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Pharmaceutical Novo Nordisk Settles Health Care Fraud Allegations
June 14, 2011
AUGUSTA – Attorney General William J. Schneider announced today that Maine reached an agreement with Danish pharmaceutical manufacturer Novo Nordisk Inc. to settle allegations of submitting false claims for its hemostasis management drug NovoSeven to MaineCare, the Maine Medicaid program.
State Medicaid programs nationwide will receive approximately $3.5 million of the $25 million settlement resolving civil liability arising out of Novo Nordisk’s off-label promotion of its bleeding disorder drug. Maine will receive approximately $22,000 as a result of the settlement.
NovoSeven was approved by the Food and Drug Administration (FDA) to treat certain bleeding disorders in hemophiliacs. Once approved by the FDA, a manufacturer may not market or promote a drug for any use not specified in the FDA-approved product label. These uses are also known as unapproved or “off-label” uses.
The U.S. subsidiary of Novo Nordisk promoted NovoSeven to health care professionals as a coagulator agent for trauma patients, general surgery, cardiac surgery, liver surgery, liver transplants and intra-cerebral hemorrhage. As a result of this unlawful promotion, Novo Nordisk caused false claims to be submitted to government health care programs that were not reimbursable by those programs. Medicare and Medicaid paid for off-label prescriptions as a result of Novo Nordisk’s campaign to influence doctors and hospitals.
“Health care patients should be able to trust that their prescription drugs are safe, effective and prescribed only for FDA approved uses,” said Attorney General Schneider. “These off-label promotions waste Maine taxpayer dollars and we will seek recovery from pharmaceutical companies for this kind of health care fraud.”
The settlement resolves a whistleblower lawsuit filed under the qui tam or whistleblower provisions of the False Claims Act that is pending in the District of Maryland. Also as part of the settlement, Novo Nordisk has agreed to enter into an expansive corporate integrity agreement that provides for procedures and reviews meant to avoid and promptly detect improper marketing practices.
The civil settlement was reached by the U.S. Attorney’s Offices for the District of Maryland and the U.S. Department of Justice Civil Division. Assistance was provided by the National Association of Medicaid Fraud Control Units with Maine represented by Assistant Attorney General Michael Miller, Director of the Healthcare Crimes Unit.
The Healthcare Crimes Unit is the Medicaid Fraud Control Unit for the State of Maine charged with investigating and prosecuting financial fraud and other crimes committed by MaineCare providers or their employees, and investigating and prosecuting abuse, neglect or exploitation of elderly and dependent persons that occurs in health care facilities or by health care providers.
To learn more about the Office of the Attorney General Healthcare Crimes Unit, go to:
CONTACT: Brenda L. Kielty (207) 626-8577