Johnson & Johnson unit Janssen Pharmaceuticals Inc. said it is considering appealing a $2.5 million settlement awarded to a 20-year-old autistic man who developed size 46 DD breasts as a young teenager, allegedly due to his use of the antipsychotic drug Risperdal.

The Risperdal lawsuit is the first to go to trial over allegations the drug maker failed to warn consumers that Risperdal side effects can cause gynecomastia, a condition which causes abnormal male breast growth in males.

In late February, a Philadelphia jury sided with the man’s family, who filed the Risperdal lawsuit on his behalf. They claimed J&J knew about the side effects of Risperdal on male breast growth, but failed to disclose data showing the true risk of developing gynecomastia. Their son was prescribed Risperdal from 2002 to 2006 when he was 7 to 11 respectively to treat autism and bipolar disorder. At the time of use, the drug was not yet approved for children but was marketed off-label to treat adolescents.

A spokeswoman for Janssen 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.”

Risperdal Lawsuits Continue

Johnson & Johnson and Janssen are facing 1,200 similar Risperdal lawsuits in courts around the country, all filed by plaintiffs who claim the drug caused them or their young sons to develop enlarged breasts.

Risperdal side effects may include male breast growth, painful breasts, nipple pain, nipple discharge, gynecomastia, and other related complications. Though not deadly, these can be extremely embarrassing conditions for young men and boys to experience and may be particularly trying for kids who are using Risperdal as an antipsychotic.

Risperdal was eventually approved in 2006 for use in children, but not before hundreds of boys were put at risk for developing gynecomastia, lawsuits claim.

FDA Commissioner David Kessler was the plaintiffs’ star witness in the Risperdal lawsuit trial, and claimed that Janssen knew about the drug’s ability to raise prolactin levels – the hormone responsible for male breast growth — but hid this fact from patients, doctors and the FDA.

“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.”

Kessler pointed to internal J&J emails as evidence the company knew about a study that showed 3.6 percent of 500 trial patients developed and continued to have gynecomastia. These findings showed that gynecomastia from Risperdal “persists” and is “not transient,” he told the jury.

“The jury in Philadelphia heard evidence that was never presented to the FDA by an American drug company,” said the lawyer representing the plaintiff and his family. “If there was ever a clear failure-to-warn case, this was it.”