After the state of Arizona injected 55-year old convicted murderer Joseph R. Wood III with an untested 2-drug execution cocktail (hydromorphone, an opioid painkiller that suppresses respiration, and a sedative called midazolam), it took him nearly two hours to die. He also “gasped and snorted” over 600 times before expiring. These things should not have happened.
Wood was convicted in 1989 of murdering an estranged girlfriend and her father. Wood, Dennis McGuire of Ohio, and Clayton Lockett of Oklahoma men whose executions were also disturbingly and recently botched, were the sort of criminals that a reliable, reasonable, sometimes-exacting, but theoretically humane justice system are intended to process and punish. All three executions used a sedative called midazolam, a sedative that doctors know little about when applied in large doses.
President Obama has said he will review how states use the death penalty. But he is likely to run into stiff opposition from departments of corrections that will resist the imposition of federal authority. As has been well-documented, a number of state legislatures have also passed or considered legislation to keep secret their execution protocols. That veil of secrecy would also cover the sources of their drugs.
Several years ago, I compiled a massive tranche of reporting on the dwindling market for lethal injection drugs. Some of this material pertains directly to the state of Arizona. The story I traced takes us back to the night of October 26, 2010, when the state of Arizona initiated the execution of Jeffrey Landrigan. Per protocol, the 50-year old native of Oklahoma was injected with the three ingredients of the widely used execution “cocktail”: sodium thiopental, a fast-acting barbiturate used to induce anesthesia; pancuronium bromide, a paralytic; and potassium chloride, which triggers cardiac arrest, killing the inmate. Considered a more humane approach to execution, the three-drug process is intended to render the inmate completely vegetative and impervious to pain by the time the actual killing stroke is applied.
The case against Landrigan was strong. Police discovered his footprint in the home of Chester Dean Dyer, a 42-year old man who had been found stabbed and strangled to death with a wire. Investigators arrested Landrigan, accusing him of murdering Dyer after the victim made an unwelcome sexual advance. Dyer’s was not Landrigan’s first murder: in 1982, he stabbed a childhood friend to death, was found guilty of first-degree murder, and received a life sentence. But the conviction was overturned, and pled down to a second-degree charge with a twenty-year prison term. But Landrigan escaped in 1989, and fled to Arizona.
At his trial, Landrigan initially claimed that he had beaten Dyer, but that someone else had murdered him. Still, he told the judge, “If you want to give me the death penalty bring it on, I’m ready’; the judge obliged.
Not all the relevant facts surfaced at the trial. Nine later after his sentencing, Landrigan revealed to a neuropsychologist that his mother abused drugs and alcohol while pregnant with him, and gave him up for adoption soon after his birth. His biological father, too, wound up on death row in Arkansas, where he died of natural causes in 2005. But thanks to shoddy, court-appointed representation, those details never surfaced at his trial.
But the Arizona Federal Public Defender’s Office, which took on Landrigan’s case in 2010, was determined to mount a far more formidable challenge against his execution. In September 2010, the Arizona Department of Corrections rejected a request from Landrigan’s attorneys for more information about the source of the drugs to be used to kill their client. In response, his attorneys asked the Arizona Supreme Court to order the Department of Corrections to disclose the information.
In oral arguments before the court, Arizona’s attorney general revealed that the drugs were not made by Hospira—at the time, the sole domestic manufacturer of sodium thiopental— suggesting that the thiopental was foreign, and potentially unregistered with the Food and Drug Administration (FDA). If so, it could be in violation of federal standards for safe human use.
Arizona’s failure to provide information about the drugs, Landrigan’s attorneys alleged, violated his Fourteenth Amendment-guaranteed rights to due process. They also alleged that the state’s use of a batch of potentially unapproved, unsafe sodium thiopental demonstrated “deliberate indifference” to the possibility that it might subject Landrigan to cruel and unusual punishment. If so, that would violate his Eighth Amendment rights.
Five days prior to his death, Landrigan’s attorneys filed a civil rights complaint with the US District Court of the District of Arizona, challenging the source of the thiopental to be used in the lethal injection. In response, Judge Roslyn Silver agreed to issue a temporary stay, ruling that Landrigan’s attorneys had not received enough information about the nature and origin of the drugs to be used. Her ruling was affirmed/upheld by the 9th US Circuit Court of Appeals.
But in a 5-4 decision handed down on October 26, the US Supreme Court overruled the lower courts, finding that “there is no evidence in the record to suggest that the drug obtained from a foreign source is unsafe” and that “[t]here was no showing that the drug was unlawfully obtained, nor was there an offer of proof to that effect.”
