After deliberating for about four hours yesterday, a federal jury ordered Takeda Pharmaceuticals and Eli Lilly & Co. to pay a combined $9 billion in punitive damages to Terrence Allen, finding that the drug makers hid the bladder cancer risks of the diabetes drug Actos (pioglitazone).
The jury found that the drug caused Allen’s disease and that Takeda and Lilly both “failed to adequately warn” about the risks, Bloomberg News reports. The jury said Takeda and Lilly executives “acted with wanton and reckless disregard” for patient safety, and this justified the punitive damage award. Of the $9 billion, Takeda is to pay $6 billion Eli Lilly $3 billion.
During the trial, Allen alleged that he developed bladder cancer after taking Actos for more than five years starting in 2006. Allen’s attorneys said Takeda executives ignored or downplayed the cancer risks and misled regulators in order to protect billions in sales. Specific warnings about Actos’s cancer risks did not come until 2011, seven years after experts said the link became clear and 12 years after the drug arrived on the market in the U.S., Bloomberg reports. Studies in the British Medical Journal and the Canadian Medical Association Journal reveal the increased likelihood of Actos users developing bladder cancer. Takeda recently halted development of TAK-875 (fasiglifam), another diabetes drug, when research linked the drug to liver damage.
This is the seventh-largest award in U.S. history, but it is almost certain to be reduced, Bloomberg News writes, because the U.S. Supreme Court has said punitive damages must be proportional to the compensatory damages that underlie them. The high court has indicated that in some cases a punitive award of ten times a compensatory award could be acceptable.
More than 2,700 Actos suits have been consolidated before U.S. District Judge Rebecca Doherty in Louisiana for pretrial information exchanges, according to court dockets. Doherty presided over the Allen trial. Bloomberg News reports that there are hundreds of claims in state courts in addition to the federal lawsuits.
Peak sales for Actos, in the year ending in March 2011, were $4.5 billion and accounted for 27 percent of Takeda’s revenue, according to Bloomberg News. Worldwide, Actos sales have totaled more than $16 billion since its 1999 release, court filings indicate. Takeda earnings have declined in the face of a generic pioglitazone competitor from Ranbaxy Laboratories Ltd.