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IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF TEXAS
Galveston Division

TEXAS DEPARTMENT OF CRIMINAL
JUSTICE,
Plaintiff,
v.
UNITED STATES FOOD AND DRUG
ADMINISTRATION,
STEPHEN OSTROFF, in his official
capacity as the Acting Commissioner of
Food and Drugs,
and
UNITED STATES OF AMERICA,
Defendants.

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Civil Action No. 3:17-cv-00001

PLAINTIFF TEXAS DEPARTMENT OF CRIMINAL JUSTICE’S FIRST
AMENDED COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

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INTRODUCTION
1.

In this case, Plaintiff Texas Department of Criminal Justice (“TDCJ”)

challenges actions by the U.S. Food and Drug Administration (“FDA”) prohibiting
importation of a shipment of the drug thiopental sodium.

TDCJ is responsible for

administering criminal sentences in Texas and has attempted to import the drug to carry
out capital sentences through lethal injection. The statutory and regulatory requirements
that FDA invokes to support its prohibitory actions do not apply in this law enforcement
context. An FDA “law enforcement” exemption precludes application of one of the
requirements at issue. And the remaining requirements also do not apply, among other
things because the drugs have labeling that does not prescribe, recommend, or suggest
any patient treatment use. TDCJ therefore respectfully requests the Court to set aside
FDA’s prohibitory actions, declare that they are unlawful, and enjoin FDA from
imposing similar prohibitions in the future.
JURISDICTION AND VENUE
2.

This Court has jurisdiction over this action under 28 U.S.C. § 1331, to

provide remedies set forth in 5 U.S.C. § 706 and 28 U.S.C. § 2201.
3.

Venue is proper in this District under 28 U.S.C. § 1391(e)(1)(B), because a

substantial part of the events or omissions giving rise to Plaintiff’s claim occurred, and
the property that is the subject of this action is situated, in this District. Venue also is
proper in this District under 28 U.S.C. § 1391(e)(1)(C), because Plaintiff resides in this
District.

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PARTIES
4.

Plaintiff TDCJ is a law enforcement agency of the State of Texas with

headquarters in this District, at 861-B IH 45 North, Huntsville, Texas. TDCJ administers
correctional facilities within this District and throughout the State of Texas. TDCJ is the
sole agency in the State of Texas with the authority and responsibility to administer
lawfully-imposed capital sentences through lethal injection. For purposes of this suit,
TDCJ represents the interests of the State of Texas.
5.

Defendant FDA has federal regulatory authority over, and has refused

admission into domestic commerce of, the thiopental sodium drugs at issue in this case.
Defendant Stephen Ostroff is the Acting Commissioner of Food and Drugs and the top
official of Defendant FDA. Defendant Ostroff is named as a defendant in his official
capacity as the Acting Commissioner of Food and Drugs. Defendant United States of
America is named as a defendant pursuant to 5 U.S.C. §§ 702-703, because this is an
action for judicial review of actions of agencies of the United States that have affected
Plaintiff adversely and will continue to do so unless remedied by this Court.
STATUTORY AND REGULATORY BACKGROUND
FDA’s Approval Process for “New Drugs”
6.

The Federal Food, Drug, and Cosmetic Act (“FFDCA”) establishes a

premarket approval process that requires FDA approval before pharmaceuticals known as
“new drugs” may be distributed in interstate commerce. 21 U.S.C. § 355(a). In order to
obtain FDA approval to market and sell a brand-name “new drug,” the sponsoring
company must submit a New Drug Application (“NDA”). An NDA must outline and
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explain the drug’s ingredients, the results of clinical tests, the results of animal studies,
how the drug behaves in the body, and how the drug is manufactured, processed, and
packaged. Before approving an NDA, FDA must evaluate numerous statutorily-defined
criteria, including whether the drug is safe and effective for its intended use. See 21
U.S.C. §§ 355(b), (d).
7.

In order to obtain FDA approval to market and sell a generic “new drug,”

the sponsoring company typically must submit an Abbreviated New Drug Application
(“ANDA”). An ANDA applicant may obtain FDA approval without conducting the full
battery of clinical and non-clinical studies required for an NDA. See generally 21 U.S.C.
§ 355(j). An ANDA applicant may rely upon a prior FDA finding of safety and efficacy
for the approved brand-name drug that is referred to in the ANDA, provided that the
proposed generic drug is the “same” with regard to active ingredients, dosage form, route
of administration, strength, and labeling. Id. § 355(j)(2)(A)(i), (ii), (iii), and (v).
8.

FDA premarket approval requirements apply only to “new drugs” as that

term is defined in 21 U.S.C. § 321(p). For FDA to demonstrate that a drug is a “new
drug,” the agency must establish that it is (1) not generally recognized by pertinent
experts as “safe and effective for use under the conditions prescribed, recommended, or
suggested in” the drug’s labeling; or (2) a drug that has become so recognized as a result
of certain investigations, but which has not, other than in those investigations, been used
to a material extent or for a material time under such conditions. 21 U.S.C. § 321(p).
The FFDCA defines “labeling” as “all labels and other written, printed, or graphic matter

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(1) upon any article or any of its containers or wrappers, or (2) accompanying such
article.” 21 U.S.C. § 321(m).
9.

