Background of the Underlying Conflict Regarding Sodium Thiopental in Executions
The opinion is the result of years of conflict regarding sodium thiopental. As the opinion explains, sodium thiopental was used by many States and the federal government in lethal injections from as far back as the 1970’s. Prior to using the substance in lethal injections, sodium thiopental was widely used as a surgical anesthetic. Historically, FDA declined to use its enforcement discretion to regulate the use of sodium thiopental in executions. Heckler v. Chaney, 470 U.S. 821 (1985). However, in 2012 the sole American Manufacturer of sodium thiopental ceased production and States could only obtain the substance by importing it from foreign suppliers. In 2011, a group of inmates from Arizona, California, and Tennessee brought suit against FDA for allowing the import of “misbranded” and an “unapproved new drug,” thiopental, to be imported in the U.S. In 2012 the U.S. District Court for the District of Columbia issued a permanent injunction requiring FDA to block the importation of sodium thiopental on these grounds. See Beaty v. FDA, 853 F. Supp. 2d 30 (D.D.C. 2012), aff ’d, Cook, 733 F.3d 1. The Texas Department of Criminal Justice (“TDCJ”) has fought vehemently against this injunction and for the release of sodium thiopental that has been seized by FDA. In 2017, FDA issued a letter confirming its authority over the imported substance (which the state of Texas did not deny) and determined the use of the drug for lethal injection was an unapproved new drug and misbranded.