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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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October 27, 2010

Lethal Injection: A Case For the FDA?

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Posted by Derek

I had trouble believing this headine today, but it's a real one. A convicted murderer was set to be executed in Arizona, but there's apparently been a shortage of sodium thiopental, which (I have to say) I didn't know was the preferred drug for this use. The Arizona authorities imported some from Great Britain, whereupon the convicted man's lawyers got a stay of execution, on the grounds that this particular material had not been FDA-approved.

Well, that's a new one. The idea that a drug being used to kill someone has to be properly evaluated for safety and efficacy is not one that would have occurred to me, but then, I'm not a lawyer. Thiopental, I should add, is not exactly an experimental drug. It's a short-acting barbituate that's been around forever as an anaesthetic. It has one supplier in the US, but can be sourced, no doubt, from many others around the world. And thus this Arizona case. I notice that many of the news stories refer to use of a "non-approved drug", but that should be more properly stated as a non-approved supplier of a drug that's been around forever, and (moreover) used a great number of times in executions and euthanasia.

This argument held things up, briefly, but the Supreme Court last night tossed that one out 5 to 4, and the prisoner involved (I've no desire to use his name) was executed. Readers from countries without the death penalty may well find this whole situation grotesque - well, you can be sure that many people inside the US do as well. My biggest problem, though, is that the prisoner involved committed his crime in 1989 and is only now paying this price for it.

Update: Here's the Supreme Court order in this case (PDF). The interesting passages:

. . .There is no evidence in the record to suggest that the drug obtained from a foreign source is unsafe. The district court granted the restraining order because it was left to speculate as to the risk of harm. . .But speculation cannot substitute for evidence that the use of the drug is “‘sure or very likely to cause serious illness and needless suffering.’” . . .There was no showing that the drug was unlawfully obtained, nor was there an offer of proof to that effect.

Comments (52) + TrackBacks (0) | Category: Current Events


1. J-bone on October 27, 2010 7:26 AM writes...

I expect you will be lambasted by death penalty opponents very soon.

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2. emjeff on October 27, 2010 7:35 AM writes...

"My biggest problem, though, is that the prisoner involved committed his crime in 1989 and is only now paying this price for it.

Spot on, Derek. Justice delayed is justice denied.

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3. Hangman Joe on October 27, 2010 7:52 AM writes...


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4. Eric Suh on October 27, 2010 8:19 AM writes...

Well, considering that the sodium thiopental is the barbiturate rather than the actual substance used to kill the convict, issues of efficacy certainly enter into play due to the ban on "cruel and unusual punishment" in the 8th amendment. I'd say a person being conscious but paralyzed and suffocating to death/having cardiac arrest is a bit cruel, at least for modern squeemish sensibilities.

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5. Jordan on October 27, 2010 8:40 AM writes...

The thiopental is just to anaesthetize the convict prior to execution. AFAIK the actual fatal ingredients are a muscle-paralyzing agent (which relaxes the diaphragm and halts breathing) and simple potassium chloride (stops the heart).

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6. processchemist on October 27, 2010 8:42 AM writes...

There's a point. They bought thiopental in UK, probably from a broker. The broker sourced the product in India, maybe China, and the quality problem is real.
It's three months that we're trying to obtain a product from two distinct UK resellers: 1st batch - totally degraded during shipment - 2nd batch - not compliant (totally wrong identity by HNMR) - 3rd batch - one source held a shipment just in time (again, quality problems)- 4th batch - they're shipping a product with lower quality profile, and we're going to test it before accepting or rejecting the batch.
When there's a global shortage of some product, you can expect the worst.

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7. No-so-average guy on October 27, 2010 8:42 AM writes...

I live in Canada and used to be against the death penalty. However, I suffered two rounds of sexual abuse as a kid and my mother was murdered by her estranged second husband (i.e. not my father). Top that off with the fact that based on legal technicalities, this waste of skin is walking around free as a bird, I am VERY PRO death penalty. I believe it should be virtually mandatory for first degree murder and you have, for the sake of argument, 3 years for appeals. After that, you're done. Yes, historically there have been miscarriages of justice, but thanks to modern forensics these are now greatly reduced. The one area where I do have concerns is a case with a lack of hard forensics because the likelihood of wrongful conviction is much higher. Nevertheless, I think we need to be nuking more convicts, not fewer. There are some crimes where your background is irrelevant. They made a choice that makes them unworthy of life. Good riddance to bad rubbish.

