North Carolina Man Files Actos Cancer Lawsuit

On August 16, a new Actos cancer lawsuit was added to the multidistrict litigation proceedings underway against manufacturers Takeda (MDL no. 2299). The complaint was made by a man from North Carolina, and was submitted to the U.S. District Court for the Western District of Louisiana, where the MDL is being heard before Judge Rebecca F. Doherty.

According to the lawsuit, the plaintiff began taking the type 2 diabetes medication in December 2008, continuing treatment until October August 2011. He was subsequently diagnosed with bladder cancer in October 2011. The lawsuit states that the plaintiff “would have chosen safer, alternative medicines” if he had known of the risk of bladder cancer associated with Actos.

Actos cancer lawsuit allegations

The FDA approved Actos in 1999. According to the complaint – and other Actos litigation – numerous studies have since linked the drug to bladder cancer, including a 2005 clinical trial. Early concerns were raised in the United States after an Actos recall was conducted in France and Germany. Takeda is accused of deliberately and maliciously withholding its knowledge of the increased risk of bladder cancer in patients taking the drug for more than one year.

On June 15, 2011, the FDA issued a Safety Announcement stating that the, “use of the diabetes medication Actos for more than one year may be associated with an increased risk of bladder cancer.” The agency simultaneously ordered Takeda to add bladder cancer to the list of Actos side effects on the label. On December 29, 2011, the U.S. Judicial Panel on Multidistrict Litigation ordered all pending federal Actos lawsuits to be centralized before Judge Doherty. The cases have been consolidated for pretrial proceedings and bellwether trials, which are designed to gauge how juries will respond to testimony and evidence repeated in the litigation.

So far, more than 1,500 lawsuits have been centralized in the Actos MDL, and there are more cases pending in state courts all over the country.

In early 2013, the first Actos trial began.  After a two month trial, a Los Angeles jury found that Takeda failed to adequately warn the public or the medical community about the potential cancer risk associated with Actos and awarded the plaintiff $6.5 million in damages. However, the judge subsequently overturned the award after dismissing expert testimony that stated the bladder cancer diagnosis was caused by the diabetes drug. The plaintiff’s Actos lawyer plans to appeal the post-verdict decision.

A small number of cases in the MDL are now being prepared for early trial dates, with the first scheduled to begin in January 2014, and the second in April 2014.

Actos cancer lawsuit lists eight counts

The North Carolina plaintiff charges the defendants with eight counts, including negligence, failure to warn, defective design and fraudulent concealment. Takeda is accused of failing to “exercise ordinary care” and of being “reckless in designing, researching, manufacturing, marketing, supplying, promoting, packaging, sale, testing, quality assurance, quality control, and/or distribution of Actos.”

The lawsuit also alleges that Takeda “possessed pre-clinical scientific studies including animal evidence” that indicated a bladder cancer risk, and a need for further testing before Actos could be released to market.