Stephen Michael West v. Derrick D. Schofield , 519 S.W.3d 550 ( 2017 )


Menu:
  •                    IN THE SUPREME COURT OF TENNESSEE
    AT NASHVILLE
    October 6, 2016 Session
    STEPHEN MICHAEL WEST ET AL. V. DERRICK D. SCHOFIELD ET AL.
    Appeal by Permission from the Chancery Court of Davidson County
    No. 13-1627-I      Claudia C. Bonnyman, Chancellor
    No. M2015-01952-SC-RDM-CV – Filed March 28, 2017
    The Plaintiffs, each convicted of first degree murder and sentenced to death, 1 brought this
    declaratory judgment action seeking to have declared facially unconstitutional the written
    protocol by which the Tennessee Department of Correction carries out an execution by
    lethal injection. After a lengthy evidentiary hearing, the trial court denied relief. The
    Plaintiffs appealed and, following a motion by the Defendants,2 this Court assumed
    jurisdiction over this matter. The Plaintiffs assert three grounds for relief in their brief to
    this Court: (1) the protocol is unconstitutional because it creates a substantial risk of
    serious harm; (2) the protocol is unconstitutional because it creates a substantial risk of a
    lingering death; and (3) the trial court erred by dismissing their claim that the protocol is
    unconstitutional because it requires the State to violate federal drug laws. We hold that
    the trial court did not err in concluding that the Plaintiffs failed to carry their burden of
    demonstrating that the protocol, on its face, violates the constitutional prohibitions
    against cruel and unusual punishment. We also hold that the trial court did not err in
    dismissing the Plaintiffs‘ claims that the protocol requires violations of federal drug laws.
    Accordingly, we affirm the trial court‘s judgment.
    1
    The condemned inmates include the following: Stephen Michael West, David Earl Miller,
    Nicholas Todd Sutton, Larry McKay, Billy Ray Irick, Abu Ali Abdur‘Rahman, Byron Black, Andre
    Bland, Kevin Burns, Tony Carruthers, Walter Caruthers (since deceased), Gary Cone (since deceased),
    James Dellinger, Jon Hall, Kennath Henderson, Henry Hodges, Stephen Hugueley, David Ivy, Don
    Johnson, David Keen, Donald Middlebrooks, Pervis Tyrone Payne, Gerald Lee Powers, William Glen
    Rogers, Oscar Smith, Andrew Thomas, Charles Wright, Edmund Zagorski, Lee Hall, Nikolaus Johnson,
    David Jordan, Richard Odom, and Corinio Pruitt (spellings pursuant to pleadings in this case).
    2
    The following persons were named defendants in the Plaintiffs‘ complaint: Derrick D.
    Schofield, in his official capacity as Tennessee‘s Commissioner of Correction; Wayne Carpenter, in his
    official capacity as Warden of Riverbend Maximum Security Institution; Tony Mays, in his official
    capacity as Deputy Warden of Riverbend Maximum Security Institution; Jason Woodall, in his official
    capacity as Deputy Commissioner of Operations; Tony Parker, in his official capacity as Assistant
    Commissioner of Prisons; John Doe Physicians 1–100; John Doe Pharmacists 1–100; John Doe Medical
    Examiners 1–100; John Doe Medical Personnel 1–100; and John Doe Executioners 1–100.
    Tenn. Code Ann. § 16-3-201(d)(1) Appeal by Permission;
    Judgment of the Chancery Court Affirmed
    JEFFREY S. BIVINS, C.J., delivered the opinion of the Court, in which CORNELIA A. CLARK,
    SHARON G. LEE, HOLLY KIRBY and ROGER A. PAGE, JJ., joined.
    Stephen M. Kissinger, pro hoc vice, and Helen Susanne Bales, Assistant Federal
    Community Defenders, Knoxville, Tennessee, for the appellants, Stephen Michael West,
    Nicholas Todd Sutton, Larry McKay, and David Earl Miller.
    Gene Shiles, Jr., and William J. Rieder, Chattanooga, Tennessee, for the appellant, Billy
    Ray Irick.
    Kelley J. Henry, Supervisory Assistant Federal Public Defender, and Michael J. Passino,
    Assistant Federal Public Defender, Nashville, Tennessee, for the appellants Edmund
    Zagorski, Abu-Ali Abdur‘Rahman, Charles Wright, Don Johnson, David Keen, Andre
    Bland, Kevin Burns, James Dellinger, David Ivy, Byron Black, Pervis Tyrone Payne,
    William Glen Rogers, Oscar Smith, Stephen Hugueley, Kennath Henderson, Jon Hall,
    Andrew Thomas, Henry Hodges, Gerald Lee Powers, Tony Carruthers, and Donald
    Middlebrooks.
    Kathleen Morrison, Nashville, Tennessee, for the appellants, Lee Hall, Jr., Nikolaus
    Johnson, David Jordan, Richard Odom, and Corinio Pruitt.
    Herbert H. Slatery III, Attorney General and Reporter; Andrée S. Blumstein, Solicitor
    General; Jennifer L. Smith, Associate Solicitor General; Scott C. Sutherland, Deputy
    Attorney General; and Linda D. Kirklen, Assistant Attorney General, for the appellees,
    Derrick Schofield, Wayne Carpenter, Tony Mays, Jason Woodall, Tony Parker, and John
    Doe Physicians, Pharmacists, Medical Examiners, Medical Personnel, and Executioners.
    OPINION
    Procedural Background
    On September 27, 2013, the Tennessee Department of Correction (―TDOC‖)
    adopted a new lethal injection protocol providing that inmates sentenced to death be
    executed by the injection of a lethal dose of a single drug, pentobarbital (―the Protocol‖).3
    3
    The prior lethal injection protocol required the use of three drugs, sodium pentothal,
    pancuronium bromide, and potassium chloride. See Abdur‘Rahman v. Bredesen, 
    181 S.W.3d 292
    , 300
    (Tenn. 2005).
    -2-
    See Tenn. Code Ann. § 40-23-114(c) (2012) (―The department of correction is authorized
    to promulgate necessary rules and regulations to facilitate the implementation of
    [executions by lethal injection].‖). The TDOC has since amended the Protocol twice. On
    September 24, 2014, the Protocol was amended to specify that the lethal injection drug to
    be used would be compounded pentobarbital rather than manufactured pentobarbital. On
    June 25, 2015, the Protocol was amended by incorporating a contract between the TDOC
    and a pharmacist for the provision of the compounded pentobarbital. Our references to
    the Protocol include these amendments.
    On November 20, 2013, Stephen Michael West, Billy Ray Irick, Nicholas Todd
    Sutton, and David Earl Miller filed a declaratory judgment action in the Chancery Court
    for Davidson County, Tennessee, against the Defendants with regard to the Protocol.
    Additional death row inmates later were allowed to intervene and file complaints,
    eventually resulting in a total of five complaints setting forth essentially identical claims
    (collectively, and as subsequently amended, ―the Complaint‖). The Complaint sought a
    declaration that, for various reasons, the Protocol violates the United States and
    Tennessee Constitutions.
    During the course of the litigation, the parties became embroiled in a discovery
    dispute, which eventually resulted in this Court‘s March 10, 2015 decision, West v.
    Schofield, 
    460 S.W.3d 113
    (Tenn. 2015). In this first interlocutory decision, we, inter
    alia, made clear that the Plaintiffs‘ declaratory judgment action was limited to
    challenging the Protocol on its face, as opposed to any as-applied challenges. 
    Id. at 131–
    32. This Court issued a second interlocutory decision after the Plaintiffs amended their
    complaint to challenge the constitutionality of a 2014 statute that designated electrocution
    as an alternative method of execution. See West v. Schofield, 
    468 S.W.3d 482
    , 484–85
    (Tenn. 2015) (holding that, because the Plaintiffs ―are not currently subject to execution
    by electrocution and will not ever become subject to execution by electrocution unless
    one of two statutory contingencies occurs in the future, their claims challenging the
    constitutionality of the 2014 statute and electrocution as a means of execution are not
    ripe‖ and reversing the trial court‘s denial of the Defendants‘ motion to dismiss these
    claims). In between these two decisions, the trial court dismissed the Plaintiffs‘ claims
    that the Protocol requires the State to violate state and federal drug laws, violates the
    federal Supremacy Clause, and constitutes a common-law civil conspiracy (―Count V‖).
    Subsequently, the litigation proceeded to trial.
    After carefully evaluating the considerable amount of proof adduced by the
    litigants, the trial court issued a comprehensive order setting forth its findings of fact and
    conclusions of law. Based upon these findings and conclusions, the trial court denied
    relief to the Plaintiffs. The Plaintiffs appealed, and we granted the Defendants‘ motion to
    accept jurisdiction pursuant to Tennessee Code Annotated section 16-3-201(d)(1) (2009).
