Drug maker Ortho-McNeil-Janssen has paid $2.1 million to North Carolina as part of a $75 million national settlement to resolve allegations that the company marketed the drug Topamax for unapproved uses, Attorney General Roy Cooper announced Monday.
“When companies pitch drugs for unapproved uses, patients and taxpayers may wind up paying for treatments that don’t even work,” Cooper said. “Our Medicaid Investigations Unit will keep working to root out this kind of waste that inflates the cost of health care for everyone.”
The settlement stems from allegations that Ortho-McNeil-Janssen Pharmaceuticals (Ortho) engaged in a company-wide scheme to improperly market Topamax. While the Food and Drug Administration (FDA) has approved Topamax to treat epilepsy and migraine symptoms, the states contend that the company also marketed it to doctors to treat other conditions for which it was not approved, such as bipolar disorder and alcohol dependency. As a result, taxpayer-funded programs such as Medicaid paid for more Topamax prescriptions than they should have.
Under the settlement, Ortho has paid North Carolina and other states a total of $50,688,483.52. North Carolina has recovered $2,119,879.73 to support state and federal Medicaid efforts in the state. Medicaid is a joint federal-state program that provides health insurance for the poor.
Ortho has also 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.
This settlement is based on two whistleblower cases filed in the United States District Court for the District of Massachusetts. A team formed by the National Association of Medicaid Fraud Control Units conducted settlement negotiations with Ortho on behalf of participating states. The North Carolina settlement was reached by the Attorney General’s Medicaid Investigations Unit (MIU) and the N.C. Division of Medical Assistance.