Depakote and Abbott's $1.6 Billion Mistake

Abbott never had FDA approval to promote Depakote for aggression and agitation in the elderly or schizophrenia. The total includes a criminal fine of $700 million and civil settlements with the states and federal government totaling $800 million. Abbott pleaded guilty to a criminal misdemeanor for misbranding the medication. Abbott is also going to pay 45 states $100 million to resolve liability with consumer protective laws. Luckily the Justice Department found no deaths due to this crime.

The company admitted that from 1998 through 2006, it "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," the Justice Department said in a news release.

"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."

Heaphy said Abbott earned about $13 billion from Depakote sales during the period investigated, but he said it was difficult to determine how much of that was the result of sales for illegal purposes. He expressed confidence that, once the fines are factored in, Abbott will not have profited from the improper practices.

Um... Ok. $13 billion minus $1.6 billion equals a profit.

No wonder this will keep happening.