Johnson & Johnson is out of options after the U.S. Supreme Court declined to hear the pharmaceutical company’s appeal of a $70 million Risperdal verdict. In the cases of Yount vs. Janssen Pharmaceuticals, the 2019 Superior Court of Pennsylvania ruling stands.

Yount’s doctor prescribed Risperdal off-label to address behavioral problems associated with autism when he was only 4 years old. At age 5, Yount developed gynecomastia, a condition where young boys develop female-like breasts due to hormone changes that do not go away with diet, exercise or the discontinued use of the drug Risperdal. At the time, Risperdal was only FDA approved for use in adults with schizophrenia or bipolar mania. However, off-label prescribing by doctors is a common practice. 

In 2016, a Philadelphia Court of Common Pleas jury returned a $70 million verdict against Janssen for failing to warn healthcare providers of the possible risk of gynecomastia in young boys and that the drug company intentionally destroyed, falsified, and concealed evidence in the case. The jury, and subsequent appeals courts, rejected J&J’s defense that the company was not responsible for warning against side effects that could result from the off-label use of their drugs.

Yount’s doctor testified that he would not have prescribed the antipsychotic drug had he known of the risk of gynecomastia. The irreversible condition requires a mastectomy to remove the excess breast tissue. 

 In the 2019 Superior Court opinion justices concluded:

“A.Y. was just 4-1⁄2 years old when first prescribed Risperdal, and he has never since known life without gynecomastia. At sixteen years of age when the jury considered its award, A.Y. was living with severe and permanent disfigurement. The undisputed record confirms he has been routinely bullied and teased by peers and is too humiliated to ever remove his shirt in recreational or social situations where it would be customary for boys to do so when enjoying ordinary pleasures of youth.” 

The High Court’s denial concludes Yount’s case for compensatory damages, however, a jury will hear argument for possible punitive damages in the Philadelphia Court of Common Pleas. Another plaintiffs case ended with a record breaking $8 billion in punitive damages, an amount that was later reduced.

In addition to the roughly 13,600 pending cases against J&J for Risperdal, the company also paid $2.2 billion in 2013 to settle civil and criminal fines in association with their marketing practices. 

U.S. Supreme Court rejects J&J appeal over Risperdal drug, Reuters, May 17, 2021