at law
Drugs and the Death Penalty by Rebecca Dresser
I
n October 2013, Missouri officials abandoned a plan to execute a convicted murderer using a novel method—an injection of propofol. The name of this drug became a household word after propofol played a role in singer Michael Jackson’s death, but this has been a popular therapeutic drug for many years. Clinicians use it in intensive care, surgery, and common procedures like colonoscopy. After deciding to halt the execution, Missouri governor Jay Nixon told corrections officials to come up with a different lethal injection protocol. But that was not a simple assignment. Missouri had proposed using propofol because officials had faced barriers to obtaining the drugs previously used for executions. Corrections officials in death penalty states are finding it harder to secure drugs for lethal injection. The events that led to Missouri’s decision illustrate the difficulties. In the past, Missouri had adopted a widely used lethal injection protocol involving three drugs—an anesthetic, a paralytic, and potassium chloride, which stops the heart. The initial anesthetic agent is supposed to induce unconsciousness before the paralytic and potassium chloride take effect. If the anesthetic is ineffective, prisoners are likely to experience suffocation from the paralytic and extreme pain from the potassium chloride injection. The problem is that supply constraints have made several
January-February 2014
anesthetizing agents unavailable to prison officials. A major cause of the shortages is a 2005 European Union measure imposing strict controls on drugs used for capital punishment. Because the EU opposes the death penalty, it prohibits the export of goods for executions. To guard against improper diversion, the EU requires a time-consuming preauthorization review for every shipment of a potential “dual use” pharmaceutical. In 2011, EU officials added short- and medium-acting barbiturate anesthetic agents to the export control list.1 These are the drugs that states have traditionally used to induce unconsciousness in condemned prisoners, and many are produced by European companies. To avoid legal problems, European drug companies have stopped selling dualuse drugs to U.S. prison officials in death penalty states. U.S. manufacturers and suppliers affiliated with European companies have also stopped providing drugs for executions. These actions have led officials in death penalty states to turn to new drugs like propofol as replacements. Nearly all the propofol used in the United States is made by Fresenius Kabi, a German drug manufacturer. A U.S. company called Hospira manufactures a relatively small quantity of the drug, but it too has stopped supplying drugs for executions. In 2012, an authorized supplier for Fresenius Kabi mistakenly
shipped twenty vials of propofol to the Missouri Department of Corrections. Hospira says that an unauthorized distributor sold corrections officials another quantity of the drug. When Fresenius and Hospira discovered the problems, they pressured Missouri officials to return the drug. The EU threatened to impose its strict export restrictions on propofol if Missouri went ahead with the execution. Medical groups and the U.S. Food and Drug Administration feared this would create a serious shortage of an important therapeutic agent. It was this combined pressure that led Missouri officials to abandon their execution plan and return the propofol to the two companies.2 Lethal Injection Challenges
S
tates began using lethal injection in the 1980s. Officials were seeking a more humane execution method than electrocution, hanging, and the gas chamber, all of which too often failed to cause a quick and painless death. The three-drug protocol was designed to remedy the problem. But soon lethal injection itself came under attack. Notorious cases of botched executions made it obvious that death by lethal injection could be inhumane too. In 1985, the U.S. Supreme Court considered a challenge to the three-drug protocol. In Heckler v. Chaney, death row inmates claimed that the FDA was legally obligated to evaluate whether the protocol was safe and effective for use in executions. Agency officials had declined to do so, and the Supreme Court ruled in their favor, finding that the decision was within the agency’s enforcement discretion.3 Last year, death row prisoners had more success in challenging an FDA decision. For years, the agency had permitted imports of foreign-made sodium thiopental, a barbiturate used in lethal injection protocols. But in 2013, a federal court of appeals permanently enjoined the FDA from allowing the drug’s entry. It turned out that the agency had never approved the drug for any domestic use. The judges said that the decision to allow sodium thiopental H AS TI N GS C E N TE R RE P O RT
9
