The Abilify lawsuit claims the manufacturers of Abilify failed to warn doctors and patients that the drug could cause compulsive behaviors, such as gambling, shopping, eating and sex. As of May 2018, more than 800 lawsuits are pending in federal court against the Abilify manufacturers.
Our law firm is accepting clients who took Abilify and began experiencing compulsive casino gambling and experienced at least $50,000 in losses.
We have been handling lawsuits against pharmaceutical companies since 1955, and each year we teach more than 1,000 attorneys how to successfully handle these types of cases. We are listed in Best Lawyers in America and The National Trial Lawyers Hall of Fame.
Why Are Abilify Lawsuits Being Filed
Otsuka Pharmaceutical and Bristol-Myers Squibb, the manufacturers of Abilify, are accused in court proceedings of negligence in the design of Abilify, and hiding evidence from the government and public of the increased risks of patients' developing compulsive urges.
Court documents state the two drug makers failed to properly test Abilify, exaggerated the benefits of the drug, and encouraged physicians to use the medication for purposes not approved by the FDA (such as, anxiety disorders, dementia, eating disorders, insomnia, obsessive-compulsive disorder and post-traumatic stress disorder).
Lawyers argue that if doctors had known the true risks, then a different medication would have been used to treat a patient's symptoms, and especially if the patient began to experience obsessive behavior.
Abilify Injuries & Side Effects
In 2016, the FDA issued a warning that it had reviewed 184 cases linking Abilify to compulsive behaviors, such as gambling, sexual behavior, shopping, eating, and impulse-control issues.
The addictive behavior was found to start almost immediately upon a patient taking Abilify, and stop once the patient switched to another medicine.
The obsessive behavior caused by Abilify is such that the person develops an uncontrollable urge to perform an act (such as, gambling), and cannot resist the desire. The person will continue to do the act even if it's causing him or her personal, social and financial injuries.
The Most Severe Injury
The use of Abilify can cause addictive behaviors. Patients can't stop performing these acts even though they desperately want to stop, and the acts are causing them harm. It appears that Abilify affects a patient's dopamine level, which then influences the individual's feelings of pleasure.
The most common side effects caused by Abilify include: anxiety; blurred vision; constipation; dizziness; drooling; drowsiness; headache; lightheadedness; nausea; restlessness; trouble sleeping; and weight gain.
Some patients have experienced high blood sugar (hyperglycemia) while taking the medication. Diabetics should check their blood sugar levels on a regular basis.
Pre-teens have been found to occasionally experience suicidal thoughts when taking this type of medication. Therefore, family members should carefully monitor children while taking Abilify.
Taking Abilify during pregnancy may cause issues with the newborn, such as withdrawal symptoms, breathing difficulties, and feeding problems. However, you should not stop taking Abilify without first speaking with your treating doctor.
Compensation in an Abilify Lawsuit
If you have experienced more than $50,000 in gambling related losses caused by Abilify, then we will be seeking the following damages for you:
- Past and future medical expenses to treat your addiction.
- Past and future mental pain and suffering that results from the addiction, such as losing family, friends, employment and finances.
- Wage loss, if any.
- Gambling losses, if any.
- Other economic losses you might have sustained as a result of your compulsive behavior.
- Punitive damages, if appropriate.
As of May 2018, more than 800 lawsuits were pending in federal court against the manufacturers of Abilify by individuals who claim to have experienced compulsive behaviors because of the drug. The cases are being heard by Chief Judge M. Casey Rodgers in the Northern District of Florida.
Abilify Lawsuit Settlement Amounts
In 2005, Bristol-Myers Squibb paid a $515 million penalty to the U.S. government to settle allegations that the company aggressively marketed Abilify to geriatric patients as well as children and adolescents for unapproved “off-label” purposes.
In 2008, Otsuka Pharmaceutical paid the U.S. government $4 million to settle claims that the company marketed Abilify to child psychiatrists and nursing homes for unapproved “off-label” purposes.
In 2016, Bristol-Myers Squibb paid $19.5 million to various state governments to settle allegations that the company minimized the risks of Abilify, misrepresented data from clinical trials, and illegally promoted the drug for "off-label" purposes. The company also paid $30 million to the state of California for illegally paying doctors to prescribe its medication, including Abilify.
In 2016, the United States Judicial Panel on Multidistrict Litigation ruled that all federal lawsuits involving Abilify and the link to compulsive behaviors are to be handled by a federal judge in the Northern District of Florida. In May 2018, the first three cases scheduled for trial settled for an undisclosed amount. All others cases have been put on hold for 120 days while the parties attempt to work out a global settlement.
Attorney Mike Papantonio Discusses the Abilify Lawsuits
Abilify Recalls & Warnings
As of this time, there has not been a recall of Abilify related to addictive behaviors. However, the FDA ordered a label change in 2016 to warn of the relationship between Abilify and pathological gambling and other compulsive behaviors.
The Abilify label now reads: "patients may not recognize [their addictive] behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole."
Interestingly, Abilify packaging in the European Union included warnings about this issue beginning in 2012, with Canada requiring the warning in 2015.
What is the Purpose of Abilify
Abilify is an anti-psychotic medication used in the treatment of schizophrenia, bipolar disorder, Tourette’s syndrome, autism, and depression.
It’s intended to help decrease hallucinations, disorganized thinking, mood swings, depressive thoughts, and tics. It's not approved to treat symptoms related to dementia, and can increase the risk of death in patients suffering from dementia.
