Abilify

  • Abilify Medical Record Review & Outsourcing Services

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.

When there is an imbalance, Abilify either increases or decreases the levels of dopamine or serotonin in the brain. 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.

Serious Alleged Injuries may include:

  • Pathological Gambling
  • Binge Eating
  • Hypersexuality
  • 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.

Lawsuit Allegations:

Defendants: Otsuka Pharmaceutical Co., Ltd., Bristol-Myers Squibb (BMS), & Otsuka America Pharmaceutical, Inc. (OAPI). 

Defendant Law Firm: Keating Muething & Klekamp (KMK Law®); Skadden Arps Slate Meagher & Flom LLP (for OAPI); & Hogan Lovells US, LLP & Arnold & Porter LLP (for BMS).

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.

Lawsuit Status:

October 2016: MDL No. 2734 for Abilify lawsuits was consolidated before 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 its docket.

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 Verdicts & Settlements

April 2018: The defendants settled three cases representing nearly 800 plus centralized lawsuits for an undisclosed amount days before they were scheduled to go for trial.  

May 02, 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.

Evidences:

  • Usage in Pharmacy Records
  • Duration of Usage
  • Indication of usage in Medical Records

Medical Record Review and claim validation of Abilify case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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