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Pharmaceutical Company to Pay Wisconsin Medicaid $526,000 to Settle Claims of Off-Label Marketing


MADISON — Attorney General J.B. Van Hollen announced today that Wisconsin has joined with other states in reaching an agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. to settle allegations that the company engaged in off-label marketing of its anticonvulsant drug, Topamax.  The agreement calls for payment of $526,902.95 to Wisconsin as part of a federal and state share of $1,157,199.75 attributable to Wisconsin Medicaid.


Ortho-McNeil-Janssen will pay the state Medicaid Programs a total of $50,688,483.52, which will be allocated to the states and the federal government based on their joint funding of Medicaid.  The state settlement is part of the recent $75,370,000 settlement between the company and the United States that was announced by the United States Attorney’s Office for the District of Massachusetts on April 29, 2010.  The remainder of the settlement, $24,106,000, is allotted for federal programs such as Medicare, TRICARE, and the Department of Veterans Affairs. 


Ortho-McNeil-Janssen Pharmaceuticals is settling allegations that it engaged in a scheme to improperly market Topamax for unapproved uses.  Topamax is a drug that is approved by the Food and Drug Administration (FDA) to treat epileptic symptoms and to aid in the prevention of migraine symptoms.  Despite Topamax’s limited indication, it is alleged that Ortho-McNeil-Janssen marketed the drug to physicians for a variety of psychiatric conditions (including, but not limited to, bipolar disorder and drug and alcohol dependency), and that as a result government healthcare programs such as Medicaid paid for more Topamax prescriptions than they should have.


As part of the settlement, Ortho-McNeil-Janssen Pharmaceuticals has entered into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.


“Recipients of  medical assistance are expected to follow program rules – and so are providers,” noted Van Hollen.  “When they don’t, we’ll make every effort to hold them accountable and protect taxpayer dollars.”