The Secrecy Behind the Drugs Used to Carry Out the Death Penalty

The sharpest battles over capital punishment today are being fought over the identity of the drugs officials seek to use in lethal injections, how those drugs are manufactured and obtained by executioners, and the obligations state officials have to share material information about the drugs with death-row inmates and the rest of the world. Late Friday, in a case out of Missouri, the Eighth U.S Circuit Court of Appeals rendered the most significant ruling yet to come out of these battles. The result is catastrophic for those who believe the means of capital punishment should generally be as transparent as its ends.

The Missouri case, and many others like it, all stem from the same development in 2011. Early that year, the manufacturers of sodium thiopental, the key ingredient in the lethal "cocktail" states were using, announced they would stop making the drug due to objections about its use for capital punishment.  That prompted state officials to scramble for other drugs and to obtain those drugs in circumstances that raise substantial doubts about the efficacy of the drugs to be used. And that in turn prompted defense attorneys to press for information about exactly what chemicals state officials plan to use to kill their clients.

And that, in turn, has caused state officials to begin to hide, in a way they never have before, the manner in which they are obtaining lethal injection drugs, the identities of the "compounding pharmacies" that are supplying the drugs, and even precisely what is in the drugs officials want to use. Last year in Georgia, for example, state lawmakers, at the request of corrections officials, passed a law that keeps this information secret even from the state's own judiciary. In Texas, meanwhile, state officials announced a few months ago that they would not return to a compounding pharmacy the lethal drugs it had obtained there.

 The issue is not just a semantic one. No execution can be entirely painless, but the Eighth Amendment prohibits "cruel and unusual" punishment, and there now are questions about whether these new injection cocktails cause impermissible suffering on the part of the condemned. In Ohio earlier this month, for example, one of these new cocktails was used on a man named Dennis McGuire, who, according to a journalist who witnessed the execution, "struggled, made guttural noises, gasped for air and choked for about 10 minutes before succumbing to a new, two-drug execution method."

Missouri Breaks

When domestic stores of sodium thiopental started dissipating, the first move Missouri made was to declare that propofol—the same drug that killed Michael Jackson—would be used to execute inmates there. But objections to the use of that drug in executions were even more pronounced than the objections had been to the use of sodium thiopental. The European Union threatened to "forbid or restrict the exportation" of the propofol to the United States (where it is used as an anesthetic in common operations). Last October, Missouri backed down—and backed away from its plans to use propofol.

Plan B, Missouri decided, was to use "an injection of five to 10 grams of pentobarbital" for its executions and to rely upon a compounding pharmacy to provide the drug. Compounding pharmacies are perhaps best known through the years for their ability to skirt federal and state regulations, so much so that President Obama last year signed into federal law a measure designed to properly regulate them. Not only did Missouri plan to use an untested drug on its death-row inmates, then, but to use one manufactured in circumstances that precluded anyone other than state officials to evaluate the drug's quality.

While all this was going on, while state officials were desperately seeking to ensure that executions would continue in Missouri, while Congress was debating whether to regulate compounding pharmacies because of the dubious products often created there, a group of prisoners sentenced to death sued George Lombardi, the director of the Missouri Department of Corrections, seeking basic information about the chemicals that would be used to kill them. In a civil case filed in 2012, they asked for basic information like this:

the identities of (1) the physician who prescribes the chemical used in Missouri executions, (2) the pharmacist who compounds the chemical, and (3) the laboratory that tests the chemical for potency, purity, and sterility.

In early December 2013, a federal trial judge granted the plaintiffs' discovery request, ordering Lombardi to provide to lawyers for the condemned men only some information about the drug, its pharmacist, and the lab in which its made, to allow the condemned men to fully evaluate the efficacy of the drugs to be used against them. The director immediately sought help from the Eighth Circuit, asking the appeals court both to stay the trial judge's discovery order and to protect state officials from ever having to disclose, even in private to lawyers, material information about the pentobarbital that is to be injected into their clients.

