FDA Pursues Dismissal of Lawsuit Over J&J Risperdal Documents

The FDA wants to kill a lawsuit that would force it to order Johnson & Johnson to release confidential documents it used to demonstrate the safety of its antipsychotic Risperdal and reconsider a citizen petition that sought stronger safety warnings for the drug.

The plaintiffs, hundreds of children who claim they suffered gynecomastia and prolactin-related adverse events as a result of taking Risperdal (risperidone), say the agency arbitrarily denied the citizen petition. The FDA argues that the petitioners failed to allege any injury sustained as a result of the denial of the petition.

Plaintiffs attorney Stephen Sheller says the documents the petition seeks contradict and call into question the safety data provided by J&J to the FDA. They are currently under seal.

The citizen petition, filed July 27, 2012, claims that some of the internal documents were never reviewed by the FDA and others were buried within document dumps of thousands of pages to conceal their relevance and significance.

The FDA denied the petition on Nov. 25, 2014. In its decision, the FDA says it asked J&J for any data the company had not previously provided and the company turned over certain information. However, the FDA declined to make the documents public.

Sheller appealed the decision on Jan. 29 in Sheller, P.C. v. United States Department of Health and Human Services, et al. in U.S. District Court for the Eastern District of Pennsylvania. The law firm is asking the FDA to revoke approval for the use of the Risperdal by children due to safety and efficacy concerns, and requests the agency require a new boxed warning for the drug and all generic versions that would warn of a lack of sufficient safety data.

The plaintiffs plan to file a response to the FDA’s motion to dismiss. No hearing date has been set. — Jonathon Shacat