Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 1 of 38 PageID# 1

IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF VIRGINIA
Richmond Division
__________________________________________
)
RICKY JOVAN GRAY,
)
)
Plaintiff,
)
982-HEH
v.
)
No. 16-cv-________
)
IMMINENT EXECUTION
TERENCE RICHARD MCAULIFFE, Governor, )
SCHEDULED FOR
Commonwealth of Virginia,
)
JANUARY 18, 2017
)
HAROLD W. CLARKE, Director,
)
Virginia Department of Corrections,
)
)
EDDIE PEARSON, Warden,
)
Greensville Correctional Center,
)
)
DAVID ZOOK, Warden,
)
Sussex I State Prison,
)
)
OTHER UNKNOWN EXECUTIONERS,
)
EMPLOYEES, AND AGENTS,
)
Virginia Department of Corrections,
)
)
Defendants.
)
_________________________________________)
COMPLAINT FOR DECLARATORY JUDGMENT
1.

There is a constitutionally intolerable risk that, on January 18, 2017, the Virginia

Department of Corrections (“VDOC”) will chemically torture Plaintiff Ricky Gray to death. The
VDOC will do so behind a veil of secrecy that frustrates Mr. Gray’s efforts to learn any
meaningful details about the chemicals that will be used to cause his death. The risk of chemical
torture is a violation of Mr. Gray’s Eighth Amendment right to be free from cruel punishment.
The veil of secrecy that the VDOC has pulled across the details surrounding how Mr. Gray is to
be executed is a violation of Mr. Gray’s Fifth and Fourteenth Amendment right to Procedural
Due Process.

1

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 2 of 38 PageID# 2

2.

Mr. Gray is a death row inmate in the custody of the VDOC, which is scheduled

to execute Mr. Gray on January 18, 2017, by lethal injection. The VDOC employs a three-drug
protocol to execute death row inmates: A first drug intended to anesthetize the inmate; a second
drug to paralyze the inmate; and a third drug to kill the inmate by inducing cardiac arrest. The
three-drug protocol is intended to kill an inmate only after the first drug’s anesthetizing effects
prevent the inmate from feeling the agonizing effects of the second and third drugs.
3.

But in reality, three-drug protocols similar to the one the VDOC intends to use to

execute Mr. Gray have on numerous occasions not operated as intended. Instead, the first drug
has sometimes failed to adequately sedate the inmate, who subsequently has endured the
torturous effects of the second and third drugs while aware of what was happening. And
recently, disturbing details have emerged about the specific drugs that the VDOC intends to use
to kill Mr. Gray, which as explained herein increase the risk that he will be executed by a
constitutionally intolerable method.
4.

Specifically, Mr. Gray recently learned that the VDOC intends to employ a novel,

radical, and never-tested application of a three-drug lethal injection protocol.

The VDOC

intends to use compounded midazolam hydrochloride (“compounded midazolam”) as the first
drug in its protocol—which is supposed to anesthetize Mr. Gray in order to render him insensate
to the otherwise-excruciating effects of the other two drugs—and compounded potassium
chloride as the third drug in the protocol, which will kill Mr. Gray by causing his heart to stop
beating. This is the first time an execution has ever been carried out in the United States using
compounded midazolam or compounded potassium chloride. It is also the first time that an
execution has ever been carried out in the United States using a combination of more than one
compounded drug.

2

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 3 of 38 PageID# 3

5.

This new and untested method of execution risks subjecting Mr. Gray to

extraordinary and needless pain and suffering. Midazolam, the first drug in the protocol, is
incapable of reliably if ever rendering inmates insensate to the excruciating level of pain inflicted
by the second and third drugs in the protocol. Indeed, midazolam lacks the chemical properties
of an anesthetic and is thus not designed for anesthesia. Worse, both the midazolam and the
potassium chloride the VDOC plans to use have been made by a compounding pharmacy. These
pharmacies typically follow an informal recipe attempting to approximate the patented process
used in manufacturing drugs approved by the U.S. Food and Drug Administration (“FDA”). The
finished product is designed to replicate a variation of—but is not the same as—any FDAapproved manufactured drug that goes by the same name. This method for creating drugs
unnecessarily adds enormous risk that the drugs will be ineffective, sub-potent, expired or
contaminated, or that they will contain unintended additives or a substantial level of particulates.
Any one of these problems increases the risk that the compounded midazolam would not work as
it is required to in order to make the planned protocol compliant with constitutional guarantees,
because it would fail to render Mr. Gray insensate to the known pain produced by the
administration of the subsequent drugs.
6.

Recent botched executions have shown the horrific results of using FDA-

approved, manufactured midazolam. Less than a week ago, Alabama botched its execution of
inmate Ronald Bert Smith using FDA-approved midazolam. For about 13 minutes after Mr.
Smith had been injected with midazolam, he struggled for breath “and heaved and coughed and
clenched his left fist.” Kent Faulk, Alabama Death Row inmate Ronald Bert Smith heaved,
coughed for 13 minutes during execution, AL.com, Dec. 8, 2016, available at
http://www.al.com/news/birmingham/index.ssf/2016/12/alabama_death_row_inmate_is_se.html.

3

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 4 of 38 PageID# 4

It was only the most recent in a long line of botched executions involving midazolam.
Separately, other executions in recent years have gone disastrously due to problems associated
with the compounding of a different drug, pentobarbital. Yet, in an unprecedented move, the
VDOC plans to execute Mr. Gray using compounded midazolam, combining the extraordinary
dangers already posed by manufactured midazolam with the inherent danger attached to using a
compounded—and by definition, unapproved—drug.
7.

The VDOC’s planned use of compounded midazolam creates an objectively

intolerable risk that Mr. Gray will not be properly anesthetized before he is injected with
chemicals that unquestionably cause pain and suffering in an inadequately anesthetized person.
In addition, the VDOC’s novel plan to use a compounded drug as the third drug in the protocol—
compounded potassium chloride, which is designed to stop Mr. Gray’s heart and complete the
execution—is extraordinarily dangerous. The use of potassium chloride in itself threatens to
inflict profound pain and suffering on Mr. Gray, who would suffer silently, trapped in the
paralysis caused by the second drug in the protocol.

Moreover, the use of compounded

potassium chloride adds the threat that the chemical will not work, leaving Mr. Gray alive,
paralyzed, and in extreme pain.
8.

Despite these hazards, a Virginia statutory provision never applied to any

previous execution prevents Mr. Gray from learning any meaningful information about the drugs
that the VDOC proposes to use to kill him. The so-called “secrecy statute,” as amended July 1,
2016, states that
[t]he identities of any pharmacy or outsourcing facility that enters
into a contract with the Department for the compounding of drugs
necessary to carry out an execution by lethal injection, any officer
or employee of such pharmacy or outsourcing facility, and any
person or entity used by such pharmacy or outsourcing facility to
obtain equipment or substances to facilitate the compounding of

4

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 5 of 38 PageID# 5

such drugs and any information reasonably calculated to lead to the
identities of such persons or entities . . . shall be confidential, shall
be exempt from the Freedom of Information Act . . . , and shall not
be subject to discovery or introduction as evidence in any civil
proceeding unless good cause is shown.
Va. Code § 53.1-234. This statute, combined with the fact that the VDOC has pled ignorance in
response to a host of basic questions about the preparation and maintenance of the drugs that will
be used to execute Mr. Gray, violates Mr. Gray’s constitutional right to procedural due process.
9.

Mr. Gray brings this complaint seeking declaratory relief pursuant to 42 U.S.C. §

1983 for violations and threatened violations of his right to be free from cruel and unusual
punishment under the Eighth and Fourteenth Amendments to the U.S. Constitution, and his right
to procedural due process under the Fifth and Fourteenth Amendments of the U.S. Constitution.
Mr. Gray seeks temporary, preliminary, and permanent injunctive relief to prevent Defendants
from executing him under the VDOC’s unsafe and untested lethal-injection protocol.
PARTIES
10.

