SAN FRANCISCO May 7, 2012 - Attorney General Kamala D. Harris today announced two historic settlements with Abbott Laboratories over the illegal off-label marketing of its Depakote drug. California joined other states and the federal government in a $1.5 billion civil and criminal settlement with Abbott Laboratories. The second largest recovery ever from a pharmaceutical company, this settlement resolves false claims made by Abbott Laboratories to Medicaid and other federal healthcare programs. The second settlement, a $100 million civil consumer protection settlement, is the largest consumer protection settlement ever reached with a pharmaceutical company.
(By: Office of the Attorney General)
As a result of the settlements, Abbott Laboratories will be restricted from marketing the drug for off-label uses not approved by the U.S. Food and Drug Administration.
"This company put people in harm's way through the deceptive off-label uses of its drug," Attorney General Harris said. "Californians should be able to trust the companies that produce pharmaceuticals and the magnitude of this settlement shows the seriousness of the offenses."
As part of the $1.5 billion settlement, Abbott Laboratories will pay the states and the federal government $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. The California gross share recovery is $52 million plus 2.5 percent annual interest, which will be split among various parties, including the U.S. Department of Health Care Services, the whistleblowers the California Department of Health Care Services and the California False Claims Act Trust.
Abbott Laboratories also pled guilty this morning to a violation of the Food, Drug, and Cosmetic Act (FDCA) and agreed to pay $700 million in criminal fines. Further as a condition of the settlement, Abbott Laboratories will enter into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General.
"We are pleased that this settlement retrieves scarce Med-Cal funds that should be used for the care of vulnerable Californians," said California Department of Health Care Services Director Toby Douglas. "Protecting the fiscal integrity of Medi-Cal remains a top priority for this department."
The $1.5 billion settlement includes 49 states and the District of Columbia and is based on four qui tam cases filed under federal and California false claims statutes. A team appointed by the National Association of Medicaid Fraud Control Units participated in the investigation and conducted the settlement negotiations with Abbott on behalf of the participating states. Team members from the Attorney General Harris' Bureau of Medi-Cal Fraud and Elder Abuse include Investigative Auditor Martha Valdez, Special Agent Supervisor Cynthia Bentley and Deputy Attorneys General Matt Kilman and Carlotta Hivoral.
The second settlement announced today included 44 other states and the District of Columbia. The $100 million consumer protection settlement included $6.7 million for California, the largest share of any state.
In the complaint filed today with the settlement agreement, the states alleged that Abbott engaged in unfair and deceptive practices when it marketed Depakote for off-label uses. Depakote is approved for treatment of seizure disorders, mania associated with bipolar disorder and prophylaxis of migraines, but the attorneys general alleged Abbott marketed the drug for treating unapproved uses, including schizophrenia, agitated dementia and autism.
As a result of the states' investigation, Abbott has agreed to significantly change how it markets Depakote and to cease promoting off-label uses.
Under the consumer protection settlement, Abbott Laboratories is:
-Prohibited from making false or misleading claims about Depakote
-Prohibited from promoting Depakote for off-label uses
-Required to ensure financial incentives on sales do not promote off-label uses of Depakote
In addition, for a five-year period Abbott must:
-Limit responses to requests by physicians for non-promotional information about off-label uses of Depakote
-Limit dissemination of reprints of clinical studies relating to off-label uses of Depakote
-Limit use of grants and continued medical education
-Disclose payments to physicians
-Register and disclose clinical trials
Joining California in the consumer protection settlement are the Attorneys General of the District of Columbia and the following states: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia and Wisconsin.