The OLC opinion was clearly designed to break through the legal logjam that has prevented states from using lethal injection drugs in executions — and it uses Evel Kneivel-style logical leaps to get there.
Lethal injections, such as the three-drug cocktail sodium thiopental, have become the primary method of execution in the United States. Of the 292 executions in the last 10 years, 289 have employed such chemicals.
U.S. drug manufacturers, not wanting their products to be associated with executions, stopped making thiopental 10 years ago, forcing states to acquire the killing drugs overseas. This move has generated legal trouble, however, as the Food, Drug, and Cosmetic Act (FDCA) prohibits misbranded drugs from entering interstate commerce, including any drug not manufactured in an establishment registered with the FDA. The statute also prohibits the use of an unapproved new drug that the FDA has not blessed as safe and effective for its proposed use.
Based on these legal provisions, a group of convicts on death row sued the FDA in 2011 and gained an injunction requiring the administration to prevent the entry of foreign-manufactured thiopental on the grounds that it was unapproved and misbranded. It also had to tell state correctional departments that the use of the drug was prohibited by law under threat of civil and criminal penalties.
That injunction remains in effect today. Among other things, it has put the FDA and death-penalty states such as Texas at loggerheads.
The Office of Legal Counsel’s opinion, authored by its well-respected head lawyer, Assistant Attorney General Steven A. Engel, attempts to take the FDA’s foot off the throat of death-penalty states. Engel points to FDA v. Brown & Williamson, a 2000 case in which the Supreme Court found that the FDA lacks regulatory authority over tobacco products as “drugs” or “devices” (Congress later granted the agency power to regulate them directly), to argue that the FDA similarly cannot regulate sodium thiopental’s use in executions. The supposition is that when used for executions, the substance is intended to kill the prisoner, so by definition the drug is not “safe” or “effective.”
But this reasoning is tendentious. Nowhere in Brown & Williamson did the court suggest that the law inherently did not cover tobacco products; rather, the court held that, lacking any safer effective use, the FDA could only regulate the products by banning them, which Congress expressly forbade. Congress has not, however, forbidden the FDA from banning the use of sodium thiopental in executions.
The OLC opinion tries to get around this problem by lumping sodium thiopental in with other means of executions — electric chairs, gallows or firing squads — that “are intended to affect the function or structure of the body,” which is one of the definitions of a “drug.” Thus, Engel argues, the FDA would have to ban all means of execution, whereas “the Constitution and laws of the United States presuppose the continued availability of capital punishment.”
This is a massive logical leap. Among other problems, it assumes that there cannot be a “safe and effective” drug in executions, but the whole point of lethal injection is to provide a safe and effective form of execution — not, of course, to extend life but to promote a humane and predictable death rather than the ghoulish lottery of untested, potentially painful drugs.
Moreover, all the opinions in the litigation that resulted in the 2011 injunction, as well as previous opinions in the Supreme Court, concluded that the FDA’s jurisdiction over drugs extends to sodium thiopental. Even Texas expressly conceded it in the injunction litigation. The OLC opinion also sidesteps the immense implications of its reasoning for the FDA’s regulation of drugs for physician-assisted suicide, animal euthanasia or recreation.
So why would OLC issue such a strained opinion? First clue: The heading of the opinion makes clear that it was ordered up by the attorney general, which is relatively rare. And a footnote states that OLC “considered” the views of the FDA. Reading between the lines, it’s a decent bet that OLC rejected the FDA’s arguments.
Apart from disarming the FDA, the opinion removes the threat of civil and even criminal liability under the FDCA for state officials who buy and use the foreign-manufactured drugs.
Finally, the OLC opinion could potentially serve as the basis for a motion to dissolve or amend the 2011 injunction. Death penalty states could argue to the court that the FDA’s jurisdiction is a threshold issue not previously considered, and the opinion here, being an official statement of the executive branch, would carry more weight than a simple argument in a brief.
None of this would be so worrisome if the opinion represented the sort of nonpartisan legal interpretation that the OLC is charged with providing. But the opinion, not least because of its dubious legal analysis, bears the distinct scent of a preferred political solution. Given the concern that the Justice Department has become a political tool for the administration, it’s yet another worrisome indication that the norms of our institutions are eroding.