Risperdal Plaintiffs Ask Judge to Release Studies, Data

On Tuesday, plaintiffs asked a Pennsylvania judge to lift a protective order on documents from pre-trial proceedings that allegedly support a connection between the antipsychotic drug Risperdal and a medical condition known as gynecomastia, the growth of breast tissue in boys. The plaintiffs stressed the importance of the “hidden” documents, saying that the public’s safety outweighs Janssen Pharmaceutical Inc.’s “claims to secrecy."

According to the plaintiffs, Janssen was more concerned with profits than public safety.

Earlier this month, Janssen asked the court to uphold its previous decision to keep documents in the litigation confidential, citing the court’s previous ruling in 2011. In their brief, the plaintiffs argued that the court’s former decision only served as a “benchmark” for the harm that will continue if the court does not intervene. New evidence from pre-trial proceedings supported the company’s misconduct, they argued, and included witnesses’ testimonies that Janssen’s statements on Risperdal’s risks were misleading and inaccurate. Meanwhile, Risperdal’s label has not changed and physicians continue to prescribe the drug, the plaintiffs said.

In its argument to retain confidentiality over the documents, Janssen also argued that the documents were exempt from public access because they were neither public records nor filed with the court. The company added that the materials were designed for scientists and researchers and would not serve any purpose to the public.

In this week’s motion, the plaintiffs retorted that the data in these confidential documents was used in articles written for or by Janssen, which were published for the public and medical community alike. Furthermore, Janssen has allegedly withheld information and selectively disclosed its study results involving the effectiveness and risks of Risperdal, which has caused repeated misrepresentations of the “safety of Risperdal to regulatory authorities, healthcare providers, and the public.” According to the plaintiffs, Janssen was more concerned with profits than public safety when it published its data or study results, and the “well-being of the public” is currently being compromised by the protective order.