FRANKFORT, Ky. (May 8, 2012) — Kentucky has joined other states and the federal government in reaching two independent settlements totaling $1.6 billion with Abbott Laboratories to settle civil and criminal allegations that the drug company illegally marketed the drug Depakote, according to Attorney General Jack Conway.
“I am pleased that these settlements have been reached and that we are able to recover money for a vital state program and for taxpayers,” Conway said. “These settlements should serve as a warning to other drug companies that the off-label marketing of drugs is illegal, puts the public’s health at risk and will not be tolerated.”
The states contend that from January 1998 through December 31, 2008, Abbott promoted the sale and use of Depakote for uses that were not approved by the Food and Drug Administration as safe and effective. This alleged conduct resulted in false claims to Medicaid and other federal healthcare programs. The states also say the covered conduct from the settlement provides that Abbott Laboratories made false and misleading statements about the safety, efficacy, dosing and cost-effectiveness of Depakote for some unapproved uses; improperly marketed the product in nursing homes; and paid illegal remuneration to health care professions and long term care pharmacy providers to induce them to promote and/or prescribe Depakote.
The $1.5 billion Medicaid settlement is the second largest recovery from a pharmaceutical company in a single civil and criminal global resolution. Abbott Laboratories will pay the 49 states, the District of Columbia and the federal government a total of $800 million in civil damages and penalties to compensate Medicaid, Medicare, and various federal healthcare programs for harm suffered as a result of its conduct.
In addition to the civil settlement, Abbott Laboratories pled guilty this morning to a violation of the Food, Drug, and Cosmetic Act (FDCA) and agreed to pay a criminal fine and forfeiture of $700 million. Abbott Laboratories also will enter into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General.
This settlement is based on four cases that were consolidated and are pending in the United States District Court for the Western District of Virginia in Abingdon, Va.
Meanwhile, Kentucky, 44 other states and the District of Columbia settled claims that Abbott’s off-label marketing and unfair and deceptive promotional practices violated Kentucky’s Consumer Protection Act. Abbott will pay $100 million to settle those claims nationally and has agreed to injunctive terms that should restrict the company’s ability to peddle Depakote for off-label uses.
Kentucky will receive a total of $4,626,425 to settle the civil allegations against Abbott Laboratories. That includes $2,978,845 in restitution and other recovery under the Medicaid settlement and $1,647,580 to settle violations to Kentucky’s Consumer Protection Act.
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