Risperdal is an antipsychotic drug developed by Johnson & Johnson (J&J).
Adam Yount, a Tennessee man, was prescribed the drug in 2003 when he was four years old. Roughly a year after taking the drug, Yount developed gynecomastia, an enlargement of breast tissue in males caused by a hormonal imbalance.
Yount’s attorneys blamed the condition on Risperdal. However, at the time Yount took the drug, it was not approved for use in children. (The drug received FDA approval for pediatric use in 2006, specifically for children with autism.)
Therefore, the drug’s warning label did not include any information on the risk of gynecomastia in children.
In 2016, a Philadelphia jury found that J&J failed to warn Yount’s healthcare providers about the risk of gynecomastia, and awarded $70 million to the plaintiff.
Yesterday, the U.S. Supreme Court rejected J&J’s bid to overturn Yount’s award and verdict. The verdict was upheld by a Pennsylvania Superior Court in 2019.
J&J argued that Yount’s doctor discontinued the treatment but that the patient’s mother requested that it be resumed, Reuters news agency reports. As such, J&J attorneys maintain the verdict was “impermissible under federal law,” arguing that gynecomastia could not have been included in the warning “because manufacturers are barred from changing their labels to include information about off-label uses.”
However, as Reuters reports, off-label uses by doctors are commonplace.
Approved by the FDA in 1993 for treating schizophrenia and bipolar mania in adults, Risperdal is the focus of thousands of lawsuits, including 10,000 that are still pending, according to Reuters.
J&J and its subsidiary, Jannsen Pharmaceuticals, paid over $2 billion to settle allegations over the marketing of Risperdal and two other drugs.
One Risperdal lawsuit that went to trial initially resulted in an $8 billion award by a jury. That award was later reduced to under $7 million.