By Jonathan Allen and Peter Szekely
(Reuters) – A U.S. District Court judge in Washington ruled on Thursday that the Justice Department’s new lethal injection protocol violated drug safety laws and ordered a planned execution for Friday to be halted.
Since resuming federal executions after a 17-year hiatus in July, the Department of Justice has been injecting condemned inmates with lethal doses of pentobarbital, a highly regulated barbiturate. The department executed three murderers in July and a fourth on Thursday and had planned to execute Keith Nelson on Friday.
U.S. District Judge Tanya Chutkan ruled that the department was breaking the Food, Drug, and Cosmetic Act (FDCA) by administering the pentobarbital without a medical practitioner’s prescription, agreeing with death row inmates who sued the government.
“Where the government argues that a lethal injection drug is legally and constitutionally permissible because it will ensure a ‘humane’ death, it cannot then disclaim a responsibility to comply with federal statutes enacted to ensure that the drugs operate humanely,” Chutkan wrote in a 13-page opinion.
Because pharmaceutical companies refuse to sell pentobarbital for use in executions, the Justice Department has said it is instead paying a pharmacist in secret to mix up small batches of the drug.
Chutkan ruled that this also violated the FDCA, which forbids pharmacists from making copies of drugs already available on the market after having received safety approval from the Food and Drug Administration.
Justice Department lawyers immediately asked the U.S. Court of Appeals for the District of Columbia Circuit to overturn Chutkan’s ruling.
That court has previously ruled that execution drugs are at least partly governed by drug safety laws. In 2013, it upheld an order, which continues to bind the FDA, that stopped imports of sodium thiopental that were headed to state execution chambers.
Prior to July, there had been only three federal executions since 1963, all between 2001 and 2003, all using sodium thiopental. As supplies of that drug vanished, Texas, Missouri and other states that use capital punishment switched to using pentobarbital, and the Justice Department announced last year it would follow suit.
Chutkan ruled that Nelson’s execution by lethal injection could proceed if the Justice Department avoided copying FDA-approved drugs and had a physician-issued prescription in the condemned prisoner’s name. The American Medical Association and other clinicians’ groups have said enabling an execution is against medical ethics.
The Justice Department has said it is necessary to promise secrecy to its pentobarbital suppliers. Soon after President Donald Trump’s inauguration in 2017, the department spent two years building a small network of companies to make and test the drug, a Reuters investigation found.
Nelson, convicted of raping and murdering 10-year-old Pamela Butler in Kansas in 1999, is one of 16 inmates on federal death row who sued the Justice Department over its lethal injection protocol.
Chutkan issued orders blocking the inmates’ executions while the litigation continued, which were swiftly overturned by the U.S. Supreme Court earlier this year, and three of the plaintiffs have since been executed by the defendants.
(Reporting by Peter Szekely; Editing by Toby Chopra and Bernadette Baum)
