Another Risperdal Lawsuit Filed, J&J on the Hook for Billions in Fines

Albany, NYAlong with the physical side effects of Risperdal, boys with gynecomastia are bullied and teased at school and will likely carry psychological scarring all their lives.

One such victim is Shaquil Byrd. He recently filed a lawsuit against Johnson & Johnson and is currently waiting for a judge to decide on a dismissal motion from the drug giant. Byrd’s case will go to trial if the motion is denied.

Byrd was prescribed Risperdal off label in 2002, when he was only nine years old. The FDA hadn’t approved the antipsychotic medication to be used by children, only to be prescribed to treat schizophrenic adults. He stopped taking the drug in 2007, but five years was long enough to have him diagnosed with gynecomastia, or abnormally large male breasts. He had surgery to remove his breasts two years ago.

Luke Malamood, Byrd’s lawyer, told NEWS10 that J&J knew gynecomastia was a frequent side effect and “one that could happen to as many as 1 out of 20 or 1 out of 15 patients.” J&J claims it is a rare side effect, happening in less than 1 out of 1,000 patients.

Malamood said these statistics didn’t get passed onto Byrd’s mom. “I felt like they used him as a guinea pig to be honest,” Eugenia Jorda, Byrd’s mother, told the news station. And doctors were also told by J&J sales representatives that Risperdal gynecomastia was rare.

On top of the four Risperdal cases that found in favor of the plaintiff (J&J shelled out just under $5 million total), the drug giant has been ordered to pay a whopping $2.2 billion in a marketing settlement with the U.S. Justice Department and a group of states. It was fined this amount mainly due to off-label promotion of Risperdal and misconduct. The federal government claimed that J&J had deliberately marketed the drug to gain access to the potentially lucrative children/adolescent market, even though the FDA only approved the drug for adult use. Reuters reported that J&J cited the Eighth Amendment in arguing against the penalty, saying it qualified as an “excessive” fine. (The $2.2 billion fine does compensate Risperdal victims.)

In all four trials so far, juries found that J&J failed to adequately warn of the risks of gynecomastia. And the company is facing more than 1,000 lawsuits, alleging that Risperdal triggered breast development in boys. It isn’t such a rare side effect as J&J would have us believe.