Introduction

In June 1Open this footnote Close this footnote 1 See Description of Death Penalty Cases Heard by the Supreme Court in the 2014-2015 Term, Death Penalty Info. Ctr., http://www.deathpenaltyinfo.org/united-states-supreme-court-decisions-2014-2015-term (last visited Mar. 17, 2015) (“Glossip will be argued in April and likely decided by the end of June.”). …Open this footnote Close the U.S. Supreme Court will decide Glossip v. Gross, a challenge to Oklahoma’s lethal-injection protocol brought by three death row inmates. 2Open this footnote Close this footnote 2 Glossip v. Gross, No. 14-7955 (U.S. argued Apr. 29, 2015). …Open this footnote Close The inmates argue that the protocol’s first drug, midazolam, violates the Eighth Amendment’s prohibition against cruel and unusual punishment because it does not reliably induce unconsciousness. Midazolam’s inadequacy, they claim, could result in “severe pain” during the protocol’s death-inducing phase. 3Open this footnote Close this footnote 3 Warner v. Gross, 776 F.3d 721, 727 (10th Cir. 2015) (quoting Record, Vol. 1, at 963) (internal quotation mark omitted), cert. granted, 135 S. Ct. 1173 (2015). …Open this footnote Close Most relevantly midazolam is not FDA approved as a stand-alone anesthetic, 4Open this footnote Close this footnote 4 See Roche Pharm., Package Insert for Versed (dated 1999), available at http://www.fda.gov/ohrms/dockets/dailys/01/Mar01/03-
2101/cp00001_exhibit_02.pdf (listing midazolam’s FDA-approved use as “induction of general anesthesia, before administration of other anesthetic agents”). Midazolam, trade name Versed, is the only anesthetic in the le-thal injection protocol in Glossip. …Open this footnote Close meaning its use in lethal injections is “off-label.” I argue that off-label drug use in lethal injections raises significant Eighth Amendment questions and that the Court should invalidate the protocol at issue in Glossip because of its lack of FDA approval. Although courts are increasingly recognizing the constitutional significance of off-label use in landmark cases like United States v. Caronia, 5Open this footnote Close this footnote 5 703 F.3d 149, 168-69 (2d Cir. 2012) (holding that a ban on marketing of off-label uses of drugs violated the First Amendment). …Open this footnote Close they have yet to analyze off-label use in the Eighth Amendment context. Instead, courts traditionally review the use of off-label execution drugs under statutory standards. 6Open this footnote Close this footnote 6 See, e.g., Cook v. FDA, 733 F.3d 1, 7-11 (D.C. Cir. 2013) (reviewing importation of drugs for off-label use in executions under the Food, Drug, and Cosmetic Act and the Administrative Procedure Act). …Open this footnote Close

Although the Glossip petitioners highlight the lack of FDA approval, 7Open this footnote Close this footnote 7 Brief for Petitioners at 13, Glossip v. Gross, No. 14-7955 (U.S. argued Apr. 29, 2015), 2015 WL 1045426 (“[M]idazolam is neither approved by FDA for use as, nor used as, the sole drug to maintain general anesthesia . . . .”). …Open this footnote Close it is a superficial component of their claim. They focus on midazolam’s pharmacology 8Open this footnote Close this footnote 8 Id. at 26 (“Midazolam’s pharmacological properties . . . mean that it cannot create deep comalike unconsciousness.”). …Open this footnote Close and the medical consensus surrounding its use, 9Open this footnote Close this footnote 9 Id. (“The medical consensus is that midazolam cannot generate deep, comalike un-consciousness.”). …Open this footnote Close and they do not directly discuss the constitutional implications of off-label use. I elaborate this underdeveloped but consequential facet of their claim in three parts. In Part I, I will examine the medical context of midazolam’s off-label use. In Part II, I will situate Glossip in the Court’s Eighth Amendment lethal injection jurisprudence. Finally, I will conclude that midazolam’s lack of FDA approval should carry great weight in the Court’s ruling on the constitutionality of Oklahoma’s protocol, and in the fate of lethal injection across the nation.

