Law suit filed against US FDA to stop importation/use of unapproved sodium thiopental in lethal injections

On behalf of six death-row prisoners from California, Arizona, and Tennessee in the USA, law firm Sidley Austin has filed suit against the Food and Drug Administration seeking to prohibit FDA from allowing the importation or use of unapproved sodium thiopental.

During the past year, FDA has knowingly permitted unapproved sodium thiopental to be imported by state corrections agencies for use in executions by lethal injection. According to Bradford Berenson, a partner in the firm’s Washington DC office, “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,” he noted.

The Complaint alleges that FDA is required to deny admission to any drug that is unapproved, misbranded or adulterated. Sodium thiopental recently imported by various states for use in lethal injections is all three. Because sodium thiopental has not been approved by the FDA - meaning that the agency has made no determination of its safety, effectiveness, purity, potency, or any other characteristic - it cannot legally be imported into the USA. Plaintiffs allege that the FDA has violated US federal law and acted in a manner inconsistent with its own prior policies and practices by allowing importation of the unapproved drug.