T. Williams v. PA DOC ( 2015 )


Menu:
  •                IN THE COMMONWEALTH COURT OF PENNSYLVANIA
    Terrance Williams; Richard                       :
    Laird; Robert Wharton; Hubert                    :
    Michael, Michael E. Ballard,                     :
    individually and on behalf of                    :
    all others similarly situated,                   :
    Petitioners                 :
    :
    v.                                :
    :
    Commonwealth of Pennsylvania                     :
    Department of Corrections,                       :   No. 353 M.D. 2014
    Respondent                      :   Argued: March 11, 2015
    BEFORE:        HONORABLE DAN PELLEGRINI, President Judge
    HONORABLE BERNARD L. McGINLEY, Judge
    HONORABLE RENÉE COHN JUBELIRER, Judge
    HONORABLE MARY HANNAH LEAVITT, Judge
    HONORABLE P. KEVIN BROBSON, Judgeh
    HONORABLE PATRICIA A. McCULLOUGH, Judge
    HONORABLE ANNE E. COVEY, Judge
    OPINION NOT REPORTED
    MEMORANDUM OPINION
    BY JUDGE McGINLEY                                    FILED: October 15, 2015
    Presently before this Court are the Department of Corrections’ (DOC)
    Preliminary Objections (POs) to a Second Amended Class Action Petition for
    Review in the Nature of a Complaint in Equity (Petition).1 Petitioners bring this
    1
    Five inmates sentenced to death in Pennsylvania (Petitioners) initially filed a petition on
    July 3, 2014, and named Terrence Williams, Richard Laird and Robert Wharton as bringing
    claims on behalf of themselves and as class representatives. The DOC filed POs on August 11,
    2014, and Petitioners filed an amended petition on the same day adding Hubert Michael as a
    fourth Petitioner.
    The DOC preliminarily objected to the amended petition.
    On September 29, 2014, Petitioners filed POs to the DOC’s POs and alleged that the
    DOC’s POs lacked specificity and that the DOC’s challenge to Petitioners’ class-action status
    (Footnote continued on next page…)
    action on behalf of themselves and a class of all 184 inmates sentenced to death in
    the Commonwealth.
    I. Brief History.
    In 1990, the General Assembly adopted the following method of
    execution: “[t]he death penalty shall be inflicted by injecting the convict with a
    continuous intravenous administration of a lethal quantity of an ultrashort-acting
    barbiturate in combination with chemical paralytic agents approved by the
    department until death is pronounced by the coroner.” 61 Pa. C.S. § 4304(a)(1);
    Amended Petition ¶ 23 at 8.
    The DOC first promulgated the lethal injection execution protocol
    (Protocol) to implement the statute in April of 1991 and revised the procedures on
    multiple occasions, most recently in 2012.2
    (continued…)
    was improperly raised because it was not raised in new matter rather than by preliminary
    objection.
    On October 21, 2014, this Court sustained Petitioners’ POs with regard to the specificity
    of the DOC’s demurrers and to the class action and denied the POs in all other regards.
    The DOC filed the present amended POs on November 7, 2014. Petitioners filed a
    second amended petition for review on November 12, 2014, and added Michael E. Ballard as a
    fifth Petitioner, but alleged identical claims as in the original petition. The DOC consented to
    this amendment and this Court issued an Order on November 14, 2014, granting the addition.
    2
    The Capital Case Procedures Manual directs:
    B. Pre-Execution Procedures
    ….
    2. Lethal Injection Team (LIT)
    a. The Department [DOC] will obtain the services
    of a sufficient number of individuals qualified to
    administer the lethal injection to ensure that a two-
    (Footnote continued on next page…)
    2
    (continued…)
    member team, at a minimum, will be available for
    each scheduled execution….
    ….
    d. All LIT members must be trained health care
    professionals who have completed intravenous
    therapy training and are experienced in performing
    venipuncture….
    ….
    3. Commencement of the Lethal Injection
    ….
    c. When the signal is given to start the execution,
    the LIT will follow this sequence:
    (1) If pentobarbital is being used:
    (a)    one     syringe      containing   2,500    mg
    pentobarbital…will be inserted in the…tube of the
    left arm IV administration set and the injection shall
    commence. The emptied syringe will be removed
    from the injection tube; and
    (b) a second syringe containing 2,500 mg
    pentobarbital…will be inserted into the…tube of the
    right arm IV administration set and the contents
    injected. The emptied syringe will then be removed
    from the injection tube.
    (c) 50ml Normal Saline…will be inserted into the…
    the left arm IV administration set and the contents
    injected to flush the line.
    (2) If thiopental is being used:
    (a) A syringe containing 1.5 gm thiopental…will be
    inserted…in the left arm IV administration set and
    the injection shall commence. The emptied syringe
    will be removed from the injection tube.
    (b) A second syringe containing 1.5 gm
    thiopental…will be inserted into the…left arm IV
    administration set and the contents injected. The
    emptied syringe will then be removed from the
    injection tube.
    (c) 50 ml Normal Saline…will be inserted into
    the…left arm IV administration set and the contents
    injected to flush the line.
    (Footnote continued on next page…)
    3
    II. Petitioners’ Amended Petition.
    Petitioners seek declaratory and injunctive relief. Petitioners request
    this Court to declare the DOC’s Protocol invalid and unlawful.
    5. Pennsylvania prescribes that the death penalty shall be
    inflicted by injecting the condemned inmate with a lethal
    combination of two types of drugs- ‘an ultrashort-acting
    barbiturate’ and ‘chemical paralytic agents.’ 61 Pa.C.S.A.
    [sic] § 4304(a)(1).
    (continued…)
    ….
    (3) Following administration of the second syringe of
    pentobarbital or the second syringe of thiopental and the
    Normal Saline:
    ….
    (4) One dose of 50 mg of pancuronium bromide, will be
    administered through…the left arm IV administration set.
