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D.C. Circuit Panel Splits on Lawfulness of Federal Execution Protocol (and Whether to Enjoin It).

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On Tuesday, the U.S. Court of Appeals for the D.C. Circuit issued an interesting, splintered opinion in In Re: In the Matter of the Federal Bureau of Prisons’ Execution Protocol Cases. The panel, which consisted of Judges Millett, Pillard and Rao, divided on whether the federal government’s execution protocol is unlawful as well as over whether, if so, it should be enjoined.

The court’s per curiam opinion (presumably written by Judge Millett) begins:

In July 2019, eight years after federal executions were put on hold due to the government’s inability to acquire one of the drugs for its then-existing lethal injection
protocol, the Department of Justice announced a revised protocol for execution by lethal injection using a single drug, pentobarbital. Plaintiffs, thirteen federal death row inmates, promptly raised statutory and constitutional challenges to the government’s revised protocol. In November 2019, the district court preliminarily enjoined the four then-scheduled executions while it (and, in turn, we) considered a pair of baseline legal challenges to the government’s lethal injection protocol. When we held that the 2019 Protocol is exempt from notice and comment requirements under the Administrative Procedure Act (APA) and that the Federal Death Penalty Act (Death Penalty Act) does not require the federal government to follow execution procedures set forth in state execution protocols that are less formal than state statutes and regulations, we vacated those injunctions and remanded for the district court to consider the balance of Plaintiffs’ challenges. See In re Federal Bureau of Prisons’ Execution Protocol Cases (In re FBOP), 955 F.3d 106 (D.C. Cir. 2020).

During the pendency of the litigation on those remaining claims, the government scheduled executions to take place within days or weeks of one another through the summer and fall. At the behest of Plaintiffs with execution dates and unresolved challenges, the district court issued a series of injunctions barring the federal government from executing inmates whose pending claims it held were likely to succeed. Each of those injunctions was vacated by either this court or the Supreme Court, and the government has since executed seven inmates, six of whom were Plaintiffs in this case at the time of their execution. In September, the district court
resolved the Plaintiffs’ remaining claims. On November 3, 2020, the district court denied the Plaintiffs’ motion to alter or amend the judgment under Rule 59(e).

The Plaintiffs then sought expedited review in this court of three of the district court’s rulings, and two Plaintiffs with upcoming execution dates moved for stays of execution
pending appeal. We affirm the district court’s grant of summary judgment to the government based on Plaintiffs’ new challenges to the Death Penalty Act, but we reverse its dismissal of the Plaintiffs’ Eighth Amendment challenge for failure to state a claim. We also hold that the district court should have ordered the 2019 Protocol to be set aside to the extent that it permits the use of unprescribed pentobarbital in a manner that violates the Federal Food, Drug, and Cosmetic Act (FDCA). But we affirm the district court’s denial of a permanent injunction to remedy the FDCA violation.

Judge Pillard wrote a separate opinion concurring in part and dissenting in part. It begins:

The court correctly holds that, because the 2019 Protocol calls for the use of pentobarbital unaccompanied by an FDCA-mandated prescription, it must be set aside as contrary to law under the APA. That conclusion alone requires a stay of the pending executions until the government complies. It is the government’s prerogative to execute the Plaintiffs by a method of its choosing. But if it elects a method subject to statutory requirements, the government must then abide by those requirements. The government could choose to execute Plaintiffs by firing squad, for instance, assuming the method remained permissible under the Eighth Amendment. But if a federal statute required that members of a firing squad first be certified marksmen, the government could not execute a death row inmate until it ensured that the members of its firing squad were so certified.

Even if equitable relief is not necessary to pause the upcoming executions, however, it is my view that the district court also erred in denying Plaintiffs an injunction  preventing the government from continuing to violate the FDCA. The district court denied the injunction for want of irreparable harm, and my colleagues affirm. Because I believe that error is of continued importance, I dissent from Part III.B of the opinion.

