A closely watched Risperdal trial opened in Philadelphia last week, where the plaintiff’s attorney accused a Johnson & Johnson subsidiary of illegally marketing the powerful antipsychotic drug for the off-label treatment of children.
Nicholas Murray was prescribed Risperdal in 2003 for Asperger’s Syndrome. At the time, the U.S. Food & Drug Administration (FDA) had not yet approved Risperdal for use in children or for the treatment of autism-related behaviors.
Murray was later diagnosed with gynecomastia, a disfiguring condition that causes men and boys to develop female-like breast. His Risperdal trial initially concluded in November 2015, when a jury in the Philadelphia Court of Common Pleas ordered Johnson & Johnson’s Janssen Pharmaceuticals subsidiary to pay Murray $1.75 million (later reduced to $685,000) for disfigurement and mental anguish.
However, Murray and other Risperdal gynecomastia plaintiffs in Pennsylvania were barred from pursuing punitive damages when the trial judge determined that New Jersey law should apply to the cases. Johnson & Johnson is headquartered in New Jersey, which does not allow punitive damages in product liability lawsuits involving FDA-approved drugs.
However, the Pennsylvania Superior Court overturned that ruling, finding that plaintiffs should have an opportunity to seek punitive damages under the rules of their home state. Murray’s new Risperdal trial began last Monday, and marks the first time a Philadelphia jury will consider the question.
“They have a target. They know who they want to make money from: kids. And not just any kids,” Murrays attorney said during last Tuesday’s opening arguments. “Kids who are the most vulnerable in our society. Kids with autism and Asperger’s and ADD.”
Two days later, jurors heard from Dr. David Kessler, a former FDA commissioner testifying on behalf of Murray. During his testimony, Kessler referred to a 2002 internal business plan from Janssen that included proposed and actual budgets for marketing Risperdal to children in 2003.
Risperdal was not approved for use in children until October 2006. At that time, the Risperdal label was updated to state 2.3% of adolescent boys treated with the drug developed gynecomastia. The condition was previously characterized as a rare side effect that only affected about 1 in 1,000 patients.
“When you sell Risperdal for indications that are not approved, you expose more children to that risk,” Kessler said. “That conduct, plus the context, is reckless. You’re doing this with a drug described as a chemical straitjacket to children who are mentally impaired. It is upsetting.”
Kessler also argued that the wording for the 2006 label update was inadequate, as it did not discuss the statistically significant association between Risperdal and hyperprolactinemia, or elevated levels of prolactin.
Prolactin is a hormone central to female breast developed. Excessively high levels are also known to cause gynecomastia in men and boys.