J-A07013-16

                          2016 PA Super 160

THOMAS D. WALTERS AND CLARA M.            IN THE SUPERIOR COURT OF
WALTERS, HIS WIFE,                              PENNSYLVANIA



                     Appellants



                v.



UPMC PRESBYTERIAN SHADYSIDE;
MAXIM HEALTHCARE SERVICES, INC.,
AND MEDICAL SOLUTIONS L.L.C. D/B/A
MEDICAL SOLUTIONS,



                     Appellees                 No. 309 WDA 2015



           Appeal from the Order Entered February 6, 2015
          In the Court of Common Pleas of Allegheny County
                 Civil Division at No(s): GD-12-018339

LINDA FICKEN AND WILLIAM FICKEN,          IN THE SUPERIOR COURT OF
HER HUSBAND,                                    PENNSYLVANIA



                     Appellants



                v.



UPMC PRESBYTERIAN SHADYSIDE;
MAXIM HEALTHCARE SERVICES, INC.,
AND MEDICAL SOLUTIONS L.L.C. D/B/A
MEDICAL SOLUTIONS,
J-A07013-16



                     Appellees                 No. 310 WDA 2015



           Appeal from the Order Entered February 6, 2015
          In the Court of Common Pleas of Allegheny County
                 Civil Division at No(s): GD-12-016165

WANDA J. BRAUN AND EDWIN J. BRAUN,        IN THE SUPERIOR COURT OF
HER HUSBAND,                                    PENNSYLVANIA



                     Appellants



                v.



UPMC PRESBYTERIAN SHADYSIDE;
MAXIM HEALTHCARE SERVICES, INC.,
AND MEDICAL SOLUTIONS L.L.C. D/B/A
MEDICAL SOLUTIONS,



                     Appellees                 No. 311 WDA 2015



           Appeal from the Order Entered February 6, 2015
          In the Court of Common Pleas of Allegheny County
                 Civil Division at No(s): GD-12-024324

RONNIE D. MURPHY AND CONNIE E.            IN THE SUPERIOR COURT OF
MCNEAL, AS CO-EXECUTORS OF THE                  PENNSYLVANIA
ESTATE OF ELEANOR Y. MURPHY, IN
THEIR OWN RIGHT

                     Appellants

                v.

UPMC PRESBYTERIAN SHADYSIDE,
MAXIM HEALTHCARE SERVICES, INC.,

                                  -2-
J-A07013-16



AND MEDICAL SOLUTIONS, L.L.C. D/B/A
MEDICAL SOLUTIONS,

                         Appellees                   No. 312 WDA 2015


                Appeal from the Order Entered February 6, 2015
               In the Court of Common Pleas of Allegheny County
                      Civil Division at No(s): GD-14-000899


BEFORE: BOWES, MUNDY AND JENKINS, JJ.

OPINION BY BOWES, J.:                                  FILED JULY 21, 2016

      Plaintiffs-Appellants Thomas D. Walters and his wife Clara M. Walters,

Linda Ficken and William Ficken, her husband, Wanda Braun and her

husband Edwin J. Braun, and Ronnie D. Murphy and Connie E. McNeal,

individually and as co-executors of the Estate of Eleanor Y. Murphy, appeal

from the trial court’s order sustaining preliminary objections in the nature of

a demurrer as to their negligence claims against UPMC Presbyterian-

Shadyside (“UPMC”) and Maxim Healthcare Services, Inc. (“Maxim”).          The

action was dismissed based upon a finding that neither defendant owed a

duty to Plaintiffs. After thorough review, we vacate that portion of the order

sustaining the demurrer as to both UPMC and Maxim based on the lack of a

common law duty of care, we affirm that portion sustaining the demurrer on

the negligence per se claim against UPMC, and we remand for further

proceedings.

      Since we are reviewing the trial court’s order sustaining preliminary

objections in the nature of a demurrer, we look to the first amended

                                     -3-
J-A07013-16



complaint for the relevant facts, and accept them as true.1             Connor v.

