A Pennsylvania judge has granted summary judgment for the defense in the Risperdal lawsuit selected for the state’s seventh gynecomastia trial. However, the decision only applies to this single case, and will not apply to any other cases currently pending in the state’s mass tort program.
More than 5,400 Risperdal claims have been centralized in the Philadelphia Court of Common Pleas, the majority of which were filed on behalf of men and boys who allegedly experienced excessive breast growth related to use of the antipsychotic drug. The case selected for the proceeding’s seventh trial involved a plaintiff who began taking Risperdal at the age of 8 to treat symptoms associated with attention deficit hyperactivity disorder.
In granting summary judgment, Judge Arnold New found that the plaintiff’s doctor had not satisfied the requirements of the learned intermediary doctrine, which requires proof that a physician would have opted for an alternative treatment had a different warning been provided by Risperdal’s manufacturers. However, his February 28th Order noted that the decision was based only on “the specific facts of this matter.”
Lawyers representing the plaintiff have promised an appeal.
“The prescribing doctor testified that he would have ‘tossed [Risperdal] out’ as a potential medicine for our client if he had been given an accurate warning,” one of his attorneys told Law360.com. “We think that testimony and other statements like it in the record clearly satisfies the learned intermediary doctrine.”
Manufactured by Johnson & Johnson’s Janssen Pharmaceuticals unit, Risperdal belongs to a class of psychiatric drugs called atypical antipsychotics. The medication is currently 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.
Plaintiffs pursuing legal claims over Risperdal and gynecomastia charge that the drug can cause the body to produce excess amounts prolactin, a hormone that plays a role in female breast development and lactation. In males, high levels of prolactin can stimulate the development of female-like breasts. The complaints note that prior to 2006, the Risperdal label listed gynecomastia as a rare side effect that appeared in less than 1 in 1,000 patients. However, in 2006 the labeling was updated to state that the condition could occur in 2.3% of male adolescents taking the drug.
The Pennsylvania litigation has been conducting a series of gynecomastia trials since early 2015. Four of those cases have resulted in verdicts favoring Risperdal plaintiffs, with damage awards ranging from $500,000 to $70 million. The defense was granted a summary judgement in another case slated for trial last December. Jurors convened for a trial that ended in March 2015 declined to award the plaintiff any damages, after they were unable to conclude that Risperdal was behind his excessive breast growth. However, they also determined that gynecomastia warnings provided to doctors and patients were inadequate.