Actos News

Actos Bladder Cancer Lawsuit Verdict Reinstated
July 16, 2015

A California appeals court has reinstated a $6.5 million verdict against Takeda Pharmaceutical Company that was nullified by the trial judge over two years ago in the first Actos bladder cancer lawsuit to go to trial.A California appeals court has reinstated a $6.5 million verdict against Takeda Pharmaceutical Company that was nullified by the trial judge over two years ago in the first Actos bladder cancer lawsuit to go to trial. A three-justice panel in California’s Second District Court of Appeal ruled today that Los Angeles County Superior Court Judge Kenneth Freeman erred in striking the testimony of key plaintiffs’ expert Dr. Norm Smith and overturning the jury’s verdict.

In the two-month trial, which began in February 2013, Dr. Smith had testified that Actos (pioglitazone) was a substantial factor in causing plaintiff Jack Cooper’s bladder cancer. After deliberating for over a week the jury agreed, finding also that Takeda had negligently failed to warn Cooper’s doctor of the bladder cancer risk associated with its drug, and that this failure to warn led to the harm Mr. Cooper suffered. Takeda was ordered to pay $5 million to Mr. Cooper and $1.5 million to his wife, Nancy, for loss of consortium. In addition to her verdict, she will receive interest and costs.

The first Actos lawsuit had resulted in a verdict for the plaintiff. Five days later, however, Judge Freeman overturned the verdict, ruling that Dr. Smith’s testimony linking the diabetes drug to Mr. Cooper’s bladder cancer was “inadmissible under prevailing California law.” Without that testimony, Freeman concluded, there was insufficient evidence linking Actos to Mr. Cooper’s illness. He therefore granted the defendant’s motion for a “judgment notwithstanding the verdict” (JNOV) – a judgment favoring Takeda in spite of the jury verdict. The judge also granted Takeda’s motion for a new trial, based on the insufficient evidence and his belief that a multiple causation instruction (see discussion below) had influenced the jury’s verdict.

Today’s appellate decision reverses Freeman’s ruling. The lower court has been ordered to enter judgment in favor of plaintiff Nancy Cooper (Mr. Cooper died in July 2014.) in accordance with the original jury verdict. The plaintiffs will also recover their costs on appeal. The appellate panel concluded that Freeman had misinterpreted and misapplied California case law regarding the “gatekeeping function” of judges—their authority to exclude expert testimony when it is simply speculative—and had improperly substituted the court’s opinion of the scientific research record for Dr. Smith’s.

This decision is the latest in a series of losses for Takeda, including a $2 million verdict against the company last October, a $2.3 million judgment in February and a recent agreement to settle thousands of Actos lawsuits for $2.37 million.

Adding to Takeda’s legal troubles is a federal racketeering class action lawsuit against the company that has been brought by a Minnesota union health and welfare benefit fund and consumers in four states. The lawsuit charges Takeda with concealing the Actos bladder cancer risk from consumers and engaging in acts of mail fraud, wire fraud, and the “use of interstate facilities to conduct unlawful activity.”

A Trying Year for Takeda

  • April 2014: Takeda & Eli Lilly & Co. ordered to pay $1.475 million in compensatory damages and $9 billion in punitive damages (later reduced to $36.8 million) in the first federal Actos bladder cancer lawsuit.

  • June 2014 - Federal judge Rebecca Dougherty rules that Takeda acted in “bad faith” in destroying evidence related to 3,500 Actos cases consolidated in her Louisiana courtroom.

  • October 2014 – A Philadelphia lawsuit ends with a verdict ordering the drug company to pay more than $2 million to a woman who claimed Actos caused her bladder cancer.

  • November 2014 - Jurors in Martinsburg, West Virginia order the Japanese drug maker to pay $155,000 for systematically destroying files related to the development and marketing ofpioglitazone.

  • February 2015 - In a second Philadelphia lawsuit, a jury awards $2.3 million to a former teacher who had filed an Actos bladder cancer lawsuit against Takeda.

  • April 2015 – Takeda agrees to settle thousands of Actos lawsuits for $2.37 billion.

The Appellate Ruling

The appeals panel found the Judge Freeman’s reasoning to be “inconsistent with California law” on two major issues:

  • The “acceptable bounds of expert testimony regarding causation.”
  • The substitution of the court’s opinion on the scientific merit of 15 Actos studies for the experts.


Judge Freeman took the position that Dr. Smith was required by law to examine all the “potential causes of Mr. Cooper’s bladder cancer” and specifically rule out each one, until Actos was the only possibility left. In the appellate panel’s view, Judge Freeman “appeared to be speculating that some unknown exposure could be lurking in the unexamined records.” However, the justices pointedly observed that “Dr. Smith was not required to search for evidence that even Takeda’s counsel failed to find and present to the jury.”

