For Immediate Release
November 5, 2013
Karin M. Eckel, Assistant Attorney General
Director of Medicaid Fraud
Attorney General Joseph A. Foster announces that New Hampshire has joined with other states and the federal government in a global settlement with New Jersey pharmaceutical manufacturer, Johnson and Johnson (J & J) and its subsidiary, Janssen Pharmaceuticals, Inc., to resolve civil and criminal allegations of unlawful marketing practices to promote the sales of their atypical antipsychotic drugs, Risperdal and Invega. As part of this settlement, New Hampshire will receive $3.8 million in restitution and other recovery.
This settlement resolves allegations that J & J and Janssen unlawfully promoted and marketed Risperdal and Invega for uses that were not approved by the Food and Drug Administration (FDA) and for uses that were not medically indicated. Once the FDA approves a drug as safe and effective, a manufacturer cannot market or promote a drug for an "off-label" use, that is, any use not specified in the FDA-approved product label. The states contend that from January 1, 1999 through December 31, 2005, the companies promoted Risperdal for off-label uses, made false and misleading statements about the safety and efficacy of Risperdal, and paid illegal kickbacks to health care professionals and long-term care pharmacy providers to induce them to promote or prescribe Risperdal to children, adolescents and the elderly when there was no FDA approval for Risperdal use in these patient populations. The states further contend that from January 1, 2007 through December 31, 2009, the companies promoted Invega for off-label uses and made false and misleading statements about the safety and efficacy of Invega. The manufacturers' alleged unlawful conduct caused false and/or fraudulent claims to be submitted to or caused purchases by government funded health care programs, including the state Medicaid programs.
A National Association of Medicaid Fraud Control Units Team worked closely with the federal government on the investigation and conducted the settlement negotiations with the pharmaceutical manufacturers on behalf of the states.
New Hampshire Department of Justice | 33 Capitol Street | Concord, NH | 03301