Court Rejects Law Firm’s Risperdal Appeal
The Third Circuit Court of Appeals has sided with a Pennsylvania federal court’s ruling that the Sheller law firm lacks standing to bring suit to compel FDA to approve its petition over the use of Janssen’s Risperdal (risperidone) and generic forms of the drug in children. Sheller represents hundreds of children who are alleged to have suffered serious injury caused by taking the drugs. The firm says that the long-term safety of Risperdal for children has not been established and current labeling of the drugs fails to adequately warn of adverse health risks.
Independent from its Risperdal litigation on behalf of the children, the court says, Sheller filed a citizen petition asking FDA to immediately revoke the approval of Risperdal for children unless and until its long-term safety could be demonstrated or, alternatively, to immediately require a Boxed Warning in the drug’s labeling based on the lack of sufficient data to prove the drugs’ safety. FDA asked Janssen to provide any data on use of the drugs in children and adolescents that had not already been submitted to the agency and denied the remainder of the petition.
Sheller brought suit seeking to compel FDA to grant the petition, claiming that the denial has been used by Janssen as support for various arguments in the litigation, forcing the law firm to spend money defending against those arguments and thus reducing its profits from contingency agreements with its clients.
The appeals court held that Janssen is entitled to defend itself against Sheller’s lawsuits regardless of whether FDA granted or denied the petition. And it said that Sheller would likewise make use of the petition in the litigation if FDA had approved it. “Put simply,” the appeals court decision says, “Sheller’s injury, increased Risperdal litigation costs, depends heavily on the actions of both Janssen and Sheller, not the FDA, and granting the petition produces only a ‘chain of contingencies [] (sic) which amounts to mere speculation’ about how Janssen and Sheller will conduct the Risperdal litigation and accrue associated litigation costs. There is simply no basis to say that a favorable decision in this case is ‘likely’ to redress Sheller’s injury.”