High Court Won’t Hear Dispute Challenging FDA Over J&J Drug

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By Dana A. Elfin

A Philadelphia-based law firm has hit the end of the road in its bid to challenge the FDA’s actions on Johnson & Johnson’s antipsychotic drug Risperdal ( Sheller P.C. v. HHS, U.S., No. 16-1097, cert. denied 5/15/17 ).

The U.S. Supreme Court declined to hear Sheller P.C.'s petition, leaving intact a Third Circuit decision finding the law firm didn’t have standing to request the FDA to either yank its approval of Risperdal for use in children or to add a black-box warning about the drug’s side effects in children. Risperdal, made by J&J subsidiary Janssen Pharmaceuticals Inc., has been linked to gynecomastia, a condition causing abnormal breast growth in boys and young men.

The high court’s refusal to take the case leaves the issue of when third parties can sue the government as muddied as ever.

Generally, third parties—who don’t have a direct, personal stake in the matter at hand—can’t sue the government, but courts have allowed third parties to sue in certain circumstances, such as where the third party is a guardian for a child in a lawsuit.

No Single Rule

“It’s a pretty complicated area and the Supreme Court hasn’t formulated a single rule on when third parties can sue,” Bradford C. Mank, James B. Helmer Jr. Professor of Law at the University of Cincinnati College of Law, told Bloomberg BNA May 15. Mank is an expert on legal standing issues.

“In some cases they’ve allowed it and not in others,” he said. “It depends on the exact circumstances. There’s no easy answer.”

The law firm petitioner isn’t happy with the answer he received to his petition.

Sheller Wants Law Changed

“It’s a sad commentary,” Stephen A. Sheller, the founding partner of Sheller, P.C., told Bloomberg BNA in a May 15 telephone call. Sheller’s firm has filed several product liability suits against J&J and Janssen on behalf of multiple children who took branded Risperdal (risperidone), generic versions of Risperdal, and Invega (paliperidone), a related drug. “We don’t have standing to protect these children and there are thousands of them,” he said. “The law needs to change.”

Jessica Castles Smith, a Janssen spokeswoman, told Bloomberg BNA May 15 the company agreed with the FDA’s original decision to reject Sheller P.C.'s citizen petition, including the agency’s conclusion that label changes to Risperdal weren’t necessary.

Risperdal Helps Patients

“Contrary to the impression plaintiffs’ attorneys have attempted to create over the course of this litigation, Risperdal is an important FDA-approved medicine that, when used as part of a comprehensive treatment plan, continues to help millions of patients with mental illnesses and neurodevelopmental conditions,” she said.

After the FDA denied its citizen petition in 2014, Sheller sued the FDA in the U.S. District Court for the Eastern District of Pennsylvania, seeking to force the FDA to act on Risperdal. The district court dismissed the suit for lack of standing and Sheller appealed to the U.S. Court of Appeals for the Third Circuit.

In 2016, the Third Circuit affirmed the lower court’s dismissal, finding Sheller’s increased litigation costs and lost profits in its cases against the drug manufacturers couldn’t be sufficiently linked to the government’s action. After the Third Circuit denied the firm’s petition for rehearing, Sheller filed a petition for certiorari with the high court in March.

Product Liability Cases Continue

Sheller told Bloomberg BNA his firm will keep fighting on behalf of the plaintiffs who took risperidone. “Whether I have standing doesn’t go to the merits of these cases, obviously,” he said. “We’re going to keep fighting.”

In 2016, Sheller was one of the lawyers who secured a $70 million verdict in state court against J&J and Janssen on behalf of a Tennessee boy who alleged he developed female-like breasts after taking Risperdal.

The companies have appealed the jury verdict.

Robert M. Palumbos with Duane Morris LLP in Philadelphia filed the certiorari petition with the Supreme Court for Sheller P.C.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

For More Information

Sheller P.C.'s petition for certiorari is at http://src.bna.com/m88. Sheller P.C.'s 2012 citizen petition is available at http://src.bna.com/m8C. The FDA's response to the citizen petition is at http://src.bna.com/m8E.

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