Archdiocese of Phila., 975 A.2d 1084 (Pa. 2009). Radiologic technologist

David Kwiatkowski was an employee of Maxim, a medical staffing agency

that placed him at UPMC, or in the alternative, an employee of UPMC, which

exercised the ability to control and direct his job performance.2               First

Amended Complaint, 11/30/12, at ¶12. On or about May 7, 2008, a UPMC

hospital employee saw Kwiatkowski enter an operating room, lift his shirt,

put a syringe in his pants, and leave the room. Id. at ¶13. When UPMC

confronted Kwiatkowski about the theft, he had three empty fentanyl

syringes on his person, an empty morphine syringe in his locker, and tested

positive for fentanyl and opiates. Id. at ¶14. Further investigation revealed

that   Kwiatkowski      stole   the    controlled   substances,   injected   himself,

substituted water in the used syringes, and placed the syringes on the

shelves to avoid detection.           Id. at ¶13.      This practice is known as

substitution.



____________________________________________


1
  For ease of reference, all citations to the pleadings and the certified record
are to the Walters case.
2
  A radiologic technologist is “[a]n individual who is a graduate of a program
in radiologic technology approved by the Council on Medical Education of the
American Medical Association or who has the equivalent of such education
and training. 28 Pa.Code 101.4 (administrative code provision implementing
Health Care Facilities Act, 35 P. S. §§ 448.101 -- 448.904).



                                           -4-
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       Plaintiffs pled that, due to the risks associated with improper use and

diversion of controlled substances, both the federal and state governments

oversee and regulate practitioners such as UPMC, who are registered to

possess and dispense controlled substances. Id. at ¶17. As a registrant,

Plaintiffs pled that, “UPMC had a legal duty to ‘provide effective controls and

procedures to guard against theft and diversion of controlled substances’”

and notify the DEA “‘in writing, of the theft or significant loss of any

controlled substances within one business day of discovery.         21 C.F.R. §

1301.76(b).’”      Id. at ¶¶19-20.        It did not report, and as a healthcare

provider, Plaintiffs pled that UPMC “knew or should have known that medical

staff such as Kwiatkowski, without intervention, would continue to engage in

conduct, including theft of controlled substances in order to satisfy” his

addiction. Id. at ¶24.

       According to Plaintiffs, UPMC did not report Kwiatkowski’s diversion of

drugs to the DEA as required by 21 C.F.R. § 1301.76(b),3 or to any other

____________________________________________


3
    21 C.F.R. § 1301.76(b) provides in pertinent part:
       (b) The registrant shall notify the Field Division Office of the
       Administration in his area, in writing, of the theft or significant
       loss of any controlled substances within one business day of
       discovery of such loss or theft. The registrant shall also
       complete, and submit to the Field Division Office in his area, DEA
       Form 106 regarding the loss or theft. When determining whether
       a loss is significant, a registrant should consider, among others,
       the following factors:

(Footnote Continued Next Page)


                                           -5-
J-A07013-16



law enforcement, governmental, or licensing agencies.             As of that date,

UPMC banned Kwiatkowski from all UPMC facilities.             Appellants pled that

both UPMC and Maxim knew or should have known that Kwiatkowski was

addicted to drugs, that he was a potential carrier of diseases associated with

intravenous drug use, and that without intervention, he would continue to

steal and use intravenous drugs, and substitute water or other substances

for the drugs.         Consequently, “[a]s a direct and proximate result of

defendant UPMC’s conduct and/or omissions, Kwiatkowski was able to seek

                       _______________________
(Footnote Continued)

             (1)       The actual quantity of controlled substances
                       lost in relation to the type of business;

             (2)       The specific controlled substances lost;

             (3)       Whether the loss of the controlled substances
                       can be associated with access to those
                       controlled substances by specific individuals, or
                       whether the loss can be attributed to unique
                       activities that may take place involving the
                       controlled substances;

             (4)       A pattern of losses over a specific time period,
                       whether the losses appear to be random, and
                       the results of efforts taken to resolve the
                       losses; and, if known,

             (5)       Whether the specific controlled substances are
                       likely candidates for diversion;

             (6)       Local trends and other indicators of the
                       diversion potential of the missing controlled
                       substance.




