Food and Drug Administration

Ohio Planned to Import Death Penalty Drug Illegally

August 19, 2015

A letter from the FDA warned the state that importing the drug would break the law.

The state of Ohio planned to illegally import sodium thiopental, a drug used for executions, according to a Food and Drug Administration letter obtained byBuzzFeed through a Freedom of Information Act request.

The June letter says that Ohio planned to “obtain bulk and finished dosage forms of sodium thiopental.” Since the drug is not available in the US, wrote Domenic Veneziano, director of the FDA’s import operation, “we assume this product would be purchased from an oversees source.”

Veneziano reminded Ohio Director of Rehabilitation and Correction Gary C. Mohr that“there is no FDA approved application for sodium thiopental, and it is illegal to import an unapproved new drug into the United States.”

According to BuzzFeed:

The prison Ohio carries out executions in registered for a DEA license to import the drug last year for a “law enforcement purpose,” but until now it was unknown if the state actually intended to use the license.

Ohio, like many other death penalty states, shrouds its execution drug suppliers in secrecy. States argue the secrecy protects their suppliers from intimidation and embarrassment, while death row inmates and open government advocates argue it removes an important check on state power.

When Nebraska received a similar letter from the FDA last year, it came out that the state paid an Indian dealer named Chris Harris more than $50,000 for enough sodium thiopental to execute hundreds of prisoners. (Nebraska has since abolished the death penalty completely.)

BuzzFeed followed up with Ohio corrections department to find out if Harris was the planned supplier for Ohio as well.

When approached by BuzzFeed News about Harris in June, Ohio DRC spokesperson JoEllen Smith said the department’s legal division would have to handle the matter. After spending weeks on the request, she only would say that Ohio had not communicated with Harris’s company, Harris Pharma, but did not specifically answer the question of if the state had purchased from him directly or indirectly. Smith did not respond to follow up questions.

Ohio’s last execution took place in January 2014, when the state gave inmateDennis McGuire 10 milligrams of midazolam, a controversial sedative whose use for lethal injections the Supreme Court recently upheld. Ohio plans a new series of executions beginning in 2016.

Many reputable drug manufacturers don’t want to be associated with the death penalty, much less the botched executions that have prevailed of late. The FDA-approved manufacturer of sodium thiopental stopped making the drug in 2011 so that it couldn’t be used for this purpose. When Missouri announced plans to use propofol, the drug found in Michael Jackson’s body at the time of his death, for executions, its German manufacturer expressed displeasure and threatened to get the European Union to stop exporting it the US completely. Many states are now struggling to find the drugs they need for executions.

This fact is compounded in Ohio, whose governor, Republican presidential candidate John Kasich, signed a “secret executions” bill this winter that exempts anyone participating in a lethal injection from public records requests. Under the law, medical and nonmedical staff, companies transporting or preparing supplies or equipment used in executions, and providers of the drugs used in lethal injections are all protected from public records requests and do not need to reveal their identity or duties.

FDA can’t allow execution drug to be imported


WASHINGTON—A federal appeals court ruled Tuesday that the Food and Drug Administration was wrong to allow a misbranded and unapproved new drug to be imported for use in executions by lethal injection.

The three-judge panel affirmed a lower court ruling barring the FDA from allowing the importation of sodium thiopental —rejecting the agency’s argument that it had discretion to allow unapproved drugs into the U.S.

The FDA policy “was not in accordance with law,” wrote Judge Douglas Ginsburg of the U.S. Court of Appeals for the District of Columbia Circuit, joined by Judges David Sentelle and Judith W. Rogers. Ginsburg and Sentelle were appointed by President Ronald Reagan; Rogers was appointed by President Bill Clinton.

Sodium thiopental is an anesthetic used to put inmates to sleep before other lethal drugs are administered. The case was brought by death row inmates in Tennessee, Arizona and California.

Among other arguments, the FDA said it needed discretion to import drugs approved overseas but not in this country in order to combat domestic shortages of medically necessary drugs.

“By its own account, however, the FDA has ways short of allowing importation of inadmissible drugs to counteract a drug shortage,” the panel wrote, such as asking other firms to increase production and expediting review of regulatory submissions.

