ABBOTT PARK, Ill. – Abbott Laboratories agreed Monday to pay $1.6 billion after dozens of state and federal authorities sued over its off-label promotion of the anti-seizure drug Depakote.
The settlement includes $700 million in criminal penalties, $100 million to states for consumer protection matters and $800 million to resolve cases brought simultaneously by the U.S. government and 49 states.
Abbott also agreed to plead guilty to misbranding, a misdemeanor under the Food, Drug and Cosmetic Act, for which it faces five years of probation.
Depakote’s three approved used by the Food and Drug Administration are to treat epileptic seizures, bipolar mania and the prevention of migraines.
Abbott reportedly earmarked $1.5 billion to cover projected settlement costs last year, and set aside an additional $100 million for the same purpose last monthg.
The lawsuits said that tests show Depakote is an ineffective solo treatment for schizophrenia, but Abbott nevertheless promoted the drug for that very off-label use, as well as to control agitation and aggression in elderly dementia patients.
Abbott had to discontinue a dementia clinical trial of Depakote in 1999 because patients reported increased incidence of adverse events, including somnolence, dehydration and anorexia, according to the Justice Department.
Prosecutors in the Western District of Virginia, which entered the settlement, say it is the second largest payment by a drug company.
“Abbott admits that from 1998 through 2006, the company maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use,” according to a statement from the Justice Department. “In addition, from 2001 through 2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use.”
“In the agreed statement of facts, Abbott also admitted that from 2001 through 2006, the Company misbranded Depakote by marketing the drug to treat schizophrenia,” the statement continues. “Abbott funded two studies of the use of Depakote to treat schizophrenia, and both failed to meet the main goals established for the study. When the second study failed to show a statistically significant treatment difference between antipsychotic drugs used in combination with Depakote and antipsychotic drugs alone, Abbott waited nearly two years to notify its own sales force about the study results and another two years to publish those results. During this time, Abbott continued to promote Depakote off-label to treat schizophrenia.”