As for the drug issue, I do agree that there is some irony here but Eric Suh does have a point about efficacy. Nevertheless, I think if the stuff meets BP standards then it's a 99.999% chance it would be USP grade so... would you like me to push the plunger?

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8. Virgil on October 27, 2010 8:52 AM writes...

The British Pharmacopoeia rules are just as strict as the USP ones (in-fact, given all the recent issues about black floaty bits in children's Tylenol, I don't think anyone in the US is in a position to claim that US manufacturing of pharmaceuticals is superior).

Regarding the case, I agree, the biggest issue here is why it took so darn long to do it. Keeping people on death row for decades at a time is stupid, expensive, and serves no purpose but to prolong their agony and that of the victims and their families.

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9. Kreig on October 27, 2010 9:05 AM writes...

Killing someone in cold blood isn't justice, it's barbaric retribution. Funny how conservatives who distrust nearly everything the government does often think it should have the right to take people's lives.

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10. p on October 27, 2010 9:10 AM writes...

Can I be against the death penalty and think this was a silly reason for a stay?

Evidently I can.

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11. Wavefunction on October 27, 2010 9:21 AM writes...

Yes, thiopental is part of the 'toxic trio', the standard combination of thiopental, pancuronium bromide and potassium chloride used in lethal injection.

I am not a big fan of the death penalty. But it seems to make sense to me that even a drug used to kill someone would have to be FDA-approved since it's supposed to induce a painless death.

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12. medchemist on October 27, 2010 9:21 AM writes...

The bigger question is whether or not the used an alcohol swab before setting up the IV as to prevent infection. We wouldn't want there to be an unnecessary infection during the execution.

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13. DarthKeller on October 27, 2010 9:25 AM writes...

I'm sorry, but I doubt very highly that the prisoner bothered to ensure his victims were treated fairly, nicely, and without any undo pain and suffering.

IMO - Hang him. If it hurts, who cares? As for the comment that this isn't justice, my question: What is? If someone murders my wife, that same night I find him/her and end their life, that would be "justice" according to your beliefs. But, then I would go to jail.

Justice is about balance: You took a life, your life must been taken.

And as for the comment that the government and their right to take a life: They have the RESPONSIBILITY to protect life, one of the ways they do is by providing punishment for those who take it. This is an idea that was created in the Declaration of Independence, and has been a part of the American legal system since that time.

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14. Matthew on October 27, 2010 9:40 AM writes...

Without wishing to get into a death penalty debate, if this person has been in jail since 1989, that's a not-inconsiderable punishment in and of itself.

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15. Kreig on October 27, 2010 9:47 AM writes...

Darth is a good example of the emotional thinking that clouds most people's judgement when it comes to the death penalty. Sure, if my wife was murdered I'd have a strong desire to kill the person who did it, without regard to their pain. But the justice system shouldn't be in the business of carrying out retribution for me. You should think more soundly when considering policy that affects everyone instead of regressing to an eye for an eye.

Yes, the first responsibility of the justice system is to protect the general population from dangerous people. Which why we have prisons. Apparently, the prison this guy was in failed on that count and its second responsibility, rehabilitation, since he escaped while imprisoned for second degree murder.

I think one big problem in people's mentality toward the death penalty is their holier than thou attitude toward convicts, and another is their misguided trust in the justice system, which continues to prove fallible and racially biased.

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16. Dana on October 27, 2010 10:47 AM writes...

If I remember correctly, the drugs they use for the lethal injection have to come from very specific sources. They don't get them from where the hospitals get them (some sort of hippocratic oath issues) so the shortage may not exist in the medical world.

I remember reading about this in one of Atul Gawande's books. Probably not The Checklist Manifesto - maybe Better?

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17. Innovorich on October 27, 2010 10:55 AM writes...

