Multiple plaintiffs have come forward to file a legal complaint in the Superior Court of the State of California against the Bristol-Meyers Squibb Co. and related corporations involved in the development and promotion of Abilify—a drug used to treat schizophrenia and bipolar disorder.

The complainants based their case—which has since been removed to U.S. District Court for the Northern District of California—upon published data suggesting a link between the use of Abilify and compulsive behavior.

The plaintiffs in the Abilify and compulsive behavior lawsuit are Richard R., Craig C., Justin F., Patrick G., Darren G., Tyrone K., Christopher M., Grace M., Juliette P., Alexander P., Anne S., and Venita W. In addition to the Bristol-Meyers Squibb Co., other defendants are the McKesson Corp., Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Co. Ltd. and unnamed entities 1-100.

The U.S. Food and Drug Administration (FDA) approved Abilify for the domestic pharmaceutical market in the fall of 2002, according to the factual section of the lawsuit.

The European Medicines Agency (EMA), the European Union’s FDA equivalent, approved the antipsychotic drug for commercial distribution around the same time. Ten years later in the fall of 2012, the EMA was the first to take serious note of reports linking the use of Abilify and compulsive behavior in the form of pathological gambling.

The EMA forced their hand by requiring the drug’s developer—Otsuka Pharmaceutical Co. Ltd.–to change the antipsychotic drug’s label. The EMA wanted the label to indicate this connection that had been reported by patients with no previous desire to gamble or history with this activity, even in a benign capacity.

Reports of the use of Abilify and compulsive behavior like out-of-control gambling had also been registered by family members and treating physicians.

Canadian drug authorities were the second to take such action in November 2015, as indicated in the lawsuit. Although Abilify had only been approved for use in Canada since 2009, the medicines oversight agency there required and instituted a label change that was effective in November 2015.

While the label change only warned of pathological gambling connection and that the drug posed a greater risk to patients with a previous gambling inclination, regulators had also noted through reports a link between the use of Abilify and compulsive behavior of a hypersexual nature.

The narrative of the legal complaint states that despite these label changes abroad, the U.S. label did not make mention of Abilify and compulsive behavior link such as pathological gambling until January 2016. When it did mention it, it was in an area of the label least likely to be viewed by physicians and patients.

The plaintiffs argue that this alleged negligence in changing the label was deliberate and designed to maximize profits of Abilify to the extent possible.

The group of plaintiffs are asking for a trial by jury and are bring ten counts against the defendants which include Strict Liability—Failure to Warn; Breach of Express Warranty, Breach of Implied Warranty; Negligence; Negligent Misrepresentation; Violation of Business and Professional Codes 17200, 17500; Violation of California Civil Code 1750; Fraudulent Concealment and Loss of Consortium.

The complainants are seeking all compensatory, statutory, and punitive damages owed to them as demonstrated by evidence provided in U.S. District Court.

The Bristol-Meyers Lawsuit is Case No. 3:18-cv-02577-EDL in U.S. District Court for the Northern District of California.