PENSACOLA — A smuggler who made headlines a decade ago and was the focus of the 2016 film War Dogs is making news again.

Efraim Diveroli of Miami Beach has joined a long line of plaintiffs suing the maker of the prescription drug Abilify for his compulsive behavior.

Abilify is the top-selling antipsychotic drug in the United States. It is prescribed to treat several mental disorders, including schizophrenia, bipolar disorder, depression and Tourette syndrome, and has been handed out copiously since it was put on the market in 2002, earning hundreds of millions of dollars for its manufacturers, according to court documents. Between April and June 2014, Bristol-Myers reported that Abilify earned $417 million in the United States and $555 million worldwide.

Diveroli, who now lives in Miami Beach, claims that Abilify “caused harmful compulsive behaviors including compulsive gambling, hypersexuality, and compulsive spending, resulting in substantial financial, mental, and physical damages."

Diveroli’s complaint is one of dozens of lawsuits claiming the same harm that were filed after the U.S. Food & Drug Administration issued a safety warning and required a label on the medication to warn users of the risk of compulsive behavior. Plaintiffs in the multidistrict litigation are seeking punitive and actual damages covering the purchase and ingestion of Abilify, as well as the cost of treatment. They are also asking for damages for "neuropsychiatric, mental, physical, and economic pain and suffering," as well as attorney fees.

William Large, president of the Florida Justice Reform Institute, told the Florida Record that drug manufacturers are often blamed for side effects that could just as likely be symptoms of the ailment the drug is meant to treat.

“Abilify is prescribed to treat depression, bipolar disorder and schizophrenia," Large said. "One of the problems that drug manufacturers have when they prescribe a drug meant to treat a certain problem is that a potential plaintiff attributes the drug, not the underlying disease, for future ailments."

When Diveroli filed his lawsuit, the cases had been consolidated in a federal court in Pensacola, to be heard by Northern District of Florida Chief Judge M. Casey Rodgers.

Who is Efraim Diveroli?

His illegal weapons deals made headlines about 10 years ago, but Diveroli’s story was most recently told in War Dogs, a Warner Bros. film starring Jonah Hill. According to an in-depth portrait by the Miami New Times, the Hollywood version isn’t far from the truth.

With two others, Diveroli landed a $300 million contract with the federal government to deliver ammunition to the Afghan army. Their plan involved buying cheap, old bullets in Albania and shipping them to Afghanistan.

“For a few delirious months starting in 2007, Diveroli, David Packouz, and Alex Podrizki were at the center of a massive international gunrunning enterprise," the article said. "They moved Chinese ammunition through Eastern Europe to the front lines in Afghanistan. But the plan spectacularly crumbled after a military investigation, scathing international headlines, a mysterious death in Albania, and, eventually, federal charges that shattered their lives."

In July 2008, federal prosecutors charged all three gunrunners with 71 counts of fraud and conspiracy, and Diveroli got four years in prison. Last year, he published an autobiography, which is adamantly disputed by Packouz and Podrizki, who say it’s “full of self-aggrandizing errors,” according to New Times. Diveroli also sued Warner Bros., claiming the film company marketed the movie as a true story when it was only based on true events, according to the Hollywood Reporter.

One of his accomplices mocked Diveroli’s lawsuits, including the new case against the makers of Abilify.

"Sounds like his new business model is filing frivolous lawsuits," Packouz told the New Times. "First the suit against Warner Bros. and now this. I sincerely hope he finds a more productive line of work."

Blaming Abilify

People suing the makers of Abilify claim the drug is to blame for gambling debts, loss of financial stability, lost wages, and other mental, physical and economic harm.

In the lawsuit, Diveroli claims that the makers of Abilify knew or should have known that the drug causes or contributes to the risk of such side effects when taken as prescribed. While the drug’s label in Europe and Canada carries warnings of “pathological gambling,” those in the United States didn’t until about a year ago.

He also claim that the makers of Abilify haven’t adequately studied the drug.

“Defendants did not warn, advise, educate, or otherwise inform Abilify users or prescribers in the United States about the risk of compulsive gambling or other compulsive behaviors," Diveroli's complaint reads. "Prior to January 2016, the U.S. label made no mention of pathological gambling or compulsive behaviors whatsoever."

He goes on to claim that the makers of Abilify added “pathological gambling” to the drug’s label in January last year but didn’t include the warning in the patient medication guide – a likelier spot to be noticed by doctors and patients, he said.

Months later, on May 3, the U.S. Food & Drug Administration posted a safety alert about the drug, warning consumers that users have reported those side effects – “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex.”

According to the FDA, the urges stopped when the user stopped taking the medication or took a smaller dose.

“These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized,” the FDA warned.

The FDA identified 184 reports linking Abilify with compulsive behavior problems since the drug was approved in November 2002, including 167 cases in the United States. The FDA added new warnings to the drug’s label and medication guide addressing the extent of compulsive behavior reported by users, saying that even though the label already includes compulsive gambling as a possible side effect, “this description does not entirely reflect the nature of the impulse-control risk FDA identified.”

Large lamented that drug companies face these kinds of lawsuits in their quest to treat ailments and disorders. He asked how drug manufacturers can venture into making medication to treat certain ailments if the people they’re trying to help are going to “turn around and sue them?”

“The issue is whether or not this drug causes ‘pathological gambling,' ” he said. “If that was a potential risk factor, the prescribing physician would have discussed that with the plaintiff.”

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Florida Justice Reform Institute
210 S Monroe St
Tallahassee, FL 32301-1824

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