Johnson & Johnson’s legal challenges with Risperdal aren't over yet. While the company has already forked over billions in government settlements and suffered multimillion-dollar court verdicts, it has now inked an eleventh-hour settlement with a Mississippi plaintiff who claimed the drug caused him to develop breasts.
Days before the case was set to go to trial, J&J agreed to settle the suit, according to law firm Arnold & Itkin. The plaintiff was a young boy tentatively diagnosed with bipolar disorder in 2004. His parents got him a prescription for J&J’s Risperdal, and soon after, the plaintiff gained weight and developed breasts, a condition called gynecomastia, the firm said.
The boy then “suffered considerable ridicule in school, causing a great deal of childhood trauma and shame,” according to a post from the firm. Risperdal was approved to treat bipolar disorder in adolescents in 2007.
The lawsuit alleged J&J knew the side effect was more common in adolescents than they had previously disclosed, but failed to warn doctors and patients about the risks. According to Risperdal’s warning label, gynecomastia occurred in 1 out of 1,000 men taking the drug. The label later warned that gynecomastia in boys is 23 times more common than in men.
The same law firm previously won a $76 million Risperdal verdict. After a legal battle following the verdict, Arnold & Itkin says two plaintiffs are now able to seek punitive damages from J&J. That's in addition to the Mississippi plaintiff's settlement.
“Facing punitive damages from multiple plaintiffs, Johnson & Johnson decided to settle with our client this weekend before today’s trial was scheduled to begin,” the firm wrote in its post on Monday.
J&J has faced a long run with Risperdal investigations and lawsuits. In 2013, the company agreed to a $2.2 billion settlement with the Department of Justice over allegations of off-label marketing—including marketing for use in children and teens before the drug was approved for those age groups—and kickbacks. At the time, then-Attorney General Eric Holder said the “conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust.”
Risperdal generated tens of billions of dollars in global sales before losing patent protection in 2007.
Aside from marketing investigations and allegations, J&J in 2016 lost a plaintiff's gynecomastia case worth $70 million. A separate jury in 2015 ordered the company to pay $2.5 million. According to J&J’s most recent quarterly SEC filing, the company faces 13,500 cases alleging harm from Risperdal.