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MADISON — Attorney General J.B. Van Hollen announced today that Wisconsin has joined with other states and the federal government in a global settlement with New Jersey pharmaceutical manufacturer, Johnson & 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. Under the terms of the civil settlement, the companies will pay more than $1.2 billion to the states and the federal government.
Wisconsin will receive more than $7.2 million in restitution and recoveries as part of more than $24 million attributable to the state Medicaid program. Wisconsin Medicaid is a healthcare assistance program for the needy and disabled jointly funded by the state and federal governments.
The settlement resolves four qui tam, or whistleblower, lawsuits filed in the United States District Court for the Eastern District of Pennsylvania, under the provisions of the federal False Claims Act and similar state False Claims statutes. In addition, Janssen Pharmaceuticals, Inc. will plead guilty in federal court to a criminal misdemeanor charge of misbranding Risperdal in violation of the Food, Drug, and Cosmetic Act. As part of the criminal plea, Janssen has agreed to pay an additional $400 million in criminal fines and forfeitures.
J & J and Janssen allegedly promoted and marketed, and introduced Risperdal and Invega into interstate commerce, 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, i.e., any use not specified in the FDA-approved product label. 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 state Medicaid programs.
As part of the global resolution, the companies will enter into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing practices.