The mother of a boy who took Risperdal filed a Risperdal gynecomastia lawsuit against the drug’s makers, alleging the drug caused her son to suffer male breast growth.

The lawsuit was filed by Roma Pierre-Auguste, on behalf of her son, identified in court documents only as E.P.H. E.P.H was prescribed Risperdal when he was eight to treat ADHD. Once E.P.H started taking the drug, the Risperdal lawsuit alleges, the child suffered serious weight gain, and began to develop female-like breasts, a condition called gynecomastia.

Hundreds of lawsuits have been filed against Janssen Pharmaceuticals, the makers of Risperdal. These Risperdal lawsuits allege that the makers of the drug were aware, or reasonably should have been aware, of the serious risk of complications like gynecomastia. One issue that has come up in Risperdal gynecomastia lawsuits is the issue of off-label usage.

Under U.S. law, a drug manufacturer must test its drug and receive U.S. Food & Drug Administration (FDA) approval before the drug may be sold. A drug manufacturer is required to test a drug for both safety and efficacy — for each purpose the drug is marketed for. Sometimes, research outpaces the approval process and a drug may work for illnesses other than those for which it was approved by the FDA. In these cases, physicians may prescribe drugs “off-label.” This means that doctors are allowed to use their professional judgment. However, drug companies are forbidden from marketing drugs off-label.

Off-label promotion is one of the core issues of Risperdal gynecomastia lawsuits. Risperdal lawsuits like Pierre-Auguste’s allege that the drug’s makers aggressively promoted the drug for off-label usages. Risperdal is only approved for treating schizophrenia, bipolar disorder, and aggression/irritability associated with autism. ADHD, the diagnosis mentioned in this Risperdal gynecomastia lawsuit, is not among the illnesses Risperdal is approved to treat. Additionally, Risperdal has not been approved for use in children. It has been alleged that Risperdal has been widely promoted for off-label usages.

This Risperdal gynecomastia lawsuit asserts that the Risperdal maker’s aggressive promotion of the drug was a major factor in E.P.H.’s use of the drug and subsequent problems. The lawsuit alleges that E.P.H. will require costly medical and psychology care after developing gynecomastia. The Risperdal gynecomastia lawsuit seeks to recoup current and future medical costs, legal fees, and other expenses resulting from use of the drug.

The Risperdal Gynecomastia Lawsuit is titled Roma Pierre-Auguste, et al. v. Janssen Pharmaceuticals Inc., et al., Case No. 6:14-cv-02209-RFD-CMH, in the U.S. District Court for the Western District of Louisiana.