Johnson & Johnson (J&J) recently announced that it has settled most of the thousands of Risperdal lawsuits filed by men who have alleged that the anti-psychotic medication caused them to develop gynecomastia, an excessive enlargement of the breast tissue. 

J&J’s announcement, reported by Reuters early in November, said that the settlement would cost the company approximately $800 million in legal expenses in the third financial quarter of this year. 

Roughly 9,000 Risperdal cases were pending against J&J. In a U.S. Securities and Exchange Commission filing from September, J&J said it reached a settlement in principle to resolve “substantially all” of the cases. 

The agreement was made with attorneys who handled the Pennsylvania state court decision in 2019 that awarded Maryland resident Nicholas Murray $8 billion in punitive damages. Murray’s award was later reduced to $6.8 million. 

Risperdal cases were also pending in California and Missouri. Risperdal plaintiffs accuse J&J of failing to warn about the risks of gynecomastia. J&J is also accused of marketing the drug for off-label uses in children; the company has denied those allegations. 

The drug was approved by the U.S. Food and Drug Administration (FDA) in 1993 for the treatment of bipolar disorder and schizophrenia. In 2006, Risperdal was approved for irritability in autistic children. 

In 2013, J&J reached a $2.2 settlement with the U.S. Justice Department to settle allegations that it improperly marketed Risperdal and two other drugs to older adults, children and people with developmental disorders. The agreement was the third-largest pharmaceutical settlement in U.S. history, according to the New York Times

Earlier this year, J&J’s attempt to overturn a Risperdal failure-to-warn case in Pennsylvania was rejected by the U.S. Supreme Court. The 2019 ruling awarded $70 million to a Tennessee man, who was prescribed the drug in 2003 when he was five years old.