States Depend on Unapproved Foreign Drugs for Executions

PHOTO Although the company is called Dream Pharma, it operates out of the back of a driving school, which is a separate business.
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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.

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