Saying that the U.S. government is determined "to hold accountable those who commit fraud," Deputy Attorney General James Cole announced last week a $1.5 billion drug liability settlement with the global pharmaceutical manufacturer Abbott Labs on charges relating to its anti-seizure drug Depakote.
Depakote is a top-selling drug approved by the Food and Drug Administration (FDA) for use in the United States by patients with bipolar disorder conditions. The agency has never approved the drug for any other use.
Notwithstanding that, federal investigators say that Abbott sales teams, under the guidance of and pursuant to the directives of top management within the company, systematically marketed the drug for additional uses over a period of many years. In fact, a specialized sales force was developed to promote Depakote to nursing home patients for use as a dementia treatment, despite no clinical evidence ever existing that the drug provides any benefit for that condition.
Depakote was additionally pushed as a treatment for schizophrenia, autism and other unapproved uses, all without any supporting studies having been done on dangerous side effects that might result for some users.
The settlement amount includes both criminal and civil fines, paid to both the federal government and states. A criminal fine and forfeiture of $700 million was assessed, with civil penalties totaling about $800 million. One-hundred million dollars will go to 45 states and the District of Columbia to settle consumer claims.
Source: Bloomberg, "Abbott Labs agrees to pay $1.5B over Depakote," Pete Yost, May 7, 2012