reasonable jury could find for nonmovant)
- Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574 (summary judgment standard and plaintiff burden)
- Martin v. Hacker, 83 N.Y.2d 1 (learned intermediary rule for prescription drugs)
- Wyeth v. Levine, 555 U.S. 555 (demanding standard for impossibility preemption in drug-labeling cases)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (preemption where manufacturer cannot unilaterally change labeling)
- Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (state-law design-defect claims preempted when compliance with both laws is impossible)
- McDowell v. Eli Lilly & Co., 58 F. Supp. 3d 391 (N.D. NY discussion that adequacy of warnings precludes related claims)
- Alston v. Caraco Pharm., Inc., 670 F. Supp. 2d 279 (prescription warning adequate when it addresses the precise malady incurred)
- Prohaska v. Sofamor, S.N.C., 138 F. Supp. 2d 422 (learned intermediary effect on negligent misrepresentation)
- Schedin v. Ortho-McNeil-Janssen Pharm., Inc., 776 F. Supp. 2d 907 (manufacturer cannot add/change black-box without FDA)
- In re Fosamax (Alendronate Sodium) Prod. Liab. Litig., 852 F.3d 268 (framework for evaluating whether FDA would have rejected labeling change)