Determining a drug’s “new drug” status based on statements in its labeling

is a fundamental foundation of FDA’s drug approval regime. A drug may be “generally
recognized as safe and effective” for some uses but not for others. See, e.g., 21 C.F.R.
§ 330.1(c)(2).

Labeling statements identify the uses for which approval is required

(absent general recognition of safety and effectiveness for that use).

The approval

standard accordingly parallels the “new drug” standard. FDA bases approval of a brandname new drug (through an NDA) on adequate and well-controlled investigations of the
drug’s effectiveness “under the conditions of use prescribed, recommended, or suggested
in the labeling or proposed labeling thereof.” 21 U.S.C. § 355(d). When it approves an
NDA, FDA determines that the brand-name new drug is safe and effective “for use under
the conditions prescribed, recommended, or suggested in the proposed labeling thereof.”
See 21 U.S.C. §§ 355(d)(1), (d)(5).
10.

The approval of a generic version of a brand-name “new drug” is similarly

tied fundamentally to conditions of use prescribed, recommended, or suggested in the
labeling. An ANDA must contain “information to show that the conditions of use
prescribed, recommended, or suggested in the labeling proposed for the new drug have
been previously approved” for the corresponding brand-name drug.

21 U.S.C.

§ 355(j)(2)(A)(i); see also 21 C.F.R. § 314.94(a)(4)(i). For FDA to approve the ANDA,
the agency must determine that (absent certain exceptions) “the labeling proposed for the

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drug is the same as the labeling approved for” the corresponding brand-name drug. 21
U.S.C. § 355(j)(4)(G).
Drugs That May be Lawfully Marketed Without FDA Premarket Approval
11.

If a drug is generally recognized by pertinent experts as safe and effective

for use under the conditions prescribed, recommended, or suggested in the drug’s
labeling, the drug is not a “new drug” within the meaning of 21 U.S.C. § 321(p).
Accordingly, such a drug may be lawfully marketed without prior FDA approval. FDA
promulgates monograph regulations defining the conditions under which many such
drugs are generally recognized as safe and effective. Numerous drugs are currently
marketed lawfully without prior FDA approval, because the drugs comply with these
monograph requirements. See generally 21 C.F.R. pts. 330-361.
12.

The FFDCA also does not require premarket approval of a drug if it has no

conditions of use prescribed, recommended, or suggested in a drug’s labeling. It is not
possible for FDA to establish that such a drug is a “new drug,” because there are no
conditions of use prescribed, recommended, or suggested in the labeling for the agency to
evaluate for general recognition of safety and effectiveness. Because such a drug is not a
“new drug,” premarket approval requirements do not apply. If FDA wishes to restrict
distribution of an unapproved drug with no conditions of use prescribed, recommended,
or suggested in its labeling, the agency does so through other regulatory requirements.

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The “Adequate Directions for Use”
Requirement and the Law Enforcement Exemption
13.

21 U.S.C. § 352(f)(1) is one of the provisions that FDA typically relies

upon if it wishes to restrict distribution of an unapproved drug with no conditions of use
prescribed, recommended, or suggested in its labeling. Section 352(f)(1) states that a
drug “shall be deemed to be misbranded . . . unless its labeling bears adequate directions
for use.” FDA’s regulations provide that “[a]dequate directions for use means directions
under which the layman can use a drug safely and for the purposes for which it is
intended.”

21 C.F.R. § 201.5.

A drug that has no conditions of use prescribed,

recommended, or suggested in its labeling generally lacks adequate directions for use,
because its labeling omits “[s]tatements of all conditions, purposes, or uses for which
such drug is intended.” Id. § 201.5(a).
14.

A drug that is misbranded under section 352(f)(1) because it lacks adequate

directions for use in its labeling is subject to a range of enforcement remedies under the
FFDCA, including import refusal, seizure, and injunction. 21 U.S.C. §§ 331(a), 332(a),
334(a), 381(a).
15.

Section 352(f)(1) authorizes FDA to promulgate regulations exempting

drugs from the “adequate directions for use” requirement if that requirement “is not
necessary for the protection of the public health.”

Under this authority FDA has

exempted numerous categories of drugs from the “adequate directions for use”
requirement.

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16.

This case involves one such drug labeling exemption: 21 C.F.R. § 201.125,

which governs “[d]rugs for use in teaching, law enforcement, research, and analysis.”
Section 201.125 applies to prescription drugs as defined in 21 U.S.C. § 353(b)(1)(A).
Under section 201.125, a prescription drug is “exempt from [21 U.S.C. § 352(f)(1)] if
shipped or sold to, or in the possession of, persons regularly and lawfully engaged in
instruction in pharmacy, chemistry, or medicine not involving clinical use, or engaged in
law enforcement, or in research not involving clinical use, or in chemical analysis, or
physical testing, and is to be used only for such instruction, law enforcement, research,
analysis, or testing.” 21 C.F.R. § 201.125.
17.