Plaintiff Ricky Gray is a person within the jurisdiction of the Commonwealth of

Virginia. He is currently an inmate under the supervision of the VDOC, Prisoner No. 1100057.
Mr. Gray is under a sentence of death and is confined at the Sussex I State Prison, Building 3,
Sussex County, Virginia. His execution is scheduled for January 18, 2017. He exhausted the
appeals of his sentence of death only 37 days ago (November 7, 2016), when the U.S. Supreme
Court denied Mr. Gray’s request for a rehearing on his petition for a writ of certiorari.
11.
Virginia.

Defendant Terence Richard McAuliffe is the Governor of the Commonwealth of
He is the final executive authority in the Commonwealth, statutorily and

constitutionally responsible for carrying out all death sentences in Virginia, including the manner
in which those sentences are executed. He has direct authority over the VDOC and its Director.

5

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 6 of 38 PageID# 6

12.

Defendant Harold W. Clarke is the Director of the VDOC, 6900 Atmore Drive,

Richmond, VA 23225, which oversees the correctional facilities where Mr. Gray is currently
incarcerated and where Mr. Gray will be killed.
13.

Defendant Eddie Pearson is the Warden at Greensville Correctional Center, 901

Corrections Way, Jarratt, VA 23870-9614. He is an employee of the VDOC and under the
authority of the Director. Greensville Correctional Center is the facility at which Defendants
plan to carry out Mr. Gray’s execution.
14.

Defendant David Zook is the Warden at Sussex I State Prison, 24414

Musselwhite Drive, Waverly, Virginia, 23891-1111. He is an employee of the VDOC and under
the authority of the Director. Sussex I State Prison is the facility where Mr. Gray is being held
on Death Row prior to being moved to Greensville Correctional Center for his execution.
15.

Upon information and belief, Unknown Employees and Agents of the VDOC are

involved in the development and carrying out of executions by lethal injection. Mr. Gray does
not know the identities of these persons.
16.

Defendants are all state officials acting under color of state law. They are all sued

in their official capacities.
JURISDICTION AND VENUE
17.

This action arises under the Fifth, Eighth, and Fourteenth Amendments to the

United States Constitution and under 42 U.S.C. § 1983. This Court has jurisdiction pursuant to
28 U.S.C. §§ 1331 (federal question), 1343 (civil rights violations), 2201(a) (declaratory relief),
and 2202 (further relief).
18.

This Court has personal jurisdiction over Defendants as they are residents of the

Commonwealth of Virginia, and are presently located in the Commonwealth of Virginia, or are

6

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 7 of 38 PageID# 7

elected or appointed officials of the Commonwealth of Virginia or otherwise acting on behalf of
the Commonwealth of Virginia.
19.

Venue in this Court is proper under 28 U.S.C. § 1391 because the events giving

rise to the claims—including executions and the procurement and maintenance of drugs used in
the executions—are set to occur in the Eastern District of Virginia. Venue in the Richmond
Division is proper under Local Rule 3(C) because all defendants reside within this Division, and
because a substantial part of the events or omissions giving rise to this claim occurred in this
Division.
EXHAUSTION OF ADMINISTRATIVE REMEDIES
20.

Exhaustion of administrative remedies is unnecessary under the Prison Litigation

Reform Act (“PLRA”), 42 U.S.C. § 1997(e), because this suit does not challenge prison
conditions and because there are no available administrative remedies that could address the
challenged constitutional violations.
21.

Nonetheless, and out of an abundance of caution, Mr. Gray submitted multiple

requests to the VDOC asking the VDOC not to use the three-drug protocol that the VDOC has
proposed, and for further information regarding the protocol. In all instances, the VDOC has
declined to provide answers or relief, instead stating that it has no authority to grant Mr. Gray’s
requests.
22.

Immediately after learning of the new protocol the VDOC intends to use in his

execution, Mr. Gray filed an Informal Complaint to begin the process of exhausting his
administrative remedies. His complaint asked that the VDOC “stop using lethal injection and
electrocution processes that knowingly or unreasonably create a serious risk of cruel and unusual
punishment because there are not reasonable safeguards.” He also asked that the VDOC provide

7

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 8 of 38 PageID# 8

him with information about the substances and process relied upon for carrying out an execution
by lethal injection so that he could “make an informed choice about [his] method of execution.”
Mr. Gray received a response denying his complaint because the Commonwealth carries out
executions at Greensville Correctional Center and Mr. Gray was being held at Sussex I State
Prison at the time. Mr. Gray submitted a grievance on November 1, 2016, for which the internal
appeals process was completed on November 14, 2016. The VDOC ruled that his request was
not accepted for intake because it was “beyond the control of the Department of Corrections.”
Inexplicably—and illustrative of the VDOC’s arbitrary and insufficient administrative review
process—although Mr. Gray filed no additional grievances or complaints, he received four
additional first-level responses from the VDOC to the November 1, 2016, grievance on
November 21–22, 2016, with new findings.

In these new responses, the VDOC takes the

position that Mr. Gray’s request for information and complaints about the objectionable
procedures developed for execution by lethal injection are “governed by the Code of Virginia.”
FACTUAL ALLEGATIONS
23.

The legislature of the Commonwealth has authorized the VDOC to carry out

death sentences by either (i) “electrocut[ion]” (i.e., the “electric chair”), or (ii) “inject[ion of] a
lethal substance” (i.e., “lethal injection”). Va. Code § 53.1-234. The inmate is required to choose
whether he wishes to be killed by “electrocution,” or by “injection with a lethal substance.” Id.
In the event he does not make the choice, the statute prescribes that lethal injection will be the
VDOC’s chosen method of execution. Id. Mr. Gray has not made any election, meaning that the
VDOC will execute him using its chosen method of lethal injection.

8

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 9 of 38 PageID# 9

24.

As described below:
a. the VDOC’s proposed lethal injection “protocol” creates a demonstrated risk
of severe pain (see infra Points I.A-B, I.D);
b. the Commonwealth has erected a “secrecy statute” that is specifically intended
to frustrate inmates’ attempts to learn about the drugs to be used in their
executions (see infra Point I.C);
c. the electrocution “option” is not a “known and available alternative” as
defined under law because electrocution, itself, is unconstitutional (see infra
Point II.A); and
d. there is, at present, at least one known alternative available to the VDOC:
execution by firing squad (see infra Point II.B).

I.

The VDOC’s Unconstitutional Lethal Injection Protocol and the Unconstitutional
“Secrecy Statute” that Shields It from Review and Scrutiny
25.

Section 53.1-234 does not prescribe a specific drug protocol to be used in an

execution by lethal injection. Rather, the statute provides simply that death is to be caused by
“inject[ion of] a lethal substance,” leaving it to the VDOC to prescribe the protocol. Va. Code §
53.1-234. The VDOC, in turn, has refused to publish or otherwise release its protocol. The
majority of the information that Mr. Gray has been able to learn about the protocol has been
gleaned through several informal communications with the Virginia Attorney General’s Office
about the drugs it has procured. Through these informal communications, Mr. Gray has learned
that the VDOC has chosen to use compounded midazolam as the first drug and compounded
potassium chloride as the third drug in its three-drug protocol.
26.

This is unprecedented. Counsel for Mr. Gray are not aware of any other instance

in which a state or any established authority or jurisdiction has used compounded midazolam to

9

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 10 of 38 PageID# 10

effectuate an execution. The use of FDA-approved midazolam, in itself, poses a host of serious
risks. But the use of a compounded preparation significantly magnifies the risks already posed
by FDA-approved midazolam.

Aggregated, these risks are substantial and create an

unacceptable threat of severe pain.
27.

As described below, midazolam is, by design, ineffective at serving the intended

purpose of placing Mr. Gray under anesthesia for the duration of the execution (see infra
subsection A), and the use of a compounded drug greatly exacerbates the risk that the midazolam
will not desensitize Mr. Gray from intolerable pain and suffering (see infra subsection B). The
risks associated with the use of compounded drugs may be even further exacerbated by improper
preparation, storage, and transport. However, the Commonwealth’s “secrecy statute” is designed
to prohibit death row inmates like Mr. Gray from obtaining discovery of this relevant
information (see infra Subsection C). Further underscoring the exceedingly cruel nature of the
VDOC’s proposed method of execution, Mr. Gray has a severe diagnosed health condition that
all but guarantees that he will experience psychological terror when subjected to lethal injection
(see infra Subsection D).
A. FDA-Approved Midazolam Poses Several Risks of Excruciating and Needless Pain and
Suffering.
28.

