Guerrilla War Against the Eighth Amendment: The Supreme Court Battles Over Off-Label Drug Lethal Injections

By Rose Carmen Goldberg*

A series of botched executions over the past several years has engendered increasing criticism of lethal injection. These high-profile miscarriages have involved prolonged visible suffering, including violent spasms and outcries about intolerable pain. Death row inmates are turning to courts for protection from painful deaths like these.

Last month the Supreme Court heard oral arguments in its first lethal injection case since 2008, Glossip v. Gross. The challenge, originally brought by four death row inmates, claims that Oklahoma’s lethal injection protocol is unconstitutional. Specifically, the inmates argue that the use of a drug called midazolam violates the Eighth Amendment’s prohibition against cruel and unusual punishment because it is not an effective anesthetic.

In a recent essay in Stanford Law Review Online, I took the inmates’ line of reasoning further. I argued that the use of non–FDA-approved drugs, a practice known as “off-label” use, in lethal injection violates the Eighth Amendment because it constitutes a substantial risk of serious harm, and the Court should invalidate any lethal injection protocol that involves off-label use. Use of non–FDA-approved drugs is not supported by official label instructions or the rigorous clinical trial evidence that underlies FDA’s approval processes.

At several points the oral arguments in Glossip honed in on the fact that midazolam’s use as an anesthetic in Oklahoma’s protocol is off-label. For instance, Justices Kagan and Sotomayor lambasted Oklahoma’s counsel for mischaracterizing midazolam as FDA-approved for use as the sole drug to induce sustained anesthesia. This focus suggests that FDA approval might be a key factor in several Justices’ decisions in the Court’s ruling on Glossip in June. This recognition of off-label use as having potential constitutional heft could also extend to larger debates about lethal injection, as many states encounter increasingly severe lethal injection drug shortages and turn to non–FDA-approved drugs.

Yet overall, the Glossip oral arguments did not reveal a consensus about the constitutional implications of off-label use, or even the appropriate Eighth Amendment standard of review. Justices Breyer, Kagan, and Sotomayor’s questions suggest that they believe that although the precise level of risk of pain might be unclear in part because of the lack of medical research on anesthesia in executions, this uncertainty itself violates the Eighth Amendment.

Justices Alito and Scalia, on the other hand, blamed death penalty “abolitionists” for the uncertainty, characterizing them as aggressive lobbyists and holding them responsible for the shortages of FDA-approved drugs that have driven states to risky off-label use. Justice Alito chafed at the idea of these advocates’ actions determining a constitutional holding, and exhorted the Court not to “countenance what amounts to a guerilla war against the death penalty.”

The Court’s decision in June will likely turn on this divided interpretation of how the Eighth Amendment applies to medical uncertainty, like that attendant off-label drug use in executions. One camp will probably follow the reasoning suggested by Justice Alito’s questions and find that the Eighth Amendment is not offended by un-quantified risks, only by measurable threats. The other contingent might, like Justice Kagan, consider the ethical barriers to robust study of off-label anesthetics in executions and find that the Eighth Amendment does not demand certainty where it is not possible.

Regardless of which side controls the June ruling, the Justices’ battle over off-label use in the oral arguments in Glossip gives visibility to the weight that courts should allot to FDA approval in their Eighth Amendment calculus. As a result, future wars over the constitutionality of lethal injection are more likely to be waged on this front.

* Rose Carmen Goldberg holds a J.D. from Yale Law School and an M.P.A from Columbia University.

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