Case 3:17-cv-00001 Document 1 Filed in TXSD on 01/03/17 Page 1 of 17

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,
ROBERT M. CALIFF, in his official
capacity as the Commissioner of Food and
Drugs,
and
UNITED STATES OF AMERICA,
Defendants.

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Civil Action No. ________________

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

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INTRODUCTION
1.

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

challenges unreasonable delay in an action by the U.S. Food and Drug Administration
(“FDA”) determining the admissibility, into domestic commerce, of an import 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. More than seventeen months ago, in July 2015, FDA detained the
imported drugs at the border. More than sixteen months ago, in August 2015, FDA
claimed three specific legal grounds for potentially refusing the drugs’ entry into
domestic commerce. None of these grounds is valid. An FDA “law enforcement”
exemption precludes application of one of the legal requirements at issue. And the other
two legal requirements also do not apply, among other things because the drugs will not
be used for patient treatment and have labeling that prohibits any patient treatment use.
2.

TDCJ has submitted detailed legal arguments to FDA explaining why this

import is lawful.

Yet FDA has refused to make a final decision as to the drugs’

admissibility, effectively preventing their importation without any definitive legal
justification. To make a final decision, FDA only needs to address pure questions of law
that the agency itself has raised. Nonetheless, the time that FDA has taken to determine
whether its own legal theories are valid exceeds the time that the Supreme Court of the
United States typically takes to resolve the most complex legal issues facing the Nation.
Because FDA’s delay is unreasonable, TDCJ requests the Court to declare that the delay
is unlawful and compel FDA to render a final admissibility decision.

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JURISDICTION AND VENUE
3.

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.
4.

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 is proper
in this District under 28 U.S.C. § 1391(e)(1)(C), because Plaintiff resides in this District.
PARTIES
5.

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.
6.

Defendant FDA has federal regulatory authority over the thiopental sodium

drugs at issue in this case. Defendant Robert M. Califf is the Commissioner of Food and
Drugs and the top official of Defendant FDA. Defendant Califf is named as a defendant
in his official capacity as the 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 failure to act, by an agency of the United States, that has
affected Plaintiff adversely and will continue to do so unless remedied by this Court.

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STATUTORY AND REGULATORY BACKGROUND
FDA’s Approval Process for “New Drugs”
7.

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
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).
8.

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).
9.

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

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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
(1) upon any article or any of its containers or wrappers, or (2) accompanying such
article.” 21 U.S.C. § 321(m).
10.

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).
11.

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
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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
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
12.

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 (and has been used under such conditions to a material extent or for a material
time), 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. pt. 330.
13.

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
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“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.
The “Adequate Directions for Use”
Requirement and the Law Enforcement Exemption
14.

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).
15.

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).
16.

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

drugs from the “adequate directions for use” labeling requirement if that requirement “is
not necessary for the protection of the public health.” Under this authority FDA has

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exempted numerous categories of drugs from the “adequate directions for use”
requirement.
17.

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.
18.

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
19.

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.”

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20.

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

the drugs at issue will not be used for patient treatment.
FDA’s Process for Refusing Admission of Imports Into Domestic Commerce
21.

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.
22.

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.
23.

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.
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24.

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
U.S.C. § 381(a)), FDA issues a “Notice of 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 Release” admitting the drugs into
domestic commerce. If FDA decides to refuse admission of the drugs, the agency issues
a “Notice of Refusal of Admission.” “Notices of Release” and “Notices of Refusal of
Admission” are “orders” within the meaning of 5 U.S.C. § 551(6) because they are the
agency’s final disposition in a matter other than rulemaking.
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
when requested. 19 C.F.R. § 113.62. If FDA issues a Notice of Refusal of Admission
for such drugs, Customs (under the basic importation bond) enforces FDA’s final agency
acting 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).

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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 of

Admission 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).
THE PARTIES’ DISPUTE
27.

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.

FDA has delayed more than

seventeen months making a final determination on admissibility of that importation.
28.

Thiopental sodium is a barbiturate that produces unconsciousness and

anesthesia. This effect is well known; the drug has been used for purposes of anesthesia
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.
29.

TDCJ has previously purchased and used thiopental sodium in numerous

executions, before it became commercially unavailable to Texas correctional facilities for

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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.
The Drugs Offered for Import
30.

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 Notification Procedures Followed by TDCJ Prior to Importation
31.

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. Consistent with applicable regulations, TDCJ is registered with
the Drug Enforcement Administration as an importer of this drug.

See 21 U.S.C.

