Gilliland v. Novartis Pharmaceuticals Corp.
34 F. Supp. 3d 960
S.D. Iowa2014Background
- Plaintiff Denise Gilliland received Zometa (a bisphosphonate) infusions from July 1, 2005 to May 1, 2009 for multiple myeloma and was diagnosed with osteonecrosis of the jaw (ONJ) in April 2010.
- Gilliland alleges claims including strict liability, negligent manufacture, negligent failure to warn, breach of express warranty, and breach of implied warranty against Novartis.
- Novartis moved to exclude plaintiff’s specific-causation expert (Dr. Eric Sung) and for summary judgment on all claims, arguing lack of admissible causation evidence and that warnings were adequate.
- The central factual dispute: whether Gilliland’s oncologists were aware of the bisphosphonate–ONJ association when they prescribed Zometa and whether a better warning would have led Gilliland to refuse treatment.
- Dr. Sung was allowed to testify that Zometa caused Gilliland’s ONJ (but not on a dosing/time-incidence opinion based on his personal observations); Novartis’s Daubert challenge otherwise rejected.
- Court granted summary judgment to Novartis on negligent manufacture and breach of express warranty claims, denied summary judgment on negligent failure to warn and breach of implied warranty, and reserved ruling on strict liability pending plaintiff briefing.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of Dr. Sung’s specific-causation opinion | Dr. Sung is qualified and performed a reliable differential diagnosis tying Zometa to ONJ | Dr. Sung failed to rule out other causes (osteomyelitis, sinusitis, drainage) and lacks expertise for some alternatives | Allowed: Dr. Sung may testify that Zometa caused Gilliland’s ONJ; excluded his personal opinion linking dosing/duration to ONJ incidence/severity |
| Failure-to-warn (adequacy to physicians / learned intermediary) | Novartis’s warnings may have been inadequate to Gilliland’s oncologists; plaintiff would have refused Zometa if warned | Warnings to physicians were adequate; even if inadequate, physicians would have still prescribed and patient’s refusal is irrelevant | Denied summary judgment: jury question exists whether oncologists were warned and whether plaintiff would have declined treatment if warned |
| Causation on failure-to-warn (role of patient choice) | Gilliland would have refused Zometa if properly warned, creating proximate causation | Defendant: physician testimony that they would have prescribed regardless negates causation; patient’s asserted refusal is irrelevant | Court held patient testimony is relevant; a reasonable jury could find plaintiff would have refused, so causation is triable |
| Negligent manufacture / breach of express warranty | Plaintiff alleges manufacturing defect and express warranties | Novartis: no evidence any infusion deviated from specs; no affirmations to or reliance by plaintiff | Granted summary judgment for Novartis on negligent manufacture and breach of express warranty (plaintiff did not oppose) |
Key Cases Cited
- Daubert v. Merrell Dow Pharms., 509 U.S. 579 (1993) (trial court gatekeeper must assess reliability and relevance of expert scientific testimony)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999) (Daubert gatekeeping applies to all expert testimony based on technical or specialized knowledge)
- Glastetter v. Novartis Pharms. Corp., 252 F.3d 986 (8th Cir. 2001) (differential diagnosis is presumptively admissible; exclude only scientifically invalid diagnoses)
- Lauzon v. Senco Prods., 270 F.3d 681 (8th Cir. 2001) (expert need not rule out every possible alternative cause; shortcomings affect weight, not admissibility)
- Celotex Corp. v. Catrett, 477 U.S. 317 (1986) (movant bears initial burden to show absence of genuine issue of material fact on summary judgment)
- Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986) (summary judgment standard: no genuine issue of material fact when reasonable jury could not find for nonmoving party)