The panel reversed another part of the lower court’s order and allowed state correctional departments to keep stocks of the drug they currently have.

The FDA said it was reviewing the decision.


Healthcare firm Fresenius Kabi receives award for action to prevent use of drug in executions

A pharmaceutical company which has taken steps to prevent its product from being used in executions by lethal injection will today receive an award recognising its ethical leadership in the industry.

Fresenius Kabi announced last September that it had put in place controls designed to ensure that its propofol product would not be sold or distributed to correctional facilities where it could be used to carry out the death penalty. Fresenius Kabi, which at the time was the sole US supplier of the anesthesia drug, acted after US states started considering the use of propofol as supplies of previously-used execution drugs became scarce.

John Ducker, the CEO of Fresenius Kabi USA, will today receive the Corporate Social Responsibility Award for Ethical Leadership in the Pharmaceutical Industry on behalf of the company. The award is presented by human rights charity Reprieve.

Mr Ducker said: “Everything we do at Fresenius Kabi is to help assure the safety and availability of therapies for patients and those who care for them,” Mr. Ducker said. “We are pleased to accept this award on behalf of our employees and customers.”

Maya Foa, Deputy Director of Reprieve’s Death Penalty Team said: “Fresenius Kabi has shown unwavering commitment to the core values of the Hippocratic Oath, taking unprecedented steps to ensure their products are used to advance the health and wellbeing of patients all over the world, and are not put to ill use. In so doing, they have shown themselves to be a true leader in ethical business.”

NEBRASKA – Unsafe for execution ? The state of Nebraska hopes to execute a man with a drug that has been recalled by its manufacturer

June 7, 2012  Source :

On the farm they called him King. He was the Archangel Michael incarnate, they believed, and he spoke directly to Yahweh. In his name, they stockpiled more than $120,000 worth of stolen ammunition and prepared for the Battle of Armageddon, which their King decreed would be fought in the windswept wheat fields of Rulo, Neb. If anyone left, the King said, he would “hunt down and kill” them, and they would “burn in hell.”

The King was an unemployed truck driver named Michael Ryan — and he wasn’t bluffing. He’s been sitting on death row since 1986 for the murder and ritualistic torture – razor blades and chains, sodomization and forced bestiality – of fellow cult member James Thimm. Save for those ideologically opposed to the death penalty, few would argue he deserves anything else.

And yet Ryan survives in a prison cell today, despite the state of Nebraska’s best efforts to kill him. His execution has been sidelined by the continuing fallout from a shortage in the execution drug sodium thiopental, which began in August 2009 — a shortage that has quietly remodeled the death penalty in the United States. As states run out of sodium thiopental, they’re turning to new and questionable supplies of execution drugs. Prisoners, meanwhile, are fighting these changes at every turn: Their sentences were clear, they argue, and this wasn’t part of them.

“It has nothing to do with whether Michael Ryan or any other death row inmate deserves to die,” says Jerry Soucie, Ryan’s attorney and employee of the Nebraska Commission for Public Advocacy. “The issue is whether those people who decide they want to exercise the power to execute somebody are in compliance with the law. And if they’re not, there’s a problem. You don’t enforce the law by engaging in lawless conduct.”

In Nebraska, the effects of the shortage have been particularly acute. Nebraska has twice purchased sodium thiopental made overseas by non-FDA approved companies. (The shortage began when Hospira, the sole FDA-approved manufacturer of sodium thiopental, ceased production.) The first time, the DEA barred Nebraska from using its new thiopental for importing the drug without a proper license.

Then last November, the Nebraska Department of Correctional Services announced it had purchased another new supply of sodium thiopental from a Swiss company called NAARI AG. Immediately following the announcement, the state attorney general’s office asked the Nebraska Supreme Court to set a new execution date for Michael Ryan. But 15 days later, NAARI CEO Prithi Kochhar sent a letter to the Nebraska Supreme Court asking for the drug’s return. In his letter, Kochhar explained that the NDCS had not purchased the sodium thiopental directly from NAARI. It had, in fact, been purchased from a Calcutta, India-based middleman named Chris Harris who was not authorized to resell the drug to Nebraska.

