States Depend on Unapproved Foreign Drugs for Executions

Feb. 8, 2011 -- Arizona death-row inmate Daniel Wayne Cook fears that when the day of his execution arrives, he will be put to death with a drug from a supplier who works out of a rented space at the rear of a West London driving school called the El Gone Driving Academy.

Because of a U.S. shortage of sodium thiopental, which is the first of three drugs used for most lethal-injection executions, some states have resorted to importing the drug from foreign sources.

Cook, convicted of a double murder in 1987, has filed suit in federal court, concerned that the non-FDA approved drug from Dream Pharma, the little-known West London supplier, might lead to pain and distress at his execution.

The lone U.S. supplier of the drug stopped production in 2009 and several of the 35 states that allow lethal injection have found themselves in short supply. The shortage has raised concerns about whether the drug should be imported from foreign sources at all or whether states should change their protocols to allow for the use of more readily available drugs.

Thiopental is used to induce a coma-like unconsciousness. It is followed by injection of another drug that paralyzes the inmate and a third that induces cardiac arrest. If the first drug is ineffective, a prisoner might feel tremendous pain by the time the third drug is injected.

Challenges are popping up across the country from death-row inmates who say that importing the drug from relatively unknown suppliers such as Dream Pharma means a lack of U.S. regulation and the reality that the drug might not work effectively, causing a prisoner to experience a cruel death.

But such challenges have largely failed in court. In one case, a U.S. District Court judge delayed the execution of Jeffrey T. Landrigan, expressing concern about the origins of the sodium thiopental.

"The Court concludes that use of sodium thiopental from a non-FDA approved source raises issues regarding its efficacy and possible side effects," Judge Roslyn O. Silver wrote.

No Review of Quality and Purity

But a 5-4 divided Supreme Court eventually reversed the ruling, finding, "There is no evidence in the record to suggest that the drug obtained from a foreign source is unsafe."

Landrigan was put to death with drugs obtained from Dream Pharma.

Lawyers for Cook and five other death-row inmates have taken a different tack. They have filed suit against the Food and Drug Administration and the Department of Health and Human Services, arguing that the FDA should prohibit the importation of the drug.

Bradford A. Berenson, a lawyer from the firm of Sidley Austin who is representing the inmates, argues that the FDA is violating federal law and its own prior policies by allowing the importation of the unapproved drug.

"Whatever one's views may be on the death penalty, no reasonable person is in favor of botched or inhumane execution," Berenson said.

FDA spokesman Christopher Kelly refused to comment, citing the pending lawsuit.

Barrett Marson, a spokesman for the Arizona Department of Corrections, said the state's entire supply of thiopental comes from Dream Pharma. In an affidavit, Charles L. Ryan, the director of the Arizona Department of Corrections, certified that the FDA had "cleared and approved" the process of shipping and receiving the chemicals.

But, lawyer Berenson said, while the FDA has facilitated the entry of the drugs into the United States, it is doing nothing to review their quality and purity.

In court papers, Berenson wrote, "if the anesthetic is ineffective, counterfeit, adulterated or subpotent, then the three-step protocol will result in the condemned prisoner experiencing the severe pain and distress associated with paralysis, respiratory arrest, and cardiac arrest."

The drug was developed by Abbott Laboratories in the 1930s and produced until about 2004, when Abbott spun off a new company called Hospira Inc. Hospira announced in January 2010 that it would permanently discontinue production.

As states run out of the drug, they have struggled with how to carry out lethal injections. And opponents of the death penalty want more information about how many states have actually imported it from foreign sources.

States Appeal to Attorney General

"We are operating under a bit of a knowledge vacuum, we don't know if other states are obtaining it," Megan McCracken of the Berkeley Law Death Penalty Clinic said.

Through open records requests, McCracken has determined that at least six states have imported their supply. Those states are Arizona, California, Arkansas, Georgia, Tennessee and Nebraska.

"The impact of the drug shortage will be different in every state," she said. "Some states have supplies of the drug, and it's unclear if they will be able to use the foreign version. Some have the domestic product but that will most likely expire by the end of March."

Two states, Oklahoma and Ohio, have already changed their drug protocols. But in other states, such a change could take months and lead to delays in executions.

"Some states are able to change their protocol with no oversight, and no requirements that they have a public hearing, other states are required to go through more of an administrative process, " McCracken said.

Richard Dieter, executive director of the Death Penalty Information Center, which opposes the death penalty, said, "If these drugs were used for any other purpose, such as hospital or prescription use, there would clearly be FDA control.

"There is still the requirement that executions be carried out humanely. There has been a complete absence of supervision and that could be dangerous. "

The attorneys general of 13 states wrote a letter Jan. 25 to U.S. Attorney General Eric Holder asking for his assistance in identifying an approved source of the drug or making supplies held by the federal government available to the states.

The letter states that many jurisdictions will soon be unable to perform executions in cases where appeals have been exhausted and governors have signed a death warrant.