Bee v. Novartis Pharmaceuticals Corp.
18 F. Supp. 3d 268
E.D.N.Y2014Background
- Bee and D. Bee, NY residents, sue Novartis over Zometa and Aredia allegedly causing Bee’s ONJ; claims include strict liability, negligence, breach of warranties, and loss of consortium.
- Bee was treated for ankylosing spondylitis and osteoporosis, transitioned from Fosamax to Aredia, then to Zometa between 1997–2004.
- Plaintiffs allege off-label use (osteoporosis/ankylosing spondylitis) with Aredia/Zometa, and that Novartis failed to warn of ONJ risks.
- Novartis purportedly updated warnings in 2003–2004 after initial ONJ reports, including a Dear Doctor letter and labeling changes.
- The MDL case evolved through Wave III with the current court denying summary judgment but denying some Daubert challenges; issues center on duty to warn, adequacy of warnings, and causation.
- Bee underwent dental extractions and later was diagnosed with ONJ; treating doctors varied in response and warnings allegedly could have altered treatment or patient actions.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Duty to warn for off-label use and learned intermediary scope | Bee's ONJ risk was foreseeable; warnings should reach treating doctors and possibly dental practitioners | Novartis had no duty to warn off-label uses or non-prescribing dentists | Genuine issues of material fact preclude summary judgment on duty to warn. |
| Adequacy of warnings given ONJ risk and timing | Warnings were insufficient and issued after risk became knowable | Warnings, once notice existed, were adequate | Question of adequacy for jury; not determinable at summary judgment. |
| General causation (duty to warn linkage to injury) | Different warnings could have altered physician/patient decisions | Warnings would not have changed Bee’s outcome or treatment | Genuine issues of material fact; causation disputed. |
| Specific causation (Aredia/Zometa caused ONJ) | Dr. Kraut’s differential diagnosis supports causation; others corroborate | Expert opinions should be excluded or are unreliable | Daubert hurdle overcome for Dr. Kraut; material facts support a trial on causation. |
Key Cases Cited
- McCarthy v. Olin Corp., 119 F.3d 148 (2d Cir.1997) (elements of failure-to-warn claim under NY law)
- In re Fosamax Prods. Liab. Litig., 924 F. Supp. 2d 447 (S.D.N.Y.2013) (causation and warnings in pharma context)
- Davids v. Novartis Pharm. Corp., 857 F. Supp. 2d 267 (E.D.N.Y.2012) (prescription-drug warnings and learned intermediary doctrine)
- Lindsay v. Ortho Pharm. Corp., 637 F.2d 87 (2d Cir.1980) (warning to doctor rather than patient; learned intermediary)
- Galioto v. Lakeside Hosp., 506 N.Y.S.2d 705 (N.Y. App. Div. 1986) (causation standards for substantial factor in NY negligence)