Abilify Litigation Guide

If you unexpectedly developed compulsive behaviors such as shopping, gambling and sexual addiction, the antipsychotic medication Abilify can be the reason. According to many plaintiffs who filed a lawsuit against Abilify manufacturers’ Bristol-Myers Squibb and Otsuka Pharmaceutical purposely downplayed its risks by hiding critical evidence from the public about a danger of developing addictive behaviors. The pharmaceutical companies also allegedly failed to warn patients and doctors about a long-term risk of type-2 diabetes in children prescribed with this medication.

What Is Abilify?

Abilify (aripiprazole) is a medication used to treat schizophrenia by helping with the management of its symptoms such as hallucinations, self-harm, disorganized thinking and delusions. It is also effective to reduce mood swings and tics, and it’s thus indicated as adjunctive therapy in patients affected by depression, autistic disorder and Tourette’s Syndrome.

Aripiprazole is an atypical antipsychotic drug that acts by modulating the production of dopamine and serotonin in the central nervous system (CNS). Differently to what happens with other similar drugs of the same class such as clozapine and risperidone (Risperdal) that simply block the action of these neurotransmitters, Abilify actually stabilizes their levels to maintain an optimal balance inside the brain. Many of the conditions treated by this drug are, in fact, caused by either over- or under-stimulation of certain CNS areas such as the mesolimbic or mesocortical pathways.

Aripiprazole received its approval by the U.S. Food and Drug Administration (FDA) in 2002, and it’s marketed in the United States by Bristol-Myers Squibb and Otsuka Pharmaceutical, a Japanese company.

Compulsive behaviors and loss of impulse control

All the atypical antipsychotic drugs are associated with several side effects ranging from weight gain to sexual hyperarousal, hyperlipidemia, cataract and extrapyramidal effects. However, the Big Pharma that marketed and advertised Abilify to millions of patients never warned them or their doctors about the risk of compulsive behaviors and loss of impulse control. After several case reports had found a link between the use of this medicine and many aberrant behaviors such as pathological gambling, binge eating, compulsive shopping and sex addiction (hypersexuality), the FDA issued a label change to alert to the general population about this risk. These uncontrollable urges subside after the drug is discontinued or the dose is reduced but may harm a patient’s life if they’re not recognized quickly.

Recently, on May 2016, the regulator highlighted how the gambling warning listed among the adverse reactions included in the aripiprazole’s label does not entirely reflect the serious impulse control danger. People suffering from pathological gambling disorders may, in fact, experience an unexpected and irresistible urge to bet their money (even if they don’t have it) on poker tournaments, casinos, blackjack tables and slot machines. They may keep gambling on credit until they end up with serious debts which may cripple them and their families. A possible mechanism that has been suggested, may involve the unique role that aripiprazole has on influencing brain dopamine, a neurotransmitter that reinforces behaviors through the reward system and the subjective feeling of pleasure.

Antipsychotics overprescription

The actual amount of yearly antipsychotics prescriptions grew by 93% in just 10 years, reaching monstrous proportions in 2011 with over 3 million U.S. patients being prescribed with one fo this drugs. Abilify alone grossed $7 billion in just one year in 2014, being the largest player in the market together with Seroquel (quetiapine).

The most concerning aspect is the fact that these medicines are currently prescribed to patients who do not suffer from schizophrenia. In fact, many patients affected by depression or bipolar disorder who failed to respond to treatment with an antidepressant, often receive Ability as an antipsychotic second-line therapy. Common antidepressants require, in fact, several weeks before they start working, and unscrupulous psychiatrists often chose to take a shortcut and administer aripiprazole or quetiapine regardless of their reduced safety and significant side effects.

On April 2015, the FDA issued an Abilify warning letter to Otsuka Pharmaceutical, explaining how their drug presentation violated the Federal Food, Drug, and Cosmetic Act (FD&C Act) with false or misleading marketing claims.

Abilify and Childhood Diabetes

Clinical studies found an association between the overprescription of antipsychotic medications in adolescents and kids and an increased risk of metabolic diseases such as type-2 diabetes. Once again, the irresponsibly aggressive marketing tactics of unscrupulous pharmaceutical companies came at the expense of the most vulnerable individuals in our society.

Several Abilify children diabetes lawsuits have been filed so far, including one brought to the attention of the Supreme Court of New York for New York City by plaintiff Cheyenne Beth Confer. According to her complaint, the 21-year old woman gained about 30 pounds in less than six months when she started taking aripiprazole at the age of 15, and was then diagnosed with diabetes. Her attorneys allege that  Bristol-Myers Squibb and Otsuka American Pharmaceutical Inc. never properly warned the victim about the increased danger of developing this metabolic disorder during treatment.

Illegal drug marketing schemes and the off-label scandal

Back in 2007, Bristol-Myers Squibb faced serious accusations from the U.S. Department of Justice that eventually ended with the company agreeing to pay  $515 million settlement to resolve all the allegations. The corporation illegally marketed Abilify to nursing homes, regardless of the fact that the drug could kill elderly patients affected by dementia and even has a “black box” warning against this use. BMS also paid kickbacks to physicians and other healthcare providers in the form of lavish entertainment and travels to luxurious resorts, to unlawfully promote the sale and use of the medication for several off-label indications especially to children and adolescents.

Why Are Lawsuits Being Filed Against Abilify’s Manufacturers?

Back in 2008, a plaintiff from Minnesota, Gary Charbonneau, lost $260,000 to pathological gambling after taking a similar drug called Mirapex (pramipexole).

After hearing his plea, a jury found Boehringer Ingelheim negligent in warning and ordered the medication’s manufacturer to compensate Charbonneau with a $8.3 million reward. As per September 2017, a total of 365 Abilify lawsuits pending in 12 district courts have been consolidated into a Multi-District Litigation (MDL No. 2734) overseen by Judge M. Casey Rodgers in the U.S. District Court for the Northern District of Florida.

All the victims claim that they experienced impulse control disorders shortly after taking the drug, for which the manufacturers never provided adequate warning. If you want to file your own individual litigation or take part in the mass tort, call now and our team of experienced attorneys will assist you through the entire legal process.