Abbott Preps for Depakote Marketing Settlement

The maker of Depakote has set aside $1.5 million to settle charges it illegally promoted off-label, or unapproved uses, of the anti-seizure drug.  The potential settlement of a U.S Department of Justice investigation was reported yesterday by The Wall Street Journal, which said Abbott Pharmaceuticals had set aside $1.5 million in the third quarter to cover a potential Depakote settlement.

The investigation was spawned by four whistleblower lawsuits filed by current and former Abbott employees who claimed the company's alleged illegal marketing of Depakote led to false claims being submitted to Medicaid and other government insurance programs for Depakote reimbursements. The whistleblowers could end up receiving a portion of any settlement the government reaches with Abbott.

Depakote is approved to treat seizures, and manic or mixed episodes associated with bipolar disorder, and to prevent migraine headaches.   Abbott is accused of marketing Depakote as a treatment for other conditions, including autism and aggression in the elderly.

While doctors are free to prescribe drugs for off-label uses, drug makers are legally prohibited from marketing medications based on unapproved uses.

While a Depakote settlement with the government has not been finalized, if the ultimate resolution includes a $1.5 million penalty, it would represent the second largest healthcare fraud fine ever levied by the Justice Department