                                            -6-
J-A07013-16



and obtain employment with other healthcare facilities, including Hays

Medical Center and be in a position to continue to steal and use controlled

substances[,] which directly affected the health and well-being of patients,”

such as Plaintiffs. Id. at ¶46. UPMC failed to report Kwiatkowski’s theft and

diversion to law enforcement and take steps necessary to ensure that

Kwiatkowski would not continue that practice.       Id. at ¶46.   Specifically,

“UPMC knew that Kwiatkowski was a traveling radiologic technician and

knew or should have foreseen that thousands of patients around the country

would be endangered if UPMC failed to take steps to prevent Kwiatkowski

from continuing his illicit conduct.” Id. at ¶64.

       After the incident at UPMC, Kwiatkowski obtained a Maryland license

and secured employment as a radiologic technologist in that state.4

Between 2008 and 2010, Kwiatkowski worked at eight other hospitals,

including Hays Medical Center in Hays, Kansas, where he encountered

Plaintiffs. He started working at that facility on May 24, 2010, and Plaintiffs

were patients in the cardiac catheterization unit during his tenure there.

Each received intravenously administered medication through a syringe that

____________________________________________


4
   Plaintiffs argue that certification through the American Registry of
Radiologic Technologists (“ARRT”) was a prerequisite for the license, and
that Kwiatkowski remained certified due to UPMC and Maxim’s failure to
report his criminal conduct.        See American Registry of Radiologic
Technologists (ARRT), 28 Pa.Code § 127.5.




                                           -7-
J-A07013-16



Kwiatkowski used to self-administer controlled substances, refilled with

water, and replaced for use by unsuspecting staff upon patients.         By that

time, Kwiatkowski was infected with hepatitis C.        Plaintiffs subsequently

tested positive for the same strain of hepatitis C as that contracted by

Kwiatkowski.   Plaintiffs alleged that he transmitted that infection to them

and others through contaminated needles. Elizabeth Murphy died due to the

infection.

      Kwiatkowski was subsequently arrested in New Hampshire and

charged with acquiring a controlled substance by misrepresentation, fraud,

forgery, deception or subterfuge in violation of 21 U.S.C. § 843(a)(3), and

tampering with a consumer product with reckless disregard for the risk to

another and placing another in danger of and actually resulting in death or

bodily injury in violation of 18 U.S.C. § 1365(a)(3).

      Plaintiffs filed the within civil actions, premising liability against UPMC

upon several theories of negligence.        First, they alleged that UPMC was

vicariously liable for the acts of its employee/agent, Kwiatkowski. Second,

Plaintiffs pled that UPMC violated the standard of care for hospitals when it

failed to take adequate steps to ensure that similar conduct was prevented

in the future. Additionally, they maintained that UPMC failed to report, as

required by law, Kwiatkowski’s theft and diversion of controlled substances

to governmental agencies or law enforcement, which would have prevented

him from continuing to engage in the theft and diversion of controlled

                                      -8-
J-A07013-16



substances. Finally, Plaintiffs pled that UPMC’s violation of federal and state

statutes that mandated the reporting of the diversion of controlled

substances to the Drug Enforcement Administration (“DEA”) constituted

negligence per se.5 Since UPMC was a registrant of controlled substances,

Plaintiffs maintained it had a duty to protect healthcare patients who could

be injured due to drug tampering.              They averred further that, had UPMC

complied with the regulations, Kwiatkowski would have been prevented from

infecting them in 2010.             Plaintiffs characterized UPMC’s conduct as

malicious, willful, wanton and so recklessly indifferent as to warrant

imposition of punitive damages.