    (5) Upon completion of the first dose of 50mg
    pancuronium bromide, a second dose of 50 mg
    pancuronium bromide will be administered through…the
    left arm IV administration set.
    (6) The…left arm IV administration set will then be flushed
    with 50 ML Normal saline.
    (7) A syringe containing 50 meq [milliequivalent]
    potassium chloride…will be inserted into…the left arm IV
    administration set and the entire contents shall be injected.
    (8) When the contents of the first potassium chloride
    syringe have been injected, the emptied syringe will be
    removed and a second syringe containing 50 meq
    potassium chloride…will be inserted in to…the left arm IV
    extension set and injected. The emptied syringe will then
    be removed.
    ….
    Commonwealth of Pennsylvania, Department of Corrections’ Procedures Manual, August 27,
    2012, at 3-27.
    4
    6. The General Assembly adopted this method of
    execution in 1990, after extensive fact-finding,
    testimony, and public debate.
    7. In April 1991, the DOC promulgated Pennsylvania’s
    first lethal injection procedures to implement [61
    Pa.C.S.] § 4304. The DOC has revised and adopted new
    procedures on multiple occasions, and in 2012, the DOC
    adopted the current execution protocol….
    8. Contrary to the statute, the protocol dictates that lethal
    injections will be administered with three different types
    of drugs. The first drug, pentobarbital, and the third drug
    potassium chloride, do not fall under either drug type
    authorized by the legislature. Further, the protocol fails
    to use ‘an ultrashort-acting barbiturate,’ as required by
    statute.
    9. The current protocol exceeds the statutory grant,
    conflicts with the express terms of the statute, and is
    inconsistent with the purpose of the statute, which was to
    adopt the most ‘humane’ method of execution. The
    DOC’s selection of lethal injection drugs outside the
    statutory grant undermines the Legislature’s decision to
    reserve for itself the selection of the types of drugs that
    will be used in executions.
    10. The DOC adopted the execution protocol in secret,
    without public notice, hearing, or comment. The DOC is
    required to follow a formal rule-making process when, as
    here, it promulgates new regulations or amends existing
    ones.      See 45 P.S. §§ 1102, 1201-1208 (the
    Commonwealth Documents Law or ‘CDL’)[3]; 71 P.S. §§
    745.1-745.15 (the Regulatory Review Act or ‘RRA’)[4];
    71 P.S. §§ 732-101- 732-506 (the Commonwealth
    Attorneys Act or ‘CAA’)[5]. Because the DOC failed to
    3
    Act of July 31, 1968, P.L. 769, as amended, 45 P.S. §§ 1102-1602, and 45 Pa.C.S. §§
    501-907, which, collectively, are known as the “Commonwealth Documents Law.” This was the
    official short title of the 1968 enactment. See Section 101 of the Act of July 31, 1968, P.L. 769.
    4
    Act of June 25, 1982, P.L. 633, as amended, 71 P.S. §§ 745.1-745.15.
    5
    Act of October 15, 1980, P.L. 950, as amended, 71 P.S. §§ 732-101- 732-506.
    5
    follow these mandatory processes, the execution protocol
    is a nullity.
    11. In addition, the protocol is unreasonable because it
    conflicts with other provisions of state and federal law,
    including restrictions that prohibit pharmacies from
    providing controlled substances without valid medical
    prescriptions, restrictions that prohibit pharmacies from
    selling certain compounded drugs, and restrictions that
    prohibit registered nurses and paramedics from
    administering the lethal drugs or otherwise participating
    in executions.
    ….
    27. Pentobarbital is neither an ultrashort-acting
    barbiturate nor a chemical paralytic agent. Pancuronium
    bromide is a chemical paralytic agent. Potassium
    chloride is neither an ultrashort-acting barbiturate nor a
    chemical paralytic agent. (Emphasis added.)
    28. The sections of the execution protocol relevant to this
    lawsuit consist of rules and regulations. The protocol
    was promulgated under the authority of a statute that
    DOC administers and which prescribes practices and
    procedures for the DOC.
    29. The DOC is required to follow a formal rule-making
    process when it promulgates new rules and regulations or
    amends existing ones.
    30. The DOC adopted and amended the execution
    protocol without public notice, hearing, or comment. In
    adopting and amending the protocol, the DOC did not
    follow the requirements of the CDL, 45 P.S. §§ 1102,
    1201-1208, the RRA, 71 P.S. §§ 745.1-745.15, or the
    CAA, 71 P.S. §§ 732-101- 732-506.
    31. Under the protocol, DOC obtains lethal injection
    drugs, including compounded drugs, from one or more
    pharmacies. The protocol is unreasonable because, under
    the federal Food, Drug, and Cosmetic Act (FDCA), DOC
    is prohibited from obtaining, and pharmacies are
    prohibited from providing, a compounded copy of an
    FDA-approved drug, like pentobarbital, through
    6
    interstate commerce. See 21 U.S.C. §§ 502-505, 582; see
    also 21 U.S.C. §§ 331, 355.
    32. Under the protocol, DOC obtains lethal injection
    drugs without a valid medical prescription. The protocol
    is unreasonable because, under the federal Controlled
    Substances Act (CSA)[6] and the Pennsylvania Pharmacy
    Act[7], DOC is prohibited from obtaining, and pharmacies
    are prohibited from providing, lethal injection drugs
    without a valid medical prescription. See 21 U.S.C. [§§
    801-971]; 63 P.S. [§§ 390-1- 390-13].
    33. The DOC utilizes a ‘Lethal Injection Team’ (LIT) to
    administer an execution. The LIT’s responsibilities
    include performing venipuncture and establishing
    intravenous lines in the condemned inmates,
    administering the lethal drugs, and participating in
    consciousness checks of the inmates.
    34. …Current members of the LIT are registered nurses
    and/or certified paramedics.