FDA-approved midazolam is a poor choice for the first drug in a three-drug

protocol that includes a paralytic drug as the second drug and potassium chloride as the third.
Unlike the second and third drugs in the protocol, the first drug must fulfill a medicinal role as an
anesthetic/sedative. FDA-approved midazolam poses several risks of pain and suffering when
used in a three-drug protocol in comparison to anesthetic drugs like sodium thiopental or
pentobarbital.

Because of its chemical properties, even if the midazolam in the

Commonwealth’s possession were FDA-approved, there would still be a high likelihood that it

10

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 11 of 38 PageID# 11

would fail to render Mr. Gray insensate or would wear off before the paralytic drug and
potassium chloride are completely administered. This is so for at least three reasons.
29.

First, FDA-approved midazolam is a member of the benzodiazepine class of

drugs, which is used to relieve anxiety. It is not used to initiate or maintain anesthesia. Instead,
it is often used as a sedative to reduce anxiety prior to induction and maintenance of anesthesia
with a different drug.

Based on known, uncontroverted scientific information regarding

midazolam, there is a substantial risk that it would fail to keep Mr. Gray in a state in which he
would be shielded from experiencing extreme pain and suffering. Importantly, FDA-approved
midazolam has no pain-relieving effects, and it is not used as a sole agent to maintain
unconsciousness in painful procedures. Accordingly, there is a high likelihood that midazolam
will fail to render Mr. Gray insensate to pain sufficient to ensure that he will not feel the intense
pain and suffering associated with the paralytic drug and compounded potassium chloride.
30.

Second, due to the way in which FDA-approved midazolam functions, it begins to

lose effectiveness rapidly—much more quickly than anesthetics like pentobarbital and sodium
thiopental. Indeed, as recent executions in other states involving midazolam have demonstrated,
while midazolam can render inmates initially unconscious,1 it is not as effective as anesthesia.
Inmates to whom midazolam have been administered have regained consciousness and have
suffered tremendously when the paralytic drug and potassium chloride were administered.
1

The VDOC has, in the past, claimed to employ a so-called “pinch test” to test the effectiveness
of the first drug in the protocol, pursuant to which—after the drug is administered—an official
participating in the execution will pinch the inmate’s toe to see if the inmate reacts. If the inmate
does not react, then the VDOC deems the inmate to be properly anesthetized. This, however, is
highly likely to result in a “false positive” because—as indicated above—the fact that there is no
reaction (i) may just as easily be attributable to the fact that the inmate is relaxed, but not
anesthetized, and/or (ii) may just be evidence that the inmate is sedated at this moment, only to
regain consciousness before he is killed. It is for this reason that the VDOC’s so-called “pinch
test” is utterly ineffective.

11

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 12 of 38 PageID# 12

31.

Third, FDA-approved midazolam has what is known as a “ceiling effect.” A

ceiling effect refers to the limits of the effect a drug can exert on the body, even when
administered in large doses. Benzodiazepines like midazolam have no effect on the brain in
amounts above their ceiling effect because the receptors on which they act become saturated.
Thus, the VDOC cannot attempt to achieve an anesthetic effect by simply increasing the dosage
of midazolam that is administered to Mr. Gray. It will do nothing to reduce the likelihood he
will feel tremendous pain and will do nothing to protect him from the grisly effects of the
paralytic drug and potassium chloride. To the contrary, whatever the dosage, it is substantially
likely that Mr. Gray will be awake and sensate to the noxious stimuli he will experience as the
result of air hunger, suffocation, the horror of being paralyzed from the paralytic drug or the
sensation of being burned alive from the inside from potassium chloride, and then cardiac arrest.
In short, because of the ceiling effect, it is not possible to overcome the inadequacy of
midazolam’s anesthetic properties by using a large dose. It is therefore not possible to prevent
Mr. Gray from experiencing unfathomable suffering following the administration of midazolam.
32.

The ghastly consequences of using FDA-approved midazolam in an execution

have been documented. For one, the use of midazolam in the protocol creates a substantial risk
of air hunger and suffocation.

Air hunger is the inability to satisfy the physiologic and

psychological urge to breathe, similar to suffocation. It is the inability to draw a breath to satisfy
the body’s involuntary need to breathe. Air hunger and suffocation are terrifying and painful
experiences. An intravenous injection of midazolam will not prevent Mr. Gray from feeling or
being aware of the agony of air hunger or suffocation.

12

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 13 of 38 PageID# 13

33.

A large dose of midazolam, such as 500 mg or 1000 mg, also carries a substantial

risk of producing what are known as “tonic-clonic seizures,” which are generalized seizures that
affect the entire brain, and convulsions. Such seizures often result in severe pain and suffering.
34.

Defendants have no scientific basis to include midazolam as the first of a three-

drug protocol. There is no basis to conclude that using midazolam to carry out a lethal injection
execution is more humane, safer, or more effective than using a proper anesthetic.
35.

The substantial risk of harm posed by midazolam is not just academic—the drug

has been implicated in numerous botched executions. For example, Ohio used midazolam mixed
with the opioid hydromorphine to execute inmate Dennis McGuire in January 2014. For 26
minutes, Mr. McGuire was left gasping for air on the execution gurney before he was killed.
Three months later, Oklahoma used midazolam in the gruesome execution of Clayton Lockett.
Mr. Lockett, who initially lost consciousness following the administration of midazolam,
regained consciousness and, struggling to speak while violently convulsing, bucking, twitching,
and writhing, said, “something’s wrong.” The executioners tried but failed to administer more
drugs, and the execution was called off, but Mr. Lockett died ten minutes later. The execution
took 43 minutes, during which Mr. Lockett exhibited extraordinary pain and suffering. Even
though there were failures in the administration of the midazolam, the official autopsy revealed
that the concentration of midazolam in Mr. Lockett’s blood was greater than the therapeutic level
necessary to render a person unconscious. Mr. Lockett’s execution, which drew intense public
interest and a media firestorm, vividly demonstrates what Mr. Gray will experience behind a veil
of paralysis.
36.

Three months after Mr. Lockett’s agonizing execution, Arizona used midazolam

to execute Joseph Wood. It took almost two hours—the longest lethal injection in United States

13

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 14 of 38 PageID# 14

history. During those two hours, Mr. Wood gasped for air at least 640 times while visibly
struggling and making sounds of pain and agony that sounded “similar to when a swimming-pool
filter starts taking in the air.” See Michael Kiefer, Reporter describes Arizona execution: 2
hours, 640 gasps, Arizona Republic, July 26, 2014. Arizona later stated that it would never
again use midazolam as part of its execution protocol.

Following Mr. Wood’s execution,

Kentucky’s Attorney General removed midazolam from the state’s protocol.
37.

Therefore, as science instructs and real-world experience confirms, FDA-

approved midazolam cannot be relied upon to effectuate a humane, constitutional execution.
The drug is simply not suited for the task.
B. Unapproved Compounded Drugs Obtained From Unknown Compounding Pharmacies
Pose an Inherent Risk of Harm.
38.

“Compounding” refers to the combining, admixing, mixing, diluting, pooling,

reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug. 21 U.S.C.
§ 353b(d)(1)). This practice is usually performed by licensed pharmacists, pursuant to a licensed
physician’s prescription order for an individual patient who cannot have his or her needs met by
an existing product approved by the FDA. For example, a physician may order a licensed
pharmacist to compound a drug if the patient has an allergy to an inactive ingredient contained in
the approved product or if the approved product is in a solid oral dosage form but the patient
needs a liquid dosage form.

Historically, the practice of pharmacy, including pharmacy

compounding, has been overseen and regulated by state boards of pharmacy. Compounded
drugs are by definition not FDA-approved and carry increased risks of contamination, subpotency, and rapid degradation.
39.