    -3-
    We now address the Plaintiffs‘ contentions that (1) the Protocol is unconstitutional
    because it creates a substantial risk of serious harm; (2) the Protocol is unconstitutional
    because it creates a substantial risk of a lingering death; and (3) the trial court erred by
    dismissing Count V. We begin our analysis with a brief review of salient portions of the
    Protocol, a document that is 98 pages long, including the three-page contract between
    Riverbend Maximum Security Institution (―Riverbend‖) and the pharmacist who is to
    provide the lethal injection drug (―the Contract‖).
    The Protocol
    After receiving a court order setting an execution date, the warden of Riverbend
    (―the Warden‖) or his designee is to contact a physician to obtain a physician‘s order for
    the lethal injection chemical, pentobarbital, described in the Protocol as ―[a]n
    intermediate-acting barbiturate‖ and consisting of ―[a] lethal dose of 100 ml of a 50
    mg/mL solution (a total of 5 grams)‖ (―the LIC‖). The Warden or his designee is to
    submit the physician‘s order to the licensed pharmacist pursuant to the Contract for the
    provision of the LIC. The Contract obligates the pharmacist to (1) provide the LIC; (2)
    compound the LIC ―in a clean, sterile environment‖; (3) ―[a]rrange for independent
    testing of the [LIC] for potency, sterility, and endotoxins‖; and (4) ―[p]erform all services
    rendered under [the Contract] in accordance [with] professional standards and
    requirements under state and federal law.‖
    Upon receipt of the LIC, the Warden and another member of the Execution Team,
    as that group is defined in the Protocol, place the LIC in a small, locked refrigerator.
    There is only one key to the refrigerator, ―issued permanently to the Warden.‖ The
    Protocol requires all delivered LIC to be ―monitored for expiration dates.‖ The Protocol
    also contains provisions for monitoring the security of the LIC.
    As to the preparation of the LIC for administration to a condemned inmate, the
    Protocol provides as follows:
    1. Prior to an execution, a minimum of two members of the Execution
    Team bring the LIC from the armory area [where the refrigerator is kept]
    directly to the Lethal Injection Room. The amount of chemical and saline
    is sufficient to make two complete sets of three (3) syringes each. One set
    is color coded red and the back-up set is color coded blue. The second set,
    however, need not be drawn into the syringes unless the primary dose
    proves insufficient for the procedure. Each syringe is numbered in the
    order it is to be administered and labeled with the name of its contents.
    Only the Warden and one member of the Execution Team have a key to the
    Lethal Injection Room.
    -4-
    2. The LIC is drawn into syringes by one member of the Execution Team.
    Another member of the Execution Team observes and verifies that the
    procedure has been carried out correctly.
    3. Only one syringe is prepared at a time. As they are prepared, the two
    sets of syringes are positioned in specific holding places in two separate
    trays color coded red and blue. The syringes are numbered, labeled, and
    placed in the order they will be administered. One member of the
    Execution Team will perform this procedure while another member of the
    Execution Team observes and verifies that the procedure has been carried
    out correctly. The Chemical Preparation Time Sheet will document the
    preparation of the LIC.
    4. Instructions for preparation of one set of syringes:
    a. Pentobarbital: The member of the [E]xecution [T]eam draws 50
    cc of Pentobarbital (50 mg/mL solution) in each of two syringes, for a total
    of 5 grams of Pentobarbital.[4] These syringes are labeled Pentobarbital
    with numbers one (1) and two (2), respectively.
    b. Saline: The member of the Execution Team draws 50 cc of
    saline solution from the IV bag into a syringe, which is labeled Saline with
    the number three (3).
    5. The tray is placed on the workstation in the Lethal Injection Room.
    6. IF NECESSARY THIS PROCESS WILL BE REPEATED FOR
    THE SECOND SET OF SYRINGES.
    7. When the execution is complete, all syringes and any of the prepared but
    unused LIC are sent to the Medical Examiner‘s office with the body.
    (Footnote added).
    As to the administration of the LIC to the condemned inmate, the Protocol
    provides that a three-member team of certified emergency medical technicians will
    conduct the insertion and monitoring of the IV lines by which the LIC will be injected
    into the condemned inmate. After the successful placement of two IV catheters into the
    inmate, and after the Warden gives the signal to proceed, the Executioner is given syringe
    number one by a member of the IV team and connects it to the IV line. The Protocol
    continues:
    4
    A ―cc,‖ or cubic centimeter, is the equivalent of one milliliter.
    -5-
    The Executioner pushes on the plunger of the #1 syringe (red) with a slow,
    steady pressure. Should there be or appear to be swelling around the
    catheter or if there is resistance to the pressure being applied to the plunger,
    the Executioner pulls the plunger back. If the extension line [to the IV]
    starts to fill with blood, the execution may proceed. If there is no blood, the
    Executioner discontinues with this line. He starts the process on the other
    line with the back-up set of syringes starting with syringe #1 (blue) . . . .
    The Protocol provides that the injection sequence is one syringe containing 50 cc of the
    LIC, a second syringe containing 50 cc of the LIC, and a third syringe containing 50 cc of
    a saline solution as a ―flush.‖ Two members of the IV team monitor the process
    throughout while in the Lethal Injection Room.5 Monitoring of the catheter sites is
    accomplished via a pan-tilt zoom camera ―which displays the exact location of the
    catheter(s).‖
    The Protocol continues:
    Following the completion of the lethal injection process, and a five-minute
    waiting period, the blinds to the official witness room are closed, the closed
    circuit TV camera is disengaged, and the privacy curtain is closed. The
    Warden then asks the physician to enter the room to conduct an
    examination. The physician reports his findings to the Warden or designee.
    If the physician pronounces the inmate deceased, the Warden or his designee informs the
    Commissioner that the sentence has been carried out.
    If, however, the physician determines that the inmate is not deceased after the
    initial dose of LIC has been injected, the physician returns to the waiting area and the
    Warden instructs the Executioner to repeat the lethal injection procedure with the second
    set of syringes. After the second dose of LIC is injected, the physician returns and again
    checks for signs of life.
    The Protocol requires that ―[t]he Execution Team‘s Officer in Charge and/or the
    Assistant Officer in Charge conducts a training session at least once each month at which
    time all equipment will be tested. The training includes a simulated execution (i.e. IV
    lines, IV Drip).‖ The simulated execution uses a saline solution. Additional training is
    conducted two weeks prior to a scheduled execution. The Executioner receives
    additional training from a qualified medical professional.
    5
    The inmate is strapped to a gurney in the Execution Chamber, adjacent to the Lethal Injection
    Room.
    -6-
    Relevant Proof
    Initially, we note that the trial court allowed the Plaintiffs to adduce proof about a
    variety of things that might conceivably go wrong in a compounded pentobarbital lethal
    injection execution as well as proof about the consequences of the Protocol being carried
    out in accordance with the Protocol‘s specific provisions. For instance, the Plaintiffs
    elicited expert proof about the risks associated with the LIC if it was compounded,
    transported, or stored improperly, i.e., in contravention of the Protocol, including the
    Contract. However, we view this proof as more appropriate to an as-applied challenge to
    the Protocol because the Protocol, on its face, does not provide for the improper
    preparation, transportation, or storage of the LIC. As the United States Court of Appeals
    for the Sixth Circuit has recognized, ―[s]peculations, or even proof, of medical
    negligence in the past or in the future are not sufficient to render a facially
    constitutionally sound protocol unconstitutional.‖ Cooey v. Strickland, 
    589 F.3d 210
    ,
    225 (6th Cir. 2009).
    Certainly, there are risks of error in every human endeavor. Indeed, as the United
    States Supreme Court has recognized, ―[s]ome risk of pain is inherent in any method of
    execution—no matter how humane—if only from the prospect of error in following the
    required procedure.‖ Baze v. Rees, 
    553 U.S. 35
    , 47 (2008) (plurality opinion). However,
    ―‗accident[s], with no suggestion of malevolence‘ [do] not give rise to an Eighth
    Amendment violation.‖ 
    Id. at 50
    (citation omitted) (quoting Louisiana ex rel. Francis v.
    Resweber, 
    329 U.S. 459
    , 463 (1947)).
    Again, this lawsuit consists of a facial challenge to the Protocol. A facial
    challenge does not involve a consideration of the Plaintiffs‘ list of things that might go
    wrong if the Protocol is not followed. Therefore, we need not itemize the substantial
    amount of proof in the record before us that relates only to potential risks that might
    occur from a failure to follow the Protocol rather than the proof of risks that are inherent
    in the Protocol itself. We turn, then, to a brief summary of the relevant proof adduced at
    trial.
    Dr. David A. Lubarsky, Professor and Chair of the Department of Anesthesiology
    at the University of Miami and board certified in anesthesiology, explained that
    pentobarbital is a sedative hypnotic drug that, in a sufficient dose, represses the brain‘s
    respiratory impulses, causing the body to become oxygen deficient and resulting in the
    cessation of cardiac activity.
