A man from New York is filing a lawsuit against Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) after their antipsychotic drug, Risperdal, caused the man to develop breasts.

Shaquil Byrd began taking Risperdal when he was only nine years old. Within months of taking the drug, his mother noticed that he was gaining weight, but it wasn’t until years later that the two realized that the drug had caused Byrd to develop gynecomastia, or male breast growth.

Risperdal was approved by the Federal Drug Administration (FDA) in 2002 for the treatment of schizophrenia and in 2003 for the short-term treatment of acute mania and mixed episodes associated with Bipolar 1 Disorder. Risperdal was not approved for use in young people until 2006.

It is now known that Risperdal can cause a variety of different side effects including gynecomastia in young men and cardiac failure, pneumonia, and strokes in the elderly. The severity of side effects for the elderly prompted the FDA to issue a black box warning – the strictest warning reserved by the FDA for drugs with reasonable evidence of association of a serious hazard with the drug – on Risperdal for elderly patients.

Risperdal Lawsuits

Thousands of lawsuits have been filed against Janssen Pharmaceuticals for failing to warn doctors and patients of the increased risks associated with Risperdal in young and old populations. Although only a select few have gone to trial, the court documents from the trials have been revealing.

Evidence from trials in 2012 revealed that Janssen trained Risperdal salespeople to promote the drug to pediatricians as early as 2003, three years before the drug was approved by the FDA use by children. While physicians are allowed to prescribe medications for off-label uses, drug manufacturers cannot promote or market a drug for any use or population not qualified by the FDA.

Janssen’s illegal marketing didn’t end there. In 2013, the U.S. Department of Justice filed charges against the company for a variety of illegal marketing practices, including paying doctors to speak favorably of the drug, offering incentives to doctors to prescribe Risperdal to children, and minimizing the risks associated with Risperdal in marketing materials. The company agreed to pay a staggering $2.2 billion fine for their misconduct.

For the many Risperdal lawsuits that are still pending, a decision by the Pennsylvania Supreme Court will determine whether or not the company will be held financially responsible. Last year, a jury awarded a man who developed breasts after taking Risperdal nearly $500,000.00 in punitive damages. The damages have been appealed, and the Supreme Court’s decision whether or not to uphold the punitive damages will set an important precedent for the remaining lawsuits.