“I knew of Chris Harris, certainly his reputation for doing business,” says Jerry Soucie, Ryan’s attorney. “No question about it, he had a shady reputation. … I was just kind of shocked the NDCS would be dealing with him.”

According to Kochhar’s letter, NAARI supplied Harris with the drug in order to have it registered in Zambia, where they hoped to extend their coverage. Instead, Harris sold all 489 grams to the NDCS for $5,411, roughly 142 times its worth.

On May 9, after discovering the breach in its supply chain, NAARI issued a voluntary recall of the drug, noting that it was illegally diverted and could therefore be potentially unsafe. Nebraska officials have chosen not to comply with the recall, and Soucie contends they are in possession of stolen goods.

“The fact that NDCS would not honor our company recall…is a little shocking to us,” says Kochhar. “It seems that NDCS is not concerned about the effect of using an unsafe drug in any operation, not least one which might be used to end someone’s life in a potentially painful way.”

And Nebraska isn’t only refusing to comply with NAARI. Last March, U.S. District Court Judge Richard Leon ruled the Food and Drug Administration was wrong to allow foreign-made sodium thiopental into the country. Furthermore, Leon ordered the FDA to notify all state correctional departments with supplies of the drug to relinquish them to the FDA. Rather than comply with that order, the Nebraska attorney general’s office asked the FDA to appeal Judge Leon’s ruling and is currently still in possession of the drug. Fourteen other states have since called for the same appeal.

“The states that are positioned better are the states looking further down the road for alternatives rather than holding on to something because they don’t want to change,” says Richard Deiter, executive director of the Death Penalty Information Center.

These states have given up on thiopental completely. As recently as May 18, Idaho announced it had switched to a lethal dose of the surgical sedative pentobarbital. Missouri recently became the first state to formally adopt the anesthetic propofol, the same drug that killed Michael Jackson. According to Deiter, Nebraska and other states resisting a change to their lethal injection protocol are only delaying the inevitable. Domestic suppliers of sodium thiopental have run dry and the drugs carry an expiration date.

“States know that as soon as they make a change, the change will be challenged in court,” Deiter says, “but not making a change is also being challenged. I think states are going to have to find a source of drugs within the United States if they’re going to carry out lethal injections in a reliable, predictable manner.”

Yet despite all of this – despite a federal ruling and company recall, despite the fact that Nebraska’s current batch of sodium thiopental was illegally imported, despite the fact that change is the only way forward – State Attorney General Jon Bruning said Ryan’s challenge is merely “a circus sideshow,” according to the Lincoln Journal Star, and Governor Dave Heineman maintains it’s simply the latest tactic employed by death penalty opponents. Both Bruning and Gov. Heineman, who continue to steer the conversation towards Ryan’s execution rather than the efficacy of the drug, declined to be interviewed.

“When the powers that be in Nebraska or wherever decide they’re going to kill someone using either stolen drugs or without the proper licensing, then why do we have a legal system at all?” Soucie says. “Why don’t we take the guy out behind the building and shoot him once in the back of the head with a 9 mm? It would be just as lawless for them to do that as it is for them to violate federal law in carrying out an execution.”

CALIFORNIA- California defies order to turn over one of three drugs used in executions

May 26, 2012 Source :

SAN FRANCISCO (AP) — California on Friday joined other states in defying a federal government order to turn over a key execution drug.

At issue is the drug sodium thiopental, one of three drugs California and dozens of other states use in lethal injections. It puts the inmate to sleep before fatal doses of two other drugs are delivered. California and others have been purchasing the drug oversees since the United States’ sole manufacturer ceased production of the anesthetic in 2011.

U.S. District Judge Richard Leon in March ruled that the Food and Drug Administration erred in allowing the prisons to import the foreign-made drug. The judge ordered the FDA to confiscate all foreign-made sodium thiopental and to warn prisons that it was now illegal to use the drug. The FDA followed the Washington D.C.-based judge’s order and sent demand letters to prisons. But beginning with Nebraska on April 20, more than a dozen states have refused to comply with the FDA order.

On Friday, California joined the protest in a letter sent to the FDA. With 725 Death Row inmates, California has the highest number of condemned prisoners.

