Janssen Pharmaceuticals, a subsidiary of health care giant Johnson & Johnson, will pay the government more than $2 billion to resolve allegations of drug misbranding, physician kickbacks, and false claims in connection with the schizophrenia medication Risperdal. The agreement is one of the largest health care fraud settlements in U.S. history, according to the U.S. Justice Department.
Janssen also has agreed to plead guilty to a misdemeanor violation of the federal Food, Drug, and Cosmetic Act for marketing Risperdal to physicians and others for unapproved uses. The company allegedly promoted Risperdal for the treatment of dementia symptoms in seniors and mental health disabilities in children, despite safety risks and warnings by the Food and Drug Administration. The settlement also resolves accusations that Janssen unlawfully promoted two other medications for unapproved uses – the heart failure drug Natrecor and the antipsychotic medication Invega.
Dr. Margaret Hamburg
The penalties against Janssen demonstrate the perilous repercussions that can result when pharmaceutical companies discount FDA regulations, FDA Commissioner Margaret A. Hamburg said in a statement.
"When pharmaceutical companies ignore the FDA’s requirements, they not only risk endangering the public’s health but also damaging the trust that patients have in their doctors and their medications," Dr. Hamburg said.
In a statement, Johnson & Johnson said Janssen accepts accountability for the actions outlined in its criminal misdemeanor plea agreement. However, the company expressly denied the government’s civil allegations, saying the civil settlement is not an admission of any wrongdoing.
"This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the health and well-being of patients around the world," said Michael H. Ullmann, Johnson & Johnson vice president and general counsel. "We remain committed to working with the [FDA] and others to ensure greater clarity around the guidance for pharmaceutical industry practices and standards."
Risperdal is approved by the FDA for the treatment of schizophrenia and manic and mixed episodes associated with bipolar I disorder. It also is indicated as an adjunct to mood stabilizers for treating acute manic or mixed episodes associated with bipolar I. But until 2005, Janssen marketed the drug for behavioral disturbances in elderly dementia patients, according to the government’s criminal and civil complaints. Sales representatives aggressively promoted the drug for such unapproved uses to nursing homes and doctors who treated the elderly, the FDA said. The government asserted also that Janssen paid speakers fees to physicians to influence them to write and increase their Risperdal prescriptions.
A federal judge must approve the settlement before it is final.