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As Bristol-Myers Squibb and Otsuka Pharmaceuticals face a growing number of Abilify lawsuits brought by individuals who have developed uncontrollable gambling problems and other impulse control disorders, the drug makers recently filed a motion for Summary Judgment, indicating that plaintiffs have insufficient expert testimony to establish general causation.
Abilify (ariprazole) is one of the top-selling brand name medications on the market in the United States, generating sales in excess of $6 billion per year. It was introduced in 2002 for treatment of schizophrenia, bipolar disorder and other major depressive disorders, but is also widely used to treat irritability, aggression, mood swings and other behavior issues.
Over the past year, nearly 200 product liability lawsuits have been filed against the manufacturers of the drug, alleging that users and the medical community were not adequately warned that side effects of Abilify may increase the risk of impulse control disorders, including compulsive gambling, shopping, eating and other damaging behaviors.
The litigation emerged after the FDA required new warning information about the link between Abilify and impulse control problems in May 2016, urging doctors, patients and caregivers to be on the lookout for symptoms of uncontrollable urges to gamble, binge eat, shop or engage in reckless sexual activity while using the medication.
Although information about the risk of Abilify impulse control disorders was added to the label in Europe as early as 2012, plaintiffs allege that the important information was withheld in the United States, causing users to suffer severe gambling losses and damage to their financial stability or family relationships due to the failure to warn.
Since October 2016, cases filed against Bristol-Myers Squibb and Otsuka Pharmaceuticals throughout the federal court system have been consolidated as part of a federal multidistrict litigation (MDL), which is centralized before U.S. District Judge Casey Rodgers in the Northern District of Florida for coordinated discovery and pretrial proceedings.
As part of the coordinated proceedings before Judge Rodgers, challenges to the admissibility of expert witnesses proposed by each side have been filed, before a small group of “bellwether” cases will be set for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.
In a motion (PDF) filed by the drug makers on July 7, Judge Rodgers was asked to grant summary judgment for the Defendants, arguing that the testimony of each of the Plaintiffs’ experts should be excluded, leaving them unable to establish general causation on the link between Abilify and impulse control disorders.
Plaintiffs have not yet responded to the motion for summary judgment, but have filed separate motions to exclude certain expert testimony proposed by the Defendants.
Judge Rodgers is scheduled to meet with the parties for a case management conference on July 31, in conjunction with a hearing on the motions to exclude expert witness testimony. The parties are also scheduled for a settlement conference in early August.
Following the pre-trial motions and any early bellwether trials in the MDL, if drug makers’ fail to reach Abilify settlements for individuals who have experienced impulse control disorders, or reach another resolution for the litigation, dozens of individual cases may be remanded back to U.S. District Courts nationwide for individual trial dates.