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March 27, 2012

"U.S. judge bars import of drug used in death penalty"

The title of this post is the headline of this new Reuters report on a seemingly significant ruling coming from the DC federal district court today. Here are the details:

A U.S. judge on Tuesday barred U.S. authorities from importing an anesthesia drug used in carrying out death sentences because the Food and Drug Administration never approved the drug for use in the United States, and he ordered supplies be confiscated.

A group of death row inmates had sued the FDA last year over improperly allowing shipments into the country of sodium thiopental, a sedative used as the first of three drugs administered in carrying out executions.

A year ago, state officials in Tennessee and Kentucky turned over their supplies of the drug to the FDA amid an investigation into how it was imported. U.S. authorities seized a supply of thiopental from state of Georgia. The FDA had sought to have the challenge dismissed, arguing that it was using its discretion by allowing the shipments into the country and also that it deferred to law enforcement with respect to the drugs used for executions.

U.S. District Judge Richard Leon sided with the inmates, criticizing the FDA for departing from its longstanding practice of not allowing unapproved drugs into the United States. "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!" Leon wrote in his 23-page opinion.

He also ordered that the FDA notify all state correctional departments with thiopental made overseas that they are not allowed to use it and that they must return their supplies to the agency immediately.  With the supply of thiopental dwindling, Leon noted, some states have switched to pentobarbital to sedate death row inmates before they are injected with the cocktail of other drugs used to carry out death sentences....

Fordham University law professor Deborah Denno called the decision "very important" and said if the thiopental was obtained from overseas, "we don't know the conditions under which those drugs were housed and transported, which could affect their quality."

A spokesman for the Justice Department, which represented the FDA in the case, declined to comment. The agency could appeal. Bradford Berenson, a lawyer for the death row inmates, said: "It's unfortunate that FDA behaved as if there were some kind of death penalty exception to the clear requirements of federal law but gratifying that a federal judge recognized that no such exception exists."

The case is Beaty et al v. Food and Drug Administration et al in U.S. District Court for the District of Columbia, No. 11-cv-289.

Via this post about the ruling appearing at The BLT, I can here link to the full Beaty opinion.  As the opinion notes, a few of the states with the most upcoming serious execution dates (Ohio, Oklahoma and Texas) have recently stopped using thiopental, so the impact of this ruling may not be profound nationwide.  But it will be interesting to see if the FDA will appeal and/or if state who still rely on thiopental in their execution protocols will now be subject to inquiry and litigation concerning the source of this drug.

March 27, 2012 at 05:42 PM | Permalink

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Comments

Hmm now this is funny and also something i saw coming!

people are getting few up with the two-faced conduct by our govt!

if we can't do it. YOU CAN'T EITHER!

they have been speindng million every year for the last little while about how dangerous it is to import drugs from outside the united states then they go and do it!

sorry nope!

Posted by: rodsmith | Mar 27, 2012 9:12:25 PM

These are not drugs, which have to be safe and effective against disease. These poisons. They have to be lethal, like bug spray or weed killer. This is yet another lawyer fiction, that these are drugs subject to FDA oversight. They are more subject to Agriculture department oversight, as effective poisons against a pest. I strongly urge prison officials and states to simply ignore this decision.

I also urge the states and prison officials to begin to manufacture these poisons in their prison industry sections. Find chemistry majors convicted of running meth labs, and have them apply the recipe to produce thiopental. Method from a recent patent:

http://www.google.com/patents/US5274093?printsec=description#v=onepage&q&f=false


Of course, obtain consent from the patent holder. If refused,, use he 1935 patented method of manufacture.

Posted by: Supremacy Claus | Mar 27, 2012 10:12:12 PM

maybe so SC but right now the FDA considers them drugs and even tried to waive contols on them where they NOW require a permit to import them after being APPROVED. Just as american verison NOW require approval.

IF the govt though it had the right to use them however they wish seems to me it would be easy enough to get some local .

Posted by: rodsmith | Mar 28, 2012 1:12:53 AM

Another RADICAL LEFT judge which will be overturned. All drugs are becoming produced overseas. The DEMS are clamoring to allow drugs in from CANADA and MEXICO - its so cheap...but not execution drugs. What logic! This judge is a loon. All I want to know is when will a conservative start a pharma company to soley produce these drugs here. Start a small comp and supply this niche market.

Posted by: deano | Mar 28, 2012 8:50:06 AM

What's most striking is the near-total failure to cite case law for the judge's main propositions. Looks like he phoned this one in...

Posted by: Anyone | Mar 28, 2012 10:50:44 AM

Judge Leon makes a point that is simple. The label on a foreign drug may say it is sodium thiopental but the vial might contain nothing but distilled water or some inert chemical that does not anesthetize. When the FDA allowed the importation of this thiopental, it had no idea what was in the vials. FDA is not supposed to allow the importation or use of drugs that might be phoney.

In states where the lethal injection protocol includes a physical consciousness check, the use of phoney, non-anesthetizing thiopental would be caught before the next drugs are injected, but the state will have gone to great expense and effort but be unable to complete the execution. In states where the protocol does not include a physical consciousness check, the execution would continue but would violate the 8th amendment.

Posted by: arfarf | Mar 28, 2012 10:58:35 AM

"callous indifference to the health consequences of those imminently facing the executioner's needle"

This is a very strange sentence, considering that the sole purpose for which these drugs are being imported and used is to end condemned murders' lives and health altogether.

But let's say arfarf is right, and that there's a legitimate -- as opposed to phony or entirely speculative -- concern about the authenticity and efficacy of the anaesthetizing agents. How does that get one past the Baze standard? And, even if we assume for argument's sake that states that don't include a consciousness check in their protocols have a problem, what's the basis for hindering states that do provide for consciousness checks? If a state that requires consciousness checks uses a sedative that doesn't do the job -- for any reason -- and therefore "will have gone to great expense and effort but be unable to complete the execution," that's a problem the state would be willing to accept. Why is it a reason to bar states from even trying, when there's no particularly good reason to believe that the drugs won't work as intended, and particularly in states that do consciousness checks to ensure that the drugs are working as intended?

Posted by: guest | Mar 28, 2012 11:33:03 AM

the problem guest is it doens't have to pass the "baze standard" it's first got to pass the smell test!

Right now it flunks!

the u.s govt is spending millions a year telling almost 400 million americans NOT to import drugs becasue they are uncontroled, unapproved and DANGEROUS...

then the govt wants to do it!

sorry NOPE!

Posted by: rodsmith | Mar 28, 2012 2:13:13 PM

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