California Department of Corrections and Rehabilitation lawyer Benjamin Rice and the other states with foreign-bought sodium thiopental contend they aren’t bound by the ruling made by a federal judge in Washington D.C. They also argue that the judge was wrong and urged the FDA to appeal.

“The CDCR is unaware of any laws or imperative that would require it to return the thiopental in question,” Rice wrote Domenic Veneziano, director of the FDA’s import operations. Rice wrote that subjecting lethal injection drugs to the same regulations designed to prevent illegal sales of controlled substances is a “strained interpretation” of the law.

FDA spokeswoman Shelly Burgess declined comment because the lawsuit at issue is still pending. The lawsuit was filed by death row inmates in three states

Local and state officials have been striving to restart executions in California since a judge blocked them in 2006 and ordered the state to overhaul its lethal injection process to ensure inmates don’t suffer cruel and unusual harm. The state’s efforts to resume executions in 2010 failed, in part, because its supply of sodium thiopental expired before it could lethally inject rapist-murderer Albert Brown. The state then turned to England-based pharmaceutical distributor Archimedes Pharma and purchased 521 grams of sodium thiopental.

Now, Los Angeles County District Attorney Steve Cooley is trying to force the issue anew. Cooley asking a judge to order the executions of Mitchell Carleton Sims and Tiequon Aundray Cox, both of whom have been on death row for more than 25 years and have exhausted their appeals. A hearing set for Friday for a judge to hear arguments was postponed until July 13.

Cooley, who is retiring after three terms, is the first district attorney in California to make the request and his attempt comes just months before voters decide whether to abolish capital punishment.

Cooley argues that the state doesn’t need to use sodium thiopental and should scrap its three-drug cocktail. Instead, Cooley wants California to start using a single-drug method employed by other states. Gov. Jerry Brown recently ordered prison officials to explore that option.

Most single-drug states, including Texas, use pentobarbital. But last week Missouri said it would begin executing inmates with the drug propofol, the same drug that accidentally killed pop star Michael Jackson. Since adopting the one-drug protocol in 2009, Ohio has carried out 15 successful executions, according to court documents.

California has executed 13 inmates since it reinstated the death penalty in 1978.

Sims was sentenced to death in 1986 after being convicted of murdering a Glendale pizza deliveryman. Sims, 52, also faces a death sentence in South Carolina for murdering two co-workers.

Cox, 46, was a gang member who gunned down a grandmother, her daughter and two grandchildren in 1984. A 14-year-old boy hid in a closet, which authorities say saved his life.


US – States urge feds to help import lethal injection drugs

May 21, 2012 Source :

