Pennsylvania State Jury Awards $ 70 Million To Adolescent Boy Who Developed Female Breasts After Taking Risperdal, An Anti-Psychotic Drug Sold By Johnson & Johnson
Risperdal is a medication manufactured by Janssen Pharmaceuticals, a division of the Johnson & Johnson Company. In August of 2003, A.Y., a four-year-old boy, was prescribed anti-psychotic drug Risperdal in order to treat ADHD. He subsequently began to grow female breasts.
In 2013, A.Y. and his mother, Billie Ann Yount, filed an action against Janssen Pharmaceuticals, Inc., Johnson & Johnson Company, and Johnson & Johnson Pharmaceutical Research and Development, LLC. Plaintiffs claimed that Johnson & Johnson failed to warn their doctors that Risperdal could cause boys to grow female breasts. They further maintained that the defendants were aware that gynecomastia was a potential side effect of Risperdal prior to 2003, but failed to inform the public, the medical community, and the Food and Drug Administration about the frequency of the side effect.
On June 20, 2016, the parties appeared for trial, which was held before Judge Paula Patrick in the Pennsylvania Court of Common Pleas for Philadelphia County. The action was one of five unrelated lawsuits that were tried to a jury over Risperdal's link to gynecomastia.
During trial, plaintiffs alleged that defendants deliberately concealed an internal document (Table 21) that demonstrated a scientific link between Risperdal and gynecomastia. Plaintiffs also alleged that defendants suppressed a portion of a later Johnson & Johnson document which confirmed Table 21's conclusions. Plaintiffs' counsel entered Table 21 into evidence at trial, argued that the link was known and that defendants were marketing the drug for off-label use on children. According to information provided by plaintiffs' counsel, A.Y.'s father testified at trial that he would not have allowed his son to take Risperdal if he had known gynecomastia was a side effect. Former FDA commissioner David Kessler testified as an expert at trial that the label for Risperdal should have been updated to denote the potential risk of gynecomastia.
Counsel for the defendants denied all liability. The defendants maintained that there was no link between Risperdal and gynecomastia. The defendants also claimed that they could not include warnings about the risk of gynecomastia in children because the drug was only approved for adults. Defendants also denied that they marketed the drug off-label. Defense counsel further argued that several of A.Y.'s treating physicians were aware of the risk of gynecomastia as a side effect and warned his family about the effects, but that the family elected to keep A.Y. on the medication for 10 years due to its benefits. Finally, defendants denied that A.Y. suffered from gynecomastia and certainly did not develop such condition while on their medicine.
On July 1, 2016, following five hours of deliberations, the jury reached a verdict in plaintiffs' favor. The jury found that defendants failed to adequately warn of the drug's possible side effects and that this failure to warn was the cause of A.Y.'s condition. The jury also found that Janssen intentionally falsified, destroyed, or concealed records containing material evidence. The jury awarded A.Y. $70,000,000.00 in damages for emotional distress and disfigurement.
Lexis Advance users may view the complete jury verdict summary, including counsel and expert information, here: A.Y. and Billie Ann Yount v. Janssen Pharmaceuticals, Inc., Johnson & Johnson Company, and Johnson & Johnson Pharmaceutical Research and Development, LLC; 2016 Jury Verdicts LEXIS 4652
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