Johnson & Johnson Agrees To Settlement Resolving Drug Marketing Allegations

John J. Hoffman

Acting Attorney General John J. Hoffman

TRENTON – New Jersey will receive approximately $18 million as a result of its participation in a national settlement resolving allegations that Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc., engaged in unlawful marketing practices to promote sales of their antipsychotic drugs Risperdal and Invega, Acting Attorney General John J. Hoffman announced today.

According to Hoffman, the two companies will pay a total of more than $1.2 billion to participating states and the federal government to resolve civil and criminal allegations of unlawful marketing. The settlement resolves four qui tam or “whistleblower” lawsuits filed in U.S. District Court for the Eastern District of Pennsylvania under the federal False Claims Act, as well as similar false claims statutes in participating states. Janssen Pharmaceuticals also 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 its criminal plea, Janssen has agreed to pay an additional $400 million in criminal fines and forfeitures.

Risperdal and Invega are among a class of drugs known as atypical or second generation antipsychotics. Johnson & Johnson and Janssen allegedly promoted both drugs for off-label uses – uses not approved by the federal Food and Drug Administration (FDA). As a result of the two companies’ alleged conduct, government-funded health care programs — including state Medicaid programs — paid for false and/or fraudulent health insurance claims.

“Marketing drugs for unapproved uses is both inappropriate and illegal, and the resultant false billing to government health care programs costs every one of us,” Acting Attorney General Hoffman said. “Through our own efforts, and by working in collaboration with our state and federal partners, we are committed to identifying such conduct, and holding the responsible parties accountable.”

Between January 1, 1999 and December 31, 2005, Johnson & Johnson and Janssen allegedly made false and misleading statements about the safety and effectiveness of Risperdal. They also allegedly paid illegal kickbacks to health care professionals to induce them to promote and prescribe Risperdal for children, adolescents and the elderly, when there was no FDA approval for use of the drug within those patient populations.

In addition, the two companies allegedly promoted Invega for off-label uses and made false and misleading statements about the safety and efficacy of the drug during a period spanning from January 1, 2007 to December 31, 2009.

Johnson & Johnson’s worldwide headquarters is located in New Brunswick. As part of the national settlement, the company and Janssen Pharmaceuticals will enter into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing practices.

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