Judge Rao also wrote separately, concurring in part, concurring in the judgment, and dissenting in part. It begins:

The district court held that the government’s decision to administer pentobarbital for lethal injections without a prescription violates the Federal Food, Drug & Cosmetic Act (“FDCA”) and so is contrary to law under the Administrative Procedure Act (“APA”). The district court also dismissed Plaintiffs’ Eighth Amendment claim for failure to state a claim and granted summary judgment to the government on Plaintiffs’ Federal Death Penalty Act (“Death Penalty Act”) claim. I agree to vacate the district court’s dismissal of the Eighth Amendment claim and affirm the grant of summary judgment on the Death Penalty Act claim. My colleagues conclude that binding circuit precedent mandates the application of the FDCA to drugs administered for capital punishment and order the district court to set aside the Protocol under the APA until the government procures prescriptions for the lethal injection drugs. I disagree that this conclusion is required by our precedent. Moreover, application of the FDCA to drugs used in lethal injections is inconsistent with the statutory text and the Supreme Court’s decision in FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000). In any event, Plaintiffs have no authority to challenge the Food and Drug Administration’s decision not to enforce the FDCA in this context. See Heckler v. Chaney, 470 U.S. 821, 837–38 (1985). Accordingly, I respectfully concur in part, concur in the judgment, and dissent in part.

In addition to concluding that the FDCA does not apply to the use of lethal injection drugs, Judge Rao took issue with the panel’s conclusion that the plaintiffs could even challenge the lawfulness of the protocol under the FDCA.

Even if the FDCA applied in this case, these Plaintiffs cannot challenge the FDA’s nonenforcement decision. As the Court held in Heckler, the “FDA’s decision not to take … enforcement action[]” to prevent the use of drugs intended for use in lethal injection is “not subject to judicial review under the APA.” 470 U.S. at 837–38. The FDCA specifically confers such enforcement authority on the government. See 21 U.S.C. § 337(a) (“[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.”) (emphasis added).  This is not an enforcement proceeding, but it is an attempt by the Plaintiffs to restrain violations of the FDCA. Section 337 gives that authority to the government.

Despite the absence of a private right of action in the FDCA, the district court held that the APA provides a private right of action for agency actions “not in accordance with law” under 5 U.S.C. § 706(2)(A). Mem. Op., Roane v. Barr, No. 19- mc-145, at *5 (D.D.C. Aug. 27, 2020), ECF No. 213. Acknowledging that the FDCA does not contain a private right of action, the district court relied on Chrysler Corp. v. Brown, 441 U.S. 281, 316–18 (1979), to find that the APA could nonetheless supply what the statute lacked: a right to enforce the FDCA’s premarketing, labeling, and prescription requirements against the federal government. Mem. Op. at *5.

The district court’s holding appears to conflict with the Supreme Court’s acknowledgement that an APA action is precluded by federal statutory schemes that foreclose private party enforcement. The APA confers a general cause of action upon persons “adversely affected or aggrieved by agency action within the meaning of a relevant statute,” 5 U.S.C. § 702, but withdraws that cause of action to the extent the relevant statute “preclude[s] judicial review,” id. § 701(a)(1). See Block v. Cmty. Nutrition Inst., 467 U.S. 340, 352–53 (1984) (holding that Congress intended to preclude consumer challenges to milk marketing orders and that such a holding
would not frustrate the statute’s objectives). “Whether and to what extent a particular statute precludes judicial review” is by necessity a fact specific inquiry that turns on the express statutory language, structure, purpose, and history, and the nature of the administrative action involved. Block, 467 U.S. at 345. It is not enough to assume, as the district court did, that the APA can provide the right of action here. Such an assumption is unwarranted under the FDCA, which places enforcement authority exclusively with the government. Cf. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001); Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013) (“Although citizens may petition the FDA to take administrative action … private enforcement of the statute is barred.”). Because enforcement of the FDCA is committed to the government, private litigants cannot sue to enforce its provisions.

It is certainly odd to see a court conclude that the execution protocol is illegal, but can still be used. It almost comes across as an effort to set a circuit precedent without provoking Supreme Court review, but perhaps that’s too cynical a take.

Of note, this is not the first time legal challenges to the federal execution protocol has split the D.C. Circuit in interesting ways. Back in April, another challenge produced four separate opinions from a three-judge panel. Given indications President-elect Biden wishes to end federal executions, however, it may be the last (at least for a while).


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Jonathan H. Adler

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