It will be more than two years before the first federal Actos case goes to trial, according to a new order issued this week by the judge overseeing the multidistrict litigation (MDL) for lawsuits filed by individuals who have developed bladder cancer after using the type-2 diabetes drug.
In December 2011, the U.S. Judicial Panel on Multidistrict Litigation established an Actos MDL, for all complaints filed in U.S. District Courts throughout the country. The cases have been centralized before U.S. District Judge Rebecca Doherty in the Western District of Louisiana for consolidated handling during pretrial proceedings.
According to an order issued by Judge Doherty on July 13 (PDF), after considering the number of lawsuits expected to be filed, the amount of discovery that needs to be completed and the time necessary to complete pretrial preparations, a detailed schedule has been set out for the MDL, culminating with the first Actos trial date in November 2014, and a second trial in January 2015.
Bellwether Trial Plan in Actos MDL
It is a common practice in complex pharmaceutical litigation, where a large number of lawsuits have been filed involving similar allegations, for a small group of cases to be prepared for early trial dates.
Known as “bellwether” cases, the outcome of these early trials are designed to allow the parties to gauge how juries are likely to respond to evidence that is going to be presented in multiple cases, and the process is may help facilitate an eventual Actos settlement agreement or other resolution for the litigation.
According to the scheduling order, Judge Doherty indicates that the Court will issue an order describing the bellwether trial protocol by October 31, 2012. Each party will then select 20 cases by June 3, 2013, to be prepared for the first trial dates.
Core discovery in these bellwether cases is expected to be completed by September 30, 2013, and the selection of the cases to be presented during the first bellwether trials will be made by October 16, 2013. The first trial date will begin on November 3, 2014 and the second trial date is set to begin January 12, 2015.
Actos Lawsuits Continue to Mount
Hundreds of individuals throughout the United States have already filed an Actos lawsuit after developing bladder cancer, and it is expected that the litigation will continue to grow over the next two years.
While the Actos statute of limitations for cases arising in states with a one year limitation period may expire next month, most states allow individuals two or three years to file their claim after the discovery that their injury may have been caused by use of the medication. Therefore, the volume of new cases is unlikely to diminish for some time.
Bladder Cancer Risk from Actos
Actos (pioglitazone) was approved by the FDA for treatment of type 2 diabetes in July 1999. It is a once-daily pill that increases the body’s sensitivity to insulin. Related medications that also contain the same active pharmaceutical ingredient include ActoPlus Met and Duetact.
Over the past 18 months, concerns have emerged about the risk of bladder cancer from Actos, after interim data released in September 2010 indicated that long-term use of the diabetes drug was linked to an increased rate of bladder cancer.
In June 2011, the FDA issued a drug safety communication to indicate that new information would be added to the warning label for Actos, which indicates that use of the medication for more than one year may increase the risk of developing bladder cancer. Although regulators in France removed the diabetes drug from the market due to the risk, the FDA has not indicated that a recall for Actos will be issued in the United States.
Earlier this month, a study by Canadian researchers confirmed that Actos side effects appear to increase the bladder cancer risk.