Janssen Pharmaceuticals and its parent company Johnson & Johnson are facing an ever-growing wave of lawsuits brought by young men over the tendency of their psychiatric medication Risperdal to cause gynecomastia.

Risperdal Gynecomastia

Risperdal, also sold under its generic name risperdone, was initially approved by the FDA in 1993 solely for treatment of schizophrenia in adults. Since then the FDA has also approved it to treat manic or mixed episodes of bipolar disorder (2003) and irritability in autistic children and adolescents (2006). In 2007 the FDA extended its approval to include treatment of schizophrenia and bipolar disorder in young people within certain age ranges.

Risperdal works in part by blocking the neurotransmitter dopamine. The same mechanism that blocks dopamine can cause an increase in the hormone prolactin, which stimulates breast growth and milk production, even in males. This abnormal development of breast tissue in males is known as gynecomastia.

Gynecomastia treatment usually only requires stopping whatever is causing it, whether a drug regimen or some underlying physiological disorder. Some physicians treat Risperdal gynecomastia with medication or radiation therapy. If gynecomastia does not resolve after 12 months, it may require surgery. In fact, the demand for gynecomastia treatment has spawned a sub-industry of cosmetic surgeons specifically advertising “man boobs surgery” services. Men’s Health magazine reports “man boobs surgery” was up 6 percent in 2011.

Janssen’s Marketing Practices

Janssen has earned a spotted reputation for promoting uses of Risperdal other than those approved by the FDA. In November 2013, the U.S. Justice Department secured a plea agreement with Janssen to pay a $400 million criminal fine for marketing Risperdal as a treatment for agitation associated with dementia in the elderly, for which the FDA had never approved. Janssen also has a history of promoting Risperdal to treat behavior changes in children even before it was first approved for use in children in 2006. (Although physicians have discretion to prescribe drugs for off-label uses on a case-by-case basis, it is illegal for the drug’s manufacturer to promote their drugs for any uses other than those approved by the FDA.)

These marketing practices are inevitably implicated in a wave of products liability lawsuits recently filed over Risperdal gynecomastia. The plaintiffs are typically young men who allege they were treated with Risperdal in their youth for behavioral health issues – some starting as far back as the mid-1990s, long before the FDA approved Risperdal for use in children or adolescents.

In their Risperdal lawsuits, they cite Janssen’s history of improper marketing as evidence the company prematurely promoted Risperdal for use in children. They argue that the risk of Risperdal gynecomastia makes the drug inherently defective as designed and manufactured. They allege that Janssen knew about the risk of developing Risperdal gynecomastia but failed to properly inform patients or their physicians about that risk. Some have gone as far as to accuse Janssen of paying doctors to prescribe Risperdal for off-label uses and commissioning questionable medical studies that promoted off-label uses.

In cases where other gynecomastia treatment fails and surgery is required, plaintiffs may seek compensation for physical harm, lost wages, and pain and suffering. Inflating the damages claimed by these plaintiffs is the emotional harm that comes with gynecomastia. It’s not hard to imagine the painful emotional effects on an adolescent boy being teased by his peers for his physical malformation or for needing “man boobs surgery,” and that emotional harm can only be aggravated by the fact that many of these plaintiffs had underlying behavioral health issues to begin with.