Free Confidential Lawsuit Evaluation: If you or a loved one was harmed by uncontrollable or pathological behaviors (gambling, eating, shopping, sex) that you feel may have been caused by Abilify, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Update: First Trials in Abilify Gambling Litigation to Begin in June
April 23, 2018 – Lawsuits involving allegations of uncontrollable gambling addictions and other compulsive behavior disorders resulting from use of Abilify are scheduled to begin this summer in the U.S. District Court, District of Florida, where all such federal claims have been consolidated into a multidistrict litigation (MDL) for pretrial handling. According to a recent order by U.S. District Judge Casey Rodgers, 3 bellwether trials have been chosen to kick off the proceedings, the first of which is slated to begin on August 6.
What is Abilify?
Abilify is an antipsychotic drug that has been approved for the treatment of schizophrenia, bipolar disorder and depression when the patient’s main antidepressant is not effective. The drug may also be used to treat the symptoms of autistic spectrum disorders (ASDs) in pediatric patients. Aripiprazole, the active ingredient contained in Abilify, works by stabilizing dopamine and serotonin (5HT) receptors in the brain. Abilify was developed by the Japanese pharmaceutical company Otsuka, and is jointly marketed in the U.S. by Bristol-Myers Squibb (BMS) and Otsuka America.
Abilify and Compulsive Behavior
Studies have found that Abilify may affect impulse control, increasing the risk of gambling addiction and other unusual behaviors that can have a devastating impact on a person’s family, employment, financial position and overall quality of life. As early as 2009, research identified a potential risk of impulse control and gambling addiction among users of dopamine receptor agonists like Abilify when used to treat Parkinson’s disease. In a Mayo Clinic study, researchers found unusually high rates of compulsive syndrome, including pathologic gambling, hypersexual behavior or a combination of the 2 problems.
Then in October 2014, a study published in JAMA Internal Medicine found additional signs of impulse control in patients treated with Abilify, which may result in abnormal behavior such as gambling addictions, risky sexual behavior and even compulsive shopping.
Abilify Side Effects
- Pathological gambling
- Uncontrollable eating
- Binge shopping
- Sexual addiction or “Hypersexuality” (obsessive pursuit of casual or non-intimate sex; pornography; compulsive masturbation; romantic intensity and objectified partner sex
- Other compulsive feelings / behaviors
- Type 2 diabetes
- Difficulty speaking
- Loss of balance control
- Muscle trembling, jerking, or stiffness
- Shuffling walk
- Stiffness of the limbs
- Twisting / uncontrolled movements of the body
- Compulsive behavior
- And more
Bristol-Myers Wants Abilify Gambling Lawsuits Centralized in Florida
October 3, 2016 – Bristol-Myers Squibb and Otsuka Pharmaceutical Co. are requesting the Northern District of Florida as the appropriate venue in the upcoming multidistrict litigation (MDL) for federal lawsuits alleging compulsive gambling side effects from Abilify. The jurisdiction was originally proposed by a couple who filed one of the dozens of lawsuits alleging that the defendants failed to adequately warn about the risk of pathological gambling from Abilify, according to Law360.
Abilify Settlement Information
The judge overseeing the federal Abilify MDL in the Northern District of Florida chose 3 cases to serve as bellwether trials, which are intended to gauge how juries are likely to respond to evidence common in the lawsuits. Depending on the outcome of these cases, parties may decide to proceed in court or through out of court settlements. The 3 Abilify bellwether trials ended in settlements for undisclosed sums before they even reached court. This makes it more likely — but not certain — that mass settlements will follow for many of the other cases.
Settlement Update: The federal judge overseeing the Abilify MDL has set a deadline of Sept 2018 for the parties to come to an agreement on terms of a global Abilify settlement.
Abilify Off-Label Use
Abilify has been approved by the FDA to treat schizophrenia, bipolar disorder and major depressive disorder. Doctors may also prescribe the drug for “off-label,” or unapproved purposes. Such uses include anxiety disorders, dementia, eating disorders, insomnia, obsessive-compulsive disorder (OCD) and post-traumatic stress disorder (PTSD). None of the off-label uses have undergone clinical trials to demonstrate efficacy or safety.
Judge Rejects Otsuka’s Bid to Take Abilify Rival Off Market
August 1, 2016 – A federal judge has rejected a lawsuit by Otsuka Pharmaceutical Co. to remove a competitor of Abilify from the market, according to Reuters. U.S. District Judge Ketanji Brown Jackson ruled Thursday that the FDA was correct in determining that Otsuka’s statutory exclusivity period for Abilify Maintena does not block a similar drug with a different active ingredient.
