Takeda Pharmaceuticals has agreed to pay $2.4 billion to settle thousands of lawsuits from patients and families who said Takeda’s diabetes drug Actos caused bladder cancer.
Takeda, based in Japan, said the settlement would resolve most of the lawsuits related to Actos (pioglitazone). The company will take a $2.7 billion charge against earnings to cover the settlement and litigation costs for the remaining cases. About 9,000 bladder cancer claims are pending against Takeda involving Actos, the New York Times reports.
The lawsuits allege that Takeda concealed the cancer risk of the top-selling medication. Last year, a Louisiana jury ordered Takeda and Eli Lilly, which had been a co-marketer of Actos, to pay a combined $9 billion in punitive damages after finding that Takeda had hidden the cancer risks. The judge later reduced the award to $36.8 million, the Times reports. According to a court filing in the Louisiana case, sales of Actos in the United States have exceeded $24 billion since the drug went on the market in 1999, with more than 100 million prescriptions. A Chicago attorney who represented Actos plaintiffs in Illinois state courts, said he believes the settlement was the largest for a drug that remained on the market. Many of the cases were brought in Illinois because Takeda’s American operations are based there.
According to the Times, the settlement will become effective if 95 percent of the plaintiffs agree to it, in which case Takeda would pay $2.37 billion. If 97 percent of plaintiffs participate, Takeda will pay $2.4 billion.
Actos, prescribed to treat Type 2 diabetes, has been increasingly linked to a higher risk of bladder cancer. In 2011, the Food and Drug Administration (FDA) said that taking Actos for more than a year could significantly increase the risk of bladder cancer and the safety label on Actos was updated to address the risk. Recent research studies provide additional support for the link. In May 2012 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. In July 2012 an article in the Canadian Medical Association Journal reported that patients taking Actos were 22 percent more likely to get bladder cancer.
More than 3,500 lawsuits have been brought over Actos and have been consolidated before U.S. District Judge Rebecca Doherty in Lafayette, Louisiana, for pretrial discovery, court dockets indicate. Another 4,500 cases have been filed in state courts in Illinois, West Virginia, California, and Pennsylvania. According to national law firm Parker Waichman, which has handled a number of Actos cases, 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 who (a) allege that they have bladder cancer; (b) first used Actos prior to December 1, 2011; and (c) either have a lawsuit currently pending or retained counsel to assert a claim within three days of the announcement of the settlement.
In their lawsuits, plaintiffs allege that Takeda executives ignored or minimized concerns about Actos’s cancer-causing potential prior to releasing the drug to market in 1999 and subsequently misled U.S. regulators about the apparent risks. In some cases, the company blamed the individual’s lifestyle for their cancer.
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