Death-Penalty Drug Import Ruled Illegal by Appeals Court

A drug used in U.S. executions, sodium thiopental, can’t be imported because it lacks Food and Drug Administration approval, a federal appeals court ruled in a lawsuit filed by death row inmates.

The U.S. Court of Appeals in Washington, in a decision issued today, upheld a lower court ruling that permanently blocked the FDA from allowing imports of “apparently misbranded or unapproved thiopental.”

The FDA violated its duties “by permitting the importation of thiopental, a concededly misbranded and unapproved new drug, and by declaring that it would not in the future sample and examine foreign shipments of the drug despite knowing they may have been prepared in an unregistered establishment,” U.S. Circuit Judge Douglas Ginsburg wrote for the three-judge panel.

The impact of the ruling on executions is unclear because the panel, reversing part of the lower court’s decision, said states aren’t obliged to turn in their stocks of sodium thiopental to the FDA. The existing quantities and expiration dates are unknown, said Megan McCracken, an attorney with the Death Penalty Clinic at University of California Berkeley School of Law.

In addition, some states have changed execution protocols to use other drugs, she said in an interview.

Six states -- Arizona, Arkansas, California, Georgia, South Carolina and Tennessee -- received the shipments of sodium thiopental at issue in the complaint. As they weren’t part of the suit, the court can’t require them to give up the drug, Ginsburg wrote.

Curtis Allen, an FDA spokesman, didn’t immediately respond to an e-mailed request for comment on the decision.

“The takeaway message is that nobody is above the law,” said McCracken. “You can’t violate the law in the name of carrying out the law.”

The case is Cook v. U.S. Food and Drug Administration, 12-05176, U.S. Court of Appeals, District of Columbia (Washington).

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