Landrigan ate a final meal of steak, fried okra, French fries, strawberry ice cream, and washed it down with a Dr. Pepper. After thanking his family and friends for attending his execution, his final words were “Boomer Sooner,” a popular University of Oklahoma cheer. At 10:26 p.m. on October 26, 2010, Landrigan was pronounced dead by the state of Arizona.
In late March 2011, the ACLU of Northern California obtained a trove of documents confirming that Landrigan had been executed using imported drugs. The documents showed that Arizona had made two foreign purchases from a UK-based supplier called Dream Pharma: one for all three ingredients of its execution cocktail, including thiopental, and an additional one for thiopental.
Why states have resorted to unapproved foreign drugs for their lethal injections has everything to do with simple supply and demand. Diminishing supplies of drugs used for lethal injections have pushed states to turn to unapproved overseas sources over the past several years, even as federal courts seek to curb their access to these unapproved products. To stave off the shortfall, Nebraska, California, Arizona, Kentucky, and others have turned to a questionable source: foreign drug distributors from overseas.
America’s lethal injection drug-supply gap dates back to late 2010, when the Illinois-based Hospira, announced that it was experiencing “raw-material supplier issues” in the production of thiopental. At the time, the company did not offer a more comprehensive explanation for its abrupt decision. But the Associated Press obtained a letter from the Kentucky governor’s office, explaining that Hospira had lost its supplier of one of thiopental’s key ingredients. Hospira, the only stateside producer of thiopental, said it would have no new batches available until January 2011.
To fix its supply problem, the company planned to transfer production to a plant in Italy, but was rebuffed by the Italian government, which—like much of Europe, including the UK, Germany, and Denmark—opposes capital punishment, and threatened to block export of the drug for use in capital punishment.
“Italy’s intent is that we control the product all the way to the ultimate end user to prevent use in capital punishment,” Hospira said in a statement. “[W]e could not prevent the drug from being diverted” and could not “take the risk that we will be held liable by the Italian authorities if the product is diverted for use in capital punishment.” As a result, Hospira chose to stop producing thiopental altogether.
With a lethal injection crisis looming, the federal government sprang to action. In June of 2011, then-US Commerce Secretary Gary Locke asked former German health minister Philipp Rosler to help fill the widening thiopental gap. As Der Spiegel reported several years ago, Rosler declined the request, and instructed German pharmaceutical companies to not sell the drug to the United States.
Ultimately, the company decided it didn’t need the headache. As Fordham law professor Deborah Denno explained to me, profits on sales of sodium thiopental were low for Hospira. Its manufacturing problems and the increasingly negative, execution-related spotlight cast on sodium thiopental likely forced its hand. “Sodium thiopental was a very small part of their business…so I don’t think it was worth it for them.
The Nebraska Department of Correctional Services (NDCS) began to feel the pinch in September of 2010, when it announced that it did not have enough thiopental to conduct a scheduled execution. Fortunately, an Indian telemarketer named Chris Harris came calling, twice. In December 2010, Harris brokered a sale of thiopental made by the Mumbai-based Kayem Pharmaceuticals to the NDCS. According to documents obtained by Jerry Soucie, an attorney with the Nebraska Commission on Public Advocacy, the purchase was for 500 grams, at a cost of $2,065.15.
But the deal with Harris—a “guy with a cell phone and the gift of gab,” Soucie says—ended inauspiciously. Because thiopental is classified as a class III controlled substance, Nebraska could not obtain it without first receiving a valid DEA license. Under the Controlled Substance Act, any entity that handles a controlled substance must register with the agency. That registration must specify how the importer plans to use the drug, as well as the location where the activity is to be carried out. According to documents obtained by Soucie, the NDCS did apply for the necessary importation license.
Kayem CEO Navneet Verma also told Soucie that Kayem was not registered with the DEA or FDA as a foreign pharmaceutical manufacturer or distributor. Soucie also learned from Verma about Kayem’s director of sales and marketing for US operations: a man named Wayne “Tony” Atwater, the owner of a Maine-based concrete-pouring company. Soucie discovered that Kayem’s US address was, fact, a mail forwarding service called Mostly Mail, located in a shopping mall in Las Vegas. Even though the NDCS did not yet possess the proper importation license, the FDA ultimately struck a deal with the NDCS allowing it to retain the Kayem shipment, as long as it agreed not to use it for lethal injections.
