A Louisiana woman has filed a Risperdal lawsuit on behalf of her son, who took the antipsychotic drug, alleging that he developed gynecomastia as a result.

Plaintiff Ramona Pierre-Auguste is the mother and guardian of her son, E.P.H. She filed this Risperdal lawsuit against Johnson & Johnson subsidiary Janssen Pharmaceuticals for his plight and for damages.

E.P.H. was around 8 years old when he was prescribed Risperdal to treat his ADHD symptoms. As with many antipsychotics, E.P.H. suffered weight gain after starting the drug therapy. With the weight came the breast growth, initially nothing seemed out of the ordinary, according to the Risperdal lawsuit.

According to the Risperdal lawsuit, no one suspected gynecomastia, also known as “man boobs,” as E.P.H. was healthy prior to ingestion. Neither his mother, nor their physician, reportedly knew of the risks associated with Risperdal, nor did they receive adequate warning of the potential injury it could cause.

Pierre-Auguste alleges in the Risperdal lawsuit that Janssen “failed to disclose a known defect and affirmatively misrepresented that Risperdal was safe for its intended use. Further, Defendants actively concealed the true risks associated with the use of Risperdal.”

Now, as a “direct and proximate result of Defendants wrongful conduct in connection with the development, design, testing, labeling, packaging, promoting, advertising, marketing, distribution, and selling of Defendants prescription medication Risperdal,” her son E.P.H. now suffers gynecomastia.

Developed in the 1980s, Risperdal (risperidone) is an antipsychotic medication created to help adults with brain-based disorders. It was not released until 1993, however, when it was approved for treating schizophrenia. It was the only drug approved to treat schizophrenic adolescents (aged 10-17), and was eventually approved to treat children in 2006.

Due to the gynecomastia, E.P.H. has suffered, and continues to suffer the emotional distress of a young boy growing up with breasts. His mother says he is constantly bullied, and “cannot conduct himself like most boys or men due to the physical deformation caused by the off-label use of Risperdal.”

Moreover, while taking Risperdal, E.P.H.’s behavior was “destructive and at times violent toward himself and others.” This anger was also directed toward his mother, Pierre-Auguste, which in turn caused her emotional distress.

The Risperdal Gynecomastia Lawsuit is Romana Pierre-Auguste v. Janssen Pharmaceutical Inc., et al., in the U.S. District Court for the Western District of Louisiana.

History of Risperdal Worries

Victims allege that Janssen marketed Risperdal for off-market use long before it was approved for use for kids in 1996. They claim in their Risperdal lawsuits that the drug maker concealed or downplayed Risperdal’s side effects and exaggerated its effectiveness. And the final straw, they say warning labels said nothing of the risks.

In 1999, the Janssen and Johnson & Johnson received a warning letter from the U.S. Food and Drug Administration (FDA) regarding the marketing of Risperdal “in a manner that was misleading, false and lacking in fair balance.”

In 2001 the FDA approached Janssen again, this time requiring them to change the labeling of Risperdal to include a statement that the safety and efficacy of the drug in children had not been proven. And in 2013, the U.S. Department of Justice fined Johnson & Johnson more than $2 million for its marketing practices for Risperdal and other drugs.

It is estimated that between 1993 and 2008, more than 1,200 children have suffered complications in connection with taking Risperdal.