On May 27, Johnson and Johnson settled a lawsuit filed on behalf of a California boy who developed gynecomastia after taking the anti-psychotic drug Risperdal. The case, resolved just hours into opening arguments, is the third Risperdal lawsuit to go to trial in Philadelphia this year.
The first Risperdal lawsuit ended in a $2.5 million loss for J&J, the jury finding the drug maker negligent for failing to warn consumers about the risk of gynecomastia. The second lawsuit was a partial victory for plaintiffs, as the jury found that J&J was negligent for failing to warn the public about the risk of gynecomastia, but the jury found that Risperdal was likely not the cause of this plaintiff’s gynecomastia.
Risperdal and Gynecomasia
In November 2008, the Wall Street Journal reported that Risperdal use was linked to the increased production of prolactin, a hormone that stimulates breast development and milk production in women. In women, excess prolactin levels can cause spontaneous milk production, but in men, excess levels can lead to gynecomastia, the abnormal growth of male breast tissue.
What is Risperdal?
Risperdal is a powerful anti-psychotic drug that was approved by the U.S. Food and Drug Administration in 1993 to treat schizophrenia in adults. In 2006 and 2007, the FDA approved additional uses for Risperdal, including the treatment of bipolar disorder in adults and juveniles, schizophrenia in children, and certain behavioral symptoms in children with autism.
There have been more than 13,000 adverse reactions reported to the FDA in connection with Risperdal, and the agency estimates that less than one percent of all serious events are ever reported, indicating that the actual number of side effects occurring is likely much higher.