Two weeks later, on December 27th, a panel of Eighth Circuit judges issued a split ruling. Director Lombardi didn't have to disclose "the identity of the prescribing physician" for the pentobarbital but did have to disclose, again to a limited number of people, "the identities of the compounding pharmacy and the testing laboratory." But again this was not a compromise in which Lombardi was at all interested. He asked the entire Eighth Circuit, on an emergency basis, to overrule itself.  The Eighth Circuit agreed to reconsider the matter and issued a ruling late Friday (here is the link) with profound ramifications in death penalty law.

The folks at St. Louis Public Radio have done excellent work reporting on this story. Here's the latest from the station, posted Saturday night, offering important context and perspective on what's happening here:

The quality of compounded drugs, unlike manufactured drugs, varies from batch to batch. Inspections by the Missouri Board of Pharmacy have found that about one out of every five drugs made by compounding pharmacies fails to meet standards. Lawyers representing death-row inmates argue that the identity is important, so they can find out if the pharmacy has been cited for shoddy practices or is even properly licensed.

The state has offered reassurances that the drug is pure and potent by having a testing lab examine it. However, the testing lab is a controversial one. Analytical Research Laboratories (ARL),  in Oklahoma City, OK, approved a batch of steroids for commercial use that ended up killing dozens in 2012. The deaths sparked debate over the regulatory practices for compounding pharmacies, which aren't regulated by the Food and Drug Administration like drug manufacturers are.

The inmate's pharmacy expert also points out the lab report found an unknown substance in the drug, but the lab still approved it.

The Eighth Circuit's Ruling

The majority ruling in In Re Lombardi sets precedent that is terrible from a First Amendment perspective, an Eighth Amendment perspective, and from a general view of due process in capital cases. It is "chilling," in the words of one death penalty expert I spoke with over the weekend. Seven judges ruled entirely in favor of Director Lombardi, reversing even the limited discovery plan that the Eighth Circuit panel had endorsed just one month ago. But it was the circular analysis the judges employed, and the potential application of it to future death penalty cases, that is most alarming here. The essence of the ruling is here:

The plaintiffs complain that Missouri’s use of compounded pentobarbital in its execution protocol creates a substantial risk of severe pain or an objectively intolerable risk of severe pain, and thus constitutes cruel and unusual punishment in violation of the Eighth Amendment. In furtherance of that claim, they seek to investigate the physician, pharmacy, and laboratory involved in the execution process.

But the plaintiffs do not allege that the risk of harm arising from the State’s current lethal-injection protocol is substantial when compared to known and available alternatives. They do not allege that a different lethal-injection protocol, or a different method of execution (e.g., lethal gas, electrocution, or firing squad), is more humane.

In denying a motion to dismiss the original complaint, and thus allowing discovery to proceed, the district court ruled that “Plaintiffs are not required to propose an alternative method of execution as an element of their Eighth Amendment claim.” R. Doc. 31, at 7.

In our view, this is a plain misreading of the Supreme Court’s decision in Baze v. Rees and the Eighth Amendment. Where, as here, there is no assertion that the State acts purposefully to inflict unnecessary pain in the execution process, the Supreme Court recognized only a limited right under the Eighth Amendment to require a State to change from one feasible method of execution to another.

The controlling opinion of the Chief Justice in Baze provides that if a State refuses to adopt a readily available alternative method of execution that would significantly reduce a substantial risk of severe pain, then “a State’s refusal to change its method can be viewed as ‘cruel and unusual’ under the Eighth Amendment.” 553 U.S. at 52 (plurality opinion) (emphasis added).

In sum: “A stay of execution may not be granted on grounds such as those asserted here unless the condemned prisoner establishes that the State’s lethal injection protocol creates a demonstrated risk of severe pain. He must show that the risk is substantial when compared to the known and available alternatives.” Id. at 61 (emphasis added).

Ponder that for a moment, for it is truly an extraordinary interpretation of the law. Instead of permitting condemned prisoners to learn more about the drug to be used to kill them, so they could determine whether its use might constitute "cruel and unusual" punishment, this court found instead that these death-row inmates have the burden of proving at the outset of the litigation that Missouri's use of pentobarbital is the worst of all "known and available alternatives." The rationale of this ruling could forever preclude any capital defendant from ever inquiring about anything related to the drugs a state chooses to use against him. 

