By PBN Staff
By PBN Staff
PROVIDENCE – Attorney General Peter F. Kilmartin announced Monday that Rhode Island will receive more than $5.6 million as its share of a multistate and federal settlement with New Jersey pharmaceutical manufacturer Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals Inc.
The settlement was made to resolve civil and criminal allegations of unlawful marketing practices to promote the sales of Janssen Pharmaceuticals’ antipsychotic drugs, Risperdal and Invega.
Under the terms of the civil settlement, the companies will pay out more than $1.2 billion to the 40 U.S. states and the District of Columbia, and to the federal government. In addition, Janssen Pharmaceuticals 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 Pharmaceuticals has agreed to pay an additional $400 million in criminal fines and forfeitures.
“This is one of the single largest settlements a pharmaceutical company has paid for failure to comply with federal and state laws regulating the marketing and sale of pharmaceuticals,” said Kilmartin in a statement. “These laws are designed to protect patients from receiving drugs that have not been approved for certain treatment, and to ensure that state taxpayer dollars are not funneled into huge profits for pharmaceutical giants.”
The lawsuits, filed under the provisions of the federal False Claims Act and similar state False Claims statutes, alleged that Johnson & Johnson and Janssen Pharmaceuticals promoted and marketed Risperdal and Invega for uses that were not approved by the Food and Drug Administration. Once the FDA approves a drug as safe and effective, a manufacturer cannot market or promote a drug for an “off-label” use not specified in the FDA-approved product label.
The states involved in the suit claim that the companies promoted Risperdal and Invega for off-label uses, made false and misleading statements about the safety and efficacy of the drugs, and paid illegal kickbacks to health care professionals and pharmacy providers to promote or prescribe Risperdal to children, adolescents and the elderly.
The manufacturers’ alleged unlawful conduct may have caused false or fraudulent claims to government-funded health care programs, including the states’ Medicaid programs, the Attorney General’s Office said.
In August 2012, the Attorney General’s Office announced that Johnson & Johnson and Janssen Pharmaceuticals had reached a $200 million dollars multistate settlement for its off-label marketing of Risperdal, for which Rhode Island received a $2.67 million share of the settlement.