The appeals panel found that Freeman, in his insistence on ruling out all possible causes, had “misapprehended” a principal known as the “substantial factor test.” Citing case law, Associate Justice Richard D. Aldrich, writing for the panel (Presiding Judge Lee Smalley Edmon and Associate Justice Patti S. Kitching concurred), explained that under this test, the plaintiff must establish a “reasonably probable causal connection between an act and a present injury,” but “it is not necessary for a plaintiff to establish the negligence of the defendant as the proximate cause of injury with absolute certainty so as to exclude every other possible cause of a plaintiff’s illness” [emphasis in original].

“Dr. Smith,” wrote Justice Aldrich, “was not required to rule out all other possible causes of bladder cancer before his testimony could be deemed admissible. The trial court’s ruling to the contrary contravened California law.” Indeed, in his testimony Dr. Smith specifically addressed smoking and diabetes as possible risk factors, but he concluded that the risk from those factors was minimal and “the most substantial causative factor for Mr. Cooper was his length of Actos and cumulative dose of Actos.”

The Court’s Gatekeeping Function

Dr. Smith based his opinion on his review of 15 epidemiological studies which indicated that Actos is associated with a significantly increased bladder cancer risk. The association is particularly strong among long-term users of Actos and those exposed to higher cumulative doses—a fact that was particularly important in this lawsuit. Mr. Cooper took Actos for over 5 years and was exposed to a cumulative dose of about 55,000 milligrams. A meta-analysis (an analysis of the results of several different studies) conducted by Takeda found that taking pioglitazone for more than 2 years, or being exposed to a cumulative dose greater than 28,000 milligrams, increased the risk of developing bladder cancer by about four and a half times. Due to his lengthy exposure history, Mr. Cooper’s risk, in Dr. Smith’s view, was likely even higher and, according to the findings of one study, it could have been nearly 7 times the risk faced by someone not exposed to Actos.

Nevertheless, Judge Freeman attacked the scientific validity of the Actos studies and suggested that they did not provide a reasonable basis for Dr. Smith’s opinion.

The appeals panel disagreed. It found Judge Freeman’s rejection of the studies was “too simplistic” and “did not take into account the varied scientific principles involved in determining the validity of the studies.” In fact, the studies, according to the three justices, “indicated exposure to Actos resulted in hazard ratios for developing bladder cancer ranging from 2.54 to 6.97.” (A hazard ratio is a number that represents the risk of developing a particular disease for people who take a drug compared to people who do not. In this case, the range suggests that someone taking Actos is two-and-a-half to nearly seven times more likely to develop bladder cancer than someone not taking the drug.)

Justice Aldrich stated that Judge Freeman had overstepped his gatekeeping function in substituting its own opinion for Dr. Smith’s. The justice cited a previous California Superior Court ruling which stated, “The courts’ evidentiary gatekeeping function is . . . not a warrant for judicial intervention in genuine scientific debates over substantive principles.”

Multiple Causation and the Motion for a New Trial

When he granted Takeda’s motion for a judgment not withstanding the verdict, Judge Freeman also granted their motion for a new trial. He did so partly because he felt that a multiple causation instruction to the jurors had unfairly influenced their verdict. Such an instruction advises the jury that a defendant does not escape a negligence claim simply because another factor contributed substantially to the plaintiff's injury or harm. That instruction, Freeman decided, was in error, since in his view neither side had produced evidence of other possible causes of the plaintiff’s bladder cancer.

Again, the appellate justices disagreed, pointing to clear testimony offered by Dr. Smith that smoking could have contributed to the plaintiff’s illness. The judgment granting a new trial and has now also been reversed.

Future Implications

The appellate ruling reinstating the 2013 verdict is expected to have broad ramifications for future litigation involving expert witnesses and may provide a more equitable playing field for plaintiffs who have been harmed by pharmaceutical drugs.

Looming ahead is Takeda’s offer to settle thousands of Actos cases for $2.37 billion and the question of how many individuals who have filed an Actos lawsuit will agree to join the settlement. There are 3,500 cases consolidated before U.S. District Judge Rebecca Doherty in Louisiana and another 4,500 in state courts.

Baum Hedlund attorney, Michael Baum, was not surprised by the reinstatement of the verdict. "The plaintiff's experts in this lawsuit offered compelling evidence that Actos had harmed Mr. Cooper. This victory is long overdue.”

“[A]fter review of all the potentials, differential diagnosis, ruling in, ruling out, carefully evaluating the occupational, environmental, and smoking, that it’s my opinion that the most substantial causative factor for Mr. Cooper was his length of Actos and cumulative dose of Actos.”

Dr. Norm Smith, plaintiff’s expert and, according to the appeals court, “one of the foremost experts in the world on bladder cancer.”


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