On Tuesday, Takeda Pharmaceuticals announced a settlement that could go as high as $2.7 billion to resolve thousands of lawsuits from patients and their families who claim the diabetes drug Actos (pioglitazone) caused their bladder cancer.
The New York Times reports that about 9,000 bladder cancer cases are pending. Takeda said the settlement would resolve most of the lawsuits. Takeda said it will take a $2.7 billion charge against earnings to cover the settlement and litigation costs for the remaining cases. The settlement will become effective if 95 percent of the plaintiffs agree to it, and Takeda would pay $2.37 billion. If 97 percent of plaintiffs participate, Takeda would pay $2.4 billion. Payment amounts to individual plaintiffs will depend on a number of factors, including cumulative dosage of the drug, the extent of the injury and their smoking history.
Court record indicate that more than 3,500 Actos lawsuits have been consolidated before U.S. District Judge Rebecca Doherty in Lafayette, Louisiana, for pretrial discovery, with another 4,500 cases filed in state courts in Illinois, West Virginia, California, and Pennsylvania. The lawsuits allege that Takeda concealed the bladder cancer risk associated with Actos. Takeda did not admit liability, but said it had settled to “reduce the uncertainties of complex litigation,” according to the Times.
Research has linked Actos, a drug used to treat Type 2 diabetes, to a higher risk of bladder cancer. In 2011, the Food and Drug Administration (FDA) said that taking Actos for more than one year could significantly increase the risk of bladder cancer and ordered changes to the Actos label to warn of the risk. In 2012, two research studies provided additional support for the link. In May of that year, the British Medical Journal published a study that revealed Actos users were twice as likely to develop bladder cancer after two years on the drug. An article that appeared in July in the Canadian Medical Association Journal reported that patients taking Actos were 22 percent more likely to get bladder cancer.
Last year, a Louisiana jury ordered Takeda and Eli Lilly, formerly a co-marketer of Actos, to pay $9 billion in punitive damages after the jury found that Takeda had hidden the bladder cancer risk. (The award was later reduced to $36.8 million, the Times reports.) A court filing in that case indicates Actos sales in the United States have exceeded $24 billion since the drug went on the market in 1999, with more than 100 million prescriptions written.
National law firm Parker Waichman, which has represented plaintiffs in Actos cases, reports that the deadline to sign up with the firm is 12:00 noon EDT on Friday, May 1, 2015. The settlement would be open to all claimants with bladder cancer who first used Actos prior to December 1, 2011, and either have a lawsuit currently pending or have retained counsel to assert a claim within three days of the announcement of the settlement.