A Philadelphia jury found Friday that the antipsychotic drug Risperdal caused a Tennessee boy to grow breasts and imposed a $70 million verdict on its manufacturer, Janssen Pharmaceuticals.
Lawyers for the boy argued that scientists for the company were well aware of the risks and sought to downplay them. The company disputed that allegation during the Common Pleas Court trial and said that physicians were fully informed of potential side effects.
It was the fifth Risperdal lawsuit tried in Philadelphia, and by far the largest verdict so far. Earlier verdicts ranged from $500,000 to $2.2 million.
"The jury got angry at these people; they don't take responsibility," said Stephen Sheller, one of the boy's lawyers.
Janssen, a subsidiary of Johnson & Johnson, said in a statement that it would appeal, and disputed that the drug had caused the boy to develop breasts.
"We know that dealing with disorders of the brain is very difficult, and we sympathize with the plaintiff in this case and his family," the statement said. "During the trial, the jury heard evidence that the FDA-approved label properly warned of Risperdal's potential side effects, that the plaintiff's physical condition was not caused by using the medication, and that the plaintiff benefited from using Risperdal."
The company said millions of patients have been helped through treatment with Risperdal.
During the trial, the plaintiff's lawyers contended that Janssen had manipulated study data showing that Risperdal was suspected of causing gynecomastia, the development of female breast tissue in young boys, to downplay the risks.
Risperdal was originally approved for schizophrenia and bipolar disorder, a small market. But the drug maker worked aggressively to expand its use, making Risperdal a $3-billion-a-year drug by targeting seniors with dementia, and children with behavioral problems and autism. Critics say many of those uses were not warranted.
The U.S. Food and Drug Administration had approved the drug only for use in adults at the time the boy, Andrew Yount, began taking it. Lawyers alleged during the trial that Janssen downplayed the risks in an effort to market the drug for use in children and adolescents.
"We are glad that Andrew's suffering now stands for something," said Terry Yount, his father. We hope this verdict gives hope to the thousands of other boys who were disfigured by Risperdal that they will get justice too."
In 2013, following a Justice Department investigation, the company paid $2.2 billion in civil and criminal penalties to settle charges that it improperly marketed the drug for use with elderly nursing home patients to control agitation, confusion, and other symptoms of dementia. Earlier, the FDA had specifically declined to approve the drug for that use. It had noted that the drug was associated with strokes in elderly patients.
In addition to J&J, federal officials reached similar agreements with the makers of other drugs marketed to patients with dementia in long-term-care facilities, including Eli Lilly, which made Zyprexa.
As part of its settlement with J&J, federal officials said the company had marketed Risperdal to children before it received approval for that purpose from the FDA in 2006.