I. The Medical Landscape

Oklahoma turned to midazolam for its executions in April 2014 after manufacturers of the anesthetics it had previously employed cut off access because of objections to its use in this context. 10Open this footnote Close this footnote 10 See Brady Dennis & Lena H. Sun, For More States, Execution Means Improvisation as Drug Supplies Dwindle, Wash. Post (Apr. 30, 2014), http://wapo.st/1rH897r. …Open this footnote Close Midazolam is FDA approved for use as an anesthetic only in combination with other anesthetic agents. 11Open this footnote Close this footnote 11 See Roche Pharm., supra note 4. …Open this footnote Close When it is the only drug administered to induce anesthesia, such as in Glossip, it is being used for a non-FDA-approved purpose, a practice known as “off-label” use. 12Open this footnote Close this footnote 12 See “Off-Label” and Investigational Use of Marketed Drugs, Biologics, and Medical Devices—Information Sheet, U.S. Food & Drug Admin., http://www.fda.gov/RegulatoryInformation/Guidances/ucm126486.htm (last updated June 25, 2014). …Open this footnote Close Although off-label use of prescription drugs is legal 13Open this footnote Close this footnote 13 See Jerry Avorn & Aaron Kesselheim, Editorial, A Hemorrhage of Off-Label Use, 154 Annals Internal Med. 566, 567 (2011) (“[O]ff-label prescribing by physicians is not illegal . . . .”). …Open this footnote Close and frequent, 14Open this footnote Close this footnote 14 See, e.g., U.S. Gov’t Accountability Office, GAO-08-835, Prescription Drugs: FDA’s Oversight of the Promotion of Drugs for Off-Label Uses 2 (2008), available at http://www.gao.gov/assets/280/278832.pdf. …Open this footnote Close it lacks critical safeguards. For one, a drug’s prescribing information only contains instructions for FDA-approved uses. These instructions are based on rigorous clinical trials, but by definition these investigations do not cover off-label uses. 15Open this footnote Close this footnote 15 See Unapproved Prescription Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval, U.S. Food & Drug Admin., http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/enforcementactivitiesbyfda/selectedenforcementactionsonunapproveddrugs/default.htm (last updated Dec. 3, 2014) (explaining that FDA’s process ensures that physicians have enough information to under-stand a drug’s risks and how to use it properly). …Open this footnote Close Moreover, off-label use is often not supported by evidence. 16Open this footnote Close this footnote 16 See, e.g., Nicole Ansani et al., United States Medical Practice Summary: Innovative Off-Label Medication Use, 21 Am. J. Med. Quality 246, 250 (2006) (finding that off-label use often occurs with “limited data support” and “potentially unfavorable risk-to-benefit ratios”). …Open this footnote Close Although a few organizations analyze off-label uses, 17Open this footnote Close this footnote 17 One example of such an organization is Truven Health Analytics. See Truven Health Analytics, Micromedex Drugdex (2013), available at http://micromedex.com/Portals/1/Assets/Brochures/International/INTL_12342_0613_INTL%20Drugdex_Web1.pdf. …Open this footnote Close these reviews can be inferior to the FDA’s approval process because studies of off-label uses of drugs often involve far fewer clinical participants and less detailed outcome analyses. 18Open this footnote Close this footnote 18 See, e.g., Rebecca Dresser & Joel Frader, Off-Label Prescribing: A Call for Heightened Professional and Government Oversight, 37 J.L. Med. & Ethics 476, 479 (2009) (referring to such reviews as “not as rigorous as FDA review”). …Open this footnote Close This lack of evidence is consequential because it raises the risk of harm. 19Open this footnote Close this footnote 19 See id. at 476 (“The potential for harm is greatest when an off-label use lacks a solid evidentiary basis.”). …Open this footnote Close Physicians who prescribe off-label cannot consistently rely on FDA guidance or prior investigations to proactively identify and avoid negative outcomes.

