               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
