Cooper v. Takeda Pharmaceuticals America CA2/3
239 Cal. App. 4th 555
Cal. Ct. App.2015Background
- Jack Cooper took Actos (pioglitazone) for ~5 years and was diagnosed with high‑grade urothelial (bladder) cancer in Nov 2011; he and his wife sued Takeda alleging failure to warn and that Actos caused his cancer.
- Trial (2013) resulted in jury verdict for plaintiffs on strict liability failure‑to‑warn, negligent failure‑to‑warn, and loss of consortium; damages $5M (Jack) and $1.5M (Nancy).
- Plaintiffs’ specific‑causation expert was urologic oncologist Dr. Norm Smith; he performed a differential diagnosis, relied on ~15 epidemiologic studies (several showing elevated hazard ratios, some >2.0 and one ~6.97 for long‑term exposure), and concluded Actos was the most substantial factor.
- Takeda challenged admissibility of Dr. Smith’s specific‑causation opinion; the trial court initially admitted his testimony but post‑verdict struck it as speculative/lacking foundation, granted JNOV and alternatively a new trial (also finding the multiple‑causation instruction improper).
- On appeal, the Court of Appeal reversed: it held the trial court abused its gatekeeping role by requiring elimination of all alternative causes and by improperly weighing epidemiological evidence; it reinstated the jury verdict and ordered judgment entered for Cooper.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of expert specific‑causation testimony (differential diagnosis) | Dr. Smith used a reliable differential diagnosis, reviewed records and epidemiology, and reasonably concluded Actos was the most substantial cause | Expert was speculative: failed to rule out occupational, environmental, smoking, diabetes, and other causes; insufficient foundation so testimony inadmissible | Court of Appeal: trial court erred; expert need not exclude all other possibilities where no substantial evidence supports those alternatives; testimony admissible (gatekeeping abused) |
| Reliance on epidemiological studies to support specific causation | Epidemiology (including studies and meta‑analyses) showed elevated relative risks >2.0 and are a proper basis to infer specific causation when combined with patient‑specific review | Studies have methodological flaws; secondary endpoints unreliable; cannot support specific causation for this patient | Court: trial court improperly substituted its judgment for the experts’ and jury; epidemiologic evidence may be weighed, not outright excluded; studies could support specific causation |
| Whether a plaintiff must eliminate all other possible causes before expert may opine | No: plaintiff must prove more‑likely‑than‑not causation; expert may rely on studies and record without excluding every conceivable cause | Yes: expert must rule out all other causes with patient‑specific investigation for admissibility | Court: California law does not require exclusion of every possibility; substantial factor test applies; trial court misapplied law |
| Jury instruction on multiple/concurrent causation (CACI 431) | Evidence (expert testimony) allowed for Actos as substantial factor while acknowledging smoking/other factors could also contribute; instruction appropriate | No evidence of concurrent causation; instruction prejudicial and unsupported | Court: multiple‑causation instruction was supported by evidence and properly given; new‑trial on that ground was erroneous |
Key Cases Cited
- Sargon Enterprises, Inc. v. University of Southern California, 55 Cal.4th 747 (2012) (trial court gatekeeping: expert must employ same intellectual rigor as in field; exclude clearly invalid/unreliable opinions)
- Sargon Enterprises, Inc. v. University of Southern California, 215 Cal.App.4th 1495 (2013) (discusses limits and standards for expert admissibility post‑Sargon)
- Sarti v. Salt Creek Ltd., 167 Cal.App.4th 1187 (2008) (rejects rule that plaintiff must eliminate all alternative causes; discusses inferences and causation standards)
- Jones v. Ortho Pharmaceutical Corp., 163 Cal.App.3d 396 (1985) (medical causation: need reasonable medical probability, not mere possibility)
- Saelzler v. Advanced Group 400, 25 Cal.4th 763 (2001) (mere possibility insufficient; expert must provide reasoned explanation supporting more‑likely‑than‑not causation)
- Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993) (federal gatekeeping principles; focus on methodology and principles, not conclusions)
- General Electric Co. v. Joiner, 522 U.S. 136 (1997) (appellate review of trial court gatekeeping and analytical gap standard)