Ortho-McNeil-Janssen Pharmaceuticals and Johnson & Johnson were hit with a recent Risperdal lawsuit in a Florida federal court, alleging the companies’ failure to accurately disclose Risperdal side effects by marketing Risperdal in a false and misleading manner, and promoting Risperdal for unapproved “off-label” uses.

Plaintiff Joshua Gallant claims 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 Gallant, Risperdal caused him 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 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.”

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 beyond 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.

Is Risperdal Harmful?

Risperdal was first approved by the U.S. Food and Drug Administration (FDA) in 1993, and is used as a treatment for schizophrenia, mania, and irritability associated with autistic disorder in children and teenagers. Risperdal belongs to a class of drugs known as atypical antipsychotics, and works by altering certain substances in the brain.

Research has surfaced supporting allegations that Risperdal may cause the gynecomastia, the development of breasts in young males. A study published in a 2006 issue of the Journal of Clinical Psychopharmacology stated that risperidone, which is the generic of Risperdal, “administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia.”

The study also indicated that because the long-term effects of Risperdal are not well documented with particular regard to growth and a delay in puberty, the drug should be prescribed with caution to children and adolescents.

Risperdal Gynecomastia Lawsuits

It has been reported that among the Risperdal lawsuits pending against Johnson & Johnson and its Janssen unit, at least 130 of these Risperdal lawsuits allege that the drug caused male adolescents to grow breasts. Risperdal has already been the subject of several lawsuits over diabetes risks, prompting New Jersey to centralize Risperdal diabetes lawsuits under mass tort procedures. State and federal courts may also centralize Risperdal gynecomastia lawsuits as those claims continue to rise.

The Risperdal Gynecomastia Lawsuit is Joshua Gallant v. Ortho-McNeill-Janssen Pharmaceuticals and Johnson & Johnson, Case No. 2:14-cv-263-FTM-29CM, in the U.S. District Court for the Middle District of Florida, Fort Myers Division.