Depakote Settlement of $1.6B Reached Between Abbott, DOJ

Abbott Laboratories has agreed to pay the federal government $1.6 billion for illegally marketing their epilepsy drug Depakote for uses that were never approved by the FDA. 

The U.S. Department of Justice (DOJ) announced on Monday that Abbott has agreed to plead guilty to criminal charges of unlawful promotion of Depakote and will pay both criminal and civil fines. It is the second largest settlement a drug company has ever reached with the U.S. government.

Abbott Laboratories has admitted that from 1998 through 2006 it marketed Depakote, an antiseizure medication given to epileptics, to treat schizophrenia and tried to convince nursing homes to use Depakote to pacify elderly dementia patients, which is many consider a form of nursing home abuse from chemical restraint. Neither use was approved by the FDA.

Drug manufacturers are only permitted to promote drugs for FDA-approved uses. Doctors, however, can prescribe drugs for any reason they see fit. Depakote has only been approved to treat epileptic seizures, bipolar mania and for the prevention of migraines.

Abbott went as far as maintaining a specially trained sales force whose job it was to push nursing homes to use Depakote to drug their more unruly residents into a stupor. The company also tried to convince doctors to use Depakote in combination with atypical antipsychotic drugs to treat schizophrenia even after the company’s own clinical trials showed that Depakote did not appear to help.

As part of the company’s plea, it will pay $700 million in criminal fines and profit forfeitures, and it will pay another $800 million in civil fines. The company has also agreed to a five year probation period.

“Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies,” said Acting Associate Attorney General Tony West. “As this criminal and civil resolution demonstrates, those who put profits ahead of patients will pay a hefty price.”

Depakote was approved in the United States in 1978 for treatment of certain forms of epilepsy.

In addition to the DOJ investigation, Abbott faces an increasing number of lawsuits filed over birth defects from Depakote, which allege that the drug maker failed to work consumers or the medical community about the risks associated with becoming pregnant while on the medication.

In 2006, the FDA added a “black box” warning about the potential risk of Depakote birth defects after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect.

Depakote pregnancy use has been linked to an increased risk of a number of severe birth defects, especially when the drug is taken during the first 28 days, when neural tube closure and other critical formations are taking place.