The U.S. Food and Drug Administration violated the law by allowing Arizona and other states to bypass regulations and import unapproved drugs to carry out executions, a U.S. District Court judge ruled Tuesday.
The ruling came in a lawsuit filed on behalf of three Arizona death-row inmates -- two of whom have already been executed -- and inmates in Tennessee and California.
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Judge Richard Leon of the U.S. District Court for the District of Columbia ordered the FDA to notify state corrections departments, including Arizona's, that they must surrender the drug, sodium thiopental, to the FDA. He also barred any future shipments from entering the country.
Leon called the FDA's decision to allow such shipments "contrary to law, arbitrary, capricious and an abuse of discretion."
However, his ruling established no penalties for the FDA's conduct and will not affect Arizona's execution schedule or procedures.
His ruling comes 18 months after The Arizona Republic disclosed that the Arizona Department of Corrections had obtained the drug from a supplier in Great Britain.
That discovery set off an international furor in which Britain and Italy shut down exports of thiopental.
The Corrections Department fought to conceal how it obtained the drug, but the FDA ultimately was identified as the agency that allowed -- even assisted -- the illegal importation.
Eventually, the federal Drug Enforcement Administration confiscated the drug from several states and informed Arizona that it could not be used in subsequent executions.
The state has since altered its execution protocol to include a different drug.
In his ruling, Leon wrote, "In the final analysis, the FDA appears to be simply wrapping itself in the flag of law-enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the executioner's needle. How utterly disappointing!"
Neither the FDA nor the Arizona Attorney General's Office responded to requests for comment Tuesday.
Dale Baich of the Federal Public Defender's Office in Phoenix, one of the principal attorneys on the case, said he was not surprised by the ruling.
"The law is quite clear that unapproved drugs cannot be imported. The FDA went above the law in allowing these drugs into the country," Baich said. "We brought the illegal-importation issue to the attention of the Arizona Department of Corrections and the FDA almost two years ago, but we were ignored."
Corrections officials said Tuesday that they are no longer in possession of the thiopental, which is still listed as an option in its execution protocol.
Thiopental is a short-acting barbiturate that was used as part of a three-drug, lethal-injection cocktail. It served as anesthesia before a paralyzing drug and a heart-stopping drug were administered. But the sole U.S. supplier of thiopental stopped producing it in 2009 because it had largely been replaced in hospitals by more modern drugs.
The thiopental shortage became apparent in May 2010, when Ohio had to scramble to obtain enough to carry out an execution. That September, the Arizona Department of Corrections, following the lead of other states, obtained the drug from a supplier in London that was not authorized to export it to the U.S.
The Republic first reported the questionable import in October 2010, the day before it was used to execute Jeffrey Landrigan. That information caused the British and Italian governments to stop exports of thiopental to the U.S. for use in executions. It is illegal for anyone in the European Economic Community to assist in capital punishment in other countries.
The FDA initially told The Republic that there was no legal mechanism to import the drug. The state Corrections Department repeatedly denied that it had gone outside legal channels to obtain it. Then, in December 2010, an FDA spokeswoman told The Republic that it would exercise "enforcement discretion" on the matter.
But e-mails obtained by The Republic under the federal Freedom of Information Act showed that FDA officials had allowed the shipments. Many of the e-mails had been redacted, but the encryption had failed, revealing that the FDA, with the approval of unnamed people at the White House, shifted responsibility for allowing the drug's import to U.S. customs officials.
That was done to avoid legal liability and to shield the FDA from any appearance of involvement with the death penalty. The FDA asked The Republic to return the unredacted e-mails. The newspaper declined.
One high-placed FDA official wrote in November 2010 that even if the agency issued a statement that it had not reviewed the drugs for "safety, efficacy or quality ... it will insert FDA into the death-penalty cases because attorneys will try to use the statement as a means to open proceedings on the safety of the imported drugs."
In a separate court proceeding in U.S. District Court in Phoenix last December, a former state Corrections official testified that a local FDA employee counseled him on how to lessen scrutiny of the foreign shipments and ease them past U.S. customs officials. In a videotaped deposition, the FDA official denied giving such advice. But his assistance in obtaining the drugs was interpreted as FDA "approval."
In April 2011, the drug was seized from some states by the DEA, and in June 2011, Arizona was told it could not use its supply. That came one day before the execution of Donald Beaty, the lead defendant in the lawsuit against the FDA.
Beaty was executed using a different drug, pentobarbital, which most states have adopted. Arizona's two most recent executions were carried out using only pentobarbital because the state Corrections Department had inadvertently let one of the other drugs in its three-drug protocol pass its expiration date.
In his ruling Tuesday, Judge Leon noted that the imported thiopental was a "misbranded and unapproved new drug," which by law cannot be distributed in the U.S. without FDA approval.
"No one is above the law -- not the Arizona Department of Corrections, not the FDA," Baich said. "The federal court, relying on the judgment of Congress, has sent a clear message that it is illegal to import drugs that have not been approved by the FDA. The states that have imported non-FDA approved drugs are now on notice that those drugs are illegal."
The Associated Press contributed to this article