In a statement attached to the released shipment, the FDA said that it “does not review or approved[sic] products for the purpose of lethal injection [and that it] has not reviewed the products…to determine their identify, safety, effectiveness, purity or any other characteristics.” But the agency also wrote that the release did not “preclude action should the product later be found violative”—stating, in other words, that it would let the state have the drugs, but would not vouch for them.
Nebraska attorney general Jon Bruning, meanwhile, was incensed. “We’re a sovereign state. You don’t need to come in and treat us like, you know, we’re Joe’s Pharmacy, hiding out in some ramshackle house out in the country. I mean, this is the state of Nebraska, doing this the right way,” an indignant Bruning vented to a local radio station on July 22, 2011.
“Why is it that…I had to go ask permission for anything that the State of Nebraska does, according to the State of Nebraska’s laws?…This isn’t being purchased for somebody’s backyard barbecue…We’re a sovereign. We don’t report to [the DEA]. The whole idea that I have to even deal with them at all bothers me. I’m working on behalf of the people of Nebraska doing a job that I was asked to do by the people of this state.”
Casting aside its poor luck, Nebraska went back to the well, finally obtaining a DEA importer license and purchasing another shipment of thiopental through Harris in November 2011. On November 3, 2011, the NDCS announced the purchase of 485 grams of thiopental for $5,411. This time, Harris obtained his supply from a Swiss company called NAARI AG (Harris and Atwater had a brutal falling out with Kayem).
Bruning wasted no time getting back to business: on the day of the purchase, he filed a motion requesting an execution date for Michael Ryan, one of Soucie’s clients. But the Nebraska purchase was news to NAARI CEO Pritihi Kochhar. Not long after the NDCS announced that it was locked and loaded, Kochhar wrote to the Nebraska supreme court, explaining that his company had been duped by Harris. Harris was “not authorised [sic] to sell the product to the Nebraska Department of Correctional Services or to anyone else in the USA,” Kochhar wrote.
According to Kochhar, NAARI had supplied Harris with thiopental in order to get it registered in Zambia, where the company hoped to eventually market the drug. But Harris instead sold it to Nebraska—at markup of roughly 142 percent. Kochhar requested that the NDCS return “the thiopental which was wrongfully diverted by Mr. Harris.” Harris, meanwhile, claimed he had delivered the thiopental to Zambia as promised, but that an interlocutor had sent it to the United States. Though the FDA ordered Nebraska to return the thiopental to NAARI in response to Kochhar’s recall, the state refused.
Closer to home, the London-based pharmaceutical wholesaler and distributor Dream Pharma has sold drugs to be used for lethal injection to Arkansas, Georgia, Kentucky, South Carolina, and Tennessee, according to the ACLU. On July 15, 2010, the Georgia Department of Corrections disclosed in a letter (addressed to a recipient whose named is redacted) that it was having trouble locating thiopental in the United States. It had already begun its search: just one day earlier, the department’s procurement director had written to a supplier (this name is also redacted) to inquire about purchasing thiopental. A representative of the suppliers responded, saying he was “more than happy to assist” by selling £91.88 pounds worth of thiopental. “We can dispatch the parcel by [REDACTED]. Which ever you prefer,” he wrote.
The supplier also knew its shipment could be obstructed. “[REDACTED] is the cheapest option, but they are very stringent with US customs, this is not to say the other carriers are any easier. . . . If for some reason, you could not release the product from US customs, we would not return the product back to the UK. We would ask for the destruction of the product.”
According to federal court documents and news stories published at the time, Georgia’s supplier was Dream Pharma. But the FDA promptly detained the shipment on July 15, alleging that it was misbranded. Then, in August, it released it to the state.
The story repeated itself one month later in Arkansas, this time with the FDA saying the thiopental was unapproved. But Arkansas appealed that decision, arguing that the drug was necessary for lethal injections, and the agency promptly released the shipment. The FDA also released a Dream shipment the day after it arrived in Arizona in September and another in Tennessee in October.
In other cases, states have helped each other fill their supply gaps, with drugs procured from abroad. But the DEA has been on the case. On February 10, 2011, the Kentucky Department of Corrections placed an order for 18 grams of thiopental (enough for three executions) with Correct Health, a Georgia-based company that provides health care services to correctional facilities.
Four days later, Correct Health FedExed the $90 shipment to Kentucky. The sodium thiopental from Correct Health was manufactured by an Austrian company called Sondoz GmbH, and distributed by a UK-based distributor called Link Pharmaceuticals Limited, renamed Archimedes Pharma UK Limited in 2006.
