The US Food and Drug Administration is being sued by six death row prisoners to try to stop it from allowing thiopental sodium, the anaesthetic used widely in lethal injections in the US, to be imported. The lawsuit accuses the FDA of violating federal law: “The law requires FDA to ensure that only safe, effective drugs are brought into the United States. When the agency allowed states to import unapproved sodium thiopental, it abdicated its responsibilities and violated federal law.”

Thiopental sodium is part of the three-drug protocol used by many US states to execute prisoners. After the sole American supplier stopped producing it, as many as five states have imported it from a British firm, apparently with the approval of the FDA.

As the drug has not been approved and therefore not shown to work as intended, the prisoners’ lawyers allege that prisoners may not be sufficiently anaesthetised. “Whatever one’s views may be on the death penalty, no reasonable person is in favour of botched or inhumane executions,” said their representative. The lawsuit requests the Washington DC federal district court declare that the FDA has violated the law, to ban it from permitting any future shipments, and to require it to recover any unapproved thiopental sodium already imported. ~ BMJ 2011;342:d818