The risks that attach to off-label use apply with particular force in the lethal injection context. The limited data on the off-label use of midazolam in that context suggest that it is associated with a grave risk—botched executions. 20Open this footnote Close this footnote 20 See, e.g., Adam Liptak & Erik Eckholm, Justices to Hear Case over Drugs Used in Executions, N.Y. Times (Jan. 23, 2015), (“Oklahoma botched the execution of Clayton D. Lockett . . . . Midazolam was also involved in prolonged, possibly painful executions last year in Ohio and Arizona.”). …Open this footnote Close The broader data on midazolam support this negative assessment. Studies have found that it is not an effective surgical anesthetic. 21Open this footnote Close this footnote 21 See, e.g., T.G. Short et al., Hypnotic and Anaesthetic Action of Thiopentone and Midazolam Alone and in Combination, 66 Brit. J. Anaesthesia 13, 17-18 (1991) (“[W]e were unable to demonstrate any anaesthetic action by midazo-lam . . . .”). …Open this footnote Close In fact, research has shown that administering midazolam can have a “paradoxical” effect in certain patients, leading to agitation and restlessness. 22Open this footnote Close this footnote 22 See, e.g., Luciano Santana Cabrera et al., Paradoxical Reaction to Midazolam Reversed with Flumazenil, 3 J. Emergencies Trauma & Shock 307, 307 (2010), available at http://www.onlinejets.org/text.asp?2010/3/3/307/66551. …Open this footnote Close

In addition, use of non-FDA-approved drugs in executions violates the enabling premise of off-label use—deference to the practice of medicine. 23Open this footnote Close this footnote 23 See, e.g., Philip M. Rosoff & Doriane Lambelet Coleman, The Case for Legal Regulation of Physicians’ Off–Label Prescribing, 86 Notre Dame L. Rev. 649, 659 (2011). …Open this footnote Close Off-label use rests on the implicit assumption that medical judgment is sufficiently risk mitigating, 24Open this footnote Close this footnote 24 See id. …Open this footnote Close but this protection is absent in the Glossip context. Oklahoma’s death penalty statute only requires that a physician pronounce death, not perform the execution. 25Open this footnote Close this footnote 25 See Okla. Stat. Ann. tit. 22, § 1014(A) (West 2011). …Open this footnote Close Similarly, the Oklahoma Department of Corrections does not require physician participation. 26Open this footnote Close this footnote 26 See Okla. Dep’t Corr., OP-040301, Execution of Offenders Sentenced to Death 7–8 (2014), available at http://www.ok.gov/doc/documents/op040301.pdf. …Open this footnote Close Indeed, one of Oklahoma’s botched midazolam executions was believed to be in part the result of inadequate medical expert support. 27Open this footnote Close this footnote 27 See Tara Culp-Ressler, Why There Weren’t Any Doctors to Prevent Oklahoma’s Botched Execution, ThinkProgress (Apr. 30, 2014, 9:05 AM), http://thinkprogress.org/ health/2014/04/30/3432495/oklahoma-execution-doctors. …Open this footnote Close Oklahoma would find it difficult to increase medical involvement; the physicians with the expertise most relevant to the administration of midazolam—anesthesiologists—face severe penalties for participation in executions. 28Open this footnote Close this footnote 28 See Rob Stein, Group to Censure Physicians Who Play Role in Lethal Injections, Wash. Post (May 2, 2010), http://www.washingtonpost.com/wp-dyn/content/article/2010/05/01/AR2010050103190.html. …Open this footnote Close The American Board of Anesthesiologists will revoke the certification of an anesthesiologist who participates in an execution, 29Open this footnote Close this footnote 29 Commentary, J. Jeffrey Andrews, Sec’y, Am. Bd. Anesthesiology, Anesthesiologists and Capital Punishment (May 2014), available at http://www.theaba.org/pdf/Capital PunishmentCommentary. …Open this footnote Close a penalty that can cause physicians to lose hospital practice privileges. 30Open this footnote Close this footnote 30 See, e.g., Stein, supra note 28 (“The loss of certification would prevent an anesthesiologist from working in most hospitals.”). …Open this footnote Close In addition, the American Medical Association, 31Open this footnote Close this footnote 31 Am. Med. Ass’n, Code of Medical Ethics, Op. 2.06—Capital Punishment (2000), available at http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion206.page?. …Open this footnote Close American Nurses Association, 32Open this footnote Close this footnote 32 Am. Nurses Ass’n, Position Statement: Nurses’ Role in Capital Punishment 1 (2010), available at http://www.nursingworld.org/MainMenuCategories/EthicsStandards/Ethics-Position-Statements/prtetcptl14447.pdf. …Open this footnote Close National Association of Emergency Medical Technicians, 33Open this footnote Close this footnote 33 Nat’l Ass’n Emergency Med. Technicians, Position Statement: EMT and Paramedic Participation in Capital Punishment (2010), available at http://www.naemt.org/docs/default-source/Advocacy-Documents/1-26-10_EMT_or_Paramedic_Participation_in_Capital_Punishment.pdf. …Open this footnote Close and American Public Health Association 34Open this footnote Close this footnote 34 Am. Pub. Health Ass’n, Participation of Health Professionals in Capital Punishment, Policy No. 8521 (1985), available at https://www.apha.org/policies-and-advocacy/public-health-policy-statements/policy-database/2014/07/08/18/10/participation-of-health-professionals-in-capital-punishment. …Open this footnote Close have all issued admonitions against their members’ involvement. This lack of medical expertise heightens the already serious risk of harm associated with Oklahoma’s use of an off-label drug in its protocol.