       The allegations against Maxim, the staffing agency that employed

Kwiatkowski, sound exclusively in negligence. According to Plaintiffs, Maxim

had a duty to act in accordance with the standard of care of reasonable

healthcare staffing agencies.          Id. at ¶42.     Maxim knew of the danger

Kwiatkowski presented to the patients at the facilities where he worked and

had a duty to ensure that Kwiatkowski would not be able to divert and

substitute drugs not only at UPMC, but also at other health care facilities

where he would seek employment and access to drugs.                 First Amended

____________________________________________


5
  Plaintiffs alleged that “at a minimum,” the failure to report violated 21
U.S.C. §801 et seq., 21 C.F.R. § 1301 et seq., and 28 Pa.Code § 25 et seq.
UPMC also was required, upon discovering the theft of controlled substances,
to file a DEA Form 106. Plaintiffs’ Amended Complaint, 11/30/12, at ¶20.



                                           -9-
J-A07013-16



Complaint, 11/30/12, at ¶67. Maxim breached that duty “by failing to report

Kwiatkowski’s theft, use, and/or diversion of controlled substances to any

state, federal, or other governmental agency and/or by failing to take

adequate steps to ensure that Kwiatkowski would not, in the future, be able

to steal, use, or divert controlled substances.”             Id. at ¶68.      As a

consequence of Maxim’s negligence, Plaintiffs averred they were injured.6

       Both Maxim and UPMC filed preliminary objections in the nature of a

demurrer alleging that, even accepting all well-pleaded facts as true, they

had no duty to Plaintiffs that would support a cause of action for negligence.

UPMC maintained that, since there was no special relationship between itself

and Plaintiffs or itself and Kwiatkowski, no duty could be inferred from the

general duty imposed on all persons not to place others at a risk of harm.

Furthermore, it warned that imposition of a duty on the facts herein was

“not only contrary to established law but would subject hospitals in this

Commonwealth to limitless liability.”          Preliminary Objections to Plaintiffs’

Amended Complaint, 12/20/12, at ¶19.               It contended further that the

negligence per se claim failed because the statutes cited by Plaintiffs were

not designed to protect them, as opposed to the general public, from the

harm alleged.
____________________________________________


6
  Plaintiffs voluntarily dismissed claims of negligence against Kwiatkowski’s
Kansas employer, Medical Solutions, and hence, those claims are not before
us.



                                          - 10 -
J-A07013-16



     Plaintiffs countered that the failure of UPMC and Maxim to report

Kwiatkowski’s theft and substitution of drugs enabled him to continue

working as a radiologic technologist in various hospitals around the country.

According to Plaintiffs, due to UPMC’s violation of that statute, it was

foreseeable that Kwiatkowski would continue to steal and substitute drugs

and endanger future patients with contaminated syringes transmitting blood-

borne pathogens.

     The trial court rejected the Plaintiffs’ negligence per se claim against

UPMC, finding “nothing in the legislation or accompanying regulations

suggesting that drug diversion by healthcare employees and its risks to

patients are specific subjects that the Controlled Substances Act addressed.”

Trial Court Opinion, 6/30/13, at 4.    Furthermore, the court held that the

notice requirements of 21 C.F.R. §1301.76(b) were only intended to protect

the general public, not a specific group encompassing Plaintiffs. As to the

common law negligence claims against UPMC and Maxim, the court relied

upon Seebold v. Prison Health Services, Inc., 57 A.3d 123 (Pa. 2012), in

holding that the law imposed no duty on the part of Defendants. The trial

court concluded from Seebold that

     (1) foreseeability is not necessarily the critical factor in deciding
     whether UPMC shall be liable to plaintiffs for UPMC’s failure to
     report; (2) since UPMC did not create the risk (but only failed to
     prevent the harm), UPMC is not liable to third persons whom it
     never treated in the absence of a court-created duty; (3) the
     default position would avoid the creation of a new duty unless
     the court is able to see with reasonable clarity the results of the

