FDA’s Immoral Stance on Lethal Injection Drugs

July 30 (Bloomberg) -- The mission of the Food and Drug Administration is to protect us from drugs that might kill because they are impure, badly manufactured, untested. Well, not all drugs, as it turns out.

When it comes to drugs used in executions, the FDA says it doesn’t check on their “potency, safety or effectiveness.” Thus, the agency allowed a small company in Mumbai that stored its drugs in a room without air conditioning to sell Nebraska enough sodium thiopental for 166 executions.

It permitted a tiny wholesaler, Dream Pharma, operating out of two rooms in the back of a driving school in London, to sell sodium thiopental -- the most critical drug in executions -- to Georgia, Arkansas, Tennessee, South Carolina and California. The FDA even helped expedite a shipment of sodium thiopental to Arizona because “it was for the purpose of executions and not for use by the general public,” the deputy director of the Arizona Department of Corrections wrote in an e-mail to his counterpart in California.

This caused one death penalty lawyer, Clive Stafford Smith, to say sarcastically that drugs “can be expedited if they are meant to kill someone, but apparently not if they are meant to save lives.”

The conundrum for the FDA, which has now been sued, arose when the only U.S. company that had FDA approval for sodium thiopental, Hospira, ceased production. With that, death penalty states scrambled abroad for the drug, an anesthetic, and their problems escalated.

Three Injections

Lethal injection was first proposed in the 19th century by a New York doctor who argued it would be cheaper than hanging. Oklahoma was the first state to deploy it, in 1977, and eventually all death penalty states followed. Most have used a three-drug protocol administered through IVs inserted into the arms of the prisoner, who is strapped onto a gurney. The first is the anesthetic. This is to render the prisoner unconscious so that he does not suffer the pain when the next drugs are injected.

The second drug, pancuronium bromide, paralyzes the diaphragm and lungs, making it impossible for the condemned to breathe. Finally potassium chloride is injected, causing death by cardiac arrest.

In a landmark ruling in 2008, Baze v. Rees, the Supreme Court held that lethal injection was not “cruel and unusual punishment,” which is proscribed by the Eighth Amendment.

But the court didn’t give blanket approval to this method of execution. The majority looked specifically and carefully at the three-drug protocol used in Kentucky that was spelled out in detailed regulations. These ranged from the amounts of drugs to the requirement that only qualified personnel could insert the IVs in the prisoner’s arms. The court concluded that this protocol did not present a “substantial risk of serious harm,” or an “objectively intolerable risk of harm,” which is the test for whether a punishment violates the Eighth Amendment.

The majority recognized that the most critical drug is the anesthetic. “It is uncontested that, failing a proper dose of sodium thiopental that would render the prisoner unconscious, there is substantial, unconstitutionally unacceptable risk of suffocation from the administration of pancuronium bromide and pain from the injection of potassium chloride,” Chief Justice John Roberts wrote.

This opened the door for lawyers representing clients facing execution to argue that the sodium thiopental being acquired from abroad was unsafe, or impure, either because it was manufactured without proper quality controls or stored improperly. The drugs came from a “non-FDA approved source,” the lawyers argued.

Inmate Lawsuit

Finding itself under increasing attack from anti-death penalty activists, the FDA issued a statement in January 2011. Yes, it had permitted the importation of sodium thiopental for executions without any review “for safety, effectiveness or quality,” the agency said. “In doing so, FDA deferred to law enforcement in the use of substances for lethal injection.”

Six death-row inmates, from California, Arizona and Tennessee, sued the FDA to force it to take action, to block the importation of sodium thiopental that had not been tested and approved. They were represented by Bradford Berenson, a Republican who was an associate White House counsel under President George W. Bush.

A federal district court judge ruled against the agency, with some strikingly pointed language about the FDA’s defense that it deferred to law enforcement agencies. “In the final analysis, 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,” wrote Judge Richard J. Leon, who was appointed to the bench by Bush. “How utterly disappointing!”

Hanging over the ruling was whether the Obama administration would appeal. If it did not, it would be a victory of sorts for death-row inmates, though not a big one. Requiring the FDA to review drugs for safety and efficacy wouldn’t stop executions. It might, however, significantly reduce unnecessary pain and suffering during an execution, which is precisely the standard set by the Supreme Court.

Fifteen states wrote to Attorney General Eric H. Holder urging him to appeal. He has done so, a notice of appeal filed in late May.

“How utterly disappointing,” to borrow from Judge Leon.

(Raymond Bonner, a lawyer and former New York Times reporter, is the author of “Anatomy of Injustice: A Murder Case Gone Wrong.” The opinions expressed are his own.)

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To contact the writer of this article: Raymond Bonner in London at

To contact the editor responsible for this article: Katy Roberts at

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