Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
May 21, 2010
U.S. Department of Justice
District of Massachusetts
ORTHO-McNEIL PHARMACEUTICAL, LLC PLEADS GUILTY TO ILLEGAL PROMOTION OF TOPOMAX AND IS SENTENCED TO CRIMINAL FINE OF $6.14 MILLION
BOSTON, Mass. - ORTHO-McNEIL PHARMACEUTICAL, LLC, a subsidiary of Johnson & Johnson, pled guilty today 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 Topamax for uses that were not approved by the FDA. The company was also sentenced at today's hearing.
United States Attorney Carmen M. Ortiz and Tony West, Assistant Attorney General for the Civil Division of the Department of Justice announced today that ORTHO-McNEIL PHARMACEUTICAL, LLC 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 Government's evidence would have proven that ORTHO-McNEIL PHARMACEUTICAL, LLC ed a promotional program called the “Doctor for a Day Program” as a tool to promote its epilepsy drug, Topamax, for uses which had never been approved by the United States Food & Drug Administration (FDA). Through the “Doctor for a Day Program,” ORTHO-McNEIL PHARMACEUTICAL, LLC paid outside physicians to accompany sales representatives on sales calls, including to psychiatrists. On these sales calls, through the Doctor for a Day, ORTHO-McNEIL PHARMACEUTICAL, LLC promoted Topamax to psychiatrists, including some in Massachusetts, for psychiatric uses. However, ORTHO-McNEIL PHARMACEUTICAL, LLC 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.
“This 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 ‘Doctor For A Day Program,' said United States Attorney Carmen M. Ortiz. “We will remain vigilant in our enforcement of these laws regardless of what form the conduct takes,” Ortiz concluded.
An affiliate of ORTHO-McNEIL PHARMACEUTICAL, LLC 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.
The criminal case was prosecuted by Assistant U.S. Attorneys Jeremy Sternberg and Susan Winkler of the U.S. Attorney's Office for the District of Massachusetts and Jill Furman of the Justice Department's Office of Consumer Litigation. It was investigated by the U.S. Department of Veterans Affairs, Office of Inspector General, Boston Resident Agency, Criminal Investigations Division, the U.S. FDA's Office of Criminal Investigations, Boston Resident Office and the Federal Bureau of Investigation's Boston Field Office.
The civil investigation and settlement was handled by Assistant U.S. Attorney Zachary A. Cunha of the U.S. Attorney's Office in Massachusetts and Trial Attorney Colin M. Huntley of the Commercial Litigation Branch of the Justice Department's Civil Division. The Corporate Integrity Agreement was negotiated by the Office of Inspector General for the Department of Health and Human Services. Assistance was provided by the National Association of Medicaid Fraud Control Units and the offices of various state Attorneys General.