Thiopental controversy: Shame on the FDA; Tough luck to the dead.

Good for the AZ Republic for staying on top of this..

----------------------

Judge: FDA allowed state to illegally gain execution drug

   Michael Kiefer

Mar. 27, 2012 10:48 PM

The Arizona Republic

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.

E-mails detail FDA's efforts to avoid responsibility regarding execution drug
Arizona Supreme Court puts off date for execution
State Supreme Court weighs killer's execution as FDA exits dispute over drug
 
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

Chuck Ryan testifies on execution drugs.

I believe this is being held in the Sandra Day O'Connor Federal Courthouse on W. Washington, for those interested in following it.

---------as reported on KTAR.com---------

Lawyers say Arizona not following execution rules

by Associated Press (December 5th, 2011 @ 9:09pm)

PHOENIX - Lawyers for Arizona death-row prisoners said Monday the state is using unvetted personnel to administer lethal injections under a sheet, away from witnesses' view, despite promises to a judge that those practices would stop.

U.S. District Judge Neil Wake, who signed off on the constitutionality of the state's step-by-step execution protocol two years ago, is now being asked to impose restrictions because of how the state is actually implementing key provisions.

Wake ruled in 2009 that lawyers in a different case hadn't shown that inmates' constitutional protections against cruel and unusual punishment were substantially jeopardized by execution processes that the attorneys argued might cause pain or other suffering.

During opening statements in the new trial that began Monday, inmate attorney Cary Sandman told Wake that previous assurances by Corrections Director Charles Ryan that the state would follow its protocol have proved unreliable.

With promises made and not kept, ``you've misled this court, the parties and the public,'' said Sandman, a federal public defender.

Ryan, who was the first witness to testify, acknowledged that his department failed to conduct required criminal background checks of execution team personnel. The failure, he said, was not intentional.

But Ryan said it's hard to recruit qualified injection-team personnel so he used his discretion to select a member, a department sergeant who was a military medical corpsman years ago but who doesn't have current experience in starting intravenous feeds.

The protocol requires that injection-team members have that experience as a primary part of their current job responsibilities.

Similarly, Ryan also testified that he used his discretion to let a physician who has been the injection team's leader for the past five executions to decide to use groin-area injections instead of injections in a limb such as an arm, as called for in the protocol.

Arizona, like many other execution states, previously used injections in inmates' arms, but the doctor said groin-area injections are more reliable, Ryan said.

And it's enough that the warden in the injection room could see the injections and alert the injection team to any problems, while a sheet draped over most of the inmate's body blocked it from the view of witnesses in an adjacent room, Ryan said.

Ryan said he didn't intentionally mislead Wake in a 2009 affidavit in which Ryan said the state would comply with the written protocol's terms.

The corrections director said the protocol itself authorized him to alter implementation. ``So I don't see that as requiring a need to advise the court that discretion may in fact be used,'' he said.

Wake did not comment during the beginning of the trial on the argument by the attorneys for the inmates that he'd been misled when he considered the protocol in 2009.

Initial testimony also focused on the state's acquisition of a formerly widely used but federally unapproved execution drug from a seller in Great Britain.

Inmate attorney Dale Baich said the state's willingness to skirt accepted procedures in getting the drug ``does not give confidence that executions will be carried out in a humane and safe manner.''

Assistant Attorney General Jeff Zick said in his opening statement that all the allegations hadn't resulted in any proof that inmates were actually subjected to substantial risks, whether from drugs or procedures used.

``Some deviations were intentional, some known and some were simply done by oversight,'' the government lawyer said.

During cross-examination by Zick, Ryan testified that no inmates complained of pain or discomfort before the past five executions conducted since Wake's 2009 ruling.

In fact, the director said, the inmates appeared comforted by the injection team's leader explanations of what he was doing. ``I believe he instilled confidence in the inmates who were to be executed,'' Ryan said.

The identity of the injection team leader and others participating in executions are confidential under state law.

Sandman asked Wake to order the state to either follow the protocol or provide details on deviations before an execution is conducted. He also said the court should appoint a monitor to ensure compliance and that the state should be barred from acquiring unapproved execution drugs.

The trial is expected to continue Wednesday and Thursday, and Wake said he try to rule in the next week or two.