Source: http://www.scribd.com/doc/155554644/Dkt-31-2013-07-23-Opinion
Timestamp: 2014-11-27 19:06:53
Document Index: 228141639

Matched Legal Cases: ['§ 381', '§ 706', '§ 331', '§355', '§ 352', '§ 321', '§ 355', '§ 381', '§ 301']

Dkt. 31 2013.07.23 Opinion
P. 1Dkt. 31 2013.07.23 OpinionDkt. 31 2013.07.23 OpinionRatings: (0)|Views: 64
|Likes: 0Published by cbsradionewsDC Circuit ruling on lethal injection drugs.DC Circuit ruling on lethal injection drugs.More info:Categories:Types, Government & PoliticsPublished by: cbsradionews on Jul 23, 2013Copyright:Attribution Non-commercialAvailability:Read on Scribd mobile: iPhone, iPad and Android.download as PDF, TXT or read online from ScribdFlag for inappropriate content|Add to collectionSee moreSee lesshttps://www.scribd.com/doc/155554644/Dkt-31-2013-07-23-Opinion07/23/2013pdftextoriginal United States Court of Appeals
Argued March 25, 2013 Decided July 23, 2013 No. 12-5176D
OOK ,
PPELLEES
PPELLANTS
Consolidated with 12-5266Appeals from the United States District Courtfor the District of Columbia(No. 1:11-cv-00289)
Daniel Tenny
, Attorney, U.S. Department of Justice,argued the cause for appellants. With him on the briefs were
Stuart F. Delery
, Principal Deputy Assistant AttorneyGeneral,
, U.S. Attorney,
Scott R. McIntosh
, Attorney,
William B. Schultz , Acting GeneralCounsel, U.S. Health and Human Services, and
Eric M. Blumberg , Deputy Chief Counsel.
Kent S. Scheidegger was on the brief for amicus curiae
Criminal Justice Legal Foundation in support of appellant.
USCA Case #12-5176 Document #1448004 Filed: 07/23/2013 Page 1 of 21
Eric A. Shumsky
argued the cause for appellees. Withhim on the brief were
Coleen Klasmeier and
Dale A. Baich
,Assistant Federal Public Defender, Office of the FederalPublic Defender for the District of Arizona.Before: R OGERS
, and G
Senior Circuit Judges
.Opinion for the Court filed by
: A group of prisonerson death row in Arizona, California, and Tennessee sued theFood and Drug Administration, the Department of Health andHuman Services, and the official in charge of each agency(collectively, the FDA) for allowing state correctionaldepartments to import sodium thiopental (thiopental), amisbranded and unapproved new drug used in lethal injection protocols, in violation of the Food, Drug, and Cosmetic Act(FDCA), 21 U.S.C. § 381(a), and the AdministrativeProcedure Act (APA), 5 U.S.C. § 706(2)(A). The districtcourt entered summary judgment for the plaintiffs, permanently enjoined the FDA from allowing the importationof apparently misbranded or unapproved thiopental, andordered the FDA to notify state correctional departments thatthe use of imported thiopental is unlawful and that existingstocks must be sent to the FDA. For the reasons that follow,we affirm the judgment of the district court but vacate the portion of its remedial order pertaining to thiopental alreadyin the possession of the states.
USCA Case #12-5176 Document #1448004 Filed: 07/23/2013 Page 2 of 21
3I. BackgroundThe Food, Drug, and Cosmetic Act (FDCA), makes itunlawful to introduce into interstate commerce a misbrandeddrug, 21 U.S.C. § 331(a), or an unapproved new drug, §355(a).
A drug is misbranded if, among other things, it was
“manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered” with the
FDA. § 352(o). An unapproved new drug is one that isneither “gener ally recognized, among experts ... as safe and
effective” for its labeled use,
§ 321(p)(1), nor approved by theFDA as safe and effective for its proposed use, § 355(d).The FDCA also regulates the importation of drugs. 21U.S.C. § 381(a) provides:The Secretary of the Treasury shall deliver to theSecretary of Health and Human Services [HHS], upon hisrequest, samples of ... drugs ... being imported or offeredfor import into the United States .... The Secretary of [HHS] shall furnish to the Secretary of the Treasury a listof establishments registered [with the FDA] ... and shallrequest that if any drugs ... manufactured, prepared, propagated, compounded, or processed in anestablishment not so registered are imported or offeredfor import into the United States, samples of such drugs... be delivered to the Secretary of [HHS] .... If it appearsfrom the examination of such samples or otherwise that... such article is adulterated, misbranded, or [anunapproved new drug] ..., then such article shall berefused admission.
The FDCA is codified at 21 U.S.C. § 301
. For convenience, we refer to sections of 21 U.S.C. as though they weresections of the Act.
USCA Case #12-5176 Document #1448004 Filed: 07/23/2013 Page 3 of 21
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