Cook v. Food & Drug Administration
733 F.3d 1, 407 U.S. App. D.C. 1, 86 Fed. R. Serv. 3d 98 (2013)
Rule of Law:
The Food, Drug, and Cosmetic Act imposes a mandatory, nondiscretionary duty on the FDA to refuse admission to foreign drugs that appear to be misbranded or unapproved, precluding the agency from claiming unreviewable enforcement discretion.
Facts:
- Several U.S. states use a three-drug lethal injection protocol for executing prisoners, which relies on sodium thiopental as the anesthetic.
- In 2009, the last domestic manufacturer of sodium thiopental ceased production, causing a shortage for state correctional departments.
- Correctional departments in states including Arizona, California, and Tennessee began purchasing thiopental from a foreign wholesaler, Dream Pharma Ltd., located in the United Kingdom.
- The imported thiopental was unapproved by the FDA and manufactured in an Austrian facility that was not registered with the FDA.
- Initially, the FDA detained shipments of the drug because they appeared to be misbranded and unapproved.
- After state officials explained the drugs were intended for lethal injections, the FDA released the shipments and allowed them to enter the United States.
- The FDA subsequently issued a policy statement declaring it would exercise 'enforcement discretion' to allow these shipments and would not review them.
- Death row inmates facing execution via these drugs initiated legal action challenging the FDA's policy.
Procedural Posture:
- Inmates sued the FDA in the United States District Court for the District of Columbia.
- The FDA moved to dismiss, arguing its enforcement decisions were unreviewable committed to agency discretion.
- The District Court denied the FDA's motion and granted summary judgment in favor of the inmate plaintiffs.
- The District Court issued a permanent injunction against the FDA and ordered the FDA to demand the return of drugs already possessed by state correctional departments.
- The FDA appealed the judgment to the United States Court of Appeals for the District of Columbia Circuit.
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Issue:
Does 21 U.S.C. § 381(a) of the Food, Drug, and Cosmetic Act impose a mandatory duty on the FDA to refuse admission to misbranded or unapproved drugs offered for import, thereby subjecting the agency's failure to do so to judicial review?
Opinions:
Majority - Ginsburg
Yes, the statute unambiguously mandates that the FDA must refuse admission to drugs that appear to violate the Act, leaving the agency no discretion to admit them. The Court rejected the FDA's reliance on Heckler v. Chaney, which generally presumes agency non-enforcement decisions are unreviewable. While Chaney applies when statutes are permissive, Section 381(a) of the FDCA uses mandatory language. Specifically, the statute states that if a drug appears to be misbranded or unapproved, it 'shall be refused admission.' The use of 'shall' in this context is a command that admits of no discretion. Furthermore, the statute provides specific exceptions (such as conditional admission for relabeling), which implies that the general rule is mandatory; otherwise, the exceptions would be superfluous. Consequently, the FDA's policy of releasing these drugs was 'not in accordance with law' under the APA. Additionally, the Court addressed a procedural issue regarding the remedy. It held that the District Court erred by ordering the states to return the drugs already in their possession because the states were necessary parties under Rule 19 but had not been joined in the lawsuit. Therefore, while the FDA acted unlawfully, the specific order requiring the return of drugs already held by the states was vacated.
Analysis:
This decision significantly limits the scope of the 'enforcement discretion' doctrine established in Heckler v. Chaney. It clarifies that while agencies generally have discretion on when to enforce laws, they cannot ignore specific statutory mandates where Congress has used imperative language like 'shall.' This creates a clear avenue for plaintiffs to challenge agency inaction or 'non-enforcement' policies when the underlying statute contains mandatory directives. It forces agencies to adhere strictly to statutory entry requirements for imports, regardless of policy preferences or deference to other state agencies (like corrections departments).
