The FDA reported in a news release last month that Janssen Pharmaceuticals, Inc. would plead guilty and pay more than $1.6 billion to resolve charges the company misbranded Risperdal and filed false claims for its uses.
On behalf of FDA, the U.S. Dept. of Justice announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) – a division of Johnson & Johnson – of Titusville, N.J. The company agreed to pay $400 million in criminal fines for placing a misbranded drug – Risperdal (risperidone) – in interstate commerce. JPI must also pay $1.25 billion as part of a Risperdal civil settlement. The plea and civil settlement penalties top $1.67 billion.
FDA Commissioner Margaret A. Hamburg, M.D. said, “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. . . Today’s announcement demonstrates that pharmaceutical manufacturers that ignore the FDA’s regulatory authority do so at their own peril.”
Risperdal was approved by the FDA in 2002 for the treatment of schizophrenia. It gained further approval in 2003 for short-term treatment of acute mania and some episodes of Bipolar 1 Disorder. The problem began when JPI began to market the drug in March 2002 for agitation associated with dementia in the elderly. The company claimed Risperdal was safe and effective for this unapproved (by FDA) indication and this age group.
The FDA’s somewhat ambiguous position and its interpretation of the law can confuse the legal issues and leave gray areas into which some companies stray, whether for greater profits or for the benefit of people who want or “need” drugs like Risperdal for unapproved uses is anybody’s guess. Like Fox “News” says: We report; you decide. Promoting drugs in this gray area can leave drug companies vulnerable to litigation such as that visited upon J & J and Risperdal by the U.S. Justice Dept.
FDA’s Mixed Signals
The FDA maintains doctors can prescribe a drug to treat patients for symptoms or diseases even when the drug is not FDA-approved for those uses, but it gets much more complicated. If a pharmaceutical manufacturer intends a particular drug be administered for a new use unapproved by the FDA, and introduces that drug into interstate commerce for that use, then that drug is misbranded; and it is illegal to introduce a misbranded drug into interstate commerce.
J & J downplayed Risperdal Risks
The U.S. Department of Justice action also alleges that JPI and Johnson & Johnson were aware Risperdal posed serious health risks for elderly people, including increased risk of stroke, but that the companies cooked the books by downplaying those risks; the trick was that JPI and J & J combined negative data with other studies in order to support a perception of decreased risk.
Before this action, JPI had received repeated warnings from the FDA regarding its misleading marketing pushes to physicians. Following a whistle blower complaint, FDA Office of Criminal Investigations began a criminal investigation.
Risperdal Fraud & Risperdal Lawsuits
JPI also marketed Risperdal for use in children with behavior challenges, despite known health risks to children and adolescents. Risperdal was not approved for children for any reason until late 2006, and the FDA repeatedly advised the company that promoting children’s use could be illegal.
The saddest part of this story may be that J & J knowingly knew it was violating FDA guidelines regarding drug labeling and promotion, yet did so anyway. The profits are apparently so large that a company as large as Johnson & Johnson can weigh the rewards of breaking the law against the punishments of paying criminal and civil penalties. Because no drug company executive has ever gone to jail over such illegality (so far as we know), and despite victims suffering from such cynical methods of doing business, this dysfunctional arrangement seems slated to continue indefinitely.
If you or a loved one was injured by Risperdal and would like to consider a Risperdal Lawsuit, contact a Risperdal Lawyer today at Matthews & Associates for a free legal consultation.
For more information, see the FDA Office of Criminal Investigations.
The Risperdal agreement was overseen by the U.S. District Court for the Eastern District of Pennsylvania. For more charges related to JPI’s healthcare fraud and other Federal agencies, click this link: U.S. Dept. of Justice.