(COLUMBUS, Ohio) -- Ohio Attorney General Mike DeWine announced today that Ohio has joined with several 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. Ohio's portion of the settlement is $52.7 million.
"Johnson & Johnson and Janssen promoted and marketed these drugs for uses that were not approved by the Food and Drug Administration and misled the public in regards to their use," said Attorney General DeWine. "These acts led to millions of dollars worth of false or fraudulent claims to be paid out in Ohio, but my office fought to get those funds back. That money will now be used to pay for appropriate medical treatments for Ohioans."
The settlement resolves four whistle-blower 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.
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.
Janssen Pharmaceuticals, Inc. will also 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.
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.
A team from the National Association of Medicaid Fraud Control Units worked closely with the federal government on the investigation and conducted the settlement negotiations with the pharmaceutical manufacturers on behalf of the states. Team members included representatives from Attorney General DeWine's Office and from the offices of the Attorneys General of New York, Massachusetts, and California.
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