Bristol-Myers to pay $19.5 million in Abilify off-label marketing settlement

Almost a decade after settling up Abilify marketing allegations with the U.S. Justice Department, Bristol-Myers Squibb agreed to pay $19.5 million to settle similar claims at the state level.

Announced by New York Attorney General Eric Schneiderman, the deal covers claims that Bristol-Myers pushed Abilify as a treatment for kids and for elderly patients with dementia, when neither use was approved by the FDA. According to the AG, the company also violated consumer protection laws by minimizing the risks of Abilify—including weight gain and metabolic side effects—and misrepresenting clinical study data.

Bristol-Myers says it's pleased to have resolved the matter and that it denies any wrongdoing in the case, noting that the company hasn't marketed Abilify since 2013. Its marketing partner, Otsuka, now handles the brand.

At $19.5 million, the Abilify marketing deal is a fraction of many state-level marketing settlements, and even more so compared with Bristol-Myers’ payments to wrap up allegations at the federal level. In 2007, the company agreed to pay $515 million to settle an off-label investigation that centered on Abilify, but also included other drugs. Bristol-Myers said it disclosed the state-level investigation in 2009.

The state settlement puts to rest more than 10 years of allegations about Abilify marketing. Last year, a U.S. judge tossed federal-court claims that Bristol-Myers and its Abilify partner, Otsuka, paid kickbacks to boost scripts of the drug. Like the new state settlement, that whistleblower suit cited promotions to pediatric psychiatrists as evidence of off-label marketing. At the time, the judge allowed the whistleblowers to pursue claims that Bristol-Myers fired them to retaliate for their off-label accusations.

Among antipsychotic drugmakers, Bristol-Myers isn’t alone in settling off-label marketing allegations. Johnson & Johnson, which markets Abilify rival Risperdal, agreed in 2013 to pay $2.2 billion in a settlement with the federal government and a group of states; that deal included a handful of other meds. Eli Lilly made a $1.4 billion deal in 2009 to settle Zyprexa marketing claims, and AstraZeneca agreed in 2010 to pay $520 million in a similar case involving its antipsychotic Seroquel.

Editor's note: This story was updated with comments from Bristol-Myers.