To me, the only argument for the death penalty is that the crime is so bad that the person doesn't "deserve" to be alive anymore (odd thought!) and that therefore tax payers money shouldn't be used to hold that person up in prison for the rest of their lives instead. So delaying the whole thing by 21 years would seem to rather defeat the object!

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18. John Spevacek on October 27, 2010 11:11 AM writes...

"There is no evidence in the record to suggest that the drug obtained from a foreign source is unsafe."

Try telling that to the FDA inspector at your next audit and watch them die laughing.

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19. Aspirin on October 27, 2010 11:21 AM writes...

-So delaying the whole thing by 21 years would seem to rather defeat the object!

Agreed. But it's still better than in China where people are given little recourse to appeals and executed within a week of the sentencing with gusto.

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20. Kismet on October 27, 2010 11:22 AM writes...

@1, yeah, why could that be? Perhaps, because there is justified criticism no matter on which side you stand?
Do you fear discussion because your position is so weak or do you really hate "off-topic" discussions that much that you had to whine in the first comment?

I say, bring on the dissenting opinions.

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21. Nate on October 27, 2010 11:24 AM writes...

IMO - Hang him. If it hurts, who cares? As for the comment that this isn't justice, my question: What is?

Great, another conservative who wishes our country could be more like Iran. It's getting kind of hard to tell who's side you guys are really on. Should we add homosexuality and apostasy to the list of capital offenses too?

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22. Osaka on October 27, 2010 11:54 AM writes...

@Nate: What?! They aren't already?! We need to get on that!

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23. Anonymous on October 27, 2010 12:13 PM writes...

This is what's wrong with the death penalty.

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24. formerlawyer on October 27, 2010 12:17 PM writes...

The United States, Japan and South Korea are the only "developed" countries that retain the death penalty.

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25. Anonymous on October 27, 2010 12:47 PM writes...

So it hasn't been approved, that's just a matter of paperwork, right? So issue a CRL demanding a 3-year phase 3 study in humans. OK, it might be hard to recruit volunteers for the clinicial trials, but that's what the R&D budget's for, right?

(Then hold an advisory committee meeting, so that FDA has someone to blame regardless of the final decision. FDA has a responsibility to ensure that only the safest drugs are used when performing an execution.)

OK, so I'm a little bitter about the FDA's obsession on safety (ARNA arguably deserved it for not having a satisfactory explanation for the rat trials, but ALKS/AMLN was a shocker. If QT intervals were an issue for the FDA, surely they could have mentioned it during the *first* CRL...)

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26. hn on October 27, 2010 1:21 PM writes...

Why not just use another anesthetic instead of thiopental?

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27. weirdo on October 27, 2010 1:39 PM writes...

Great, I see we have found posters for whom the world consists of "those evil conservatives" and "us, the righteous people".

I know plenty of "conservatives" who are against the death penalty, and plenty of "liberals" who are for it (and *gasp*, hunt too). This is not an issue that breaks down so neatly along political lines (does any?).

But I would hope we can at least all agree that this is NOT something to be taken lightly. If the State is going to do this, they can't cut corners.

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28. Direct Arylator on October 27, 2010 1:52 PM writes...

This is less about the death penality than setting a precedent for law. Whether or not you are for or against Capital punishement, I think the process could be optimized to eliminate any doubt as to its "cruel or not" nature.

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29. Ed on October 27, 2010 2:00 PM writes...

My interpretation of the case: Apparently, the state refused to say where the thiopental actually came from. The prisoner's petition was suggesting that since the source was unknown, Arizona's thiopental was unsafe for use in humans. The lower courts agreed. The Supreme Court took the opposite tact - that since there was no proof that the drug was from an unsafe source, it was OK. Conveniently, the State of Arizona did not supply the information necessary to decide whether the thiopental source was OK or not.

I think the Supreme Court mucked up the decision by letting the State keep secret information that was critical to the prisoner's petition. If the source manufactures drugs for human use, there is no problem. You can argue that the supplier will potentially be boycotted by anti-death penalty protesters, but such protesters could easily generate a list of thiopental suppliers in Great Britain and boycott all of them.