    35. Registered nurses may perform venipuncture only
    when it has been ‘ordered in writing for the patient by a
    doctor of the healing arts.’ 49 Pa. Code § 21.12(a). The
    execution protocol is unreasonable because it conflicts
    with this statutory prerequisite. (Emphasis added.)
    36. Registered nurses may administer anesthesia only if
    certified as a Registered Nurse Anesthetist, and only
    under the direction of, or in consultation with, a
    physician. 49 Pa. Code. [sic] §21.17. The execution
    protocol is unreasonable because it conflicts with these
    statutory prerequisites. (Emphasis added.)
    37. Direct or indirect participation in an execution is
    contrary to the ethical standards of the nursing
    profession. Willful violation of the nursing laws or of
    ethical standards may be punished by suspension or
    6
    21 U.S.C. §§ 801-971.
    7
    Act of September 27, 1961, P.L. 1700, as amended, 63 P.S. §§ 390-1- 390-13.
    7
    revocation of the nursing license, criminal prosecution,
    and/or a civil fine. 63 P.S. [§] 223; 63 P.S. [§] 224(a).
    The execution protocol is unreasonable because it
    conflicts with these ethical and statutory provisions.
    38. Paramedics may lawfully administer only certain
    drugs, and a paramedic may lawfully administer other
    drugs only when acting under the orders of a physician.
    See 28 Pa. Code. [sic] § 1005.11. Absent a physician’s
    order, paramedics may not lawfully administer sodium
    thiopental, pancuronium bromide, or potassium
    chloride….(Emphasis added.)
    39. Direct or indirect participation in an execution is
    contrary to the ethical standards of the paramedic
    profession. Paramedics who willfully or negligently
    practice beyond the scope of their authorization face
    disciplinary or corrective action. See 28 Pa. Code §
    1003.27. The execution protocol is unreasonable because
    it conflicts with these ethical and statutory provisions.
    Exhaustion of Administrative Remedies
    40. There is no administrative remedy available to
    Petitioners. DOC refuses to provide a copy of the
    execution protocol to death row inmates and, where an
    inmate files an administrative grievance as ‘frivolous’
    and provides no administrative recourse.
    ….
    Claims for Relief
    Claim 1
    The execution protocol adopted by the Department of
    Corrections exceeds and conflicts with the statutory
    authorization set forth in [Pa.C.S. 61] § 4304.[8]
    Claim 2
    The execution protocol adopted by the Department of
    Corrections violates the requirements of the
    8
    Claim I is based on the allegations raised in Petitioners’ Amended Petition at paragraphs
    8-9 and 27-28.
    8
    Commonwealth Documents Law, 45 P.S. §§ 1102, 1201-
    1208, the Regulatory Review Act, 71 P.S. §§ 745.1-
    745.15, and the Commonwealth Attorneys Act, 71 P.S.
    §§ 732-101 to 732-506. The execution protocol is also
    unreasonable in that it conflicts with ethics provisions
    and with state and federal law, including the federal
    Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 502-505,
    582; the federal Controlled Substances Act, 21 U.S.C. §§
    802, 822, 829; the Pennsylvania Pharmacy Act, 63 P.S.
    [§§ 390-1- 390-13]; as well as 28 Pa. Code. § 1005.11,
    41 Pa. B. 2286, 49 Pa. Code § 21.12, 49 Pa. Code. §
    21.17, 63 P.S. 223, and 63 P.S. 224(a).
    Petition, August 26, 2014, ¶¶ 5-11, 27-40 at 2-3 and 9-12.
    III. The DOC’s Amended Preliminary Objections.
    The DOC preliminarily objects to the Petition and asserts:
    I. In the Nature of a Demurrer:
    1. Claim I…fails to state any claim for which relief may
    be granted.
    ….
    4. …[T]he execution protocol does not impermissibly
    conflict with the statutory provisions [of Section 4304 of
    the Prisons and Parole Code (Code), 61 Pa. C.S. §
    4304(a)(1)] and therefore Claim I should be dismissed
    because it fails to allege sufficient facts to provide any
    relief to petitioners. (Emphasis added.)
    5. Claim II…fails to state a claim for which relief may be
    granted.
    ….
    7. As a matter of law, this Court can review the
    provisions of the execution protocol adopted by the
    Department of Corrections and determine that it does not
    impermissibly conflict with the state and federal laws
    listed in the Amended Petitioner [sic] and therefore
    Claim II should be dismissed with prejudice.
    9
    II. Lack of Jurisdiction.
    8. The [A]mended [P]etition presents no claim that is ripe
    for review.
    9. Insofar as [P]etitioners’ claims seek to have the Court
    determine that the DOC’s lethal injection protocol
    conflicts with federal law, including the Food, Drug and
    Cosmetic Act (‘FDCA’), 21 U.S.C. §§ 502-505 and 582,
    and the Controlled Substances Act (‘CSA’), 21 U.S.C. §§
    802, 822 and 829, the Court lacks jurisdiction to hear and
    decide such issues.
    10. Insofar as [P]etitioners’ claims seek to have the
    Court determine that the participation of nurses and/or
    paramedics in effectuating capital punishment violates
    their respective professional ethical standards, the Court
    lacks jurisdiction to hear and decide such issues.
    11. Insofar as [P]etitioners’ claims seek to have the
    Court determine whether there has been compliance with
    the Pennsylvania Pharmacy Act (‘PPA’), 63 P.S. §390-1
    et seq., the Court lacks jurisdiction to hear and decide
    such issues.
    III. Lack of Standing/Capacity to Sue.
    12. None of the [P]etitioners have standing to challenge
    the legality of the DOC’s execution procedures.
    (Emphasis added.)
    13. Insofar as [P]etitioners seek to have the Court
    determine that the participation of nurses and/or
    paramedics in effectuating capital punishment violates
    their respective professional ethical standards, they lack
    standing to pursue such issues. (Emphasis added.)
