Drugmaker Loses First Risperdal Lawsuit

Philadelphia, PAA jury in the first Risperdal lawsuit that went to trial last month alleging Johnson & Johnson hid the risks of Risperdal gynecomastia found in favor of the plaintiff - potentially good news for about 1,200 claims waiting trial.

The almost month-long trial in Philadelphia Common Pleas Court ended with the verdict agreed upon by 11 jurors. Judge Ramy Djerassi ordered Janssen Pharmaceuticals, a subsidiary of the giant drugmaker, to pay $2.5 million to Austin Pledger, a 20-year-old autistic man from Alabama who developed 46DD breasts after taking Risperdal in 2002. FDA Commissioner David Kessler, a main witness for the plaintiff, claimed that the drug company knew Risperdal use could lead to gynecomastia but failed to warn patients, doctors and the FDA.

Pledger started taking Risperdal in 2002, but a warning to the label wasn’t added until 2006, and Pledger then stopped taking the drug. One of J&J’s own studies showed that the anti-psychotic drug contained higher levels of the hormone prolactin, which can cause men to develop breasts, but they chose to hide the data.

It’s not the first time that J&J has been accused of failure to warn, fraud and aggressive marketing tactics. Just two years ago, the company agreed to pay $2.2 billion to settle off-label marketing allegations by a number of US states and the Justice Department. J&J was accused of Risperdal off-label marketing to children and teens before it was approved by the FDA for pediatric use.

Plaintiff’s attorney Thomas Kline said the Philadelphia jury heard evidence that was never given to the FDA by an American drug company. He told Reuters that, if there was ever a clear-cut failure-to-warn case, the Risperdal trial was it.

As for J&J, spokeswoman Robyn Frenze told the Philadelphia Inquirer that the drug company is disappointed with the ruling and may appeal the decision. “We firmly believe this verdict should be overturned,” Frenze said. During the trial, Janssen presented abundant evidence showing that the FDA-approved label properly warned of the medication’s potential side effects and the plaintiff’s physician was aware of those side effects. The evidence also showed that Mr. Pledger was not harmed by using Risperdal and, in fact, his quality of life was significantly improved during the time he was taking Risperdal.”

Pledger claimed he grew breasts when he was only eight years old and that his gynecomastia is permanent - hardly improving his quality of life, both physically and psychologically.