Abbott to pay $1.3 bn to settle Depakote epilepsy drug claims

Medical products and drug maker Abbott Laboratories has agreed to pay $1.3 billion to settle the US government claim for promoting its Depakote epilepsy drug for unapproved uses.

Abbott has reached a tentative agreement with federal prosecutors and state officials and agreed to pay about $800 million to resolve civil claims over Depakote and about $500 million in criminal penalties for marketing the epilepsy medicine for unapproved uses, Bloomberg reported over the weekend, citing three people familiar with the settlement.

Abbott last week said that it has set aside $1.5 billion for a potential off-label marketing settlement with the US Justice Department (DoJ). The DoJ had also said in June that it was in active talks with Abbott to wrap up the Depakote probe.

The US Food & Drug Administration had only approved Depakote for the prevention of migraines, treating acute manic episodes in bipolar patients and halting seizures in adults and children.

This is a whistle-blower lawsuit bought on by former and current Abbott sales employees alleging that the company's off-label marketing of Depakote began in the late 1990s, when false claims were filed for prescription reimbursement to the government health programs including Medicaid.

The lawsuit also alleges that Abbott pushed the epilepsy drug for treatment for autism, sexual compulsions, agitated and aggressive dementia patients, and other condition. The unapproved uses were promoted in a variety of US healthcare programs, including long-term care and assisted-living facilities.