A judge for the US District Court for the District of Columbia ruled Thursday that the Department of Justice’s (DOJ) new lethal injection protocol violates Food and Drug Administration (FDA) laws.
This case arose when Keith Nelson, a prisoner sentenced to death in 2002, sued the government for failing to adhere to the Administrative Procedure Act (APA). More specifically, Nelson argued that the Bureau of Prisons and the DOJ acted arbitrarily and capriciously in failing to provide justification for their failure to comply with the Food, Drug, and Cosmetic Act (FDCA) and that the government’s use of pentobarbital in lethal injections violated the FDCA.
In her opinion, Judge Tanya Chutkan stated that “the government’s failure to acquire a prescription for the use of the pentobarbital in Nelson’s execution is contrary to law and thereby violates the APA.” In addition, she dismissed the government’s argument that lethal injection drugs cannot be regulated by the FDCA by pointing to the DC Circuit’s precedent and the Supreme Court’s refusal to consider whether the FDCA applies to drugs used for executions.
Chutkan further wrote:
This precedent forecloses the government’s argument that because lethal injection drugs are intended to kill, they could not possibly be regulated by laws intended to ensure that a drug is “safe and effective” for its intended use. Violations of the FDCA carry “the risk that the drugs will not function as intended,” therefore the statute must apply in the lethal-injection context, because a lethal injection drug that does not function as intended may “result in conscious suffocation, pain, and cardiac arrest.” This is especially so where, as here, Defendants have justified the Protocol on the grounds that pentobarbital will render inmates insensate during the execution process. Where the government argues that a lethal injection drug is legal and constitutionally permissible because it will ensure a “humane” death, it cannot then disclaim a responsibility to comply with federal statutes enacted to ensure that the drugs operate humanely.
This ruling halted Keith Nelson’s execution, which was set to be carried out on Friday.