imports was not within the agency’s discretion, because the federal Food, Drug and Cosmetic Act explicitly requires the FDA to reject shipments of misbranded and unapproved drugs.4 Other court cases have challenged state injection protocols on constitutional grounds. Attorneys in these cases usually argue that the protocols are administered by personnel unqualified to perform tasks like preparing the drugs and verifying the inmates’ unconsciousness. Improperly administered lethal injection has the potential to cause extreme and prolonged pain, they contend, which violates the Eighth Amendment’s prohibition against cruel and unusual punishment.5 The Supreme Court ruled on one of these challenges in the 2008 case of Baze v. Rees, in which prisoners challenged Kentucky’s execution protocol requiring professional training and experience for the people who place the intravenous catheters used in executions.6 The protocol directed the warden and deputy warden to ensure that prisoners were unconscious before the paralytic and potassium chloride were administered. After considering these and other elements of Kentucky’s protocol, all but two members of the Court agreed that it was constitutional. The justices failed to agree on a standard for judging the constitutionality of lethal injection executions, however. Two agreed with Chief Justice Roberts, who wrote that the Eighth Amendment does not require states to eliminate any avoidable risk of pain to condemned prisoners. According to his opinion, only methods that present a “substantial” or “objectively intolerable” risk of serious harm are forbidden. Although other justices proposed different standards for evaluating an execution method’s constitutionality, the one proposed by Justice Roberts has been influential in subsequent lower court cases. The Questionable Future of Lethal Injection
S
tates have tried to address concerns like those raised in Baze by requiring or permitting physicians or other 10 HASTI N G S C E N T E R R E P ORT
trained medical professionals to participate in executions. Although leading professional organizations say it is unethical for physicians, nurses, physician assistants, and emergency medical technicians to participate in executions, some medical professionals remain willing to perform various execution tasks, such as placing catheters and pronouncing death.7 The prisoners who challenged Kentucky’s execution procedures wanted the state to replace the three-drug protocol with one using a single overdose of a barbiturate. This method presents a reduced risk of pain and is used in physician-assisted suicide and animal euthanasia. Some states have moved to a one-drug execution protocol, but the drug shortages I described earlier have made this more complicated. Officials attempting to obtain barbiturates for any form of lethal injection protocol face an uphill task. The shortages have led states to seek alternatives to standard lethal injection drugs. Missouri officials came up with propofol as an alternative, and in October 2013, Florida used another sedative, midazolam, in an execution. Other states, including Texas and Georgia, have obtained execution drugs from U.S. compounding pharmacies, which make small amounts of drugs and are not regulated by the FDA.8 After the decision to abandon the propofol execution protocol, Missouri officials took this route, obtaining one of the standard lethal injection barbiturates from a compounding pharmacy.9 But inmates have filed lawsuits arguing that executions using untested methods and possibly substandard drugs present too high a risk of pain to pass constitutional muster. Commentators have also argued that states using novel lethal injection protocols are conducting research on prisoners in violation of state and federal rules governing human subject research.10 The challenges to lethal injection are likely to persist. The EU’s export restrictions and the 2013 appellate court decision blocking imports of sodium thiopental create serious impediments to using drugs in executions. Indeed,
Missouri Attorney General Chris Koster has said that he would consider restoring Missouri’s gas chamber, closed since 1965, to bypass the lethal injection problems.11 Yet some death penalty states could go in a different direction. Although the death penalty still has significant support, public support for alternatives to the death penalty is increasing. Capital cases are expensive, and state budgets are tight. High costs and concern about erroneous convictions have led a few states to abolish the death penalty in recent years. Barriers to obtaining lethal injection drugs could lead more states to do away with the death penalty altogether. Acknowledgment
Thanks to Paul Litton for reviewing a draft of this column. 1. European Commission Press Release, “Commission Extends Control over Goods Which Could Be Used for Capital Punishment or Torture,” December 20, 2011. 2. C. M. McDaniel and V. LaCapra, “Governor Nixon Halts Execution Using Controversial Drug,” St. Louis Public Radio, October 11, 2013, http://news.stlpublicradio.org/post/ gov-nixon-halts-execution-using-controversial-drug-why-change-plans. 3. Heckler v. Chaney, 470 U.S. 821 (1985). 4. Cook v. FDA, No. 12-5176 (D.C. Circuit, July 23, 2013). 5. D. Denno, “Introduction, The Lethal Injection Debate: Law and Science,” Fordham Urban Law Journal 35 (2008): 701-34. 6. Baze v. Rees, 553 U.S. 35 (2008). 7. P. Litton, “Physician Participation in Executions, the Morality of Capital Punishment, and the Practical Implications of Their Relationship,” Journal of Law, Medicine & Ethics 41 (2013): 333-52. 8. See R. Dresser, “Drug Compounding, Drug Safety, and the First Amendment,” Hastings Center Report 43, no. 2 (2013): 9-10. 9. M. Fernandez, “Executions Stall as States Seek Different Drugs,” New York Times, November 8, 2013. 10. Seema Shah, “How Lethal Injection Reform Constitutes Impermissible Research on Prisoners,” American Criminal Law Review 45 (2008): 1101-47. 11. Jeremy Kohler, “Governor Postpones Execution Over Drug,” St. Louis Post-Dispatch, October 12, 2013. DOI: 10.1002/hast.247
January-February 2014
