July 23, 2013
Federal court says Nebraska, other states can keep lethal injection drug
By KEVIN O'HANLON
The Lincoln Journal Star
A federal appeals court on Tuesday said Nebraska and several other states do not have to surrender their foreign-made supplies of a lethal-injection drug, even though they were imported illegally.
But the court said the U.S. Food and Drug Administration cannot allow such shipments into the United States in the future, rejecting the agency's argument that it had discretion to allow unapproved drugs into the country.
The opinion, from a three-judge panel of the U.S. Court of Appeals District of Columbia Circuit, came in an appeal of a ruling last year by U.S. District Judge Richard Leon, who said the FDA must immediately notify state correctional departments in possession of any foreign-manufactured sodium thiopental that using such drugs is against the law and the drugs must be returned immediately to the FDA.
The court ruled that because the states were not part of the original lawsuit against the FDA, Leon's order that they surrender the drugs was too broad.
That means the issue of whether Nebraska can use the sodium thiopental now likely will be hashed out in federal court in Nebraska or the state Supreme Court.
Nebraska and several other states in which sodium thiopental is part of the execution protocol were forced to buy it overseas when the last U.S. manufacturer quit making it in 2010 because of death-penalty opposition from overseas customers. Nebraska's sodium thiopental was made by a Swiss company and came in two batches.
Leon sided with lawyers for death row inmates in Tennessee, Arizona and California who say the foreign-made sodium thiopental is an unapproved drug. But FDA lawyers pointed to a 1985 U.S. Supreme Court ruling in Heckler v. Chaney that said the FDA's decision to not take enforcement action in a lethal-injection drug case was not subject to judicial review.
That case involved a challenge by death-row inmates in Texas and Oklahoma who argued that U.S.-manufactured lethal injection drugs in the possession of prison officials had not been certified by the FDA as "safe and effective" for human executions and thus should be barred from being distributed via interstate commerce.
The FDA argued that Leon "expressly rejected FDA’s explanations that it does not want to expend resources on an area it considers distant from its public health mission and that it has historically deferred to law enforcement."
Leon's ruling also said the FDA is prohibited from allowing foreign-made sodium thiopental into the United States.
Lawyers for the inmates argued that the FDA's actions were arbitrary and capricious. They say the FDA issued a directive in January 2011 that set a general policy of automatically allowing all foreign thiopental shipments destined for prisons.
The appeals court said federal law "imposes mandatory duties upon the agency charged with its enforcement.
"The FDA acted in derogation of those duties by permitting the importation of thiopental, a concededly misbranded and unapproved new drug, and by declaring that it would not in the future sample and examine foreign shipments of the drug despite knowing they may have been prepared in an unregistered establishment," the court said. "The district court could not remedy the FDA’s unlawful actions, however, by imposing upon the interests of nonparties to this suit. The order of the district court pertaining to the thiopental already in the possession of the states ... is therefore vacated, but the underlying judgment of the district court is affirmed.
The court said federal law "requires the FDA to (1) sample 'any drugs' that have been 'manufactured, prepared, propagated, compounded, or processed' in an unregistered establishment and (2) examine the samples and determine whether any 'appears' to violate' federal law.
"If from the examination of such samples or otherwise, the FDA finds an apparent violation of the act, then it must ... refuse admission to the prohibited drug," the court said.
http://journalstar.com/news/state-an...e7c7024a7.html
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