Topamax Illegal Marketing Charges Settled

Johnson & Johnson subsidiaries, Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals, have agreed to pay $81 million to settle federal charges regarding the illegal marketing of <"">Topamax.

Topamax, made by Ortho-McNeil Neurologics, a division of Johnson & Johnson, was originally approved to treat epilepsy in adults and children. In 2004, the approved uses of Topamax were expanded to include the prevention of migraine headaches.

The settlement with the U.S. Justice Department resolved lawsuits filed in 2003 and 2004 under the False Claims Act, which lets citizens with knowledge of fraud sue on behalf of the government and share in a recovery. The companies had been accused of promoting Topamax for unapproved psychiatric uses. The government said that Ortho-McNeil Pharmaceutical hired physicians through its “Doctor-for-a-Day” program to join sales representatives in visiting doctors and to speak to colleagues about unapproved uses and doses.

According to a statement from Ortho-McNeil-Janssen, Ortho-McNeil Pharmaceutical will admit that from 2001 to 2003 it promoted Topamax “for certain uses not approved” by the FDA. The statement said the “Doctor-for-a-Day” program was voluntarily discontinued before the company received the government’s first subpoena in the investigation.

Under the terms of the agreement, Ortho-McNeil Pharmaceutical LLC agreed to plead guilty to a misdemeanor and pay a $6.14 million criminal fine for misbranding the drug. Ortho-McNeil-Janssen Pharmaceuticals also will pay $75.37 million to resolve civil allegations that it illegally marketed Topamax and caused false claims to be submitted to government health programs. Ortho-McNeil-Janssen also will sign a five-year corporate integrity agreement with the U.S. Health and Human Services Department.

Under the civil settlement, the federal government will get $50.69 million and state Medicaid programs will get $24.68 million. Three whistleblowers will share more than $9 million.

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