Late last week, a Pennsylvania jury ordered Takeda Pharmaceuticals to pay more than $2 million to a woman who claimed her bladder cancer was caused by the company’s diabetes drug Actos (pioglitazone).
The jury found that Takeda officials failed to adequately warn the patient in this case about the cancer risk associated with Actos, Bloomberg News reports. The woman’s attorney said in an interview that Takeda “clearly failed to warn, and it clearly caused her damage,” describing the verdict as “fair,” given that his client now faces a life with bladder cancer.
In 2011, the U.S. Food and Drug Administration (FDA) indicated that taking Actos for more than one year could significantly increase the risk of developing bladder cancer; the Actos safety label was updated to address this risk. Also, studies published in 2012 in the BMJ and the Canadian Medical Association Journal reported an increased likelihood of Actos users developing bladder cancer.
The 79-year-old woman in this case is the seventh Actos patient to take a lawsuit to trial. Court records indicate that more than 2,700 Actos suits have been consolidated before U.S. District Judge Rebecca Doherty in Louisiana for pretrial proceedings. According to Bloomberg News, in addition to the federal lawsuits, there are hundreds of claims pending in state courts.
The Pennsylvania jury is now the fourth jury to find liability against Takeda for cases involving claims that Actos caused the plaintiff at trial to develop bladder cancer.
Prior to this, in April 2013, a California jury awarded $6.5 million to a couple who alleged that the husband’s terminal bladder cancer was a result of his having had taken Actos. The case was the first of more than 3,000 Actos bladder cancer cases filed nationwide to reach trial and involving allegations that Takeda neglected to advise physicians about Actos’ health risks. The man was diagnosed with bladder cancer in December 2011 after taking Actos for five years and the case was heard first due to his grave diagnosis.
In another case, a massive $9 billion verdict was reached in April 2014 by a Louisiana federal jury. The jury ordered Takeda and Eli Lilly & Company to pay a couple whose bellwether trial was brought over allegations that the drug makers hid Actos’ cancer risks to ensure sales were not adversely impacted. This was the first federal jury decision in a multidistrict litigation (MDL) involving Actos. Takeda was ordered to pay $6 billion in punitive damages; Eli Lilly was found responsible for $3 billion. The companies, which jointly market Actos, will split the $1.5 million in actual, or compensatory, damages.
In September 2013, a Maryland jury found for Takeda because the plaintiff’s bladder cancer death was blamed, in part, on his smoking. In Maryland, state contributory law—so-called “negligence doctrine”—mandates that if the patient in any way contributed to his/her death following consumption of a named product, then the company that manufactured the product may not be penalized. Regardless, the jury did find for the man’s family in the amount of $1.77 million.
Juries are clearly understanding the cases and finding fault on behalf of Takeda despite that the drug maker claims that it is the patients’ lifestyles, and not Takeda’s behaviors and practices, that are to blame.