A nationwide shortage of a commonly used imported drug used in capital punishment has prompted 15 states on Monday to urge the U.S. Justice Department to intervene. Led by Oklahoma officials, the move comes as the 33 states with the death penalty — all of whom use lethal injection as the primary execution method — struggle to preserve existing stock or search for legally acceptable chemical alternatives. A federal judge in March had blocked the importation of thiopental into states like Arizona, South Carolina, and Georgia saying it was a “misbranded drug and an unapproved drug.” Judge Richard Leon in Washington ordered state corrections departments to return suspected foreign-made thiopental to the Food and Drug Administration. The states called that a “flawed decision” and now want the FDA to appeal that judge’s decision, saying upcoming executions are being undermined. Attorneys General Scott Pruitt in Oklahoma and Marty Jackley in South Dakota are leading the legal effort. “At the very core of the states’ police powers are their powers to enact laws to protect their citizens against violent crimes. As state attorneys general, we are tasked with enforcing those laws, including in instances where capital punishment is authorized for the most heinous of crimes,” according to attorneys general from the 15 states. States argued the federal agency had routinely released the imported drug for executions, a practice suspended after the judge’s ruling. “If the (court) decision is not overturned, we as state attorneys general will be forced to take actions to ensure execution by lethal injection remains a viable option.” This comes after Texas officials disclosed Monday they only have enough drugs on hand for 23 more executions. The next scheduled execution in the U.S. is Bobby Hines in Texas on June 6. Missouri earlier this month announced new protocols, and will use an entirely new drug. Propofol is a surgical anesthetic that in large doses can be administered fatally, but has never been used in the U.S. to put prisoners to death. Officials in Ohio, Texas and other states last year cited a nationwide shortage of sodium thiopental in their decisions to separately use pentobarbital, a barbiturate that has alternately been used to put animals to sleep. Some states use a single execution drug, others rely on a three-drug mixture or cocktail. Pentobarbital has become the new legal flashpoint over capital punishment. It was used in a U.S. execution for the first time in December 2010, when it was administered as the first ingredient in a three-drug cocktail used in a lethal injection given to an Oklahoma inmate. It also has limited Food and Drug Administration approval in smaller doses for humans as a mild anesthetic and to treat some seizures. Many physicians say they no longer administer it to people for medical purposes. The second drug in the three-drug cocktail — pancuronium bromide — paralyzes all muscle movement.The third drug, potassium chloride, induces cardiac arrest and death. In 2009, Ohio became the first state to perform an execution with a single drug, using a higher concentration of sodium thiopental. There were no reported complications and its use encouraged other states to follow suit. The nation’s only manufacturer of sodium thiopental since announced it was stopping production. Many capital punishment opponents claim sodium thiopental, which renders the prisoner unconscious, can wear off too quickly, and that some prisoners would actually be awake and able to feel pain as the procedure continued. The European manufacturers of both pentobarbital and sodium thiopental have opposed using their products for executions in the United States. Pentobarbital is widely available and has been used for physician-assisted suicide, including in Oregon, where the practice is legal in limited circumstances. Nationwide, death penalty use continues to decline. Connecticut recently became the latest state to ban capital punishment, although the 11 people on death row will remain there. Only 43 people were executed in the U.S. in 2011, down three from the previous year, and a 56% decline from 13 years ago, when nearly 100 people were put to death. Eighteen have been executed so far in 2012.

MISSOURI : Missouri finds a drug option for executions: Propofol

May 18, source :

KANSAS CITY, Mo. _ The state of Missouri is back in the execution business with a drug that’s never been used to put prisoners to death in the United States.

Stymied by a chemical shortage affecting every death-penalty state, the Missouri Department of Corrections said this week that it now will carry out death sentences with propofol, a widely used surgical anesthetic that also played a factor in singer Michael Jackson’s death.

Attorneys representing some of the state’s death row inmates learned of the plan Thursday, after corrections officials met with some inmates and informed them of the new protocol.

Defense attorneys said it’s too early to say what, if any, legal challenges might be mounted in regard to the new one-drug execution protocol that replaces Missouri’s previous three-drug cocktail.

“It’s something we will have to look at very carefully,” said Joseph Luby, an attorney with the Death Penalty Litigation Clinic in Kansas City. “Propofol has no track record in executions.”

Missouri is the first state to formally adopt the use of propofol, also known by the brand name Diprivan, for use in lethal injections, said Richard Dieter, executive director of the Death Penalty Information Center in Washington, D.C.

“No one has used it yet,” Dieter said. “Other states may have considered it.”

Deborah Denno, a law professor at Fordham University in New York and nationally known expert on lethal injection issues, called it a “pretty extraordinary development” that raises many questions.

“I would anticipate legal challenges,” she said.

Missouri’s last execution took place in February 2011. Since shortly after that, the state has been unable to obtain the anesthetic that put inmates to sleep before they are injected with two other chemicals that stop the lungs and heart. Officials also had been unable to obtain an alternative drug that some states had adopted to take its place.

With news that the corrections department had obtained a different drug, Missouri Attorney General Chris Koster on Thursday asked the state Supreme Court to set execution dates for 19 inmates. They include Michael Taylor, one of the killers of Ann Harrison, a Kansas City teenager kidnapped in 1989 while waiting for the school bus in front of her house, and Allen Nicklasson, convicted of kidnapping and killing Excelsior Springs businessman Richard Drummond in 1994 after Drummond stopped to help Nicklasson and a co-defendant when their car broke down.

Koster said in his motion that there are no legal impediments or stays now in place to stop the executions.

“Unless this court sets an execution date after a capital murder defendant’s legal process is exhausted, the people of Missouri are without legal remedy,” Koster said in his motion.

According to Supreme Court procedures, lawyers for the inmates must be given the opportunity to file responses before the Supreme Court sets execution dates.

