PENSACOLA — A district-court judge in Florida will oversee consolidated litigation against the makers of a brand of medications used to treat several mental disorders.
According to topclassactions.com, the United States Judicial Panel on Multidistrict Litigation transferred more than 20 cases brought against Bristol Myers Squibb Company, Otsuka Pharmaceutical Co. Ltd., and Otsuka America Pharmaceutical Inc., the makers of Abilify. The lawsuits allege that the drug caused impulse-control problems in users, leading them to gamble compulsively or engage in other compulsive behavior.
According to the Pensacola News Journal, Judge M. Casey Rodgers of the Northern District of Florida will preside over the discovery stage of the litigation.
George F. Indest III, who specializes in health law and leads The Health Law Firm in Orlando, told the Florida Record that he thinks this is an unexpected choice for the proceedings.
“I am somewhat puzzled by the venue selected for these cases,” he said. “The Northern District of Florida, to my knowledge, does not handle a great number of multi-district litigation cases. It is a relatively small court in a small city. It is my understanding that Bristol-Myers and its co-defendant, Otsuka Pharmaceutical Co., consented to a plaintiff’s motion to transfer the cases to Florida. The defendants must have had a reason for wanting this.”
Indest previously lived in Pensacola and described it as a small community that attracts tourists and is home to many in the military.
“I believe its population tends to be more conservative and better-educated than many other places in Florida, so this may be one of the factors that caused the defendants to agree to this,” he said, adding that he’s known Judge Rodgers since she practiced as an attorney in Pensacola. “She should handle these cases fairly and efficiently.”
In May, the Food and Drug Administration announced it would add a new warning label to Abilify, also called aripiprazole, to alert users to an impulse-control risk. The medication is used for disorders including schizophrenia, bipolar disorder, Tourette’s disorder, and irritability associated with autistic disorder. If combined with antidepressants, it can also treat depression, according to the FDA.
“Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse-control risk FDA identified,” the FDA reported in a safety alert. “In addition, FDA has become aware of other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping and sexual actions.”
Plaintiffs in the lawsuits claim they experienced side effects involving compulsive gambling behaviors. During discovery, both sides will have to tackle central questions. The MDL panel sent the cases to Florida, saying “all the actions involve factual questions relating to whether Ability was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.”
Indest, who is not directly involved in this litigation, said lawsuits often follow FDA announcements like this. He thinks defendants could proceed by questioning the science that allegedly links Abilify with the described behaviors.
“It has been more difficult in recent years for plaintiffs to have the scientific testimony of expert witnesses admitted in evidence in the face of motions by the defense to exclude such evidence as ‘junk science’ not meeting the standards of the Frye case,” he said, referring to the general acceptance test used to determine if scientific evidence is admissible. “Therefore, I think the defense’s position may be to attack the evidence presented by the plaintiffs as being unreliable and not scientifically sound.”