    14. Petitioners lack standing to pursue claims under the
    PPA, the Regulatory Review Act (‘RRA’), 71 P.S. §
    745.1 et seq., the Commonwealth Documents Law
    (‘CDL’), 45 P.S. § 1101 et seq., or the Commonwealth
    Attorneys Act (‘CAA’), 71 P.S. § 732-101 et seq.
    10
    15. Petitioners lack standing to pursue claims under
    either the FDCA or the CSA.
    The DOC’s POs, ¶¶ 1, 4, 5, 7-15 at 1-3.
    IV. Discussion.
    A. Whether Claim I Of The Petition States A Claim
    For Which Relief May Be Granted?
    To begin, Petitioners allege that the procedures outlined in the
    Protocol are inconsistent with Section 4304(a)(1) of the Code, 61 Pa. C.S. §
    4304(a)(1), for the following reasons: 1) the Protocol fails to require the use of an
    ultrashort-acting barbiturate as required by the statute; 2) the use of pentobarbital
    and potassium chloride violates legislative intent because the drugs are neither
    ultrashort-acting barbiturates nor chemical paralytic agents; and 3) the law only
    allows for two drugs to be administered while the Protocol provides the use of
    three drugs.
    Section 4304(a)(1) of the Code provides that “[t]he death penalty shall
    be inflicted by injecting the convict with a continuous intravenous administration
    of a lethal quantity of an ultrashort-acting barbiturate in combination with chemical
    paralytic agents approved by the department [DOC] until death is pronounced by
    the coroner.” 61 Pa. C.S. § 4304(a)(1). This question of interpretation is one of
    first impression.
    11
    The DOC argues9 that Petitioners fail to state a claim in Claim I for
    two reasons. First, the Protocol lists two options for the first drug injected into an
    inmate: pentobarbital or sodium thiopental. Sodium thiopental is an ultrashort-
    acting barbiturate and Petitioners do not allege otherwise. Second, nothing in the
    statute limits the DOC to using only ultrashort-acting barbiturates in combination
    with chemical paralytic agents.
    The DOC explains that Petitioners’ allegations fail to state a claim
    because “nothing in the plain language of the statute prohibits the [DOC] from
    using another drug or drugs in addition to an ultrashort-acting barbiturate and
    chemical paralytic agent…” The DOC’s brief at 10. The DOC argues that nothing
    in the statute bars the DOC from using any other drug(s) as part of its execution
    procedures and therefore the Protocol does not violate state law.
    9
    When ruling on preliminary objections in the nature of a demurrer, this Court will
    assume that the Petitioners’ factual allegations are true. May v. Kosinski, 
    86 A.3d 945
    , 948 n.6
    (Pa. Cmwlth. 2014). However, “the court need not accept as true conclusions of law,
    unwarranted inferences from facts, argumentative allegations, or expressions of opinion.” Penn
    Title Insurance Company v. Deshler, 
    661 A.2d 481
    , 483 (Pa. Cmwlth. 1995). “A demurrer will
    not be sustained unless the face of the complaint shows that the law will not permit recovery, and
    any doubts should be resolved against sustaining the demurrer.” 
    Id. Therefore, this
    Court’s
    inquiry is limited to whether it is certain, based on the facts alleged, that the DOC’s Protocol is
    consistent with the statute and does not violate legislative intent.
    As with all cases involving the interpretation of a statute, this Court is guided by the
    provisions of the Statutory Construction Act of 1972. “The object of all interpretation and
    construction of statutes is to ascertain and effectuate the intention of the General Assembly.” 1
    Pa. C.S. § 1921. “Generally speaking, the best indication of legislative intent is the plain
    language of a statute.” Sternlicht v. Sternlicht, 
    876 A.2d 904
    , 909 (Pa. 2005) (citations omitted).
    “Words and phrases shall be construed according to rules of grammar and according to their
    common and approved usage.” 
    Id. (quoting 1
    Pa. C.S. § 1903).
    12
    The term “ultrashort-acting barbiturate” in the statute is singular while
    the term “chemical paralytic agents” is plural.          However, when interpreting
    specific phrases in statutes, “the singular shall include the plural, and the plural, the
    singular.” 1 Pa. C.S. § 1903. Thus, it is possible to interpret this phrase as
    requiring the use of both ultrashort-acting barbiturates and chemical paralytic
    agents in all executions, and providing the DOC with the discretion to use more
    than one type of each drug as it deems necessary.
    Under the maxim expression unius est exclusion alterius, “the express
    mention of a specific matter in a statute implies the exclusion of others not
    mentioned.” West Penn Allegheny Health Systems v. Medical Care Availability &
    Reduction of Error Fund, 
    11 A.3d 598
    , 605-06 (Pa. Cmwlth. 2010). Applying this
    maxim means the failure to mention an additional type of drug after specifying two
    specific types of drugs, may imply exclusion of an additional type of drug. As
    with all cases involving the interpretation of a statute, we are guided by the
    provisions of the Statutory Construction Act of 1972.              “The object of all
    interpretation and construction of statutes is to ascertain and effectuate the
    intention of the General Assembly.” 1 Pa. C.S. § 1921. “Generally speaking, the
    best indication of legislative intent is the plain language of a statute.” Sternlicht v.
    Sternlicht, 
    876 A.2d 904
    , 909 (Pa. 2005) (citations omitted).
    At this early stage of the litigation, taking Petitioners’ allegation that
    pentobarbital and potassium chloride are neither ultrashort-acting barbiturates nor
    chemical paralytic agents as true, Petitioners have stated a claim that the Protocol
    violates the statute. Therefore, the DOC’s first PO is overruled.
    13
    B. Whether The First Portion Of Claim II Of The Amended Petition States A
    Claim Upon Which Relief May Be Granted?
