Risperdal gynecomastia plaintiffs could soon learn if the Pennsylvania Supreme Court will hear an appeal of a lower court decision that, if confirmed, will prevent hundreds from pursuing their claims.
The appeal involves two Risperdal lawsuits, both filed in 2014 on behalf of plaintiffs who experienced excessive male breast growth (gynecomastia) allegedly related to their use of the antipsychotic medication. The cases were dismissed when a judge in the Philadelphia Court of Common Pleas granted summary judgment to Johnson & Johnson and its Janssen Pharmaceuticals subsidiary, after finding that the statute of limitations on the claims had expired in 2009.
In November, the Pennsylvania Superior Court upheld the trial court’s decision, finding that the plaintiffs should have been in a position to suspect Risperdal as the cause of their gynecomastia when the drug’s label was updated in October 2006.
“Their breasts were there, and had been there, for years,” the Superior Court’s 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.”
The case is now before the Pennsylvania Supreme Court, which has not yet indicated if it will hear the appeal.
If the decision stands, hundreds of Risperdal lawsuits currently pending in the mass tort program underway in Philadelphia will be subject to dismissal.
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.
Risperdal was not approved for use in children until October 2006. That same month, the drug’s prescribing information was modified to note that gynecomastia had occurred in 2.3% of male adolescents, Prior to the modification, the label described the condition as a rare side effect affecting just 1 in 1,000 patients
The majority of Risperdal lawsuits pending in the Philadelphia Court of Common Pleas involve gynecomastia.
The mass tort program began a series of Risperdal gynecomastia trials in February 2015. Out of seven cases that have made it before a jury, five have resulted in plaintiffs’ verdicts, with compensatory damage awards ranging from $2.5 million to $70 million.