                                    - 11 -
J-A07013-16



      decision and to determine with reasonable certainty that the
      change will serve the best interests of society; and (4) the case
      law which permits recovery where there is no relationship
      between the plaintiff and the defendant must be narrowly
      construed because of the Supreme Court’s “stated concern about
      imposing liability upon healthcare providers without limits.”
      [Seebold,] 57 A.3d at 1240.

Trial Court Opinion, 6/20/13, at 13. In response to Plaintiffs’ insistence that

UPMC need only comply with a reporting requirement, which is hardly

onerous, the court stated that Plaintiffs’ position failed to account for

inevitable employee error in reporting, and that UPMC should not be exposed

to “potentially limitless liability because of simple employee error.”   Id. at

14. The court held that UPMC’s duty extended only to its patients. As to

Maxim, the court found no duty to report the information it received from

UPMC regarding Kwiatkowski’s diversion of drugs. All claims against UPMC

and Maxim were dismissed.

      Plaintiffs filed the within appeal and they present four questions for our

review:

      I.    Does a defendant hospital have a duty to protect patients
            of other healthcare facilities who may come in contact with
            the hospital’s former agent/employee when the defendant
            hospital knew the agent/employee had diverted drugs
            while working at its facility, knew or should have known
            that the agent/employee would engage in the same
            conduct with subsequent healthcare employers and knew
            or should have known that drug diversion creates a high
            degree of risk of causing harm to hospital patients that
            come in contact with staff who are known to divert drugs?

      II.   Does a defendant hospital’s violation of a mandatory
            reporting requirement in a federal regulation intended to

                                    - 12 -
J-A07013-16



              curtail drug diversions in hospital facilities create a
              statutory duty that the defendant hospital owes to hospital
              patients who are subsequently harmed because the drug
              diverter’s conduct went unreported and as such, he was
              able to continue to continue to gain employment in other
              healthcare facilities, allowing him to continue to engage in
              drug diversions that created a high degree of risk of
              causing harm to hospital patients?

       III.   Is a hospital patient injured by a health care worker’s
              diversion and substitution of controlled substances part of
              a class of individuals which the Federal Controlled
              Substances Act was intended, at least in part, to protect,
              such that a defendant hospital’s violation of a federal
              controlled Substance Act regulation mandating the
              reporting of drug diversion constitutes negligence per se
              when a patient is harmed as a direct result of the
              violation?

       IV.    Does a defendant medical staffing agency have a duty to
              protect patients of healthcare facilities that may come in
              contact with the agency’s former employee when the
              defendant knew or should have known the employee had
              diverted drugs while in its employment, knew or should
              have known that the employee would engage in the same
              conduct with subsequent healthcare employers and knew
              or should have known that drug diversion creates a high
              risk of causing harm to hospital patients that come in
              contact with staff who are known to divert drugs?

Appellants’ brief at 5-6.7

____________________________________________


7
    As their premise for imposing a legal duty, Plaintiffs have pled that both
UPMC and Maxim were Kwiatkowski’s employers, and each knew of
Kwiatkowski’s diversion and substitution of controlled substances at UPMC
and the risk presented. Consequently, we will address together Plaintiffs’
first and fourth issues involving the duty question, noting distinctions when
the facts warrant different treatment or analysis of UPMC or Maxim.
Similarly, since Plaintiffs’ second and third issues implicate negligence per se
generally, we will discuss them together.



                                          - 13 -
J-A07013-16



      Preliminary objections in the nature of a demurrer test the legal

sufficiency of the complaint.    The trial court considering a demurrer must

treat all material facts set forth in the challenged pleadings as true, as well

as all inferences reasonably deducible therefrom. The demurrer should be

sustained only where it is “clear and free from doubt that the pleader will be

unable to prove facts legally sufficient to establish the right to relief.”