“There is no timetable as far as when the court would rule (on dates),” said spokeswoman Beth Riggert. “The court rules when it deems it appropriate.”

Missouri and every other state using lethal injection once used the same three-drug mixture that employed sodium thiopental to anesthetize prisoners. The drug has been employed in all 68 executions Missouri has carried out since 1989.

Inmates in Missouri and across the country had filed numerous legal challenges to the method, alleging that it created the risk of inflicting cruel and unusual punishment if not administered properly. However, the U.S. Supreme Court ruled in 2008 that the method was not unconstitutional.

In early 2010, shortages of sodium thiopental began cropping up, and in early 2011 the only domestic supplier announced it would no longer manufacture the drug.

States also had difficulty obtaining it from foreign sources, and on March 27, a federal court in Washington, D.C., banned any importation of sodium thiopental and ordered the Food and Drug Administration to contact every state that it believed had any foreign-manufactured thiopental and instruct them to surrender it to the FDA. It also permanently prohibited importation of the drug.

With thiopental in short supply, some states began to substitute another anesthetic, pentobarbital, for use in the three-drug method.

In February 2011, Ohio began using pentobarbital by itself to execute prisoners. Earlier this year, Arizona became the second state to switch to one-drug executions using pentobarbital.

Dieter, with the death penalty information center, said pentobarbital has been used, either by itself or in combination with other drugs, in the last 45 executions in the United States.

But last July, its Danish manufacturer announced that it was imposing restrictions on how pentobarbital was distributed to prevent its use in executions.

Since its on-hand supply of thiopental expired in March 2011, Missouri had been unsuccessful in finding it or pentobarbital.

In announcing its new protocol this week, Missouri Department of Corrections officials did not comment on when they obtained the new drug or where it was obtained.

According to Missouri’s new written protocol, inmates will be injected with 2 grams of propofol. A Kansas City anesthesiologist said that amount is 10 times the dosage that would be used in a surgical setting for a 220-pound patient.

According to Missouri’s new protocol, the chemical will be prepared by a doctor, nurse or pharmacist. An intravenous line will be inserted and monitored by a doctor, nurse or emergency medical technician. Department employees will inject the chemicals.

Doctors say the drug is used widely in medical settings and does not have some of the side effects, like post-operative nausea and vomiting, of previously used anesthetics. It was developed in England in the late 1970s.

Currently, only one execution date is pending in Missouri. Michael Tisius, convicted of killing two jailers in Randolph County, is scheduled to be put to death Aug. 3.

An attorney representing Tisius could not be reached for comment Friday.

US – US hospitals face medicine shortages as crucial supplies diverted to executions

May 8, 2012 Source

US hospitals are facing shortages of a key medicine used in surgical anaesthesia as death rows stockpile the same drug for use in executions, new figures have shown.

Prisons across the USA are holding large stockpiles of pancuronium bromide, a paralysing agent designed to relax muscles during surgery, in order to use it as part of a three-drug execution ‘cocktail.’

The US Food and Drug administration (FDA) has repeatedly warned that the country is facing shortages of the medicine, which date back as far as 2010. Yet various Departments of Corrections, which don’t use the drug for medicinal purposes, but only in executions, are hoarding large quantities. Virginia alone, for example, holds 60 vials of the drug, enough to treat roughly 50-60 patients in emergency medical operations.

The executing states’ behaviour is particularly controversial as the use of pancuroniumwhich slowly suffocates the prisoner is not even necessary in executions, as a third drug is employed to stop the heart. The second stage is purely cosmetic, paralysing the prisoner so that onlookers can’t see any signs that they might be in distress. Worse still, by paralysing the prisoner, the use of pancuronium creates a serious risk that they will be left unable to signal that the first drug, an anaesthetic, has failed to work – and therefore will die in excruciating pain, unable to move or even to speak.

Legal action charity Reprieve is calling on manufacturers to put in place procedures to ensure that the drug reaches only legitimate, medical users, and is not diverted to execution chambers – which will also help to reduce the shortages hospitals currently face.

Pancuronium bromide is manufactured by Hospira, a company which has repeatedly stated its opposition to the use of its medicines in executions. Thus far, however, it has taken no active steps to prevent this use. The result is that Hospira’s pancuronium bromide is currently unavailable for the doctors who have legitimate medical need for it, while executioners apparently have ample supplies.  

