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The End of the Open Market for Lethal-Injection Drugs

Updated: Dec 29, 2020

The New Yorker


By Lincoln Caplan (to read source article, click here)

May 21, 2016

Last week, the global drug company Pfizer announced sweeping new restrictions on the distribution of seven of its products, preventing them from being used to carry out the death penalty. Pfizer came into possession of those products, which include sedatives, paralytics, a pain medication, and a drug used to prevent or treat low levels of potassium in the blood, when it acquired the pharmaceutical company Hospira, in September. Its decision is an enormously significant one for the death penalty in the United States, and ends a long and chaotic chapter in which governments, drug companies, and activists worldwide have gradually closed the open market for the federally approved drugs that have been used for lethal injections.

“Manufacturers never wanted their medicines to be used to end the lives of prisoners,” Maya Foa, the director of the death-penalty team at Reprieve, an international human-rights organization, told me. Foa advised Hospira and other pharmaceutical manufacturers on ways they could protect their products from being misused in the death penalty. “Their business is in making medicines to save and improve the lives of patients. The last thing they want is for the medicines they promote as lifesaving to be used in lethal-injection executions.”

When Oklahoma adopted a three-drug protocol for lethal injection, in 1977, leading the way for other states, capital punishment took on the appearance of a medical procedure. The first drug induces unconsciousness, the second drug causes paralysis and halts breathing, and the third stops the heart. Lethal injection was said to be humane, at least compared with the other methods used during this period: electrocution, which entails smoke and burning flesh, and has sometimes caused the person being electrocuted to catch fire; the gas chamber, which is ghastly in the slowness of the asphyxiation it causes; hanging, which can snap a person’s head off or leave him alive but strangling to death; and the firing squad, efficient yet primitive.

Examples from the past five years, however, have thoroughly disproved the pretense that lethal injection is a more professional procedure. Thanks to good scholarship and good lawyering, we now know that, while the drugs that are injected have been tested and approved for medical use, none of them have been validated through medical testing for use in executions. We also know that careful training in the administration of lethal injections is the exception rather than the rule. States have published manuals with conflicting instructions, have followed sloppy procedures for executions, and have been reprimanded for holding them in inadequate spaces. In 2014, the legal scholar Austin Sarat wrote that, of all executions by lethal injection carried out between 1980 and 2010, about seven per cent were botched, often causing apparently agonizing pain for the person being executed.

Looking back, the problems that have drawn public scrutiny should not come as much of a surprise. By the time the Supreme Court agreed to review Kentucky’s lethal-injection protocol, in 2007, death-row prisoners had brought so many lawsuits challenging lethal injection that the Court effectively put a moratorium on executions in all thirty-six states with capital punishment on the books. In Baze v. Rees, the Court upheld Kentucky’s lethal-injection protocol by 7–2, on the ground that the inmates challenging it had failed to prove that the protocol created “a demonstrated risk of severe pain.” Justice John Paul Stevens voted to uphold the death penalty in the state, out of respect for precedent, but in his concurrence he expressed his opposition to capital punishment for the first time. He also predicted that the ruling, rather than ending the controversy about lethal injection, would generate even more debate, ultimately leading to questions “about the justification for the death penalty itself.”

The legal scholar Deborah Denno has documented more than three hundred lawsuits filed in the six years following the Baze decision that have cited the case in challenging lethal injection as a method of execution. Most of them were unsuccessful, but they reveal that twenty states, rather than maintaining protocols substantially similar to Kentucky’s, made “unfettered substitutions” in “desperate attempts to adhere to their execution schedules” as a result of drug shortages. Those substitutions meant that inmates were guinea pigs for new forms of lethal injection. Drug companies, for their part, didn’t want their drugs used in executions, and tried maneuvers, many without success, to prevent that use.

In 2009, Hospira suspended production of sodium thiopental, a short-acting anesthetic that was the first drug administered in lethal injections. In 2010, after Hospira stopped making sodium thiopental, Oklahoma switched to using pentobarbital as an anesthetic. In 2011, the Copenhagen-based Lundbeck imposed controls on the use of pentobarbital. In 2012, Missouri replaced its three-drug protocol for lethal injections with a one-drug protocol, using propofol. Within a year, the drug-makers Fresenius Kabi, Teva, and Hospira had put distribution controls on propofol and other drugs that were part of state protocols for lethal injections. In 2013, Arkansas replaced its three-drug protocol with a one-drug protocol, using phenobarbital; the next month, the British company Hikma put controls on phenobarbital. In the past five years, about two dozen companies, making thirteen different drugs, have blocked their use in lethal injections, according to Reprieve.