    In their second claim Petitioners assert that the Protocol violates the
    requirements of the Documents Law, the Review Act, and the Attorneys Act.
    The DOC argues that Petitioners fail to state a claim in Claim II for
    two reasons.      First, the Protocol is part of a DOC manual detailing internal
    operating procedures which is not subject to the requirements of the Documents
    Law, Review Act, and Attorneys Act. The Protocol has no impact on the general
    public and, thus, the public need not participate in the establishment of the
    Protocol. Given the unique prison environment, the DOC must have the right to
    enforce reasonable rules separate from formal regulations. The DOC does not
    dispute that the Protocol was not promulgated in accordance with these statutes.
    Essentially the DOC argues that the Protocol is not a regulation and, therefore, it is
    not required to follow formal rule-making procedures.10
    This Court must determine, assuming the averments of Petitioners are
    true, whether under no circumstances may the Protocol be considered a regulation
    requiring formal rule-making procedures.
    A regulation promulgated in violation of the requirements of the
    Documents Law, the Review Act, and the Attorneys Act will be declared a nullity.
    Borough of Bedford v. Department of Environmental Protection, 
    972 A.2d 53
    , 62
    (Pa. Cmwlth. 2009). Conversely, the DOC may issue “non-legislative rules” such
    10
    The DOC also contends that in arguing that the Protocol is unreasonable, Petitioners
    failed to show that the Protocol violates any other state or federal law.
    14
    as statements of policy or interpretative rules that do not go through the normal
    rule-making process. Northwestern Youth Services Inc. v. Department of Public
    Welfare, 
    66 A.3d 301
    (Pa. 2013).11 Applying the “binding norm test” assists in
    determining whether a statement or rule was issued by an administrative agency.
    Department of Environmental Resources v. Rushton Mining Company, 
    591 A.2d 1168
    , 1173 (Pa. Cmwlth. 1991). Under the binding norm test, an agency decision
    is not a statement of policy if it is binding on the agency. 
    Id. “To determine
    whether an agency has attempted to establish a binding norm without required
    procedure, courts consider the plain language of the enactment, the manner in
    which the agency implemented the provision and whether its discretion is restricted
    by the provision.” Cash America Net of Nevada, LLC v. Commonwealth, 
    978 A.2d 1028
    , 1033 (Pa. Cmwlth. 2009).               If the Protocol was designed to be a non-
    legislative rule, but, in effect, binds the DOC, the statement of policy or
    interpretive rule may function as a regulation for purposes of the Documents Law,
    11
    In Northwestern Youth Services, the Supreme Court explained:
    Non-legislative rules…come in an abundance of formats with a
    diversity of names, including guidances, manuals, interpretative
    memoranda, staff instructions, policy statements, circulars,
    bulletins, advisories, press releases and others. When such
    documents fairly may be said to merely explain or offer specific
    and conforming content to existing statutes or regulations within
    the agency’s purview, they are regarded as ‘interpretative rules,’
    which generally are exempt from notice-and-comment rulemaking
    and regulatory-review requirements. Additionally, ‘statements of
    policy’- or agency pronouncements which are not intended to bind
    the public and agency personnel, but rather, merely express an
    agency’s tentative, future intentions- also are not regulations
    subject to notice-and-comment rulemaking and regulatory-review
    requirements.
    Northwestern Youth 
    Services, 66 A.3d at 310-12
    .
    15
    Review Act, and Attorneys Act and may only be deemed valid if it was
    promulgated through the normal rule promulgation procedure. See Transportation
    Services Inc. v. Underground Storage Tank Indemnification Board, 
    67 A.3d 142
    ,
    153 (Pa. Cmwlth. 2013) (stating “[i]f an interpretative rule or statement of policy
    functions as a regulation, then it will be nullified due to the agency’s failure to
    obey the processes applicable to the promulgation of a regulation”) (citations
    omitted).
    In the present case, the Protocol is part of an internal operating
    manual and allegedly reflects the current procedures employed by the DOC
    personnel, as opposed to the DOC’s “tentative future intentions.” Northwestern
    Youth Services 
    Inc. 66 A.3d at 311
    . The Protocol may bind the DOC personnel by
    the use of terms such as “must”, “shall” or “will.” Petitioners’ brief notes that the
    word “will” appears 108 times in non-redacted portions of the Protocol and “shall”
    appears twenty-four times. Petitioners’ Brief at 7, n.2. Conversely, the term
    “may” appears only four times and words “can” and “could” do not appear at all.
    Petitioners’ Brief at 7, n.2.
    In response, the DOC cites the Supreme Court’s decision in Small v.
    Horn, 
    722 A.2d 664
    , 669 (Pa. 1998), for the proposition that it has the discretion to
    issue internal operating procedures without following the formal rule-making
    process. In Small, nine inmates challenged the DOC’s issuance of bulletins which
    revoked the inmates’ permission to wear civilian clothing. Our Supreme Court
    determined that the DOC’s bulletins were not “regulations” for purposes of the
    Commonwealth Documents Law or the Regulatory Review Act, but instead
    16
    embodied decisions that were inherently committed to the DOC’s discretion
    because the issue was clearly internal to the operation of a prison and had little
    public impact. See Orozco v. Department of Corrections, 
    83 A.3d 1161
    (Pa.
    Cmwlth. 2014) (addressing the confiscation of items upon transfer from an out of
    state prison); Bundy v. Beard, 
    924 A.2d 723
    , 728 (Pa. Cmwlth. 2007) (addressing
    the confiscation of inmate mail); and Weaver v. Department of Corrections, 
    829 A.2d 750
    , 752 (Pa. Cmwlth. 2003) (addressing the removal of artwork from an
    inmate’s cell).
    Our Supreme Court has “recognized a category of agency decisions
    that are inherently committed to the agency’s sound discretion and that cannot
    reasonably be subjected to the normal public participation process.” 
