The Pennsylvania Supreme Court is debating weighing in on whether the two-year statute of limitations in thousands of Risperdal gynecomastia lawsuits pending in a mass tort program in Philadelphia County should start running in October 2016 to coincide with the Risperdal label update. Unless the High Court weighs in on the issue and reverses the lower court’s ruling, a number of Risperdal lawsuits in the mass tort proceeding are in jeopardy of being dismissed due to the expiration of the applicable statute of limitations.
Risperdal makers Johnson & Johnson and Janssen Pharmaceuticals are accused of failing to warn that that their antipsychotic could disfigure boys and young men. The drug contains the active ingredient risperidone, and is indicated for the treatment of schizophrenia, bipolar disorder and irritability with autism in adults and children. Risperdal side effects include weight gain, metabolic changes, and the production of prolactin, the hormone that triggers lactation in pregnant women. In adolescent boys, this can cause female-like breast growth, a condition called gynecomastia.
In October 2006, Janssen updated the safety label of Risperdal to reflect that the risk of gynecomastia occurring was greater than previously reported.
At the center of the issue are two lawsuits filed in 2014, one by Joshua Winter and the other by Jonathan Saksek. Winter claims he noticed his breast growth in 1998, but didn’t file his Risperdal lawsuit until March 2014. Saksek filed his in February 2014.
The lawsuits were dismissed when the judge granted summary judgment to Johnson & Johnson and Janssen after determining, in both cases, that the plaintiffs should have known by June 2009 that their breast growth was caused by Risperdal. By then, the court surmised, the drug’s safety label had been updated for more than two years. Additionally, several studies had been published on the Risperdal side effect and much media attention garnered as a result. The judge also said that the same decision would be applied across the entire Risperdal mass tort program.
“Their breasts were there, and had been there, for years,” the opinion said. “Their breasts were clearly not temporary by 2006. Accordingly, by that date, reasonable minds would not differ in finding that appellants knew, or should have known, of their injuries and the cause of those injuries by this point.”
Winter and Saksek argued that they had no way of knowing until much later that their breast growth was related to their use of Risperdal. Their cases were consolidated for appeal.
If the Pennsylvania Supreme Court justices decide to hear the appeal, the outcome could affect hundreds of cases filed after the October 2006 time bar.