Drugs and the Death Penalty by Rebecca Dresser
I
n October 2013, Missouri officials abandoned a plan to execute a convicted murderer using a novel method—an injection of propofol. The name of this drug became a household word after propofol played a role in singer Michael Jackson’s death, but this has been a popular therapeutic drug for many years. Clinicians use it in intensive care, surgery, and common procedures like colonoscopy. After deciding to halt the execution, Missouri governor Jay Nixon told corrections officials to come up with a different lethal injection protocol. But that was not a simple assignment. Missouri had proposed using propofol because officials had faced barriers to obtaining the drugs previously used for executions. Corrections officials in death penalty states are finding it harder to secure drugs for lethal injection. The events that led to Missouri’s decision illustrate the difficulties. In the past, Missouri had adopted a widely used lethal injection protocol involving three drugs—an anesthetic, a paralytic, and potassium chloride, which stops the heart. The initial anesthetic agent is supposed to induce unconsciousness before the paralytic and potassium chloride take effect. If the anesthetic is ineffective, prisoners are likely to experience suffocation from the paralytic and extreme pain from the potassium chloride injection. The problem is that supply constraints have made several
January-February 2014
anesthetizing agents unavailable to prison officials. A major cause of the shortages is a 2005 European Union measure imposing strict controls on drugs used for capital punishment. Because the EU opposes the death penalty, it prohibits the export of goods for executions. To guard against improper diversion, the EU requires a time-consuming preauthorization review for every shipment of a potential “dual use” pharmaceutical. In 2011, EU officials added short- and medium-acting barbiturate anesthetic agents to the export control list.1 These are the drugs that states have traditionally used to induce unconsciousness in condemned prisoners, and many are produced by European companies. To avoid legal problems, European drug companies have stopped selling dualuse drugs to U.S. prison officials in death penalty states. U.S. manufacturers and suppliers affiliated with European companies have also stopped providing drugs for executions. These actions have led officials in death penalty states to turn to new drugs like propofol as replacements. Nearly all the propofol used in the United States is made by Fresenius Kabi, a German drug manufacturer. A U.S. company called Hospira manufactures a relatively small quantity of the drug, but it too has stopped supplying drugs for executions. In 2012, an authorized supplier for Fresenius Kabi mistakenly
shipped twenty vials of propofol to the Missouri Department of Corrections. Hospira says that an unauthorized distributor sold corrections officials another quantity of the drug. When Fresenius and Hospira discovered the problems, they pressured Missouri officials to return the drug. The EU threatened to impose its strict export restrictions on propofol if Missouri went ahead with the execution. Medical groups and the U.S. Food and Drug Administration feared this would create a serious shortage of an important therapeutic agent. It was this combined pressure that led Missouri officials to abandon their execution plan and return the propofol to the two companies.2 Lethal Injection Challenges
S
tates began using lethal injection in the 1980s. Officials were seeking a more humane execution method than electrocution, hanging, and the gas chamber, all of which too often failed to cause a quick and painless death. The three-drug protocol was designed to remedy the problem. But soon lethal injection itself came under attack. Notorious cases of botched executions made it obvious that death by lethal injection could be inhumane too. In 1985, the U.S. Supreme Court considered a challenge to the three-drug protocol. In Heckler v. Chaney, death row inmates claimed that the FDA was legally obligated to evaluate whether the protocol was safe and effective for use in executions. Agency officials had declined to do so, and the Supreme Court ruled in their favor, finding that the decision was within the agency’s enforcement discretion.3 Last year, death row prisoners had more success in challenging an FDA decision. For years, the agency had permitted imports of foreign-made sodium thiopental, a barbiturate used in lethal injection protocols. But in 2013, a federal court of appeals permanently enjoined the FDA from allowing the drug’s entry. It turned out that the agency had never approved the drug for any domestic use. The judges said that the decision to allow sodium thiopental H AS TI N GS C E N TE R RE P O RT
9
