Additional Coverage of Cook v. FDA

Yesterday's ruling by the U.S. Court of Appeals for the District of Columbia in Cook v. FDA is available in Adobe .pdf format.

"Import of Lethal Injection Drug Blocked by D.C. Circuit," is by Zoe Tillman for the Blog of Legal Times, Law.com.  Here's the beginning of this detailed article:

The U.S. Food and Drug Administration was wrong to allow states to import a "misbranded and unapproved new drug" used in lethal injection cocktails without first examining it, the U.S. Court of Appeals for the D.C. Circuit ruled today.

In a unanimous ruling, a three-judge panel upheld a trial judge's order blocking the FDA from allowing continued imports of sodium thiopental. The court found the agency "acted in derogation" of its duty to examine foreign shipments of a drug prepared by a company not registered with the FDA. The court rejected the agency's argument that it had discretion in deciding whether to review the shipments and could permit unreviewed imports in deference to law enforcement agencies.

The case was brought by a group of death row inmates in Arizona, California and Tennessee. Eric Shumsky of Orrick, Herrington & Sutcliffe, who argued for the death row inmates on appeal, said today that given the fact that the drug imports violated federal law, "this always was just a case about whether FDA was going to have to follow the law."

Sidley Austin partner Coleen Klasmeier, a lead attorney for the death row inmates and chair of the firm's product regulatory practice, said the ruling had broader implications for future court challenges to agency decisions. Courts are "increasingly willing to push back from assertions from federal agencies of unreviewable discretion," she said, adding that today's decision created a "more robust role" for the courts.

The Wall Street Journal Law blog posts, "Appellate Court Blocks Import of Key Lethal-Injection Drug," by Ashby Jones.

A three-judge panel of the U.S. Court of Appeals for the D.C. Circuit unanimously upheld a lower-court ruling from last year that banned the FDA from allowing states to import sodium thiopental, a drug often used as part of a three-drug lethal-injection protocol.

The appellate court essentially ruled that the FDA, by allowing shipments of an unapproved drug to come into the country, was ignoring federal law.

“When Congress commands an agency to act in a certain fashion, the agency has to follow the law,” said Eric Shumsky, a lawyer for the plaintiffs. “That’s what this case was all about from the start.”

A spokesman for the FDA said the agency “is reviewing the decision.”

Despite its longtime use as an anesthetic, sodium thiopental is not an approved drug under federal law.

In 2011, however, the agency decided that “in defer[ence] to law enforcement” agencies, it wouldn’t ban shipments of sodium thiopental from entering the country. At the time, the lone U.S.-based manufacturer still making sodium thiopental abruptly stopped, so several state correctional departments had begun ordering it from the U.K.

A group of death-row inmates in Arizona, California and Tennessee filed suit, claiming the 2011 policy violated federal law.

In a March 2012 ruling, U.S. District Judge Richard Leon agreed with the inmates, finding that the FDA acted “arbitrarily and capriciously and abused its discretion” in permitting shipments of thiopental.

"Nebraska ACLU urges state to surrender supply of lethal injection drug," is by Paul Hammel for the Omaha World-Herald.

The Nebraska ACLU is urging the state to surrender its supply of a key lethal injection drug following a court ruling Tuesday in Washington, D.C.

If that happened, Nebraska would be unable to carry out the death penalty, and might be forced to join several other states in switching the drugs it uses in lethal injections.

And:

The case was brought by death-row inmates in Arizona, California and Tennessee, who argued that such foreign-made drugs, without an FDA review, might be defective.

The court said the ruling applied only to those three states and that Nebraska can keep its supply.

But Amy Miller of the Nebraska ACLU said the decision makes it “a shoo-in” that a lawsuit brought by a death-row inmate in Nebraska would be successful.

Miller urged Nebraska officials to avoid the cost of a lawsuit and surrender its supply of foreign-made sodium thiopental to the FDA.

"Federal court says Nebraska, other states can keep lethal injection drug," is by Kevin O'Hanlon for the Lincoln Journal Star.

The opinion ruling, 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 USDA 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.

And:

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.

Earlier coverage begins with yesterday's post announcing the DC Court's ruling.