Two subsidiaries of Johnson & Johnson, Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc., have agreed to pay more than $81 million to settle allegations that they violated the False Claims Act by illegally promoting the epilepsy drug, Topomax.  The total to be paid includes a criminal fine of $6.14 million, a federal civil settlement of $50,688,483.52, and a state Medicaid civil settlement of $24,681,516.48.  The settlement relates to two separate lawsuits brought by whistleblowers under the qui tam provisions of the False Claims Act.  As part of the settlement, the whistleblowers will receive a total of more than $9 million from the federal governmen’s share of the civil recovery.

In accordance with the settlement, Ortho-McNeil Pharmaceutical will plead guilty to a misdemeanor for misbranding Topomax.  The drug is only approved by the FDA for treatment of partial onset seizures, but the companies allegedly marketed it for a range of “off-label” psychiatric uses, which were unapproved by the FDA.  The government alleged that such marketing tactics included the so-called “Doctor-for-a-Day” program, in which outside physicians were hired to accompany sales representatives on their sales visits to healthcare providers, and to speak at lectures and dinners about off-labels uses for Topomax.  By promoting Topomax for unapproved uses, the drug companies allegedly caused false claims for reimbursement to be submitted to government healthcare programs.

The settlement also calls for Ortho-McNeil-Janssen to enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.  The agreement will require the company to institute procedures aimed at preventing and detecting similar violations in the future.

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