    Dr. Lubarsky opined that the 100 milliliter bolus injection called for by the
    Protocol6 was ―a very large volume for a bolus injection‖ and that, in a medical setting,
    6
    As noted above, one cubic centimeter (one ―cc‖) is the equivalent of one milliliter. The two 50
    -7-
    such volumes were usually injected using a central IV line as opposed to a peripheral IV
    line as called for in the Protocol. Dr. Lubarsky explained that using a peripheral IV line
    for injecting such a large volume of fluid increased the risk of the fluid migrating from
    the vein into the surrounding tissue (―extravasation‖).              Such extravasation of
    pentobarbital would be ―very painful.‖ Dr. Lubarsky also opined that the risk of the
    pentobarbital leaching into the tissue surrounding the vein was increased because the
    injection was being administered by someone other than a medical professional and
    because the IV line was being monitored by camera rather than by a bedside medical
    professional. This risk of extravasation was also increased by the extended length of the
    IV tubing called for in the Protocol. Dr. Lubarsky also stated that the risk of
    extravasation increased if the LIC contained precipitate, i.e., particulate matter.
    Dr. Lubarsky defined death as ―the point where you have cardiac function that is
    irreversibly stopped.‖ He stated that his review of eight pentobarbital executions
    conducted in Arizona indicated that ―it did not appear that all the inmates had ceased
    cardiac electrical activity when the [electrocardiogram] was turned off and the inmate
    declared dead.‖ He added, ―Actually, there was electrical activity continuing in a couple
    of cases when the machine was turned off and apparently the inmate was declared dead.‖
    According to Dr. Lubarsky, ―as long as there‘s electrical activity [i]t‘s potentially
    possible that the heart, again, not only could restart but, specifically in cases of drug
    overdose, the declaration of death has to be amended, if you will, to go beyond physical
    signs and symptoms because physicians can be fooled and that is so noted, especially as
    regards pentobarbital.‖ He stated, ―you can‘t use physical signs and . . . actually you are
    not allowed to actually declare death or brain death in people who have a massive amount
    of barbituates coursing through their body because the signs [of heartbeat and breathing]
    are known to be unreliable.‖ Thus, he was concerned after reviewing execution records
    from Arizona ―that the inmates are being declared dead before they meet the criteria for
    being declared dead.‖
    On cross-examination, Dr. Lubarsky acknowledged that a properly administered
    dose of 5 grams of pentobarbital is likely lethal, and he acknowledged that each time this
    dose has been used in an execution it has resulted in the inmate‘s death. He also
    acknowledged that the proper administration of the LIC would result in a quick and
    complete loss of consciousness. Tellingly, Dr. Lubarsky had this to say during his cross-
    examination:
    I don‘t believe that lethal injection can be carried out in a humane fashion
    because I don‘t believe that we have the trained people to do the procedures
    the way they need to be done, nor the quality control, process control, or
    cc injections of the LIC provided for by the Protocol therefore equal 100 milliliters.
    -8-
    testing of the hypotheses that these methods will work perfectly before
    they‘re applied to human beings.
    (Emphasis added).
    Dr. James Hoffman Ruble, Associate Professor at the University of Utah College
    of Pharmacy, testified about the differences between manufactured and compounded
    drugs. Manufactured drugs are regulated by the Food and Drug Administration, but
    compounded drugs are not. Dr. Ruble explained that manufactured pentobarbital ―is not
    available in the United States for purposes of lethal injection.‖
    After a number of people died from the injection of contaminated compounded
    drugs, the United States Pharmacopeia adopted General Chapter 797 (―USP 797‖). USP
    797 regulates the compounding of sterile pharmaceutical preparations. The LIC called
    for in the Protocol is a compounded sterile pharmaceutical preparation. To prepare the
    LIC, the compounding pharmacist must begin with bulk powdered pentobarbital. 7 This
    chemical is then mixed with ―a liquid vehicle,‖ most likely water. ―In addition,
    compounding pharmacies may be including other inactive ingredients, e.g., propylene
    glycol, alcohol, hydrochloric acid, sodium hydroxide. Small amounts of these
    ingredients may be added, for example, to adjust pH, tonicity, and solubility of the
    finished preparation.‖ According to Dr. Ruble, ―The manual combination or mixing of
    these ingredients, that is, the ‗compounding‘ process, must be carried out under specific
    environmental conditions, using equipment that is properly calibrated and maintained,
    and performed by personnel that are highly trained and whose competency and aseptic
    technique is verified at regular intervals.‖
    Dr. Ruble expressed concern about a provision in the Protocol at the bottom of
    page 35, a page entitled ―Procurement, Storage, Accountability, and Transfer of the
    Chemical.‖ The provision states, ―NOTE: The chemical manufacturer may change
    the concentration of the chemical solution without notification. The label should be
    carefully checked.‖ Dr. Ruble testified, ―I believe that there is a risk of error in the
    protocol as a result of that process.‖
    Dr. Ruble opined that the Protocol ―fails to provide sufficient safeguards to
    maintain the stability and potency of compounded pentobarbital and creates a substantial
    risk that the drug will precipitate or otherwise be unfit for intended use‖ and that the
    ―[i]njection of a solution which contains precipitated pentobarbital salt would be
    7
    According to Dr. Ruble, ―pentobarbital [active pharmaceutical ingredient] in bulk powder form
    is not currently available for sale for purchase by compounding pharmacies in the U.S. for use in
    compounded pentobarbital preparations.‖ Dr. Ruble did not explain how other states have been able to
    execute persons with injections of compounded pentobarbital.
    -9-
    expected to be extremely painful upon administration and expected to cause a pulmonary
    embolism which is known to be extraordinarily painful.‖
    Dr. Ruble‘s written report was admitted into evidence and contains the following
    statements regarding his review of the Protocol:
    For purposes of evaluation of the protocol you [the Plaintiffs‘ attorneys]
    have asked me to assume that the Tennessee Department of Correction and
    Pharmacist do only those things that are written down and I am not to read
    into the protocol actions which are not contained therein. With these
    assumptions in mind, it is my professional opinion that the Tennessee
    Lethal Injection protocol fails to provide sufficient safeguards to maintain
    the stability and potency of compounded pentobarbital and creates a
    substantial risk that the drug will precipitate or otherwise be unfit for
    intended use. . . .
    Problems with the Tennessee Lethal Injection Protocol include:
    1) The protocol addresses expiration dates, but does not address
    beyond use dates. Beyond use dates are not the same as expiration dates.
    2) The protocol allows the chemical manufacturer (the pharmacist)
    to change the chemical concentration of the compounded solution without
    warning or notice; but fails to provide direction to the individual charged
    with administering the drug as to how to correct for such a change in
    concentration. Instead, the individual is specifically instructed to draw up a
    set amount of solution into a syringe. This provision of the protocol creates
    a substantial risk of a subpotent amount of drug being administered to the
    inmate.
    3)     The protocol requires procurement of the compounded
    pentobarbital ―upon receipt of an order setting an execution date.‖ I am
    informed that Tennessee law requires that the execution date be no less than
    7 days from the date of the order scheduling the execution but that no
    execution date has been on such a short time frame since the execution of
    Robert Coe in 2000. The drug is refrigerated, not frozen, according to the
    protocol. As previously stated, the [beyond use date] for refrigerated
    pentobarbital is three days and that assumes that the drug is kept
    refrigerated from manufacture through administration.
    4) The protocol permits the drug to be transported at room
    temperature for an indeterminate amount of time.
    -10-
    5) The protocol provides that the drug will be removed from the
    refrigerator on Day 38 and thus will come to room temperature for an
    indeterminate amount of time.
    6) The protocol does not require temperature logs from the time the
    drug leaves the compounding pharmacy through the storage and use of the
    drug. As such, there is no way to determine that the drug has been
    maintained at the proper temperature.
    7) The protocol does not provide for packing and transport of the
    compounded pentobarbital in accordance with USP 797 standards.
    8) The protocol does not provide for training of staff charged with
    procurement, storage, and administration of compounded pentobarbital as
    required by USP.
    (Footnote added). Dr. Ruble‘s written report also states generally that a ―beyond use
    date‖ is defined by USP 797 as ―‗the date or time after which a [compounded sterile
    product such as the LIC] shall not be stored or transported‘‖ and that, ―[i]f not stored
    properly, [compounded sterile products] can be damaged and rendered unusable.‖ His
    report also acknowledges that the USP guidelines on which he relies are aimed at the
    preparation of pharmaceutical products ―for medicinal use.‖ (Emphasis added).
    On cross-examination, Dr. Ruble acknowledged that Tennessee had adopted USP
    797 and that pharmacists licensed by Tennessee must comply with USP 797 when
    compounding sterile pharmaceutical preparations. He acknowledged that the Contract
    required the pharmacist to compound the LIC in compliance with USP 797. He also
    acknowledged that USP 797 imposed handling, transporting, and labeling requirements
    for the LIC. He agreed that, if the LIC were prepared, handled, transported, and labeled
    as required, there was a low risk that the LIC would precipitate or be unfit for use,
    ―[a]ssuming that the pharmacist has the adequate experience in compounding and
    understanding of the regulations.‖ Importantly, he also acknowledged that, in rendering
    his opinion that the Protocol failed to provide sufficient safeguards, he presumed that
    USP 797 was not going to be entirely complied with.
