U.S. District Judge Rebecca Doherty, assigned by the U.S. Judicial Panel on Multidistrict Litigation to preside over federally filed lawsuits against Takeda Pharmaceuticals America Inc. regarding the diabetes drug Actos and the increased risk of bladder cancer, has scheduled an initial hearing.
Judge Doherty will also appoint lead attorneys for the cases, which are expected to reach into the thousands.
Sales of Actos were stopped in France and Germany last year by Takeda Pharmaceuticals Co. Ltd., though in the United States sales continue under a FDA increased warning regarding the association between long term use of the drug and bladder cancer.
The Associated Press reports Takeda issued a statement regarding the drug, “Takeda is confident in the therapeutic benefits of Actos and its importance as a treatment for type 2 diabetes. As a science and evidence-based company, Takeda firmly stands behind the substantial data available confirming the positive risk/benefit profile of Actos, which includes twelve years of clinical and patient experience with the product.”
The consolidated lawsuits allege that researchers found that patients who use the drug for longer than 12 months have an increased risk of developing bladder cancer. The lawsuits also allege Takeda knew of the bladder cancer risks and concealed that knowledge and failed to adequately warn physicians and their patients about those risks.