Twenty-one death row inmates won an order barring use of sodium thiopental, an imported drug given as anesthesia prior to administration of lethal injections.
U.S. District Judge Richard Leon in Washington today ruled that the federal Food and Drug Administration violated its own rules by allowing entry of the drug into the country without first ensuring its efficacy.
“Prisoners on death row have an unnecessary risk that they will not be anesthetized properly prior to execution,” Leon wrote in a 22-page ruling, adding that the agency had created a “slippery slope” for entry of other unapproved drugs.
In an accompanying two-page order, the judge banned the import of thiopental, calling it a misbranded and unapproved drug, and directed Arizona, California, Georgia, South Carolina and Tennessee and any others with stocks of the barbiturate to send them to the FDA.
Attorneys for the inmates had argued that use of the drug during execution could lead to so-called anesthesia awareness, in which they may experience suffocation, pain and cardiac arrest.
The shipments of thiopental entering the U.S. originated from an Austrian facility owned by Sandoz International GmbH, a German company, according to the complaint. The drug was shipped to the U.S. from a London wholesaler, Dream Pharma Ltd., the inmates said.
Dream Pharma bought the drug from a unit of Archimedes Pharma Ltd., a closely held company based in Reading, U.K., according to the complaint.
The FDA countered that release of the imported drug within the U.S. was an act of enforcement discretion, and that “reviewing substances imported or used for the purpose of state-authorized lethal injection clearly falls outside of FDA’s public health role,” according to Leon’s ruling.
The judge heard arguments from both sides on Feb. 9.
Leon said there was no dispute that the FDA hadn’t reviewed foreign or domestic thiopental for safety and effectiveness. Because it was unapproved, the federal Food, Drug and Cosmetic Act required the agency to bar its import, he said.
Shelly Burgess, a spokeswoman for the FDA, said she couldn’t immediately comment on the judge’s decision.
The case is Beaty v. Food and Drug Administration, 11-cv- 289, U.S. District Court for the District of Columbia (Washington).
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