Richmond v. McHale, 35 A.3d 779, 783 (Pa.Super. 2012). If there is any

doubt as to whether preliminary objections in the nature of a demurrer

should be sustained, that doubt should be resolved in favor of overruling the

preliminary objections. Id.

      On appeal from an order sustaining or overruling a demurrer, our

standard of review is to determine whether the trial court committed an

error of law.   Like the trial court, for purposes of our review “all material

facts as set forth in the complaint, as well as all inferences reasonably

deducible therefrom, must be accepted as true.”       Bilt-Rite Contractors,

Inc. v. the Architectural Studio, 866 A.2d 270, 272 (Pa. 2005).            The

issue before us is “whether, on the facts averred, the law says with certainty

that no recovery is possible” and any doubt must be resolved in favor of

overruling the demurrer.      Id. at 274 (quoting MacElree v. Philadelphia

Newspapers, Inc., 674 A.2d 1050, 1056 (Pa. 1996)).

      To establish a common law cause of action in negligence, a plaintiff

must demonstrate that the defendant owed a duty of care to the plaintiff,

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the defendant breached that duty, the breach resulted in injury to the

plaintiff, and the plaintiff suffered an actual loss or damage. Lux v. Gerald

E. Ort Trucking, Inc., 887 A.2d 1281, 1286 (Pa.Super. 2005). "[A] duty or

obligation recognized by the law, requiring the actor to conform to a certain

standard of conduct[,]" is the first element of negligence.        Atcovitz v.

Gulph Mills Tennis Club, Inc., 812 A.2d 1218, 1222 (Pa. 2002). Whether

a duty of care exists is a question of law assigned initially to the trial court

and subject to plenary review on appeal. Winschel v. Jain, 925 A.2d 782,

796 (Pa.Super. 2007); Sharpe v. St. Luke's Hosp., 821 A.2d 1215, 1219

(Pa. 2003). Where, however, the plaintiff makes a prima facie showing of a

duty, the applicable standard of care, whether it was breached, and whether

the breach was a cause in fact of the injury are questions of fact for the jury.

K.H. ex rel. H.S. v. Kumar, 122 A.3d 1080, 1094 (Pa.Super. 2015).

      As our High Court reiterated in Althaus ex rel. Althaus v. Cohen,

756 A.2d 1166, (Pa. 2000):

            In determining the existence of a duty of care, it must be
      remembered that the concept of duty amounts to no more than
      ‘the sum total of those considerations of policy which led the law
      to say that the particular plaintiff is entitled to protection’ from
      the harm suffered[.] To give it any greater mystique would
      unduly hamper our system of jurisprudence in adjusting to the
      changing times.”

Althaus, at 1168-69 (quoting Sinn v. Burd, 404 A.2d 672, 681 (Pa.

1979)). The Court went on to quote the late Dean Prosser:




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      These are shifting sands, and no fit foundation. There is a duty if
      the court says there is a duty; the law, like the Constitution, is
      what we make it. Duty is only a word with which we state our
      conclusion that there is or is not to be liability; it necessarily
      begs the essential question. When we find a duty, breach and
      damage, everything has been said. The word serves a useful
      purpose in directing attention to the obligation to be imposed
      upon the defendant, rather than the causal sequence of events;
      beyond that it serves none. In the decision whether or not there
      is a duty, many factors interplay: The hand of history, our ideas
      of morals and justice, the convenience of administration of the
      rule, and our social ideas as to where the loss should fall. In the
      end the court will decide whether there is a duty on the basis of
      the mores of the community, 'always keeping in mind the fact
      that we endeavor to make a rule in each case that will be
      practical and in keeping with the general understanding of
      mankind.'

Id.

