Stephen Sheller of Sheller PC has filed a petition of certiorari to the U.S. Supreme Court over whether he has standing to sue the FDA after denying his 2012 citizen’s petition to either revoke the agency’s approval of the drug Risperdal for pediatric use or add a black-box warning of the drug’s side effects in children.

Sheller represents hundreds of children in Pennsylvania who took Risperdal and Invega and are suing Johnson & Johnson (J&J) and its subsidiary Janssen over serious side effects of the drugs. The lawsuits claim the drugs can cause gynecomastia, the abnormal breast growth in adolescent boys. Through the discovery process of the lawsuits, Sheller obtained documents that he believes would warrant revoking the use of Risperdal in children or the black-box warning, if the FDA would request the documents from J&J. A confidentiality agreement keeps Sheller from providing the documents directly to the FDA.

In a June 2013 program of The American Law Journal, Sheller sparred with a pharmaceutical defense attorney over revolving door politics and other conflicts of interest between the FDA and pharmaceutical companies. He also discussed Risperdal and his citizen’s petition.

In 2014 the FDA rejected the citizen’s petition without giving an explanation as to why it would not give Sheller a hearing, a violation of the Administrative Procedures Act.

Sheller sued the FDA and U.S. District Judge Legroom Davis found that Sheller did not have standing to challenge the FDA. Upon appeal, October 2016 the 3rd U.S. Circuit of appeals agreed with Judge Davis, Sheller did not have standing.

If a plaintiff’s attorney who has represented hundreds of children injured by the anti-psychotic drug Risperdal does not have standing to challenge the FDA’s denial of a citizen’s petition about the drug, then who does?

Now working with appellate litigator Howard Bashman, Sheller has petitioned the U.S. Supreme Court to answer this question. Bashman believes plaintiff’s attorneys are the best-situated challengers to bring a successful citizen’s petition for relabeling drugs. Although Bashman could not find another case directly on point, he does believe the justices will be interested in questions of constitutional standing. This petition could provide the opportunity to answer the question: “Who has a constitutional right to challenge a government action?”

Click here for update on petition to the Supreme Court

Who can challenge FDA label decisions? Not plaintiffs’ firm with drug cases – 3rd Circuit, Reuters, December 9, 2016

FDA Berated Over inaction on Antipsychotic, Courthouse News Service, January 30, 2015