MDL Panel Set to Consider Consolidation of Actos Bladder Cancer Litigation

A panel of federal judges is preparing to decide whether to consolidate the federal Actos bladder cancer litigation before one judge for coordinated pretrial management. 

The U.S. Judicial Panel on Multidistrict Litigation has scheduled to hear oral arguments for a motion for centralization of the Actos lawsuits on December 1, at their next hearing session at the Tomochichi United States Courthouse in Savannah, Georgia.

A motion was filed by plaintiffs’ lawyers in August to centralize the federal litigation over bladder cancer from Actos into an MDL. Although Takeda Pharmaceuticals has indicated they agree the Actos suits should be consolidated for discovery and pretrial proceedings, they disagree about where the cases should be centralized.

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Dozens of Actos cases have been filed in various federal district courts throughout the United States by individuals who have developed bladder cancer after taking the type II diabetes drug. All of the complaints involve similar allegations that Takeda Pharmaceuticals failed to warn of Actos side effects that could increase the risk of bladder cancer.

The first bladder cancer lawsuit over Actos was filed on July 29, 2011. While a scheduling order from the MDL panel indicates that there are only 11 cases being considered, Takeda released documents last month that stated that the company was aware of at least 54 cases that have been filed in federal district courts throughout the United States.

If an Actos MDL is formed, all cases involving allegations that plaintiffs developed bladder cancer from Actos would be transferred to the same judge. In addition, as Actos lawyers continue to review and file new complaints in federal courts throughout the United States, those cases would also be transferred into the MDL for pretrial litigation.

Actos (pioglitazone) was approved by the FDA to treat Type 2 Diabetes in July, 1999. It is a once-a-day pill that increases the body’s sensitivity to insulin. 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 $4.3 billion in sales for Takeda Pharmaceuticals.

FDA officials began reviewing the potential risk of Actos bladder cancer problems in September 2010, after interim data from an on-going 10 year study found that users may face an increased risk the longer they take the drug. Data from the study conducted by Takeda Pharmaceuticals, the makers of Actos, indicated that after 24 months, the rate of exposure and the increased risk of bladder cancer reached statistical significance.

In June, an Actos recall was issued in France after a review of public insurance data identified an increased incidence of bladder cancer with Actos use. That led to stronger warnings in the United States and other countries, and has increased awareness about the potential link between Actos and bladder cancer.

Some estimates suggest that more than 1,000 cases may ultimately be included as part of the Actos litigation. Even if the lawsuits are consolidated as part of an MDL, they still remain individual claims and would be remanded back to the court where they were originally filed for trial if an Actos settlement agreement is not reached during pretrial proceedings.


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