Execution by . . . Heroin?: Why States Should Challenge the FDA's Ban on the Importation of Sodium Thiopental

• Author: Matthew C. Bergs
• Position: M.H.A. candidate, The University of Iowa College of Public Health, 2018; J.D. candidate, The University of Iowa College of Law, 2017; B.A., Marquette University, 2013
• Pages: 761-791

N2_BERGS_UPDATED (DO NOT DELETE) 1/15/2017 9:55 AM

761

Execution by . . . Heroin?: Why States

Should Challenge the FDA’s Ban on the

Importation of Sodium Thiopental

Matthew C. Bergs*

ABSTRACT: This Note traces the history of the lethal injection drug shortage and its

impact on how states carry out the death penalty. Though this topic has received much

attention in recent years, relatively little attention has been paid to the D.C. Circuit’s

decision in Cook v. FDA, which exacerbated the shortage. In Cook, the D.C. Circuit

enjoined the FDA from exercising its enforcement discretion to allow the importation of

sodium thiopental, the primary anesthetic used by states in lethal injection executions.

This decision is significant because it effectively required the FDA to ban the importation

of sodium thiopental, forcing states to find other ways to carry out executions. Many

states have turned to new drugs and manufacturers, while others have returned to past

methods of execution. However, states’ use of alternative drugs and manufacturers has

had disastrous consequences, and the return to old methods of execution constitutes an

unacceptable regression towards inhumane and barbaric punishment. Thus, this Note

argues that states should make every effort to obtain sodium thiopental. Potential

avenues to obtain the drug include adhering to the FDA’s regulations or litigating

against the FDA’s regulations. Renewed access to sodium thiopental will resolve many

of the problems plaguing the administration of lethal injection.

I. INTRODUCTION & BACKGROUND .................................................. 762

A. HISTORY OF LETHAL INJECTION AS A METHOD OF EXECUTION ... 763

B. DEVELOPMENT OF THE LETHAL INJECTION DRUG SHORTAGE ..... 765

II. ASSESSMENT OF THE D.C. CIRCUIT’S DECISION IN COOK V. FDA ... 768

A. EXPLANATION OF THE SUPREME COURT’S DECISION IN

HECKLER V. CHANEY ............................................................. 769

B. ANALYSIS OF THE D.C. CIRCUIT’S DECISION IN COOK V. FDA ... 770

C. WHY COOK V. FDA WAS WRONGLY DECIDED ........................... 771

*

M.H.A. candidate, The University of Iowa College of Public Health, 2018; J.D.

candidate, The University of Iowa College of Law, 2017; B.A., Marquette University, 2013. I would

like to thank Professor Todd Pettys and Dr. Ben Gillig for their invaluable comments on earlier

drafts of this Note. I would also like to thank the Iowa Law Review Volume 102 Editorial Board for

its assistance in preparing this Note for publication. Finally, I would like to thank my parents,

Dr. Joe and Carrie Bergs, to whom I am deeply indebted, both literally and figuratively.

N2_BERGS_UPDATED (DO NOT DELETE) 1/15/2017 9:54 AM

762 IOWA LAW REVIEW [Vol. 102:761

III. RESPONSES TO THE D.C. CIRCUIT’S DECISION IN COOK V. FDA .... 772

A. EXPERIMENTING WITH ALTERNATIVE DRUGS ............................ 773

B. ENGAGING WITH COMPOUNDING PHARMACIES .......................... 776

C. RETURNING TO PAST METHODS OF EXECUTION ......................... 779

D. IGNORING THE FDA’S RESTRICTIONS ........................................ 783

IV. POTENTIAL SOLUTIONS TO THE D.C. CIRCUIT’S DECISION IN

COOK V. FDA .................................................................................. 786

A. ADHERE TO THE FDA’S REGULATIONS ...................................... 786

B. LITIGATE THE FDA’S REGULATIONS ......................................... 788

V. CONCLUSION ................................................................................ 790

I. INTRODUCTION & BACKGROUND

“I’ve heard everything from using heroin to using nitrogen to going back to the

electric chair. That’s a debate that probably we need to have.”1

A lethal injection drug shortage has crippled the “machinery of death.”2

In recent years sodium thiopental, one of the most reliable and effective

anesthetics3 used by states in lethal injection executions, has become

unavailable in the United States.4 The D.C. Circuit’s decision in Cook v. FDA

to enjoin the United States Food and Drug Administration (“FDA”) from

allowing the importation of sodium thiopental5 has compounded the

shortage, forcing states into what has been described by some as “an almost

Wild West frenzy.”6 Now officials are exploring new and old frontiers such as

alternative drugs, alternative manufacturers, and past methods of execution

in an effort to find a solution to the shortage.7 Such efforts have been largely

unavailing, however, and have renewed the debate over whether the death

1. Karen Kasler, Lethal Injection Drug Shortage Causes Lawmakers to Consider Changing

Execution Method, WXVU (Oct. 23, 2015), http://wvxu.org/post/lethal-injection-drug-shortage-

causes-lawmakers-consider-changing-execution-method#stream/0.

2. Callins v. Collins, 510 U.S. 1141, 1145 (1994) (Blackmun, J., dissenting).

3. See Robert Lowes, Anesthesiologists Ask FDA to Okay Importation of Sodium Thiopental, MEDSCAPE

(Feb. 11, 2011), http://www.medscape.com/viewarticle/737303 (discussing the American Society of

Anesthesiologists’ request to the FDA that it allow the importation of sodium thiopental because it

“remains a mainstay of anesthesia induction medications” and, therefore, “[i]ts availability must be

ensured”).

4. Ty Alper, Opinion, Why the Execution Drug Shortage Won’t Go Away, L.A. TIMES (Apr. 13,

2015, 11:22 PM), http://www.latimes.com/opinion/op-ed/la -oe-alper-lethal-injection-shortages-

20150414-story.html.

5. Cook v. FDA, 733 F.3d 1, 3 (D.C. Cir. 2013).

6. Gregg Zoroya, Death Penalty Spurs Wild West Scramble for Drugs, USA TODAY (Mar. 17,

2014, 6:49 PM), http://www.usatoday.com/story/news/nation/2014/03/09/executions-lethal-

injection-drugs-prisons-death-penalty/5866947.

7. See infra Part III.