Nebraska's planned use of a lethal injection drug made by an overseas manufacturer was thrown in doubt Tuesday following a ruling by a federal judge in Washington.
U.S. District Judge Richard Leon said the Food and Drug Administration ignored the law in allowing foreign-made sodium thiopental into the country. He ordered the FDA to immediately notify any state correctional departments with foreign-manufactured sodium thiopental that its use is prohibited by law and that the drug must be returned to the FDA.
"It is hereby ordered that the FDA ... immediately notify any and all state correctional departments which it has reason to believe are still in possession of any foreign manufactured thiopental that the use of such drug is prohibited by law and that, that thiopental must be returned immediately to the FDA," Leon wrote, "and ... be permanently enjoined from permitting the entry of, or releasing any future shipments of, foreign manufactured thiopental into interstate commerce."
Sodium thiopental has been in short supply since 2010, when the only U.S. manufacturer, Hospira Inc., ended production because of death-penalty opposition from overseas customers.
Nebraska prison officials recently bought a supply of the drug made by a Swiss company.
Shannon Kingery, spokeswoman for the Attorney General, said: "We have not seen this court's decision, but the U.S. Supreme Court previously rejected similar arguments by death row inmates."
Late last year, Nebraska prison officials said they bought sodium thiopental made by Naari, a pharmaceutical company headquartered in Switzerland. In fact, they bought the drug from a middleman named Chris Harris, who had bought it from Naari and then sold it to the state.
Attorney Jerry Soucie of the Nebraska Commission of Public Advocacy has been arguing that Nebraska should not be allowed to use the sodium thiopental made by Naari.
Soucie, who represents death-row inmate Michael Ryan, declined immediate comment on Tuesday's ruling.
Soucie has said Harris and his company, Harris Pharma LLP, were not authorized to sell the drug, which were samples meant for use in testing. That, he contends, means Harris misappropriated the thiopental from Naari, and Nebraska prison officials are in possession of stolen property.
Nebraska is among 10 states that have purchased the drug from foreign sources. The U.S. Drug Enforcement Administration has seized supplies from several because they were imported illegally or because of questions over how they were manufactured. Nebraska twice has bought sodium thiopental made overseas. The DEA did not seize the first batch but told the state it could not use it because it was imported illegally. Nebraska then got a proper import license and bought the supply from Harris.
Judge Leon sided with lawyers for death row inmates in Tennessee, Arizona and California who want to keep out sodium thiopental, because it is an unapproved drug manufactured overseas. The Obama administration argued the FDA had discretion to allow unapproved drugs into the United States.
But Leon said the FDA's actions were "contrary to law, arbitrary, capricious and an abuse of discretion." He said that plain language of the law says an article that appears to be misbranded or unapproved "shall be refused admission."
Sodium thiopental recently became even harder to get after the European Union instituted a rule prohibiting the export of some barbituric acids, including sodium thiopental.
Nebraska's three-drug protocol calls for a dose of sodium thiopental to render the inmate unconscious, followed by pancuronium bromide to paralyze him or her, then potassium chloride to stop the heart.
Leon scolded the FDA, saying: "Put simply, this appears to be nothing more than the FDA, once again, stubbornly clinging to every last ounce of its discretionary authority!"
The FDA declined to comment on the ruling or say whether it planned to appeal.
Leon also said the FDA was undermining its own policy of maintaining a closed drug distribution system designed to keep dangerous drugs out of U.S. commerce.
"By opening up the 'closed' drug system by allowing an unapproved drug -- thiopental -- into the United States, defendants jeopardize their own system and threaten the public health by creating a risk that thiopental could incorrectly end up in the hands of the general public," he wrote.
Ryan was convicted in the cult-related 1985 killings of James Thimm, 26, and Luke Stice, 5, near Rulo and was sentenced to death for Thimm's murder.