Even if you're pro-death penalty, you should raise your eyebrows at this decision by the Court and Arizona. Imagine if the prisoner got veterinary thiopental, and had a severe allergic reaction during the execution. This would be grounds for a multi-million dollar lawsuit, and would give every other death-row inmate grounds for another cruel-and-unusual punishment appeal. Worst-case, all executions could be delayed for years as they have in the past when various problems emerged in the execution protocol.

@26 - The specific lethal injection method has been heavily litigated, which is why some states recently switched to a single-drug protocol. You can't just choose whatever drug you have in the cabinet. The process is further complicated because, while lethal injection is a quasi-medical procedure, most doctors won't consult about the process or protocols on Hippocratic oath grounds. I don't see randomized clinical trials ever.

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30. MV on October 27, 2010 2:57 PM writes...

What are the implications of this decision on prescription drug importation into the US? It seems to me that any law banning such import is now greatly weakened.

It will be interesting to see how this death penalty appeal case decision will be applied to other laws.

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31. wei on October 27, 2010 3:17 PM writes...

maybe the execution procedure can be outsourced to mexico

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32. medchemist on October 27, 2010 3:35 PM writes...

@29, veterinary thiopental and develop an allergic reaction during the execution??? They are being killed, not treated for an illness. I have always found it interesting to argue cruel and unusual punishment while they are being killed. I don't know, maybe it is just me.

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33. Sili on October 27, 2010 3:42 PM writes...

My biggest problem, though, is that the prisoner involved committed his crime in 1989 and is only now paying this price for it.
Because twenty-one years incarceration, not knowing if you'll live or die, is just a stroll in the park? Permalink to Comment

34. drug_hunter on October 27, 2010 4:32 PM writes...

My take on this discussion thread: we've proven (yet again) that it is a bad idea for Derek to bring up any topics that can be transmogrified into political issues.

So let me get ahead of the curve and beg Derek not to post anything about the massive looming gov't budget cuts in the UK.

Instead, I vote for more entries on how Derek won't work with uranium hexafluoride or whatever.

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35. Woodward hoffmeister on October 27, 2010 4:47 PM writes...

As a European, the pro-death sentence arguments from the US seem, shall we say, eye-brow raising? Siding with the most extreme countries in the world on this issue should surely worry any right minded American. As this is a scientific blog, perhaps we should consider the complexity of life - what are we - a bag of chemicals; 70% h20 plus a few nucleic acids, some calcium, etc. The magic that gives us consciousness is way beyond our understanding. No-one has the right to take a life (whether in the US, EU, Middle East, China, mid-africa) for whatever reason - punishment, revenge, anger, whatever. We don't understand it, we can't create it. As for the chance of wrongly executing someone, isn't just one false conviction enough to not have a death sentence? What if it were YOU that was wrongly convicted, or your son, or daughter...

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36. Anonymous BMS Researcher on October 27, 2010 5:31 PM writes...

I grew up in Wisconsin, a State that repealed the death penalty over 150 years ago. Every decade or so there is another attempt to bring it back, but these have all failed. My personal view on the death penalty: it *might* be acceptable if the criminal justice system first underwent some pretty dramatic reforms, but with the system we have now the error rate is orders of magnitude too high.

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37. skeptical on October 27, 2010 6:20 PM writes...

Oh, come on Derek, no sense in the pretense. Political neutrality is not something you'll ever be accused of.

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38. Anonymous on October 28, 2010 2:53 AM writes...

@33. Totally missing the point. Whether death is "much worse" or only "slightly worse" than 21 years in prison has NOTHING to do with whether you think that the death penalty is the appropriate punishment for this crime.

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39. Petros on October 28, 2010 10:53 AM writes...

This has also proved to be highly contentious in the UK due to the use that the drug was put to.

apparently any export from the UK, from the sole supplier, within Europe would have to be notified to the regulatory authorities but shipping, via a wholesaler, outside of Europe does not require notifcation to the authorities (or the manufacturer)

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40. Sili on October 28, 2010 11:19 AM writes...

@33. Totally missing the point. Whether death is "much worse" or only "slightly worse" than 21 years in prison has NOTHING to do with whether you think that the death penalty is the appropriate punishment for this crime.
The specific wording was "paying the price"? If killing the guy is the payment, what then is the incarceration? Interest? Permalink to Comment

41. Anonymous on October 28, 2010 3:58 PM writes...

The difference between Iran and US is that one has due process while the other one doesn't. Or do they not teach that in lib-school?

