The jury has spoken in the latest Actos trial, and the verdict was this: Takeda Pharmaceutical didn't properly flag the risks of its diabetes drug, and Takeda should pay $1.7 million to the family of Diep An, an Actos patient who died of bladder cancer.
But as Bloomberg reports, no sooner had the Maryland jury delivered its verdict than Judge Brooke Murdock tossed it out. That's because the jurors also found that An's 30 years of smoking contributed to his death. Smokers are at least three times as likely to get bladder cancer as nonsmokers, the American Cancer Society says.
It's the second time that a jury has decided Takeda didn't do enough to warn doctors and patients that Actos could increase the risk of bladder cancer. It's also the second time that a judge has set aside the verdict. In another bladder-cancer case earlier this year, a California judge threw out the jury's $6.5 million damages award.
Thousands more lawsuits claim that Takeda covered up Actos' links to bladder cancer and blame the diabetes drug for patients' disease and deaths. One of the An family's lawyers hailed today's verdict, if not its eventual fate. "We consider the verdict to be a vindication of our claims that Takeda failed to properly disclose the risks of this drug," the lawyer told Bloomberg.
Takeda, meanwhile, said it was pleased with the outcome. The Japanese drugmaker has maintained that it handled Actos safety warnings properly. Takeda also says there's no proof that Actos actually causes bladder cancer. Until it fell off patent last August, the drug was Takeda's top product, with peak sales of about $4.5 billion. Its 2012 sales amounted to 122.9 billion yen, or about $1.5 billion.
The FDA has been eyeing the data on Actos and its potential cancer risks for more than a decade. In fact, as the drug was approved in 1999, the agency ordered a 10-year safety study to assess the drug's links to bladder cancer. In June 2011, after sifting through interim data from that study, the FDA alerted doctors to an apparent increase in cancer risk in patients who used the drug for the longest periods of time and at the highest doses. FDA also required stronger cautionary language on the drug's label. That long-term study continues, with final data due in 2014, Takeda told Bloomberg.
- see the story from Bloomberg
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