In 2012, a multistate outbreak of fungal meningitis linked to contaminated steroid

injections compounded at the New England Compounding Center in Framingham,

14

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 15 of 38 PageID# 15

Massachusetts resulted in nearly 800 cases of illness and 64 deaths. In response to this public
health crisis, Congress enacted the Drug Quality and Security Act (“DQSA”). Title I of the
DQSA, commonly referred to as the Compounding Quality Act (“CQA”), clarified the FDA’s
enforcement authority with respect to compounding pharmacies under 21 U.S.C. § 353A. The
act enhanced the FDA’s oversight over compounding pharmacies by increasing the number of
inspections of compounding pharmacies the agency can conduct.
40.

In 2014, the FDA conducted more than 90 inspections of compounding facilities,

which led to numerous facilities engaged in poor sterile practices being forced to cease
production of sterile drugs and recall drugs manufactured under substandard conditions. The
FDA has stated that “[n]ew problems continue to be identified at compounding pharmacies
across

the

country.”

FDA,

Implementation

of

the

Compounding

Quality

Act,

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/
ucm375804.htm (last visited Dec. 1, 2016). Although the FDA has increased its oversight of
compounding pharmacies, compounded drugs are still not subject to the FDA’s drug approval
process, and compounding pharmacies are not subject to the FDA’s current good manufacturing
practice (cGMP) regulations.
41.

Compounding

involves the use of raw ingredients,

including

Active

Pharmaceutical Ingredients (APIs), which are the active ingredients in the compounded drug.
There are significant questions about the quality of APIs used in compounding. Compounding
pharmacies have been identified as “a primary route of entry for counterfeit bulk drugs.”
Prepared Statement of Honorable Fred Upton before the Subcommittee on Oversight and
Investigations

-

Counterfeit

Bulk

Drugs,

June

8,

2000,

available

http://www.gpo.gov/fdsys/pkg/CHRG-106hhrg65846/html/CHRG-106hhrg65846.htm.

15

at
It is

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 16 of 38 PageID# 16

difficult to trace the raw chemicals back to the original manufacturer for information about their
quality and integrity. Accordingly, a chemical labeled as a particular active ingredient may
actually be a different ingredient, and there is no way to have confidence that the APIs are not
contaminated. If poor ingredients are used, “[t]he compounded drug may be contaminated,
super-potent or sub-potent, non-sterile, or at risk of an unusually short shelf life.” Id.
42.

Because compounding pharmacies do not typically have the type of sophisticated

equipment used by large-scale drug manufacturers—equipment that is necessary to produce both
high quality and large quantities of pharmaceuticals—compounding pharmacies keep batch sizes
small. Compounded drugs often degrade and lose efficacy more quickly than non-compounded
drugs. For this reason, compounding pharmacies usually set relatively short “beyond use dates”
(“BUDs”) for compounded drugs. A BUD is the compounded drug equivalent of an expiration
date.

Moreover, unlike manufactured drugs, compounded drugs are not subject to release

testing, which means that compounded drugs are not required to meet the stringent requirements
regarding contamination, dilution, and degradation that manufactured drugs are required to meet.
43.

According to United States Pharmacopeia (“USP”) chapter 797, Pharmaceutical

Compounding—Sterile Preparations, storage periods for high-risk compounded sterile
preparations (CSPs) cannot exceed the following time periods before administration (in the
absence of passing a sterility test): 24 hours, if stored at room temperature; 72 hours, if kept
refrigerated; or 45 days if kept in a solid, frozen state. To set a BUD beyond these periods,
extensive and documented sterility testing is necessary. Even then, dates are usually set within
90 days. Estimated BUDs depend on the nature and quality of raw ingredients used, the quality
of the process applied by the compounding pharmacy, and the precision and professionalism of
the testers of the drug in question. Whether the pharmacy employs the more stringent conditions

16

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 17 of 38 PageID# 17

to increase the BUD beyond three days can be determined by inspecting documentation relevant
to the pharmacy and the testing.
44.

Because any BUD can be dramatically affected by subsequent storage conditions,

CSPs must be kept in carefully prescribed conditions related to the stability and properties of the
specific medicine in question. Stability “depends on the purity and concentration of specific
ingredients, packaging and environmental exposure and storage (humidity, illumination and
temperature), especially for solutions. Small changes in any one of those variables can cause
rapid loss of drug strength or much shorter than expected shelf-life.” David Newton & Bernard
Dunn, A Primer on USP Chapter 797 “Pharmaceutical Compounding-Sterile Preparations,”
and

USP

Process

for

Drug

and

Practice

Standards,

available

at

http://www.nhia.org/members/documents/usp_797_primer.pdf. For example, difference by one
pH unit in some solutions can decrease stability to less than 50% of the BUD time assigned.
“[T]here can be danger in either assuming correct compounding or expecting a seemingly small
formulation change to produce an insignificantly small stability change.”

Id.

Thus, it is

imperative to test both stability and sterility multiple times over a drug’s shelf life, not just
shortly after it is compounded.
45.

The risks posed by poor storage conditions of compounded execution drugs have

been amply demonstrated. In March 2015, a syringe of compounded pentobarbital sodium in the
Georgia Department of Corrections’ possession was discovered to have precipitated, appearing
“cloudy” just hours prior to the scheduled execution of Kelly Gissendaner. The Department of
Corrections sent the drug to a lab for analysis, and concluded that the likely cause of the
precipitation was the temperature of the drugs, which were kept in poor storage conditions.

17

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 18 of 38 PageID# 18

Mark Berman, After execution hiatus, Georgia says its lethal injection drugs were kept too cold,
Wash. Post (Apr. 16, 2015).
46.

The risks posed by using drugs from compounding pharmacies have also been

demonstrated. When Oklahoma executed inmate Michael Lee Wilson in January 2014, it used
compounded pentobarbital as the first of three drugs. Upon administration of the purported
pentobarbital, Mr. Wilson cried out, “I feel my whole body burning!” Charlotte Alter, Oklahoma
Convict Who Felt “Body Burning” Executed with Controversial Drug, Time Magazine (Jan. 10,
2014). Mr. Wilson’s reaction is consistent with exposure to contaminants introduced by the
unsafe compounding of pentobarbital, as shown by a report analyzing the execution that found
“the injection used in Mr. Wilson’s execution likely contained cross-contaminates that he was
allergic to, [and] bacteria and endotoxins could have had an altered pH due to contaminates or
inadequate procedures used in the preparation of the drug.” Inmate Jose Luis Villegas similarly
complained of a burning sensation when Texas executed him with compounded pentobarbital in
April 2014. See Vivian Kuo & Ralph Ellis, U.S. Supreme Court grants stay of ‘excruciating
execution,’ CNN (May 21, 2014).

Likewise, when inmate Eric Robert was executed with

compounded pentobarbital in South Dakota in October 2012, he gasped heavily, his skin turned a
blue-purplish hue, his eyes remained open throughout the execution, and his heart continued to
beat ten minutes after he stopped breathing. He took more than twenty minutes to die. See Dave
Kolpacl

&

Kristi Eaton,

Eric

Robert

Execution,

Associated

Press,

available

at

http://www.huffingtonpost.com/2012/10/16/erlc-robert-execution_n_196940.html. These events
were consistent with the administration of a compounded drug that was contaminated or subpotent.

18

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 19 of 38 PageID# 19

47.

Risks attendant to the use of a sub-standard compounded drug include that the

compounded drug will be sub-potent, expired, contaminated, contain unintended additives, or
will contain a substantial level of particulates. Further, deficiencies in storing and handling the
drugs in compliance with very specific guidelines create the risk that the compounded drugs will
expire before they are used. Any one of these issues increases the risk that the compounded
midazolam would not work as it is required to render Mr. Gray insensate.
48.

The VDOC supplied Mr. Gray’s counsel with photographs of the bottles

containing the purported compounded midazolam and purported compounded potassium
chloride the VDOC plans to use for Mr. Gray’s execution. The labels on these bottles indicate
that the BUDs for the CSPs are in early 2017. The VDOC has not provided any evidence to
support these BUDs, and, for the reasons noted above, significant risk exists that these
compounded drugs will destabilize by Mr. Gray’s scheduled execution.
49.

