As reported in previous editions of Project Press, shortages of drugs used in lethal injections began in 2011 when Hospira Inc., the sole U.S. manufacturer of sodium thiopental, announced that it would no longer produce that drug, and Lundbeck, the Danish manufacturer of pentobarbital, placed restrictions on the distribution of pentobarbital to prevent its sale to any prison or corrections department in the United States. Several states have reacted to the shortage of sodium thiopental by switching to a single-drug protocol, most commonly using large doses of pentobarbital. Other states have introduced legislation changing their protocols to use unknown and untested procedures and drugs. For example, Georgia changed its execution protocol from a three-drug combination to a single-drug method using pentobarbital in July 2012.
The State faced numerous legal challenges to this change in the weeks before its scheduled executions of prisoners Warren Hill and Andrew Cook. Mr. Hill first challenged Georgia's revised protocol on administrative grounds, which the Georgia Supreme Court dismissed on February 4, 2013. The court found that the corrections department's decision to replace a three-drug execution cocktail was not subject to the Administrative Procedure Act, which requires a public hearing before any such change may be made. Georgia then rushed to execute the two men before its stockpile of pentobarbital expired at the end of February 2013. On February 20, 2013, lawyers for Andrew Cook and Warren Hill filed appeals contending that their executions should be stopped because the pentobarbital was dispensed without a prescription. The next day, the Georgia Supreme Court dismissed both Mr. Cook's and Mr. Hill's stays related to the prescription drug issue, and Mr. Cook was executed a few hours later. Mr. Hill was granted a stay on separate grounds.
Separately, on March 26, 2013, the Georgia legislature approved a measure to keep secret the identities of the companies that provide drugs for executions. Information about lethal injection drugs, such as the expiration dates, could be withheld from the public if Governor Nathan Deal signs House Bill 122. The proposed law would also make the identities of those who make and supply the lethal injection drug a "confidential state secret," giving Georgia the discretion to withhold the information.
Like Georgia, Arkansas also revised its lethal injection protocol after the Arkansas Supreme Court struck down the previous lethal injection law last year. The court held that the law violated the separation of powers delineated in the Arkansas Constitution by delegating the power to choose the lethal injection drug to the Department of Corrections. In February 2013, the Arkansas legislature passed a law amending its execution protocol, detailing the procedures that must be followed, including that the state must use a lethal dose of a barbiturate. The new law, however, still allows the Department of Corrections to determine which drug to use. While the new law would allow Arkansas to resume executions, litigation regarding access to information about the drugs is likely to continue. In another parallel to the developments in Georgia, an Arkansas trial court ruled on March 26, 2013, that death-sentenced persons cannot use Arkansas' open records law to obtain information about the origin and history of the drugs.
Missouri also announced plans in 2012 to switch to a one-drug protocol using propofol, a drug that has never before been used for executions and is best known for the role it played in Michael Jackson's death. This change, however, may also be thwarted by the actions of a pharmaceutical company. Teva Pharmaceutical Industries LTD announced in March 2013 that it plans to control the distribution of propofol to prevent the drug from being used in U.S. executions. Hospira, which is also licensed to sell propofol in the United States, has not announced similar restrictions on the distribution of propofol but is currently receiving pressure from its investors to put such restrictions in place.
Last year, a federal district court issued an order stating that the U.S. Food and Drug Administration (FDA) had a mandatory duty to ban importation of sodium thiopental because it is produced overseas and not approved for use in executions. The court also ordered the FDA to notify state corrections departments that they must turn over their stockpiles of the drug. The U.S. Court of Appeals for the D.C. Circuit recently heard oral arguments in the Justice Department's appeal of last year’s ruling. A Justice Department lawyer urged the court to allow the FDA to import the drug, arguing that it is within the agency's discretion to allow for the importation of some foreign drugs even when they have not received regulatory approval.