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Media Alerts - Cook v. FDA
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July 23, 2013
  Cook v. FDA
Headline: D.C. Circuit enjoins importation and release of misbranded and unapproved lethal injection drugs

Area of Law: Administrative Law

Issue(s) Presented: Whether the FDA's policy statement allowing the importation of misbranded and unapproved sodium thiopental for the execution of state prisoners and its failure to refuse admission to specific shipments of the drug violates the Food Drug and Cosmetic Act (FDCA) and the APA.

Brief Summary: Sodium thiopental, a drug used in lethal injections in several states, has not been manufactured in the United States since 2009. Since that time, states that use it have ordered the drug from Dream Pharma Ltd., a wholesaler located in the United Kingdom. Neither Dream Pharma nor the manufacturer, Archimedes Pharma U.K. Ltd., is registered with the FDA. Because the shipments of sodium thiopental are therefore "unapproved" within the meaning of the Food Drug and Cosmetic Act (FDCA) ยง 331(a), the FDA detained the first two shipments from Dream Pharma. After state actors explained the intended purpose of the thiopental, the FDA permitted subsequent shipments. In 2011, the FDA issued a policy statement explaining that it neither approved nor reviewed thiopental for use in lethal injections but that, in deference to law enforcement agencies, it would exercise its enforcement discretion not to review shipments and to allow processing through custom's automated system for importation. A group of prisoners on death row in Arizona, California, and Tennessee sued the FDA alleging that the policy statement and FDA's failure to refuse shipments from Dream Pharma violated the APA and FDCA. The FDA argued that its determination not to take enforcement action was unreviewable because such matters are committed to the agency's discretion. The United States District Court for the District of Columbia disagreed, determining that the FDA's conduct was reviewable and that the FDA violated the law. The FDA appealed, and the D.C. Circuit affirmed.

The D.C. Circuit found that it did not need to decide whether Chevron deference applies to an agency's determination that matters are committed to its unreviewable discretion because the FDA had violated the clear, mandatory provisions of the statute. The court distinguished Heckler v. Chaney on the basis that, in this case, the statute did not merely authorize the agency to take action; it made rejection of misbranded and unapproved drug shipments mandatory. Because the FDA lacked discretion to permit misbranded and unapproved shipments, the D.C. Circuit affirmed. The court did, however, vacate that portion of the district court's order that applied to state parties that had not been joined in the lawsuit.

For the full text of this opinion, please visit

Panel (if known): Rogers, Ginsburg, Sentelle

Argument Date (if known): March 25, 2013

Date of Issued Opinion: July 23, 2013

Docket Number: 12-5176

Decided: July 23, 2013

Case Alert Author: Tiffany Kelley

Counsel (if known): Daniel Tenny, Stuart F. Delery, Ronald C. Machen, Jr., Scott R. McIntosh, William B. Schultz, and Eric Blumberg for appellant. Eric A. Shumsky, Coleen Klasmeier, and Dale A. Baich for appellees.

Author of Opinion: Ginsburg

Case Alert Circuit Supervisor: Elizabeth Beske, Ripple Weistling

    Posted By: Ripple Weistling @ 07/23/2013 03:28 PM     DC Circuit  

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