Plaintiffs in product liability lawsuits against Johnson & Johnson’s Janssen Pharmaceuticals division involving the antipsychotic drug Risperdal, last week asked a Pennsylvania judge to release clinical study data that they say should not remain under seal, as the data has been since 2011.
Johnson & Johnson’s Janssen Pharmaceuticals division faces nearly 275 product liability suits over the use of Risperdal in children. Attorneys for the plaintiffs say the sealed documents, which pertain to a series of clinical studies, are vital to the public interest and should be released. Janssen entered a motion asking the court to continue protecting the confidentiality of the documents, Law360 reports.
The plaintiffs’ complaint alleges that Risperdal causes gynecomastia–abnormal growth of breast tissue in adolescent boys–and they argue that the protected material should not be considered proprietary because it consists of studies about the effectiveness and risks of the drug, according to Law360. The brief states that these are “safety documents that require disclosure for the well-being of the public, full and unfettered review by regulatory authorities, and the education of healthcare providers who are prescribing this powerful drug.” Many of the boys diagnosed with gynecomastia have needed surgery to remove the breasts.
In last month’s motion, Janssen’s attorneys argued against the release of the documents, indicating that the documents were exempt from public review because they were neither public records nor had the documents been filed with the court. The plaintiffs’ brief asserts, “Plaintiffs now possess evidence that Janssen systematically under-reported or misrepresented clinically important study results relating to the occurrence of gynecomastia … in the child and adolescent market. However, the discovery that plaintiffs have uncovered is protected behind the shield of the protective order entered in this case.”
Janssen, through a spokesperson said the company supports the release of clinical trial data that helps the advancement of science and medicine. Meanwhile, Janssen’s Pamela Van Housten told Law360, “We believe these documents should continue to be confidential to protect patient privacy, intellectual property, and scientific integrity.”
Settlements have been reached in two cases in the first group of Risperdal product liability cases, and court documents indicate that a second set of cases is scheduled for trial in Philadelphia in June 2014.
Johnson & Johnson agreed to a $2.2 billion payment to settle civil and criminal claims brought under the federal False Claims Act, Law360 reports. J&J is alleged to have promoted off-label use of Risperdal and two other drugs through kickbacks and perks to doctors. Though doctors are permitted to prescribe a drug for uses other than those for which it was approved, drug makers are not legally permitted to market a drug except for uses approved by the U.S. Food and Drug Administration (FDA).