Since healthcare giant Johnson & Johnson (J&J) and its subsidiary Janssen Pharmaceuticals settled a Risperdal case in October, other plaintiffs in the Risperdal litigation hoped the settlement would set a precedent for the remaining cases. However, the companies made it clear the October settlement does not mean they are throwing in the towel, so plaintiffs are wondering what’s next in the Risperdal litigation.
Because the October settlement was confidential, other plaintiffs can only speculate what exactly led the companies to the decision to settle the case before it went to trial. The facts of the case they do know sound very similar to their own claims. The plaintiff was six years old when he began taking Risperdal to treat symptoms of Asperger’s syndrome. The drug eventually caused the boy to develop gynecomastia, the growth of female breast tissue.
Although Janssen and J&J denied all wrongdoing, past Risperdal trials awarded multimillion-dollar verdicts to the plaintiffs. The companies might be willing to try their luck in the next trial, but they continue to face an astonishing number of Risperdal lawsuits.
According to J&J’s October filing with the U.S. Securities Exchange Commission (SEC), the company faces over 15,400 Risperdal lawsuits. The sheer number of Risperdal claims illustrates just how much the companies downplayed the risk of gynecomastia to the FDA.
Risperdal’s original label indicated gynecomastia was a rare side effect, occurring in less than 0.1% of patients. In 2006, the company updated Risperdal’s label to include the risk of gynecomastia at 2.3%. However, the real risk of developing gynecomastia from Risperdal is 5.5%.
The companies reported lower rates of gynecomastia by manipulating clinical trial data, and former commissioner of the FDA, David Kessler, testified the companies hid the real rate of gynecomastia from the agency and its regulators.