    Dr. Larry D. Sasich, a faculty member at Idaho State University‘s Pharmacy
    Program and a member of the Federal Drug Administration‘s Advisory Committee, also
    testified on behalf of the Plaintiffs. He stated that compounding the LIC could result in a
    dose contaminated with bacteria, fungi, and ―cross-contaminants.‖ Dr. Sasich also
    8
    The Protocol sets forth a three-day ―Death Watch period.‖ On Day 1, among other things,
    ―[t]he condemned inmate is moved to Death Watch status in Building 8.‖ On Day 2, among other things,
    the inmate ―orders his last meal.‖ The execution takes place on Day 3.
    -11-
    explained that pentobarbital ―is one of those drugs where the acidity is very critical to
    insure that it stays in solution because you don‘t want to—if it doesn‘t stay in solution,
    then it clumps.‖ The danger of clumping, or precipitate forming in the compounded
    pentobarbital solution, was that ―[i]t would probably block the blood supply. It would be
    a catastrophic event. And . . . it could be extremely painful.‖
    Dr. Sasich opined that, based on his review of the Protocol, there was a likelihood
    that the compounded LIC would be out of date and/or improperly stored, rendering the
    LIC unsuitable for use. He also opined that the outside testing of the LIC required by the
    Contract was unreliable.
    Dr. Lance B. Becker, the Director of the Center for Resuscitation Science and the
    Division Chief of Emergency Critical Care within the Department of Emergency
    Medicine at the University of Pennsylvania, testified that ―it would be pretty
    straightforward and simple to fully revive an individual right after‖ he was executed
    according to the Protocol and declared dead by the physician. He maintained that the
    scientific evidence suggested that half of condemned inmates could be restored to life
    thirty minutes after being declared dead following an execution according to the Protocol.
    Dr. Becker explained that CPR and related resuscitative steps would be required to
    restore the executed inmate to life.
    The Plaintiffs also called Debra K. Inglis, the TDOC‘s general counsel, to testify
    about the development of the Protocol. Asked about the Protocol‘s provision that the
    LIC‘s ―chemical manufacturer may change the concentration of the chemical solution
    without notification. The label should be carefully checked,‖ Ms. Inglis indicated that
    this provision was left over from the previous protocol that utilized manufactured drugs.
    With respect to a compounded LIC, the Protocol required the compounding pharmacist to
    provide the ―specific thing ordered by the physician.‖ Ms. Inglis stated, ―That can‘t be
    changed.‖ Thus, the provision ―really doesn‘t have a lot of application when we are
    dealing with a compounded chemical for a particular person in response to a particular
    physician‘s order.‖
    The Defendants called Dr. Feng Li, the Acting Medical Examiner for Davidson
    County, Tennessee, and board certified in clinical and forensic pathology. Dr. Li testified
    that the LIC called for by the Protocol was 25 to 50 times greater than the regular
    therapeutic dose of pentobarbital.9 He stated that the large dose, coupled with the speed
    of its administration, would cause an individual to ―lose consciousness very, very
    9
    If the inmate is not declared dead after the first set of syringes is administered, the Protocol calls
    for the injection of the second set of syringes. According to Dr. Li, the administration of the second set of
    syringes would equal 50 to 100 times the clinical dose of pentobarbital.
    -12-
    quick[ly].‖ Dr. Li opined that, after injection of the LIC, the inmate‘s brain would suffer
    irreversible damage in a ―very short period of time.‖
    Dr. Li‘s written report was admitted into evidence and includes the following:
    4. . . . In the execution context, the dose and rate of administration
    [of the pentobarbital] will have a rapid and profound effect on
    consciousness, respiratory and circulatory functions. The inmate will
    quickly lose consciousness and become comatose. Respiration and
    circulation will be depressed resulting in death. Unconsciousness is a state
    when the ability to maintain an awareness of self and the environment is
    lost. In this state, the inmate completely lo[ses] responsiveness to people
    and other environmental stimuli.
    5. It is my opinion, to a reasonable degree of medical certainty, in
    the execution context, that the intravenous administration of 5 grams of
    pentobarbital will render the inmate unconscious within seconds and, for an
    average human being will result in death within minutes and that the
    Protocol‘s contingency provision for the administration of an additional 5
    grams of pentobarbital will certainly result in death.
    6. It is my opinion, to a reasonable degree of medical certainty, that
    there is a negligible risk that a condemned inmate to whom 5 grams of
    pentobarbital is properly administered pursuant to the Protocol will
    experience any pain and suffering associated with the execution process.
    Dr. Li reviewed the records associated with thirty pentobarbital executions
    conducted in Georgia, Ohio, and Texas.10 All of these executions resulted in the inmate
    being declared dead within thirty minutes of the first injection of pentobarbital. Based on
    10
    Three of these executions were conducted by Georgia in December 2014 and January 2015.
    The records of these executions admitted as exhibits do not indicate the source of the pentobarbital used
    in these executions. However, the United States Court of Appeals for the Eleventh Circuit has indicated
    that, as of December 8, 2015, Georgia had executed seven inmates using compounded pentobarbital. See
    Terrell v. Bryson, 
    807 F.3d 1276
    , 1279 (11th Cir. 2015), petition for cert. docketed, (U.S. Dec. 8, 2015).
    Ten of these executions were conducted by Ohio between March 2011 and September 2013.
    The records of these executions admitted as exhibits do not identify the source of the pentobarbital.
    Seventeen of these executions were conducted by Texas between October 2013 and March 2015.
    The records of these executions admitted as exhibits do not identify the source of the pentobarbital.
    However, the United States Court of Appeals for the Fifth Circuit has stated that ―Texas has used
    compounded pentobarbital to execute thirty-two prisoners since 2013 . . . .‖ Wood v. Collier, 
    836 F.3d 534
    , 537 (5th Cir. 2016).
    -13-
    the records Dr. Li reviewed, only one inmate spoke: Jose Villegas in Texas stated as the
    first injection began, ―It does kind of burn. Good-bye.‖ Mr. Villegas gasped several
    times and then ceased moving.
    The Defendants also called Dr. Roswell Lee Evans, Jr., the dean of, and professor
    in, the Department of Pharmacy Practice at Auburn University. Dr. Evans stated that he
    is a pharmacist licensed in Georgia. Dr. Evans opined that the proper intravenous
    administration of five grams of pentobarbital ―would induce a coma and death shortly
    thereafter.‖ He also opined that it was ―unlikely‖ that the inmate ―would experience very
    much pain and suffering at all that would be beyond a needle stick.‖
    Dr. Evans described the process of compounding pentobarbital in accordance with
    USP 797:
    [T]he raw product or the active ingredient would be provided, purchased
    and in a powdered form. That compound would then be weighed according
    to the volume of the injection that‘s going to be made and the right
    concentration.
    The drug would be dissolved in sterile water, adjusted for
    appropriate pH, filtered into a sterile vial, and stored in an appropriate
    environment. In this case it should be refrigerated.
    A sample of that compound, whether it‘s a duplicate of that
    compound, in other words, you might make two samples in the same way,
    some—that compound needs to be tested for sterility, for concentration, for
    pyrogenicity by outside laboratories.
    Dr. Evans explained that a ―pyrogen‖ was ―something that would create a toxic reaction.‖
    Dr. Evans also testified that ―this is a really simple compound to make,‖ and that
    ―any pharmacist could actually formulate, regardless of whether they are compounding or
    not, could formulate this drug and create a solution that would be a 50-milligram per
    milliliter concentration.‖ When asked whether he would be ―confident‖ that the LIC
    would be equivalent to manufactured pentobarbital if a pharmacist prepared the LIC
    pursuant to the Contract, including adhering to USP 797, Dr. Evans responded, ―In terms
    of concentration, yes.‖
    Dr. Evans testified that the compounding pharmacist ―is actually responsible for
    the appropriate transportation under appropriate temperature conditions, . . . including all
    the appropriate labeling for storage.‖
    -14-
    Dr. Evans reviewed the ―execution logs‖ of seventeen executions that took place
    in Texas and three executions that took place in Georgia, each of which utilized the single
    drug, compounded pentobarbital. Nothing in these logs indicated to him that the inmates
    suffered any pain or suffering.
    On cross-examination, Dr. Evans agreed that the Protocol did not require stability
    testing of the LIC, but he stated that stability would ―show up as a result of the potency‖
    testing required.