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42. Tim on October 28, 2010 5:26 PM writes...

The problem here is that FDA has never asserted jurisdiction over pharmaceuticals used in executions. They rejected a petition to do so 30 years ago, Letter from FDA Comm'r A.H. Hayes, Jr., to D.E. Kendal, FDA Dkt No. 80P-0513 (July 7, 1981), and the Supreme Court upheld the agency's decision not to act in Heckler v. Chaney, 470 U.S. 821 (1985).

As for the 21-year delay, I think this initially appears unconscionable to non-Americans because they think about the problem in the context of their own legal systems. The U.S. system favors post-conviction safeguards over speedy executions, and structural features -- like the right to a jury trial -- make this a preferable balancing. Before a typical state death-row inmate is executed, the following courts will consider the validity of the sentence: the state trial court, the state appellate court on direct review, the state supreme court on direct review, the Supreme Court of the United States on direct review, a state trial court on collateral review, a state appellate court on collateral review, the state supreme court on collateral review, perhaps the Supreme Court of the United States on collateral review, a federal district court on a habeas corpus petition, a U.S. circuit court of appeals on the habeas petition, and the Supreme Court of the United States on the habeas petition. That's a lot of courts, and this doesn't even include the state pardon and clemency process.

For death penalty cases, the U.S. has decided that the right of the condemned to have every opportunity to appeal trumps his interest in a speedy execution. We like to be sure we're getting it right before we kill someone. Granted, the system is not always perfect, and some innocent prisoners have been executed. Whether there is any acceptable error rate for state executions is a question for Congress and ethicists, but, as a matter of law, our Constitution simply does not allow rapid executions.

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43. Bored on October 28, 2010 8:24 PM writes...

The 16th-century punishment for regicide (killing a king or other leader of a nation) in many parts of Europe was public disembowelment. Regicide was remarkably rare in 16th century Europe. Try Google-ing Balthasar Gerard, the assasin of Prince William of Orange. His execution is quite remarkable reading. We've come a long way in 400 years... or have we?

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44. Nate on October 28, 2010 8:34 PM writes...

The difference between Iran and US is that one has due process while the other one doesn't. Or do they not teach that in lib-school?

Due process, in the US, also includes the right to appeal court decisions, instead of heading straight to the gallows - or do they not teach that in conservative school? (We also don't turn executions into gruesome spectacles to sate your bloodlust, which was my original point.) Besides, there are far too many examples of capital cases being prosecuted with gross misconduct by prosecutors, judges, or defense attorneys (usually court-appointed). If you look at the list of exonerated death row inmates, it's terrifying how long some of them spent in prison waiting to be executed before their convictions were overturned.

Of course the appeals process isn't the only aspect of due process that some conservatives want to throw away - indefinite detention and torture aren't hallmarks of due process either, but they're standard practice in countries like Iran.

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45. LeeH on October 29, 2010 9:18 AM writes...

Execute first, ask questions later, that's what I say. I mean, c'mon, the guy wouldn't be under suspicion if he didn't do it, would he? Just look at him. Pretty shady looking character, in my opinion. If he didn't actually commit the crime, he must of done SOMETHING, after all. You can't let THOSE people just walk around free, or worse, sit in a cushy prison with all the creature comforts. Let's face it, if you can't trust the government and 12 good, intelligent, upstanding people to decide who lives and who dies, who can you trust? There would be mass chaos! Raping and pillaging in the streets! Dogs and cats interbreeding! I mean, if it were me, and they threw me in prison for something I didn't do, I'd say "Well, just stick that needle in me! That's best for society! I understand. You can't get it right every time, after all. 95% accuracy, that's pretty good! 'Tis a far, far, better thing I do..."

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46. Sili on October 29, 2010 3:38 PM writes...

The difference between Iran and US is that one has due process while the other one doesn't.
Yeah. It may be draconian, but at least Iran ensures it's defendants have proper representation.
For death penalty cases, the U.S. has decided that the right of the condemned to have every opportunity to appeal trumps his interest in a speedy execution. We like to be sure we're get