Risperdal manufacturers are under scrutiny as more than 1,300 lawsuits allege the manufacturers failed to warn consumers that one of the drug’s side effects is gynecomastia, commonly referred to as “man boobs.”

This anti-psychotic medication is widely prescribed to treat various medical conditions, including: bipolar disorder, autism, and schizophrenia. Physicians occasionally prescribed Risperdal off-label to treat ADD and ADHD.

Plaintiffs who have filed Risperdal lawsuits claim the medication caused male breast growth as large as a 46DD cup size. Male consumers allege the embarrassing Risperdal side effect does not go away, even after discontinuing the drug. Some plaintiffs further claim that they had to undergo surgery in order to remove the breast growth.

Risperdal Complications

The U.S. Food and Drug Administration approved Risperdal to treat physiological conditions in 1993, but did not approved the drug for pediatric use until 2006. The medication is often prescribed off-label for conditions like anxiety, depression, and sleeping disorders. While prescribing a drug for an off-label use is not illegal, those filing Risperdal lawsuits allege that the popular medication’s label gives little warning of the gynecomastia side effect.

When doctors first started prescribing Risperdal to children, the side effects were widely unknown. Since then, research findings have discovered that boys between the ages of 10 and 18 are susceptible to developing Risperdal breast tissue growth.

Risperdal studies have found that the medication increases levels of prolactin, which stimulates breast growth and milk production in women. However, young men have reported the drug not only caused the development of breasts, but also caused nipple pain, nipple discharge, and breast pain.

Plaintiffs who have filed Risperdal lawsuits allege that Johnson & Johnson and their subsidiary Janssen Pharmaceuticals knew of the gynecomastia risk, but omitted the side effect from the warning label in order to boost sales. 

Risperdal Lawsuits and Settlements

A Risperdal class action lawsuit investigation is underway, and will examine the issue of whether consumers were adequately warned of the risk of male breast growth. In general, those filing Risperdal lawsuits seek financial compensation for what they describe as an extremely embarrassing condition that they were unaware was even a possibility.

In response to the gynecomastia lawsuits, Risperdal manufacturers allege that breast growth is a normal part of puberty, even in young men. However, plaintiffs dismiss that argument and claim that male nipple discharge and producing milk is not a “normal” part of male development.

Several Risperdal lawsuits have already been settled. In one Risperdal lawsuit, a plaintiff who alleged he developed man boobs after being prescribed the medication as a seven-year old was awarded $2.5 million, after a jury found the defendant failed to warn of the side effect.

In a separate case, Johnson & Johnson settled with the U.S. Justice Department for $2.2 billion to absolve criminal and civil fines. The case accused the company of improperly marketing Risperdal and Invega to adults and children with developmental disabilities.