The makers of the blockbuster drug Abilify have until September 1 to find a way to settle more than 800 lawsuits alleging that the antipsychotics and antidepressants have caused uncontrollable urges to gamble, binge, shop and have sex. have – all without any warning.
The deadline for that “global settlement” was recently ordered by Judge M. Casey Rodgers in Florida’s Northern District Court, who hears all lawsuits in a condensed process called multidistrict litigation (MDL).
Judge Rodgers made the call after the creators of Abilify, Bristol-Myers Squibb and Otsuka, individually settled three lawsuits from the MDL earlier this year. All three were settled for undisclosed amounts. Those cases had been carefully selected by the court and used as so-called ‘bellwether trials’. That is, they were otherwise test cases, so they set a precedent for settlement. In the event that Bristol-Myers Squibb and Otsuka fail to settle the remainder by the deadline, the court will move another set of lawsuits from the MDL to court.
Either way, the trial will likely provide patients with a solution that drug researchers have been unable to provide until now.
There is currently limited scientific data on whether and how the popular drug causes such compulsive behavior — and in whom. Obtaining such data would likely require massive, resource-intensive clinical studies. But thousands of patients who have already taken the drug have linked its use to unusual behaviors and impulses that they say have wreaked havoc on their lives and finances.
Sex, drugs and casinos
In one case, recently highlighted by statusDenise Miley says she became a compulsive gambler pretty much overnight. She started the drug for depression and anxiety in December 2014. Soon after, the devoted mother of four began sneaking away from work, her children’s sporting events, and gatherings with friends to visit a nearby casino. To satisfy her intense desires, she secretly tapped her family’s bank accounts and pension funds and took out a loan for $50,000. And that was all within the short six-month period she was on Abilify. Her interest in gambling abruptly disappeared after she ended up in a treatment center that got her off the drug.
In a lawsuit originally filed in January 2016 (PDF) – which is now part of the MDL and subject to the “global settlement” due in September – she and her husband Bristol-Myers accuse Squibb and Otsuka of wrongful conduct and negligence that resulted in losses of more than $75,000.
In another case, highlighted by the Daily Beast, a married woman became addicted to sex and shopping while taking drugs. “I started to become obsessed with sexual fantasies and taking pictures of myself to send to a few select ‘friends,'” she wrote in a letter to her lawyer. “I just couldn’t stop with the pictures and fantasies.” She set up a daring Facebook page and was sexting several men—to the point that her boss noticed and her husband understood. She had also done extravagant errands, bought cars and built an extension to their garage with money from loans. She and her husband later had to file for bankruptcy.
They didn’t suspect Abilify was behind the sudden impulsiveness until her husband caught a commercial for the drug warning of such behavior as a side effect. “The drug has destroyed my life, my reputation and the lives of my loved ones,” she later wrote to her lawyer.
The fine print
Abilify (generic name aripiprazole) was first approved by the Food and Drug Administration in 2002 to treat schizophrenia, but later gained approval to treat bipolar disorder, Tourette’s disorder, and irritability associated with autism spectrum disorders. It is also used as an adjunct treatment for major depressive disorder and is used off-label for a host of other conditions, including anxiety and eating disorders.
While it’s unclear how it might trigger compulsive behavior, Abilify is known to have an effect by activating certain subsets of dopamine receptors. These are components of nerve cells that detect chemical signals — also known as neurotransmitters, in this case dopamine — that are sent by other nerve cells. Dopamine plays a role in reward-seeking behavior and addiction, among other things.
However the drug works in people’s minds, it worked like a charm on the market. Sales of Abilify have brought in more than $51 billion in the US alone since its debut. And while a generic version hit the U.S. market in 2015, the brand-name drug continues to sell healthily.
But with the success came a steady stream of reports from patients linking the drug to compulsive behaviors. In 2012, the European Medicines Agency required Abilify to be provided with a special warning, taking into account post-market reports of pathological gambling. In 2015, Canadian regulators also recognized a clear risk of gambling and hypersexuality. They added a warning to the prescribing information. However, the FDA didn’t get the hint until 2016, when it finally issued its own warning.
By then, much damage had been done, according to the hundreds of plaintiffs in the MDL — as well as others. Not all lawsuits involving Abilify have made their way to the MDL. Bristol-Myers Squibb and Otsuka reported that more than 900 cases have been filed in state and federal courts alleging that Abilify caused compulsive behavior. This does not apply to cases in Canada. Others estimate that the total number of lawsuits is above 1,600.
And this isn’t the first time the drug has gotten into such legal trouble. In 2007, Bristol-Myers Squibb paid more than $515 million to pay federal charges, including illegally marketing Abilify for pediatric use and for treating dementia-related psychosis — both off-label uses. In 2016, the company reached a $19.5 million settlement with 42 states and the District of Columbia, again over illegally marketing Abilify for pediatric use and elderly patients with dementia. The states and DC also accused the company of downplaying Abilify’s risks.