Reprieve investigator, Maya Foa said: “Regardless of your views on the death penalty, it cannot be right that hospitals are facing shortages of medicines while executing chambers sit on huge stockpiles. These drugs are being diverted from their legitimate, medical use in order to kill. Manufacturers like Hospira must put in place controls to ensure this is not allowed to happen.”

SOUTH DAKOTA – Death penalty delay looms

april, 17, source :

A federal judge’s ruling in March that the Food and Drug Administration allowed unapproved tranquilizing drugs into the country might delay an execution in South Dakota. But it is not likely to ultimately imperil the death penalty here or in 33 other states.

South Dakota Attorney General Marty Jackley acknowledged the planned September execution of Rodney Berget might be postponed as the state and federal government work their way through the ramifications of U.S. District Court Judge Richard Leon’s ruling regarding the drug sodium thiopental.

Berget was sentenced to death after he and two other inmates were convicted of killing prison guard Ron Johnson during an escape attempt last year at the South Dakota State Penitentiary.

South Dakota is among the states that administer thiopental as a tranquilizer in a series of lethal drugs that also paralyze the lungs and stop the heart. However, U.S. drug companies stopped making thiopental several years ago, leaving an Italian company as the only source for the drug.

The Italian government this year barred the thiopental made there from being used in executions, so American states that use the drug are forced to rely on their existing stockpiles. Now, though, the FDA, is being forced to go after those state stockpiles.

In a federal lawsuit brought by death penalty opponents, Leon ruled the FDA disregarded its responsibility to ensure the safety of imported drugs when it allowed Italian thiopental to be brought into this country.

In response to that, the FDA sent South Dakota a letter April 6 telling it “to make arrangements for the return to the FDA of any foreign-manufactured thiopental in its possession.”

Jackley has refused. He sent a letter back the following day saying the state’s thiopental already has cleared customs and been independently tested to ensure it was pure and adequately potent. He invited the FDA to work with the state on further testing if it has concerns about the thiopental in South Dakota’s hands.

But Jackley is walking a careful middle ground. While acknowledging the FDA’s authority to oversee drugs, he is not ceding the state’s right to have a death penalty.

“The state’s position is we have a duty to carry out a judge’s sentence and to serve justice on behalf of a victim’s family. We would hope the federal agencies appreciate that position and work with us to ensure that carrying out the courts’ sentences is done in a constitutional manner,” Jackley said.

While Berget’s scheduled execution probably could be postponed while the drug issue plays out, the May 13 planned execution of Eric Robert, Berget’s accomplice, already has been pushed back by a state Supreme Court review of his mandatory appeal.

Other inmates on the state’s death row, Donald Moeller, convicted in 1992 of rape and murder, and Charles Rhines, also convicted of murder in 1992, have appeals ongoing and no execution dates have been set for them, according to Jackley.

In the short term, states probably can get around the thiopental issue by resorting to other drugs.

“Twelve states that I am aware of have switched to pentobarbital,” said Richard Dieter, executive director of the Death Penalty Information Center in Washington, D.C.

Jackley notes South Dakota’s death penalty statute is written to give the state wide latitude in the drugs it uses to carry out executions. But Dieter and Joan Fisher, a federal defense lawyer in Sacramento, Calif., who founded a pioneering death penalty defense unit in Idaho, suggest the same problem with access in the case of thiopental ultimately could arise with pentobar bital.

Like thiopental, it now is manufactured only overseas.

“This does underscore the fact the U.S. is dependent on overseas for certain drugs. That’s a larger problem,” Dieter said.

“Things are changing so quickly on us it’s hard to keep up with state corrections departments,” Fisher said of the ability of states to use new execution drugs and thereby evade defense attorney arguments that the drugs are not being appropriately regulated by the FDA.

However, while she admits the current furor over thiopental is merely “a speed bump” in blocking executions, she differs with Jackley on the larger issue. Death penalty foes and defense lawyers might find challenges over execution drugs a fertile field for lawsuits, said Fisher.

“I suspect there is the potential for more litigation than the attorney general would like,” she said.