imports was not within the agency’s discretion, because the federal Food, Drug and Cosmetic Act explicitly requires the FDA to reject shipments of misbranded and unapproved drugs.4 Other court cases have challenged state injection protocols on constitutional grounds. Attorneys in these cases usually argue that the protocols are administered by personnel unqualified to perform tasks like preparing the drugs and verifying the inmates’ unconsciousness. Improperly administered lethal injection has the potential to cause extreme and prolonged pain, they contend, which violates the Eighth Amendment’s prohibition against cruel and unusual punishment.5 The Supreme Court ruled on one of these challenges in the 2008 case of Baze v. Rees, in which prisoners challenged Kentucky’s execution protocol requiring professional training and experience for the people who place the intravenous catheters used in executions.6 The protocol directed the warden and deputy warden to ensure that prisoners were unconscious before the paralytic and potassium chloride were administered. After considering these and other elements of Kentucky’s protocol, all but two members of the Court agreed that it was constitutional. The justices failed to agree on a standard for judging the constitutionality of lethal injection executions, however. Two agreed with Chief Justice Roberts, who wrote that the Eighth Amendment does not require states to eliminate any avoidable risk of pain to condemned prisoners. According to his opinion, only methods that present a “substantial” or “objectively intolerable” risk of serious harm are forbidden. Although other justices proposed different standards for evaluating an execution method’s constitutionality, the one proposed by Justice Roberts has been influential in subsequent lower court cases. The Questionable Future of Lethal Injection
S
tates have tried to address concerns like those raised in Baze by requiring or permitting physicians or other 10 HASTI N G S C E N T E R R E P ORT
trained medical professionals to participate in executions. Although leading professional organizations say it is unethical for physicians, nurses, physician assistants, and emergency medical technicians to participate in executions, some medical professionals remain willing to perform various execution tasks, such as placing catheters and pronouncing death.7 The prisoners who challenged Kentucky’s execution procedures wanted the state to replace the three-drug protocol with one using a single overdose of a barbiturate. This method presents a reduced risk of pain and is used in physician-assisted suicide and animal euthanasia. Some states have moved to a one-drug execution protocol, but the drug shortages I described earlier have made this more complicated. Officials attempting to obtain barbiturates for any form of lethal injection protocol face an uphill task. The shortages have led states to seek alternatives to standard lethal injection drugs. Missouri officials came up with propofol as an alternative, and in October 2013, Florida used another sedative, midazolam, in an execution. Other states, including Texas and Georgia, have obtained execution drugs from U.S. compounding pharmacies, which make small amounts of drugs and are not regulated by the FDA.8 After the decision to abandon the propofol execution protocol, Missouri officials took this route, obtaining one of the standard lethal injection barbiturates from a compounding pharmacy.9 But inmates have filed lawsuits arguing that executions using untested methods and possibly substandard drugs present too high a risk of pain to pass constitutional muster. Commentators have also argued that states using novel lethal injection protocols are conducting research on prisoners in violation of state and federal rules governing human subject research.10 The challenges to lethal injection are likely to persist. The EU’s export restrictions and the 2013 appellate court decision blocking imports of sodium thiopental create serious impediments to using drugs in executions. Indeed,
Missouri Attorney General Chris Koster has said that he would consider restoring Missouri’s gas chamber, closed since 1965, to bypass the lethal injection problems.11 Yet some death penalty states could go in a different direction. Although the death penalty still has significant support, public support for alternatives to the death penalty is increasing. Capital cases are expensive, and state budgets are tight. High costs and concern about erroneous convictions have led a few states to abolish the death penalty in recent years. Barriers to obtaining lethal injection drugs could lead more states to do away with the death penalty altogether. Acknowledgment
Thanks to Paul Litton for reviewing a draft of this column. 1. European Commission Press Release, “Commission Extends Control over Goods Which Could Be Used for Capital Punishment or Torture,” December 20, 2011. 2. C. M. McDaniel and V. LaCapra, “Governor Nixon Halts Execution Using Controversial Drug,” St. Louis Public Radio, October 11, 2013, http://news.stlpublicradio.org/post/ gov-nixon-halts-execution-using-controversial-drug-why-change-plans. 3. Heckler v. Chaney, 470 U.S. 821 (1985). 4. Cook v. FDA, No. 12-5176 (D.C. Circuit, July 23, 2013). 5. D. Denno, “Introduction, The Lethal Injection Debate: Law and Science,” Fordham Urban Law Journal 35 (2008): 701-34. 6. Baze v. Rees, 553 U.S. 35 (2008). 7. P. Litton, “Physician Participation in Executions, the Morality of Capital Punishment, and the Practical Implications of Their Relationship,” Journal of Law, Medicine & Ethics 41 (2013): 333-52. 8. See R. Dresser, “Drug Compounding, Drug Safety, and the First Amendment,” Hastings Center Report 43, no. 2 (2013): 9-10. 9. M. Fernandez, “Executions Stall as States Seek Different Drugs,” New York Times, November 8, 2013. 10. Seema Shah, “How Lethal Injection Reform Constitutes Impermissible Research on Prisoners,” American Criminal Law Review 45 (2008): 1101-47. 11. Jeremy Kohler, “Governor Postpones Execution Over Drug,” St. Louis Post-Dispatch, October 12, 2013. DOI: 10.1002/hast.247
January-February 2014
