Pa. Supreme Court Denies Janssen's Appeal

  •  verdict

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).

We are social:

Accreditations

NSIC - CRISIL

NSIC-CRISIL has assigned a "SE 2A" rating to Neural IT, indicating a company with High Performanc...

ISO 27001 Certification

Neural IT is officially ISO 27001:2013 (ISO 27001) certified by Alcumus ISOQAR Limited as the Cer...

HIPAA

Neural IT has successfully implemented HIPAA for securing Health records....

Associations

NYSTLA

NYSTLA - "Neural IT is proud to be associated with NYSTLA (New York State Trial Lawyers Associati...

CAOC

CAOC - "Neural IT is proud to be associated with CAOC (Consumer Attorneys of California) as a Ven...

CAALA

CAALA - "Neural IT is proud to be associated with CAALA (Consumer Attorneys Association of Los An...

News & Events

Friends Of CAALA 2020
It is a treasured moment for Neural IT to be associated as an Affiliate Member for so many years and receive an…
sharing-smiles-sharing-happiness-on-national-smile-day-event-neural-it
Amidst the chaos of COVID-19 pandemic, we have something to cheer about as today is National Smile Day, and a smile is…
Happy Mother's Day from Neural IT
The cagey pandemic has halted our lives, but the only spirits that kept igniting during the crisis are the ones whom we…

Latest Tweets