STORY FROM: Drugs & Medical Devices

Law Firm Lacks Standing to Sue FDA for Refusal to Revoke Risperdal’s Approval, 3rd Cir. Affirms

PHILADELPHIA — A law firm that represents plaintiffs in Risperdal mass tort litigation lacks Article III standing to sue the Food and Drug Administration for its denial of a citizen’s petition urging it to revoke the drug’s approval or to require a black box warning, a federal appellate court has ruled.

In an Oct. 6 opinion, the 3rd Circuit U.S. Court of Appeals found the law firm cannot demonstrate that the FDA’s denial of the petition caused it to suffer injury, and therefore it lacks standing.

Sheller P.C. is a law firm that represents hundreds of children who are alleged ...

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