Lethal Injection

Posted: February 11, 2006
in
I assumed that our decision would bring the debate about lethal injection as a method of execution to a close. It now seems clear that it will not. The question whether a similar three-drug protocol may be used in other States remains open, and may well be answered differently in a future case on the basis of a more complete record. Instead of ending the controversy, I am now convinced that this case will generate debate not only about the constitutionality of the three-drug protocol, and specifically about the justification for the use of the paralytic agent, pancuronium bromide, but also about the justification for the death penalty itself.

Baze v. Rees (2008) (Stevens, J., concurring).

Four Methods of Lethal Injection in 2011
Method Example of use in 2011: Date:
3-drugs, starting with sodium thiopental Alabama 1/13/11
3-drugs, starting with pentobarbital Oklahoma 1/6/11
1-drug sodium thiopental Ohio 2/17/11
1-drug pentobarbital Ohio 3/10/11
The three-drug protocol uses an anesthetic (specified above), followed by pancuronium
bromide to paralyze the inmate and potassium chloride to stop the inmate's heart. The
one-drug protocol uses a lethal dose of an anesthetic.
See Executions in 2011 

New: State-by-State Lethal Injection Information

New: "Ohio faces snags in execution system" by Andrew Welsh-Huggins (AP), covering Ohio's newly-suggested backup execution protocol, which would use two drugs previously untested in lethal injections

New: "Should executions be televised?" by Fordham University law professor Deborah Denno

New: "Lethal injection scramble" map from ACLU of Northern California shows which states have obtained sodium thiopental from foreign sources, and includes information on price and quantity of drugs and DEA seizures

New: STATEMENT FROM LUNDBECK, INC., maker of pentobarbital, on distribution restrictions to prevent use in executions (July 1, 2011)

New: 25 prominent European doctors have written an open letter to Hospira, Inc. President Michael Ball, asking him to restrict distribution of pancuronium bromide, a muscle relaxant that is used as the 2nd drug in many lethal injections. Read the letter here.

PRESS RELEASE: "Georgia Department of Corrections Violates Federal Law in Desperate Effort to Get Drugs for Executions," (Press Release on behalf of John Bentivoglio, February 24, 2011)

Letter to Attorney General Eric Holder from attorneys for Georgia death row inmate alleging illegal importation of sodium thiopental. (Feb. 24, 2011)
Response from attorneys who filed suit against the FDA to the letter from the state AGs to Eric Holder (Feb. 16, 2011).
PRESS RELEASE: Lawsuit Filed Against FDA on Lethal Injection on behalf of death row inmates stating that the FDA's failure to monitor importation of lethal injection drugs is illegal (February 2, 2011)

STATEMENT FROM LUNDBECK, INC., maker of pentobarbital, on the use of their drugs for executions. (Jan. 26, 2011)

Letter to Attorney General Eric Holder from 13 state attorneys general requesting help in securing lethal injection drugs (January 25, 2011)

STATEMENT FROM HOSPIRA, sole U.S. manufacturer of thiopental sodium, on their ending of their production of this drug. (Jan. 21, 2011)

STATEMENT FROM THE U.S. FOOD & DRUG ADMINISTRATION concerning the importation of lethal injection drugs (Jan. 4, 2011)

STATEMENT FROM HOSPIRA, sole U.S. manufacturer of thiopental sodium, on the use of their drugs for executions. (Mar. 31, 2010)

See also:

DEATH PENALTY IN FLUX: States where executions are on hold
METHODS OF EXECUTIONS BY STATE
Information about the Romell Broom botched execution


ARBITRARINESS
 Prior to the Supreme Court's granting certiorari in Baze v. Rees (see above), some executions were stayed while others were allowed to go forward. From the day after the Court agreed to hear Baze, all executions were stayed. In commenting on the earlier inconsistencies, Douglas A. Berman, an expert in criminal sentencing law at Ohio State University's Moritz College of Law, said: "I am sure the court is trying to apply some sort of sensible standard. But they need to do a heck of a lot better job explaining why." (Washington Post, Feb. 10, 2006). Since the Court's decision in Baze on April 16, 2008, execution dates have been set in many states, and some executions have taken place. In some states, no execution dates have been set as the lethal injection issue remains unresolved.

