(Reuters) – The US Supreme Court rejected Johnson & Johnson's bid to overturn a $ 70 million jury verdict against the drug company for failing to warn of risks associated with the off-label use of its antipsychotic drug Risperdal. ] The court dismissed the company's appeal of a November 2019 decision by the Superior Court of Pennsylvania confirming the verdict in favor of a Tennessee man named Adam Yount, who was prescribed the drug at age 4 in 2003.
A jury in the Philadelphia Court of Common Pleas 2016 found that the company did not warn Yount & # 39 ;s caregivers about the risk of gynecomastia, an enlargement or swelling of breast tissue in men caused by a hormonal imbalance, and that it intentionally falsified, destroyed or concealed evidence in the case.
The warnings on drug labels are monitored by the US Food and Drug Administration. However, "off-label" use ̵
Mr. Yount developed gynecomastia at age 5 as a result of taking Risperdal, according to his lawyers. J&J has said that Mr. Yountt's doctor stopped the treatment but the patient's mother requested that it be resumed. The drug at that time had not been approved for pediatric use, so the label did not contain a specific warning about gynecomastia in children.
J & J's lawyers have stated that the verdict was unlawful under federal law. It said it could not have included the warning because manufacturers are barred from changing their labels to include information about off-label use.
The FDA approved Risperdal in 1993 to treat schizophrenia and bipolar disorder in adults, but it was not until 2006 that its use was approved for irritability associated with autism in children.
New Brunswick, New Jersey-based J&J and its Janssen Pharmaceuticals unit have faced thousands of Risperdal-related lawsuits and 10,000 remain, according to the company. One case resulted in an initial jury trial of $ 8 billion, which was later reduced to $ 6.8 million.
In 2013, the company separately agreed to pay $ 2.2 billion to regulate US criminal and civilian probes for its marketing of Risperdal and two other drugs. Catalog