In this case, the drugs at issue fall within the exemption that applies to

drugs “shipped or sold to . . . persons . . . engaged in law enforcement, . . . and [are] to be
used only for such . . . law enforcement.” 21 C.F.R. § 201.125.
Requirements for Warnings to Protect Patients
18.

The FFDCA also requires that patients who use drugs are protected by

necessary and adequate labeling warnings. 21 U.S.C. § 352(f)(2) states that a drug “shall
be deemed to be misbranded . . . unless its labeling bears . . . such adequate warnings
against use in those pathological conditions or by children where its use may be
dangerous to health, or against unsafe dosage or methods or duration of administration or
application, in such manner and form, as are necessary for the protection of users.”
19.

In this case, no labeling warnings are necessary to protect patients, among

other things because the drugs at issue will not be used for patient treatment.

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FDA’s Process for Refusing Admission of Imports Into Domestic Commerce
20.

The FFDCA establishes a regime in which FDA and the U.S. Bureau of

Customs and Border Protection (“Customs”) work together to admit into domestic
commerce (or refuse admission of) drugs that are offered for import. In general, Customs
has the formal responsibility to police the border (just as it does for all other products
offered for import), and FDA provides the substantive expertise necessary to evaluate
whether drugs should be admitted into domestic commerce.
21.

The FFDCA gives Customs authority to collect samples of drugs offered

for import and deliver them to FDA, at FDA’s request. 21 U.S.C. § 381(a). In practice,
Customs has delegated this authority to FDA, so that FDA is the agency that collects the
samples. When FDA decides to collect a sample, FDA detains the drugs by issuing a
“hold” order that prevents introduction of the drugs into domestic commerce. The drugs
are detained for purposes of the examination described below. 21 C.F.R. § 1.90.
22.

The FFDCA gives FDA authority to conduct an “examination” of a sample

of imported drugs. 21 U.S.C. § 381(a). The purpose of the examination is for FDA to
determine whether it “appears from the examination of such samples” that the agency
should refuse the drugs’ admission into domestic commerce. Id. Section 381(a) allows
FDA to refuse admission of a drug into domestic commerce, among other things, if the
drug violates the premarket approval requirements of 21 U.S.C. § 355 or the misbranding
requirements of 21 U.S.C. § 352.
23.

If it “appears from the examination of such samples” of imported drugs that

any of the enumerated statutory criteria for refusal of admission have been met (21
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U.S.C. § 381(a)), FDA issues a “Notice of FDA Action” order that detains the drugs and
prevents their admission into domestic commerce.

At the same time, FDA gives the

owner or consignee notice and an opportunity for an informal hearing.

21 U.S.C.

§ 381(a); 21 C.F.R. § 1.94(a). If the owner or consignee persuades the agency that the
drugs should not be refused, FDA issues a “Notice of FDA Action” order also known as a
“Notice of Release,” which admits the drugs into domestic commerce. If FDA decides to
refuse admission of the drugs, the agency issues a “Notice of FDA Action” order also
known as a “Notice of Refusal.” “Notices of Release” and “Notices of Refusal” are
“orders” within the meaning of 5 U.S.C. § 551(6) because they are the final disposition of
FDA in a matter other than rulemaking.
24.

An FDA Notice of Refusal is final and definitive, not tentative or

interlocutory. A Notice of Refusal definitively effectuates FDA’s final determination that
it is unlawful to distribute the refused drugs in interstate commerce. A Notice of Refusal
and the underlying substantive determination that an import is refused, is a final agency
action within the meaning of 5 U.S.C. § 704, because it marks the consummation of the
agency’s decision-making process regarding admissibility of the drugs into domestic
commerce and determines rights or obligations, or triggers legal consequences,
concerning the drugs offered for import.
25.
import.

Customs enforces FDA’s final agency action refusing admission of an

For most imported drugs, Customs conditionally releases the drugs to the

custody of their owner or consignee at the time of importation, provided that the importer
posts a bond that would be forfeited if the drugs are not returned to Customs custody
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when requested. 19 C.F.R. § 113.62. If FDA issues a Notice of Refusal for such drugs,
Customs (under the basic importation bond) enforces FDA’s final agency action by
demanding redelivery of the drugs from the owner or consignee, so that Customs can
require their export or destruction (with the owner or consignee choosing whether the
drugs will be exported or destroyed). 19 C.F.R. § 141.113(c)(3); 21 U.S.C. § 381(a).
26.

Under very unusual circumstances, even where the owner or consignee has

otherwise complied with the basic importation bond requirements, Customs does not
release the drugs to the custody of their owner or consignee at the time of importation and
instead transfers the drugs to the custody of FDA pending consideration of their
admissibility into domestic commerce. If FDA later issues a Notice of Refusal for such
drugs, Customs enforces FDA’s final agency action by requiring their export or
destruction (with the owner or consignee choosing whether the drugs will be exported or
destroyed). 21 U.S.C. § 381(a).
PREDICT
27.

