Actos Class Action Lawsuit Filed Over Bladder Cancer Risk

A class action lawsuit has been filed against Takeda Pharmaceuticals and Eli Lilly on behalf of all users of the diabetes drug Actos, seeking financial compensation and medical monitoring as a result of the drug makers’ failure to adequately warn about the risk of bladder cancer from Actos.

The Actos class action lawsuit was filed last month in the U.S. District Court for the Eastern District of Louisiana on behalf of two users of the drug who developed bladder cancer, and one of their spouses. However, the complaint seeks class certification to include coverage for the millions of individuals who used Actos in the United States since it was introduced in 1999.

Actos (pioglitazone) is a prescription medication approved by the FDA for treatment of Type II diabetes. The drug increases the body’s sensitivity to insulin, and has increased in popularity in recent years, generating an estimated $4.3 billion in sales last year and becoming one of the ten best selling drugs in the United States.

Recently, concerns have surfaced about a potential increased risk of bladder cancer from Actos. In June 2011, the FDA issued warnings indicating that use of Actos for more than one year has been associated with a bladder cancer risk. As a result of the high incidence of cancer identified, French drug regulators forced an Actos recall to be issued in that country, and many have suggested that Actos should be removed from the market in the United States as well.

In recent months, dozens of individuals throughout the United States have filed an Actos bladder cancer lawsuit, alleging that Takeda pharmaceuticals failed to adequately research their medication or warn about the potential risks associated with use.

According to allegations raised in the class action lawsuit over Actos filed on September 16, Takeda had a significant financial incentive to suppress, misrepresent and conceal the potential dangers assocaited with Actos to maximize their profits at the expense of the health of patients taking the drug. As a result of the drug maker’s failure to appropriately disclose material information about the known risk of cancer from Actos, the complaint alleges that users did not have adequate information about the risks of using Actos and were therefore unable to avoid exposing themselves to a risk of injury.

“Clearly, the relationship between Actos and bladder cancer has been known, or should have been known, to Defendants,” the class action Actos complaint alleges. “Despite their knowledge, Defendants refused to inform patients, doctors or the medical community about the risks and put their profits before people.”

Plaintiffs indicate that they are bringing the Actos class action to recover money damages, medical monitoring and other relief for all individuals who ingested Actos in the United States or it’s territories since it was introduced in July 1999. Actos was taken by millions of people each week, resulting in a class that could include a millions if the complaint is certified.

The U.S. Judicial Panel on Multidistrict Litigation is expected to decide later this year whether the federal Actos litigation, which currently consists of more than 50 individual lawsuits and this one class action, should be centralized before one judge for pretrial proceedings. If the cases are consolidated, the cases would be managed in a manner similar to how an Actos class action suit would be handled during discovery and pretrial litigation. However, if an Actos settlement or other resolution is not reached, each case would be handled individually for trial.