Abbott Labs pays $1.5 billion to settle Depakote litigation

Abbott Labs on Monday pleaded guilty to marketing the anti-seizure, mood-stabilizing drug Depakote to treat conditions for which it did not have Food and Drug Administration approval, according to news reports. The company agreed to pay $1.5 billion, which includes a $700 million criminal fine and forfeiture and $800 million for federal and state civil settlements.

 Abbott admitted that the drug was marketed to treat conditions for which it was not approved including schizophrenia, dementia and autism. According to the Associated Press, a specially trained sales team promoted the drug to nursing homes because it was not subject to federal regulations preventing unnecessary medications in this care setting.

In addition to the fine, Abbott also agreed to a five-year probation period.

Topics: Regulatory Compliance