The FDA reported in a November news release 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. Hundreds of Risperdal Lawsuits have also been filed by individuals in state courts across the country.
J & J enters Guilty Plea
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, FDA said, agreed to pay “$400 million in criminal fines for introducing a misbranded drug – Risperdal (risperidone) – into interstate commerce.” JPI must also pay $1.25 billion as part of a Risperdal settlement for the civil part of the plea bargain. The plea and civil settlement penalties top $1.67 billion.
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, visit this link:
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.”
J & J ignored FDA Warnings
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 they 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 efforts to encourage physicians to write prescriptions for Risperdal. Following a whistle blower complaint, FDA’s Office of Criminal Investigations began to investigate.
J & J’s Criminal Marketing to Children
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. Hundreds of boys have since developed breasts, a condition called gynecomastia, as a result of taking Risperdal.
The especially egregious element of the criminal behavior by Johnson & Johnson is that the company knowingly violated FDA guidelines regarding drug labeling and promotion. The profits were apparently so lucrative that a company as large as J & J could 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 injuries from such cynical methods of doing business, this arrangement seems slated to continue indefinitely. User beware!
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.
Risperdal Approval Timeline
Risperdal was first approved by the FDA for the treatment of schizophrenia in 2002. It gained additional approval for short-term treatment of acute mania and some episodes of Bipolar 1 Disorder in 2003. 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 for this age group.
The FDA’s somewhat ambiguous position and its interpretation of the law can 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 for its Risperdal by the U.S. Justice Dept.
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 its drug to be used for a new use unapproved by the FDA, and introduces that drug into interstate commerce for that use, the drug is misbranded; and it is illegal to introduce a misbranded drug into interstate commerce.
Free Legal Consultation
Matthews & Associates is handling Risperdal cases. Call toll free 888-520-5202 or email us for a free legal case evaluation.