In dissenting from a 6th Circuit refusal to grant a stay based on a lethal injection challenge to Tennessee inmate Sedley Alley, Judge Boyce Martin, Jr., wrote: "[T]he dysfunctional patchwork of stays and executions going on in this country further undermines the various states' effectiveness and ability to properly carry out death sentences. We are currently operating under a system wherein condemned inmates are bringing nearly identical challenges to the lethal injection procedure. In some instances stays are granted, while in others they are not and the defendants are executed, with no principled distinction to justify such a result." (Alley v. Little, No. 06-5650 (6th Cir. May 16, 2006) (Martin, J., dissenting from denial of a rehearing en banc)).

See also U.S. District Court Judge Gregory Frost's opinion in Cooey v. Taft (denying a stay for John Spirko in Ohio):
"[T]his Court is now confronted with two different unreported decisions by two different appellate panels, both concerned with the same issues of law and both reaching wholly opposite, unexplained results.
. . .
This Court's inability to discern the appellate rationale for denying or granting a stay does not promote confidence in the system, does not promote consistency in court decisions, and does not promote the fundamental value of fairness that underlies any conception of justice."


DRUGS USED IN VARIOUS STATES
All thirty-five death penalty states authorize lethal injections for their executions. Almost all the states use a 3-drug combination for lethal injections: an anesthetic (either pentobarbital or sodium thiopental), pancuronium bromide (a paralytic agent, also called Pavulon), and potassium chloride (stops the heart and causes death). Two states use only a lethal dose of an anesthetic for executions (Ohio & Wash.).  New Mexico has abolished the death penalty, but 2 inmates face execution by the 3-drug method.

See state-by-state chart of current drugs used, including international sources of some drugs.

See also D. Denno,

"When Legislatures Delegate Death: The Troubling Paradox Behind State Uses of Electrocution and Lethal Injection and What It Says About Us,"

63 Ohio State Law Journal 63 (2002) (Updates from DPIC research).

In federal executions, the method is determined by the state in which the sentencing took place. All 3 of the federal executions in the modern era have been by lethal injection carried out in a federal facility in Indiana. Apparently the same 3-drug combination is used, though prison officials did not reveal the exact ingredients. (See Washington Post, Dec. 5, 2000). The U.S. Military has not carried out any executions since reinstatement. It plans to use lethal injection. 

Recent Developments: 

Following is Hospira's statement:  http://phx.corporate-ir.net/phoenix.zhtml?c=175550&p=irol-newsArticle&ID=1518610&highlight=

Hospira Statement Regarding Pentothal™ (sodium thiopental) Market Exit

LAKE FOREST, Ill., Jan. 21, 2011 - Hospira announced today it will exit the sodium thiopental market and no longer attempt to resume production of its product, Pentothal™.

Hospira had intended to produce Pentothal at its Italian plant. In the last month, we've had ongoing dialogue with the Italian authorities concerning the use of Pentothal in capital punishment procedures in the United States – a use Hospira has never condoned.  Italy's intent is that we control the product all the way to the ultimate end user to prevent use in capital punishment.  These discussions and internal deliberation, as well as conversations with wholesalers - the primary distributors of the product to customers - led us to believe we could not prevent the drug from being diverted to departments of corrections for use in capital punishment procedures.

Based on this understanding, we cannot take the risk that we will be held liable by the Italian authorities if the product is diverted for use in capital punishment. Exposing our employees or facilities to liability is not a risk we are prepared to take.

Given the issues surrounding the product, including the government's requirements and challenges bringing the drug back to market, Hospira has decided to exit the market. We regret that issues outside of our control forced Hospira's decision to exit the market, and that our many hospital customers who use the drug for its well-established medical benefits will not be able to obtain the product from Hospira. 