FDA has implemented an electronic screening tool for import operations

called Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting
(“PREDICT”). PREDICT uses automated data mining and pattern discovery processes to
create a different customized risk score for every import line within every import entry
involving a product regulated by FDA. PREDICT assigns a risk score to every import
line based on an electronic assessment of information in an FDA database, including
information regarding the compliance history of the foreign manufacturer and importer
and the characteristics of the specific product being imported. The risk score cumulates
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different risks identified in the database. Imported products determined by PREDICT to
be of sufficiently lower risk are given an automated “May Proceed,” which automatically
authorizes the products to enter domestic commerce without any review by FDA
personnel (provided that they are not held due to any other screening criteria). Imported
products determined by PREDICT to be higher risk are flagged for review by FDA
personnel for possible further review, including detention.
28.

When FDA refuses an import entry of drugs, the refusal is entered into the

PREDICT database and added to the compliance history for the drug and its importer.
Through the operation of the PREDICT system, FDA’s refusal of one import materially
increases the risk scores for the drug and its importer. By materially increasing the risk
scores, FDA’s refusal of a single import materially reduces the chance that future imports
of the same drug by the same importer will automatically be admitted into domestic
commerce, without review by FDA personnel. By materially increasing the risk scores,
FDA’s refusal of a single import materially increases the chance that future imports of the
same drug by the same importer will be detained at the border and scrutinized for
possible compliance issues by FDA personnel.
THE PARTIES’ DISPUTE
29.

This case arises out of a dispute concerning the importation of a drug

(thiopental sodium) by TDCJ solely for a law enforcement use: effectuating lawfullyimposed capital sentences through lethal injection.
30.

Thiopental sodium is a barbiturate that produces unconsciousness and

anesthesia. This effect is well known; the drug has been used for purposes of anesthesia
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since before the FFDCA was enacted in 1938. Thiopental sodium has been used in
hospitals for many decades as a prescription anesthetic. In addition, for many years and
in numerous different jurisdictions, thiopental sodium has been used (alone or in
combination with other drugs) to impose capital sentences through lethal injection.
31.

TDCJ has previously purchased and used thiopental sodium in numerous

executions before it became commercially unavailable to Texas correctional facilities for
that purpose. Through the import at issue in this case, TDCJ is attempting once again to
utilize thiopental sodium for purposes of imposing lawful capital sentences.
FDA’s Rules Governing Imports of
Thiopental Sodium to be Used by Correctional Facilities
32.

On January 5, 2011, FDA adopted a document entitled “Guidance for

handling pending and future shipments of Sodium Thiopental.” Sodium thiopental and
thiopental sodium are different names for the same drug. The January 2011 “Guidance”
was a “rule” within the meaning of 5 U.S.C. § 551(4) because it was an agency statement
of general or particular applicability and future effect designed to implement, interpret, or
prescribe law or policy.
33.

The January 2011 rule established the FDA procedures governing

admissibility of all imports of sodium thiopental intended to be shipped to correctional
facilities. The January 2011 rule directed all applicable FDA personnel to release such
imports automatically into domestic commerce for shipment to correctional facilities and
exempted such imports from the normal process through which the agency would
determine admissibility of an import.

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34.

On March 28, 2012, FDA revoked the January 2011 rule. On April 16,

2012, FDA issued a new directive governing admissibility of all imports of sodium
thiopental intended to be shipped to correctional facilities. The April 2012 directive (and
related written or unwritten implementation procedures) constitute a “rule” within the
meaning of 5 U.S.C. § 551(4) as an agency statement of general or particular
applicability and future effect designed to implement, interpret, or prescribe law or
policy. On information and belief, the April 2012 rule, which is referred to hereafter as
the “import ban rule,” is still in effect and is binding on the agency.
35.

On information and belief, FDA has applied and effectuated, and continues

to apply and effectuate, the import ban rule as a binding requirement to refuse all imports
of sodium thiopental intended to be shipped to correctional facilities. On information and
belief, this import ban rule applies regardless of how the drugs are labeled.
The Drugs Offered for Import
36.

Each vial of drug offered for import by TDCJ and at issue in in this case

bears a label identifying the drug as thiopental sodium and containing the legend: “For
law enforcement purpose only.” There are no statements in the drug’s label or labeling
prescribing, recommending, suggesting, or otherwise addressing the drug’s conditions of
use. The thiopental sodium is listed with FDA, and was manufactured and labeled at a
foreign facility registered with FDA, consistent with applicable regulatory requirements.
See 21 C.F.R. § 207.40.
37.

The label for each vial of thiopental sodium also includes an “Rx Only”

legend and a “CIII” legend (indicating that the drug is a schedule III controlled
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substance). Consistent with applicable regulations, TDCJ is registered with the Drug
Enforcement Administration (“DEA”) as an importer of this drug.

