Settlement talks may still be in the works, but Abbott Laboratories and federal prosecutors have at least reached a tentative agreement regarding the company’s illegal marketing of Depakote. Abbott will be required to pay $800 million for the resolution of civil claims, as well as $500 million in criminal penalties associated with marketing the epilepsy drug for unapproved uses. All told, the drug company has agreed to pay approximately $1.3 billion in order to settle the state and federal claims associated with Depakote.
Abbott Labs began marketing Depakote to elderly patients suffering from Alzheimer’s and dementia, despite the fact it was not approved for the treatment of these diseases. The drug maker also continued to market Depakote for other unapproved uses, including aggression in patients with autism and other disorders. Depakote is only approved by the FDA for the prevention of migraines, the treatment of acute manic episodes in bipolar patients and the halting of seizures in adults and children.
The settlement agreement between Abbott and the government will be the third-largest of its kind in U.S. history, following Pfizer’s $2.3 billion payout over the illegal marketing of Bextra and the $1.4 billion Eli Lilly & Co. paid over sales of its antipsychotic medication, Zyprexa.
