Stephen Wendell v. Glaxosmithkline LLC
858 F.3d 1227
| 9th Cir. | 2017Background
- Maxx Wendell, treated for ulcerative colitis beginning age 12, received long‑term thiopurine therapy (6‑MP/Purinethol and later generic) and intermittent anti‑TNF therapy (Remicade, then Humira). He developed hepatosplenic T‑cell lymphoma (HSTCL) in July 2007 and died the same year at age 21.
- Plaintiffs (Maxx’s parents) sued multiple drug manufacturers and distributors under California law for negligence and strict liability, alleging the drugs and inadequate warnings caused HSTCL.
- GSK manufactured Purinethol until July 1, 2003; Teva later marketed the drug. Remicade labeling was updated in 2006 to warn of postmarketing HSTCL cases in young males receiving both anti‑TNF agents and thiopurines; Humira’s label lacked that warning when prescribed.
- The district court granted summary judgment for Teva, excluding plaintiffs’ expert causation testimony (Drs. Shustov and Weisenburger) as unreliable under Federal Rule of Evidence 702/Daubert and finding no evidence that Maxx’s prescribing physician relied on Teva’s warnings; it denied reconsideration as to GSK.
- The Ninth Circuit reversed: it held the district court abused its discretion in excluding the experts, and found genuine issues of material fact about whether a warning would have changed the prescribing physician’s conduct.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of expert causation testimony (Rule 702/Daubert) | Experts used differential diagnosis, literature review, clinical experience, and Bradford Hill factors to opine that 6‑MP and anti‑TNF exposure substantially caused Maxx’s HSTCL. | Experts’ opinions are unreliable: developed for litigation, not peer‑reviewed, lack animal/epidemiological studies, cannot rule out idiopathic disease or IBD as cause. | Reversed: experts were sufficiently qualified and used reliable methodology; exclusion was abuse of discretion; testimony admissible. |
| Duty to warn / causation of injury (physician reliance) under California law | Dr. Rich’s testimony shows he reads labels sometimes and changed prescribing when warned (e.g., switched from Remicade to Humira); later ceased combination therapy—so a warning could have affected his conduct. | No evidence Dr. Rich relied on Teva’s labeling when prescribing Purinethol to Maxx. | Reversed: genuine factual dispute exists whether adequate warnings would have altered Dr. Rich’s prescribing; summary judgment improper. |
| Denial of leave to file motion for reconsideration re: GSK | Plaintiffs sought reconsideration; district court denied it as moot because of its rulings on causation/reliance. Plaintiffs argue those underlying rulings were erroneous. | GSK contends plaintiffs abandoned merits and do not challenge summary judgment to GSK. | Reversed: because district court’s Daubert/reliance rulings are reversed, the denial of leave to seek reconsideration is also reversed. |
| Alternative defenses (Teva’s additional grounds) | Plaintiffs maintain liability based on failure to warn and causation evidence. | Teva raised several alternative grounds (no duty for off‑label use, no duty re: competitor product, physician already had information, timing/proximate cause). | Not decided: Court declined to affirm on alternative grounds because they require further factfinding; remand appropriate. |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (Sup. Ct. 1993) (trial judge’s gatekeeping role for expert reliability)
- Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311 (9th Cir. 1995) (Daubert II) (focus on experts’ basis for opinions and flexibility of factors)
- Messick v. Novartis Pharm. Corp., 747 F.3d 1193 (9th Cir. 2014) (review standards for expert admissibility and summary judgment interplay)
- Clausen v. M/V New Carissa, 339 F.3d 1049 (9th Cir. 2003) (differential diagnosis and methods of science as reliable bases for expert testimony)
- Kennedy v. Collagen Corp., 161 F.3d 1226 (9th Cir. 1998) (permitting expert reliance on clinical observation and literature absent conclusive epidemiology)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (Sup. Ct. 1999) (expert must employ same level of intellectual rigor in court as in practice)
- Motus v. Pfizer Inc., 358 F.3d 659 (9th Cir. 2004) (applying state substantive law with federal procedural rules in diversity cases)
- Carlin v. Superior Court, 920 P.2d 1347 (Cal. 1996) (manufacturer’s duty to warn physicians of known or knowable risks)