See 21 U.S.C.

§ 957(a)(1).
The Import Ban Rule and the Notification
Procedures Followed by TDCJ Prior to Importation
38.

In response to a press inquiry on or about May 29, 2015, FDA stated

categorically that it is unlawful for any state to import sodium thiopental for purposes of
lethal injection. On information and belief, FDA’s statement was a reference to the
import ban rule requiring refusal of imports of the drug intended to be shipped to state
correctional facilities.
39.

On June 8, 2015, TDCJ filed a Controlled Substance Import Declaration

with DEA explaining that TDCJ proposed to import thiopental sodium intended for law
enforcement purposes.
40.

After a number of communications between DEA and TDCJ, DEA issued a

written response on July 13, 2015, stating that DEA would notify Customs and FDA of
the upcoming importation. According to DEA, FDA had contacted DEA and asserted
that it was illegal to import the drug.
41.

On July 24, 2015, a foreign distributor shipped 1000 vials of thiopental

sodium via air freight to TDCJ. The shipment arrived at the Houston, Texas international
airport the same day.

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FDA’s Detention of the Thiopental Sodium
42.

FDA examined the goods by July 29, 2015. Following an initial detention

of the goods by FDA that was rescinded without explanation, Customs detained the
goods on August 5, 2015. The Customs Detention Notice indicated that the goods were
detained at the request of FDA “ . . . for FDA [admissibility] and further analysis.”
43.

On August 24, 2015, FDA issued a new notice of detention. The notice of

detention alleged that the detained shipment of thiopental sodium appears to: “(1) lack
adequate directions for use” in violation of 21 U.S.C. § 352(f)(1); “(2) lack adequate
warning against use in pathological condition or by children where it may be dangerous
to health or against an unsafe dose, method, administering duration, application, in
manner/form, to protect users” in violation of 21 U.S.C. § 352(f)(2); and “(3) be a new
drug without an approved new drug application” in violation of 21 U.S.C. § 355(a).
The Informal Hearing on Admissibility
44.

On October 23, 2015, TDCJ filed a written submission with FDA

presenting written testimony, argument and exhibits in connection with the informal
hearing on refusal of admission required by 21 C.F.R. § 1.94.
45.

TDCJ’s October 23 submission explained that the drugs do not violate the

“adequate directions for use” requirement of 21 U.S.C. § 352(f)(1), because the drugs fall
within the “law enforcement” exemption to that requirement established by FDA
regulation (21 C.F.R. § 201.125).
46.

TDCJ’s October 23 submission also explained that the drugs do not violate

the warning requirement of 21 U.S.C. § 352(f)(2), because that requirement does not
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apply under circumstances where there are no patients using the drugs. In the alternative,
TDCJ argued that even if the requirement did apply, the “law enforcement purpose only”
legend on the drugs’ label satisfied the requirement.
47.

Finally, TDCJ’s October 23 submission explained that the drugs at issue do

not violate the drug approval requirements of 21 U.S.C. § 355(a), because those
requirements only apply to “new drugs,” and the thiopental sodium at issue is not a “new
drug,” because there are no conditions of use prescribed, recommended, or suggested in
its labeling.
48.

On April 15, 2016, FDA issued a Tentative Decision on admissibility of the

drugs. The Tentative Decision stated that the agency had tentatively determined that the
thiopental sodium appeared to be an unapproved new drug that violated 21 U.S.C.
§ 355(a) and appeared to be a misbranded drug that violated 21 U.S.C. §§ 352(f)(1) and
352(f)(2).
49.

TDCJ submitted its response to FDA’s Tentative Decision on May 20,

2016, explaining again that the thiopental sodium did not violate any of the three
statutory provisions at issue.
FDA’s Order Refusing Admission of the Thiopental Sodium
50.

On April 21, 2017, FDA issued a Notice of Refusal refusing admission of

the thiopental sodium into domestic commerce on the ground that the drugs appeared to
lack adequate directions for use (in violation of 21 U.S.C. § 352(f)(1)) and appeared to be
unapproved new drugs (in violation of 21 U.S.C. § 355(a)). The Notice of Refusal states
that the drugs must be re-exported or destroyed within 90 days, or within such additional
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time as the District Director of Customs specifies. Currently the refused thiopental
sodium remains detained in the custody of FDA in this District.
51.

FDA explained the substantive basis for the refusal in an April 20, 2017

memorandum.

In the memorandum, FDA presented legal arguments supporting its

determination that the drugs appeared to lack adequate directions for use (in violation of
21 U.S.C. § 352(f)(1)) and appeared to be unapproved new drugs (in violation of 21
U.S.C. § 355(a)).

Although FDA’s detention notice and April 15, 2016 Tentative

Decision had included an additional claim (alleging a violation of 21 U.S.C. § 352(f)(2)),
the April 20, 2017 memorandum dropped that claim (as did the April 21, 2017 Notice of
Refusal).
52.

