Davids v. Novartis Pharmaceuticals Corp.
857 F. Supp. 2d 267
E.D.N.Y2012Background
- Ms. Davids alleges BRONJ from IV Zometa used to treat metastatic breast cancer.
- Fosamax (an oral bisphosphonate) and dental history are alleged contributing factors.
- FDA approved Zometa in 2002; plaintiff claims Novartis withheld ONJ risk information and misled labeling.
- Ms. Davids received monthly Zometa infusions Oct 2003–Jan 2005; last infusion Jan 6, 2005.
- Plaintiff’s medical/dental history includes prior extractions and periodontal issues; causation contested by defendants.
- MDL proceedings consolidated three Davids-style cases; Davids remanded with Daubert and summary-judgment motions pending.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of previously challenged experts’ testimony | Deutsch/Parisian rulings should control Davids | Facts differences require case-specific Daubert review | Adopt Deutsch/Parisian orders; admissibility governed by those rulings |
| Kraut’s general and specific causation opinions | Kraut qualified; supports BRONJ causation | Kraut’s opinions unreliable/not qualified | Denied—Kraut’s causation opinions admissible |
| Non-retained experts’ specific causation opinions | Non-retained experts should be allowed to testify | Most are unqualified to opine on causation | Allowed for Dr. Ruggiero; others excluded for lack of qualification |
| Summary judgment on causation and warnings | Evidence raises triable issues on specific and proximate causation | No triable issue; Zometa not linked to BRONJ or proximate causation | Summary judgment denied on specific and proximate causation; breach of implied warranty covered; express warranty dismissed |
Key Cases Cited
- Deutsch v. Novartis Pharms. Corp., 768 F.Supp.2d 420 (E.D.N.Y.2011) (Daubert/causation rulings guidance adopted)
- Parisian v. Novartis Pharms. Corp., 794 F.Supp.2d 382 (E.D.N.Y.2011) (Parisian Daubert Order confirming admissibility)
- Forman v. Novartis Pharms. Corp., 793 F.Supp.2d 598 (E.D.N.Y.2011) (Punitive damages ruling; Daubert context)
- In re Fosamax Prods. Liab. Litig., 688 F.Supp.2d 259 (S.D.N.Y.2010) (Admissibility of medical-differential causation opinions)
- In re Aredia and Zometa Prods. Liab. Litig. (Simmons), 754 F.Supp.2d 934 (M.D.Tenn.2010) (Treating-physician causation standards in Daubert)