Abbott to pay $1.6 bn to settle Depakote epilepsy drug suits
09 May 2012
Abbott Laboratories, the $39 billion US-based medical products and drug maker yesterday agreed to pay $1.6 billion to the US federal government and most states for promoting its Depakote epilepsy drug for unapproved uses.
Pleading guilty, the Abbott Park, Illinois-based company will pay federal and state governments $800 million to resolve civil allegations, $700 million in criminal penalties and $100 million to states to resolve consumer protection matters.
The company also will plead guilty to misbranding, and agreed to a five-year probation during which it must report any probable violations of the law to the probation office, according to the US Department of Justice (DoJ).
Abbott's settlement marks the culmination of a four-year investigation into it's sales strategy to expand the market Depakote.
The US Food & Drug Administration (FDA) had only approved Depakote for the prevention of migraines, treating acute manic episodes in bipolar patients and halting seizures in adults and children.
A whistle-blower lawsuit bought on by former and current Abbott sales employees had alleged 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 alleged that the company gave doctors and pharmacists illegal kickbacks to talk about off-label uses of the drug to boost sales.
