Actos Lawsuit Over Bladder Cancer Filed by Ohio Man

An Ohio couple has filed a lawsuit over Actos against Takeda Pharmaceuticals and Eli Lilly, alleging that the drug makers failed to disclose data showing an increased bladder cancer risk from their popular diabetes drug. 

The complaint was filed against the two pharmaceutical companies by John and Joanne Scaro on July 29 in the U.S. District Court for the Northern District of Ohio. While Actos is now solely owned by Takeda Pharmaceuticals, it was originally marketed jointly by the two companies.

According to the Actos lawsuit, John Scaro was diagnosed with bladder cancer in February 2011, after taking Actos since 2009. The complaint accuses the companies of putting out a defective product, failing to warn consumers about the potential Actos bladder cancer side effects, and violating Ohio consumer protection laws. The couple seeks both compensatory and punitive damages.

Takeda Pharmaceuticals and Eli Lilly allegedly knew about the potential increased risk of bladder cancer with Actos use before the drug was even approved, but sat on the information according to the complaint. The lawsuit indicates that a two year carcinogenicity study conducted on rats found that male rats developed tumors when they had Actos in their blood at levels equivalent to a clinical dose, but the results were not included in clinical trial data published in 2005.

In September 2010, the FDA began a review of the risk of bladder cancer from Actos after a study by Kaiser Permanente.

Earlier this summer, insurers in France found increased incidents of bladder cancer among Actos users, leading to an Actos recall in France and Germany. Other European countries and the FDA have allowed the drug to stay on the market with new Actos bladder cancer label warnings.

Actos (pioglitazone) was approved by FDA to treat Type 2 Diabetes in July, 1999. The medication has grown in popularity in recent years, after studies linked it’s primary competitor, Avandia, to an increased risk of heart attacks and death. Last year, Actos generated $3.4 billion in sales for Takeda Pharmaceuticals.

The drug maker now faces a growing number of Actos lawsuits over bladder cancer, which are being pursued by individuals throughout the United States.