The Pennsylvania Supreme Court has denied Janssen's appeal to review an intermediate court’s reinstatement of action over a lawsuit alleging that its antipsychotic drug Risperdal causes gynecomastia.
The bid followed after the state's Superior Court overturned a Philadelphia County trial judge's mid-trial decision in July to discard claims against the Johnson & Johnson unit for lack of evidence.
The Court records state that plaintiff Tommy Moroni consumed Risperdal for about four years since 2004, to overcome attention deficit hyperactivity disorder, oppositional defiant disorder, and depression. Two years later, after Moroni stopped the use of drugs, his doctor diagnosed him with gynecomastia or the abnormal growth of female breast tissue in men.
Judge Sean Kennedy discarded the lawsuit, filed in 2013, during a trial in December 2016 after ruling that medical experts had failed to clear legal standards followed in Texas, where Moroni lived when he started taking the drug, for evidence they hoped would show a link between Risperdal and Moroni's condition.
In July, a 3-judge-panel of the Pennsylvania Superior Court ruled that the case should be evaluated under Pennsylvania law since it was procedural, thereby remanded the case back to Philadelphia and ordered a new trial.
The drug, when Moroni started using it, was only approved to treat schizophrenia in adults. The warning label included gynecomastia as a "rare" side effect occurring in fewer than one in 1,000 patients. The drug, when finally approved for treating symptoms of autism in children in October 2006, had a warning label indicating a 2.3% rate of gynecomastia in adolescent patients.