####

The following article summarizes the latest developments in the lethal injection controversy and the search for appropriate drugs:

http://informant.kalwnews.org/2010/11/inside-the-evolving-market-for-lethal-injection-drugs/
November 10, 2010 | 11:43 AM

Inside the evolving market for lethal injection drugs
By Rina Palta

Lawsuits, international trade regulations, and raw material shortages are
complicating the market for drugs used in executions.

Next week, the Oklahoma's department of corrections will go to court with a
request-one that prison operators around the country will no doubt be
watching. Oklahoma officials will be asking the court for permission to use
a new execution drug: one that's generally used to euthanize animals.

Oklahoma's not the only one that's been forced to think outside the box when
it comes to finding drugs to use in carrying out lethal injections. A
nationwide shortage of sodium thiopental, a drug commonly used in the lethal
injection process, has states scrambling to find alternative sources for
their execution supplies. Which is also raising concerns about the origins
of some of these drugs-and questions about whether or not they're effective,
reliable, and have been obtained legally. Here's a state-by-state look at
the controversy.

California
California does not have any executions scheduled at the moment. The last
one, scheduled for September 30, was called off pending cases in federal and
state courts that charge the state's lethal injection process does not
adequately ensure that an inmate does not experience pain while dying. At
that time, it came out that California's stock of sodium thiopental expired
the next day, October 1. At the last minute (before the execution was called
off) the state obtained a new stock of the drug-12 grams of sodium
thiopental (enough, theoretically, for four executions) with an expiration
date in 2014. California has not said where the drugs came from-only that
they obtained the stock legally from within the United States. The
controversy here is that they could not have obtained the drugs from
Hospira, the sole US manufacturer of the drug, and the only one approved by
the Food and Drug Administration (FDA). Hospira, which says there's a
shortage of raw materials to make thiopental, has not made any since 2009.
The last batch they made carries a 2011 expiration date. As court cases
progress and executions (presumably) resume, the legal question will be
whether the state must reveal its source for the drug and whether they can
carry out an execution using drugs made by a producer that has not been
certified by the FDA.

Texas and Ohio
The states of Texas and Ohio reportedly have stockpiles of sodium
thiopental, purchased before the drug became scarce. Both will likely run
out sometime next year if Hospira does not resume manufacturing soon.

Arizona
Purchased a stock of sodium thiopental on the same day as California,
September 30. Under pressure from a court, the state revealed that it
obtained the drug from a manufacturer in England. On October 26, the state
executed Jeffrey Landrigan using the drugs from Great Britain. A federal
judge had attempted to delay the execution until she could determine the
legality of using non-FDA-approved drugs, but the US Supreme Court, in a 5-4
split decision, overruled and allowed it to go ahead. Reports from those who
attended the execution suggest that the drug appeared effective.

Tennessee
Has also reportedly turned to England in search of sodium thiopental, which
has spurned a lawsuit in the UK, where there is no capital punishment. The
lawsuit, brought about by a human rights group, asks the country's Business
Secretary to intervene and add regulations to the export of sodium
thiopental that would prevent it from being used in executions. This past
weekend, a Tennessee court granted a stay of execution to Stephen Michael
West, who was scheduled to die last night. At issue, evidence that suggests
a previously executed man may have died of suffocation instead of being
painlessly put to death by lethal injection.

Arkansas
Is reportedly not on the market for sodium thiopental, but is a source of
the drug for other states. Executions are currently on hold in Arkansas,
which reportedly prompted the state to make its supply of sodium thiopental
available to both Oklahoma, which has already made use of it, and Tennessee.

If England does halt its exports of sodium thiopental, and Hospira does not
start manufacturing again soon, it's likely more states will be following
Oklahoma's example and looking for permanent replacements for the drug.
Needless to say, court rooms will be busy.

http://www.nature.com/news/2011/110121/full/news.2011.53.html
27 January 2011 | Nature |
 
News: Explainer
Death-row drug dilemma
Lack of anaesthetic used in lethal injection exposes ethics gaps in the supply chain.
 
http://www.nature.com/news/2011/110121/full/news.2011.53.html
27 January 2011 | Nature |
By Emma Marris
 
A shortage of a drug used in executions in the United States has sent US states scrambling to find supplies, or alternative drugs. Among the 35 states in which capital punishment is legal, some — including Arizona and California — had been sourcing a key execution drug, sodium thiopental, through a company in London — until UK government officials put a stop to its export. The only US company making the drug, which sought to move its manufacturing base to Italy, has now given up producing sodium thiopental because it cannot assure Italian officials that it won't be used for executions.
 
