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INTRODUCTION

On July 16, 2015, in Cooper v. Takeda Pharmaceuticals America, Inc., et al. (“Cooper”), the Second District Court of Appeal reinstated a $6.5 million verdict against Takeda Pharmaceuticals America, Inc., Takeda Pharmaceuticals U.S.A., Inc., and Takeda Pharmaceutical Company Limited (collectively, “Takeda”). While the trial court found that an expert’s testimony can only be valid if the expert is able “to rule out all other possible causes. . . , even where there was no substantial evidence that other such causes might be relevant,” the Court of Appeal disagreed. In fact, the Court of Appeals determined that the trial court exceeded the proper boundaries of its gatekeeping function when it struck Plaintiffs Jack and Nancy Cooper’s (“the Coopers”) causation expert’s testimony on such grounds.

Although not published, Cooper is an important decision. It extends the reasoning employed by the Fourth District Court of Appeal in Sarti v. Salt Creek Ltd.—a food-borne illness case—to a pharmaceutical injury case, meaning that these principles can potentially be applied even further to toxic injury cases that involve claims of extended exposure periods. In these cases, evidence of exposure to alternate causes can be difficult to obtain. Applying Cooper to these cases would allow experts to testify that a particular cause was a substantial factor, without necessarily first debunking alternative causes. This puts defendants in prolonged exposure cases at a severely unfair disadvantage.

NANCY COOPER v. TAKEDA PHARMACEUTICALS AMERICA, INC.

Trial Court Proceedings

Plaintiffs filed their Complaint in Los Angeles Superior Court, alleging that Jack Cooper’s use of Takeda’s prescription drug, Actos®, caused Jack Cooper to develop bladder cancer. The jury found that Takeda had failed to adequately warn Jack Cooper’s doctor about the risk of bladder cancer, and that this failure was a substantial factor in causing Jack Cooper’s injury. As such, Takeda was found liable for strict liability, negligence, and loss of consortium, and the Coopers were awarded $6.5 million in damages.

Before, during, and after the trial, Takeda challenged the admissibility of general and specific causation testimony offered by Plaintiffs’ urologic oncologist expert, Dr. Norm Smith. Specifically, Takeda attacked Dr. Smith’s differential diagnosis upon which Dr. Smith based his opinion that Actos® was a substantial contributing factor to Jack Cooper’s cancer.

Following the trial, Takeda filed a motion asking the court to strike Dr. Smith’s testimony, which the trial judge granted, finding Dr. Smith’s testimony speculative and lacking foundation. The trial judge then also granted Takeda’s motion for a new trial on the grounds that, without Dr. Smith’s testimony, there was insufficient evidence to support the verdict and that the trial court erred in instructing the jury on concurrent causation. The Coopers appealed to the California Court of Appeal.

The Appeal

The Court of Appeal found that the trial court erred in striking the expert’s testimony. “By requiring that the expert rule out all other possible causes for Jack Cooper’s bladder cancer, even where there was no substantial evidence that other such causes might be relevant, the [trial] court exceeded the proper boundaries of its gatekeeping function in determining the admissibility of the complex scientific testimony.”

The Court of Appeal found it significant that Cooper’s expert did not suggest that Mr. Cooper had developed bladder cancer only because of exposure to Actos®, but rather allowed for the possibility that smoking had played a role in the development of his cancer, opining in the end that the Actos® exposure was the “most substantial” factor in causing Mr. Cooper’s bladder cancer, though it was a factor. Therefore, “the evidence was clearly sufficient to support the jury’s finding that Actos® was a substantial factor in causing Mr. Cooper’s bladder cancer,” since Dr. Smith did not rule out smoking as a potential cause of Mr. Cooper’s bladder cancer.

The Court of Appeal reversed the trial court’s rulings and entered judgment in favor of Takeda.

IMPACT OF COOPER BEYOND PHARMACEUTICALS

While Cooper is unpublished, it raises concerns regarding the use of expert causation testimony in cases such as pharmaceutical injury cases and toxic exposure cases, which involve long-tail exposure and alternate causes.

The Cooper Court’s opinion correctly articulates the rule under the “substantial factor” test – it is not necessary for a plaintiff to establish negligence of the defendant as the proximate cause of the injury with absolute certainty so as to exclude every other possible cause of the plaintiff’s injury. However, the Court of Appeal also creates a potential unfairness in the burden of proof it requires in cases where evidence of alternate causes can become worn or erased by the passage of time.

Essentially, Cooper can be interpreted to give plaintiffs’ causation experts extreme leeway where evidence is not directly available to the expert, but could be developed through a proper differential diagnosis. The burden then shifts to defendants to develop evidence of alternate causes. This becomes a much tougher challenge, as defendants must do so by navigating through the discovery process and all of the procedural protections afforded to plaintiffs in the discovery process.

Cooper further makes obtaining a defense verdict an uphill battle. As such, it is vitally important that, early on in the litigation process, defense counsel focus on potential alternate causes and use investigative and discovery methods to try to develop evidence where plaintiffs’ experts have likely failed to do so.
Walsworth has significant experience developing evidence of alternate causation and working with experts through all stages of investigation, discovery and trial.