Actos Bellwether Trial Set to Begin in Federal MDL

Jury selection is expected to begin today in the first federal bellwether trial to address allegations that side effects of Actos caused bladder cancer.

The Actos bellwether trial involves a lawsuit brought by Terrence Allen and his wife, Susan, which will be the first case out of nearly 2,700 lawsuits pending throughout the federal court system to go before a jury.

The process of questioning potential jurors, known as voir dire, is expected to take about two and a half days, followed by pretrial rulings on jury instructions and finalization of the verdict sheet.

Opening statements are likely to begin on February 3, before U.S. District Judge Rebecca F. Doherty, who is presiding over the centralized federal Actos MDL (multidistrict litigation) in the U.S. District Court for the Western District of Louisiana. Trial is expected to last about six weeks, with the plaintiffs taking about 20 trial days to put on their case, and the makers of Actos expected to take another another 11 trial days for the defense.

The Allen case has been selected as a “bellwether” trial, which is designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout other Actos bladder cancer lawsuits.

All of the cases center around similar allegations that Takeda Pharmaceuticals failed to adequately warn consumers and the medical community about the potential risk of bladder cancer associated with long-term use of the diabetes drug.

According to the complaint (PDF) filed in the Allen case, Terrence Allen took Actos from 2004 until 2011, when he was diagnosed with bladder cancer. The plaintiffs allege that Takeda Pharmaceuticals knew about the link between Actos and bladder cancer in the early 2000s, yet withheld this important safety information. Allen maintains that if he and his physicians had known about the risk of bladder cancer, he would have been prescribed a different drug for treatment of his type 2 diabetes.

Actos Trial May Gauge Jury Response in Other Cases

The Allen trial will be closely watched by lawyers representing other individuals with similar claims, as the outcome may influence negotiations to reach potential Actos settlement agreements in other cases.

At least three prior Actos cases have gone to trial in various state courts throughout the country with mixed results. In May 2013, a California jury found that Takeda failed to warn about the Actos bladder cancer risk and awarded $6.5 million in damages to a man given an expedited trial date due to his grave health. However, the trial judge reversed the verdict after granting a post-trial motion to exclude the plaintiffs’ expert witness testimony.

A second trial was held in Maryland state court in September 2013, which resulted in another jury finding that Takeda failed to adequately warn about the Actos risks, finding that the plaintiff should receive $1.77 million in damages. However, that case resulted in a defense verdict for the drug maker under a unique Maryland law, known as contributory negligence, as the jury also found that the plaintiff failed to exercise reasonable care for his own health, which nullified the negligence of the drug maker.

A third Actos bladder cancer trial concluded late last year in Nevada state court, which resulted in a defense verdict after the jury determined that both Actos and the plaintiff’s history as a smoker contributed to the development of bladder cancer. In that case, the plaintiff also ordered generic versions of Actos from online pharmacies, which raised questions as to whether Actos or unknown factors in the generic versions purchased online could have contributed to the development of the disease in that case.

Following the Allen trial, it was previously expected that a second Actos bellwether trial would begin in the federal MDL on April 14, 2014. However, in an Order (PDF) issued by Judge Doherty on January 17, that second pilot trial was continued without a new date selected.

If Takeda Pharmaceuticals fails to settle Actos cases or otherwise resolve a large number of cases following the bellwether trial process, Judge Doherty may begin remanding hundred of individual cases back to U.S. District Courts throughout the country for individual trial dates.