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Risperdal Plaintiffs Seeks Release of Johnson & Johnson Study Data

Dec 16, 2013

Plaintiffs in product liability lawsuits against the Johnson & Johnson unit, Janssen Pharmaceuticals, Inc. which makes the antipsychotic drug Risperdal told a Pennsylvania judge last week that documents describing the medication’s risks are vital to the public interest and should not remain under seal.

Attorneys for plaintiffs in nearly 275 product liability suits against Janssen Pharmaceuticals sharply criticized a motion entered by the drug maker seeking to maintain a 2011 order protecting the confidentiality of a series of clinical studies on Risperdal, Law360 reports.

The plaintiffs’ complaint claims Risperdal caused gynecomastia—abnormal growth of breast tissue in adolescent boys—and they argue that the protected material consisted of observations about the effectiveness and risks of the drug and so should not be considered proprietary, according to Law360. 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.”

Janssen filed a motion in late November claiming that counsel for the plaintiffs were improperly seeking to publicly release a series of clinical studies that were kept under seal by the 2011 court order, according to Law360. The company argued that the documents in question were exempt from public review because they were neither filed with the court nor deemed public records, but the plaintiffs’ brief says that the “[p]laintiffs now possess evidence that Janssen that 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.”

A Janssen spokeswoman told Law360 on Wednesday that the company fully supported the release of clinical trial data when it would help the advancement of science and medicine, but, Pamela Van Housten said, “We believe these documents should continue to be confidential to protect patient privacy, intellectual property, and scientific integrity."

In November Johnson & Johnson agreed to pay $2.2 billion to resolve civil and criminal claims from whistleblowers under the federal False Claims Act that J&J, through kickbacks to doctors, illegally promoted off-label use of three of its drugs, including Risperdal, Law 360 reports.

Settlements have been reached in two cases in the first set of Risperdal cases in Pennsylvania court. Court records indicate that a second set of Risperdal cases is scheduled to go to trial in early June 2014.

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