Boys and young men who took the powerful psychoanalytic drug Risperdal (risperidone) and developed breast tissue may be eligible for compensation. The condition, called gynecomastia, is believed to be caused by an increase in the female hormone prolactin.These female-like breasts may be permanent unless removed by surgery (mastectomy).

What is Risperdal?

Risperdal is a powerful antipsychotic originally approved in 1993 for the treatment of schizophrenia in adults. In the late 1990’s and early 2000’s, physicians began to prescribe the drug for children “off-label” (meaning for uses unapproved by the FDA) for the treatment of behavioral issues or psychological conditions including autism.

Why is gynecomastia a serious side effect?

The growth of breasts can seriously impact a young boy’s mental state and attitude about himself. Children and adolescents with this condition have been known to become withdrawn, angry, aggressive or even suicidal.

This drug can also cause rapid weight gain and other physical changes, sometimes masking the breast growth.

Williams Cuker Berezofsky offers no cost, no obligation consultations to young men and parents of boys who believe gynecomastia breast development may be related to taking Risperdal prior to the drug’s approval for children in 2007.

Call 215-557-0099 or fill out this inquiry form to learn more.

Why are there lawsuits?

Currently there are several thousand lawsuits filed, some in Pennsylvania, on behalf of these boys and young men. They allege that the drug company, Janssen (a division of Johnson & Johnson), knew but downplayed the risk of gynecomastia in boys and young men yet marketed it illegally for use in children anyway.

Can a drug company legally market drugs off-label?

Risperdal’s manufacturer, Janssen/Johnson & Johnson, settled an off-label marketing charge by the U.S. Department of Justice for $2.2 billion. A whistleblower and the government claimed the drug company marketed the drug illegally to physicians claiming that the drug was successful in treating various mental and behavioral conditions in children. The drug was later approved for use in children, but was not at the time of the alleged off-label marketing.

If a doctor believes a drug could help a patient, they are allowed to prescribe the drug “off-label.” Sometimes doctors have used the drug in the past and seen improvement, collaborated with others to know how it works, or read research on the drug.

Off-label use is not necessarily illegal or improper, though marketing drugs for off-label uses is.



Former FDA chief calls J&J misleading on Risperdal, The Philadelphia Inquirer, January 31, 2015

Mother brought to tears hearing Johnson & Johnson’s Risperdal tactics, The Philadelphia Inquirer, January 30, 2015

FDA Risperdal Drug Labeling and Regulatory History

Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations, U.S. Department of Justice, November 2013

Risperidone Indications: FDA-Approved and Off-Label Uses, Psychopharmacology Institute, September 27, 2013 (includes when FDA approved the drug on-label for children)