Pa. Supreme Court Denies Janssen's Appeal

Pa. Supreme Court Denies Janssen's Appeal

Introduction

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 the plaintiff consumed Risperdal for about four years since 2004, to overcome attention deficit hyperactivity disorder, oppositional defiant disorder, and depression. Two years later, after he 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 the plaintiff lived when he started taking the drug, for evidence they hoped would show a link between Risperdal and the plaintiff'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 the plaintiff 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.

Risperdal (risperidone) is a class of drugs called atypical antipsychotic, developed and manufactured by Janssen Pharmaceuticals, a division of Johnson & Johnson. It was initially approved in the U.S. by the FDA in 1993 for the treatment of schizophrenia and for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder. In 2008, Janssen announced the launch of an authorized generic version of Risperdal (R) and added that it would continue to make available branded Risperdal. 

Due to its antiadrenergic, antiserotonergic, and anti-histaminergic properties and being a dopamine antagonist, Risperdal is used in the treatment of schizophrenia in adults and adolescents aged 13-17 years; for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults, and alone in children and adolescents aged 10-17 years; for the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years. Risperdal has also been marketed as an off-label treatment option for people with Attention Deficit Disorder (ADD).