Global health-care giant Johnson & Johnson will pay more than $2.2 billion to settle allegations that it misrepresented drugs and used kickbacks to promote their sales, the Justice Department said Monday.
In one of the largest health-care fraud settlements in US history, J&J's criminal and civil fine covers allegations the company promoted Risperdal and other prescription drugs for uses not approved as safe and effective by the Food and Drug Administration (FDA), the department said.
The settlement further covers kickbacks J&J allegedly paid to physicians and pharmacies for prescribing and promoting those drugs.
"This global settlement resolves multiple investigations involving the antipsychotic drugs Risperdal and Invega -- as well as the heart drug Natrecor and other Johnson & Johnson products," Attorney General Eric Holder said in a statement.
"The settlement also addresses allegations of conduct that recklessly put at risk the health of some of the most vulnerable members of our society -- including young children, the elderly, and the disabled."
J&J is to pay $485 million in criminal fines and forfeiture and a total of $1.72 billion in civil settlements with the federal government and states.
The government charged that J&J unit Janssen Pharmaceuticals had promoted Risperdal without FDA approval for treatment of psychotic symptoms and associated behavioral disturbances exhibited by elderly, non-schizophrenic dementia patients.
Janssen will pay a total of $400 million, including a criminal fine of $334 million and forfeiture of $66 million. Janssen's guilty plea requires approval by the US district court.
In separately filed civil complaints, the government alleged that J&J and Janssen promoted Risperdal and Invega to doctors -- and to nursing homes -- as a way to control behavioral disturbances in elderly dementia patients, children, and the mentally disabled.