    Trial Court’s Ruling
    The trial court found that the medical and pharmacy experts who testified agreed
    ―that the injection of five grams of pentobarbital, if compounded properly and if
    administered properly, will likely cause death with minimal pain and with quick loss of
    consciousness.‖ The trial court noted that Tennessee‘s current one-drug Protocol lowered
    the possibility of pain that was present in the prior three-drug protocol and that, in Baze,
    the United States Supreme Court had determined that Kentucky‘s three-drug protocol
    was, nevertheless, constitutional. The trial court also noted several safeguards set forth in
    the Protocol that were similar to those examined in Baze, including the Protocol‘s
    requirement that the IV lines be established by ―emergency medical technicians who are
    trained to administer venipuncture in IV fluid therapy.‖
    The trial court determined that, ―[e]xcept for precipitation that can occur in
    compounding, [it] must find that if the licensed pharmacist complies with USP 797 as the
    compounding pharmacist is required to follow a sedative should work as intended.‖ As
    to the possibility of precipitate forming in the LIC, the trial court found that this potential
    problem does not cause ―a serious risk of severe pain because the [P]rotocol requires the
    IV team to continuously monitor the injection sites and assure the clear and unobstructed
    flow of the drug through the long tubing.‖ Additionally, the trial court found that the
    Defendants ―demonstrated that numerous one-drug executions have taken place without
    discernible painful muscle infiltration from an imperfect IV.‖ The trial court found that
    ―although perfect IV delivery of pentobarbital may not occur following the [P]rotocol,
    accidents such as those about which Dr. Lubarsky has genuine concern did not occur
    during the execution of inmates in Ohio, Georgia, and Texas.‖ Indeed, the trial court
    noted that ―[t]he execution of Mr. Villegas of Texas was the only execution among the
    numerous executions discussed using pentobarbital that raised the spectrum [sic] of
    visible pain.‖
    The trial court rejected the Plaintiffs‘ claims about the LIC‘s possible lack of
    potency ―because there are two lethal doses of the drug if one [dose] is not adequately
    potent to kill the inmate.‖ The trial court also concluded that ―[t]he State is reasonably
    -15-
    relying upon pharmacist direction for transport, storage, and days for use‖ and that ―[r]isk
    of poor storage conditions is minimal.‖
    Based on these findings, the trial court concluded that it could not find that the
    possibility of an accident in the compounding or administration of the LIC ―causes the
    [P]rotocol to violate the Eighth Amendment prohibition against cruel and unusual
    punishment.‖ The trial court also concluded that the Plaintiffs ―did not identify an
    alternative method of execution that is feasible, readily implemented, and which
    significantly reduces a substantial risk of severe pain; nor did the Plaintiffs demonstrate
    that no lethal injection protocol can significantly reduce the substantial risk of severe
    pain.‖
    The trial court also determined that the Plaintiffs ―did not carry their burden to
    establish that Tennessee‘s use of pentobarbital in its protocol entails a substantial risk of
    lingering death‖ because they did not ―demonstrate even a minimal risk that inmates will
    awake‖ after being declared dead following a lethal injection execution. The trial court
    also stated that there was ―no authority‖ for it to decide that ―death over 30 minutes
    without pain is a lingering death and a violation of the Eighth Amendment.‖ Finally, the
    trial court rejected the Plaintiffs‘ contention that the State imposes cruel and unusual
    punishment by failing to attempt resuscitation after pronouncing the inmate dead and his
    sentence served following injection of the LIC.
    Analysis
    Standard of Review
    The resolution of a constitutional claim after an evidentiary hearing ―generally
    presents a mixed question of law and fact.‖ Abdur‘Rahman v. Bredesen, 
    181 S.W.3d 292
    , 305 (Tenn. 2005). ―On appeal, our standard of review is de novo with a
    presumption of correctness extended only to the lower court‘s findings of fact.‖ 
    Id. Eighth Amendment
    Claims of Cruel and Unusual Punishment
    The Eighth Amendment to the United States Constitution prohibits the infliction
    of ―cruel and unusual punishments.‖ U.S. Const. amend. VIII. The Plaintiffs contend
    that the Protocol violates this provision in two distinct ways: (1) by exposing them to a
    substantial risk of serious harm and/or (2) by exposing them to a substantial risk of a
    lingering death.
    -16-
    Risk of Serious Harm
    The United States Supreme Court most recently considered an Eighth Amendment
    claim against a lethal injection protocol in Glossip v. Gross, 
    135 S. Ct. 2726
    (2015).11 In
    Glossip, condemned inmates in Oklahoma filed a civil rights action in federal court
    contending that the three-drug lethal injection protocol used by Oklahoma violated the
    Eighth Amendment because it created an unacceptable risk of severe pain. 
    Id. at 2731.
    After an evidentiary hearing, the federal district court denied the inmates‘ application for
    a preliminary injunction, and the United States Court of Appeals for the Tenth Circuit
    affirmed. 
    Id. The Supreme
    Court granted certiorari and affirmed. 
    Id. The Glossip
    Court reiterated and emphasized its earlier holding in Baze v. Rees,
    
    553 U.S. 35
    (2008) (plurality opinion), that an Eighth Amendment challenge to a lethal
    injection protocol based on the infliction of pain requires the complaining inmates to
    satisfy two prerequisites.12 First, the inmates must establish that the protocol ―presents a
    risk that is ‗sure or very likely to cause serious illness and needless suffering and give rise
    to sufficiently imminent dangers.‘‖ 
    Glossip, 135 S. Ct. at 2737
    (quoting 
    Baze, 553 U.S. at 50
    ) (internal quotation marks omitted). ―To prevail on such a claim, ‗there must be a
    substantial risk of serious harm, an objectively intolerable risk of harm that prevents
    prison officials from pleading that they were subjectively blameless for purposes of the
    Eighth Amendment.‘‖ Id. (quoting 
    Baze, 553 U.S. at 50
    ) (internal quotation marks
    omitted). Second, the inmates ―must identify an alternative [method of execution] that is
    ‗feasible, readily implemented, and in fact significantly reduce[s] a substantial risk of
    severe pain.‘‖ 
    Id. (quoting Baze,
    553 U.S. at 52); see also 
    Baze, 553 U.S. at 61
    (stating
    that an inmate asserting an Eighth Amendment challenge to a state‘s lethal injection
    protocol must establish ―that the State‘s lethal injection protocol creates a demonstrated
    risk of severe pain‖ and ―that the risk is substantial when compared to the known and
    available alternatives‖). The Glossip Court affirmed the denial of relief to the inmates
    because they had failed to satisfy either prerequisite. 
    Glossip, 135 S. Ct. at 2731
    .
    For the same reasons, the Plaintiffs‘ Eighth Amendment claim in this case that the
    Protocol exposes them to a substantial risk of severe pain must fail. First, the proof does
    not preponderate against the trial court‘s conclusion that the Plaintiffs ―did not carry their
    burden to establish [that] Tennessee‘s protocol using compounded pentobarbital imposed
    a substantial risk of serious harm and qualifies as cruel and unusual.‖ The Plaintiffs‘
    11
    Glossip was filed on June 29, 2015. The trial court in this case began hearing proof on the
    merits on July 7, 2015.
    12
    While the Baze opinion relied upon by the Glossip Court was a plurality opinion, the Glossip
    decision was a majority opinion. See 
    Glossip, 135 S. Ct. at 2730
    .
    -17-
    proof on this point consisted of experts opining on the pain that an inmate would feel if
    the LIC infiltrated into the tissue surrounding the inmate‘s vein. Such an event could
    occur if the LIC had precipitated or if the IV line were not successfully placed or
    maintained or if the LIC were injected too quickly. We hold that these mere possibilities
    are not sufficient to satisfy the Plaintiffs‘ burden to establish a substantial risk of severe
    pain. See 
    Baze, 553 U.S. at 62
    (holding that ―[t]he risks of maladministration [that the
    petitioners] have suggested—such as improper mixing of chemicals and improper setting
    of IVs by trained and experienced personnel—cannot remotely be characterized as
    objectively intolerable‖) (internal quotation marks omitted); see also, e.g., Wood v.
    Collier, 
    836 F.3d 534
    , 540 n.26 (5th Cir. 2016) (rejecting Eighth Amendment challenge
    to compounded pentobarbital and noting that ―[t]he prisoners aver that, because the drug
    is produced by compounding pharmacies, it could be contaminated or perhaps be some
    drug other than pentobarbital. This argument does not close the distance between a mere
    possibility and a sure or very likely risk that contamination will occur and will bring
    extreme pain‖); Zink v. Lombardi, 
    783 F.3d 1089
    , 1101 (8th Cir. 2015) (rejecting Eighth
    Amendment challenge to execution protocol using compounded pentobarbital because
    ―[t]he prisoners rely on allegations of generalized harms resulting from the use of a
    compounding pharmacy to produce the pentobarbital and have failed to provide anything
    more than speculation that the current protocol carries a substantial risk of severe pain‖);
    Terrell v. Bryson, 
    807 F.3d 1276
    , 1279 (11th Cir. 2015) (Marcus, J., concurring)
    (expert‘s opinion that there was a ―real possibility‖ that compounded pentobarbital could
    have an undetected dangerous pH level or be invisibly polluted with contaminants and
    ―could result in excruciating pain and suffering upon injection‖ does not meet the burden
    of proof imposed by Glossip/Baze) (internal quotation marks omitted), petition for cert.
