The U.S. Supreme Court’s refusal May 15 to hear a case about whether a plaintiffs’ law firm has standing to challenge the FDA’s drug labeling actions leaves the issue of when third parties can sue the government as murky as ever (Sheller P.C. v. HHS, U.S., No. 16-1097, cert. denied 5/15/17).
Philadelphia-based law firm Sheller P.C. petitioned the high court to review a 2016 Third Circuit decision finding it 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.
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 some constitutional cases involving fundamental rights, constitutional scholar and standing expert Bradford Mank, James Helmer, Jr. professor at the University of Cincinnati College of Law, told me.
Third Parties Have Additional Hurdles
The Supreme Court has required parties seeking third-party standing to make two additional showings, Mank said.
Those involve whether the party asserting the right has a “close” relationship with the person who possesses the right and whether there is a “hindrance” to the possessor’s ability to protect his own interests, he said.
“In cases involving First Amendment and other important constitutional rights, the court has been especially willing to allow third-party suits, but in nonconstitutional areas of law, the court has been much less willing to do so.”
The upshot here? Sheller P.C. is out of luck.
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