Cook v. Food

• Decision Date: 23 July 2013
• Docket Number: Nos. 12–5176,12–5266.,s. 12–5176
• Court: U.S. Court of Appeals — District of Columbia Circuit
• Parties: Daniel Wayne COOK, et al., Appellees v. FOOD & DRUG ADMINISTRATION, et al., Appellants.

733 F.3d 1

Daniel Wayne COOK, et al., Appellees

v.FOOD & DRUG ADMINISTRATION, et al., Appellants.

Nos. 12–5176, 12–5266.

United States Court of Appeals,District of Columbia Circuit.

Argued March 25, 2013.

Decided July 23, 2013.

Appeals from the United States District Court for the District of Columbia (No. 1:11–cv–00289).

Daniel Tenny, Attorney, U.S. Department of Justice, argued the cause for appellants. With him on the briefs were Stuart F. Delery, Principal Deputy Assistant Attorney General, Ronald C. Machen Jr., U.S. Attorney, Scott R. McIntosh, Attorney, William B. Schultz, Acting General Counsel, U.S. Health and Human Services, and Eric M. Blumberg, Deputy Chief Counsel.

Kent S. Scheidegger was on the brief for amicus curiae Criminal Justice Legal Foundation in support of appellant.

Eric A. Shumsky argued the cause for appellees. With him on the brief were Coleen Klasmeier and Dale A. Baich, Assistant Federal Public Defender, Office of the Federal Public Defender for the District of Arizona.

Before: ROGERS, Circuit Judge, and GINSBURG and SENTELLE, Senior Circuit Judges.

Opinion for the Court filed by Senior Circuit Judge GINSBURG.

GINSBURG, Senior Circuit Judge:

A group of prisoners on death row in Arizona, California, and Tennessee sued the Food and Drug Administration, the Department of Health and Human Services, and the official in charge of each agency (collectively, the FDA) for allowing state correctional departments to import sodium thiopental (thiopental), a misbranded and unapproved new drug used in lethal injection protocols, in violation of the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 381(a), and the Administrative Procedure Act (APA), 5 U.S.C. § 706(2)(A). The district court entered summary judgment for the plaintiffs, permanently enjoined the FDA from allowing the importation of apparently misbranded or unapproved thiopental, and ordered the FDA to notify state correctional departments that the use of imported thiopental is unlawful and that existing stocks must be sent to the FDA. For the reasons that follow, we affirm the judgment of the district court but vacate the portion of its remedial order pertaining to thiopental already in the possession of the states.

I. Background

The Food, Drug, and Cosmetic Act (FDCA), makes it unlawful to introduce into interstate commerce a misbranded drug, 21 U.S.C. § 331(a), or an unapproved new drug, § 355(a).^* A drug is misbranded if, among other things, it was “manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered” with the FDA. § 352( o). An unapproved new drug is one that is neither “generally recognized, among experts ... as safe and effective” for its labeled use, § 321(p)(1), nor approved by the FDA as safe and effective for its proposed use, § 355(d).

The FDCA also regulates the importation of drugs. 21 U.S.C. § 381(a) provides:

The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services [HHS], upon his request, samples of ... drugs ... being imported or offered for import into the United States.... The Secretary of [HHS] shall furnish to the Secretary of the Treasury a list of establishments registered [with the FDA] ... and shall request that if any drugs ... manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs ... be delivered to the Secretary of [HHS].... If it appears from the examination of such samples or otherwise that ... such article is adulterated, misbranded, or [an unapproved new drug] ..., then such article shall be refused admission.

The duties of the Secretary of the Treasury under § 381(a) are administered by Customs and Border Protection, a unit of the Department of Homeland Security, see Del Monte Fresh Produce N.A., Inc. v. United States, 706 F.Supp.2d 116, 117 n. 1 (D.D.C.2010); those of the Secretary of HHS are administered by the FDA, see FDA, 2 Staff Manual Guides 1410.10, at 1 (2012), http:// www. fda. gov/ downloads/ About FDA/ Reports Manuals Forms/ Staff Manual Guides/ UCM 273771. pdf. In addition to physically examining samples, as required by § 381(a), the FDA “receives notification from [Customs] of all formal and informal entries of articles under FDA jurisdiction at ports of entry” and “electronically screen[s]” those entry data “against criteria developed by FDA.”

FDA, Regulatory Procedures Manual 9–2 to 9–3 (2013), http:// www. fda. gov/ downloads/ ICECI/ Compliance Manuals/ Regulatory Procedures Manual/ UCM 074300. pdf.

