In a setback to Johnson & Johnson JNJ +0.51%, 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.”
Thank You Mr Silverman.