Abilify Labels Updated to Include Impulse-Control Problem Warning
May 3, 2016 – FDA is requiring new warnings to be added to the labeling of aripiprazole-containing antipsychotic medications (Abilify, Abilify Maintena, Aristada) regarding compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex. The agency warned that the impulsive behaviors, though rare, may cause harm to the patient or others if not identified. These problems were reported to have ended upon discontinuing the medication or reducing the dose, according to the FDA.
FDA Rejects Abilify/Ingestible Sensor Combo
May 2, 2016 – The first U.S. regulatory test for a drug that incorporates medication adherence technology has been rejected, according to FierceMedicalDevices. FDA issued a complete response letter to Otsuka Pharmaceutical and Proteus Digital Health for their drug/device combination of Abilify with Proteus’ ingestible sensor. The agency is seeking data on the performance of the product under the specific conditions in which it is likely to be used, as well as further human factors investigations to evaluate use-related risks and confirm that users can use the device safely and effectively.
The case is: Cheyenne Beth Confer v. Bristol-Myers Squibb Co. et al., case number 158295/2014, in the Supreme Court of the State of New York, County of New York.
Atypical Antipsychotics Linked to Weight Gain, Other Outcomes in Children
In October 2009, a study published in the Journal of the American Medical Association (JAMA) identified a link between atypical antipsychotics like Abilify and significant weight gains in pediatric patients. Researchers at the Zucker Hillside Hospital in Queens, New York, noted 10-to-13 pound gains in children during their first 3 months of treatment with Abilify.
“Weight gain was pervasive even in medications usually considered to be weight neutral in adults,” said Dr. Christoph Correll, an Albert Einstein College of Medicine psychiatrist and lead author of the study. “The worry is that weight gain sustained over long periods of time can cause adverse outcomes like diabetes and heart attacks and strokes.”
Study Finds American Children Most Likely to be Prescribed Antipsychotics
A recent study conducted by researchers in the U.S., Germany and The Netherlands found that American children are approximately three times more likely to be prescribed antipsychotic medications compared to their European counterparts. Researchers attributed the differences to regulatory practices and cultural beliefs about the role of prescription drugs in treating children’s psychological problems.
“Direct to consumer drug advertising, which is common in the U.S., is likely to account for some of the differences. The increased use of medication in the US also reflects the individualist and activist therapeutic mentality of US medical culture,” said lead researcher Julie Zito.
Antipsychotic Prescription Rates Skyrocketing in U.S.
Experts estimate that about one million American children are treated for schizophrenia, and prescription rates for atypical antipsychotic drugs have increased by more than five-fold in the last 15 years. These medications are being increasingly prescribed to treat outbursts and aggression in pediatric patients with a wide range of diagnoses representing about 80% of the prescriptions written for autism, ADHD, bipolar disorder, depression and anxiety, despite the drugs’ potential side effects. Some of these uses are “off-label”, and have not been approved by the FDA.
Has There Been a Recall?
As information about Abilify’s side effects continues to surface, many have questioned whether its minimal health benefits outweigh the risks, and whether the drug should be recalled. At this time, no recall has been issued for Abilify, and there are no indications that the FDA is planning to remove the drug in the near future. However, the manufacturer may be required to provide stronger and more effective warnings for the public and medical communities.
Am I Eligible to File a Claim?
You may be eligible to file a claim against the makers of Abilify if you have proof of losing a minimum of $10,000 to compulsive gambling or compulsive spending, or proof of excess weight gain from compulsive eating.
Courts may also award punitive damages against Bristol-Myers Squibb if the court finds that the company’s actions were particularly egregious, and to ensure that neither they nor other organizations engage in suc behavior in the future.
Most Abilify lawsuits name Bristol-Myers Squibb (BMS) and Otsuka Pharmaceuticals as co-defendants. The 2 companies maintain a partnership over the development, design, testing, labeling, packaging, promoting, advertising, marketing, distribution and selling of Abilify. Otsuka discovered Abilify, which was first sold in the U.S. in 2002. BMS marketed the drug until 2013.
Lawsuits contend that Abilify’s manufacturers knew or should have known about the drug’s potential to cause uncontrollable and/or compulsive behavior, and that they ignored these risks in an attempt to maximize profits. The companies are also accused of designing and manufacturing a defective drug, as well as failing to warn, advise, educate or otherwise inform Abilify users about these dangers.
Do I Have an Abilify Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Abilify Lawsuits. We are handling individual litigation nationwide and currently accepting new compulsive bahviors cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by Abilify side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.