Law Firm Cannot Challenge Denial of Risperdal Petition, Court Rules

A federal court panel ruled that the Philadelphia law firm Sheller PC cannot challenge the FDA’s denial of a citizen petition, saying the firm lacks standing based on its failure to show a causal relationship between the agency’s actions and its financial burdens.

A three-judge panel for the U.S. Court of Appeals for the Third Circuit affirmed that a lower court judge did not err when he granted a motion to dismiss the case, said Judge Julio Fuentes, who wrote the opinion for the panel.

Sheller contended that the FDA decision to deny its citizen petition — which asked the agency to revoke the approval of Janssen’s anti-psychotic Risperdal and require a black box label for the drug — led to increased spending for the firm, because Janssen relied on the agency’s denial to defend itself in court.