Takeda Pharmaceutical of Japan must pay US$6.5 million in damages to a California man who said Asia's largest drug-maker failed to warn consumers that its Actos diabetes drug could cause cancer, a jury ruled in the first of more than 3,000 lawsuits over the medication to go to trial.
Jurors in state court in Los Angeles found that Osaka-based Takeda did not provide adequate bladder-cancer warnings to Jack Cooper and his doctors about Actos. Cooper, now 79, took the drug for more than four years before being diagnosed with the disease in 2011.
Takeda officials said they had filed motions seeking to have the verdict and the entire case thrown out and that Judge Kenneth Freeman review those requests this week.
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 played down concerns about the drug's cancer-causing potential before it went on sale in the US in 1999, and misled US regulators about the medicine's risks.
Cooper's case was heard on an expedited basis after Freeman found he 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 did not tell regulators about the findings for seven years.
Michael Miller, one of Cooper's lawyers, produced internal Takeda e-mails in which executives urged colleagues to persuade the US Food and Drug Administration not to demand increased warnings about bladder cancer on Actos' label.
Even after FDA officials asked the drug-maker in 2005 and 2006 to update warnings about Actos' health risks, Takeda executives "stalled and delayed" because the company "was making [US]$1.6 billion a year" on the drug, Miller argued.
The company contends Cooper was more likely to develop bladder cancer because he was an elderly male former smoker who suffered from diabetes.
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 harm, according to court filings.
Jurors awarded US$5 million in compensatory damages to Cooper and US$1.5 million to his wife. The panel rejected the couple's request that Takeda face a punitive-damage award, according to the filings.Topics: Drug Safety Cancer Health