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Ortho-McNeil Pharmaceutical, LLC Pleads Guilty to Illegal Promotion of Topamax and is Sentenced to Criminal Fine of $6.14 Million
Date:5/21/2010

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 U.S. 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 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 FBI'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
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SOURCE U.S. Department of Justice
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