    Small, 722 A.2d at 669
    (internal quotation marks omitted).        These include, inter alia,
    “reasonable rules of internal prison management to ensure public safety and prison
    security.” 
    Id. The test
    used by the Supreme Court in Small as to whether these
    decisions are committed to agency discretion is whether the measure had more
    than an “incidental effect on the general public” so that “it is reasonable to
    conclude that the Legislature did not intend the measure to be subjected to the
    normal public participation process.”     
    Id. at 670
    (Internal quotation marks
    omitted.)
    Contrary to DOC’s arguments, the DOC’s policies concerning inmate
    dress codes or inmate mail are distinguishable from the Commonwealth’s
    procedure with regard to carrying out the death penalty. Issues of dress and inmate
    mail are internal to the operation of the prison, with an “incidental effect on the
    17
    general public . . . .” See 
    Small, 722 A.2d at 670
    . Conversely, the General
    Assembly has specifically enacted legislation addressing execution procedures and
    so we cannot say that the legislature intended prison policies regarding execution
    “not to be subjected to the normal public participation process.” (Footnote
    omitted.) 
    Id. at 670
    .
    Accordingly, Petitioners have sufficiently pled a cause of action in the
    first portion of Claim II and the DOC’s second PO is overruled and DOC shall file
    an answer to Claim II of the petition for review.
    C. Whether The Second Portion Of Claim II Of The Petition Fails To State A
    Claim Upon Which Relief May Be Granted?
    Petitioners argue in the second portion of Claim II that the Protocol is
    “unreasonable” because it conflicts with the Federal Drug and Controlled
    Substances Acts and the Pharmacy Act. For example, Petitioners contend that the
    Protocol permits the DOC to procure the drugs through interstate commerce in
    violation of FDCA provisions and without a valid medical prescription. These
    claims appear to raise issues of fact that cannot be resolved by POs.
    Accordingly, the second portion of the DOC’s PO to Claim II is
    overruled and DOC must answer the Petition for Review.
    D. The DOC’s PO Asserting Lack of Jurisdiction.
    The DOC next contends that under the justiciability doctrine, the
    matter is not ripe for review because not all Petitioners have active death warrants
    signed by the Governor and those Petitioners under active warrants have had their
    18
    executions judicially stayed.12 However, the DOC fails to take into account that
    the Petitioners have all been sentenced to death by a court of this Commonwealth
    and each Petitioner remains incarcerated on death-row.13
    The justiciability doctrine of ripeness addresses the appropriate time
    for judicial intervention. Town of McCandless v. McCandless Police Officers
    Association, 
    901 A.2d 991
    , 1002 (Pa. 2006). The Supreme Court has focused its
    ripeness jurisprudence on the principle “that the courts should not give answers to
    academic questions or render advisory opinions or make decisions based on
    assertions as to hypothetical events that might occur in the future.” Philadelphia
    Entertainment & Development Partners, L.P. v. City of Philadelphia, 
    937 A.2d 385
    , 392 (Pa. 2007).
    This Court considers Petitioners’ allegations that the drugs listed in
    the Protocol will be used to execute Petitioners as more than “rank speculation”
    because the Protocol was adopted by the DOC and has been in effect since August
    28, 2012.
    Accordingly, this Court has jurisdiction and this PO is overruled.14
    12
    Pursuant to Section 4302(a) of the Code, 61 Pa. C.S. § 4302(a), once an execution
    warrant is signed by the Governor the execution must occur within 60 days unless a reprieve or
    judicial stay is granted.
    13
    See Petition ¶¶ 14-18 at 4-5.
    14
    The DOC also argues that this Court lacks jurisdiction to determine compliance with
    various state and federal laws because those laws are enforced, in the first instance, by the
    relevant state and federal agencies. However, the Petitioners are not asking this Court to enforce
    compliance with various state and federal laws. Therefore, the DOC’s contention that this Court
    lacks jurisdiction to do so is irrelevant.
    19
    E. The DOC’s POs Asserting Lack of Standing.
    The DOC contends that the Petitioners lack standing because there is
    nothing in the Petition that demonstrates any of the Petitioners are “actually facing
    the administration of lethal injection, which in terms of the drugs it uses, does not
    comport with the state statute.” The DOC’s Brief at 22. The DOC also argues that
    Petitioners lack standing to pursue the various federal and state claims asserted
    because none of the statutes allow for a private cause of action. Finally, the DOC
    contends that Petitioners lack standing to assert that the Protocol violates the
    professional ethical standards of both nurses and paramedics.
    1. Whether Petitioners have standing to challenge the Protocol?
    “In Pennsylvania, the doctrine of standing at issue in this matter is a
    prudential, judicially created principle designed to winnow out litigants who have
    no direct interest in a judicial matter.” Office of Governor v. Donahue, 
    98 A.3d 1223
    , 1229 (Pa. 2014). “The core concept” of standing is that a person who “is not
    adversely affected in any way by the matter he seeks to challenge is not
    ‘aggrieved’ thereby and has no standing to obtain a judicial resolution of his
    challenge.” William Penn Parking Garage, Inc. v. City of Pittsburgh, 
    346 A.2d 269
    , 280 (Pa. 1975). An aggrieved party is one who can establish a “direct and
    immediate interest in the outcome of the litigation.” Fumo v. City of Philadelphia,
    
    972 A.2d 487
    , 496 (Pa. 2009).
    A party’s interest is substantial when it surpasses the
    interest of all citizens in procuring obedience to the law;
    it is direct when the asserted violation shares a causal
    connection with the alleged harm; finally, a party’s
    interest is immediate when the causal connection with the
    alleged harm is neither remote nor speculative.
    20
    
    Donahue, 98 A.3d at 1229
    .
