A Risperdal gynecomastia lawsuit has been filed in New York against Janssen Pharmaceuticals and Johnson & Johnson, alleging the drug manufacturers failed to adequately warn about the risks of male breast growth and other dangers associated with Risperdal.

Plaintiffs Jacqueline D. and her adult son Anthony D., claim that Anthony 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 Jacqueline, Anthony’s legal guardian, Risperdal caused serious, permanent injuries including gynecomastia, weight gain, depression, aggressive behavior, insomnia, and impaired motor skills.

The Risperdal lawsuit further alleges the drug manufacturers’ negligence in manufacturing, testing, advertising, and post-market safety monitoring of Risperdal.

Risperdal (risperidone) is a powerful second-generation antipsychotic approved for the treatment of schizophrenia in adults and adolescents. Risperdal is also approved to treat bipolar disorder in adults and adolescents, and autism spectrum disorders in children and adolescents. Risperdal is also used “off-label” for attention deficit hyperactivity disorder (ADHD), anxiety, sleep difficulties and depression.

Risperdal was first approved by the U.S. Food and Drug Administration (FDA) to treat schizophrenia in 1993, and the FDA later expanded its approved uses.

Risperdal Side Effects

What makes Risperdal work is also what can cause side effects. It works by altering the levels of dopamine and serotonin in the brain, but it can also cause a number of complications brought on by the abnormal levels of hormones in the body. Risperdal side effects include:

• Breast development in boys (gynecomastia)
• Movement disorders
• Diabetes
• Heart problems and death

Gynecomastia is the enlargement of breast tissue in males, particularly adolescents. Risperdal greatly increases levels of prolactin, a hormone that stimulates production of milk in pregnant women. This increase may be one reason that boys taking these drugs may experience abnormal breast growth.

Research has surfaced supporting allegations that Risperdal may cause 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 Lawsuits

Hundreds of individual lawsuits have been filed against Johnson & Johnson by patients who say they experienced humiliation and psychological trauma from male breast growth resulting from these drugs.

As of October 2012, Johnson & Johnson had settled a handful of Risperdal claims, even as the litigation surrounding the medication continued to grow. The manufacturers of Risperdal had to deal with a multibillion-dollar government settlement that covers illegal marketing charges, as well as similar settlements with states totaling nearly $2 billion. The problems stem from the companies’ marketing of Risperdal for off-label (unapproved) uses in children in the 1990s and early 2000s.

This Risperdal Gynecomastia Lawsuit is Case No. 2:14-cv-07306-SJF-ARL, in the U.S. District Court for the Eastern District of New York.