According to a memo detailing the purchase, Kentucky did not know the source of the drug, or whether it was FDA-approved at the time of the purchase. It also did not know if the manufacturer was based overseas, nor—by its own admission—did it seek answers to these questions. To date, Kentucky has “no documentation that would reflect where Correct Health purchased their supply of sodium thiopental,” according to Kentucky department of corrections public information officer Todd Henson.
But the DEA quickly swept in. On March 24, Martin Redd, a supervisor with the agency’s Louisville district office, emailed his superiors to inform them that he would be heading to the Kentucky State Penitentiary to take custody of the drugs. One week later, the Kentucky department of corrections issued a statement announcing the release of its sodium thiopental for the DEA to “use as evidence in a case in another jurisdiction.” Because the department did not know when or if the drugs would be returned, it planned to continue searching for a new supply. In addition to the Kentucky seizure, the DEA also took thiopental supplies from Georgia, South Carolina, Alabama, and Tennessee in the spring of 2011.
The DEA declined to comment on the circumstances of these seizures. But it appears to have gone after questionable drug shipments more aggressively than the FDA. “In our view, the DEA has been much more diligent in fulfilling its statutory responsibility,” Brad Berenson says.
Richard Dieter, the executive director of the Death Penalty Information Center, points out that these states’ willingness to enter into seemingly ill-advised, fly-by-night business deals with unapproved suppliers may strike some as bizarre. “Who do we know in the drug world that could get us some sodium thiopental?” he joked. “There’s this little place in Great Britain that has some, or some place in India. Okay, let’s get it here! FedEx it at night, we’ll get it here tomorrow.”
Why have states clung to thiopental? A resistance to change despite the presence of viable alternatives like pentobarbital. Even this alterative, though, grew less viable after its chief manufacturer, a Denmark-based company called Lunbeck, announced it would block sales of the drug to the US for lethal injections last July.
“They have used sodium thiopental for over 1,000 executions in the United States. They know that when you start changing drugs, that there might be unexpected results or adverse allergic reactions. . . with sodium thiopental, they at least had a track record.
The responsibility for keeping unapproved drugs out of the country is split between the FDA and the Drug Enforcement Administration (DEA). The FDA’s chief domestic function is to review and approve new drugs for sale. But under the Food, Drug, and Cosmetic Act (FDCA), it also has the authority to regulate the production and distribution of drugs, and to block drug shipments that are “misbranded” or unapproved by the FDA. A drug is deemed misbranded if it is “manufactured, prepared, propagated, compounded, or processed in an establishment” not registered with the FDA, not properly listed with the FDA, or if its packaging is not properly labeled. It is also illegal to introduce a drug into interstate commerce that has not been previously reviewed and approved by the FDA.
For an entity to import controlled substances—defined as buying them directly off the international market—it must file a form with the DEA at least 15 days in advance of the scheduled importation, and notify the agency once it receives the drug. Successful registration with the DEA allows them to possess, manufacture, distribute, or dispense controlled substances.
Both the FDA and the DEA, then, play key roles in policing imports. But the FDA has assumed something of a hands-off approach. Since 1985, the agency has exercised its “enforcement discretion,” declining to review substances whose uses fall outside the public health realm, including lethal injection. That decision not to decide has opened up a vacuum, granting states a certain measure of freedom to obtain their drugs from potentially dubious sources.
And states as politically and ideologically diverse as Texas and California have run with that freedom, failing to divulge the full details of their lethal injection procedures. In response, defense attorneys for death row inmates around the country like Jeffrey Landrigan have challenged corrections departments, filing repeated public information requests and lawsuits seeking details on the source of their execution drugs, and how they plan to administer them.
While some attorneys appeal lethal injection protocols as a means of buying time for their clients and delaying executions, others view these challenges as salvos in the broader battle to end capital punishment altogether. But in either case, the information compiled by attorneys in recent years has shed new light on the mechanics of lethal injection in the United States.
The veil of secrecy began to fall with Morales v. Tilton, a lethal injection case that came before the District Court for the Northern District of California in 2006. In the case, attorneys for death row inmate Michael Morales were challenging California’s use of corrections officers, rather than medical technicians, to administer lethal injections. Such untrained hands, they alleged, could make mistakes that would subject inmates to cruel and unusual punishment.
