Abbott Laboratories Settlement

Deputy Attorney General James M. Cole announces a $1.5 billion resolution with Abbott Laboratories Inc. for the off-label promotion of drug, Depakote. The resolution - the second largest payment by a drug company - includes a criminal fine and forfeiture totaling $700 million and civil settlements federal and state governments totaling $800 million.

Deputy Attorney General James M. Cole discusses the criminal and civil investigations into Abbott Laboratories. "This morning, Abbott Laboratories, a major health care company, pleaded guilty to a criminal charge of misbranding and agreed to pay a total of $1.5 billion to resolve criminal and civil liability for illegally marketing the prescription drug, Depakote, for uses that were never approved as safe and effective by the Food and Drug Administration."

Acting Associate Attorney General Tony West discusses Abbott Laboratories' $800 million civil settlement for its unlawful marketing and illegal remuneration. Acting Associate Attorney General Tony West was joined by Assistant Special Agent in Charge of the Defense Criminal Investigative Service Paul Sternal, Virginia Attorney General Ken Cuccinelli, Deputy Attorney General James M. Cole, U.S. Attorney for the Western District of Virginia Timothy Heaphy, U.S. Department of Health and Human Services Inspector General Daniel R. Levinson and Internal Revenue Service Chief of Criminal Investigation Richard Weber at the announcement.

U.S. Department of Health and Human Services Inspector General Daniel R. Levinson announces the Corporate Integrity Agreement (CIA) Abbott Laboratories signed with the Department of Health and Human Services, which will hold Abbott accountable for future The five-year CIA requires, among other things, that Abbott's board of directors review the effectiveness of the company's compliance program, that high-level executives certify to compliance, that Abbott maintain standardized risk assessment and mitigation processes and that the company post on its website information about payments to doctors.

U.S. Attorney for the Western District of Virginia Timothy Heaphy details the specifics of the criminal case, which was filed in the U.S. District Court for the Western District of Virginia. "The resolution announced today includes a self-policing mechanism by which Abbott's board of directors will monitor compliance with the law and report any violations, as well as a period of probation and court supervision. We credit Abbott's acceptance of responsibility and encourage other pharmaceutical companies to impose the similar mechanisms to prevent off-label marketing, which damages health care consumers."

Virginia Attorney General Ken Cuccinelli discusses the cooperative investigation between the department, the Virginia Attorney General's Medicaid Fraud Control Unit and other federal agencies. The Abbott resolution was the result of close cooperation between the department, the Virginia Attorney General's Medicaid Fraud Control Unit and other federal agencies.