Criminal Prosecution of Johnson & Johnson

In May 2010, Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc., both subsidiaries of Johnson & Johnson, paid more than $81 million to resolve criminal and civil FCA liability arising from the illegal promotion of the epilepsy drug Topamax. The government alleged that Ortho-McNeil Pharmaceutical promoted the sale of Topamax for off-label psychiatric uses through a practice known as the "Doctor-for-a-Day" program. Using this program, Ortho-McNeil hired outside physicians to join sales representatives in their visits to the offices of health care providers and to speak at meetings and dinners about prescribing Topamax for unapproved uses and doses. As part of the global resolution, Ortho-McNeil Pharmaceutical LLC pled guilty to a misdemeanor and paid $6.1 million criminal fine for the misbranding of Topamax in violation of the FDCA. In addition to the criminal fine, Ortho-McNeil-Janssen Pharmaceuticals paid $75.4 million to resolve civil allegations under the FCA that they 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. Finally, Ortho-McNeil entered into a 5-year CIA with HHS/OIG.

Source: HHS Health Care Fraud and Abuse Control Program, Annual Report for FY 2010

This article was posted on July 15, 2012.

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