The Notice of Refusal was issued by an FDA Compliance Officer, and the

related memorandum was signed by the Acting Director of FDA’s Southwest Import
District Office. These officials had the authority to, and did, make the agency’s final
decision on admissibility of the drugs, as the officers designated by the FDA District
Director to act on the District Director’s behalf in administering and enforcing the
agency’s refusal authority. See 21 C.F.R. §§ 1.83(b), 1.94.
53.

The Notice of Refusal (and related memorandum) is an “order” within the

meaning of 5 U.S.C. § 551(6) because it is a final disposition in a matter other than
rulemaking. We refer to the Notice of Refusal and related memorandum hereafter as the
“refusal order.”
54.

The refusal order is a final and definitive, not tentative or interlocutory,

determination that it is unlawful to distribute the refused thiopental sodium in domestic
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commerce. The refusal order is a final agency action within the meaning of 5 U.S.C.
§ 704, because it marked the consummation of the agency’s decision-making process
regarding admission of the drugs into domestic commerce and determined rights or
obligations, or triggered legal consequences, concerning the drugs.
55.

The refusal order directly harms TDCJ by preventing TDCJ from having

the option of using the drugs at issue in lawful executions. This harm will continue
unless and until the Court issues the remedies requested below.
56.

The refusal order also independently and directly harms TDCJ by injuring

TDCJ’s reputation. In the refusal order, FDA has formally decided that TDCJ — a law
enforcement agency — has attempted to import drugs in violation of federal law. The
refusal order has caused, and is substantially likely to continue to cause, adverse publicity
that has and will injure TDCJ’s reputation by asserting that TDCJ has attempted to import
drugs in violation of federal law. These injurious collateral consequences of the refusal
order will continue until the Court issues the remedies requested below.
57.

The refusal order also injures TDCJ by directly causing a substantial risk of

continuing and future harm to TDCJ. There currently are more than 200 offenders who
have received a capital sentence in Texas and are awaiting execution through lethal
injection. During recent years, TDCJ has executed numerous prisoners by administering
lethal injection.

TDCJ will continue to execute additional prisoners through lethal

injection, on a recurring and continuing basis, for the foreseeable future. TDCJ therefore
needs a continuing and recurring supply of drugs to be used for lethal injection. TDCJ
intends to continue importing thiopental sodium, with the same labeling as the import
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currently under dispute, for purposes of lethal injection. The refusal order creates a
substantial risk that FDA will detain and refuse, or request Customs to detain so that FDA
will refuse, future shipments of thiopental sodium that TDCJ wishes to import into the
United States. This substantial risk of harm will continue unless and until the Court
issues the remedies requested below.
58.

Coordination between FDA and DEA creates a substantial risk that the

refusal order will cause the detention of such future shipments. FDA and DEA are in
communication regarding the regulatory status of thiopental sodium. DEA regulations
require TDCJ to file a new Controlled Substance Import Declaration with DEA before
initiating each such future import. The Controlled Substance Import Declaration notifies
DEA in advance that a controlled substance is to be imported into the United States.
When TDCJ files Controlled Substance Import Declarations in connection with future
imports of thiopental sodium, it is highly likely that DEA will notify FDA of the
proposed imports, and that (based on the refusal order) FDA either will detain the drugs
or direct Customs to detain the drugs. In addition, on information and belief, information
regarding the refusal order either has been or will be entered into the PREDICT database.
Entry into the PREDICT database materially increases the chance that FDA will detain
such future imports.
59.

There is a substantial risk that because of the refusal order, FDA will refuse

such future imports when they are detained, because FDA will follow the rationale of the
refusal order in denying the admission of such imports into domestic commerce. For a
period of almost two years, FDA analyzed the lawfulness of TDCJ’s import and has
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issued its final determination on that issue. There is no realistic possibility that FDA
would reach a different determination regarding the admissibility of future imports by
TDCJ of the same drug, with the same labeling, to be used for the same purpose. Such
refusals will directly harm TDCJ by preventing TDCJ from having the option of using the
drugs at issue in lawful executions. The remedies requested below will redress this harm.
60.

In the alternative, based on the facts set forth in the foregoing paragraphs,

TDCJ at a minimum has a reasonable expectation that when it imports future shipments
of thiopental sodium with the same labeling, FDA will refuse the import, based on the
same legal analysis set forth in the refusal order challenged in this case, unless a court
intervenes.
61.

There is no adequate judicial remedy that is an alternative to the remedies

requested in this Complaint.
COUNT I
Agency Action in Excess of Statutory Jurisdiction, Authority, or Limitations
(21 U.S.C. §§ 355(a) and 381(a) – Refusal Order)
62.

Plaintiff hereby incorporates by reference each and every allegation set

forth in paragraphs 1 through 61 above.
63.

The refused thiopental sodium does not violate, or appear to violate, any

provision of the FFDCA. Admission of the refused thiopental sodium into domestic
commerce is lawful.
64.