II. The Legal Landscape

The Glossip petitioners are facing substantial legal hurdles. The Supreme Court has never before invalidated a method of execution, 35Open this footnote Close this footnote 35 Baze v. Rees, 553 U.S. 35, 48 (2008). …Open this footnote Close and courts have not fully addressed the Eighth Amendment implications of off-label drug use in executions. However, the inmates’ chances of success will increase if the Court applies the Baze v. Rees standard 36Open this footnote Close this footnote 36 See id. at 48, 61-62. …Open this footnote Close and recognizes the centrality of the off-label component of the lethal injection protocol at issue in Glossip. In Baze, death-row inmates challenged Kentucky’s three-drug lethal injection protocol on the ground that the risk of misadministration of the first drug, a different drug than midazolam, constituted cruel and unusual punishment. The inmates claimed that the complexity of the intravenous procedure, in combination with the inadequate qualifications of the administering personnel, 37Open this footnote Close this footnote 37 Id. at 54 (“Petitioners contend that there is a risk of improper administration of thiopental because the doses are difficult to mix into solution form and load into syringes . . . [and] because of inadequate facilities and training . . . .”). …Open this footnote Close created a “significant risk that the procedures w[ould] not be properly followed.” 38Open this footnote Close this footnote 38 Id. at 49. …Open this footnote Close The Baze inmates conceded that a properly administered anesthetic and protocol would result in a constitutional and “humane death.” 39Open this footnote Close this footnote 39 Id. at 41. …Open this footnote Close

The Court rejected the Baze petitioners’ challenge and established a two-part test for assessing the constitutionality of a lethal injection protocol. 40Open this footnote Close this footnote 40 The Baze test is widely regarded as ill-defined. See, e.g., Deborah W. Denno, Lethal Injection Chaos Post–Baze, 102 Geo. L.J. 1331, 1335 (2014) (referring to the Baze standard as “vague and diffuse”). Nonetheless, these two factors form the core of the Baze test. …Open this footnote Close The test instructs courts to consider whether a protocol is “objectively intolerable” 41Open this footnote Close this footnote 41 Baze, 553 U.S. at 53 (“[I]t is difficult to regard a practice as ‘objectively intolerable’ when it is in fact widely tolerated.”). …Open this footnote Close and involves a “substantial risk of serious harm.” 42Open this footnote Close this footnote 42 Id. (“It is uncontested that, failing a proper dose of sodium thiopental that would render the prisoner unconscious, there is a substantial, constitutionally unacceptable risk of suffocation . . . and pain . . . .”). …Open this footnote Close The protocol at issue in Glossip likely satisfies both prongs. The Baze determination of whether the use of a drug in executions is “objectively intolerable” turns on frequency of use; a drug is less likely to be “objectively intolerable” if many states use it in their protocols. 43Open this footnote Close this footnote 43 Id. …Open this footnote Close Only four of the thirty-two death penalty states use midazolam as part of their official execution protocols, 44Open this footnote Close this footnote 44 See State by State Lethal Injection, Death Penalty Info. Ctr., http://www.deathpenaltyinfo.org/state-lethal-injection (last visited Mar. 21, 2015). …Open this footnote Close and at least one state has postponed further executions because it does not want to use midazolam. 45Open this footnote Close this footnote 45 See, e.g., Mark Berman, Ohio Drops Controversial Lethal Injection Drug, Postpones Upcoming Execution, Wash. Post (Jan. 9, 2015), http://wapo.st/1Iz6HMV. …Open this footnote Close This widespread distaste paints Oklahoma’s use of midazolam as intolerable, meeting the first prong of the Baze test.

