The Lawletter Vol 36 No 11
Early in 2011, the sole U.S. manufacturer of sodium thiopental—used by many state officials as part of the process of administering the death penalty by lethal injection—announced that it was ending production of the drug. That announcement and the subsequent shortage of the drug caused delays in executions in California and Oklahoma and caused those and other States to scramble to find alternative sources for the drug. Ultimately, these States reached out to foreign suppliers and began to import sodium thiopental for use in executions. However, under the federal Food, Drug, and Cosmetic Act, the Food and Drug Administration ("FDA") is charged with preventing the importation of drugs from other countries unless they have been specifically approved by the FDA. In a suit brought by death-row inmates from Tennessee, California, and Arizona, the inmates argued that the FDA had ignored its responsibility to keep the unapproved foreign sodium thiopental from entering the United States. In response, the FDA argued that it had no jurisdiction over drugs used for executions.Siding with the inmates, a federal district court judge in Washington, D.C., on February 27, 2012, held that the FDA's actions were "contrary to law," Beaty v. FDA, Civ. No. 11-289 (RJL), slip op. at 12 (D.D.C. filed Mar. 27, 2012), and "arbitrary, capricious, [and] an abuse of discretion," id. at 18, and found that the plain language of the law requires that an article that appears to be unapproved "shall be refused admission," id. at 12. The judge then blocked the FDA from allowing the drug into the country and further ordered the FDA to immediately contact state correctional departments to inform them that the use of foreign‑manufactured sodium thiopental is prohibited by law and to require them to send their supplies of the unapproved drug to the FDA. This ruling is sure to have an impact on the ability of States to carry out scheduled executions.