In the refusal order, FDA erroneously concluded that the refused thiopental

sodium is or appears to be an unapproved new drug that violates, or appears to violate, 21
U.S.C. § 355(a).
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65.

The refused thiopental sodium may be lawfully admitted into domestic

commerce without prior FDA approval.

The approval requirements of 21 U.S.C.

§ 355(a) do not apply to drugs with labeling that does not prescribe, recommend, or
suggest any conditions of use for the drugs, because such drugs are not “new drugs”
within the meaning of 21 U.S.C. § 321(p). The labeling of the refused thiopental sodium
does not prescribe, recommend, or suggest any conditions of use for that drug. Therefore
the approval requirements of 21 U.S.C. § 355(a) do not apply to the refused thiopental
sodium.
66.

The refusal order is a final agency action that prohibited importation of

thiopental sodium without statutory authority. FDA had no authority to refuse admission
of the drugs under 21 U.S.C. § 381(a), because the drugs do not violate, and do not
appear to violate, 21 U.S.C. § 355(a). The refusal order is a final agency action in excess
of statutory jurisdiction, authority, or limitations within the meaning of 5 U.S.C.
§ 706(2)(C).
67.

Under 5 U.S.C. § 706(2)(C), this Court should hold unlawful and set aside

the refusal order.
68.

Under 5 U.S.C. § 706(2)(C) and 28 U.S.C § 2201, this Court should declare

the refusal order unlawful and direct FDA to provide notice of that declaratory judgment
to Customs and DEA.
69.

Under 5 U.S.C. § 706(2)(C), this Court should enjoin FDA from refusing

admission into domestic commerce of future imports of thiopental sodium with the same

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labeling. The injunction also should direct FDA to remove references to the refusal order
from the PREDICT database.
COUNT II
Agency Action in Excess of Statutory Jurisdiction, Authority, or Limitations
(21 U.S.C. §§ 352(f)(1) and 381(a) – Refusal Order)
70.

Plaintiff hereby incorporates by reference each and every allegation set

forth in paragraphs 1 through 61 above.
71.

The refused thiopental sodium does not violate, or appear to violate, any

provision of the FFDCA. Admission of the refused thiopental sodium into domestic
commerce is lawful.
72.

In the refusal order, FDA erroneously concluded that the refused thiopental

sodium is misbranded, or appears to be misbranded, within the meaning of 21 U.S.C.
§ 352(f)(1). The drugs are exempt from the requirements of section 352(f)(1) under 21
C.F.R. § 201.125.
73.

The refused thiopental sodium is a prescription drug within the meaning of

21 U.S.C. § 353(b)(1)(A).
74.

Use of thiopental sodium to administer lawfully-imposed capital sentences

through lethal injection is a use of the drug for law enforcement purposes. TDCJ is a
state agency that is regularly and lawfully engaged in law enforcement. The refused
thiopental sodium is exempt from the requirements of 21 U.S.C. § 352(f)(1) under 21
C.F.R. § 201.125, because the drugs were shipped or sold to persons engaged in law
enforcement, and the drugs are to be used only for such law enforcement.

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75.

The refusal order is a final agency action that prohibited importation of

thiopental sodium without statutory authority. FDA had no authority to refuse admission
of the drugs under 21 U.S.C. § 381(a), because the drugs are not misbranded, and do not
appear to be misbranded, under 21 U.S.C. § 352(f)(1). The refusal order is a final agency
action in excess of statutory jurisdiction, authority, or limitations within the meaning of 5
U.S.C. § 706(2)(C).
76.

Under 5 U.S.C. § 706(2)(C), this Court should hold unlawful and set aside

the refusal order.
77.

Under 5 U.S.C. § 706(2)(C) and 28 U.S.C § 2201, this Court should declare

the refusal order unlawful and direct FDA to provide notice of that declaratory judgment
to Customs and DEA.
78.

Under 5 U.S.C. § 706(2)(C), this Court should enjoin FDA from refusing

admission into domestic commerce of future imports of thiopental sodium with the same
labeling. The injunction also should direct FDA to remove references to the refusal order
from the PREDICT database.
COUNT III
Agency Action in Excess of Statutory Jurisdiction, Authority, or Limitations
(21 U.S.C. §§ 381(a), 352(f)(1) and 355(a) – Import Ban Rule)
79.

Plaintiff hereby incorporates by reference each and every allegation set

forth in paragraphs 1 through 61 above.
80.

The import ban rule is a final and definitive, not tentative or interlocutory,

binding requirement for FDA to refuse admission of imports of thiopental sodium
intended to be shipped to correctional facilities, regardless of how the drugs are labeled.
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The import ban rule denies FDA decisionmaking discretion regarding such imports. The
import ban rule is a final agency action within the meaning of 5 U.S.C. § 704, because it
marked the consummation of the agency’s decision-making process regarding the
requirements for admission of such drugs into domestic commerce and determined rights
or obligations, or triggered legal consequences, concerning the drugs.
81.

