311 F. Supp. 3d 5
D.C. Cir.2018Background
- Plaintiffs (three individuals and the Center for Responsible Science) petitioned FDA in May 2014 to add three specific warnings about limits of animal testing to the agency's informed-consent regulation for clinical trials.
- The proposed elements would inform trial participants that animal data may not predict human safety or efficacy, note prior participant deaths/serious injuries, and warn that the investigational drug may later prove unsafe or ineffective.
- FDA denied the Citizen Petition in April 2017, explaining the proposed language was drug-trial–specific while the regulation covers all clinical research, making the additions inappropriate for the existing rule.
- Plaintiffs sued under the Administrative Procedure Act seeking declaratory and injunctive relief, alleging the denial was arbitrary and capricious.
- Defendant (FDA Commissioner) moved to dismiss for lack of Article III standing, arguing none of the plaintiffs satisfied injury, causation, and redressability requirements.
- The district court found the individual plaintiffs lacked standing because they already possess the information they seek and any future participation would be a voluntary choice, and found CRS’s organizational allegations too conclusory to show a concrete drain on resources; the court granted dismissal but gave leave to amend.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Article III standing of individual plaintiffs | They face risk from inadequate informed consent and thus will be harmed without the mandated warnings | Individuals already possess the information; any future harm would stem from their own choices, not FDA denial | Individuals lack standing; dismissal as to them granted |
| Organizational standing of CRS | CRS will have to divert substantial resources to compensate for FDA inaction, frustrating its mission | CRS’s allegations are generic and fail to show a concrete, provable drain on resources causally tied to the denial | CRS’s allegations insufficient at this stage; organizational standing not established on current pleadings |
| Causation between FDA denial and alleged future injuries | Denial prevents a regulatory change that would provide consistent warnings to trial participants | The denial does not cause individuals’ decisions or injuries because the proposed language is generic and already known to plaintiffs | Court finds lack of traceability for individuals; CRS must plead specifics to show causation |
| Redressability by judicial relief (mandating amended regulation) | A judicial order requiring the regulation be amended would redress informational injury and resource diversion | Even if ordered, generic language would not change the information plaintiffs already have; CRS must show specific redressable programmatic harms | Court concludes redressability fails on current record for individuals; CRS may amend to allege specific redressable injuries |
Key Cases Cited
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (standing requires injury, causation, redressability)
- Nat'l Ass'n of Home Builders v. EPA, 667 F.3d 6 (organization must show concrete drain on resources, not mere advocacy costs)
- Food & Water Watch, Inc. v. Vilsack, 808 F.3d 905 (advocacy spending alone insufficient for organizational injury)
- Jerome Stevens Pharm., Inc. v. FDA, 402 F.3d 1249 (courts may consider materials outside the pleadings on jurisdictional challenge)
- Trudeau v. Federal Trade Comm'n, 456 F.3d 178 (courts need not accept legal conclusions disguised as factual allegations)
- Comite de Jornaleros de Redondo Beach v. City of Redondo Beach, 657 F.3d 936 (organizational standing requires evidence showing diversion of resources to counteract challenged policy)
- Ciralsky v. CIA, 355 F.3d 661 (distinguishing dismissal of case from dismissal of complaint; leave to amend appropriate)