The situation demonstrates that although pharmaceutical supply chains are global, the morals and mores of drug use are decidedly local. Will US states be forced to stop executing their death-row inmates by a drug embargo? And who decides which drugs are used to inject prisoners condemned to die? Nature explores an ethical dilemma.
 
How common is lethal injection?
 
Lethal injection is a common mode of execution in the United States. Of 1,238 executions since 1976 there, 1,064 have been by injection of lethal drugs. Outside the country, China is executing more prisoners given the death sentence by injection and fewer by firing squad. Officals there have called it "cleaner, safer and more convenient", according to a report by human-rights organization Amnesty International.
 
How was the US protocol devised?
 
A standard three-drug sequence is used in the United States to execute prisoners condemned to death. It was not developed by any scientific panel of pharmacologists or ever published in a peer-reviewed forum. Rather, it was invented by one man in 1977: then Oklahoma chief medical examiner Jay Chapman. Chapman was interested in devising a more humane alternative to the electric chair or firing squad. He chose three drugs, to be administered in sequence: sodium thiopental to render the condemned unconscious; pancuronium bromide, to paralyse the body and lungs; and potassium chloride to stop the heart.
 
Experts have challenged the protocol as administered as cruel. One study suggested that some dying prisoners are aware and suffering as their lungs and heart stop1.
 
Chapman's home-made recipe caught on, however. It is the standard for most of the US states that execute prisoners by lethal injection.
 
Why is there a shortage of sodium thiopental?
 
In recent years, sodium thiopental has been used less and less often for anaesthesia, as newer drugs have gained favour. For some time, all the sodium thiopental in the United States has come from a drug company called Hospira, based in Lake Forest, Illinois. In the summer of 2009, Hospira had to suspend production of the drug. The company that made the active ingredient — which Hospira would not name, but US Food and Drug Administration (FDA) records identify as Abbott Laboratories — stopped making it. Hospira began looking for a replacement source and was planning to move production of vials of the drug for all its markets to a plant in Liscate, near Milan, Italy.
 
Near the beginning of this year, the Italian government demanded that Hospira assure that none of the drug would be used for executions. Unable to control who buys their products and what they use them for, Hospira decided to stop making sodium thiopental on 21 January. "We cannot take the risk that we will be held liable by the Italian authorities if the product is diverted for use in capital punishment," the company said in a statement. "Exposing our employees or facilities to liability is not a risk we are prepared to take."
 
Hospira dropped the drug "with regret", according to spokesman Daniel Rosenberg, who says that it still has a legitimate medical use, although it currently accounts for less than a quarter of a percent of Hospira's sales. The decision will, however, end the company's qualms about the use of its product by prisons, which is something the company has long opposed. "We've been regularly reaching out to every state in the country to tell them that we don't approve of this use," says Rosenberg.
 
Has the shortage stopped any executions?
 
It delayed some. States had to work hard to find unexpired vials of the drug, and California and Arizona among others ended up importing some from a UK-based concern called Dream Pharma, based in west London, according to the London-based prisoner-rights group Reprieve. But on 30 November, the UK Department of Business, Innovation and Skills banned all export of sodium thiopental to the United States. "Our government is completely against capital punishment," says a spokesperson for the department. "The only trade we were doing on this drug was for capital punishment."
 
The UK government is now considering whether there is enough legitimate trade in the two other drugs that are used in the US execution protocol to warrant keeping their export uncontrolled. (Pancuronium bromide, for instance, is used as a muscle relaxant.) Meanwhile, companies and government officials in Germany have come together against supplying the United States with any sodium thiopental for executions, according to the Associated Press.
 
