Risperdal Lawsuits: 3 for Plaintiffs, 1 for Johnson & Johnson

December 23, 2015, 1:30PM. By Jane Mundy

Philadelphia, PAOut of the four Risperdal trials to date this year, plaintiffs have won three. Philadelphia juries have found that Janssen Pharmaceuticals, a subsidiary of J&J, failed to provide adequate warnings regarding Risperdal gynecomastia - a condition that involves abnormally enlarged male breast tissue. This outcome is good news for 1,600 cases still pending.

The latest trial resulted in a $500,000 award for Timothy Stange, who took Risperdal from 2006 to 2009 to control Tourette syndrome. (The FDA approved Risperdal for using the drug in children in 2006.) About one year after he started taking Risperdal, when Stange was 12 years old, he began to develop enlarged breasts. And he gained about 60 pounds, which at first disguised his breasts. But when Stange began to lose weight, he was ridiculed and bullied at school. At age 18, he underwent breast reduction surgery, but no amount of surgery could reduce the emotional trauma. And the jury agreed. In fact, the jury based its verdict solely on Stange’s humiliation in high school and not the physical trauma, as there were no evident scars from surgery.

Stange’s attorneys argued in court that not only did Janssen conceal information about the risk of increased prolactin levels, which results in enlargement of breast tissue, the drug company also lied on its labeling information. The Risperdal label claims that gynecomastia only occurred in one case for every 1,000. But counsel claimed that the incidence rate was closer to five cases in 1,000 Risperdal patients.

Austin Pledger’s case was the first to go to court. Pledger took Risperdal in 2002 to manage his mood swings, but the drug caused him to develop severe gynecomastia - he developed size 46-DD breasts. After hearing testimony from a J&J biochemist who revealed that the drug giant knew about the risk of boys developing breasts but hid it, a jury awarded Pledger in February $2.5 million.

William Cirba, who started taking Risperdal when he was only six years old, was the second case, and the only case to date that resulted in favor for the defendants. Although the jury determined that the Risperdal maker was negligent in its labeling information, there was insufficient evidence to prove Risperdal was the cause of gynecomastia.

And the third Risperdal lawsuit resulted in an award of $1.7 million for mental anguish and disfigurement for plaintiff Nicholas Murray, who took the drug to treat schizophrenia when he was only nine years old. The FDA had only approved Risperdal to treat adults at that time.

Upcoming Risperdal lawsuits

So what do these three plaintiff wins mean for Johnson & Johnson? Attorneys speculate that these Risperdal losses for the drug company might result in a massive settlement. J&J is facing 1,600 more lawsuits, all of which are pending in the Philadelphia court system.

And faced with damning evidence from Dr. David Kessler, commissioner of the FDA from 1990 to 1997, who filed a report that claimed Janssen controlled and influenced the findings of a 2003 study that looked at the potential side effects of Risperdal on children, J&J might be wise to cut its losses sooner than later.