Japanese pharmaceutical giant Takeda has been ordered to pay $6.5m in damages to a Californian man after jurors found the company failed to provide the claimant and his doctors with adequate warnings about the bladder cancer risk from its Actos diabetes drugs.
In the court case, which is the first of 3,000 suits against Takeda over Actos’ bladder cancer risk, claimant Jack Cooper said Takeda failed to properly warn him and his doctors of the risk of cancer.
Cooper took the drug for more than four years before developing bladder cancer in 2011.
After five days of deliberation, jurors in a Los Angeles state court last week sided with the claimant and ordered Takeda to pay $5m in damages to Cooper and $1.5m to his wife, according to The Japan Times.
Figures compiled by Bloomberg suggest that at Actos’s sales peak in 2011, sales of the drug were worth, or 27% of Takeda’s revenue.
Lawyers representing former Actos users in court filings claim Takeda researchers ignored or downplayed concerns about Actos’s potential cancer-causing side effects and mislead US regulators before it went on sale in 1999.
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During the two-month trial, Cooper’s lawyers showed email messages in which colleagues were urged to deal with this issue "very carefully and successfully not to cause any damage for this product globally" and to persuade US Food and Drug Administration officials not to order increased warnings about Actos’s bladder cancer-causing potential.
The company is also accused of stalling after being asked to update warnings about Actos in 2005/2006.
During the case, Takeda’s lawyers argued Actos didn’t cause Cooper’s bladder cancer and that he was more likely to develop bladder cancer because he was in a high-risk category.
"We respectfully disagree with the jury’s verdict and believe we showed in this trial Takeda acted responsibly," general counsel for Takeda’s US unit, Kenneth Greisman, told The Japan Times.
Takeda has already filed motions seeking to have the verdict and the case thrown out of court. Judge Kenneth Freeman will review these requests next week.
Following Actos’ loss of patent protection in 2012, Takeda won US regulatory approval three months ago for its replacement, Nesina.
Next year the company will face back-to-back trials in Illinois for 3,000 claims that Actos caused bladder cancer or other ailments.
Image: Takeda’s heaadquarters in in Chuo-ku, Osaka, Japan. Photo: Courtesy of GFDL.