The import ban rule directly harms TDCJ by preventing TDCJ from having

the option of using thiopental sodium in lawful executions. The harm from the import
ban rule is independent of the harm from the refusal order. The harm from the import
ban rule persists without regard to any particular import shipment initiated by TDCJ. The
harm from the import ban rule will continue unless and until the Court invalidates that
rule through the remedies requested below.
82.

The approval requirements of 21 U.S.C. § 355(a) do not apply to drugs with

labeling that does not prescribe, recommend, or suggest any conditions of use for the
drugs, because such drugs are not “new drugs” within the meaning of 21 U.S.C. § 321(p).
The labeling of the refused thiopental sodium does not prescribe, recommend, or suggest
any conditions of use for that drug. Therefore the approval requirements of 21 U.S.C.
§ 355(a) do not apply to the refused thiopental sodium.
83.

The refused thiopental sodium is a prescription drug within the meaning of

21 U.S.C. § 353(b)(1)(A).
84.

Use of thiopental sodium to administer lawfully-imposed capital sentences

through lethal injection is a use of the drug for law enforcement purposes. TDCJ is a
state agency that is regularly and lawfully engaged in law enforcement. The refused
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thiopental sodium is exempt from the requirements of 21 U.S.C. § 352(f)(1) under 21
C.F.R. § 201.125, because the drugs were shipped or sold to persons engaged in law
enforcement, and the drugs are to be used only for such law enforcement.
85.

The import ban rule exceeds FDA’s statutory authority under 21 U.S.C.

§§ 381(a), 352(f)(1) and 355(a) by requiring FDA to refuse admission of imports that are
lawful to distribute in domestic commerce.

Such lawful imports include thiopental

sodium that is labeled like the refused thiopental sodium.
86.

The import ban rule is a final agency action in excess of statutory

jurisdiction, authority, or limitations within the meaning of 5 U.S.C. § 706(2)(C).
87.

Under 5 U.S.C. § 706(2)(C), this Court should hold unlawful and set aside

the import ban rule to the extent that it prohibits TDCJ from importing thiopental sodium,
for law enforcement purposes, that is labeled like the refused thiopental sodium.
88.

Under 5 U.S.C. § 706(2)(C) and 28 U.S.C § 2201, this Court should declare

that the import ban rule is unlawful to the extent that it prohibits TDCJ from importing
thiopental sodium, for law enforcement purposes, that is labeled like the refused
thiopental sodium. The Court should direct FDA to provide notice of the declaratory
judgment to Customs and DEA.
89.

Under 5 U.S.C. § 706(2)(C), this Court should enjoin FDA from enforcing

the import ban rule to the extent that it prohibits TDCJ from importing thiopental sodium,
for law enforcement purposes, that is labeled like the refused thiopental sodium.

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PRAYER FOR RELIEF
Plaintiff respectfully requests the Court to grant the following relief:
I.

Hold unlawful and set aside FDA’s refusal order;

II.

Hold unlawful and set aside FDA’s import ban rule to the extent that
it prohibits TDCJ from importing thiopental sodium, for law
enforcement purposes, that is labeled like the refused thiopental
sodium.

III.

Issue the declaratory judgment described in paragraphs 68, 77 and
88 above and direct FDA to inform Customs and DEA of that
declaratory judgment;

IV.

Issue the injunction described in paragraphs 69, 78 and 89 above;
and

V.

Award such other relief as this Court deems just and proper.

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Respectfully submitted,
/s/ Daniel G. Jarcho
Daniel G. Jarcho, Attorney in Charge
Tamara R. Tenney
ALSTON & BIRD LLP
950 F Street, N.W.
Washington, D.C. 20004
(202) 239-3254 (telephone)
(202) 239-3333 (fax)

April 26, 2017

Edward L. Marshall
Chief, Criminal Appeals Division
State Bar No. 00797004
S.D. Tex. Bar No. 22642
Matthew Ottoway
Assistant Attorney General
State Bar No. 24047707
S.D. Tex. Bar No. 892308
Texas Attorney General’s Office
P.O. Box 12548, Capitol Station
Austin, Texas 78711-2548
(512) 936-2891 (telephone)
(512) 320-8132 (fax)

Attorneys for Plaintiff Texas Department of Criminal Justice

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CERTIFICATE OF SERVICE
I hereby certify that on April 26, 2017, I electronically filed the foregoing First
Amended Complaint with the Clerk of the Court for the U.S. District Court, Southern
District of Texas, using the electronic case-filing system of the Court. The electronic
case-filing system sent a “Notice of Electronic Filing” (NEF) to the following counsel of
record, who consented in writing to accept the NEF as service of this document by
electronic means:
Alexander V. Sverdlov
Trial Attorney
Consumer Protection Branch
Civil Division
U.S. Department of Justice
P.O. Box 386
Ben Franklin Station
Washington, DC 20044
/s/ Daniel G. Jarcho
Daniel G. Jarcho