update Risperdal Plaintiffs Request the Unsealing of Key Clinical Studies Data

Risperdal plaintiffs have asked a Pennsylvania judge to unseal clinical studies data, citing its importance to the public interest, according to court documents. The Rottenstein Law Group LLP, which represents clients in Risperdal lawsuits, notes that the documents detail potential risks associated with the antipsychotic drug.

The request from attorneys representing plaintiffs in about 300 Pennsylvania state Risperdal lawsuits is a response to an initial request from Johnson & Johnson and subsidiary Janssen Pharmaceuticals to uphold a 2011 order to keep the documents sealed, according to court documents (In re: Risperdal Litigation; Case No. 100300296, Philadelphia Court of Common Pleas, Pennsylvania.)

J&J previously argued that because the documents are generated for researchers and regulators, and not for the general public, there is no reason to unseal them, according to court documents.

“The plaintiffs in these cases allege that Risperdal causes gynecomastia, which is the enlargement of breast tissue in males,” said Rochelle Rottenstein, principal of the Rottenstein Law Group LLP. “They believe the sealed data speaks to their allegations, and so they are requesting that the courts order the documents to be made available.”

Recently, J&J agreed to pay $2.2 billion in civil and criminal fines to settle claims it improperly marketed the antipsychotic medication Risperdal to children, seniors and people with developmental disabilities, according to a Nov. 4 New York Times story. The United States Department of Justice announced the settlement, which also includes heart-failure drug Natrecor and the antipsychotic Invega. The federal government alleges that J&J marketed the drug to high-risk groups from 1999 to 2005, the story said. Part of the settlement includes J&J’s pleading guilty to a criminal misdemeanor for its role in promotion of the drug to those groups.

Risperdal has been shown to almost double the risk of heart disease and pneumonia in elderly dementia patients, according to the U.S. Food and Drug Administration.

 

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