Stanley v. Novartis Pharmaceuticals Corp.
11 F. Supp. 3d 987
C.D. Cal.2014Background
- Plaintiff Deborah Stanley (California resident) alleges ONJ after treatment with Novartis drugs Aredia and Zometa and later pamidronate; claims left: failure to warn, negligence (failure to warn), breach of implied warranty, and strict liability (design) — some claims previously dismissed by stipulation.
- Plaintiff received bisphosphonate therapy from 2001–2009 (Aredia → Zometa → pamidronate); multiple dental extractions occurred in 2009 after most bisphosphonate infusions had ceased; dentist who performed extractions was not told of prior bisphosphonate therapy.
- Novartis updated Aredia/Zometa labeling in 2003–2005 to note reported cases of osteonecrosis of the jaw (ONJ), sent Dear Doctor/Dentist letters, and posted info on MedWatch/ADA sites.
- Novartis moved for summary judgment and to exclude certain expert testimony (treating physicians and retained expert Dr. Eric Sung); Novartis also sought a Daubert hearing. Plaintiff opposed.
- Court excluded treating physicians’ specific-causation testimony, admitted Dr. Sung’s causation opinion (but excluded his dosing opinion), allowed his exam testimony despite late disclosure (reopened limited discovery for supplemental deposition).
- On summary judgment the court denied Novartis relief on failure-to-warn and specific causation (genuine issues exist), granted summary judgment on strict-product-design strict liability (Comment k), denied summary judgment on implied warranty (no privity bar for drugs), refused to apply New Jersey punitive-damages law and held California law applies.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of treating physicians' specific-causation testimony | Treating docs can testify on causation | Novartis sought exclusion under Daubert/Rule 702 | Excluded: treating physicians may testify to symptoms/diagnosis/treatment but not specific causation |
| Admissibility of retained expert Dr. Eric Sung (causation) | Sung is qualified; performed differential diagnosis attributing ONJ to bisphosphonates | Novartis argued Sung lacked expertise re: alternate causes (osteomyelitis, interferon) and used unreliable methodology | Admitted: Sung is qualified and his causation opinion is sufficiently reliable; Daubert hearing denied |
| Sung's dosing opinion and late disclosure of his examination | Plaintiff sought to rely on Sung's opinion tying cumulative dose/duration to causation and his exam | Novartis contended dosing opinion is conclusory/unreliable and exam disclosure was untimely | Dosing opinion excluded for lack of reliable methodology; exam testimony allowed as harmless (defendant allowed additional depo) |
| Failure-to-warn proximate causation | Stanley: inadequate warnings prevented dental precautions that would have avoided injury | Novartis: physicians say they still would have prescribed even if warned | Denied summary judgment: disputed fact whether physicians would have altered monitoring/treatment or warned patient creates triable issue |
| Strict liability (design defect) for prescription drug | Plaintiff asserted design defect | Novartis argued Comment k protects properly prepared prescription drugs with appropriate warnings | Granted for Novartis: strict liability design defect claim barred by Comment k principles under California law |
| Implied warranty and privity | Plaintiff asserted breach of implied warranty against manufacturer | Novartis argued privity required | Denied summary judgment: privity exception for drugs applies; claim survives |
| Punitive damages choice-of-law | Plaintiff sought punitive damages under California law | Novartis urged New Jersey law (precludes punitive for FDA-approved drugs) | Denied summary judgment; court applies California punitive-damages law (NJ law would materially limit relief; comparative-impairment favors CA) |
Key Cases Cited
- Anderson v. Liberty Lobby, 477 U.S. 242 (summary judgment standard)
- Celotex Corp. v. Catrett, 477 U.S. 317 (summary judgment burden shifting)
- Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (gatekeeping reliability/relevance of expert testimony)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (trial court gatekeeping discretion for expert testimony)
- Clausen v. M/V New Carissa, 339 F.3d 1049 (differential diagnosis methodology admissibility)
- Brown v. Superior Court, 44 Cal.3d 1049 (Comment k and prescription-drug design-defect treatment)