Risperdal (risperidone) is an antipsychotic medicine approved by the FDA for the treatment of schizophrenia and bipolar disorder in adults and adolescents. It has also been cleared to treat autism spectrum disorders in younger patients. However, Risperdal has been linked to severe side effects, especially when prescribed as an “off-label” treatment for disorders it was not intended or approved for by the FDA.
Many young patients that took Risperdal have been stricken with gynecomastia, a condition that results in the enlargement of breast tissue in males that usually requires surgical removal by a reconstructive surgeon. The disease has been attributed to Risperdal’s stimulation of prolactin, a hormone common in women who are pregnant or nursing. Boys who develop breast tissue after taking the drug not only suffer physical changes, they can experience severe emotional trauma.
Despite the known threat of gynecomastia, the drug’s manufacturer, Johnson & Johnson’s Janssen Pharmaceuticals, Inc. (JPI), continued to market Risperdal to treat children with behavior challenges. Ironically, prior to late 2006 Risperdal was not approved to treat children for any purpose. The FDA repeatedly advised JPI that its actions were problematic and could be evidence of a violation of the law.
To date, thousands of lawsuits have been filed in several states on behalf of injured boys and young men treated with Risperdal. They accuse Johnson & Johnson of improper marketing practices that failed to warn users about the Risperdal side effects and risks associated with the drug. They also allege the company promoted research statistics that were skewed in the company’s favor.
FDA Actions and Risperdal Lawsuits
In November 2013, the U.S. Department of Justice announced a guilty plea agreement with JPI and a $400 million criminal fine for introducing Risperdal as a misbranded drug into interstate commerce. JPI was also ordered to pay $1.25 billion under a separate civil settlement concerning the same drug. The combined criminal plea and civil settlement agreement related to Risperdal totals more than $1.67 billion.
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If you or someone you know have taken Risperdal and been harmed by the drug, you may be entitled to compensation. Our team of attorneys is ready to help you from several locations throughout New York State, with offices to serve you in: Schenectady, NY, Albany, NY, Saratoga, NY, Plattsburgh, NY, Buffalo, NY, New York City, NY, White Plains, NY, Rochester, NY – as well as Manchester, VT and Burlington, VT.
Call Harding & Mazzotti, LLP to speak with a Risperdal lawyer today at 1800LAW1010 (1.800.529.1010). We’re here to fight for your rights and get you the compensation you deserve.