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• Actos lawsuits have been steadily growing in number since June 2011, when the U.S. Food and Drug Administration (FDA) warned that use of Actos for one year or more had been linked to the development of bladder cancer, which reads:“The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.”
• In April of this year, one Actos lawsuit concluded with a Superior Court judge in Los Angles awarding $6.5 million to the plaintiff, who had taken Actos for four years and was subsequently diagnosed with bladder cancer. However, the judge overseeing the case granted Takeda Pharmaceuticals’ request to set aside the verdict. (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court.)
• According to an August 15 update from the U.S. Judicial Panel on Multidistrict Litigation (JPML), more than 2,500 Actos bladder cancer lawsuits are currently pending in the federal litigation. (In re: Actos Product Liability Litigation, MDL No. 2299.)
• All of the lawsuits pending in the Western District of Louisiana accuse Takeda Pharmaceuticals of 1) concealing knowledge that Actos is associated with an increased risk of bladder cancer; and 2) failing to provide adequate warnings to doctors and patients regarding the drug’s association with an increased risk of bladder cancer, among other things.
• Actos lawsuits alleging the type 2 diabetes medication can cause bladder cancer continue to be filed nationally. Most recently, 14 such Actos lawsuits were filed in Wayne County Circuit Court in West Virginia.
Here we provide an update on the Actos lawsuits.
Actos Multi-district Litigation (MDL)
• The judge overseeing some 1,300 consolidated federal Actos bladder cancer lawsuits from across the US held an important status conference on the case on July 25, 2013, during which lawyers representing the plaintiffs briefed the judge about the progress of the lawsuits.
• During the hearing, US District Judge Rebecca F. Doherty in the Western District of Louisiana scheduled the next status conference for August 22.
• Doherty was chosen by a national federal panel of judges to oversee pre-trial evidence-gathering and legal procedures in the Actos litigation and possibly eventually decide whether to grant the litigation class-action status.
• According to court documents, the first trial in the federal Actos bladder cancer litigation in Western District of Louisiana is scheduled to begin on January 27, 2014.
• An MDL is more practical for both the plaintiffs and the judicial system, as it allows for trying all cases on an individual basis. An MDL is a special federal legal procedure that speeds up the process of handling complex cases such as complex product liability lawsuits. An MDL can take place when civil actions involving one or more common questions of fact are pending in different districts. Additionally, MDLs reduce the likelihood of duplicative discovery and conflicting pretrial rulings from different judges.
Actos Product History
• Approved by the FDA in 1998 for the treatment of type 2 diabetes, Actos, also known as Pioglitazone, the active ingredient in Actos, is also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact).
• Following the FDA warning for bladder cancer, issued in June 2011, Germany and France pulled Actos from their markets.
• In June, 2013, India also banned Actos and other pioglitazone-containing drugs, citing an association with bladder cancer and congestive heart failure.
• In 2002, the Actos package label included the following warning regarding the risk of Actos side effects: “In insulin combination studies, a small number of patients with a history of previously existing cardiac disease developed congestive heart failure when treated with ACTOS in combination with insulin.” In July 2004, the label was changed to add “Carcinogenesis, Mutagenesis, Impairment of FertilityÚ to the precautions.
• The FDA has also announced a potential safety issue with Actos (pioglitazone HCL) being linked to rhabdomyolysis. A potential safety issue means that the FDA has not established that there is a causal link between the two but that the drug is associated with the risk. FDA is evaluating the issue to determine if there is a need for regulatory action regarding Actos and rhabdomyolysis.