Did the FDA 'help' states obtain sodium thiopental?
 
Not according to a spokesperson — but they didn't hinder the states either. They did not interfere with the importation of the drug from the United Kingdom, despite knowing where the drug was headed. A spokesperson says: "In 2009 and 2010, FDA permitted the importation of several shipments of sodium thiopental to state Departments of Correction. In doing so, FDA deferred to law enforcement in the use of substances for lethal injection, which is consistent with the agency's long-standing policy. The agency did not conduct any review of these products for safety, effectiveness or quality."
 
Now that Hospira has stopped making the drug and the United Kingdom has controlled export, will a lack of sodium thiopental end lethal injection in the United States?
 
Unlikely. States may be able to source the drug from countries less squeamish about its end use. Or, more likely, they will follow the lead of Oklahoma, which has recently switched to using pentobarbital in place of sodium thiopental. Pentobarbital is made by only one company in the United States, Lundbeck, based in Deerfield, Illinois, and owned by Copenhagen-based company H. Lundbeck.
 
A spokeswoman for Lundbeck, Sally Young, seemed horrified on Wednesday that her company's product had almost surely been used as part of the process to execute three prisoners in Oklahoma. She only learned of the use from reporters. "We do not in any way promote any off-label use of the product," she says. "The use of our product to end lives contradicts everything we are in business to do."
 
With both its active ingredient supplier and wholesale manufacturer in the United States, Lundbeck may not face any disruptions of its supply chain on moral grounds, as Hospira did.
 
Young says Lundbeck has sent a letter to the state of Oklahoma formally objecting to the use of pentobarbital in executions, but "from a legal perspective, we can't control that".
 
If the FDA won't and the manufacturer can't stop a drug from being used in executions, who in the United States can?
 
A manufacturer can stop a drug being used for executions by ceasing to make it, although this will also affect any patients using the drug medicinally. Manufacturers sell to wholesalers, or sometimes direct to pharmacies. Then drugs are prescribed by a doctor and dispensed by a pharmacist, and it is these two professionals who ultimately bear the onus of deciding whether the use of a drug is appropriate. The American Medical Association has forbidden its members from participating in executions, so any medical professionals who order drugs for executions do so at the risk of their professional reputations (see 'Will medics' qualms kill the death penalty?').
 
Oklahoma's Department of Corrections (DOC) spokesman Jerry Massie says that they obtained pentobarbital from "a private pharmacist" who is being kept anonymous for fear that he will be a target for attacks. The transaction is apparently in cash, and no receipt is filed. "He just obtains it and we pick it up from him," says Massie. "No prescription or anything."
 
Phil Woodward, executive director of the Oklahoma Pharmacists Association, says that according to the Oklahoma Pharmacy Practice Act, "a pharmacist would need a prescription from a physician" before dispensing the drugs. "So somewhere within the DOC, a physician would still have to submit an order for this product." As to whether the anonymous pharmacist acted ethically, Woodward says, "Our association has never taken a stand one way or the other on this matter."
- - - - -
References
1. Koniaris, L. G., Zimmers, T. A., Lubarsky, D. A. & Sheldon, J. P. Lancet 365, 1412-1414 (2005). |
 

ADDITIONAL RESOURCES
New Execution Protocols

Delaware's new execution protocol (Aug. 31, 2007)

Ohio's new execution protocol (Jan. 2008) (revised 2009; now a 1-drug protocol with a backup plan if IV cannot be inserted)

Georgia's new execution protocol (June 7, 2007) - provides for physician assistance with execution

California's proposed Lethal Injection Protocol (May 15, 2007).

Florida's new Lethal Injection Protocol (May 9, 2007)

Tennessee's new Lethal Injection Protocol (April 30, 2007)

South Dakota's new execution protocol (Aug. 8, 2006; rev, July 1, 2007)

U.S. Military's new execution protocol (Jan. 2007)


Articles and Reports


Legal Resources


DPIC Resources

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