Each of the plaintiffs in this action has been sentenced to death under the laws of Arizona, California, or Tennessee. At the time of the complaint those states and many others executed prisoners by injecting them with a sequence of three drugs: (1) sodium thiopental, which induces anesthesia; (2) pancuronium bromide, which causes paralysis; and (3) potassium chloride, which stops the heart. Baze v. Rees, 553 U.S. 35, 44, 128 S.Ct. 1520, 170 L.Ed.2d 420 (2008) (plurality opinion). The administration of thiopental is critical because absent “a proper dose ... render[ing] the prisoner unconscious, there is a substantial, constitutionally unacceptable risk of suffocation from the administration of pancuronium bromide and pain from the injection of potassium chloride.” Id. at 53, 128 S.Ct. 1520. Although thiopental has been used as an anesthetic since the 1930s, it is presently an unapproved new drug.

In 2009 the last domestic manufacturer of thiopental stopped making it. Several state departments of correction then began ordering thiopental from Dream Pharma Ltd., a wholesaler located in the United Kingdom. The thiopental sold by Dream was prepared and marketed by Archimedes Pharma UK, Ltd., which obtained unfinished thiopental from a facility in Austria; neither Dream nor Archimedes was registered with the FDA. The FDA therefore detained the first two shipments from Dream because, per § 381(a), the thiopental appeared to be a misbranded and unapproved new drug. After state officials explained the purpose of the imported thiopental, however, the FDA released the shipments. Several states, including Arizona, California, and Tennessee, thereafter imported thiopental from Dream without interference from the FDA.

In 2011 the FDA issued a policy statement concerning the importation of thiopental for the execution of state prisoners. The FDA stated that it “neither approves nor reviews [thiopental] for use in lethal injections.” Rather, in “defer[ence] to law enforcement” agencies, henceforth it would exercise its “enforcement discretion not to review these shipments and allow processing through [Customs'] automated system for importation.”

The plaintiffs then brought this suit alleging the FDA's policy statement and its failure to “refuse[ ] admission,” § 381(a), to certain specific shipments of thiopental coming from Dream violated the APA. The FDA argued first that its “decision not to take enforcement action with respect to thiopental is not subject to judicial review because ‘agency refusals to institute investigative or enforcement proceedings' are ‘committed to agency discretion.’ ” Beaty v. FDA, 853 F.Supp.2d 30, 39 (D.D.C.2012) (quoting Defendants' Memorandum in Support of Motion to Dismiss and/or for Summary Judgment and in Opposition to Plaintiffs' Motion for Summary Judgment at 1, 14–15). The district court, however, reasoned the FDA's conduct was reviewable because it “did not involve a decision whether to initiate enforcement proceedings ... [but rather its] duty to obey the law and deny admission to a drug according to unambiguous statutory provisions.” Id. at 40. On the merits of the dispute, the district court held the FDA acted contrary to law because § 381(a) “impose[s] a mandatory obligation on [the FDA] to refuse to admit the misbranded and unapproved drug, thiopental, into the United States.” Id. at 39. The district court also held the FDA had been arbitrary and capricious, in violation of the APA, because it had “acted inconsistently with FDA regulations, acted inconsistently with its longstanding practices, and acted in a manner contrary to the purpose of the FDCA, thereby threatening the public health.” Id. at 41. The district court therefore granted summary judgment for the plaintiffs.

In a separate order, the district court granted the plaintiffs declaratory and injunctive relief. It declared the thiopental that had been imported already was a misbranded and unapproved new drug that “cannot lawfully be ... imported into the United States.” The district court permanently enjoined the FDA from “permitting the entry of, or releasing any future shipments of, foreign manufactured thiopental that appears to be misbranded or [an unapproved new drug].” Finally, the district court ordered the FDA to “immediately notify any and all state correctional departments which it has reason to believe are still in possession of any foreign manufactured thiopental that the use of such drug is prohibited by law and that, that thiopental must be returned [sic] immediately to the FDA.”

II. Analysis

The FDA's principal contention on appeal is that its “determination whether to invoke [§ 381(a) ] and refuse admission to any particular drug offered for import is ... not subject to judicial review.” On the merits, the FDA briefly argues its actions were neither arbitrary and capricious nor otherwise contrary to law. Underlying both arguments is the claim that § 381(a) gives the FDA unreviewable enforcement discretion and that, pursuant to Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984), the court should defer to the FDA's interpretation of the statute.

Whether Chevron applies to an agency's interpretation that a statute commits a matter to its discretion and thereby precludes judicial review is not entirely clear....