Abbott Labs to Pay $1.5 Billion in Depakote Settlement
Abbott Laboratories Inc. pleaded guilty and agreed to pay a $1.5 billion settlement for the company’s off-label promotion of anti-seizure drug Depakote.
Depakote may be used only for epileptic seizures, bipolar mania and migraines. The company paid millions in illegal “rebates” to pharmacists to recommend it to elderly dementia patients and to treat schizophrenia.
The drugs caused dehydration, anorexia and sleepiness in nursing home patients.
It was the second largest payment by a drug company – and includes a criminal fine totaling $700 million and civil settlements with the U.S. Justice Department and the states totaling $800 million.
“Abbott has pleaded guilty to misbranding Depakote,” said Deputy Attorney General James M. Cole. “The FDA never approved the drug as safe and effective for the off-label use.”
Depakote is used by nearly 2.5 million people each and every year around the country. Depakote is available in a variety of forms including delayed and extended-release tablets, sprinkle capsules, Depakene capsules and syrup.
Targeting the elderly
“The size of this settlement demonstrates the seriousness of Abbott’s illegal actions. The company placed vulnerable elderly and pediatric patients at extreme risk by marketing Depakote for purposes not approved by the FDA and by paying kickbacks to induce doctors to write prescriptions,” said Grant & Eisenhofer partner Reuben Guttman of Washington, D.C., who represented whistleblowers who exposed Abbott’s tactics in a 2007 lawsuit.
Under the settlement, the company has agreed to enter a five-year probationary period designed to ensure that there is no repeat of the company’s misconduct.
Abbott unlawfully promoted Depakote for other unapproved uses, including psychiatric conditions in children and adolescents, schizophrenia, depression, anxiety, conduct disorders, obsessive-compulsive disorder, post-traumatic stress disorder, alcohol and drug withdrawal, attention deficit disorder and autism.
As part of today’s resolution, the whistleblowers who alerted the government will receive $84 million from the federal share of the settlement amount.