AG Cooper announces record-breaking settlement with Abbott Labs
Release date: 5/7/2012
Drug maker to pay $100 million over marketing for Depakote
Raleigh: Abbott Laboratories will pay North Carolina and 45 other states $100 million to resolve allegations that it improperly marketed the drug Depakote, Attorney General Roy Cooper announced today.
“Marketing drugs for off-label uses is misleading and can be dangerous,” Cooper said. “Drug makers have a responsibility to make sure their drugs do what they say they do.”
Depakote is approved by the U. S. Food and Drug Administration to treat seizure disorders, mania associated with bipolar disorder and prophylaxis of migraines. Cooper and the other attorneys general allege
that Abbott representatives engaged in unfair and deceptive practices by marketing Depakote for off-label uses. For example, Abbott marketed the drug to treat schizophrenia and agitation associated with dementia even though clinical studies showed the drug was not effective in treating these disorders.
North Carolina served on the executive committee that helped negotiate the settlement
and will receive $3.5 million for consumer protection efforts. In addition, the State Health Plan for Teachers and State Employees will get $390,531.51 and the state prison system will get $184,468.49 to reimburse them for drugs purchased.
This is the largest ever consumer protection settlement involving a pharmaceutical company, trumping a 2011 settlement where AstraZeneca paid $68.5 million to resolve allegations about the drug Seroquel.
As a result of the states’ investigation, Chicago-based Abbott has agreed to significantly change how it markets Depakote and to cease promoting it for off-label uses.
Under the settlement, Abbott Laboratories is:
- Prohibited from making false or misleading claims about Depakote,
- Prohibited from promoting Depakote for off-label uses, and
- Required to ensure financial incentives on sales do not promote off-label uses of Depakote.
In addition, for a five-year period, Abbott must register and disclose clinical trials, and it may only allow scientifically trained personnel, not sales representatives, to disseminate reprints of clinical studies relating to off-label uses of Depakote.
Joining North Carolina in today’s settlement are: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia and Wisconsin.
Media contact: Noelle Talley (919) 716-6413