After about four hours of deliberations, a federal jury in Lafayette, Louisiana awarded $9 billion in punitive damages to Terrence Allen, finding that Takeda Pharmaceuticals and Eli Lilly & Co. hid the bladder cancer risks of the diabetes drug Actos (pioglitazone) from Allen, who developed the disease.
The jury said the drug caused Allen’s disease and the two drug makers, partners in marketing and selling the drug for seven years, “failed to adequately warn” about the risks, Bloomberg News reports. The jury said the punitive damages were justified because Takeda and Lilly executives “acted with wanton and reckless disregard” for patient safety. Takeda was ordered to pay $6 billion, Eli Lilly $3 billion.
Allen, who took Actos for more than five years starting in 2006, said the drug caused his bladder cancer. Allen’s attorneys said Takeda executives ignored or downplayed cancer risks and misled regulators in order to preserve billions in Actos sales. Takeda did not provide warnings about bladder cancer risks until 2011, though experts say the link was clearly shown years earlier, Bloomberg News reports. Two studies, one in the British Medical Journal and one in the Canadian Medical Association Journal, showed Actos users have increased risk of developing bladder cancer after as little as one year taking the drug.
Bloomberg News says the award – the seventh largest in U.S. history – is almost certain to be reduced. The U.S. Supreme Court has said punitive damages must be in proportion to the compensatory damages that underlie them. In some cases, the high court said, punitive damages ten times the compensatory award could be acceptable.
Court dockets indicate that more than 2,700 Actos suits have been consolidated before U.S. District Judge Rebecca Doherty, who presided over the Allen trial. Bloomberg News reports that, in addition to the federal lawsuits, hundreds of Actos claims have been filed in state courts.
Actos reached peak sales of $4.5 billion in the year ending in March 2011, accounting for 27 percent of Takeda’s revenue, according to Bloomberg News. Since Actos came on the market in 1999, worldwide sales have totaled more than $16 billion, but a generic pioglitazone from Ranbaxy Laboratories Ltd. now challenges Actos for market share.