Kickbacks, Misbranding and Criminal Accusations: Johnson & Johnson Agrees to Pay $2.2 Billion to End Investigations

The once-trusted healthcare products giant Johnson & Johnson entered into an agreement in November with the U.S. Department of Justice to pay one of the largest healthcare fraud settlements in U.S. history.

Facing civil complaints and criminal allegations, Johnson & Johnson and its subsidiaries agreed to pay $2.2 billion to end investigations into off-label marketing of the drugs Risperdal, Invega and Natrecor, a cardiac medication.

In its investigation, the Department of Justice found Johnson & Johnson or its subsidiaries engaged in the following:

- Representatives of Johnson & Johnson subsidiary Janssen created an eldercare focus unit to market Risperdal to nursing home patients. At the time, the company knew Risperdal increased the risk of stroke and other serious side effects in seniors.

- Janssen was advised by the Food and Drug Administration (FDA) at the time that marketing Risperdal as safe for elderly dementia patients was inaccurate. Further, the FDA cautioned Janssen that behavioral issues seen in some dementia patients might be appropriate responses to frightening living conditions. Marketing Risperdal to this kind of patient is highly unethical.

- Despite knowledge that Risperdal is associated with a higher risk of diabetes in elderly patients, Janssen sold the drug as a safer option than other antipsychotic medications presenting the same risk of diabetes.

- Between 1999 and 2005, Janssen heavily promoted Risperdal to mental health providers for children. The company marketed Risperdal as a drug of choice for attention deficit hyperactivity disorder (ADHD), although it was not approved for any use in children prior to 2006.

In announcing the settlement, U.S. Attorney General Eric Holder stated, “The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust.”