§ 957(a)(1).
32.

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

written response on July 13, 2015, stating that DEA had notified Customs and FDA of
the upcoming importation. According to DEA, FDA had contacted DEA and asserted
that it was illegal to import the drug, because it appeared to be misbranded or in violation
of the new drug approval requirements of 21 U.S.C. § 355.
33.

On July 24, 2015, the 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
34.

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.”
35.

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
36.

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.
37.

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).
38.

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.
39.

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.
40.

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).
41.

TDCJ responded to FDA’s Tentative Decision on May 20, 2016, explaining

again that the thiopental sodium does not violate any of the three statutory provisions at
issue.
FDA’s Failure to Issue a Final Decision
on the Admission of the Thiopental Sodium into Domestic Commerce
42.

As of the date of this Complaint, FDA has failed to issue a Final Decision

regarding admissibility of the thiopental sodium that TDCJ has offered for import into
domestic commerce.

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43.

The thiopental sodium at issue currently remains detained in the custody of

FDA within this District.
44.

The issues presented for resolution by FDA, concerning admissibility of the

drugs at issue, are pure questions of law (involving a small administrative record) that
can be resolved without a substantial investment of agency resources. On information
and belief, FDA’s failure to issue a Final Decision regarding the admissibility of the
drugs is not legitimately attributable to limitations in agency resources.
45.

FDA’s failure to issue a Final Decision regarding admissibility of the drugs

directly harms, and unfairly prejudices, TDCJ by preventing TDCJ from utilizing the
drugs (which TDCJ has purchased and owns) for lethal injection.
COUNT I
Agency Action Unlawfully Withheld
or Unreasonably Delayed in Violation of 5 U.S.C. § 706(1)
46.

Plaintiff hereby incorporates by reference each and every allegation set

forth in paragraphs 1 through 45 above.
47.

FDA’s process for determining admissibility of the drugs at issue is an

“adjudication” within the meaning of 5 U.S.C. § 551(7), because it is an agency process
for formulation of an “order” within the meaning of 5 U.S.C. § 551(6). FDA’s Final
Decision on the admissibility of the drugs at issue would be an “order” within the
meaning of 5 U.S.C. § 551(6) because it would be the final disposition of FDA in a
matter other than rulemaking. FDA’s Final Decision on the admissibility of the drugs at
issue also would be an “agency action” within the meaning of 5 U.S.C. § 551(13) and a
“final agency action” within the meaning of 5 U.S.C. § 704.
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48.

21 U.S.C. § 381(a) imposes a mandatory duty on FDA to issue a Final

Decision on the admissibility of the drugs at issue.
49.

5 U.S.C. § 555(b) imposes a mandatory duty on FDA to issue a Final

Decision on admissibility of the drugs at issue within a reasonable time.
50.

By failing to issue a Final Decision on admissibility of the drugs more than

seventeen months after FDA ordered the drugs’ detention for potential refusal of their
admission into domestic commerce, and more than sixteen months after FDA identified
the three specific legal grounds for the detention and potential refusal of admission, FDA
has failed to issue the Final Decision within a reasonable time as required by 5 U.S.C.
§ 555(b). For the same reason, FDA’s failure to issue the Final Decision is an agency
action unlawfully withheld or unreasonably delayed within the meaning of 5 U.S.C.
§ 706(1).
51.

Under 5 U.S.C. § 706(1), the Court should issue an injunction compelling

FDA to issue the Final Decision on admissibility of the drugs.
52.

Under 28 U.S.C. § 2201, this Court should declare that FDA’s failure to

render a Final Decision on admissibility of the drugs is an agency action unlawfully
withheld or unreasonably delayed within the meaning of 5 U.S.C. § 706(1).
53.

TDCJ has no other adequate judicial remedy that is an alternative to the

remedies requested in this Complaint.

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

Issue a mandatory injunction compelling FDA to issue the Final Decision
on admissibility of the thiopental sodium offered for import;

II.

Issue a declaratory judgment declaring that FDA has unlawfully withheld
or unreasonably delayed issuing the Final Decision on admissibility of the
imported thiopental sodium offered for import; and

III.

