For over three years, pharmaceutical giant Johnson & Johnson has been fielding Risperdal lawsuits alleging gynecomastia side effects occurred when taking their Risperdal drug, resulting in billions of dollars in liability for the company.

Risperdal, also known by its generic name risperidone, is a psychiatric medication commonly used as an antipsychotic. It is produced and sold by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The FDA initially approved Risperdal in 1993 for the treatment of schizophrenia and later expanded its approved uses to include other mental disorders such as bipolar disorder and autism.

Risperdal has generated ample revenue for Johnson & Johnson; sales of Risperdal peaked at $4.5 billion in 2007, and total sales since the drug first hit the market in 1993 add up to over $40 billion.

Risperdal Gynecomastia

Risperdal was designed to avoid certain side effects associated with some older psychiatric medications. For example, some of those medications suppress the hormone-regulating activity of the pituitary gland in a number of patients. Risperdal features a chemical mechanism that counters that particular drug effect. But that same mechanism also causes release of the hormone prolactin, which stimulates development of breast tissue.

In males, this abnormal development of breast tissue is known as gynecomastia and can develop in males of all ages, though most Risperdal gynecomastia involve young adolescent men. Risperdal gynecomastia symptoms may also include pain, tenderness, and discharge from the nipples. The newly developed breast tissue may have to be surgically removed, requiring recovery time and add to a patient’s mounting medical expenses. Physical gynecomastia symptoms can also cause significant emotional trauma and social consequences.

Risperdal Lawsuits

Around 2012, patients allegedly suffering from gynecomastia symptoms filed several hundred Risperdal lawsuits. Numerous plaintiffs have made successful claims for Risperdal gynecomastia even several years after they stopped taking Risperdal. In the first Risperdal gynecomastia case to go to trial, one plaintiff alleged he exhibited gynecomastia symptoms as early as age 9. Additionally, his Risperdal lawsuit claims he had been given Risperdal as a behavioral restraint at a time when Risperdal was not approved for use in children.

Previous Risperdal lawsuits have also successfully established Johnson & Johnson’s liability based on improper marketing practices. In 2004, the FDA began investigating Johnson & Johnson for allegedly marketing Risperdal for unapproved use in children and as a treatment for mental disorders not specifically approved by the FDA. Since then, Johnson & Johnson has been required to pay billions of dollars in fines, settlements and jury awards based on improper marketing of Risperdal and the harm associated with Risperdal gynecomastia itself.