Numerous lawsuits have been filed against the makers of Abilify. The lawsuits concern both the drug’s side effects, as well as the manufacturer’s marketing.
2016 Abilify Lawsuit Settlement
In 2016, Bristol-Myers Squibb reached a nearly $20 million settlement following accusation that the company improperly marketed Abilify. While the manufacturer denied any wrongdoing in the settlement, the company was accused of marketing the drug to seniors with dementia and Alzheimer’s even though it was not approved for such patients.
The settlement, which began with a consumer protection investigation in 2009, involved a coalition of 42 states and the District of Columbia and was settled in December 2016. In a collection of statements, attorneys general criticized the drug manufacturer for failing to stop promoting Abilify for seniors with dementia, as well as for misrepresenting the risks for children.
Off-Label Marketing Investigation
Prior to the 2016 settlement, Abilify was the subject of a U.S. Department of Justice investigation, also involving marketing. The department accused Bristol-Myers Squibb of illegal marketing, specifically promoting Abilify to child psychiatrists, pediatric specialists and nursing homes — all off-label marketing.
In that 2007 case, the Justice Department ordered the company to pay a $515 million fine to settle. Bristol-Myers Squibb also settled a case in California — this one for $30 million — involving accusations that the company lavishly rewarded doctors with dinners, trips, rounds of golf and concert tickets in exchange for prescribing the drug.
Current Abilify Lawsuits
More recently, and following the 2016 safety warning from the FDA, lawsuits involving Abilify have focused on the drug’s impact on impulse control. The drug manufacturer is facing accusations that Abilify sparked uncontrollable urges to gamble, eat, shop or have sex.
These cases involving impulse control are being combined into a centralized federal Multi-District Litigation in the Northern District of Florida. These Abilify lawsuits, unlike a class action, are independent and include plaintiffs nationwide.
Bristol-Myers Squibb is being accused of failing to adequately warn patients of the gambling issue, or other related issues, in order to protect sales of Abilify. While the U.S. did not issue its warning related to this issue until 2016, Europe required a warning label addressing “pathological gambling” in 2012, and Canada required impulse-control warnings in 2015.