Ortho-McNeil-Jannsen Pharmaceuticals and Johnson & Johnson are named as defendants in a recent personal injury lawsuit in Louisiana court, alleging the companies failed to accurately disclose Risperdal’s risks, marketed Risperdal in a false and misleading manner, and promoted Risperdal for unapproved “off-label” uses.

Plaintiff Miriam R. filed the Risperdal lawsuit on behalf of her minor child, claiming that he was injured as a result of his use of Risperdal, an antipsychotic medication manufactured, marketed, and distributed by Johnson & Johnson’s Janssen unit. According to Miriam, Risperdal caused her child to suffer “serious and debilitating physical, psychological, pecuniary and related injuries, including gynecomastia.”

The Risperdal gynecomastia lawsuit further alleges a series of misrepresentations and omissions committed by Jannsen Pharmaceuticals and Johnson & Johnson, including “failing to publish or report negative studies about Risperdal and presenting false and misleading studies and reports concerning Risperdal.”

The Risperdal Controversy

Risperdal is an atypical antipsychotic that is used to treat adolescents and adults with schizophrenia and bipolar disorder, as well as irritability associated with autistic disorder in children ages 6 to 16. Risperdal is also being used more and more as a treatment for ADHD, even though this is an off-label use that has not been approved by the U.S. Food & Drug Administration (FDA). While Risperdal has been on the market since 1996, it wasn’t until 2006 that the FDA approved the use of Risperdal in children.

The issue concerning Risperdal involves children, especially boys who allegedly developed gynecomastia due to their use of the medication. In addition to claiming the use of Risperdal caused male breast growth, Risperdal lawsuits filed on behalf of children allege that Johnson & Johnson improperly marketed the drug for pediatric use before the FDA cleared it for such purposes.

What is Gynecomastia?

Gynecomastia is a condition that causes male patients to develop or grow breasts. Mental health physicians report that gynecomastia or male breasts can have a significantly harmful mental and emotional effect on boys and young men, often causing shame and humiliation and deep self-hatred. The emotional scars may last well past any surgical remedies as boys may be severely taunted by their peers and suffer emotional trauma when trying to engage in normal activities. Many doctors have reportedly recommended that adolescent males who suffer from gynecomastia undergo surgery. Mild cases can be resolved with liposuction, while more severe cases will require a mastectomy.

Risperdal Gynecomastia Lawsuits

Risperdal lawsuits are mounting in courts around the country on behalf of men and boys who allegedly developed gynecomastia, or male breast growth, due to their use of the antipsychotic drug. In fact, as of October 2012, Johnson & Johnson had already settled a handful of Risperdal gynecomastia lawsuits, even as the litigation surrounding the medication continued to grow. Just a little over a year later, the company reached a settlement with the federal government to resolve charges that it improperly marketed a number of drugs, including Risperdal.

The Risperdal Gynecomastia Lawsuit is Case No. 3:14-cv-00741-JWD-RLB, in the U.S. District Court for the Middle District of Louisiana (Baton Rouge).