A class action lawsuit, issued on the behalf of users of the anti-diabetic drug Actos who have developed bladder cancer, was filed on July 31, 2012, in the Superior Court of Montreal.  The claimants, all residents of Quebec, are suing the manufacturers and distributors of Actos: the Japan-based Takeda Pharmaceutical Company, it affiliates, and Eli Lilly & Co., Takeda’s U. S. partner.  The suit alleges “the defendants knew or ought to have known that Actos materially increases the risk of bladder cancer and failed to disclose those risks in a timely manner and have failed to recall the drug.”

Approved in the United States in 1999 and in Canada in 2000, Actos, or pioglitazone, belongs to a class of medications called thiazolidinediones (TZD). This oral medication is prescribed to treat Type 2 diabetic patients who are not insulin dependent.  Used in conjunction with diet and exercise, Actos is intended to aid in two ways: to help the body use naturally produced insulin more effectively and to stop the liver from overproducing sugar.  Promoted by the manufacturer as a safer alternative to other anti-diabetes drugs, Actos, while beneficial to some, also has numerous severe and life-threatening side effects including the increased risk of bladder cancer.  According to the Canadian Medical Association Journal, one study found that in general, diabetic patients are at a forty percent higher risk then the non-diabetic population of developing bladder cancer and “taking Actos adds a twenty-two percent risk to an already-high risk of bladder cancer.”

In June 2011, the U. S. Food and Drug Administration (FDA), based on the results of an independent French study, announced that the “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer” and required a label and Warnings and Precautions update. The French study found a statistically significant increased risk of long-term use (more than one year) and bladder cancer and an increased risk of higher cumulative dosing (28,000 mg or greater) and bladder cancer.  The European community took this study seriously and acted immediately: use by new patients in both France and Germany was halted immediately.

The proposed Representative Plaintiff of the Canadian class action is Jimmy Whyte, a 64 year-old retiree living in Kahnawake, Quebec. Whyte began taking Actos in November 2008 to help manage his diabetes, but in early 2012, he was diagnosed with bladder cancer. A similar class action was filed in Ontario in December 2011.

In the United States, thousands of lawsuits have also been filed against Takeda since 2011. These cases were consolidated into a Multidistrict Litigation, or MDL. Unlike a class action where one person or group files a lawsuit based on the same grievance for a larger group, a MDL is a procedure in which all civil cases of a similar type are transferred to one federal judge. This allows plaintiffs to save time, money, and resources and still retain their own attorney and negotiate their own terms. A panel of seven federal judges appointed by the U.S. Supreme Court meets periodically to determine who will oversee each MDL. On December 29, 2011, the panel determined that all Actos cases would be part of an MDL No. 2299 presided over by U. S. District Judge Rebecca Doherty of the Western U. S. District Court of Louisiana. In July 2012, Judge Doherty issued an important ruling regarding these lawsuits: the first Actos lawsuits will go to trial in November 2014.

If you have developed bladder cancer and are taking or have taken Actos, there is a high likelihood that the cancer is a result of Actos consumption.   Don’t miss your chance to become part of the MDL.  Any Actos user who has been diagnosed with bladder cancer (including transitional cell carcinoma, squamous cell carcinoma, and adenocarcinoma) should contact us at once.  Even if a healthcare professional has not mentioned a possible link between Actos and the bladder cancer, patients may still have a valid claim for compensation against Takeda, the drug’s manufacturer. Many treating physicians, especially those who treat cancer, are more focused on treatments, cures, and prognosis for the future then on causes. The patient’s historical exposure to potential carcinogens is typically of more interest to epidemiologists, the scientists who focus on causation.