Risperdal Lawsuits – Fraud & Settlement News

The FDA reported in a risperdal-johnson-johnsonNovember 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:

$2.2 Billion in Fines for J & J

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.

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2 Comments
  1. I was given risperdal by my therapist for PTSD but I’m a Vietnam combat veteran so the legal eagles could care less. They want child clients who naturally would get a larger settlement than me, making more money for them… sad sad situation for me.

  2. Sorry to hear of your risperdal issues, it’s still unbelievable to me.
    when my son was 7 and being treated for A.D H.D. he had insomnia, naturally sleeping pills for a 7 year old is probably dangerous and frowned upon.

    His doctor, a highly respected and wonderful man decided on Risperdal.
    I was told it was safe and a “wonder drug” it would help with ADHD and insomnia, much safer than something like Ambien.

    This was before I had a computer and before the company put the actual correct warning on the info.

    I didn’t like the effect it had and didn’t want my son to stay on it so we discontinued the treatment.

    Soon after my son began to rapidly gain weight (7 years he was 87 at 14 he is 330) he developed speech problems, extremely high blood pressure and large breast.
    He was ridiculed, told he was a girl and the object of constant teasing and mental distress.
    We had absolutely no idea these problems were linked to risperdal until 7 years later a woman in passing mentioned a lawsuit about male breast.
    To think all this time our doctors have been trying to figure our what happened and why it’s happening the answer was a stupid pill he took so a short time. I am so angry, I think criminal charges should be brought against any employee who knew.

    My son will never be OK again, the years of social isolation and torture have damaged him tremendously.

    What can I do to make them take responsibility for ruining my babies childhood, his issues won’t end with breast reduction.i need legal advice because he didn’t deserve this, he couldn’t sleep my god if we had known what would possibly happen no way would I risk it.

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