The $70 million award was handed by a jury to the family of Andrew Yount, who alleged he grew female breasts after being diagnosed Risperdal as an adolescent to treat psychiatric problems. According to the lawsuit, although Risperdal's warning label indicated gynecomastia was a rare side effect, scientists were allegedly aware that Risperdal was linked to an increase in prolactin, a hormone that can cause gynecomastia (abnormal breast tissue growth).
In addition to the $70 million, a judge awarded Yount $6.7 million in delay damages. Yount's lawsuit was filed in 2013 but not heard in court until 2016. Janssen has said it will appeal the jury's award.
When Yount took Risperdal in 2003 it was approved only to treat schizophrenia in adult patients. It is not illegal for doctors to prescribe medications off-label but it is illegal for companies to market drugs for unapproved uses. The maker of Risperdal paid more than $2 billion in 2013 to resolve charges that it illegally marketed the drug for unapproved uses.
In October, Johnson & Johnson (parent company to Janssen Pharmaceuticals) agreed to settle a different lawsuit that was scheduled to begin in court. The terms of the settlement are confidential and the identity of the boy involved in the lawsuit has been kept private. The lawsuit alleges a boy who was six years old was prescribed Risperdal to treat symptoms of Asperger's syndrome and developed gynecomastia.
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Janssen has said it stands by the safety of Risperdal and its drug helps millions of patients.
Lawsuits filed against Janssen allege the company purposely misled patients and medical professionals about the risk of gynecomastia. According to an SEC filing from J&J, as of October 2, 2016, the company faced 15,400 lawsuits concerning Risperdal.
The Yount lawsuit is Andrew Yount v. Janssen Pharmaceuticals Inc., et al., case number 1304002094, in the Court of Common Pleas of Philadelphia County, Pennsylvania. The settled case is N.F. et al. v. Janssen Pharmaceuticals Inc. et al., case number 13500998, in the Court of Common Pleas of Philadelphia County, Pennsylvania.