Judge Jeremy Fogel’s review of past death row cases seemed to affirm that suspicion. He found that in six of California’s eleven previous lethal injections, the “inmates’ breathing may not have ceased as expected,” convincing him to rule that the state’s lethal injection procedure violated the Eighth Amendment. The key implication: that a state’s execution methods—both the drugs used and how they are administered—must pass the Eighth Amendment smell test. While the federal government cannot micromanage the state-by-state details of capital punishment procedure, it can weigh in on anomalous, alarming results, Fogel ruled. Since Morales, similar litigation has surfaced in Missouri and Arizona.
In addition to its role in reviewing and approving new drugs for sale, the FDA also has a separate responsibility to screen imported drugs at the border. “It doesn’t matter what your purpose is in screening the drug,” Berenson says. “If that drug is unapproved—is not legal to import—you cannot import it. Period.” How the drug will be used and by who becomes is irrelevant.
The agency’s position to decline to review products used for lethal injection dates back to the Supreme Court’s 1985 decision in Heckler v. Chaney . In the case, attorneys for convicted murderer Larry Chaney and over two-dozen fellow death row inmates sued the FDA, in an effort to block the use of lethal-injection drugs until the agency had ruled on whether the drugs in use were safe for humans.
In the majority opinion ruling in favor of Chaney, Chief Justice William Rehnquist wrote that “an agency’s decision not to prosecute or enforce. . .is a decision generally committed to an agency’s absolute discretion.” By not ruling on a “drug that produces a 100 percent death rate,” the FDA exercised its power of discretion, legal scholar Garrett Epps wrote in The American Prospect several years ago.
Brad Berenson says that Heckler had a relatively narrow implication, and did not mean that the FDA cannot choose whether or not to follow the law as set forth by Congress. “It’s very particular to the exercise of certain kinds of enforcement discretion, where the statutory regime makes it clear that the agency has got the ability to decide whether or not to pursue a particular investigation or case,” he explains.
But the FDA also wants to preserve and project a certain image. “This is a federal agency designed to protect the health of the citizens,” Richard Dieter says. “The death penalty is not at all where they felt they should be. That was their position in 1985, and that was their position even recently.”
As recently, in fact, as January 2011, when the FDA put out a statement explaining its position on releasing shipments of imported thiopental. Issued in response to an inquiry from the Wall Street Journal, the statement suggested that it would defer to “law enforcement in the use of substances for lethal injection.” But it also reiterated that “[r]eviewing substances imported or used for the purpose for state-authorized lethal injection clearly falls outside of FDA’s explicit public health role.”
“It’s like telling doctors they have to monitor lethal injections. [FDA officials] don’t want to be part of it if they can help it,” Dieter says.
The FDA’s refusal to inject itself into the broader debate over capital punishment came to a head in March 2011, when a group of death row inmates in Tennessee, Arizona, and California, sued the FDA and Department of Health and Human Services in an effort to block the use of foreign-produced thiopental in lethal injections. They argued that the FDA had violated provisions of the Food, Drug, and Cosmetic Act by allowing misbranded thiopental to enter the country.
As their attorney Brad Berenson explained to me, the basis of the plaintiffs’ suit was simple: there is no legitimate reason for the FDA to allow states to import unapproved drugs. Berenson also says that the FDA let the drugs into the country despite a long, contentious history of blocking states from importing prescription drugs from Canada (Vermont v. Leavitt). The FDA, in contrast, held that drugs used for this purpose were not their concern, and that states were choosing to use them for such purposes at their own risk. In July of 2013, a federal appeals court ruled that the FDA had, indeed failed in its responsibility to block misbranded and unapproved imported drugs.
For defense attorneys, procedural reform of lethal injection is not the sole objective. Their motive in challenging death sentences—leveling objections over procedure or tainted evidence—is often to delay, in hopes of ultimately convincing a judge to throw out a death sentence. Challenging the execution protocol itself, the type of drug to be used, or its source, becomes the logical, final roadblock.
But prosecutors “want to be able to trump that, and to have the drugs and not be stopped by drug companies or by defense attorneys,” Richard Dieter told me. “Both sides are trying to upset the other, either with a motion, a new twist on the law, or. . . using all the powers that they have.”
It seemed time to unearth all that material. The growing catastrophe surrounding execution in America may be reaching something of an inflection point, and it felt silly to continue sitting on it. I’ll leave you with this sobering graf from the keeper of the American conscience, Amy Davidson:
[Wood] lost, but the manner of his death suggests, at the very least, that there needs to be more transparency about the means of execution. . . . It has become hard for states to get what they need to kill people; companies don’t really want to go into the business, or if they do they don’t want to advertise it. That is not tenable, when we are all being asked to be complicit in a death. Or perhaps it is a reminder that we might choose not to be.