What is more, the Commonwealth has increased exponentially the risks

associated with the use of compounded drugs in lethal injections by removing itself entirely from
its standard oversight and regulatory function with regard to compounding pharmacies.
Generally, compounding is considered the “practice of pharmacy.” Va. Code § 54.1-330; 54.13401. This designation brings the pharmacy under a robust set of regulations and laws regarding
the preparation and dispensation of compounded drugs. The Virginia Board of Pharmacy has the
right to inspect compounding pharmacies’ facilities and records and, if standards are not
followed, the Board may suspend or revoke licensure and registration. Pursuant to the abovedescribed “secrecy statute,” however, “[t]he compounding of” drugs to be used for lethal
injection “(i) shall not constitute the practice of pharmacy . . . (ii) is not subject to the jurisdiction
of the Board of Pharmacy, the Board of Medicine, or the Department of Health Professions; and

19

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 20 of 38 PageID# 20

(iii) is exempt from the provisions of . . . the Drug Control Act.” Va. Code § 53.1-234. By
statute, the Commonwealth has relieved itself of responsibility—mandated in all other
pharmaceutical contexts—to regulate the preparation, maintenance, and sourcing of compounded
drugs in executions.
50.

Because of the inherent risks and lack of safeguards in using compounded drugs,

and because midazolam is an inherently inadequate anesthetic, there is a high likelihood that the
supply of compounded drugs the VDOC plans to use in its lethal-injection protocol will not
properly anesthetize Mr. Gray for the duration of the execution process. Without adequate
anesthesia that lasts the duration of the execution, Mr. Gray will experience excruciating pain as
a result of the conscious asphyxiation caused by the paralytic agent and the painful internal
burning and cardiac event caused by the potentially defective compounded potassium chloride
overdose.
C. The VDOC Claims Ignorance Regarding the Drugs It Will Use to Kill Mr. Gray, and
Virginia’s Legislature Has Enacted an Unconstitutional Statute Designed to Frustrate
Mr. Gray’s Ability to Take Discovery on These Drugs.
51.

The foregoing description constitutes what Mr. Gray knows about the protocol

that the VDOC intends to use, which he learned from two informal e-mails from the Attorney
General’s Office (one on October 6, 2016, and another on November 4, 2016). Use of the threedrug protocol that relies on midazolam to anesthetize Mr. Gray against noxious stimuli, coupled
with the use of compounded drugs that introduce risks of pain and suffering and drug failure,
poses substantial risks that Mr. Gray will experience overwhelming pain and suffering during his
execution, precisely the kind of cruel and unusual punishment forbidden by the Eighth
Amendment.

20

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 21 of 38 PageID# 21

52.

But there is much that Mr. Gray doesn’t know, due to a combination of (i)

admitted ignorance on the part of the VDOC about the drugs it intends to administer to Mr. Gray,
and (ii) a secrecy statute that purports to prohibit Mr. Gray from learning the provenance of the
execution drugs or anything directly from the compounding pharmacy itself.
53.

The Virginia Attorney General’s office has not provided any information about:
a. the identity or capacity of the compounding pharmacy that made the
compounded midazolam and potassium chloride;
b. the credentials of the compounding pharmacy that made the midazolam and
potassium chloride or any persons or agents involved in mixing, testing,
storing or transferring the chemical mixtures of compounded midazolam and
potassium chloride;
c. the exact date that the midazolam and potassium chloride were compounded;
d. the manufacturers of the ingredients used in the compounded midazolam and
potassium chloride;
e. the ingredients used to make the preparations, the circumstances under which
the preparations were made, or whether these ingredients were manufactured
by an FDA-approved registered facility and comply with standards of the
United Sates Pharmacopeia;
f. the manner in which the preparations have been stored, handled, and
transported since they were compounded;
g. how the Beyond Use Dates were set;
h. a description of the facility at which the drugs were compounded;

21

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 22 of 38 PageID# 22

i.

any inspections or other regulatory enforcement efforts undertaken in
connection with the compounding pharmacies; or

j.

what information the VDOC obtained about the appropriateness of using
compounded midazolam in the execution of inmates sentenced to death in
Virginia.

54.

In response to a question about how much midazolam will be administered to Mr.

Gray, the Attorney General’s office confusingly stated that “[the] VDOC does not anticipate
changing the dosage of [this] substance[] from the amount used in prior executions by lethal
injection.” However, the Commonwealth has never before used midazolam in an execution, and
no state has ever used compounded midazolam as the first drug in a three-drug lethal injection
protocol. If the VDOC were to administer a dosage of midazolam that is equal to the dosage of
the anesthetic drug used in prior executions, the midazolam—a much weaker drug than
pentobarbital or sodium thiopental—would not come close to anesthetizing Mr. Gray. The
VDOC’s belief that “not . . . changing the dosage . . . from the amount used in prior executions
by lethal injection” would be adequate to prevent Mr. Gray from suffering excruciating pain as a
result of the second and third drugs in the lethal injection protocol is wholly unsupported.
55.

Further, Mr. Gray has no way of learning this critical information, due to the so-

called “secrecy statute” enacted by the legislature in 2016. This statute purports to prohibit the
VDOC from disclosing:
The identities of any pharmacy or outsourcing facility that enters
into a contract with the Department for the compounding of drugs
necessary to carry out an execution by lethal injection, any officer
or employee of such pharmacy or outsourcing facility, and any
person or entity used by such pharmacy or outsourcing facility to
obtain equipment or substances to facilitate the compounding of
such drugs and any information reasonably calculated to lead to the
identities of such persons or entities.

22

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 23 of 38 PageID# 23

Va. Code § 53.1-234. This information “shall be confidential, shall be exempt from the Freedom
of Information Act . . . , and shall not be subject to discovery or introduction as evidence in any
civil proceeding unless good cause is shown.” Id. In short, absent litigation and court-ordered
discovery, Mr. Gray is cut off from obtaining and reviewing information necessary to learn about
the effectiveness of these dangerous compounded drugs.
56.

The secrecy statute incentivizes the VDOC to turn to compounding pharmacies

for its lethal injection supplies even if the VDOC could obtain manufactured, FDA-approved
versions of the drugs (and, at present, Mr. Gray has no idea if the VDOC has even attempted to
do so).2 If applicable, the secrecy statute would shield the VDOC from discovery or disclosure
requests regarding the quality or legitimacy of the compounding pharmacies at the expense of
inmates’ constitutional rights to procedural due process. The VDOC is so desperate to avoid
disclosing its suppliers and the source of the APIs that it was willing to pay tens of thousands of
dollars for compounded drugs that, in reality, should cost in the tens or hundreds of dollars, at
most. In this case, the VDOC has paid the exorbitant sum of $66,000 for the two compounded
drugs that will be used to execute Mr. Gray. By enacting the secrecy statute, the Commonwealth
has developed a dangerous “gray” (if not black) market of secret lethal injection suppliers,
exempt from scrutiny by industry regulators, law enforcement, potential litigants, or Virginia
residents.
57.

The VDOC is actively attempting to prevent Mr. Gray from vindicating his

Eighth Amendment right to be free from cruel punishment. The VDOC is dangerously ignorant
about the dubious drugs that it intends to administer to Mr. Gray to cause his death. The VDOC
2

It is known that some states are able to get some version of anesthetic drugs like pentobarbital.
It is not known whether these drugs are coming from reputable manufacturers.

23

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 24 of 38 PageID# 24

has also enacted a barrier to Mr. Gray learning anything about the compounding process or the
quality of the drugs to be used by forbidding the disclosure of any information that might enable
Mr. Gray to assess the proposed method of execution without litigation. Without reasonable
inquiry, these circumstances create an unnecessary and intolerably high risk that the drugs that
will be administered to Mr. Gray will violate his Eighth Amendment rights.
D. Ricky Gray Has a Diagnosed Psychological Condition that Creates a Substantial Risk
He Will Suffer True Psychological Terror as a Result of the Lethal Injection Drugs.
58.

As described above, the second drug in the three-drug protocol (in this case,

manufactured roncuronium bromide) is a paralytic drug. It serves no purpose in anesthetizing
Mr. Gray or in killing him. It will be administered to Mr. Gray purely to for cosmetic reasons, so
that viewers do not see him writhing and showing outward signs of distress while the lethal third
drug is administered. It is this drug that makes a horrifyingly painful execution appear to
observers as though the inmate has peacefully gone to sleep. In the event that Mr. Gray is
conscious while paralyzed—which, for reasons described above, is highly likely—he will
experience a new level of personal terror, due to a diagnosed medical condition resulting from
terrifying childhood trauma and abuse.
59.

