Medical and consumer products conglomerate Johnson & Johnson will pay more than 2.2 billion dollars to settle criminal and civil allegations of improper marketing of several prescription drugs, the US Justice Department said Monday.
Federal authorities described the case as one of the largest health-care fraud settlements in US history, including criminal fines and penalties of 485 million dollars and civil settlements with federal and state governments of 1.72 billion dollars.
Antipsychotic drug Risperdal, approved by the US Food and Drug Administration only for treatment of schizophrenia, was allegedly marketed by a Johnson & Johnson subsidiary for use in elderly patients with dementia. Other violations involved marketing the drug to treat behavioral issues in the elderly and other long-term nursing patients.
Additional off-label marketing violations by subsidiaries involved another antipsychotic drug, Invega, and the drug Natrecor, approved only to treat specific symptoms of severe congestive heart failure. Further allegations involved payments of kickbacks to physicians who prescribed some of the drugs and to a major pharmacy firm serving nursing homes.
"The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust," US Attorney General Eric Holder said. "This multibillion-dollar resolution demonstrates the Justice Department's firm commitment to preventing and combating all forms of health-care fraud."
He said the company "recklessly put at risk the health of some of the most vulnerable members of our society, including young children, the elderly and the disabled."
Johnson & Johnson general counsel Michael Ullmann said in a statement that the company had "reached closure on complex legal matters spanning almost a decade." The company "accepts accountability for the actions described in the misdemeanour plea. The settlement of the civil allegations is not an admission of any liability or wrongdoing, and the company expressly denies the government's civil allegations."
The company accepted a five-year corporate integrity agreement with federal authorities.
The settlement is to be paid from money previously set aside with no new charge to earnings, Johnson & Johnson said.
Johnson & Johnson to pay 2.2 billion dollars over drug marketing
Medical and consumer products conglomerate Johnson & Johnson will pay more than 2.2 billion dollars to settle criminal and civil allegations of improper marketing of several prescription drugs, the US Justice Department said Monday.
Federal authorities described the case as one of the largest health-care fraud settlements in US history, including criminal fines and penalties of 485 million dollars and civil settlements with federal and state governments of 1.72 billion dollars.
Antipsychotic drug Risperdal, approved by the US Food and Drug Administration only for treatment of schizophrenia, was allegedly marketed by a Johnson & Johnson subsidiary for use in elderly patients with dementia. Other violations involved marketing the drug to treat behavioral issues in the elderly and other long-term nursing patients.
Additional off-label marketing violations by subsidiaries involved another antipsychotic drug, Invega, and the drug Natrecor, approved only to treat specific symptoms of severe congestive heart failure. Further allegations involved payments of kickbacks to physicians who prescribed some of the drugs and to a major pharmacy firm serving nursing homes.
"The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust," US Attorney General Eric Holder said. "This multibillion-dollar resolution demonstrates the Justice Department's firm commitment to preventing and combating all forms of health-care fraud."
He said the company "recklessly put at risk the health of some of the most vulnerable members of our society, including young children, the elderly and the disabled."
Johnson & Johnson general counsel Michael Ullmann said in a statement that the company had "reached closure on complex legal matters spanning almost a decade." The company "accepts accountability for the actions described in the misdemeanour plea. The settlement of the civil allegations is not an admission of any liability or wrongdoing, and the company expressly denies the government's civil allegations."
The company accepted a five-year corporate integrity agreement with federal authorities.
The settlement is to be paid from money previously set aside with no new charge to earnings, Johnson & Johnson said.
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