Patients who took Abilify and suffered compulsive sex, gambling and shopping side effects have requested that the US Judicial Panel on Multidistrict Litigation consolidate 26 federal lawsuits against the manufacturers into the US District Court for the Norther District of Florida.
A decision on the motion, filed on June 24, is expected soon, because the defendants are also seeking consolidation. An MDL would centralize 26 Abilify cases filed by four different law firms, pending in 12 different federal district courts before 14 different federal judges. The case is In Re: Abilify Compulsive Behavior Products Liability Litigation.
In addition, 13 Abilify compulsive behavior lawsuits pending in New Jersey state court have been consolidated in one proceeding for pretrial coordination. In total, Plaintiffs’ counsel anticipate that hundreds of additional Abilify compulsive behavior cases will be filed.
24 million patients
Since its U.S. launch over 13 years ago, an estimated 24 million patients have used Abilify with sales in 2013 totaling $2.3 billion. Doctors widely prescribe it to treat patients with schizophrenia, bipolar disorder, and major depressive disorder. The defendants are Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co., Ltd. and Otsuka America Pharmaceutical, Inc.
The movants recommend the new MDL be supervised by Judge Margaret Catharine “Casey” Rodgers in Pensacola, FL, before whom two Abilify compulsive behavior cases are pending. There are no MDLs pending in the Florida courthouse.
Denise Miley and Brad Miley of Maple Grove, Minnesota, filed the first lawsuit on January 12, 2016, in the District of Minnesota, Miley v. Bristol-Myers Squibb Company, Case 0:16-cv-00067.
Abilify was introduced in 2002 as an atypical anti-psychotic prescription medicine discovered by Defendant Otsuka Pharmaceutical Co., Ltd. In November 2012, the European Medicines Agency required that the defendants warn patients and the medical community in Europe that Abilify use included the risk of pathological gambling.
Warnings since 2012
Agencies began issuing warnings in 2012:
- In November 2012, the European Medicines Agency required that the defendants warn patients and the medical community in Europe that Abilify use included the risk of pathological gambling.
- In November 2015 Canadian regulators concluded that there is “a link between the use of aripiprazole and a possible risk of pathological gambling or hypersexuality.”
- On May 3, 2016, the FDA, in an “FDA Safety Communication,” announced that warnings about “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex” would be added to the Abilify label. From 2005 to 2013, an FDA report showed that Abilify accounted for at least fifty-four reports of compulsive or impulsive behavior problems, including thirty reports of compulsive gambling, twelve reports of impulsive behavior, nine reports of hypersexuality, and three reports of compulsive shopping.
Among the issues that must be decided in a case are:
- Whether and to what extent Abilify is a substantial factor in causing the alleged compulsive behavior.
- When Defendants learned of any such connection between Abilify and the alleged compulsive behavior.
- Whether, and for how long, Defendants concealed any such knowledge from prescribing physicians.
- Whether Defendants failed to provide adequate and timely warnings and instruction about the alleged relationship between Abilify and compulsive behavior.
- Whether Defendants engaged in fraudulent and illegal marketing practices including, but not limited to, making unsubstantiated claims about the effectiveness and superiority of Abilify.
- Whether Defendant Otsuka Pharmaceutical Co, Ltd. is subject to personal jurisdiction in the United States courts.