Throughout Mr. Gray’s childhood, he was frequently raped by his older step-

brother. Among other horrific abuses, his step-brother would hold him down so that he couldn’t
move, and then penetrate him anally. This severe and protracted sexual abuse has left Mr. Gray
with lifelong scars, both physical and psychological. Mr. Gray also suffered from brutal physical
abuse at the hands of his father during his childhood. Because of these traumas, Mr. Gray suffers
from Posttraumatic Stress Disorder, the hallmark of which is a terrifying nightmare in which Mr.
Gray continues to experience himself as a child being raped. In these nightmares, Mr. Gray

24

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 25 of 38 PageID# 25

desperately tries to move away from his attacker, to move his arms or his legs, but they will not
move. He is paralyzed, utterly helpless.
60.

This recurring nightmare is a classic description of the physiological state known

as “tonic immobility.” Tonic immobility is a physiological response to extreme terror and
helplessness.

The body, via signals sent down the vagal nerve, shuts down.

Heart rate,

respiration rate, and blood pressure all plummet, and the muscles cease functioning. According
to a trauma expert who evaluated Mr. Gray, it is extremely likely that Mr. Gray experienced
tonic immobility many times during the rapes he endured as a child, and now re-experiences the
terrifying state in his nightmares. To this day, Mr. Gray suffers this nightmare on such a
frequent and disabling basis that he needs to have some light in his cell at night, so that if he
wakes up in terror, believing that he is still a child and still being raped, he will more quickly be
able to ground himself in the present.
61.

The VDOC’s protocol will mimic this state of paralysis and tonic immobility.

This will cause Mr. Gray extreme terror, and play upon one of Mr. Gray’s most significant and
longstanding fears.

Mr. Gray will therefore experience the psychological torture from his

nightmare of being harmed while immobilized, a personalized torment that counsels in favor of
an alternative method of execution.

25

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 26 of 38 PageID# 26

II.

The VDOC Has at Least One Known and Available Alternative that Significantly
Reduces the Substantial Risk of Severe Pain Imposed by Midazolam and the
Compounded Three-Drug Protocol: the Firing Squad3
A. Execution by Electrocution Is Not a “Known and Available Alternative,” Because It
Also Carries a Recognized Risk that the Inmate Will Suffer Severe Pain and Is, In
Itself, Unconstitutional.
62.

As noted above, the Virginia legislature has authorized the VDOC to carry out

death sentences by electrocution if the inmate requests it. Va. Code § 53.1-234. This “option,”
however, is not an option at all: death in the “electric chair” carries with it a recognized risk of
severe pain that renders death by electrocution a violation of the Eighth Amendment’s
prohibition against cruel punishment. The Commonwealth admits as much. As recently stated
by Defendant Governor McAuliffe:
[When Virginia executes people via the electric chair,] we take
human beings, we strap them into a chair, and then we flood their
bodies with 1,800 volts of electricity, subjecting them to
unspeakable pain until they die. . . . Virginia citizens do not want
their commonwealth to revert back to a past when excessively
inhumane punishments were committed in their name.
L. Vozzella and M. Berman, In a move that could jeopardize executions, McAuliffe wants to
shield the identity of makers of lethal-injection drugs, Wash. Post, Apr. 11, 2016.
63.

Electrocution can inflict gruesome pain and suffering.

According to a 1985

description by Justice Brennan, electrocutions remained virtually identical to those conducted
more than a century earlier:

3

Plaintiff focuses here on the available alternative of the firing squad. But it of course is the
case that other available alternatives may exist, such as a single-dose lethal injection protocol
using barbiturates such as pentobarbital or sodium thiopental, as other states are increasingly
adopting. Permitting Mr. Gray the opportunity to seek discovery concerning the method by
which the Commonwealth intends to execute him could enable him to determine whether such a
“one-drug” protocol could be an option.

26

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 27 of 38 PageID# 27

Witnesses routinely report that, when the switch is thrown, the
condemned prisoner “cringes,” “leaps,” and “fights the straps with
amazing strength.” “The hands turn red, then white, and the cords
of the neck stand out like steel bands.” The prisoner’s limbs,
fingers, toes, and face are severely contorted. The force of the
electrical current is so powerful that the prisoner’s eyeballs
sometimes pop out and “rest on [his] cheeks.” The prisoner often
defecates, urinates, and vomits blood and drool. “The body turns
bright red as its temperature rises,” and the prisoner’s “flesh swells
and his skin stretches to the point of breaking.” Sometimes the
prisoner catches on fire, particularly “if [he] perspires
excessively.” Witnesses hear a loud and sustained sound “like
bacon frying,” and “the sickly sweet smell of burning flesh”
permeates the chamber. This “smell of frying human flesh in the
immediate neighbourhood of the chair is sometimes bad enough to
nauseate even the Press representatives who are present.” In the
meantime, the prisoner almost literally boils: “the temperature in
the brain itself approaches the boiling point of water,” and when
the postelectrocution autopsy is performed “the liver is so hot that
doctors have said that it cannot be touched by the human hand.”
The body frequently is badly burned and disfigured.
Glass v. Louisiana, 471 U.S. 1080, 1086–88 (1985) (Brennan and Marshall, JJ., dissenting from
denial of certiorari).
64.

Virginia has had at least four botched electrocutions—electrocutions where pain,

agony, or grotesque treatment were visible to witnesses—since 1976:
On August 10, 1982, Frank J. Coppola’s head and legs burst into
flames. On October 17, 1990, blood poured from Wilbert Lee
Evans’s eyes and nose and witnesses noted audible moaning and a
sizzling sound like a pressure cooker before its top has been taken
off. On August 22, 1991, Derick Lynn Peterson moaned audibly as
electric current was applied to him, and after two minutes of
current and a four minute wait, a prison doctor determined he was
still alive; after another four-minute wait, the doctor again
announced that he was still alive; finally a second surge of
electricity was applied bringing the total length of time for the
electrocution over thirteen minutes. A witness to Roger Keith
Coleman’s May 20, 1992, electrocution reported smoke coming
from Coleman’s leg. Coleman required two 1,700-volt jolts to die.

27

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 28 of 38 PageID# 28

M. Shapiro, “State of Electrocution,” Va. Lawyer Magazine 32 n.25 (Dec. 2012), available at
http://www.vsb.org/docs/valawyermagazine/vl1212-electrocution.pdf.
65.

Medical evidence shows that electrocution does not render a person instantly

unconscious because the amount of electricity that reaches the skull is insufficient to cause
complete incapacitation. As electrical currents run through the body, they can cause severe
muscle contractions, burned and charred skin, and heart stoppages similar to a heart attack, all of
which an inmate will feel as he dies.
66.

This execution method is plainly inconsistent with “the evolving standards of

decency that mark the progress of a maturing society.” Roper v. Simmons, 543 U.S. 551, 561
(2005) (quoting Trop v. Dulles, 356 U.S. 86, 100–01 (1958) (plurality opinion)). Indeed, as the
Supreme Courts of Georgia and Nebraska have held, the pain and suffering caused by
electrocutions is a form of cruel and unusual punishment inconsistent with basic notions of
human dignity. State v. Mata, 745 N.W.2d 229 (Neb. 2008); Dawson v. State, 554 S.E.2d 137
(Ga. 2001). No state currently uses electrocution as its primary or only execution method. See
Mata, 745 N.W.2d at 263.
B. Although the Commonwealth Has Refused to Provide, by Statute, a “Known and
Available Alternative” that Passes Constitutional Muster, At Least One Exists: The
Firing Squad.
67.

The firing squad has been a generally recognized form of punishment in the

United States since before the nation’s founding. The first recorded firing squad execution took
place in 1608, when the colony of Virginia executed George Kendall for conspiring with Spain.
Deborah W. Denno, The Firing Squad as a “Known and Available Method of Execution” PostGlossip, 49 U. Mich. J. L. Reform 749, 778 (2016). After the Supreme Court reinstated the
death penalty in 1976 following a nine-year hiatus, see Gregg v. Georgia, 428 U.S. 153 (1976)

28

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 29 of 38 PageID# 29

(joint opinion of Stewart, Powell, and Stevens, JJ.), the first executed inmate died at the hands of
a five-man firing squad just one year later. Kirk Johnson, In Utah, Execution Evokes Eras Past,
N.Y. Times, June 16, 2010, available at goo.gl/p9D9k3. In all, firing squads have executed 144
American inmates. Denno, supra at 778.
68.

