Sheller v. United States Department of Health & Human Services
663 F. App'x 150
| 3rd Cir. | 2016Background
- Sheller, P.C., a law firm representing children in suits alleging Risperdal (risperidone/paliperidone) causes gynecomastia and weight gain, sued the FDA after the agency denied most of its citizen petition.
- The Petition sought revocation of pediatric approvals or, alternatively, a black-box warning for Risperdal; FDA requested additional data from Janssen but otherwise denied relief.
- Sheller alleges the FDA’s denial has been used by Janssen in the parallel state-court Risperdal litigation to support defense arguments, forcing Sheller to incur extra litigation costs and reducing its contingency-fee profits.
- Sheller brought suit in federal district court under subject-matter jurisdiction for federal questions; the district court dismissed for lack of Article III standing.
- The Third Circuit affirmed, holding Sheller failed to adequately plead causation and redressability for its asserted injury (increased litigation costs/lost profits).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Standing (Article III) — injury, causation, redressability | Sheller: FDA denial caused Janssen to rely on that denial in litigation, increasing Sheller’s costs and reducing profits | Appellees: Any extra costs flow from Janssen’s litigation strategy and Sheller’s own actions, not the FDA denial | Held: No standing — Sheller fails causation and redressability elements |
| Causation — traceability to government action | Sheller: Janssen’s use of the denial is fairly traceable to FDA conduct | Appellees: Janssen could make the same arguments regardless of FDA action; denial did not authorize otherwise-illegal conduct | Held: FDA denial did not authorize third-party conduct and is not fairly traceable |
| Redressability — relief likely to remedy injury | Sheller: A court order enjoining FDA to grant the Petition would remove Janssen’s support and redress costs | Appellees: Even if FDA granted Petition, Janssen and Sheller would likely continue their litigation strategies, so relief is speculative | Held: Relief would not likely redress Sheller’s litigation-cost injury |
| Third-party standing exceptions | Sheller: Denial created factual/legal predicate used by third party; this fits exceptions | Appellees: Neither exception applies — no authorization of illegal third-party conduct and no substantial evidence of causal link | Held: Neither third-party exception applies; standing fails |
Key Cases Cited
- Massachusetts v. EPA, 549 U.S. 497 (recognizing concrete adverseness and standing principles)
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (defining particularized injury requirement)
- Defenders of Wildlife, 504 U.S. 555 (standing requirements: injury, causation, redressability)
- Clapper v. Amnesty Int’l USA, 133 S. Ct. 1138 (standing requires avoidance of speculative chains of contingencies)
- Constitution Party of Pa. v. Aichele, 757 F.3d 347 (third-party conduct/authorization and causation discussion)
- Finkelman v. Nat’l Football League, 810 F.3d 187 (plaintiff bears burden to plead standing)