Off-label use bears more directly on Baze’s second prong, a “substantial risk of serious harm.” The Court divides this standard into two factors: the inevitability and level of pain. According to the Court, accidental pain in an execution is not unconstitutional because missteps are inevitable even in humane procedures. 46Open this footnote Close this footnote 46 Baze, 553 U.S. at 50. …Open this footnote Close Yet the Court will find intentionality where missteps and accidents happen repeatedly. 47Open this footnote Close this footnote 47 Id. (differentiating an “innocent misadventure” from an “objectively intolerable risk” by example, characterizing a series of failed electrocution attempts as intentional and unconstitutional harm). …Open this footnote Close The Court denied the Baze petitioners’ claim precisely because it attacked infrequent accidental misadministration rather than recurring problems. 48Open this footnote Close this footnote 48 See id. at 41, 50. …Open this footnote Close Glossip’s off-label use, in contrast, is not one-off or accidental. Midazolam is a sanctioned feature of Oklahoma’s protocol, 49Open this footnote Close this footnote 49 See Brief for Respondents at 1, Glossip v. Gross, No. 14-7955 (U.S. argued Apr. 29, 2015), 2015 WL 1619433. …Open this footnote Close implemented intentionally in response to shortages of anesthetic drugs. 50Open this footnote Close this footnote 50 See, e.g., Warren Richey, Death Penalty Case: Oklahoma Lethal Injection Drug Faces Supreme Court Test, Christian Sci. Monitor (Apr. 28, 2015), http://m.csmonitor.com/USA/Justice/2015/0428/Death-penalty-case-Oklahoma-lethal-injection-drug-faces-Supreme-Court-test-video. …Open this footnote Close Moreover, Oklahoma continues to use midazolam despite recurring problems with its administration in executions; even if an individual incident could be viewed as “accidental,” the pattern of harm raises an inference of intentionality. Thus the Glossip petitioners’ challenge should succeed where the Baze petitioners failed.

Oklahoma could argue that its use of off-label midazolam is accidental. According to this line of reasoning, Oklahoma did not start using midazolam by intentional design. Forces beyond its control (drug shortages) forced it to substitute its FDA-approved anesthetic of choice for an off-label product. Justice Thomas may find this argument persuasive. In his Baze concurrence, he claims that the standard requires a “deliberate[] design[] to inflict pain.” 51Open this footnote Close this footnote 51 Baze, 553 U.S. at 94 (Thomas, J., concurring in the judgment). …Open this footnote Close Although Baze provides only limited guidance as to what constitutes an “accident” under the Eighth Amendment, the detail it does provide cuts against Thomas’s reading, which is not precedent. Rather, repeated implementation of lethal injection practices that disregard serious risks and poor outcomes, irrespective of any design to injure, is the authoritative standard. Glossip meets this benchmark.

Under the second prong of this part of the Baze test, the risk of pain must transcend the suffering inherent in execution in order to generate constitutional concerns. 52Open this footnote Close this footnote 52 Id. at 47 (majority opinion). …Open this footnote Close According to Baze, prolonged death is a strong indication that a protocol has breached the constitutionally permissible level of risk. 53Open this footnote Close this footnote 53 Id. at 49 (“Punishments are cruel when they involve torture or a lingering death . . . .” (quoting In re Kemmler, 136 U.S. 436, 447 (1890)) (internal quotation mark omitted)). …Open this footnote Close Oklahoma’s off-label use of midazolam meets this criterion not only because of documented prolonged deaths in midazolam executions, 54Open this footnote Close this footnote 54 See, e.g., Michael L. Radelet, Examples of Post–Furman Botched Executions, Death Penalty Info. Ctr., http://www.deathpenaltyinfo.org/some-examples-post-furman-botched-executions (last updated July 24, 2014) (“Mr. Lockett died 43 minutes after the execution began . . . .”). …Open this footnote Close but also because of the elevated risk of harm resulting from the inadequate medical evidence 55Open this footnote Close this footnote 55 See, e.g., Ansani, supra note 16. …Open this footnote Close that attends off-label use. Defenders of off-label executions may argue that there is no rigorous evidence that midazolam is inherently harmful, and that a handful of unsightly executions cannot serve as empirically sound data. They might also characterize the evidence that midazolam does not perform well as an anesthetic in the surgical context as inapposite to lethal injection. These arguments, however, ignore the fact that Baze does not require scientific certitude; it only requires a substantial risk. 56Open this footnote Close this footnote 56 Baze, 553 U.S. at 50. …Open this footnote Close This risk is present in Glossip because of the absence of medical evidence and guidance.