    docketed, (U.S. Dec. 8, 2015); Wellons v. Comm‘r, Ga. Dep‘t of Corr., 
    754 F.3d 1260
    ,
    1265 (11th Cir. 2014) (rejecting Eighth Amendment challenge to compounded
    pentobarbital because ―speculation that a drug that has not been approved [by the Food
    and Drug Administration] will lead to severe pain or suffering ‗cannot substitute for
    evidence that the use of the drug is sure or very likely to cause serious illness and
    needless suffering‘‖ (quoting Mann v. Palmer, 
    713 F.3d 1306
    , 1315 (11th Cir. 2013)));
    Whitaker v. Livingston, 
    732 F.3d 465
    , 468 (5th Cir. 2013) (rejecting Eighth Amendment
    challenge to compounded pentobarbital when inmates ―pointed to only hypothetical
    possibilities‖ that the state‘s choice of pharmacy, its lab results, and its training of its
    executioners were defective and were unable to ―point to some hypothetical situation,
    based on science and fact, showing a likelihood of severe pain‖), cert. denied, __ U.S. __,
    
    134 S. Ct. 417
    (2013); Whitaker v. Livingston, No. CV H-13-2901, 
    2016 WL 3199532
    ,
    at *8 (S.D. Tex. June 6, 2016) (rejecting inmates‘ Eighth Amendment challenge to
    execution by compounded pentobarbital and holding that ―[n]o allegation that rises above
    the speculative exists that maladministration—however generated—causes unintended
    suffering from Texas‘s use of compounded pentobarbital‖); Owens v. Hill, 758 S.E.2d
    -18-
    794, 802–03 (Ga. 2014) (rejecting inmate‘s attack on compounded pentobarbital because
    inmate‘s proof ―that there is some risk that a lack of sterility could lead to symptoms that
    are irrelevant to a person being executed [and] that there is an undetermined risk that a
    compounding pharmacy acting in its routine role of producing a well-known medication
    according to the directions in a prescription will fail to produce an effective drug free of
    visible precipitates‖ ―fall[s] far short of satisfying the legal standard applied under the
    Eighth Amendment, which involves a showing of a ‗substantial risk of serious harm‘ that
    is ‗sure or very likely to cause serious illness and needless suffering‘‖ (quoting 
    Baze, 553 U.S. at 49
    –50)).
    The Plaintiffs also have failed to carry their burden of proving their claim that the
    Protocol‘s lack of specificity exposes them to a substantial risk of severe pain. As our
    Court of Appeals has recognized, ―[a] lethal injection protocol is not constitutionally
    infirm simply because it does not specify every step of the procedure in explicit detail.‖
    Abdur‘Rahman v. Bredesen, No. M2003-01767-COA-R3-CV, 
    2004 WL 2246227
    , at *17
    (Tenn. Ct. App. Oct. 6, 2004) (citing LaGrand v. Lewis, 
    883 F. Supp. 469
    , 470 (D. Ariz.
    1995), aff‘d sub nom. LaGrand v. Stewart, 
    133 F.3d 1253
    (9th Cir. 1998); Sims v. State,
    
    754 So. 2d 657
    , 668 (Fla. 2000)), aff‘d, 
    181 S.W.3d 292
    (Tenn. 2005).
    Second, the Plaintiffs failed to demonstrate ―a known and available alternative
    method of execution that entails a lesser risk of pain.‖ 
    Glossip, 135 S. Ct. at 2731
    .
    Indeed, the Plaintiffs affirmatively abandoned any effort to satisfy this Eighth
    Amendment prerequisite. Apparently, the Plaintiffs concluded that they did not need to
    meet the second Glossip/Baze requirement based upon some language used by this Court
    in an order filed in a different case involving Plaintiff West, State v. Stephen Michael
    West, No. M1987-000130-SC-DPE-DD (Tenn. Nov. 29, 2010), which this Court referred
    to in passing in West v. Schofield, 
    460 S.W.3d 113
    , 117 n.2 (Tenn. 2015). In that 2010
    order, this Court stated the following:
    In any proceedings on remand, the standards enunciated in the
    plurality opinion in Baze v. Rees, 
    553 U.S. 35
    , 51 (2008) apply. The
    burden is on Mr. West to prove that the revised protocol creates an
    ―objectively intolerable risk of harm that qualifies as cruel and unusual.‖
    Baze v. 
    Rees, 553 U.S. at 52
    . In order to carry this heavy burden, he must
    demonstrate that the revised protocol imposes a substantial risk of serious
    harm, and he must either propose an alternative method of execution that is
    feasible, readily implemented, and which significantly reduces the
    substantial risk of severe pain, Baze v. 
    Rees, 553 U.S. at 52
    –53, or
    demonstrate that no lethal injection protocol can significantly reduce the
    substantial risk of severe pain.
    -19-
    State v. Stephen Michael West, No. M1987-000130-SC-DPE-DD, at 3 (Tenn. Nov. 29,
    2010) (―the West Order‖) (final two emphases added). This Court cited to no authority in
    the West Order for the proposition that a condemned inmate may raise a successful
    Eighth Amendment challenge by proving that ―no lethal injection protocol can
    significantly reduce the substantial risk of severe pain,‖ and Glossip does not construe
    Baze in this manner.
    This Court may not construe the Eighth Amendment of the United States
    Constitution in a manner that is contrary to the United States Supreme Court‘s
    interpretation. See, e.g., James v. City of Boise, Idaho, __ U.S. __, 
    136 S. Ct. 685
    , 686
    (2016) (―The Idaho Supreme Court, like any other state or federal court, is bound by this
    Court‘s interpretation of federal law.‖); Marmet Health Care Ctr., Inc. v. Brown, 
    565 U.S. 530
    , 531 (2012) (―When this Court has fulfilled its duty to interpret federal law, a
    state court may not contradict or fail to implement the rule so established.‖). Glossip,
    which was filed after the 2010 West order but before the trial in this matter began, made
    clear the burden of proof that a condemned inmate must satisfy in Eighth Amendment
    challenges to a lethal injection protocol. The Plaintiffs did not satisfy that burden of
    proof.13
    Because the Plaintiffs have failed to satisfy either prerequisite imposed by the
    Supreme Court for a successful Eighth Amendment challenge to an execution protocol on
    the basis that the Protocol creates an unacceptable risk of severe pain, we hold that the
    Plaintiffs are not entitled to relief under the Eighth Amendment on this basis.
    Risk of Lingering Death
    The Plaintiffs assert that the Protocol also violates the Eighth Amendment because
    it exposes them to an unacceptable risk of a lingering death. The Plaintiffs contend that
    this is a free-standing basis for an Eighth Amendment challenge, citing In re Kemmler,
    
    136 U.S. 436
    , 447 (1890); Estelle v. Gamble, 
    429 U.S. 97
    , 102 (1976); 
    Baze, 553 U.S. at 49
    ; and Brown v. Plata, 
    563 U.S. 493
    , 510–11 (2011).
    In Kemmler, the Supreme Court stated that ―[p]unishments are cruel when they
    involve torture or a lingering death; but the punishment of death is not cruel within the
    meaning of that word as used in the [Eighth 
    Amendment].‖ 136 U.S. at 447
    (emphasis
    added). The high court reiterated this statement in Baze. See 
    Baze, 553 U.S. at 49
    . In
    13
    Moreover, we agree with the trial court that the Plaintiffs also failed to prove that no lethal
    injection protocol could significantly reduce the substantial risk of severe pain, even if that proof were
    relevant to their Eighth Amendment challenge.
    -20-
    Gamble, the Supreme Court recognized that a prison‘s failure to meet an inmate‘s
    medical needs might produce a ―lingering death‖ in violation of the Eighth Amendment.
    
    Gamble, 429 U.S. at 103
    . Similarly, in Plata, the Supreme Court recognized that a
    prison‘s failure to provide ―sustenance‖ to an inmate could result in a ―lingering death‖ in
    violation of the Eighth Amendment.14 
    Plata, 563 U.S. at 510
    .
    The Plaintiffs contend in their brief to this Court that ―[i]nmates executed under
    [the Protocol] will remain alive from 34 minutes up to over 1 hour after their
    executioners have finished injecting all required lethal injection drugs.‖ The Plaintiffs
    base this statement on proof in the record that some of the inmates previously executed in
    other states with pentobarbital may have continued to experience some electrical activity
    in their hearts, even after having been declared dead by a physician. However, the
    Plaintiffs cite to no authority supporting the proposition that an execution requiring up to
    an hour for death to result is a ―lingering death‖ prohibited by the Eighth Amendment,
    particularly when the inmate is unconscious for all but the first few seconds of the
    process.15 Moreover, the Supreme Court‘s examples of state conduct that might produce
    a ―lingering death‖ in violation of the Eighth Amendment—failure to provide medical
    care and failure to provide food—imply strongly that a ―lingering death‖ is one that takes
    much longer than an hour and one during which the inmate is consciously suffering.
