Johnson & Johnson and Janssen Pharmaceuticals promoted antipsychotic drugs for “off-label use”
The Attorney General’s Health Care Fraud Division has secured approximately $ 41,972,615 million in a 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, often prescribed to treat bipolar disorder, schizophrenia and autism.
“This major settlement makes a statement that Michigan’s hardworking taxpayers deserve better than to be duped into paying for more than they should have,” said Attorney General Bill Schuette.
J & J and Janssen allegedly marketed, and introduced Risperdal and Invega into interstate commerce, for uses not approved by the Food and Drug Administration (FDA) and for uses that were not medically designated. 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.
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 persuade 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.
From January 1, 2007 through December 31, 2009, the companies also promoted Invega for off-label uses and made false and misleading statements about the safety and efficacy of Invega. As a result of the manufacturers’ unlawful conduct, false and/or fraudulent claims were submitted to or caused purchases by government funded health care programs, including the state Medicaid programs.
Under the terms of the civil settlement, the companies will pay more than $1.2 billion to the states and the federal government. A total state and federal share for Michigan is expected to be approximately $41,972,615. Most of the money from the settlement goes back to the state Medicaid program. 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. Janssen has agreed to pay an additional $400 million in criminal fines and forfeitures under its criminal plea agreement. The settlement resolves four 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.
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.
This $41,972,615 settlement will add to the $91,892,404 recovered by Schuette and his Health Care Fraud Division (HCFD) since he took office in 2010 resulting from criminal restitution orders, civil judgments, court orders and settlements requiring the return of funds to the Medicaid Program.
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