$19.5M settlement reached with drug maker for deceptive marketing

Illinois Attorney General Lisa Madigan and 12 other attorneys general announced a $19.5 million settlement over unfair and deceptive marketing of the drug Abilify for unapproved uses in older patients.

Bristol-Myers Squibb Company allegedly marketed Abilify, which is used to treat schizophrenia, to older patients with symptoms of dementia and Alzheimer's disease, which were not approved by the U.S. Food and Drug Administration.

In a complaint filed on Thursday, December 8, along with the settlement, the attorneys general alleged that in 2006, Abilify received a FDA warning stating that older patients with dementia-related psychosis who were treated with antipsychotic drugs, such as Abilify, have an increased risk of death.

The complaint alleged that BMS minimized and misrepresented the risks of using Abilify for these unapproved uses. It also alleges BMS overstated the findings of scientific studies in favor of increased use of Abilify.

Under the settlement, BMS' marketing of any drugs containing aripiprazola will be restricted.

BMS will be prohibited from making false or misleading claims about Abilify, including its safety or efficacy in comparison with other drugs and implications of clinical studies relating to the drug.

The settlement will also limit BMS financial incentives to sales representatives and health care providers and the dissemination of information that may promote off-label use of Abilify and other practices affecting off-label promotion, Illinois will receive more than $500,000 from the settlement.

In addition to Illinois, the following states and the District of Columbia joined the settlement: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.

The settlement was handled by Assistant Attorney General Paige Boggs in Madigan's consumer protection bureau.