Johnson & Johnson was ordered to pay $8 billion in punitive damages to a Maryland man yesterday, after a Philadelphia jury found that its Janssen Pharmaceuticals subsidiary intentionally downplayed the potential for Risperdal to cause gynecomastia in boys.
According to The Legal Intelligencer, the Risperdal verdict is the largest so far in a mass tort litigation that includes nearly 7,000 similar cases. The award is also the biggest verdict awarded by a Pennsylvania jury since 1994.
Nicholas Murray was prescribed Risperdal in 2003 for Asperger’s Syndrome, roughly three years before the U.S. Food & Drug Administration (FDA) approved the powerful antipsychotic drug for use in children or to curb behavioral issues associated with autism.
Murray was later diagnosed with gynecomastia, a condition that causes men and boys to develop female-like breasts. He claimed Johnson & Johnson and Janssen failed to warn doctors about this potential side effect while improperly promoting Risperdal for use in children and other off-label indications.
Murray was initially awarded $680,000 in compensatory damages after his Risperdal lawsuit went to trial in November 2015. However, he and other Risperdal plaintiffs in the Philadelphia Court of Common Pleas were initially precluded from seeking punitive damages after the trial judge determined that New Jersey law should apply to their cases. Johnson & Johnson maintains headquarters there, and New Jersey law prohibits punitive damage awards in cases involving FDA-approved drugs.
The Pennsylvania Superior Court later reversed that decision, ruling that plaintiffs should have the opportunity to pursue punitive damages under the laws of their home state. Murray was thus granted a new trial on punitive damages.
Murray’s second Risperdal verdict came just five hours after his attorneys asked the jury to “send a message” to Johnson & Johnson. The panel approved the $8 billion punitive award by a vote of 10-to-2.
“This jury resoundingly told Johnson & Johnson that its actions were deliberate and malicious,” one of Murray’s Risperdal lawyers said in a statement to The New York Times. “The conduct that the jury saw in the courtroom was clear and convincing that J&J disregarded the safety of the most vulnerable of children. This is an important moment, not only for this litigation, but for J&J, which is a company that has lost its way.”
Johnson & Johnson obviously disagrees, calling the Risperdal verdict grossly “disproportionate with the initial compensatory award.” The company has promised an appeal.
More than 13,400 plaintiffs throughout the United States are pursuing Risperdal lawsuits over gynecomastia and other alleged side effects.
The antipsychotic medication came to market in the 1990s, and was initially approved to treat adults with schizophrenia and bipolar disorder. The FDA did not clear Risperdal for use in children until October 2006, when it was approved to treat autism-related behaviors. The agency has expanded Risperdal’s approved indications several times since then, and they now include the treatment of adolescents with schizophrenia, as well as the treatment of children and adolescents with bipolar mania.
In October 2006, the drug’s label was also updated to note that 2.3% of adolescent boys treated with Risperdal had developed gynecomastia. Up until that point, the label characterized gynecomastia as a rare side effected observed in just 1 out of every 1,000 patients.
In November 2013, Johnson & Johnson and Janssen agreed to pay $2.5 billion to settle federal civil and criminal charges over their drug marketing practice. Among other things federal prosecutors alleged that the companies had illegally promoted Risperdal for use in children long before the FDA approved any pediatric indications.