Another constitutionally relevant consequence of midazolam’s off-label use is the lack of prescribing instructions. The Baze Court itself emphasized the Eighth Amendment significance of FDA-approved label instructions, characterizing them as a bulwark against harm. 57Open this footnote Close this footnote 57 Id. at 54 (“[I]f the manufacturers’ instructions . . . are followed, . . . there would be minimal risk . . . .” (third alteration in original) (quoting Joint Appendix at 761, Baze, 553 U.S. 35 (No. 07-5439)) (internal quotation mark omitted)). …Open this footnote Close And although Baze upheld a three-drug protocol much like the one at issue in Glossip, the Baze protocol specified the use of sodium thiopental for anesthesia, which, unlike midazolam, is FDA approved as a self-standing anesthetic and has label instructions for that purpose. 58Open this footnote Close this footnote 58 Thiopental Sodium, DailyMed, https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=48745 (last visited Apr. 28, 2015) (indicating use “as the sole anesthetic agent for brief . . . procedures”). …Open this footnote Close Thus Glossip stands apart from Baze on the crucial questions of level of risk as well as inevitability, and these distinctions call for a different outcome in Glossip.

Conclusion: Unconstitutionality of Off-Label Drug Executions

Oklahoma was the first state to use lethal injections. 59Open this footnote Close this footnote 59 Vince Beiser, A Guilty Man, Mother Jones (Sept. 1, 2005, 3:00 AM), http://www.motherjones.com/politics/2005/09/guilty-man. …Open this footnote Close Its off-label use of midazolam is grounds for making it the first state to have its method of execution declared unconstitutional, with other states positioned to fall in its wake. The controversy at the core of Glossip is not unique to Oklahoma; other states have turned to off-label drugs because of drug shortages. 60Open this footnote Close this footnote 60 See, e.g., Lacking Lethal Injection Drugs, States Find Untested Backups, NPR (Oct. 26, 2013, 5:19 PM ET), http://n.pr/17QrAkE. …Open this footnote Close The Eighth Amendment prohibits a “substantial risk of serious harm,” 61Open this footnote Close this footnote 61 Baze, 553 U.S. at 50 (quoting Farmer v. Brennan, 511 U.S. 825, 842 (1994) (internal quotation marks omitted)). …Open this footnote Close and midazolam and other off-label drugs run afoul of this requirement. Off-label use entails increased risks because of inadequate evidentiary bases and the absence of label instructions. In Glossip’s death penalty context, with glaring gaps in medical professional involvement and clinical data, these risks reach “substantial” proportions. The FDA’s silence on midazolam’s use as a stand-alone anesthetic speaks volumes, and the Court should listen.

Recognition of the Eighth Amendment implications of off-label use could position Glossip as the death knell for lethal injection. And even if the Court upholds Oklahoma’s protocol, the demise of lethal injections may still be on the horizon. Denial of the inmates’ claim would in effect sanction the use of non-FDA-approved drugs. In all likelihood, upholding the Oklahoma protocol would trigger wider off-label use, implementation of executions previously suspended because of a hesitancy to use unapproved drugs, 62Open this footnote Close this footnote 62 See, e.g., Denno, supra note 40, at 1336. …Open this footnote Close and more botched executions. This chain of events could culminate in increased awareness of the risk of pain involved in lethal injection using off-label drugs and could foster pressure for abolition. 63Open this footnote Close this footnote 63 See Wade Goodwyn, Botched Lethal Injection Executions Reignite Death Penalty Debate, NPR (Jan. 6, 2015, 5:45 PM ET), http://n.pr/1wSjmDU (arguing that botched executions increase opposition to lethal injection because “[a] clean and painless death by injection has played a major role in preserving capital punishment”). …Open this footnote Close Irrespective of the Court’s decision in Glossip, drug shortages and increasing reliance on off-label drugs is driving lethal injection into troubled constitutional waters.

Many thanks to Dr. Aaron Kesselheim of Harvard Medical School/Brigham and Women’s Hospital for his invaluable guidance and to the editors of the Stanford Law Review for their excellent editorial support.