Abilify lawsuits claim manufacturers did not warn patients of serious side effects. Some say the antipsychotic drug caused compulsive gambling and eating. Users also reported issues with compulsive shopping and sex. More than 2,800 Abilify lawsuits have been filed. Some cases have settled for a total of $534 million.
Why Are People Filling Abilify Lawsuits?
Abilify, Abilify Maintena and Aristada are used to treat several disorders, including schizophrenia, bipolar disorder, depression and Tourette's disorder. Despite concerns over stroke risks in elderly patients and weakened impulse control in adults, Bristol-Myers Squibb (BMS) continues to market Abilify as a safe and effective treatment for psychological disorders.
Previously, European and Canadian health officials increased regulation of Abilify, requiring changes to the drug's labeling and marketing materials. These changes ensured that doctors and patients were informed of the possible risks of using the atypical antipsychotic drug. In the U.S., however, Abilify did not carry these warnings until several years later, leading some patients to claim that the company willfully deceived consumers.
FDA Abilify Warning
In May 2016, the U.S. Food and Drug Administration (FDA) issued a boxed warning about Abilify's risks for compulsive behavior. According to the FDA's safety communication, this warning label was added in response to approximately 200 reported cases of compulsive gambling, eating, shopping, or sexual behaviors by patients taking Abilify. A black box warning is the most severe warning that the FDA can issue a medication. The agency also required BMS to add additional information to Abilify's medication guides, to more explicitly address the compulsion risks.
Abilify has also been used for off-label uses for years. Many doctors have prescribed Abilify to elderly patients with dementia-induced psychosis, or to children with autism, to help with aggression and mood swings. While it's not illegal for a doctor to prescribe a medication for off-label use, it is illegal for the manufacturer to market the drug for off-label uses. None of the off-label uses for Abilify have been studied for efficacy or safety, and the drug is not approved by the FDA for these uses.
Compulsive Behavior Associated with Abilify
The most common claim in lawsuits is that use of the antipsychotic drug aripiprazole led to compulsive behavior - that is, uncontrollable urges, loss of impulse control, or addictive patterns. Patients have reported obsessions that lead to significant financial losses, unusual hypersexuality, which in some cases became sex addiction, or similar activities such as binge eating or compulsive shopping. Of these, the most often reported compulsion was gambling.
Dozens of case reports support the link between Abilify use and compulsive behavior, especially pathological gambling. Additionally, Abilify acts as a dopamine agonist, which means it stimulates a part of the brain responsible for rewarding feelings. Such feelings include those experienced after winning a bet, engaging in sexual activity, or eating a delicious meal. Researchers believe that Abilify's modification of dopamine pathways may explain the strong compulsions seen in some patients.
Although the science is inconclusive, this link did drive the European Medicines Agency (EMA) and Health Canada officials to order Bristol-Myers Squibb to change the labels on Abilify to reflect the risk for compulsive behavior and gambling addiction. In 2016, the FDA followed suit, requiring a black box warning on Abilify labels.
Abilify and Stroke Risks
Like several other antipsychotic medications, Abilify has been linked to an increased risk of stroke, which can be deadly. Despite these discoveries, Abilify is often prescribed as a treatment for dementia-induced psychosis in elderly patients, even though the drug is not approved to treat this mental disorder. In 2016, the FDA issued a warning about the increased risk of death in elderly patients who take Abilify.
Many legal claims have alleged that BMS knowingly marketed the drug for off-label use to treat psychotic behavior in elderly dementia patients without disclosing the increased risk of death.
Hyperglycemia, Type 2 Diabetes and Abilify
As with other medications for mental disorders, Abilify has been associated with substantial weight gain, though in a smaller percentage of patients than many other similar drugs. Additionally, Abilify can sometimes cause an increase in blood sugar, known as hyperglycemia.
Both hyperglycemia and rapid weight gain are risk factors for type 2 diabetes. Some patients who took Abilify and later developed type 2 diabetes have filed lawsuits claiming that Bristol-Myers Squibb did not adequately warn them of this risk.
In addition to the dozens of individual lawsuits filed against BMS for Abilify side effects, the Judicial Panel on Multidistrict Litigation (JPML) has centralized hundreds of cases in multidistrict litigation (MDL), designated MDL 2734, in re: Abilify Products Liability Litigation. These cases are being handled by the United States District Court for the Northern District of Florida to increase the efficiency of the process.
According to the complaints, individuals are filing lawsuits to seek damages related to pathological gambling losses, medical expenses, and lost income they claim were caused by the defective drug. Many legal complaints also seek punitive damages that hold Otsuka Pharmaceutical Co. and BMS accountable for their deceptive marketing practices.
The first three bellwether trials began in 2018 and settled for undisclosed amounts. In May of 2018, Judge M. Casey Rodgers enacted a Global Settlement Order requiring BMS to create a global settlement framework addressing the remaining aripiprazole lawsuits in MDL 2734. Though the parties failed to meet the initial settlement deadline, a new docket filing indicates that a global settlement was reached as of February 15, 2019.
According to a June 2020 docket filing, settlement administration is currently ongoing in MDL 2734.
Abilify Settlements and Verdicts
2016 Abilify Settlement: $19.5 million
In 2016, Bristol-Myers Squibb and a coalition of 42 states agreed to settle claims that the company had illegally promoted Abilify for off-label uses, including use by children and elderly patients with dementia. The claim also raised questions about whether BMS misled patients about the risk of weight gain when taking Abilify.
Despite the lawsuit payout, BMS continues to deny any wrongdoing in its marketing efforts. Nonetheless, the drug manufacturer did agree to a few terms in the settlement, including a prohibition to promoting Abilify for off-label use, making false claims about the drug, and obscuring information about side effects. They also are prohibited from paying health care providers to attend promotional events for Abilify, among other restrictions.
2007 Abilify Settlement: $515 million
In September 2007, Bristol-Myers Squibb paid more than $515 million to settle a federal investigation into its marketing techniques for Abilify. The U.S. government claimed that between 2000 and 2003 pharmaceutical company made illegal payments to physicians for prescribing Abilify and provided similar illegal benefits to pharmacies that filled the prescriptions.
Furthermore, the government accused BMS of marketing their drug for off-label uses and to unapproved age groups. The allegations also claimed that the drugmaker had purposefully and irresponsibly inflated the price of the drug.
The settlement let BMS escape a full trial, but it also came with strings attached. Part of the agreement required the corporation to report accurate drug prices to the Office of Inspector General of the Department of Health and Human Services.
Frequently Asked Questions About Abilify Lawsuits
Who Is Eligible to File a Lawsuit for Abilify Side Effects?
If you or a loved one experienced compulsive behavior, high blood sugar, Type 2 Diabetes, or a stroke after taking Abilify, you may be eligible for compensation related to pain, suffering, lost wages or other circumstances associated with Abilify.
What Compensation is Available for an Abilify Side Effects Lawsuit?
You may be eligible for damages associated with medical treatment, travel to and from healthcare appointments, lost wages, pain, suffering or future medical care. You could also receive punitive damages designed to punish BMS for its role in contributing to harmful side effects.
How Much Does it Cost to File an Abilify Lawsuit?
Prescription drug lawsuits like those filed for Abilify are typically done on contingency. This means that you will only be required to pay legal fees after you receive compensation for your case. If your case is not successful, you will not be required to pay anything.