An Abilify settlement has been reached with Bristol-Myers Squibb Co. for a total of $19.5 million to resolve claims brought forth by the 43 Attorneys Gen. that the company improperly marketed its antipsychotic drug Abilify.

The Abilify settlement will distribute settlement funds among the 43 different states whose attorneys general brought these claims.

It will also restrict some of the improper business practices that the company allegedly engaged in.

Abilify (aripiprazole) was first approved by the FDA back in 2002 as an antipsychotic drug used in the treatment of schizophrenia.

The attorneys general alleged that the improper marketing by Bristol-Myers Squibb, Abilify’s promoter, encouraged sales of the drug for unapproved uses.

The allegations stated that the makers of Abilify engaged in trade practices that were unfair or deceptive when it marketed Abilify.

The recent Abilify lawsuit alleged that Bristol-Myers Squibb marketed Abilify to be used in elderly patients suffering from dementia and Alzheimer’s disease despite the drug not having FDA approval for these uses.

Abilify currently holds a “black box” warning, the strictest type of warning label of its kind, that states elderly patients suffering from dementia-related psychosis who are treated with antipsychotic drugs like Abilify have an increased risk of death.

The complaint additionally alleges that the manufacturer made false and misleading representations about the risks associated with Abilify, essentially minimizing the risks and misrepresenting them.

Additionally, Bristol-Myers Squibb allegedly overstated the research results of relevant scientific studies by failing to include the limitations that affected the interpretation of the results of the studies, the Abilify lawsuit states.

The Abilify lawsuit also states that Bristol-Myers Squibb promoted Abilify to be used by children. It has not received FDA approval for such a use.

As a result of the Abilify settlement, Bristol-Myers Squibb will also have limits placed on its financial incentives provided to sales reps and healthcare providers, limits on how information can be disseminated that promotes off-label use of Abilify, and limits on other practices that affect the off-label promotion of the drug.

Legal Issues Beyond the Current Abilify Settlement

The current Abilify settlement is not the only legal battle Bristol-Myers Squibb is fighting over the use of Abilify.

A number of products liability lawsuits have been filed stating that users of Abilify have been suffering severe side effects linked to addictive behaviors, such as gambling addiction, shopping addiction, sexual addiction and more.

These Abilify lawsuits state that Bristol-Myers Squibb is aware of the risks associated with these addictive behaviors and the use of its product Abilify but has not taken proper measures to inform patients and physicians of the risk.

The plaintiffs allege that Abilify labels in Canada and the European Union have had such warnings in place for years, but similar warnings were not in place the United States until December 2015.