    The Plaintiffs acknowledge in their brief to this Court that their claim that the
    Protocol violates the Eighth Amendment by causing a ―lingering death‖ ―has never
    before been addressed by any court.‖ But see Walker v. Johnson, 
    448 F. Supp. 2d 719
    ,
    724 (E.D. Va. 2006) (holding that Virginia‘s then three-drug protocol included sufficient
    safeguards, including the placing of two working IV lines, the high dosage of the lethal
    drugs, the manner in which the drugs were prepared and handled, the qualifications of the
    execution team members, and the repetitive training required of them, to avoid a
    lingering death). Respectfully, we decline to hold that a lethal injection protocol that
    causes unconsciousness within seconds violates the Eighth Amendment because it may
    take an hour or more for the inmate‘s heart to cease all electrical activity or because there
    may be some possibility that the inmate could be resuscitated after being declared dead.
    The intended result of an execution is to render the inmate dead. Therefore, as a result,
    14
    Although we question whether the United States Supreme Court would consider a lingering-
    death claim without requiring the Plaintiffs to demonstrate a known and available alternative method of
    execution as set forth under Baze and Glossip, we will address the merits of the lingering death argument
    without deciding this issue.
    15
    Indeed, one of the Plaintiffs‘ attorneys told the trial court that their lingering death claim is one
    of first impression: ―A claim of lingering death has never been brought in any court at any time.‖ The
    Plaintiffs‘ attorney explained to the trial court that ―[t]he central part of the lingering death claim is [that
    the executed inmate pronounced dead] can be revived; therefore, he is not dead.‖
    -21-
    the State is under no obligation to attempt revival efforts. We hold that the Plaintiffs are
    not entitled to relief on this basis.
    Claims under the Tennessee Constitution
    Similarly to the federal constitution, the Tennessee Constitution provides that
    ―excessive bail shall not be required, nor excessive fines imposed, nor cruel and unusual
    punishments inflicted.‖ Tenn. Const. art. I § 16. The Plaintiffs request that this Court
    hold that the Protocol violates this state constitutional provision.
    Preliminarily, we hold that this Court should apply a similar two-prong test as that
    adopted by the United States Supreme Court in Baze and Glossip to determine if there
    has been a violation of this provision of the Tennessee Constitution.16 Accordingly, to
    prevail on this claim, the Plaintiffs must (1) establish that the Protocol ―presents a risk
    that is ‗sure or very likely to cause serious illness and needless suffering, and give rise to
    sufficiently imminent dangers,‘‖ 
    Glossip, 135 S. Ct. at 2737
    (quoting 
    Baze, 553 U.S. at 50
    ) (internal quotation marks omitted), and (2) ―identify an alternative [method of
    execution] that is ‗feasible, readily implemented, and in fact significantly reduce[s] a
    substantial risk of severe pain,‘‖ id. (quoting 
    Baze, 553 U.S. at 52
    ).
    With regard to the first prong of this test, the Plaintiffs complain that the identity
    of the pharmacist who will compound the LIC has been withheld from them. They argue
    that they were ―thus prohibited from learning or presenting evidence on the issue of
    whether the contract with the pharmacist . . . provides adequate protections against the
    substantial risks of serious harm presented by using a high-risk sterile compound for
    purposes of executions by lethal injection‖ and that ―[i]t is cruel and unusual punishment
    under the Tennessee Constitution to put prisoners to death while asking all persons to pay
    no attention to that man behind the curtain.‖ The Plaintiffs cite no authority for their
    proposition that the pharmacist‘s unknown identity creates a substantial risk of severe
    pain, and we have found none. Therefore, the Plaintiffs have failed to satisfy this first
    prong. Likewise, for the same reasons set forth above with regard to the federal
    constitutional claim, we conclude that the Plaintiffs have failed to identify a known and
    available alternative method of execution. As a result, we hold that the Plaintiffs are not
    entitled to relief on this basis under the Tennessee Constitution.
    The Plaintiffs also ask this Court to declare that the death penalty violates the
    Tennessee Constitution in light of ―evolved standards of decency.‖ We respectfully
    16
    We conclude that there is no difference in language between the United States Constitution
    and the Tennessee Constitution which would warrant application of a different standard under the
    Tennessee Constitution.
    -22-
    decline that request. The validity of the death penalty as a punishment is not at issue in
    this declaratory judgment action challenging the method of execution. The Plaintiffs are
    not entitled to relief on this basis.17
    We have held that the Protocol, on its face, does not violate the Eighth
    Amendment. We now also hold that the Protocol, on its face, does not violate Article I,
    section 16, of the Tennessee Constitution.
    Dismissal of Count V
    The Plaintiffs devote a significant portion of their briefed argument to this Court
    challenging the trial court‘s dismissal of the claims they included in Count V of their
    complaint. These claims revolve around the Plaintiffs‘ theory that an execution pursuant
    to the Protocol violates federal laws regulating the provision and use of certain
    prescription drugs, specifically the federal Controlled Substances Act, 21 U.S.C. §§ 801–
    904 (2012) (―the CSA‖). Pentobarbital falls within the ambit of the CSA. See 21 C.F.R.
    § 1308.12(e)(3) (2016) (listing Schedule II controlled substances). The CSA limits
    physicians to prescribing sodium pentobarbital for legitimate medical purposes. See 21
    C.F.R. § 1306.04(a) (2005).
    The trial court concluded that the Plaintiffs have no cause of action under the CSA
    and granted the Defendants‘ motion for judgment on the pleadings. We review the trial
    court‘s ruling de novo with no deference afforded to the trial court. Mortg. Elec.
    Registration Sys., Inc. v. Ditto, 
    488 S.W.3d 265
    , 275 (Tenn. 2015). We construe the
    dismissed claims in the Plaintiffs‘ favor, taking their factual allegations as true and giving
    them the benefit of the inferences that can reasonably be drawn from the pleaded facts.
    
    Id. (quoting Harman
    v. Univ. of Tenn., 
    353 S.W.3d 734
    , 736 (Tenn. 2011)).
    The Plaintiffs acknowledge in their brief that ―in actions brought by death
    sentenced inmates challenging lethal injection protocols, claims invoking the Controlled
    Substances Act have not been well received,‖ citing Zink v. Lombardi, 
    783 F.3d 1089
    ,
    1113–14 (8th Cir. 2015) (per curiam) (rejecting condemned inmates‘ alleged right not to
    be executed by compounded pentobarbital in violation of CSA because the CSA does not
    create a private right of action); Durr v. Strickland, No. 2:10-cv-288, 
    2010 WL 1610592
    ,
    at *2–3 (S.D. Ohio Apr. 15, 2010) (dismissing complaint that use of sodium thiopental
    violates the CSA because no private right of action exists under that Act), aff‘d, 
    602 F.3d 17
                This Court repeatedly has upheld the death penalty as permissible under the Tennessee
    Constitution. See, e.g., State v. Henretta, 
    325 S.W.3d 112
    , 143 (Tenn. 2010); State v. Thacker, 
    164 S.W.3d 208
    , app. at 254–56 (Tenn. 2005); State v. Black, 
    815 S.W.2d 166
    , 187–91 (Tenn. 1991); and
    cases cited therein.
    -23-
    788, 789 (6th Cir. 2010); Irick v. Ray, No. 3:10-1004, 
    2010 WL 4810653
    , at *4 (M.D.
    Tenn. Nov. 19, 2010) (concluding that ―no private right of action exists under . . . the
    CSA . . . , and therefore, any injury allegedly suffered by the [condemned inmate] cannot
    be redressed through a declaratory judgment action‖), aff‘d, 
    628 F.3d 787
    (6th Cir.
    2010); West v. Ray, No. CIV 3:10-0778, 
    2010 WL 3825672
    , at *4 (M.D. Tenn. Sept. 24,
    2010) (dismissing request for declaratory judgment that lethal injection protocol violates
    the CSA because the CSA does not provide for a private right of action), aff‘d, 401 F.
    App‘x 72 (6th Cir. 2010); and Ringo v. Lombardi, No. 09-4095-CV-C-NKL, 
    2010 WL 3310240
    , at *2–3 (W.D. Mo. Aug. 19, 2010) (same); see also Jones v. Hobbs, 745 F.
    Supp. 2d 886, 892–94 (E.D. Ark. 2010) (declining to vacate judgment dismissing
    complaints that Arkansas lethal injection protocol violated CSA because CSA did not
    create a private cause of action), aff‘d sub nom. Williams v. Hobbs, 
    658 F.3d 842
    (8th
    Cir. 2011). Indeed, the Plaintiffs have not provided us with a single case in which a
    condemned inmate has successfully challenged a lethal injection protocol on this basis,
    and we have found none.