States have generally been secretive about how they carry out lethal injections, but in the past five years they have become especially so. They are mainly concerned about losing their providers of lethal-injection drugs should the companies’ names become public: companies that do not want their products associated with executions will know that their drugs are being used. In 2013, Georgia passed the Lethal Injection Secrecy Act, which treats the names of companies that provide and supply drugs, and the names of the people who carry out executions, as state secrets. Federal courts have denied legal efforts by inmates to know which drugs will be used to execute them and what evidence exists of the drugs’ efficacy, but with the disappearance of F.D.A.-approved drugs there is a more compelling argument, based on the standard of fairness in due process, that inmates have a right to such information.

States have also been increasingly misleading in their efforts to obtain drugs for executions. In one lawsuit, a chain of e-mails from July, 2011, surfaced, from the Ohio Department of Mental Health, which was trying to purchase pentobarbital for use in lethal injections. In the e-mail chain, a wholesaler explains that Lundbeck would no longer sell it to the wholesaler, and gives the department the phone number for the company so the state can try to buy it directly. The final e-mail, apparently from one department official to another, says, “When you call them to see if they will sell to us make sure you say we are the Department of Mental Health do not mention anything about corrections in the phone call or what we use the drug for.”

In another lawsuit, according to a 2014 account in the Lens, a nonprofit public-interest newsroom in New Orleans, the Louisiana Department of Corrections would not disclose the supplier of a drug that it had purchased for an upcoming execution. Ulysses Gene Thibodeaux, the chief judge of the state’s Third Circuit Court of Appeals, revealed to the Lens that it came from Lake Charles Memorial Hospital, where he is a member of its operator’s board of directors. He said, “We assumed the drug was for one of their patients, so we sent it. We did not realize what the focus was. Had we known of the real use, we never would have done it.”

When Hospira stopped producing sodium thiopental, one state after another ran out of the anesthetic. In scrambling to find another supplier, several states showed themselves to be more interested in scoring product than in administering the death penalty in a fair, reliable manner. An opportunistic distributor called Dream Pharma, which operated out of the back of the Elgone Driving Academy, in London, supplied untested sodium thiopental to Arizona, Arkansas, California, Georgia, South Carolina, and perhaps other states, before the British government tightened its export restrictions and later banned the sale of sodium thiopental from the United Kingdom. A federal appeals court later prohibited the F.D.A. from letting sodium thiopental from foreign suppliers into the country.

Twenty of the thirty-one states with the death penalty on the books now have a formal or informal moratorium on executions, in almost all cases because they have been unable to obtain approved drugs to use in lethal injections. In 2015, there were twenty-eight executions in the U.S., the lowest number since 1994. This year, there have been fourteen executions so far—six in Texas, five in Georgia, and one each in Alabama, Florida, and Missouri. Prisons in those states can’t buy drugs for lethal injections from American manufacturers. They can’t import drugs from foreign manufacturers—which, in any case, will not supply them. In short, their options are severely restricted, which will almost certainly lead to more botched executions.

Texas, Georgia, and Missouri are among the small number of states that have carried out executions using drugs made by compounding pharmacies, which combine, mix, or alter drugs, typically to meet the need of an individual patient—say, by removing an ingredient to which a patient is allergic. These pharmacies are not required to register with the F.D.A., and the F.D.A. does not approve their products. They must be licensed by the pharmacy board in the state where they operate, but state oversight has often been scandalously lax. In February, Oklahoma Attorney General Scott Pruitt said he wants the state to open its own compounding pharmacy, in order to guarantee a supply of the drugs that the state needs for lethal injections. (This despite the fact that no department of corrections could meet a basic requirement for obtaining a drug made by a compounding pharmacy: a medical prescription for an individual patient.)

Oklahoma’s turn toward compounding pharmacies is part of the fallout from Glossip v. Gross, one of the most important death-penalty cases decided by the Supreme Court in the past generation. Charles Warner, Richard Glossip, and two other prisoners sentenced to death in Oklahoma had filed a lawsuit against the state after its gruesome execution of Clayton Lockett. The state had used midazolam as the first drug in the protocol, which failed to fully anesthetize Lockett, causing him searing pain. Last June, the Justices upheld the use of the drug by 5–4. They said that Glossip’s lawyers had not shown that the state had had a better option, or that the use of midazolam was “sure or very likely to result in needless suffering.”

