The Wall Street Journal Pharmalot Blog
In a setback to Johnson & Johnson, a Philadelphia jury decided the health care giant must pay $2.5 million in damages for failing to warn that its Risperdal antipsychotic could cause gynecomastia, which is abnormal development of breasts in males. The lawsuit was brought by the family of an autistic boy who took the drug in 2002 and later developed size 46 DD breasts, according to a lawyer for the family.
The case has drawn attention for a few reasons. For one, this was the first lawsuit claiming J&J hid the risks of gynecomastia to go to trial after a handful of cases were settled in recent years. The trial also served as a reminder that J&J paid $2.2 billion two years ago to resolve criminal and civil allegations of illegally marketing Risperdal to children and the elderly.
Moreover, former FDA commissioner David Kessler served as a paid expert witness for the family and testified that J&J knew about the risks associated with Risperdal, but failed to disclose the data showing the extent to which youngsters may develop gynecomastia. In a report prepared for a 2012 case that was settled, Kessler wrote that J&J’s Janssen unit, which marketed the drug, had violated the law.
“There was grave mistreatment of children,” says Stephen Sheller, the attorney for Austin Pledger, who took the drug between 2002 and 2006, when he was first seven years old. At the time, Risperdal was not approved for children. J&J “hid data from the FDA, prescribing doctors and parents. Documents showed they knew there was much higher percentage of children getting gynecomastia than they admitted.”
A Janssen spokeswoman sent a note saying 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. She declined to respond to questions about the Kessler testimony or his 2012 report (which you can read here, here, here and here).
Meanwhile, J&J says there are about 1,200 such lawsuits filed in courts around the country, although most are in Philadelphia, according to Sheller.
While the compensatory damages were a relatively modest $2.5 million, the verdict is not good news for J&J, according to Carl Tobias, a University of Richmond School of Law professor who teaches product liability law. “It doesn’t bode well for the company,” he says. “But we’ll have to see some more verdicts before we know whether J&J is serious about settlement negotiations.”