The Pennsylvania Supreme Court has revived thousands of Risperdal lawsuits, after finding both the trial court and the state’s Superior Court erred in establishing a statute of limitations that resulted in their dismissal.
The ruling affects about 40% of the more than 7,000 Risperdal gynecomastia claims currently pending in a mass tort litigation underway in the Philadelphia Court of Common Pleas.
The statute of limitations controversy began when the trial court judge determined that the deadline for filing such cases expired two years after June 2009 and granted the defendants summary judgement in two Risperdal lawsuits — Saksek v. Janssen and Winter v. Janssen.
The plaintiffs appealed to the Pennsylvania Superior Court, which moved the deadline back even further, to two years after October 31, 2006. That’s the date the Risperdal label was modified to state that gynecomastia, or excessive male breast growth, occurred in 2.3% of those taking the drug.
That decision resulted in the blanket dismissal of thousands of cases.
Plaintiffs then appealed to the state’s highest court, the Pennsylvania Supreme Court.
In a 6-1 decision handed down yesterday, the majority of the justices ruled that the statute of limitations questions should have been left for juries to decide.
“This is not to say that the publicity (including the medical journal articles) cited by the trial court in this case was insufficient to place Winter and Saksek on notice (at any particular point in time) that their ingestion of Risperdal was the cause of their gynecomastia or that their enlarged breasts were in fact the result of the growth of female breast tissue and not mere overall weight gain,” the majority opinion stated. ”Rather, we conclude only that reasonable minds could differ, thus requiring that the factual issues relating to Janssen’s statute of limitations defense must be submitted to a jury for resolution.”
Risperdal first received U.S. Food & Drug Administration (FDA) approval to treat adults with bipolar disorder and schizophrenia in 1993. Since then drug’s approved indications have been expanded to include children and adolescents with bipolar mania; adolescents with schizophrenia; and irritability in pediatric patients related to autism spectrum disorders.
The FDA did not approve Risperdal for use in children until October 2006. However, many Risperdal gynecomastia plaintiffs began taking the drug in childhood, years before the FDA cleared any pediatric indications. They claim that Johnson & Johnson and its Janssen Pharmaceuticals illegally promoted Risperdal for pediatric use prior to October 2006 and concealed its potential to cause gynecomastia in men and boys.
Risperdal lawsuits have been going to trial in Philadelphia since February 2015, and many juries have found for plaintiffs. In fact, the most recent Risperdal gynecomastia trial concluded last month, when a jury awarded $8 million in punitive damages to a plaintiff who was prescribed the medication in 2003 to treat Asperger’s Syndrome. In November 2015, another Philadelphia jury had awarded the same plaintiff $680,000 in compensatory damages.