Product liability lawsuits filed on behalf of individuals who allegedly developed gambling addictions and other compulsive behavior disorders due to their use of Abilify will begin going to trial this summer in the U.S. District Court, District of Florida, where all such federal claims have been centralized for coordinated pretrial proceedings.
According to an Order issued by the Court on March 13th, three Abilify lawsuits have been selected for those trials:
The Lyons case will go to trial on June 18th, with the Viechec lawsuit to follow on August 6th. The third bellwether trial will begin on August 27, when the Lilly claim goes before a jury.
Per the March 13th Order, the upcoming trials will not serve as true bellwethers, as the three Abilify lawsuits were not selected in a way that would ensure they were representative of other cases pending in the proceeding. Rather, the cases were chosen for convenience because they were originally filed in the Northern District of Florida.
The Court is currently working to establish protocols for selecting cases for a second round of trials.
In mid-March, plaintiffs proposed that the next group of trial cases be chosen from Abilify lawsuits filed in California and Florida, which have the majority of claims. They also want the cases to involve plaintiffs who took the antipsychotic medication for major depressive disorder or depression, which are the most common reasons for prescribing the drug. Finally, they have asked that the Court focus on cases involve gambling addictions, rather than other compulsive behaviors.
By contrast, defendants have proposed that the Court establish a discovery pool of 25 Abilify lawsuits, which would be randomly selected from all of the cases pending in the Northern District of Florida. They have further asked that the cases not reflect any broad categories, arguing that this would ensure that those ultimately selected for trial are truly representative of the claims pending in the proceeding.
Abilify (aripiprazole) is an atypical antipsychotic medication approved for the treatment of schizophrenia and other psychiatric disorders. In May 2016, the U.S. Food & Drug Administration (FDA) announced label updates for all aripiprazole-containing medications, after a review of the agency’s adverse event database revealed more than 180 reports of impulse control disorders potentially associated with their use.
More than 150 of the cases reported to the FDA involved gambling addictions, while the remaining included reports of compulsive sexual behavior, shopping and eating. In most cases, the affected individuals had no prior history of compulsive behaviors and reported that they began experiencing uncontrollable urges shortly after they initiated treatment aripiprazole. In most cases, the urges subsided when the patient stopped using aripiprazole.
Prior to the label May 2016 label modification, the prescribing information for Abilify and other aripiprazole-containing medications did note compulsive gambling as a possible side effect. However, the FDA determined that the prior wording did not completely reflect the nature of the impulse-control risk associated with aripiprazole.