Takeda Suffers Another Hit in Actos Legal Battle

October 10, 2014

A Pennsylvania jury last week ruled that Takeda must pay more than $2 million for downplaying bladder cancer risks of its diabetes drug Actos, a verdict one legal expert believes could embolden other plaintiffs to move forward with their lawsuits.

The outcome of this case is being closely watched by parties in roughly 3,500 cases still pending in various federal courts and up to 5,000 cases in state courts.

Attorneys for other Actos cases can tell their clients they should “move forward on this because so far people have been going to court and winning,” says Erik Gordon, a business professor with the University of Michigan.

Plaintiffs in Pennsylvania were able to overcome a common defense that the patient’s cancer was caused by other factors, such as smoking, as well as win on arguments of failure to warn, he said.

In this case, plaintiff Frances Wisniewski alleged Takeda sales representatives gave physicians sales materials that downplayed Actos’ (pioglitazone hydrochloride) overall risks and failed to warn physicians of the drug’s cancer risks. Wisniewski, who contracted bladder cancer after taking Actos, also contended that Takeda failed to adequately test the product prior to placing it on the market, making the company liable for its safety issues, according to court filings.

The jury in the Philadelphia Court of Common Pleas ruled in favor of Wisniewski on Oct. 3.

Takeda, which denied that it misled or induced providers to prescribe Actos, said it is considering its options, including whether to appeal. The drugmaker also has denied that Actos causes bladder cancer, and said it has acted responsibly with respect to the drug.

Previous cases have gone both ways for Takeda. In May, a Las Vegas jury found Takeda not liable for bladder cancer in two women who took Actos. But a jury in a Louisiana federal case slapped Takeda and Eli Lilly, which marketed Actos until 2006, with $9 billion in punitive damages, a verdict the firms have tried unsuccessfully to repeal. Lilly has been a party in some trials but not the Pennsylvania case. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.