
Home » Law Firm Cannot Challenge Denial of Risperdal Petition, Court Rules
Law Firm Cannot Challenge Denial of Risperdal Petition, Court Rules

October 14, 2016
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.
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