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.
A spokesperson for the FDA and the U.S. Department of Justice could not immediately be reached for comment.
Sodium thiopental, according to court filings, is used to anesthetize inmates before they receive the drugs that cause death. Without anesthesia, the inmates would be subjected to suffocation and pain in violation of their constitutional rights.
After U.S. companies stopped making the drug, states started importing it from overseas. The thiopental at issue was prepared and sold by companies that weren't registered with the FDA. The agency detained two early shipments that "appeared to be a misbranded and unapproved new drug," according to today's opinion, but released them after state officials explained how the drug would be used.
In 2011, the agency issued a policy statement saying it wasn't taking a position on the use of the drug for lethal injections but would exercise its discretion to allow shipments without review in deference to law enforcement.
In a March 2012 opinion, U.S. District Judge Richard Leon found the agency acted "arbitrarily and capriciously and abused its discretion" in permitting shipments of thiopental without examining it. The federal Food, Drug, and Cosmetic Act was clear that the agency "shall" review and block drugs in violation of the law, Leon found.
Senior Judge Douglas Ginsburg, writing for the D.C. Circuit, said in today’s ruling that the statute "unambiguously" imposed mandatory duties on the agency when it came to imports from unregistered companies.
"The plaintiffs argue each of these directives is unambiguously binding: The FDA must request samples of all drugs offered for import that have been made in an unregistered establishment, must examine those samples for a violation of the FDCA, and must refuse admission to any drug that appears, through the sampling process or otherwise, to violate the FDCA. We agree," Ginsburg wrote.
Since the individual states importing the drug weren't parties to the case, the D.C. Circuit concluded Leon couldn't impose an order that affected the states' interests. It vacated a section of the order requiring the FDA to tell the states the drug was illegal and that they should return it to the federal government.
Shumsky said he didn’t think that decision would have much practical effect, since the FDA already notified states of Leon's ruling after it was released and the affected states either said they no longer had the drug or that the court didn't have jurisdiction to issue its order.
Arizona and Tennessee no longer have the drug, Shumsky said, but California does. The state’s stock is set to expire by the spring of next year; California is reviewing its lethal injection protocol.
D.C. Circuit Judge Judith Rogers and Senior Judge David Sentelle also heard the case, which was argued in March.