Cook v. Food & Drug Administration
733 F.3d 1
D.C. Cir.2013Background
- Plaintiffs are death-row inmates from Arizona, California, and Tennessee challenging FDA policy on importing thiopental for lethal injections under the FDCA and APA.
- FDA detained shipments of thiopental from Dream Pharma UK after import concerns, then released them following explanations to state officials.
- In 2011 FDA issued a policy stating it would not review thiopental shipments for lethal injections, effectively deferring enforcement.
- The district court granted summary judgment for plaintiffs and issued injunctive relief, enjoining admissions of imported thiopental and directing FDA to notify states to return stock.
- The DC Circuit affirms the district court’s judgment that FDA violated the FDCA by admitting and failing to sample/examine thiopental, but vacates part of the remedial order directing states to return thiopental already in their possession.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether §381(a) is reviewable and imposes mandatory duties | Cook argues §381(a) mandates sampling, examination, and refusals. | FDA argues enforcement discretion applies and Chaney applies. | §381(a) imposes mandatory duties; reviewable under APA. |
| Whether the district court properly treated Rule 19 as a defect and remedy | States with possession of thiopental have interests under Rule 19. | Nonparties need not be joined if feasible relief cannot be shaped. | States were required parties; remanded to shape relief; remedial order vacated as to states. |
| Whether FDA’s policy admitting thiopental violated the FDCA | FDA admitted unregistered, misbranded, unapproved thiopental. | Policy complied with discretion and did not violate §381(a). | FDA acted contrary to law; policy not in accordance with the FDCA. |
Key Cases Cited
- Heckler v. Chaney, 470 U.S. 821 (U.S. 1985) (agency discretion in enforcement reviewable only with statutory guidelines)
- Citizens for the Preserve Overton Park v. Volpe, 401 U.S. 402 (U.S. 1971) (limits on judicial review for agency actions in absence of law to apply)
- TRW Inc. v. Andrews, 534 U.S. 19 (U.S. 2001) (textual interpretation of mandatory language and exceptions)
- Village of Barrington, Ill. v. Surface Transp. Bd., 636 F.3d 650 (D.C. Cir. 2011) (Chevron applicability and agency discretion discussed)
- Drake v. FAA, 291 F.3d 59 (D.C. Cir. 2002) (agency discretion under review when statute provides guidance)
- Republic of Philippines v. Pimentel, 553 U.S. 851 (U.S. 2008) (sua sponte considerations of required parties under Rule 19)