A Risperdal lawsuit filed by Kentucky Attorney General Jack Conway has settled for $15.5 million. The suit accused Janssen Pharmaceuticals of failing to adequately disclose the risks associated with Risperdal, and of illegally marketing the drug for unapproved or “off-label” purposes.
Free Confidential Lawsuit Evaluation: If you or a loved one experienced abnormal breast enlargement (gynecomastia) after taking Risperdal, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the Problem?
March 29, 2016 – According to allegations raised in the complaint, Janssen marketed Risperdal (generic: risperidone) off-label as a treatment for dementia in non-schizophrenic elderly patients. It was alleged that a study conducted by the drugmaker found a doubled rate of death among elderly patients treated with Risperdal. And yet, not only did Janssen promote Risperdal for this unapproved use, it created an elder care salesforce to further target the elderly market, according to the lawsuit.
It is legal for doctors to prescribe medications off-label at their discretion when the feel the potential benefits outweigh the risks. However, it is illegal for a manufacturer to actively market or promote a drug for purposes beyond the scope of indications formally approved by the U.S. Food & Drug Administration (FDA).
The Kentucky lawsuit further alleged that even though the FDA approved Risperdal for use in children with Attention-deficit/hyperactivity disorder (ADHD) in 2007, Janssen actively marketed the drug for this purpose before it was formally approved.
The major side effect linked to Risperdal is gynecomastia, which is the development of male breasts stemming from a hormonal imbalance created by risperidone (the main active ingredient contained in Risperdal).
It was alleged in the Kentucky lawsuit that Janssen knew Risperdal could cause gynecomastia in boys and young men, yet it did not update the drug’s warning label with this information over fears the company could lose up to $150 million per year in sales.
Finally, it was alleged that Janssen promoted Risperdal as an antipsychotic that delivered benefits with minimal risk of weight gain and diabetes. However, the company’s own internal studies indicated that patients treated with the drug presented with equal weight gain and a greater risk of type 2 diabetes after one year of use compared to patients who took a rival medication.
“Janssen and Johnson & Johnson put patients at risk when they marketed Risperdal without disclosing the drug’s known side effects,” Conway said in a press release. “These side effects were even more harmful to children and elderly patients.”
Janssen has not admitted to any wrongdoing with regards to its marketing of Risperdal.
“Going forward, we have tough terms in the settlement that will govern the way Risperdal can be marketed in the future here in Kentucky,” Conway said. “It is my hope that the General Assembly will allocate the money to expand addiction treatment in Kentucky.”
Do I Have a Risperdal Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Risperdal lawsuits. We are handling individual litigation nationwide and currently accepting new gynecomastia cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by Risperdal side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a lawsuit and we can help.