Johnson & Johnson, the US-based pharmaceutical major, will pay $2.2 billion to resolve civil and criminal allegations involving the marketing of off-label, unapproved uses for three prescription drugs, Justice Department officials announced in Washington on Monday.
The cases, which date from the late 1990s through the early 2000s, involve alleged kickbacks to doctors and pharmacies to promote the antipsychotic drugs Risperdal and Invega, and heart drug Natrecor.
The widely anticipated agreement is one of the largest health-care fraud settlements in US history.
Federal investigators accused a Johnson subsidiary of promoting Risperdal for controlling anxiety and aggression in elderly dementia patients, as well as for treating behavioural problems in other ''vulnerable'' populations such as children and the mentally disabled, though the Food and Drug Administration initially approved the drug only for schizophrenia.
Officials said the company also promoted off-label uses for Invega and ''made false and misleading statements about its safety and efficacy.''
In addition, justice department officials said another Johnson & Johnson subsidiary undertook an ''aggressive campaign'' to market Natrecor for some patients with less severe heart disease than the drug was designed to treat.
The settlement includes criminal fines and forfeited profits worth about $485 million, as well as civil payments to the federal government and various states totalling more than $1.7 billion, the Justice Department said.
''The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,'' US Attorney General Eric H Holder Jr said in announcing the settlement.
''This multibillion-dollar resolution demonstrates the Justice Department's firm commitment to preventing and combating all forms of health-care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.''
The deal marked the latest in a string of high-profile fraud settlements that the government has sought against the pharmaceutical industry in recent years. The Justice Department said it has recovered nearly $17 billion since 2009 by bringing cases under the False Claims Act, with about $12 billion of that involving fraud against federal health-care programs.
In the largest settlement, British drug manufacturer GlaxoSmithKline agreed last year to plead guilty to criminal charges and pay $3 billion in fines for improperly marketing numerous drugs and not reporting safety data about a diabetes medication.