US – Lethal Injection As the Death Penalty’s Last Stand

april 16,2012 source : David A. Love *Witness to innocence*

Are we witnessing the beginning of the end of the death penalty in America? All of it might come down to a basic issue of supply.

So, what do you do if you are a hangman who runs out of rope? To put it in more conventional terms, suppose you are a state that executes people by lethal injection, but you’re running out of the lethal chemicals used to put people down like animals.

Perhaps you’d do what some states have done and buy your chemicals on the black market, so to speak.

In March, Judge Richard J. Leon, a federal judge in Washington, D.C., issued an order andopinion banning the importation of sodium thiopental, an anesthetic and the first of a three-chemical cocktail administered to a condemned inmate. Once the inmate is unconscious, he or she is injected with pancuronium bromide, which paralyzes the person, and potassium chloride, which causes death through cardiac arrest.

According to the judge, it was disappointing that the Food and Drug Administration (FDA) broke the law by allowing shipments of the drug from foreign countries, unapproved for the purpose of executions. Without FDA approval, according to the judge, the sodium thiopental would fail to put the inmate to sleep, causing “conscious suffocation, pain, and cardiac arrest.”

Judge Leon ordered the FDA to notify state corrections departments that they must surrender the drug to the FDA.

The drug is only available overseas, as the only U.S. manufacturer recently ceased production last year amid controversy over its use. Moreover, the European Union recently announcedrestrictions on export of the drug. But with sodium thiopental unavailable, the most logical replacement is pentobarbital. This replacement drug, which is a more expensive alternative, has been used by 12 states to put 47 people to death since 2010, according to the Death Penalty information Center, and is widely used to put down animals. In addition, the chemical is used to treat insomnia and as a seizure treatment for epilepsy.

Manufacturers of pentobarbital, including Danish manufacturer Lundbeck, Inc., have made it known to various states that they do not want the drug used for executions. States such as Arizona, Georgia and Texas apparently have stockpiled pentobarbital and say they have enough supply for this year’s executions.

Texas apparently bought $50,000 worth last year and wants to block information on its stockpile, and the state has accused the anti-death penalty group Reprieve of “‘intimidation and commercial harassment’ of manufacturers of medical drugs used in lethal injections.” Arizonahas had its lethal injection protocols challenged, as inmates have sued the state for giving the state’s corrections director too much discretion. Meanwhile, Ohio just resumed executions after a federally-imposed six-month moratorium because prison officials were not following proper procedures. And Alabama stayed an execution in March after the condemned inmate argued that Pentobarbital does not completely sedate and amounts to cruel and unusual punishment under the Eighth Amendment.

With both domestic and international public pressure on the purveyors of death, it seems they’re feeling the heat, as well they should. Willing executioners are in short supply, and former executioners have seen enough to know they want no part of it. Further, they have likely killed innocent people. Many doctors are unwilling to break their Hippocratic oath to do no harm, or are forbidden to do so.

Used to extinguish 1,100 lives in 35 states — some of them most certainly innocent — lethal injection is the prominent form of capital punishment in the U.S. Marketed as the clean, humane form of capital punishment, lethal injection was billed as the friendly, painless type of execution. But we should ask, how harmless can you really make a lynching?

If lethal injection falls out of favor, either through a dwindling supply of the poisonous cocktail of death, lack of public support or a court ruling, what do the states do after that? Do they return to the hangman’s noose? That seems unlikely, reminds us too much of the strange fruit hanging from the trees that Billie Holiday used to sing about.

What about the electric chair, which has been known to cook people alive? Or the gas chamber, like the Nazis used to do?

Then there’s the firing squad. Better yet, how about stoning, or drawing and quartering, which is really old school?

Here’s a better idea. Just get rid of the death penalty for good. America is the only Western nation that executed people last year. And the U.S. is in the top five of nations that execute, putting us in league with China, Iran, North Korea and Yemen. We’ll never get it right with the death penalty because executions are so wrong.

No matter how the state kills a person, you can’t wipe the blood from your hands.

David A. Love is the Executive Director of Witness to Innocence, a national nonprofit organization that empowers exonerated death row prisoners and their family members to become effective leaders in the movement to abolish the death penalty.