Bristol-Myers faces further litigation regarding the persistent allegations of Abilify behavior problems including compulsive gambling.

Plaintiff Vivian D. recently filed her lawsuit against Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co. Ltd., and Otsuka America Pharmaceutical Inc., alleging that Abilify behavior problems caused her physical damages.

Vivian says she took Abilify from 2003 to 2017, during which she allegedly suffered bodily injury. Vivian claims that her injury was a direct result of Abilify behavior problems and caused her “pain and suffering, disability, mental anguish, loss of capacity for the enjoyment of life, expense of medical care and treatment, loss of earnings, loss of ability to earn money and other economic losses, and aggravation of previously existing conditions.”

According to Vivian’s lawsuit, her losses are permanent and continuing, meaning she will suffer losses in the future.

What is Abilify?

Abilify (aripiprazole) is an anti-psychotic drug primarily used to treat schizophrenia and bipolar I disorder; the drug can also be used as an add-on treatment for depression, a treatment of Tourette’s syndrome, and a treatment for irritability associated with autism.

Abilify works to treat symptoms of mental disorders by influencing the levels of dopamine in the brain. Dopamine is a neurotransmitter that helps control the brain’s reward and pleasure centers which has been repeatedly linked to impulsive behavior and gambling. Although this mechanism may help control symptoms of psychotic disorders such as schizophrenia and bipolar disorder, evidence allegedly suggests that it may lead to compulsive Abilify behavior problems.

Abilify was initially approved for use by the FDA in 2002. Between 2005 and 2015, the U.S. Food & Drug Administration (FDA) received at least 30 reports of compulsive behavior and at least 24 reports of other Abilify behavior problems.

In a 2011 report to the European Medicines Agencies, the drug’s manufacturers said that the possibility that Abilify caused compulsive gambling “could not be excluded.” A year later, in 2012, foreign regulations of Abilify were changed so that the drug’s label would reflect the potential connection with compulsive behaviors. However, this change did not occur in the U.S. until later.

In May 2016, the FDA issued a warning that Abilify was associated with “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex.” The FDA recommended that doctors “make patients and caregivers aware of the risk of these uncontrollable urges,” “closely monitor” patients, and consider reducing or stopping the drug if Abilify behavior problems emerge, the lawsuit claims. Allegedly, Abilify’s label did not include any mention of these Abilify behavior problems until after this FDA announcement.

The lawsuit argues that the drug manufacturers knew or should have known that Abilify behavior problems were a possible side effect and that they should have warned patients and doctors of the risks. Vivian aims to hold the drug manufacturers responsible for her damaging Abilify behavior problems under federal and state consumer protection laws.

Vivian accuses the defendants of strict liability, breach of warranty, negligence, negligent misrepresentation, violation of Pennsylvania’s Unfair Trade Practices and Consumer Protection Law, and fraudulent concealment.

The Abilify Lawsuit is Case No. 3:18-cv-00764-MCR-GRJ and is part of Abilify MDL, In re: Abilify (aripiprazole) Products Liability Litigation, Case No. 3:16-md-02734-MCR-GRJ, in the United States District Court for the Northern District of Florida.