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In re Abilify (Aripiprazole) Prods. Liab. Litig.

United States District Court for the Northern District of Florida, Pensacola Division

March 15, 2018, Decided; March 15, 2018, Filed

Case No. 3:16-md-2734


 [*1300]  AMENDED ORDER1

This is a multidistrict product liability action against the manufacturers and marketers of the prescription drug Aripiprazole, more commonly known as Abilify.2 Plaintiffs allege that, after taking Abilify as prescribed, they developed impulsive and irrepressible urges to engage in certain harmful behaviors, including impulsive gambling, eating, shopping, and sex.3 Defendants  [*1301]  deny the allegations and maintain that Abilify could not, and did not, cause Plaintiffs' impulse control problems.

Defendants [**4]  have moved for summary judgment on the issue of general causation—that is, whether Abilify is capable of causing uncontrollable impulses to engage in certain harmful behaviors. See ECF No. 428. Both the motion, see id., and the response, see ECF No. 463, are supported by expert testimony. Each side challenges the other's experts as unreliable and those motions are also pending.4 A four-day evidentiary hearing was conducted jointly with Magistrate Judge Gary R. Jones of this Court, and Judge James J. Deluca of the New Jersey Superior Court, who presides over multiple similar cases in New Jersey state court. Now, having carefully considered the law, the voluminous record, and the parties' arguments, the Court concludes that Plaintiffs have satisfied their burden to demonstrate that a genuine dispute of material fact exists as to whether Abilify can cause uncontrollable impulsive behaviors in individuals taking the drug.

I. Background

Abilify is an atypical antipsychotic drug developed and manufactured by Defendants Otsuka Pharmaceutical Co., Ltd. and Otsuka America Pharmaceutical, Inc., who jointly market and distribute it in the United States with Defendant Bristol-Myers Squibb [**5]  Company (collectively, "Defendants"). See Master Complaint, ECF No. 108-1 at 5.5 In 2002, Abilify was approved by the Food and Drug Administration ("FDA") for the treatment of schizophrenia. Since then, Abilify also has been approved for use in patients with bipolar disorder, irritability associated with autistic disorder, Tourette's Syndrome, and as an add-on treatment for major depressive disorder. See Product Label, ECF No. 428-1 at 2. "[T]ens of millions of patients worldwide have used Abilify to help manage the symptoms of these very debilitating mental health conditions." See DSJ, ECF No. 428-26 at 9.6

In 2010, the first published reports suggesting a possible link between Abilify and pathological gambling began appearing in the medical literature. More published reports followed, as well as hundreds of informal reports from patients and healthcare professionals to Defendants and the FDA, describing the onset of impulsive gambling and other impulse control disorders in patients treated with Abilify. The scientific community, the FDA, Defendants, and public health agencies worldwide took notice and began examining whether Abilify is linked to impulse control disorders. The research [**6]  findings and conclusions of these bodies are at the heart of the motions currently pending before this Court.

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299 F. Supp. 3d 1291 *; 2018 U.S. Dist. LEXIS 43033 **; 2018 WL 1357914


Prior History: In re Abilify (Aripiprazole) Prods. Liab. Litig., 232 F. Supp. 3d 1342, 2016 U.S. Dist. LEXIS 138872 (J.P.M.L., Oct. 3, 2016)


gambling, reliable, causation, receptors, pathological, disorders, dopamine, impulse control, studies, epidemiological, patients, methodology, biological, database, scientific, exposure, impulsive, statistical, expert opinion, statistically significant, adverse event, behaviors, effects, factors, in vitro, brain, clinical trial, disease, drugs, agonist

Evidence, Admissibility, Expert Witnesses, Daubert Standard, Testimony, Qualifications, Scientific Evidence, Standards for Admissibility, Helpfulness, Expert Witnesses, Torts, Products Liability, Weight & Sufficiency, Types of Evidence, Testimony