Actos Lawsuit Award Overturned

San Diego, CAA judge has overturned a $6.5 million award in an Actos side effects lawsuit, after finding that the plaintiff did not adequately prove a link between Actos and bladder cancer. Specifically, the judge found the plaintiff in the Actos lawsuit did not prove his cancer was caused by the medication.

The lawsuit (Cooper v. Takeda Pharmaceuticals America, Inc., CGC-12-518535) involved 79-year-old Jack Cooper, who took Actos for four years before he was diagnosed with bladder cancer. According to a press release (5/25/13), the jury deliberated for five days before awarding Cooper $6.5 million.

Meanwhile, Bloomberg (5/2/13) reports that Takeda Pharmaceutical Co., argued after the verdict was issued that Cooper did not prove his cancer was caused by Actos. The company’s argument swayed the judge, who threw out the verdict. According to Bloomberg, Cooper’s lawsuit was the first of approximately 3,000 lawsuits to go to trial. A lawyer for Cooper told Bloomberg they planned to appeal the judge’s decision.

According to a different Bloomberg article (4/15/13), the plaintiff argued that Takeda hid the risk of cancer associated with its diabetes drug to protect sales. Lawyers for the plaintiff produced e-mails that suggested executives were concerned about the US Food and Drug Administration (FDA) updating the warning label for Actos to include information about bladder cancer.


However, in June 2011, the FDA issued a warning that use of Actos for more than one year could be associated with an increased risk of bladder cancer. That announcement came after a review of an interim analysis of a 10-year study on Actos. According to the FDA safety communication, although there was no overall increased risk of bladder cancer associated with pioglitazone (Actos) use, there was an increased risk seen in patients who had the longest exposure to the drug and in those who had the highest cumulative dose.

Meanwhile, officials in France suspended the use of pioglitazone based on an epidemiological study that also suggested an increased risk of bladder cancer in patients who used the medication.

Lawsuits against Takeda are in federal court in Louisiana and state courts in California and Illinois. Takeda has said there is no proof that Actos causes bladder cancer. Lawyers for the company argued that Cooper likely developed bladder cancer for reasons other than his use of Actos.