The antipsychotic medication Risperdal has drawn a wave of civil lawsuits as well as criminal prosecution for its makers Janssen Pharmaceuticals and Johnson & Johnson largely due to its tendency to cause male breast growth.

Risperdal (risperidone) is also sold under the brand names Risperdal and Risperdal M-Tab. It first received FDA approval in 1993. Currently, Risperdal is approved for short-term treatment of adults with schizophrenia or with acute manic or mixed episodes associated with extreme mood swings, and also for the symptomatic treatment of irritability in autistic children and adolescents.

Risperdal uses a dopamine-blocking mechanism that raises prolactin, a hormone that stimulates development of breast tissue and production of milk. In males, an increase in prolactin can result in gynecomastia. Some scientific literature states as many as 90 percent of Risperdal users experience a rise in prolactin during treatment.

Gynecomastia is the abnormal development of breast tissue in men and boys. While most cases of gynecomastia have no discernible cause, the condition is a known side effect of Risperdal and other drugs.

Treatment typically requires nothing more than discontinuing the drug causing the condition. But when gynecomastia persists 12 months or more, it may be necessary to surgically remove the excess tissue. Surgery necessitates recovery time and may leave residuals such as scarring, irregularities of shape, and nerve damage.

The physical changes may pass, but gynecomastia can be particularly emotionally damaging, particularly when it occurs in children and adolescent boys. In a study published in April 2013, researchers compared the psychological health of a group of adolescent boys with gyneomastia compared to another group of boys with no abnormal breast development. The researchers found the boys in the gynecomastia group scored lower in terms of mental health, social functioning, and self-esteem.

Criminal Prosecution

In November 2013, the U.S. Justice Department secured a guilty plea, a $400 million criminal fine, and a $1.25 billion fine against Janssen for improperly marketing Risperdal for off-label uses. (While physicians are allowed to prescribe medications on a case-by-case basis for uses other than those approved by the FDA, the medication’s manufacturers are barred from promoting the drugs for such “off-label” uses.)

The prosecution mainly addressed Janssen’s marketing of Risperdal as a treatment for agitation associated with dementia in the elderly. Janssen was also cited for marketing Risperdal as a behavioral health treatment in children and adolescents before it was FDA-approved for use in people that age and despite the known risks of Risperdal side effects in patients that age.

On the civil side, nearly 1,300 Risperdal lawsuits have been filed so far. Many plaintiffs are former psychiatric patients who were prescribed Risperdal in their youth for off-label treatment of behavioral problems.

Some plaintiffs raise the issue of Janssen’s improper promotion of Risperdal for psychiatric treatment of children before the FDA had approved the drug for use in patients that young. Plaintiffs typically allege that Janssen and Johnson & Johnson failed to disclose the risk of Risperdal gynecomastia and may have actively hidden that information from the public.