The federal court tapped to oversee what could eventually be hundreds of Abilify gambling lawsuits convened its Initial Conference on November 7th. An Order filed in the U.S. District Court, Northern District of Florida, on October 19th indicated that a number of issues were to be addressed during the proceeding, including the litigation’s organizational structure and the status of Abilify cases pending in both state and federal courts.
Abilify is an antipsychotic medication indicated to treat schizophrenia and other mental illnesses. This past May, the U.S. Food & Drug Administration (FDA) announced label updates for Abilify and other medications that contain aripiprazole, after a review of the agency’s adverse event database revealed more than 180 reports of impulse control disorders potentially associated with the medications. Over 150 of those reports involved compulsive gambling, while the remaining cited compulsive sexual behavior, shopping and eating, as well as multiple impulse-control problems.
All of the cases were reported to the FDA in the 13 years since Abilify was approved for use in the U.S. In most of the instances, the affected patients had no prior history of compulsive behaviors, and reported that they began experiencing uncontrollable urges shortly after they started taking the drug. In most of the cases, the urges subsided once dosage was decreased or treatment ceased.
It’s worth noting that prior to the FDA’s May announcement, all aripiprazole labels – including Abilify’s – mentioned compulsive gambling as a possible side effect. However, the agency determined in the course of its review that the wording did not completely reflect the nature of the impulse-control risk associated with aripiprazole.
The federal Abilify litigation was established last month by the U.S. Judicial Panel on Multidistrict (JPML) in order to allow all federally-filed cases involving allegations of compulsive gambling to undergo coordinated pretrial proceedings, including discovery and motions practice. A multidistrict litigation is intended to promote judicial efficiency when a large number of lawsuits have been filed over the same product, and which put forth similar allegations of fact.
At least 50 Abilify lawsuits are already pending in the Middle District of Florida. Plaintiffs similarly allege that the medication was defectively designed and manufactured, and claim that its manufacturers knew or should have known of Abilify’s alleged link to gambling addictions. Plaintiffs further accuse Abilfy’s manufacturers of failing to provide doctors and patients with adequate instructions and warnings for its use.