Enlarge / Bottles of Bristol-Myers Squibb Co. Abilify brand medication sits on a pharmacy shelf in Princeton, Illinois, on Wednesday, October 22, 2014. Getty | Bloomberg reader comments 28 Share this story Makers of the blockbuster drug Abilify have until September 1 to come up with a way to settle more than 800 lawsuits that…
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Makers of the blockbuster drug Abilify have until September 1 to come up with a way to settle more than 800 lawsuits that claim the anti-psychotic and anti-depressive drug spurred uncontrollable urges to gamble, binge eat, shop, and have sex—all without any warning.
The deadline for that “global settlement” was ordered recently by Judge M. Casey Rodgers in the Northern District Court of Florida, which is handling all the lawsuits in a lumped process called multidistrict litigation (MDL).
Judge Rodgers made the call after Abilify’s makers, Bristol-Myers Squibb and Otsuka, settled three lawsuits from the MDL individually earlier this year. All three were settled for undisclosed sums. Those cases had been carefully selected by the court and used as so-called bellwether trials. That is, they were test cases for the rest, thus they set a precedent for settlement. In the event that Bristol-Myers Squibb and Otsuka fail to come up with a way to settle the rest by the deadline, the court will move a fresh batch of lawsuits from the MDL to trial.
Either way, the litigation will likely provide patients with a resolution that, so far, drug researchers have not been able to give them.
There’s currently limited scientific data on whether or how the popular drug actually causes such compulsive behaviors—and in whom. Getting such data would likely require massive, resource-intensive clinical trials. Yet thousands of patients who have already taken the drug have linked its use to out-of-character behaviors and impulses that they say wreaked devastation on their lives and finances.
Sex, drugs, and casinos
In one case, highlighted recently byStat, Denise Miley says she became a compulsive gambler virtually overnight. She started taking the drug for depression and anxiety in December 2014. Quickly after, the devoted mother of four began sneaking away from work, her kids’ sporting events, and gatherings with friends to hit up a nearby casino. To satisfy her intense urges, she secretly tapped her family’s bank accounts and retirement funds and took out a loan for $50,000. And that was all within the brief six-month period she was on Abilify. Her interest in gambling abruptly vanished after she landed in a treatment facility that took 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 accuse Bristol-Myers Squibb and Otsuka of wrongful conduct and negligence that led to losses in excess of $75,000.
In another case, highlighted by the Daily Beast, a married woman became hooked on sex and shopping while on the drug. “I started becoming obsessed with sexual fantasies and with 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 risqué Facebook page and was sexting several men—to the point that her boss took notice and her husband caught on. She had also gone on extravagant shopping splurges, buying cars and building an addition onto their garage using 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 that warned of such behaviors as a side-effect. “The drug has destroyed my life, my reputation, and the lives of those I love,” 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 for treating bipolar disorder, Tourette’s disorder, and irritability associated with autism spectrum disorders. It’s also used as an add-on treatment for major depressive disorder and used off-label for a host of other conditions, including anxiety and eating disorders.
Though it’s unclear how it might trigger compulsive behavior, Abilify is known to take effect by activating certain subsets of dopamine receptors. These are components of nerve cells that detect chemical signals—aka neurotransmitters, in this case dopamine—that are sent from other nerve cells. Dopamine plays a role in reward-seeking behaviors and addiction, among other things.
However the drug works on people’s minds, it worked like a charm on the market. Sales of Abilify brought in more than $51 billion in the US alone since its debut. And even though a generic version came on the US market in 2015, the brand-name drug continues to have healthy sales.
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 that Abilify be labeled with a special warning, noting the post-market reports of pathological gambling. In 2015, Canadian regulators likewise acknowledged an apparent risk of gambling and hypersexuality. They added a warning to its prescribing information. The FDA didn’t get the hint until 2016, however, 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 of the lawsuits involving Abilify have made their way into the MDL. Bristol-Myers Squibb and Otsuka reported that more than 900 cases have been filed in state and federal court alleging Abilify caused compulsive behavior. That doesn’t include cases in Canada. Others have estimated that the lawsuits total above 1,600.
And this isn’t the first time that the drug has landed in such legal trouble. In 2007, Bristol-Myers Squibb paid out more than $515 million to settle federal charges that included illegally marketing Abilify for pediatric use and to treat 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.