"Judge Bars Imported Drugs in Executions," is the title of John Schwartz' brief item in today's New York Times.
A federal judge has prohibited the use of imported death penalty drugs and has ordered the Food and Drug Administration to collect the drugs from any states that have imported them. Judge Richard J. Leon of the Federal District Court in Washington ruled Tuesday in a case brought on behalf of death row inmates in Arizona, California and Tennessee. States that use sodium thiopental to render prisoners unconscious as part of their execution protocols reached out to foreign suppliers when the sole domestic manufacturer stopped producing the drug, which had not been approved for importation. The F.D.A. said it had no jurisdiction over execution drugs.
The Memorandum Opinion in Beaty v. FDA and the District Court's Order are available in Adobe .pdf format.
The AP filing is, "Judge blocks importation of lethal-injection drug," by Frederic J. Frommer. It's via Contra Costa Times.
U.S. District Judge Richard Leon sided with lawyers for death row inmates in Tennessee, Arizona and California who want to keep out sodium thiopental, because it is an unapproved drug manufactured overseas. The Obama administration argued it had discretion to allow unapproved drugs into the U.S.
But Leon said the FDA's actions were "contrary to law, arbitrary, capricious, and an abuse of discretion." He said that plain language of the law says that an article that appears to be misbranded or unapproved "shall be refused admission."
Leon scolded the agency: "Put simply, this appears to be nothing more than the FDA, once again, stubbornly clinging to every last ounce of its discretionary authority!"
Sodium thiopental is an anesthetic used to put inmates to sleep before other lethal drugs are administered. The drug's U.S. manufacturer announced last year that it would no longer produce it, which forced corrections officials to delay many executions. Many of the nation's 34 death penalty states switched to an alternative drug, pentobarbital -- a point Leon stressed.
In addition to blocking the FDA from allowing the drug into the country, Leon also ordered the FDA to immediately notify any state correctional departments with foreign-manufactured
thiopental that its use is prohibited by law, and that the drug must be returned to the FDA.
A lawyer for the death row challengers, Brad Berenson, said in an email that "it was especially gratifying that the court recognized that even the most despised members of our society are entitled to the protections Congress gave to all Americans in the Food Drug and Cosmetic Act."
Reuters posts, "US judge bars import of drug used in death penalty," by Jeremy Pelofsky via the Chicago Tribune.
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.
"Federal judge bars import of execution drug," is Mike Ward's report for the Austin American-Statesman.
U.S. District Judge Richard Leon issued the 22-page decision in a case filed by 21 condemned convicts against the federal Food and Drug Administration, which they alleged had violated its own rules by allowing entry of the powerful anesthetic into the United States without first ensuring its efficacy.
“Prisoners on death row have an unnecessary risk that they will not be anesthetized properly prior to execution,” Leon wrote in his order, believed to be the first to address the issue of the importation of execution drugs.
Texas used sodium thiopental until about a year ago when, after its sole overseas supplier announced it was stopping production, prison officials switched to another drug: pentobarbital.
In his order, Leon said the drug had been misbranded and was unapproved by the FDA. He ordered five states — Arizona, California, Georgia, South Carolina and Tennessee — and any others with stocks of the barbiturate to surrender them to the FDA.
According to news reports, attorneys for the death row convicts had argued that use of the drug during execution could lead to so-called anesthesia awareness, in which they may experience suffocation, pain and cardiac arrest.
According to court filings, the shipments of thiopental entering the United States came from an Austrian facility owned by Sandoz International GmbH. The drug was shipped from a London wholesaler, Dream Pharma Ltd., which purchased it from a third firm, the Britian-based Archimedes Pharma Ltd., the filings state.
In court filings, FDA officials had argued that their decision to allow the drugs to enter the United States was an act of “enforcement discretion,” insisting that for them to review drugs used in lethal injections carried out by states was outside their public health role as an agency.
"Neb. must turn over lethal injection drug," is by Paul Hammel for the Omaha World-Herald.
A federal judge's ruling Tuesday in Washington, D.C., will block any executions from being carried out in Nebraska, at least for several months.
And:
Jerry Soucie, a defense attorney representing two death-row inmates in Nebraska, said the ruling should put a halt to executions in Nebraska because the state will have to surrender its supply of sodium thiopental.
“It's a very big deal,” Soucie said.
A spokeswoman for the Nebraska attorney general said the office had not yet seen the court's decision. “But the U.S. Supreme Court previously rejected similar arguments by death row inmates,” spokeswoman Shannon Kingery said.
Tuesday's ruling is expected to generate an appeal, which eventually could rise to the U.S. Supreme Court.
But the appeals could take several months to resolve, thus potentially holding up any executions in Nebraska, unless the state joins 14 other states in changing the drugs it uses for executions or obtains a legal order blocking the confiscation of the sodium thiopental.
A leading death penalty supporter, State Sen. Mike Flood of Norfolk, the speaker of the Legislature, said he didn't think Tuesday's ruling would require a change in lethal injection drugs, but it does raise “another hurdle” in carrying out an execution.
Sen. Brad Ashford of Omaha, who opposes the death penalty, said the judge's ruling moves the issue another step closer to challenges of lethal injection as unconstitutional cruel and unusual punishment.
The Lincoln Journal Star reports, "Ruling clouds Nebraska's use of lethal injection drug," by Kevin O'Hanlon.
Late last year, Nebraska prison officials said they bought sodium thiopental made by Naari, a pharmaceutical company headquartered in Switzerland. In fact, they bought the drug from a middleman named Chris Harris, who had bought it from Naari and then sold it to the state.
Attorney Jerry Soucie of the Nebraska Commission of Public Advocacy has been arguing that Nebraska should not be allowed to use the sodium thiopental made by Naari.
Soucie, who represents death-row inmate Michael Ryan, declined immediate comment on Tuesday's ruling.
Soucie has said Harris and his company, Harris Pharma LLP, were not authorized to sell the drug, which were samples meant for use in testing. That, he contends, means Harris misappropriated the thiopental from Naari, and Nebraska prison officials are in possession of stolen property.
Nebraska is among 10 states that have purchased the drug from foreign sources. The U.S. Drug Enforcement Administration has seized supplies from several because they were imported illegally or because of questions over how they were manufactured. Nebraska twice has bought sodium thiopental made overseas. The DEA did not seize the first batch but told the state it could not use it because it was imported illegally. Nebraska then got a proper import license and bought the supply from Harris.
Judge Leon sided with lawyers for death row inmates in Tennessee, Arizona and California who want to keep out sodium thiopental, because it is an unapproved drug manufactured overseas. The Obama administration argued the FDA had discretion to allow unapproved drugs into the United States.
But Leon said the FDA's actions were "contrary to law, arbitrary, capricious and an abuse of discretion." He said that plain language of the law says an article that appears to be misbranded or unapproved "shall be refused admission."
Earlier coverage of the ruling begins at the link, and coverage of Nebraska lethal injection issues begins at this link.
Related posts are in the international and lethal injection indexes.
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