    As argued with regard to Claim I, the DOC maintains that no
    Petitioner is actually facing the administration of lethal injection by the methods
    detailed in the Protocol because the imposition of their sentences have been
    delayed by either a judicial stay, reprieve, or because the Petitioner is not under an
    active execution warrant. Again, each Petitioner has been sentenced to death and
    currently resides on death row. Accordingly, each Petitioner has a direct interest in
    the execution process and drugs utilized as described by the Protocol.
    The DOC also argues that Petitioners lack standing to challenge
    whether the Protocol was promulgated in violation of the Documents Law, Review
    Act, or Attorneys Act or otherwise conflicts with state or federal law. To the
    extent Petitioners are sufficiently aggrieved by the contents of the Protocol to
    confer standing to challenge the legality of the Protocol, Petitioners would also
    have standing to challenge whether it was promulgated in the manner prescribed
    by law.
    The DOC’s preliminary objection that the Petitioners lack standing to
    challenge the Protocol is overruled.
    2. Whether Petitioners have standing to challenge whether the Protocol violates
    the professional ethical standards of paramedics and nurses?
    A petitioner only has standing if he is adversely affected in any way
    by the matter he seeks to challenge. William 
    Penn, 346 A.2d at 280
    . A review of
    the record reveals that Petitioners have not supplied facts or allegations
    21
    demonstrating they are in any way personally aggrieved by nurses and paramedics
    carrying out their roles on LITs in violation of their respective ethical obligations.
    Further, Petitioners did not reference the specific ethical standard to which they are
    referring and chose to not supply arguments in response to the DOC’s POs in this
    regard.
    The DOC’s PO as it relates to this portion of Claim II addressing
    whether Petitioners have standing to challenge whether the Protocol violates the
    professional ethical standards of paramedics and nurses is sustained.
    ____________________________
    BERNARD L. McGINLEY, Judge
    22
    IN THE COMMONWEALTH COURT OF PENNSYLVANIA
    Terrance Williams; Richard                :
    Laird; Robert Wharton; Hubert             :
    Michael, Michael E. Ballard,              :
    individually and on behalf of             :
    all others similarly situated,            :
    Petitioners          :
    :
    v.                           :
    :
    Commonwealth of Pennsylvania              :
    Department of Corrections,                :   No. 353 M.D. 2014
    Respondent               :
    ORDER
    AND NOW, this 15th day of October, 2015, the Department of
    Corrections’ Preliminary Objections are overruled in part and sustained in part.
    The Preliminary Objection in the nature of a demurrer is overruled.              The
    Preliminary Objection with regard to jurisdiction is overruled. The Preliminary
    Objection with regard to whether the Petitioners have standing to challenge the
    Protocol is overruled. The Preliminary Objection with regard to standing to assert
    claims related to the ethical standards of nurses and paramedics is sustained.
    The Department of Corrections is directed to file an answer within
    thirty days of the entry of this Order.
    ____________________________
    BERNARD L. McGINLEY, Judge
    IN THE COMMONWEALTH COURT OF PENNSYLVANIA
    Terrance Williams; Richard                :
    Laird; Robert Wharton; Hubert             :
    Michael, Michael E. Ballard,              :
    individually and on behalf of             :
    all others similarly situated,            :
    Petitioners   :
    :
    v.                           :   No. 353 M.D. 2014
    :   Argued: March 11, 2015
    Commonwealth of Pennsylvania              :
    Department of Corrections,                :
    Respondent        :
    BEFORE: HONORABLE DAN PELLEGRINI, President Judge
    HONORABLE BERNARD L. McGINLEY, Judge
    HONORABLE RENÉE COHN JUBELIRER, Judge
    HONORABLE MARY HANNAH LEAVITT, Judge
    HONORABLE P. KEVIN BROBSON, Judge
    HONORABLE PATRICIA A. McCULLOUGH, Judge
    HONORABLE ANNE E. COVEY, Judge
    OPINION NOT REPORTED
    CONCURRING OPINION
    BY JUDGE BROBSON                              FILED: October 15, 2015
    I join in most of the majority opinion. I write separately to note my
    concurrence with the majority’s conclusion that Claim 1 of the Amended Petition,
    challenging the death penalty protocol (Protocol) of the Pennsylvania Department
    of Corrections (DOC) as inconsistent with 61 Pa. C.S. § 4304(a)(1), should
    withstand DOC’s demurrer. This section provides:
    The death penalty shall be inflicted by injecting
    the convict with a continuous intravenous administration
    of a lethal quantity of an ultrashort-acting barbiturate in
    combination with chemical paralytic agents approved by
    the department until death is pronounced by the coroner.
    The coroner shall issue the death certificate.
    (Emphasis added.) Unlike the majority, I do not believe this section can or should
    be read as precluding DOC from administering drugs not listed in the statute
    during execution, so long as those drugs serve some lawful purpose other than
    hastening death.
    It is undisputed that the Protocol provides for the administration of a
    three-drug cocktail in the following order: (1) pentobarbital or sodium thiopental,
    (2) pancuronium bromide, and (3) potassium chloride. With respect to the first
    step in the Protocol, Petitioners allege that, unlike sodium thiopental, pentobarbital
    is not an ultrashort-acting barbiturate. Neither of the drugs in step two or three of
    the Protocol is an ultrashort-acting barbiturate. Accordingly, to the extent the
    Protocol allows DOC to substitute pentobarbital for the statutorily-required
    ultrashort-acting barbiturate, the Protocol would appear to be contrary to the will of
    the General Assembly, as expressed in 61 Pa. C.S. § 4304(a)(1). Also, Petitioners
    allege that potassium chloride is neither an ultrashort-acting barbiturate nor a
    chemical paralytic agent. Accordingly, to the extent DOC includes potassium
    chloride in the Protocol to hasten death and not for some other lawful purpose, its
    inclusion in the cocktail would also appear to violate the will of the General
    Assembly. Accordingly, while I concur with the majority’s decision to overrule
    DOC’s preliminary objection in the nature of a demurrer to Claim 1 in the
    Amended Petition, I would only allow Petitioners to pursue the above challenges to
    the DOC Protocol as part of Claim 1.