Two states, Oklahoma and Utah, currently allow for the firing squad. Okla. Stat.

tit. 22 § 1014; Utah Code § 77-18-5.5(1)–(4). Under both state statutes, the firing squad can be
used only when other execution methods—lethal injection, for example—are held
unconstitutional or are otherwise unavailable. Id. In 2010, a firing squad executed Utah inmate
Ronnie Lee Gardner. See Kirk Johnson, Double Murderer Executed by Firing Squad in Utah,
N.Y. Times, June 18, 2016, available at goo.gl/t7BaAu. At least three of Utah’s eight death-row
inmates are set to die by the firing squad in coming years, having elected death by firing squad
under an earlier version of the Utah statute that has since been repealed. Michael Muskal, Three
of Utah’s 8 Death Row Inmates Have Chosen Firing Squads, L.A. Times, Mar. 24, 2015,
available at goo.gl/Tc65mp.
69.

The firing squad is used around the world as a method of execution.

Approximately 28 countries conduct firing-squad executions. See “Methods of Execution,”
Cornell Center on the Death Penalty Worldwide (June 22, 2012), available at goo.gl/uauqVF.
Of the 58 countries that still retain capital punishment, five times as many use firing squads as
use lethal injection. See id.; see also “Death Sentences and Executions: 2015,” Amnesty Int’l
Global Report, available at goo.gl/phBwa0.
70.

For more than 400 years, the firing squad has been an available execution method

in the United States. Thus, the firing squad is clearly a known execution method.

29

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 30 of 38 PageID# 30

71.

The firing squad is also an available alternative to the VDOC. Upon information

and belief, there are numerous people employed by the VDOC who have the training necessary
to successfully perform an execution by firing squad. According to the U.S. Department of
Justice, Virginia employed 22,848 state and local law-enforcement officers in 2008—roughly
293 officers per 100,000 residents. Bureau of Justice Statistics, “Census of State and Local Law
Enforcement Agencies, 2008,” U.S. Department of Justice 15 (2011), available at goo.gl/Qas08i.
It is feasible for the VDOC to find a group of these trained officers to conduct a firing-squad
execution. In Utah, for instance, the state invites law-enforcement officers to volunteer for a
position on the firing squad. Denno, supra at 783 n. 244. “[T]hose from the area where the
crime happened” have priority. Brady McCombs, Firing Squad Gets Final OK. So How Does It
Work?, The Associated Press, Mar. 24, 2015, available at goo.gl/fKE5wx. The state then selects
five individuals from the volunteer pool. Id. Upon information and belief, Utah has never
experienced a volunteer shortage. Id. The shooters remain anonymous, and one of their rifles
“is loaded with a blank round so nobody knows which officer killed the inmate.” Id.
72.

Virginia’s large law-enforcement population means, upon information and belief,

that the Commonwealth also has the guns and ammunition for a firing-squad execution. Police
departments nationwide spend an average of $43,894 each year on guns and $248,940 on
ammunition. Police Research Executive Forum, “Police Department Service Weapon Survey” 4
(2013), available at goo.gl/bu8a14. The guns and ammunition to arm a five-man firing squad
would be but a small fraction of the state’s total weapon supplies. The types of firearms needed
are neither hard to find nor difficult to use. Utah firing squads, for example, rely on .30 caliber
Winchester rifles. McCombs, supra. The average police department in the United States owns

30

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 31 of 38 PageID# 31

212 rifles, and 93 percent of police departments equip some of their officers with a rifle or other
assault weapon. Police Research Executive Forum, supra, at 2.
73.

While Virginia may not yet have permitted the firing squad by state law, nothing

in Glossip v. Gross requires that the alternative method of execution be expressly permitted by
the state’s existing execution protocol. 135 S. Ct. 2726, 2796 (2015). Furthermore, requiring
that an alternative method be expressly permitted by statute would have the practical effect of
allowing the Commonwealth to protect an unconstitutional method of execution from review by
revising its execution protocol to prohibit any other alternative, which the Court in Glossip did
not intend to do.
74.

Although the VDOC may not have developed a protocol for carrying out a firing-

squad execution, on information and belief, model procedures are available and readily
implementable.

Utah’s firing-squad protocol is instructive.

The state follows a simple

procedure: First, “[t]he prisoner is seated in a chair that is set up in front of a wood panel and in
between stacked sandbags that keep the bullets from ricocheting around the room.” McCombs,
supra. “About twenty or twenty-five feet across from the inmate is the opposite wall with two
slit-like openings. The anonymous firing squad members stand behind this wall and put their
high-powered guns through the openings.” Denno, supra at 783–84. Second, “[a] doctor then
places a round white target on the inmate’s chest.” Id. at 784. Third, each squad member aims
and fires. Id. Because “firearms have no purpose other than destroying their targets . . . [e]ight
or ten large-caliber rifle bullets fired at close range can inflict massive damage, causing instant
death every time.” Wood v. Ryan, 759 F.3d 1076, 1103 (9th Cir. 2014) (reversed on other
grounds).

31

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 32 of 38 PageID# 32

75.

The firing squad significantly reduces a substantial risk of severe pain when

compared with the midazolam three-drug protocol lethal injection. A study of executions from
1900 to 2010, for example, concluded that while 7.12 percent of the 1,054 lethal-injection
executions were “botched,” none of the 34 firing-squad executions went awry. Glossip v. Gross,
135 S. Ct. 2726, 2796 (2015) (Sotomayor, J., dissenting) (citing A. Sarat, Gruesome Spectacles:
Botched Executions and America’s Death Penalty 177 (2014)); see also Wood, 759 F.3d at 1103
(the firing squad is “foolproof”; lethal injection is “inherently flawed and ultimately doomed to
failure.”); Denno, supra at 781 (A “study of executions from 1976 to 2001 failed to detect any
botched firing squad executions, even though other methods, including lethal injection, were
consistently problematic.” (citing Arif Khan & Robyn M. Leventhal, Medical Aspects of Capital
Punishment Executions, 47 J. Forensic Sci. 847, 849–50 (2002))). “Just as important, there is
some reason to think that [death by firing squad] is relatively quick and painless.” Glossip, 135
S. Ct. at 2796 (Sotomayor, J., dissenting). That contrasts sharply with death by lethal injection,
which, as shown throughout this Complaint, has caused a number of prolonged and
extraordinarily painful executions in recent years.
FIRST CAUSE OF ACTION
Declaratory Judgment re:
Violation of Ricky Gray’s Right to be Free from Cruel and Unusual Punishment
Under the Eighth and Fourteenth Amendments to the U.S. Constitution
76.

Mr. Gray incorporates by reference each and every statement and allegation set

forth in this Complaint as if fully stated here.
77.

The Eighth Amendment guarantees every person the right to be free from cruel

and unusual punishment.

Cruel and unusual punishment is inflicted where a method of

32

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 33 of 38 PageID# 33

execution creates a “substantial risk of serious harm, an objectively intolerable risk of harm
. . . .” Baze v. Rees, 553 U.S. 35, 50 (2008) (citation and internal quotation marks omitted).
78.

Further, the Eighth Amendment requires that state conduct surrounding capital

punishment not be arbitrary and capricious, Furman v. Georgia, 408 U.S. 238, 255 (1972), and
that such conduct comport with “evolving standards of decency that mark the progress of a
maturing society,” Roper v. Simmons, 543 U.S. 551, 561 (2005); Atkins v. Virginia, 536 U.S.
304, 312 (2002).
79.

The Eighth Amendment is applicable to the states through the Due Process Clause

of the Fourteenth Amendment. Baze, 553 U.S. at 47.
80.

The use of a three-drug lethal injection protocol with compounded midazolam

violates the Eighth Amendment’s prohibition against cruel and unusual punishment because it
does not comport with prevailing standards of decency, and thus its use as a method of execution
must be categorically barred.
81.

