Last week, death row inmate Clayton Lockett was killed by Oklahoma in a slow, torturous death, after the state used a drug whose source was not disclosed to administer a lethal injection. But this was only one of a number of executions performed using experimental drugs or those from an unknown source, as states facing drug shortages look for new ways to keep putting inmates to death.
These moves by states to try new untested methods, dosages, or sources of drugs are not just questionable under the Eighth Amendment prohibition of cruel and unusual punishment. They also amount to human experimentation, according to a new analysis from the Johns Hopkins University Bloomberg School of Public Health.
Experiments on human subjects are regulated by the Food and Drug Administration (FDA), and every time states undertake a new lethal injection method without first submitting an application to the FDA, they are violating federal law, the school’s Clinic For Public Health Law & Policy concludes.
As far as the clinic is aware, not a single state is currently reporting new execution protocols to the FDA. But enforcing this provision of FDA regulations would ensure that states do not engage in what amounts to human experimentation without first checking with the agency that oversees the health and safety of U.S. pharmaceuticals.
“The obvious intent of the regulation is that if people are using drugs in a new way — and that would include using new dosages of drugs — that the Food and Drug Administration should have an opportunity to make an evaluation of whether that is safe to the people to whom the drug should be administered,” said Stephen P. Teret, founding director of the clinic.
Teret said states are purportedly experimenting with new drug protocols not just to achieve the goal of putting someone to death, but also the goal of ensuring they “put someone to death without causing that person such unusual pain that it would violate the Eighth Amendment the United States Constitution.” In achieving this, he said, states have the same obligation to ensure human health and safety by clearing new protocols with the FDA.
The study was initiated after a professor at the Johns Hopkins School of Medicine, Jonathan M. Zenilman, suggested that lethal injections might be human research subject to federal regulation. Teret said the clinic did not go into its investigation trying to achieve abolition of capital punishment.
“In fact we never even discussed what individual students and faculty members’ personal positions were with regard to capital punishment,” he said. “Our goal was a much more narrow goal which is to examine whether the states are in violation of federal law when they are using these new drugs in new amounts in an experimental way to achieve capital punishment.”
According to the clinic’s analysis, states are in violation of federal law every time they fail to submit new drug protocols to the FDA in what is known as an “Investigational New Drug” application. In that application, they must specify how they will meet protocol requirements laid out in the regulation. They don’t have to wait for their protocol to be approved, but FDA does have 30 days to put a “clinical hold” on the submitted protocol.
Teret said the clinic has been in contact with lawyers who may challenge the executions on this basis. But the clinic’s analysis suggests it may be difficult for inmates to overcome procedural hurdles in filing a lawsuit. Instead, the burden may be on the FDA to enforce the provision against Departments of Correction.