The Dissent

Three judges of the Eighth Circuit dissented from this dubious view. They wrote:

Next, the majority elects to adopt a reading of Baze which places an absurd burden on death row inmates. The pleading standard advanced by the majority would require the prisoners to identify for the Director a readily available alternative method for their own executions. Now, any individual wishing to challenge a state's execution method as unconstitutional must identify a readily available alternative method for their own deaths before any discovery has been conducted to survive a Rule 12(b)(6) motion to dismiss.

The challenge of proposing a readily available alternative method seems nearly impossible if the prisoners are denied discovery and, thus, unable to ascertain even basic information about the current protocol. The proposition that a plaintiff must propose an alternative method for his own execution in order to state a claim for relief under the Eighth Amendment is unreasonable.

Assuming, for the sake of argument, the dicta in Chief Justice Roberts' plurality opinion in Baze is the new pleading standard, the prisoners have still sufficiently alleged a claim under the Eighth Amendment. The prisoners seek an alternative protocol to Missouri's current method of producing and testing compounded pentobarbital. They desire a method which ensures the chemical composition, purity, efficacy, and safety of compounded pentobarbital. The prisoners have never argued properly compounded and tested pentobarbital would not be an alternative method.

Instead, the prisoners' argument is the use of a compounded substance purported to resemble pentobarbital, acquired from a non-traditional, non-FDA-approved compounding pharmacy which likely lacks the ability to test chemicals for identity, potency, purity, and contamination, is what violates the Eighth Amendment. It is clear the readily available alternative method here is one which guarantees the chemicals used in Missouri's executions do not cause "serious illness and needless suffering" and "give rise to 'sufficiently imminent dangers.'" Baze, 553 U.S. at 50.

Confused about which set of judges you should believe? Do yourself a favor and read Baze v. Rees yourself so you can decide whether the justices in Washington intended the result we see here in Missouri. Indeed, Friday's ruling cries out for review and reversal by the Supreme Court before another court in another state adopts the dubious reasoning applied by the majority here. Whatever else the protections of the first amendment and the eighth amendment mean, they mean a person who is about to be executed has a right to know precisely how and with what ingredients the state intends to kill him.

Postscript 

In Missouri, in Oklahoma, in Texas, in Ohio, in Louisiana, wherever state officials ardently seek to impose capital punishment the story since 2011 has been the same. Bureaucrats know they have been forced to use dicier, less efficient drugs for these executions in the absence of sodium thiopental. They understand that the means by which they are obtaining these drugs, if not outright shady, does not come close to ensuring a level of transparency and independent review that both the medical community, and the legal community, see all the time in the ordinary course of business.

In response to these concerns these officials have not made the process of capital punishment more transparent or made themselves more accountable for the lethal drugs they seek to use in our name. They have not candidly acknowledged the legitimate questions that surround the use of and products from these compounding pharmacies. They've headed instead in precisely the opposite direction. They have sought to increase secrecy over the drugs they want to use. And they have sought to demonize critics instead of responding substantively to the criticism surrounding compounded chemicals.

What does the Eighth Circuit ruling really mean? It means that no independent mind will evaluate the drugs to be used in upcoming Missouri executions. It means there will be no evidentiary hearing into the qualifications of the testing lab that reportedly tested the compounding pharmacy's pentobarbital already used in two executions in Missouri. It means that executives at Analytic Research Laboratories will not have to answer questions before the execution of another Missouri prisoner, a man named Herbert Smulls, who is scheduled to be injected with pentobarbital sometime after midnight this coming Wednesday.

It means that Smull's lawyers won't be able to inquire, for example, into what appears to be hundreds of lawsuits that have been filed against this lab over the years or precisely what it's role was in all those meningitis deaths in New England a few years ago. It means that the federal judiciary, which ultimately is responsible for the fair and just administration of the nation's death penalty, will not evaluate what one expert for the inmates described as the "numerous deficiencies and failures of ARL as chronicled by the Food and Drug Administration." It means, in other words, that we are seeing here a nearly complete abdication of the judiciary's role to ensure that capital punishment is neither arbitrary nor capricious.