• Bloomberg


Takeda Pharmaceutical Co. owes $6.5 million in damages to a California man who said Asia’s largest drugmaker failed to warn consumers its Actos diabetes drug could cause cancer, a jury said in the first of more than 3,000 lawsuits over the medication to go to trial.

Jurors in state court in Los Angeles deliberated for more than five days before finding Osaka-based Takeda didn’t provide adequate bladder-cancer warnings to Jack Cooper and his doctors about Actos.

Cooper, 79, took the drug for more than four years before being diagnosed with the disease in 2011.

“I hope this verdict makes Takeda realize it’s time to solve the problems with Actos that they’ve known about for years,” Michael Miller, one of Cooper’s lawyers, said after the jury’s ruling was announced.

The verdict comes almost three months after Takeda won U.S. regulatory approval for Nesina, a diabetes drug to replace Actos, which lost patent protection last year.

Actos sales peaked in the year ended March 2011 at $4.5 billion, or 27 percent of Takeda’s revenue at the time, according to data compiled by Bloomberg.

Takeda officials said Friday they’ve filed motions seeking to have the verdict and the entire case thrown out and to have Judge Kenneth Freeman review those requests next week.

“We respectfully disagree with the jury’s verdict and believe we showed in this trial Takeda acted responsibly” in its handling of Actos, Kenneth Greisman, general counsel for Takeda’s U.S. unit, said in a telephone interview.

Takeda faces more than 3,000 suits alleging Actos caused bladder cancer or other ailments, according to court records. Cooper’s suit was among those gathered before Freeman in Los Angeles. Other cases are in state court in Illinois.

More than 1,200 suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges. The first federal case is set for trial in January, according to court filings.

Lawyers for former Actos users contend in court filings that Takeda researchers ignored or downplayed concerns about the drug’s cancer-causing potential before it went on sale in the U.S. in 1999, and misled U.S. regulators about the medicine’s risks.

Cooper’s case was heard on an expedited basis after Freeman found the former Pacific Bell Telephone Co. cable splicer was “gravely ill,” according to court filings.

During the almost two-month trial, Cooper’s lawyers told jurors that while Takeda’s own research found links between Actos and bladder cancer as early as 2004, company officials didn’t tell regulators about the findings for seven years.

Miller, Cooper’s lawyer, produced internal Takeda email messages in which executives urged colleagues to persuade the U.S. Food and Drug Administration not to demand increased warnings about bladder cancer on Actos’ label.

“Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally,” Takeda executive Kiyoshi Kitazawa said.

Even after FDA officials asked the drugmaker in 2005 and 2006 to update warnings about Actos’ health risks, Takeda executives “stalled and delayed” because the company “was making $1.6 billion a year” on the drug, Miller argued.Sara Gourley, one of Takeda’s lawyers, countered FDA researchers hadn’t concluded Actos caused bladder cancer. The drug didn’t cause Cooper to contract the illness, she said.

The company contends Cooper was more likely to develop bladder cancer because he was an elderly male former smoker who suffered from diabetes. That placed him in high-risk categories for the disease regardless of his Actos use, she said.

“The evidence is not only clear, it is overwhelming, that Mr. Cooper is in the highest-risk groups, and that his bladder cancer had nothing to do with Actos,” Gourley told jurors.

Still, jurors found Takeda officials “failed to adequately warn” Cooper’s doctors about Actos’ cancer risk and that failure was “a substantial factor” in causing Cooper harm, according to court filings.

Jurors awarded $5 million in compensatory damages to Cooper and $1.5 million to his wife. The panel rejected the couple’s request that Takeda face a punitive-damage award, according to the filings.

Losing the first of more than 3,000 Actos suits that are slated for trial is “a disaster for Takeda,” Hunter Shkolnik, a New York-based lawyer for former Actos users, said in an interview Friday.

“They will be facing back-to-back trials of stronger cases next year,” Shkolnik said. “This loss is devastating to the company.”

Greisman countered that the company will continue to “vigorously defend” against Actos suits and will evaluate cases individually as they come up for trial.

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