Janssen Pharmaceuticals is named as a defendant in another civil action lawsuit filed in Louisiana court, alleging the drug manufacturer failed to accurately disclose Risperdal side effects, marketed Risperdal in a false and misleading manner, and promoted Risperdal for unapproved “off-label” uses.

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

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

Cometria’s allegations join those of dozens of other parents suing Janssen and J&J for failing to warn them about Risperdal’s effects on male breast growth. Her Risperdal gynecomastia lawsuit, filed December 2, 2014, is Case No. 5:14-cv-03355, in the U.S. District Court for the Western District of Louisiana (Shreveport Division).

What is Risperdal?

Risperdal is an antipsychotic drug that may increase levels of prolactin, a hormone which stimulates breast development. Risperdal 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. The active ingredient in Risperdal is risperidone, which works by affecting the levels of dopamine and serotonin in the brain. These neurotransmitters are known to affect mood and behavior.

In 2006 and 2007, the FDA approved additional uses for Risperdal including schizophrenia in children, bipolar disorder in adults and children, and behavioral disorders caused by autism in children. 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).

Young males who have taken Risperdal and are displaying increased levels of the hormone prolactin may develop “man boobs.” Boys who have developed breasts may experience pain or nipple discharge. This is scientifically referred to as gynecomastia.

What is Gynecomastia?

Gynecomastia is enlargement or development of breast tissue in males.  It is more common and particularly disturbing in children and adolescents.  The development of gynecomastia is usually a permanent change that will require surgical removal by a reconstructive surgeon.

Male breast growth has been attributed to Risperdal’s stimulation of prolactin, a hormone common in women who are pregnant or nursing.  Adolescents or boys who develop breast tissue suffer not only physical changes but also severe emotional trauma.

Many doctors recommend that males with gynecomastia undergo surgery. While mild cases can be resolved with liposuction, more severe cases will require a mastectomy.

This psychological trauma and expenses related to gynecomastia surgery have led to dozens of lawsuits against Janssen seeking compensation for damages related to Risperdal side effects.

Risperdal 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 lawsuits, even as the litigation surrounding the medication continued to grow.

Just a little over a year later, the company reached a Riserpdal settlement with the federal government to resolve charges that it improperly marketed a number of drugs, including Risperdal.