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Johnson & Johnson And Janssen Pharmaceuticals, Inc. To Pay Vermont $1,387,680 To Resolve Health Care Fraud Allegations

CONTACT: Edward Baker, Assistant Attorney General, (802) 828-5511

November 7, 2013

Attorney General William H. Sorrell announced today that Vermont has joined with other states and the federal government in a global $1.2 billion settlement with New Jersey pharmaceutical manufacturer, Johnson & Johnson (J&J) and its subsidiary, Janssen Pharmaceuticals, Inc. (Janssen), to resolve civil and criminal allegations of unlawful marketing practices to promote the sales of their atypical antipsychotic drugs, Risperdal and Invega.

Under the terms of the civil settlement, Vermont will receive $1,387,680 as part of the resolution of four separate lawsuits alleging that J&J and Janssen 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. Specifically, the states contend that during the period 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 Vermont Medicaid program.

As part of the global resolution, J&J and Janssen will enter into a Corporate Integrity Agreement with the federal government, which will closely monitor the company’s future marketing practices. In addition, Janssen will plead guilty to a criminal misdemeanor violation of the Food, Drug, and Cosmetic Act, and pay a criminal fine. According to Attorney General Sorrell, this settlement is “further proof that Vermont will not tolerate marketing violations by the pharmaceutical industry, and will work closely with other states, whistleblowers, and the federal government to aggressively investigate reports of industry misconduct as they arise.”

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