More than 100 Actos lawsuits are being consolidated in a multidistrict litigation, which involves all federal cases that allege injury as a result of taking the Type II diabetes medication. The cases will be centralized in the Western District of Louisiana.
Actos (pioglitazone), which was jointly launched by Takeda Pharmaceuticals America Inc. and Eli Lilly and Co. in 1999, was approved for the treatment of Type II diabetes. Last year, the U.S. Food & Drug Administration (FDA) announced that, following release of early data from a Kaiser Permanente study that revealed increased risks for bladder cancer in people taking Actos, it began its own safety review. The Kaiser study found that bladder cancer risks increased with increased dosing and duration of Actos use; significantly statistical significance was seen following two years of Actos use.
This year, the agency issued another safety communication indicating that taking Actos for over one year may be linked to increased risks for bladder cancer. A 40 percent increased risk for bladder cancer was seen in Actos users when compared to people who never took Actos, said the FDA. The agency then mandated that revised risk information be included in the “Warnings and Precautions” section of the Actos label.
Plaintiffs filed a motion this summer to transfer 11 pending cases in federal district courts and all other Actos injury actions subsequently filed, to one judge for pretrial hearings, said Harris Martin. The plaintiffs also urged for the coordinated docket to be moved to the U.S. District Court for the Southern District of Illinois. The Court consented to the assignment and a subsequent order indicated that over 100 cases will be transferred. The docket has been assigned to the Honorable Judge Rebecca F. Doherty, U.S. District Court for the Western District of Louisiana (MDL 2299).
“We are persuaded that the Western District of Louisiana is an appropriate transferee district for this litigation,” the U.S. Judicial Panel on Multidistrict Litigation (JPML) wrote, said Harris Martin. “The allegations in this nationwide litigation do not have a strong connection to any particular district, and related actions are pending in numerous districts across the country. Some plaintiffs support centralization in the Western District of Louisiana, mostly in the alternative, and the defendants also support centralization in this district in the alternative, although they emphasized at oral argument that this district was a distant second choice to their primary suggestion. Notably, centralization in the Western District of Louisiana permits the Panel to assign the litigation to an experienced judge who sits in a district in which no other multidistrict litigation is pending,” the Panel continued.
The petition to consolidate also stated that “In 2008, with the knowledge of the risk associated with developing bladder cancer while using Actos long term, Takeda achieved its marketing goal by making Actos the tenth best-selling medication in the U.S., all while placing American citizens utilizing Actos at risk of developing bladder cancer” Harris Martin indicated. “In the last year, the medication had global sales of $4.8 billion and accounted for approximately 27 percent of Takeda’s total revenue.”
We previously wrote that one plaintiffs’ attorney told Bloomberg News that the link between Actos and bladder cancer is “unusually strong and clear.” Another lawyer noted that bladder cancer is a “signature injury because there aren’t a lot of other things that cause that particular illness.” According to the Bloomberg report, Takeda acknowledged in September that it was sued 54 times by people claiming to have developed Actos bladder cancer; however, attorneys said in the report that they receive Actos lawsuit inquiries daily, and expect as many as 10,000 complaints will ultimately be filed.
Meanwhile, in June, the French and German governments suspended Actos sales after a separate study commissioned by French regulators demonstrated an increased risk of bladder cancer associated with Actos in people who took it the longest and at the highest cumulative dose. On July 12, Takeda Pharmaceuticals officially recalled Actos from the market in France.