Ortho-McNeil Pharmaceutical, LLC, which is a Johnson & Johnson subsidiary, just pled guilty in U.S. District Court in Boston to one count of misdemeanor violation of the Food, Drug & Cosmetic Act for illegally promoting its epilepsy drug <"http://www.yourlawyer.com/topics/overview/topamax_birth_defects">Topamax for uses that were not approved by the U.S. Food and Drug Administration (FDA). Ortho-McNeil was also sentenced, said the FDA.
United States Attorney Carmen M. Ortiz and Tony West, Assistant Attorney General for the Civil Division of the Department of Justice announced that Ortho-McNeil was sentenced by U.S. Magistrate-Judge Robert B. Collings to pay a criminal fine of $6.14 million. Hess was charged in September 2009 and later pleaded guilty.
At the plea hearing, the prosecutor told the Court that, had the case proceeded to trial, the governmentâ€™s evidence would have proven that Ortho-McNeil led a promotional program called the â€œDoctor for a Day Programâ€ as a tool to promote its epilepsy drug, Topamax, for uses which had never been approved by the FDA. Through the â€œDoctor for a Day Program,â€ Ortho-McNeil paid outside physicians to accompany sales representatives on sales calls, including to psychiatrists, promoting Topamax to psychiatrists, including some in Massachusetts, for psychiatric uses.
Ortho-McNeil had never applied to the FDA for any approval for Topamax to treat any psychiatric disorders and there was no data from any well-controlled clinical trial to demonstrate that Topamax was safe and effective to treat any psychiatric conditions.
â€œThis case should send a strong reminder that the off-label promotion of pharmaceuticals is illegal, whether it is done directly by company employees, or through programs such as the â€˜Doctor For A Day Program,â€™â€ said United States Attorney Carmen M. Ortiz. â€œWe will remain vigilant in our enforcement of these laws regardless of what form the conduct takes,â€ Ortiz concluded.
An affiliate of Ortho-McNeil called Ortho-McNeil-Janssen Pharmaceuticals, Inc. will also pay $75.37 million to resolve civil allegations under the False Claims Act that it illegally promoted Topamax and caused false claims to be submitted to government health care programs for a variety of psychiatric uses that were not medically accepted indications and therefore not covered by those programs. Also as part of the settlement, Ortho-McNeil-Janssen Pharmaceuticals entered into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.
Topamax 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 agreement resolves 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.
According to an earlier statement from Ortho-McNeil-Janssen, Ortho-McNeil Pharmaceutical admitted that, from 2001 to 2003, it promoted Topamax â€œfor certain uses not approvedâ€ by the FDA. The statement said the â€œDoctor-for-a-Dayâ€ program was voluntarily discontinued before the company received the governmentâ€™s first subpoena in the investigation.