Jury Finds Link Between Risperdal and Male Breasts

A Philadelphia jury has decided that Johnson & Johnson must pay $2.5 million in damages for failing to warn patients of the link between Risperdal and male breasts. The antipsychotic drug can cause gynecomastia — the abnormal development of breasts in males.

This particular lawsuit was brought by the family of an autistic boy who took Risperdal from 2002 to 2006, starting when he was seven years old and eventually developed size 46DD breasts. While this is the first gynecomastia case to be heard by a jury, thousands more are pending in courts across the country. Several other cases have been settled out of court.

The pharmaceutical giant was forced to pay $2.2 billion two years ago to resolve criminal and civil allegations of illegally marketing Risperdal to children and the elderly.

Risperdal and male breasts

In a statement, a Janssen spokeswoman said the drug maker is “disappointed and will consider all of our options going forward, including appeals. We firmly believe this verdict should be overturned. During the trial, Janssen presented abundant evidence showing that the FDA-approved label properly warned of the medication’s potential side effects and the plaintiff’s physician was aware of those side effects.”

“The evidence also showed that Mr. Pledger was not harmed by using Risperdal and, in fact, his quality of life was significantly improved during the time he was taking Risperdal,” the statement says.

Risperdal not approved for children until 2006

Risperdal was approved by the U.S. Food and Drug Administration in 1993 for use by adults with schizophrenia. It was not approved for children and adolescents until 2006.

Drug companies are not permitted to officially market drugs for unapproved uses, but doctors can prescribe them to patients. By 2006, when the drug was approved for use by children and adolescents, a Janssen sales representative had already made more than 20 visits to the plaintiff’s pediatric neurologist in a Birmingham suburb. He was prescribed the drug because his mother wanted something to help curb his irritability caused by autism.

The plaintiff’s doctor testified in front of Common Pleas Court Judge Ramy Djerassi that he was not aware of the results of one Janssen study suggesting that the drug could cause gynecomastia. The doctor said he would have discussed this risk with the family if he would’ve realized it was a possible side effect. When the drug was approved for use by children with autism in 2006, the doctor said he, like many others, didn’t thoroughly read the entire revised label and would have appreciated a Janssen representative informing him of the increased risk.

Janssen’s attorneys argued that the company adequately relayed the risks of the drug. However, former FDA Commissioner, David Kessler, testified on behalf of the plaintiffs, saying the company did not do enough to warn the medical community, patients and the FDA of the potential to develop gynecomastia, as one of its own studies reveals higher levels of the hormone prolactin, which can lead to the condition.

“If somebody is sending a sales rep into a doctor’s office, into a pediatric neurologist’s office, and doing it multiple times, you have an obligation to provide adequate direction,” Kessler said. “Tell the good. Tell the bad.”

As additional Risperdal lawsuits are working through the legal system, Janssen is expected to appeal the decision to the Superior Court.

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