Abilify (aripiprazole) is an atypical antipsychotic developed by Otsuka Pharmaceutical Co., Ltd. In 1999, Otsuka partnered with Bristol-Myers Squibb (BMS) to complete development, obtain approvals, and market aripiprazole in the U.S. In November 2002, it was approved by the FDA for the treatment of schizophrenia in adults. In October 2007, the FDA approved Abilify for the treatment of schizophrenia in adolescents aged 13-17 years. In 2004, it was approved to treat symptoms related to Bipolar I Disorder in adults. Later in 2008, it was approved to treat patients 10 to 17 years old. This was followed by an approval for the treatment of unipolar depression as an adjunct with an antidepressant medication in November 2007. In 2009, it was approved to treat irritability associated with an autistic disorder for patients 6 to 17 years old. Abilify is not approved for the treatment of dementia-related psychosis. Elderly patients treated with antipsychotic drugs for dementia-related psychosis are at an increased risk of death.
Aripiprazole is used predominantly for the treatment of schizophrenia and bipolar disorder but can also be used as an add-on treatment for major depressive disorder, obsessive-compulsive disorder (OCD), tic disorders, and irritability associated with autism.
Abilify is known to decrease hallucinations and improve concentration. When there is a hormonal imbalance, Abilify either increases or decreases the levels of dopamine or serotonin in the brain. The drug arbitrates its action by either blocking receptors or by binding to them and inducing an opposite response to the receptor's normal role. A large number of patients treated with Abilify were reported to develop the habit of compulsive gambling and got racked up with large amounts of debts. Other pathological behaviors like excessive eating, excessive shopping, and Hypersexuality are also noted who started using or increased dosage of Abilify.
Young patients with depression and elderly patients with dementia consuming Abilify are found to be at a high risk of suicidal thoughts or actions. It also increases the risk of developing diabetes.
In 2013, the marketing rights were returned to Otsuka by BMS; however, BMS kept manufacturing the drug.
In November 2017, the FDA approved Abilify MyCite, a digital pill containing a sensor intended to record when its consumer takes their medication.
Some Facts As Stated By The FDA:
- Aripiprazole is available under the brand names Abilify, Abilify Maintena, Aristada, and also as generics.
- Common side effects of aripiprazole include dizziness, lightheadedness, drowsiness, excess saliva/drooling, blurred vision, weight gain, constipation, feeling the urge to move constantly, and trouble sleeping.
- In 2015, approximately 7.7 million prescriptions for oral aripiprazole were dispensed and approximately 1.6 million patients received a dispensed prescription for oral aripiprazole from U.S. outpatient retail pharmacies.
Serious Alleged Injuries May Include:
- Pathological Gambling
- Binge Eating
- Dementia Suicide Risk
FDA Safety Warnings:
In 2004, the FDA required a boxed (“black box”) warning to be added to package inserts for antidepressants in order to call attention to an increased risk of suicidal thoughts and behavior (suicidality) in children and adolescents taking these drugs. In 2007, the FDA extended the age range covered by the warning to include young adults up to 24 years of age.
In 2006- For Abilify, the black box warning indicated that the drug increases the risk of death by stroke in elderly patients with psychosis related to dementia. The FDA did not recommend this medication for elderly people who had dementia.
On May 3, 2016, the FDA warned that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex had been reported with the use of the antipsychotic drug aripiprazole.
Defendants: Otsuka Pharmaceutical Co., Ltd., Bristol-Myers Squibb (BMS), Otsuka America Pharmaceutical, Inc. (OAPI).
Defendant Law Firm:
Otsuka is represented by Matthew A. Campbell, Rand K. Brothers and Luke A. Connelly of Winston Strawn LLC and Hal K. Litchford and Kelly Overstreet Johnson of Baker Donelson Bearman Caldwell Berkowitz PC.
Bristol-Myers is represented by Larry Hill and Charles F. Beall Jr. of Moore Hill Westmoreland PA; Anand Agneshwar, Matthew Eisenstein and Paige H. Sharpe of Arnold Porter; and Lauren S. Colton of Hogan Lovells.
Defendants’ Liaison Counsel
Larry Hill - Moore, Hill Westmoreland, P.A.
Allegations: Allegations include Abilify harmed patients by causing uncontrollable urges, resulting in financial, psychological, and physical damages. The defendants failed to adequately study the drug and its possible side effects. The defendants knew – or should have known – that Abilify causes or contributes to compulsive behaviors. The defendants spent millions of dollars on misleading advertising that overstated the drug’s benefits and understated the risks and made payments to physicians to promote Abilify. The benefits of using the product do not outweigh the risks.
Plaintiff Steering Committee appointed by US District Judge M. Casey Rodgers
Behram V. Parekh - Kirtland Packard LLP.
Chris T. Hellums - Pittman, Dutton Hellums, P.C.
George T. Williamson, Jennifer R. Liakos - Napoli Shkolnik PLLC.
M. Brandon Smith, Esq. - Childers, Schlueter Smith L.L.C.
Marlene J. Goldenberg - GoldenbergLaw, PLLC.
Shanon J. Carson - Berger Montague, P.C.
October 2016: Abilify lawsuits are consolidated under MDL No. 2734, presided by U.S. District Judge M. Casey Rodgers, in the Northern District of Florida. As of November 2018, the court papers show nearly 2,000 pending lawsuits in the Abilify MDL.
May 2018: Abilify New Jersey MCL Designation – Atlantic County for centralized management by Judge Nelson C. Johnson; trials were expected to begin by the end of 2018.
Important Legal Proceedings, Verdicts Settlements:
April 2018: The defendants settled three cases representing nearly 800 plus centralized lawsuits for an undisclosed amount of days before they were scheduled to go for trial.
May 2018: A global settlement order released by Judge Rodgers stating the defendants had time until September 1, 2018, to determine how they will settle a large number of lawsuits filed against them. Though the parties indicated progress about the settlement negotiations, a final settlement program news had not been submitted to the court.
June 2018: Judge Rodgers indicated that a group of 100 cases to be picked randomly before July 6, 2018, for the second trial pool.
August 2018: Judge Rodgers instructed all plaintiffs in Abilify litigation to furnish more information to estimate the inventory of the alleged gambling cases filed against the drug makers in the federal MDL.
September 2018: Six Abilify cases selected for "Fast-Tracked" discovery.
November 2018: 21 Abilify cases remanded back to their home state courts to allow the litigation to move forward in the state court system while the bellwether trial process continues in the federal courts.
December 2018: The Court announced the discovery schedule for six Abilify gambling cases that were selected for a fast-tracked discovery and trial.
January 2019: Bristol-Myers Squibb Co and Otsuka Pharmaceutical Company requested the judge to toss gambling lawsuits filed by 550 plaintiffs unless they furnish more information linked to their use and past medical records.
February 2019: Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co. Ltd. reached a confidential global settlement with thousands of plaintiffs who alleged that the antipsychotic drug causes uncontrollable gambling urges.
September 2019: U.S. District Judge M. Casey Rodgers dismissed 149 cases linked to the side effects of the antipsychotic drug due to plaintiffs' failure to comply with court orders following the announcement of a global settlement by the defendants Otsuka Pharmaceutical Co. Ltd. and Bristol-Myers Squibb Co. in February 2019.
- Usage In Pharmacy Records
- Duration Of Usage
- Indication Of Usage In Medical Records