    The Plaintiffs contend, nonetheless, that they are asserting a viable Eighth
    Amendment claim on this basis under Brewer v. Landrigan, 
    562 U.S. 996
    (2010). In
    Landrigan, the condemned inmate was facing execution pursuant to Arizona‘s three-drug
    protocol. Landrigan v. Brewer, No. CV-10-02246-PHX-ROS, 
    2010 WL 4269559
    , at *1–
    2 (D. Ariz. Oct. 25, 2010), aff‘d, 
    625 F.3d 1144
    (9th Cir. 2010), and vacated, 
    562 U.S. 996
    (Oct. 26, 2010). The inmate sought a stay of his execution on the grounds that the
    sodium thiopental, the first drug to be administered pursuant to the protocol, had been
    ―manufactured by a foreign source not approved by the FDA,‖ thereby ―creat[ing] a
    substantial and unnecessary risk of serious harm in violation of his rights under the
    Eighth Amendment.‖ 
    Id. at *4.
    The inmate produced an affidavit from a physician
    indicating that drugs produced by foreign manufacturers ―are more likely to contain
    harmful contaminants.‖ 
    Id. at *10.
    In spite of the trial court‘s order requiring Arizona to
    provide information regarding the drug, Arizona ―repeatedly refused to provide any of
    the underlying factual information necessary for resolution of [the inmate‘s] claims,‖
    even declining to submit ―an affidavit stating that the drug was obtained through
    reputable sources and there was no reason to question that it would function as intended.‖
    
    Id. at *9.
    The trial court concluded that,
    [w]ithout the assurance of FDA-approval, the Court is left to speculate
    whether the non-FDA approved drug will perform in the exact same
    manner as an FDA-approved drug and whether the non-FDA approved drug
    will cause pain and suffering. This is not a factual issue the Court can
    resolve by adopting [Arizona‘s] assurances that sodium thiopental ‗is
    -24-
    simply a chemical compound‘ and the source of that compound is
    irrelevant.
    
    Id. at *10.
    The trial court granted the inmate a temporary restraining order staying his
    execution ―to allow the Court to fully consider his challenge to Arizona‘s use of sodium
    thiopental obtained from an unidentified, non-FDA approved source.‖ 
    Id. at *12.
    Arizona subsequently sought to have vacated the district court‘s order. We recite
    here the full substantive text of the United States Supreme Court‘s memorandum decision
    granting the application to vacate and relied upon by the Plaintiffs in support of their
    Count V claims:
    The application to vacate the order by the district court granting a
    temporary restraining order, presented to Justice KENNEDY and by him
    referred to the Court, is granted. There is no evidence in the record to
    suggest that the drug obtained from a foreign source is unsafe. The district
    court granted the restraining order because it was left to speculate as to the
    risk of harm. See Order Granting Motion for a Temporary Restraining
    Order in Landrigan v. Brewer, 
    2010 WL 4269559
    , No. CV-10-02246-PHX-
    ROS (D. Ariz.), Doc. 21, p. 15 (―[T]he Court is left to speculate . . .
    whether the non-FDA approved drug will cause pain and suffering.‖). But
    speculation cannot substitute for evidence that the use of the drug is ―‗sure
    or very likely to cause serious illness and needless suffering.‘‖ Baze v.
    Rees, 
    553 U.S. 35
    , 50, 
    128 S. Ct. 1520
    , 
    170 L. Ed. 2d 420
    (2008) (quoting
    Helling v. McKinney, 
    509 U.S. 25
    , 33, 
    113 S. Ct. 2475
    , 
    125 L. Ed. 2d 22
          (1993)). There was no showing that the drug was unlawfully obtained, nor
    was there an offer of proof to that effect. The motion to file documents
    under seal is denied as moot.
    
    Landrigan, 562 U.S. at 996
    (second emphasis added). The Plaintiffs claim that this
    opinion stands for the proposition that an Eighth Amendment claim is made out if there is
    a showing or an offer of proof that an execution drug is ―unlawfully obtained.‖ They
    further claim that compounded pentobarbital to be used in an execution is necessarily
    ―unlawfully obtained‖ because the CSA mandates that pentobarbital be used only for a
    ―legitimate medical purpose.‖
    We disagree. In context, it appears to us that the Supreme Court in Landrigan
    used the term ―unlawfully obtained‖ as referring to drugs obtained from black or grey
    market sources, the quality of which would obviously be subject to question, or imported
    from a legitimate source without administrative compliance with the relevant federal
    -25-
    laws, see West v. Brewer, No. CV-11-1409-PHX-NVW, 
    2011 WL 6724628
    , at *10 (D.
    Ariz. Dec. 21, 2011) (reciting the administrative errors the Arizona Department of
    Corrections made in importing sodium thiopental from a British source, resulting in the
    Department of Justice informing the Arizona Department of Corrections that its supply of
    the drug was imported without compliance with the CSA). However, the Arizona inmate
    in the Landrigan decision had made no showing that the sodium thiopental to be used in
    his execution had been obtained from such questionable sources, or had been obtained
    without compliance with the relevant laws. Rather, he had shown merely that Arizona
    had obtained the drug from a foreign source. Accordingly, the inmate had failed to
    satisfy Baze‘s requirement that Arizona‘s use of the foreign-sourced drug was ―sure or
    very likely to cause serious illness and needless suffering.‖
    In addition to rejecting the Plaintiffs‘ construction of Landrigan, we reject their
    attempt to utilize the CSA in this context. First, as indicated above, numerous courts
    have held that the CSA does not provide a private cause of action which would permit the
    Plaintiffs to enforce its provisions for their benefit. Second, as the United States Supreme
    Court has made clear, ―the CSA ‗repealed most of the earlier antidrug laws in favor of a
    comprehensive regime to combat the international and interstate traffic in illicit drugs‘‖
    and ―sought to ‗conquer drug abuse and to control the legitimate and illegitimate traffic in
    controlled substances.‘‖ Gonzales v. Oregon, 
    546 U.S. 243
    , 269 (2006) (quoting
    Gonzales v. Raich, 
    545 U.S. 1
    , 12 (2005)). State-sanctioned executions do not fall within
    the ambit of the legislative purpose embodied in the CSA. Indeed, the federal
    government allows the use of lethal injections for the execution of federal condemned
    inmates. See 18 U.S.C. § 3596(a) (providing that a death sentence imposed by a federal
    court is to be carried out ―in the manner prescribed by the law of the State in which the
    [death] sentence is imposed‖). Clearly, the federal government does not consider those
    of its own executions that are conducted by lethal injection to violate a regulatory scheme
    for the prescription and use of controlled substances. We are not persuaded that we
    should construe the CSA in a manner contrary to that of the federal government‘s
    interpretation.18
    The Plaintiffs also alleged in Count V a cause of action under the Supremacy
    Clause of the federal Constitution. The trial court dismissed this claim as follows:
    18
    In Gonzales v. Oregon, the Supreme Court concluded that ―the CSA‘s prescription requirement
    does not authorize the Attorney General to bar dispensing controlled substances for assisted suicide in the
    face of a state medical regime permitting such 
    conduct.‖ 546 U.S. at 274
    –75. Analogously, Tennessee‘s
    statute permitting the TDOC to formulate the appropriate method for conducting an execution, including
    by lethal injection, does not authorize the United States Attorney General to bar the dispensing of
    compounded pentobarbital to the TDOC for execution purposes or to seek penalties against the doctors or
    pharmacists who assist the TDOC.
    -26-
    The Supremacy Clause is not a source of any federal rights. It is a conflict
    of law provision that declares truth which flows immediately and
    necessarily from the institutions of a federal government. For this Court to
    find that there is a private right of action under the Supremacy Clause
    would substantively change the federal rule established by Congress in the
    [CSA], and as such, is disapproved.
    We agree. See Armstrong v. Exceptional Child Ctr., Inc., 
    135 S. Ct. 1378
    , 1383 (2015)
    (stating that the Supremacy Clause ―instructs courts what to do when state and federal
    law clash‖); Chapman v. Houston Welfare Rights Org., 
    441 U.S. 600
    , 613 (1979)
    (recognizing that the Supremacy Clause ―is not a source of any federal rights‖); see also
    Michigan Corr. Org. v. Michigan Dep‘t of Corr., 
    774 F.3d 895
    , 906–07 (6th Cir. 2014).
    The Plaintiffs failed to establish any authority for a cause of action under either the CSA
    or the Supremacy Clause. Therefore, even reading these claims liberally in favor of the
    Plaintiffs, the trial court properly dismissed this claim.
    Finally, Count V contained a claim that the Defendants engaged in a common-law
    civil conspiracy to violate the Plaintiffs‘ rights ―by entering into an agreement to take
    their lives by unlawful means including, but not limited to, the commission of federal
    felonies in order to obtain and use controlled substances to kill them.‖ These ―federal
    felonies‖ allegedly arise from the Defendants‘ alleged violation of the CSA by obtaining
    the LIC. Because the Plaintiffs have no viable claim that the Defendants will commit any
    violation of the CSA, the trial court properly dismissed this claim.
    In sum, we hold that the trial court did not err in dismissing the Plaintiffs‘ Count V
    claims and that the Plaintiffs are not entitled to relief on this basis.
    Conclusion
    We affirm the trial court‘s judgment.
    _________________________________
    JEFFREY S. BIVINS, CHIEF JUSTICE
    -27-