The dissent by Justice Stephen Breyer, which got a lot of deserved attention, took a step back from the case to argue that it was time for the Court to reconsider whether capital punishment is cruel and unusual, and therefore prohibited by the Constitution. His opinion eclipsed an equally lucid dissent by Justice Sonia Sotomayor, about Oklahoma’s lethal-injection protocol. When Lockett was injected with the paralytic and heart-stopping drugs after being injected with midazolam as the anesthetic, he woke up, writhed, and eventually spoke. In doing that, she wrote, “he demonstrated the critical difference between midazolam’s ability to render an inmate unconscious and its ability to maintain the inmate in that state.” (Paige Williams wrote for The New Yorker that “one of Lockett’s lawyers, a witness, later told reporters, ‘It looked like torture.’ “) Sotomayor concluded, “The Court’s determination that the use of midazolam poses no objectively intolerable risk of severe pain is factually wrong.”

Oklahoma is now one of the states with a formal moratorium on carrying out executions, until at least five months from this past Thursday, when a grand jury submitted a report about its investigation into the state’s lethal-injection practices in recent executions. The grand jury recommended no indictments. But it faulted one senior state official after another for doing his or her job negligently, or much worse—in the case of Steve Mullins, the Governor’s General Counsel at the time, “flippantly and recklessly.” (After testifying before the grand jury, Mullins, Anita Trammell, the former warden at the Oklahoma State Penitentiary, and Robert Patton, the former director of the Department of Corrections, all resigned their positions.)

The report reveals that the total cost of the drugs for the Warner execution and for five subsequent executions was $869.85, paid for in hundred-dollar bills, as Paige Williams reported, “to make the purchases more difficult to track and, therefore, harder to legally challenge.” The report also makes clear that the secrecy in the state’s practices badly damaged “the execution process.” The report leaves the impression that Oklahoma is devoting substantial resources to what Marc Hyden, a national coördinator of Conservatives Concerned About the Death Penalty, this week called “an error-prone government program marred by egregious mistakes” in the Washington Post.

Oklahoma undertook the investigation in 2015, after it made a horrendous error in Warner’s execution, which the Supreme Court had declined to stay while his case was pending. According to an official autopsy, the state had mistakenly used potassium acetate—used as a diuretic, a food preservative, or a deicer—instead of potassium chloride as the heart-stopping drug in Warner’s execution. After the lethal drugs were administered and before he lost consciousness, Warner said, “My body is on fire.” Eight months after Warner’s death, Governor Mary Fallin stayed Glossip’s execution a few hours before he was scheduled to be put to death, because staff members at the Oklahoma State Penitentiary opened a sealed box with drugs for the execution and discovered that they again had potassium acetate.

According to a Gallup poll, about three-fifths of Americans favor the death penalty, and two-fifths oppose it. When people are asked whether they favor capital punishment or life without parole, about half favor each option. The political scientist Frank Baumgartner and his colleagues have taken a deeper look, by creating a comprehensive index of public opinion about the death penalty from 1976 through 2015, based on four hundred and eighty-eight national surveys on sixty-six questions. They have found a remarkable correlation between public opinion and the number of death sentences, with both falling drastically in the past two decades. The decline in support for the death penalty, they said, is part of a decline in support for harsh criminal-justice policies over all. “No matter how we look at it,” they wrote, in the Washington Post, “for the past 20 years, the death penalty has been dying.”

Polling done last year by YouGov found that lethal injection is the only form of capital punishment that a majority of Americans do not consider cruel and unusual, and of the more than fourteen hundred executions carried out since the death penalty was last reinstated, in 1976, eighty-eight per cent were performed using this method. Of the more than eight hundred executions in the United States since 2000, ninety-eight per cent were carried out this way. Lethal injection has become the all but universal means of execution, yet it is now illegal for a state to purchase drugs for use in an execution from a foreign supplier, and risky for a state to buy them from a compounding pharmacy—and there is no other source. Soon enough, states will run out of drugs needed for lethal injections, and will be faced with the choice of whether to use another method.

The campaign to halt lethal injections as a mode of capital punishment by restricting access to the lethal drugs has not yet ended the death penalty. But it may very well have accelerated the end game that Breyer invoked in his Glossip dissent. In the five years between Hospira’s decision to stop making sodium thiopental and Pfizer’s decision to stop supplying drugs for executions, the unsuccessful effort, by one state after another, to carry out lethal injections in a manner that meets standards of fairness and reliability has made it increasingly clear that states cannot constitutionally perform these types of executions. If they can’t do that, how can the Supreme Court continue to permit capital punishment under the Constitution? The Court is unlikely to take on an issue this fundamental when it is at the mercy of a polarized Senate and self-important Republican leaders who refuse to confirm the President’s nominee for the Court’s ninth Justice. But the churn that the campaign has quickened will inevitably give rise to a legal controversy that will force the Justices to face just such a question.

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