Risperdal Plaintiffs Seek Release of Johnson & Johnson Study Data

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News Inferno; December 16, 2013

Last week, plaintiffs in a number of product liability lawsuits against Johnson & Johnson (J&J) involving the antipsychotic drug Risperdal, told a Pennsylvania judge that documents describing the medication’s risks are vital to the public interest should not remain under seal.

Nearly 275 product liability lawsuits have been brought against J & J’s Janssen Pharmaceuticals unit, and attorneys for the plaintiffs blasted 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 alleges that Risperdal caused 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 observations 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.”

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