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

Respectfully submitted,
Benjamin L. England
BENJAMIN L. ENGLAND &
ASSOCIATES, LLC
810 Landmark Drive, Suite 126
Glen Burnie, MD 21061
(410) 220-2800 (telephone)
(443) 583-1464 (fax)

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

January 3, 2017

/s/ Edward L. Marshall
Edward L. Marshall, Attorney In Charge
Chief, Criminal Appeals Division
State Bar No. 00797004
S.D. Tex. Bar No. 22642
Matthew Ottoway
Assistant Attorney General
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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1' PLAINTIFF and Drug Administration, Robert M. Califf, in his

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IR 

 

   

      

   

I3 110 Insurance PERSONAL INJURY PERSONAL INJURY 3 625 Drug Related Seizure Cl
I3 120 Marine Cl 310 Airplane I3 365 Personal Injury - of Property 2  USC 881 CI 423 Withdrawal 130 Miller Act 13 315 Airplane Product Product Liability I3 690 Other 28 USC 157 
I3 I40 Negotiable Instrument Liability I3 367 Health Care/ [3 400 State Reapportionment
I3 150 Recovery of Overpayment I3 320 Assault, Libel Pharmaceutical I- Cl 410 Antitrust
Enforcement of Judgment Slander Personal Injury Cl 820 Copyrights Cl 430 Banks and Banking
C1 15] Medicare Act I3 330 Federal Employers? Product Liability I3 830 Patent Cl 450 Commerce
I3 152 Recovery of Defaulted Liability I3 368 Asbestos Personal Cl 840 Trademark I3 460 Deportation
Student Loans I3 340 Marine ury Product I3 470 Racketeer Influenced and
(Excludes Veterans) Cl 345 Marine Product Liability .  - 5  i Corrupt Organizations
I3 153 Recovery of Overpayment Liability PERSONAL PROPERTY I3 710 Farr Labor Standards I3 861 l-lIA (1395t?? C1 480 Consumer Credit
of Veteran?s Bene?ts I3 350 Motor Vehicle I3 370 Other Fraud Act I3 862 Black Lung (923) CI 490 Cable/Sat TV
I3 160 Stockholders? Suits i3 355 Motor Vehicle I3 371 Truth in Lending CI 720 Labor/Management I3 863 (405(g)) i3 850 Secruities/CmmnoditieS/
I3 190 Other Contract Product Liability I3 380 Other Personal Relations I3 864 SSID Title XVI Exchange
I3 195 Contract Product Liability 3 360 Other Personal Property Damage 3 740 Railway Labor Act I3 865 RSI (405 I3 890 Other Statutory Actions
I3 I96 Franchise Injury I3 385 Property Damage I3 751 Family and Medical C1 891 Agricultural Acts
. 3 362 Personal Injury - Product Liability Leave Act I3 893 Environmental Matters
Medical Malpractice I3 790 Other Labor Litigation C1 895 Freedom of Information

    
    
 

           

 
   

 

 

 

 

 

 

 

 

 

 

 

 :v I3 791 Employee Retirement FEDERAL Act
I3 210 Land Condemnation I3 440 Other Civil Rights Income Security Act El 870 Taxes US. Plaintiff C1 896 Arbitration
I3 220 Foreclosure I3 441 Voting I3 463 Alien Detainee or Defendant) 899 Administrative Procedure
Cl 230 Rent Lease Ejectment I3 442 Employment I3 510 Motions to Vacate CI 871 IRS?Third Party Act/Review or Appeal of
I3 240 Torts to Land I3 443 Housing/ Sentence 26 USC 7609 Agency Decision
CI 245 Tort Product Liability Accommodations I3 530 General I3 950 Constitutionality of
I3 290 All Other Real Property I3 445 Amer. w/Disabilitics - El 535 Death Penalty State Statutes

Employment Other: I3 462 Naturalization Application

I3 446 Amer. w/Disabilities - I3 540 Mandamus Other I3 465 Other Immigration
Other I3 550 Civil Rights Actions
I3 448 Education I3 555 Prison Condition
I3 560 Civil Detainee -
Conditions of
Confinement
V.  (Place an  in One Box Only)
1 Original. 2 Removed from I3 3 Remanded from I3 4 Reinstated or I3 5 Transferred from I3 6 Multidistrict I3 8 Multidistrict
Proceeding State Court Appellate Court Reopened Another District Litigation - Litigation -
(speci?') Transfer Direct File
git? tl?e  )Statute under which you are ?ling (Do not cite jurisdictional statutes unless diversig?):
CAUSE OF ACTION Brief description of cause:_ .
Unreasonable delay in agency action
REQUESTED IN I3 CHECK IF THIS IS A CLASS ACTION DEMAND 5 CHECK YES only if demanded in complaint:
COMPLAINT: UNDER RULE 23, JURY DEMAND: I3 Yes 

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