Abbott Laboratories has pleaded guilty and agreed to pay $1.5 billion over allegations that it promoted the anti-seizure drug Depakote for uses that were not approved by the Food and Drug Administration.
The company systematically promoted off-label use of the medication as a dementia treatment for nursing home residents. Abbott also paid kickbacks to physicians and long-term pharmacists to encourage its use, according to court records.
At a news conference Monday, U.S. Attorney Timothy Heaphy said the practice went beyond questionable practices by “some rogue sales representatives.” In fact, top officials at Abbott knew about and encouraged the misleading practice from 1998 to at least 2006.
The case includes a criminal fine and forfeiture of $700 million and civil settlements with the federal government and states totaling $800 million. The company also agreed to enter a five-year probationary period. Depakote is an anti-seizure and mood-stabilizing drug that is routinely prescribed for bipolar disorder.
