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Takeda Pharmaceuticals faces it’s second trial for an Actos lawsuit involving allegations that the drug maker knew it’s blockbuster diabetes drug increased the risk of bladder cancer, but placed the desire for profits before the safety of consumers by failing to provide adequate warnings.
A case began in the Baltimore City Circuit Court of Maryland this week, involving a complaint filed by the family of Diep An, who died last year from bladder cancer after using Actos for treatment of type 2 diabetes.
According to allegations raised during opening statements, the family’s lawyers indicate that evidence will be presented during trial that will establish Takeda knew about the risk of bladder cancer from Actos years before warnings were provided to consumers or the medical community.
Diep An began using Actos in 2007 and was diagnosed with bladder cancer in September 2011. He died from the disease in January 2012, and the family alleges that death was directly caused by his use of Actos.
The trial begins as Takeda faces thousands of similar Actos bladder cancer lawsuits throughout the United States. The An family’s case will be the second to reach a jury after a California state court case resulted in a $6.5 million award in May for damages from Actos. However, that verdict was subsequently reversed by the trial judge after key expert witness testimony was excluded.
Concerns About Actos Bladder Cancer Side Effects
Actos (pioglitazone) is a type 2 diabetes drug that has been used by millions of Americans since it was introduced by Takeda in 1999. However, in recent years, concerns have emerged about an increased risk of bladder cancer following long-term use of Actos.
The FDA first announced that there may be a possible connection between bladder cancer and Actos in September 2010, after preliminary data from an on-going 10 year study suggested that there may be an increased risk the longer the drug is taken.
In May 2011, a study by Italian researchers found a disproportionate number of Actos bladder cancer reports in the FDA’s own Adverse Event Reporting System Records.
Actos cancer concerns did gain widespread media attention until the summer of 2011, when a study by French insurers revealed an increased risk of bladder cancer. As a result of the risk, Actos recalls have been issued in several European countries, but the medication has remained on the market in the United States with stronger warnings placed on all medications containing pioglitazone, the active pharmaceutical ingredient in Actos.
Federal Actos Litigation Trials Begin January 2014
Most of the complaints over Actos filed nationwide are pending in the federal court system, where more than 1,500 lawsuits are currently centralized for pretrial proceedings as part of an MDL, or Multidistrict Litigation, before U.S. District Judge Rebecca H. Doherty in the Western District of Louisiana.
As part of the Actos litigation in the federal MDL, a small group of cases are being prepared for early trial dates, known as “bellwether” cases. The first Actos trial in the MDL is scheduled to begin on January 27, 2014, involving a case originally selected by the plaintiffs. That case will be followed by a second trial scheduled to begin on April 14, 2014, involving a defendant pick.
On August 26, Judge Doherty issued a list of monthly conferences (PDF) that will be held throughout the next year in the MDL, as well as an order for all parties to meet and confer (PDF) over what evidence should and should not be allowed in the trials.
In complex pharmaceutical litigation, early trial dates are important in facilitating a possible resolution for a large number of lawsuits, as the outcomes may help the parties gauge how juries are likely to respond to certain evidence and testimony that could be similar to what is offered in a number of cases. Following the federal “bellwether” trials, if an Actos settlement agreement is not reached, Takeda could face hundreds of individual trials in courts throughout the country if the MDL cases are remanded back to their home U.S. District Courts for individual discovery and resolution.