The first lawsuit against Takeda Pharmaceuticals and related companies over Actos injuries will be heard February 19 in Los Angeles Superior Court.
In that case, Mississippi resident Jack Cooper alleges that he developed bladder cancer as a result of taking Actos to treat his type 2 diabetes. Mr. Cooper filed his lawsuit in California, where Japan-based Takeda keeps its North American headquarters.
Because it will be the first Actos case to go to trial, Mr. Cooper’s lawsuit will serve as a bellwether for potentially thousands of other such cases filed throughout the country. A recent Business Week report estimates the number of Actos claims against Takeda could reach 10,000 in the U.S.
All lawsuits involving Actos filed in federal courts have been consolidated for multidistrict litigation (MDL) under Judge Rebecca Doherty in U.S. District Court for the Western District of Louisiana. Trying all of the lawsuits together with a handful of representative cases under one judge simplifies the discovery process and ensures uniformity in rulings. The MDL process also frees the court from individually trying thousands of lawsuits.
Last summer, the U.S. Food and Drug Administration (FDA) issued an Actos alert, warning doctors and patients that taking the drug for more than a year significantly increased the patient’s risk of developing bladder cancer. The FDA approved Actos for the treatment of type 2 diabetes in July 1999, and the drug, designed to regulate blood glucose levels, quickly became a blockbuster drug for Takeda. In 2010, Actos drug earned Takeda more than $2.6 billion.
Most plaintiffs suing Takeda over bladder cancer injuries claim the drug maker did not adequately warn them about the serious risks. One recent study published in the Canadian Medical Journal found that Actos use was associated with a 22-percent increase in developing bladder cancer. Other adverse effects linked to Actos use include causing or worsening of congestive heart failure, liver damage, bone fracture, and impaired vision.