    P. KEVIN BROBSON, Judge
    PKB-2
    IN THE COMMONWEALTH COURT OF PENNSYLVANIA
    Terrance Williams; Richard Laird;        :
    Robert Wharton; Hubert Michael,          :
    Michael E. Ballard, individually and     :
    on behalf of all others similarly        :
    situated,                                :
    Petitioners          :
    :   No. 353 M.D. 2014
    v.                           :
    :   Argued: March 11, 2015
    Commonwealth of Pennsylvania             :
    Department of Corrections,               :
    Respondent              :
    BEFORE:     HONORABLE DAN PELLEGRINI, President Judge
    HONORABLE BERNARD L. McGINLEY, Judge
    HONORABLE RENÉE COHN JUBELIRER, Judge
    HONORABLE MARY HANNAH LEAVITT, Judge
    HONORABLE P. KEVIN BROBSON, Judge
    HONORABLE PATRICIA A. McCULLOUGH, Judge
    HONORABLE ANNE E. COVEY, Judge
    OPINION NOT REPORTED
    CONCURRING OPINION
    BY JUDGE McCULLOUGH                                    FILED: October 15, 2015
    I join in the Majority opinion but write separately to make two
    observations.
    The first relates to the assertions by several inmates (Petitioners) that
    the death penalty protocol (Protocol) of the Department of Corrections (the
    Department) violates section 4304(a)(1) of the Prisons and Parole Code (Code), 61
    Pa.C.S. §4304(a)(1). In pertinent part, section 4304(a)(1) of the Code states that
    lethal injection shall consist of “an ultrashort-acting barbiturate in combination
    with chemical paralytic agents approved by the [D]epartment….” 61 Pa.C.S.
    §4304(a)(1).      Petitioners aver that pentobarbital is not an “ultrashort-acting
    barbiturate” and that potassium chloride is not a “paralytic agent.”1 For purposes
    of demurrer, this Court must accept Petitioners’ allegations as true. See Bell v.
    Township of Spring Brook, 
    30 A.3d 554
    , 557 n.7 (Pa. Cmwlth. 2011).
    I believe that our General Assembly is in a better position than the
    courts to determine whether an arguably borderline drug fits (or should fit) within
    the statutory definition. Seebold v. Prison Health Services, Inc., 
    57 A.3d 1232
    ,
    1245 & n.19 (Pa. 2012). Unlike this Court, the General Assembly has at its
    disposal    objective     fact-finding    tools,   including     the    ability to     conduct
    comprehensive investigations and policy hearings. See 
    id. Given that
    the death
    penalty is still legally permissible in Pennsylvania, there is necessarily an
    overwhelming public interest in ensuring that it is only imposed in strict
    accordance with the law. See Commonwealth v. McKenna, 
    383 A.2d 174
    , 180-81
    (Pa. 1978). Therefore, I submit that the issue as to whether a particular drug
    should be used in the lethal injection process should be determined by the
    legislature, and I would urge our General Assembly to revise section 4304(a)(1)
    and provide a detailed and explicit manner for determining which drugs may
    properly be used in a lethal injection.2
    1
    According to the Protocol, the sequence of administered drugs is as follows: (1)
    pentobarbital or thiopental; (2) pancuronlum bromide; and (3) potassium chloride. (Protocol,
    Section 3(c)(1)-(9), at 4-25—4-27.)
    2
    I note that the Majority has determined that Petitioners have stated a viable claim that
    the Protocol is invalid for failing to following the requirements of this Commonwealth’s laws
    with respect to promulgating regulations.
    PAM - 2
    I am also troubled by Petitioners’ allegation that licensed registered
    nurses participate as members of the lethal injection team (LIT) and perform
    venipuncture and administer anesthesia intravenously absent a medical doctor’s
    order, in violation of 49 Pa. Code §21.12(1).3 The Department does not dispute
    that a registered nurse performs these functions during the lethal injection process,
    but argues that the regulation does not apply because a nurse is not engaged in the
    practice of professional nursing. I agree with the Majority that Petitioners lack
    standing to challenge or otherwise pursue a claim under 49 Pa. Code §21.12(1).
    Nonetheless, Petitioners raise significant concerns, the merits of
    which should be assessed by the State Board of Nursing (Board), and specifically
    whether registered nurses participating as part of the LIT may be violating the
    duties imposed by the Board.               The Board also should consider whether the
    Protocol’s requirement that the identity of the members of the LIT, including
    registered nurses, “will remain confidential,” (Protocol, Section 4(B)(2)(c), at 4-3),
    creates an anonymity that could potentially cause inter-agency conflict and make it
    difficult for the Board to exercise its regulatory and enforcement powers.
    Accordingly, I would recommend that the Board either issue an advisory opinion
    or clarify its regulations, see section 2.1 of the Professional Nursing Law, Act of
    3
    This section states:
    § 21.12. Venipuncture; intravenous fluids.
    Performing of venipuncture and administering and withdrawing
    intravenous fluids are functions regulated by this section, and these
    functions may not be performed unless:
    (1) The procedure has been ordered in writing for the patient by a
    licensed doctor of the healing arts.
    49 Pa. Code §21.12(1).
    PAM - 3
    May 22, 1951, P.L. 317, as amended, added by the Act of July 3, 1974, P.L. 432,
    63 P.S. §212.1, so that registered nurses know whether they are complying with
    their professional duties or whether they could be subject to disciplinary action. At
    the very least, I would suggest that the Board investigate the matter.
    With these observations being stated, I join the Majority opinion.
    ________________________________
    PATRICIA A. McCULLOUGH, Judge
    Judge Leavitt joins.
    PAM - 4