Lawsuit Challenges FDA's Inaction on Lethal Injection Drugs in Many States

On February 2, the national law firm of Sidley Austin LLP filed a suit against the Food and Drug Administration (FDA) in federal court on behalf of six death row inmates from Arizona, California, and Tennessee.  The suit seeks to compel the FDA to bar the importation or use of unapproved sodium thiopental, a drug used by most states in lethal injections, but no longer available in the U.S.  The plaintiff's brief states that, following a nationwide shortage of sodium thiopental in 2010, the FDA illegally allowed prison officials to obtain the lethal injection drug from sources outside of the U.S., while refusing to investigate the safety and purity of the imported drugs.  The inmates are represented by Bradford A. Berenson, a former associate counsel to President George W. Bush and a partner at Sidley.  In a statement released by the law firm, Berenson said, "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."  Berenson, a supporter of the death penalty, also said that the lawsuit is "not about halting executions but rather about ensuring that illegal drugs are not used in carrying out otherwise lawful sentences."  Read full press release from Sidley Austin LLP and read Complaint filed against FDA.

The suit alleges that inmates from the named states face execution with drugs that have been illegally imported and may cause severe harm.  The suit states that the imported sodium thiopental is "unapproved, misbranded, [and] adulterated," all in violation of federal law. 

(N. Koppel, "FDA Dragged Into Execution-Drug Controversy," The Wall Street Journal, February 2, 2011).  See Lethal Injection.