A state may not impose a death sentence upon any inmate using an

unconstitutional method of execution. Accordingly, there should be no requirement to plead an
alternative method of execution when making a claim, such as this, that a method of punishment
is categorically unconstitutional. “Irrespective of the existence of alternatives, there are some
risks ‘so grave that it violates contemporary standards of decency to expose anyone unwillingly
to’ them.” Glossip, 135 S. Ct. at 2793 (Sotomayor, J., dissenting, joined by Ginsburg, J., Breyer,
J., and Kagan, J.) (quoting Helling v. McKinney, 509 U.S. 25, 36 (1993)).
82.

For purposes of this claim, Mr. Gray does not concede there is a way to

constitutionally carry out a lethal injection execution that uses a three-drug compounded

33

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 34 of 38 PageID# 34

midazolam method. Mr. Gray asserts that such an execution is per se unconstitutional. This
distinguishes Mr. Gray from the inmate in Baze.
83.

Therefore, Mr. Gray should not be required to plead or prove any alternative

method of execution in order to prevail on this claim. Should the Court nevertheless find that
pleading an alternative method is required, however, Mr. Gray incorporates by reference, as if
fully set forth here, the alternative methods and procedures proposed in this Complaint.
84.

Defendants, acting in their official capacities under color of Virginia law, intend

to execute Mr. Gray by injecting him with compounded midazolam as the first drug. This
creates a substantial risk of serious harm because, among other reasons, there is a high likelihood
that it will fail to render Mr. Gray insensate to the excruciatingly painful and agonizing effects of
the second and third drugs in Defendants’ three-drug protocol.
85.

Moreover, Defendants intend to execute Mr. Gray by injecting drugs made by a

compounding pharmacy lacking adequate promises of safety, and the many risks attendant to
using a sub-standard compounded drug include that the drug will be sub-potent, expired, or
contaminated, or that will contain unintended additives or a substantial level of particulates.
Likewise, deficiencies in storing and handling the drugs in compliance with very specific
guidelines create the risk that the compounded drugs will expire before they are used.
86.

Therefore, the three-drug lethal injection protocol employed by the VDOC does

not comport with “evolving standards of decency that mark the progress of a maturing society,”
as demonstrated by the fact that at least 13 states across the country have adopted or announced
that they will adopt a protocol that does not pose the substantial risks of serious harm that are
present in the VDOC’s three-drug protocol. See “State by State Lethal Injection,” Death Penalty
Information Center, available at http://www.deathpenaltyinfo.org/state-lethal-injection.

34

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 35 of 38 PageID# 35

SECOND CAUSE OF ACTION
Declaratory Judgment re:
Violation of Mr. Gray’s Right to Procedural Due Process
Under the Fifth and Fourteenth Amendments to the United States Constitution
87.

Mr. Gray incorporates by reference each and every statement and allegation set

forth in this Complaint as if fully stated here.
88.

The Fifth and Fourteenth Amendments guarantee that “[n]o person…shall be

deprived of life, liberty, or property without due process of law.” U.S. Const. amend. V (1791);
U.S. Const. amend XIV (1868) (“nor shall any State deprive any person of life, liberty, or
property, without due process of law”); see also Adams v. United States ex rel. McCann, 317
U.S. 269, 276 (1942) (“procedural devices rooted in experience were written into the Bill of
Rights not as abstract rubrics in an elegant code but in order to assure fairness and justice before
any person could be deprived of ‘life, liberty, or property.’”).
89.

Due process entitles a person whose constitutional rights might be affected by

state actions to, at minimum, both notice of those actions and an opportunity to be heard “at a
meaningful time and in a meaningful manner.” Fuentes v. Shevin, 407 U.S. 67, 80 (1972)
(“Parties whose rights are to be affected are entitled to be heard; and in order that they may enjoy
that right they must first be notified.”).
90.

Executing Mr. Gray without giving him notice of the procedures to be used to kill

him violates his rights under the Fifth and Fourteenth Amendments.
91.

The Virginia Attorney General’s office has not provided Mr. Gray any

information about:
a. the identity or capacity of the compounding pharmacy that made the
compounded midazolam and potassium chloride;

35

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 36 of 38 PageID# 36

b. the credentials of the compounding pharmacy that made the midazolam and
potassium chloride or any persons or agents involved in mixing, testing,
storing or transferring the chemical mixtures of compounded midazolam and
potassium chloride;
c. the exact date that the midazolam and potassium chloride were compounded;
d. the manufacturers of the ingredients used in the compounded midazolam and
potassium chloride;
e. the ingredients used to make the preparations, the circumstances under which
the preparations were made, or whether these ingredients were manufactured
by an FDA-approved registered facility and comply with standards of the
United Sates Pharmacopeia;
f. the manner in which the preparations have been stored, handled, and
transported since they were compounded;
g. how the Beyond Use Dates were set;
h. a description of the facility at which the drugs were compounded;
i.

any inspections or other regulatory enforcement efforts undertaken in
connection with the compounding pharmacies; or

j.

what information the VDOC obtained about the appropriateness of using
compounded midazolam in the execution of inmates sentenced to death in
Virginia.

92.

By failing to disclose essential information about the lethal injection protocol and

effectively preventing Mr. Gray from learning such information directly from the compounding

36

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 37 of 38 PageID# 37

pharmacy, Defendants have denied Mr. Gray the ability to effectively protect his Eighth
Amendment rights and have thwarted his right to judicial review.
93.

Through its secrecy statute and its lack of disclosure, the Commonwealth has

deliberately prevented Mr. Gray from learning crucial information about his impending
execution, thus denying him the ability to review and challenge the protocol pursuant to his due
process rights under the Fifth and Fourteenth Amendments.
REQUEST FOR RELIEF
WHEREFORE Mr. Gray respectfully requests that this Court grant the following relief:
(a)

Temporary, preliminary, and permanent injunctive relief by enjoining the

Defendants from executing Mr. Gray with inadequate anesthesia in the form of compounded
midazolam and using unsafe compounding methods in their execution procedures that violate his
right to be free from cruel and unusual punishment under the Eighth Amendment, as applied to
the states via the Fourteenth Amendment;
(b)

Temporary, preliminary, and permanent injunctive relief by enjoining the

Defendants from enforcing Virginia’s statutory prohibition on producing discovery in this civil
proceeding concerning the source of the compounded drugs to be used in an execution, Va. Code
§ 53.1-234;
(c)

Issuance of an Order declaring unconstitutional the Defendants’ lethal-injection

protocols and procedures, as a violation of Mr. Gray’s right to be free from cruel and unusual
punishment under the Eighth Amendment, as applied to the states via the Fourteenth
Amendment, and the right to equal protection under the Fourteenth Amendment;
(d)

Issuance of an Order declaring unconstitutional under the Fifth and Fourteenth

Amendments of the United States Constitution, Virginia’s statutory prohibition on producing

37

 Case 3:16-cv-00982-HEH Document 1 Filed 12/14/16 Page 38 of 38 PageID# 38

discovery in this civil proceeding concerning the source of the compounded drugs to be used in
an execution, Va. Code § 53.1-234;
(e)

An award of costs, including reasonable attorney’s fees, pursuant to 42 U.S.C.

§ 1988; and
(f)

Such other and further relief as this Court may deem just and appropriate.

Dated: December 14, 2016

Respectfully submitted,
HOGAN LOVELLS US LLP
By:

/s/ Haley K. Costello Essig
Haley K. Costello Essig (Bar # 85541)
Park Place II, Ninth Floor
7930 Jones Branch Drive
McLean, Virginia 22102
Tel: (703) 610-6100
Fax: (703) 610-6200
E-mail: haley.essig@hoganlovells.com
Lisa J. Fried
Nathaniel S. Boyer
875 Third Avenue
New York, New York 10022
Tel: (212) 918-3000
Fax: (212) 918-3100
E-mail: lisa.fried@hoganlovells.com
E-mail: nathaniel.boyer@hoganlovells.com
Pro Hac Vice Applications Forthcoming
Counsel for Plaintiff Ricky Jovan Gray

38