Abilify (aripiprazole) initially received FDA approval in 2002. It's one of a number of “second generation” atypical antipsychotic medications, commonly known as SGAs. Other frequently-prescribed drugs in this class include Saphris (asenapine maleate), Clozaril (clozapine), Seroquel (quetiapine fumarate), and Risperdal (risperidone).
The drug is intended to work by blocking receptors in the brain's dopamine pathways, which are involved in reward-motivated behaviors. Manufacturers claim the drug helps reduce moodiness, hyperactivity, and aggressive behaviors.
Following initial approval in the U.S. for the treatment of schizophrenia, Abilify went on to receive approval for:
- bipolar disorder (2004)
- clinical depression (2007)
- autism-associated irritability and various psychological disorders experienced by teenagers (2009)
By 2013, Abilify was the top-selling prescription drug in the U.S., with multi-billion dollars in annual sales.
Abilify Lawsuit News
FDA Warns Abilify Can Cause Compulsive Sex and Gambling
The FDA has issued a warning that the use of Abilify is linked to uncontrollable urges to eat, gamble, shop and have sex. Reported in Time Magazine - Abilify Compulsive Behavior Warning
A Popular Antipsychotic Drug Is Causing Uncontrollable Urges
Abilify is a best-selling drug that “is used to treat schizophrenia, and can be used in combination with other drugs to treat depression,” as STAT News puts it. It turns out that it can also, in rare cases at least, cause some very odd side effects. STAT reports that in a warning posted yesterday, the FDA explained that the drug appears to sometimes cause people to have urges to engage in various forms of behavior impulsively, ranging from sex to gambling. Reported in New York Magazine - Abilify Uncontrollable Urges
Abilify drug blamed for compulsive gambling
"The mother of two said she lost custody of her kids and possession of her house to a gambling habit she said began in 2008 after she was prescribed Abilify for depression.” Reported in FOX 31 - Compulsive Gambling & Abilify
Calgary woman part of class-action lawsuit against drug maker
"A Calgary woman is one of hundreds of Canadians who said their lives were negatively impacted by the drug Abilify and are taking part in a class-action lawsuit. Christina Milisic was prescribed the drug in 2013 to help with hallucinations and paranoia, but instead of relief, she quickly noticed strange new behaviors that she couldn’t control, especially gambling.” Reported in CTV News - Canadian Abilify Class Action
Bristol-Myers to pay $19.5 million in Abilify off-label marketing settlement
Almost a decade after settling up Abilify marketing allegations with the U.S. Justice Department, Bristol-Myers Squibb agreed to pay $19.5 million to settle similar claims at the state level. Announced by New York Attorney General Eric Schneiderman, the deal covers claims that Bristol-Myers pushed Abilify as a treatment for kids and for elderly patients with dementia, when neither use was approved by the FDA. Reported in Fierce Pharma - Abilify Off-Label Settlement
Bristol-Myers pays $30 million to settle kickback charges
After nearly a decade of litigation, Bristol-Myers Squibb agreed to pay $30 million to settle charges by California officials of paying kickbacks to induce doctors to prescribe several of its medicines. Among the many medicines for which doctors were persuaded to write more prescriptions were the Pravachol cholesterol pill; the Plavix blood thinner; the Abilify antipsychotic; the Glucophage diabetes treatment; and the BuSpar antianxiety drug. Reported in STAT - Abilify Kickback Scheme
Bristol-Myers Squibb to Pay More Than $515 Million to Resolve Allegations of Illegal Drug Marketing and Pricing
The Government alleged that, from 2002 through the end of 2005, BMS knowingly promoted the sale and use of Abilify, an atypical antipsychotic drug, for pediatric use and to treat dementia-related psychosis, both “off-label” uses. The Food and Drug Administration has approved Abilify to treat adult schizophrenia and bi-polar disorder, but has not approved the use of Abilify for children and adolescents or for geriatric patients suffering from dementia-related psychosis. In fact, the FDA has mandated that the label for Abilify carry a “black box” warning concerning its use in the treatment of dementia-related psychosis. Reported in Department of Justice - Illegal Drug Marketing
Abilify Off-Label Marketing Case Settled For $4M
Otsuka Pharmaceutical Co. Ltd. agreed to pay $4 million to settle allegations brought by the U.S. Department of Justice, claiming the company marketed its anti-psychotic drug Abilify for off-label uses by targeting child psychiatrists and nursing homes. Reported in LAW 360 - Abilify Illegal Marketing
FDA and Scientific Studies Regarding Abilify
The FDA Warns of Link Between Abilify and Obsessive Behavior
The FDA issued a warning that compulsive or uncontrollable urges to gamble, binge-eat, shop, and have sex have been reported with the use of the anti-psychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. Reported in FDA Abilify Safety Communication
The FDA identified 167 patients between 2002 and 2016 that began experiencing new urges leading to compulsive behavior after starting Abilfy treatment. Within days to weeks of reducing or discontinuing the medicine, all of the patients reported their intense urges stopped. None of the patients had a history of pathological gambling, compulsive sexual behavior, binge eating, or compulsive shopping prior to starting the treatment.
Safety information for antipsychotic drug Abilify and risk of certain impulse-control behaviours
Labels for the prescription antipsychotic drugs Abilify and Abilify Maintena (aripiprazole) have been updated in Canada to advise of an increased risk of impulsive behaviours of pathological gambling and hypersexuality. Reported in Health Canada - Abilify Safety Concerns