November 11, 2013 — The Department of Justice (DOJ) has announced that Johnson & Johnson (J&J) and its subsidiary Janssen will pay more than $2.2 billion to settle civil and criminal lawsuits. J&J is accused of improperly marketing Risperdal, Invega, and Natrecor, including paying kickbacks to doctors who prescribed the drugs, and promoting them for uses that were not approved by the FDA.
The criminal charges allege that Janssen promoted Risperdal to elderly dementia patients as a treatment for anxiety, agitation, depression, hostility, and confusion. However, during this time, Risperdal was only approved for treat schizophrenia. Under terms of the plea agreement, Janssen will pay $400 million.
Although doctors are allowed to prescribe drugs for off-label purposes, drug companies are not allowed to promote them for anything except what the FDA has approved.
The complaint further alleges that Janssen knew that Risperdal could increase the risk of strokes in elderly patients, but skewed data to make it appear that there was a lower overall risk of adverse events. When a second study confirmed the link between Risperdal and strokes, Janssen stalled on publishing the data until a physician who worked on the study concluded that “this gives the strong appearance that Janssen is purposely withholding the findings.” In 2005, the FDA required a Black Box Warning on the label for Risperdal to warn that it could increase the risk of strokes and death among elderly patients with dementia.
According to Attorney General Eric Holder:
“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust. … 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.”
Risperdal Promoted to Children
In addition to promoting Risperdal for elderly dementia patients, Janssen allegedly promoted if for use in children between 1999-2005. The DOJ alleged that Janssen knew Risperdal posed risks to children, including the risk of elevated prolactin, which is a hormone that can stimulate breast growth in males (a condition called gynecomastia). Risperdal has also been linked to “medically serious weight gain,” which can cause type-2 diabetes.
Even so, Janssen marketed Risperdal as a safe and effective treatment for children with moderate behavior disorders, including attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder, obsessive-compulsive disorder, and more. Risperdal was not FDA-approved for any uses in children until 2006. Before 2006, the FDA repeatedly warned Janssen against promoting Risperdal for use in children.