Plaintiffs in two recently-dismissed Risperdal lawsuits have asked the Pennsylvania Supreme Court to reset the statute of limitations governing their claims, asserting that were unaware of the link between risperidone and gynecomastia until 2013.
The plaintiffs were adolescents when their physicians prescribed Risperdal in the 1990s. Initially, their excessive breast development was attributed to weight gain. In 2013, however, the plaintiffs’ mothers viewed television commercials that discussed the relationship between Risperdal and gynecomastia.
By 2014, they had each filed separate Risperdal lawsuits in the Philadelphia Court of Common Pleas. However, their claims were dismissed when the trial court decreed that the governing statute of limitations had begun to toll in August 2009.
Last year, the Pennsylvania Superior Court went even further, finding that the statute of limitations had started to toll when the Risperdal label was modified in October 2006.
The plaintiffs have since appealed to the Pennsylvania Supreme Court to reverse the lower courts’ decisions and reinstate their Risperdal lawsuits in Philadelphia.
According to a brief filed with the Supreme Court on October 31st, the plaintiffs were never told about gynecomastia while they were taking Risperdal.
“Neither boy had a reason to recognize his breast growth as the manifestation of pathological female breast tissue growth rather than fatty tissue growth secondary to weight gain or puberty,” the brief states. “And neither had a medical background such that either might have had a basis for understanding any relationship between Risperdal, hormone levels, and the development of permanent female breasts in boys.”
The brief further notes that both plaintiffs had stopped taking Risperdal by 2004. As such, there is no reason either one should have known about or investigated the October 2006 label modifications.
“The October 2006 insert may have sufficed to put somebody on notice of the Risperdal-gynecomastia connection so as to cause that individual’s Risperdal claims against Janssen to accrue by that date,” the brief continues. “But nothing in this record suggests that the label change sufficed to place Jonathan or Joshua on notice as a matter of law. Janssen has a classic jury argument. The Court should require Janssen to make that argument to a jury, and allow jurors to decide its persuasiveness.”
Risperdal is an atypical antipsychotic medication approved to treat adult and adolescent schizophrenia, bipolar disorder in adults and children ages 10-to-17, and irritability in children (5-to-16 years of age) with autistic disorder. It is also frequently prescribed off-label to treat children with ADHD.
Janssen brought Risperdal to market in 1993. However, the U.S. Food & Drug Administration (FDA) did not approve the medication for any pediatric indications until October 2006. That same year, the Risperdal label was modified to state that gynecomastia occurred in about 2.3% of adolescent boys treated with the drug. Previously, the label had characterized the condition as a rare side effect that affected just 1 out of 1,000 men.
The Philadelphia Court of Common Pleas is home to a mass tort program that houses more than 6,200 Risperdal lawsuits, all of which put forth similar allegations regarding gynecomastia. The Pennsylvania Supreme Court’s final ruling on the statute of limitations will affect 40% of the pending claims.