      Recognizing that “the legal concept of duty of care is necessarily

rooted in often amorphous public policy considerations, which may include

our perception of history, morals, justice and society[,]” the Althaus Court

identified five factors that should be weighed in determining whether a duty

exists in a particular case. Id. at 1168. Those factors are:

      (1) the relationship between the parties;

      (2) the social utility of the actor's conduct;

      (3) the nature of the risk imposed and foreseeability of the harm
      incurred;

      (4) the consequences of imposing a duty upon the actor; and

      (5) the overall public interest in the proposed solution.




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Althaus, supra at 1168-69 (citations omitted). Courts are not required to

weigh each factor equally and no individual factor is dispositive.      Id. at

1169. "[A] duty will be found to exist where the balance of these factors

weighs in favor of placing such a burden on a defendant."          Phillips v.

Cricket Lighters, 841 A.2d 1000, 1008-09 (Pa. 2003). "Whether a duty

exists is ultimately a question of fairness.”   Campo v. St. Luke's Hosp.,

755 A.2d 20, 24 (Pa.Super. 2000).

      Common Law Duty of Care on the Part of UPMC and Maxim

      Plaintiffs contend first that, “the utility of imposing a duty [upon UPMC

and Maxim] outweighs the costs associated with doing so.” Appellants’ brief

at 24. They cite the compelling public interest in preventing the diversion of

prescription drugs, especially from hospitals, as evidenced by federal

statutes and regulations requiring hospitals and other drug registrants to

secure drugs and report theft. Moreover, substitution, which is the removal

of prescription drugs from a syringe often through injection and replacement

with water, presents not only the risk that diluted medication will be

administered to patients, but that the person diverting and substituting will

contaminate the syringe and transmit potentially fatal diseases such as HIV

and hepatitis C. Plaintiffs maintain that UPMC knew that Kwiatkowski was

diverting and substituting fentanyl yet failed to report it to law enforcement,

which would have halted his access to future patients at facilities where

Kwiatkowski worked. Maxim knew Kwiatkowski was an addict and knew or

                                    - 17 -
J-A07013-16



should have known that, without intervention, Kwiatkowski would continue

to steal controlled substances to maintain his habit.8 According to Plaintiffs,

“UPMC and Maxim could and should have foreseen that Kwiatkowski’s

diversion of fentanyl, if unchecked and unreported, was likely to cause harm

to the class of individuals to which plaintiffs belonged, i.e., those likely to

receive care from the drug addict Kwiatkowski if his habit was allowed to

continue.” Id. at 27.

       Plaintiffs point to the nature of Kwiatkowski’s harm-producing conduct

at UPMC, which was identical to his conduct at Hays Medical Center, as

evidence that it was foreseeable to UPMC and Maxim that Kwiatkowski would

seek other health-related employment to facilitate access to prescription

drugs, divert them for his own use, and substitute diluted substances for

injection through contaminated needles to unsuspecting patients, unless he

____________________________________________


8
   The allegation that Maxim knew of Kwiatkowski’s addiction and diversion
of drugs suffices for our purposes of finding a duty. We note further that, in
a subsequent filing, Maxim acknowledged that UPMC notified it that
Kwiatkowski was terminated “for cause, reason – misconduct[,]” and that it
knew the termination was “related to narcotics.” Response in Opposition to
Plaintiffs’ Motion for Reconsideration of the Court’s June 20, 2013 Order,
8/12/13, at unnumbered 3.            Additionally, Maxim represented that
Kwiatkowski worked at a minimum of seven hospitals, not including Hays
Medical Center, after being terminated at UPMC, and that Maxim was “not
responsible for or associated with Kwiatkowski” or his placement in at least
six of those hospitals. Id. at unnumbered 7. The reasonable inference to be
drawn from the latter statement is that the agency may have placed
Kwiatkowski at other healthcare facilities after it knew the reason for his
termination by UPMC.



                                          - 18 -
J-A07013-16



was reported to authorities and denied access.      They rely upon Moran v.

Valley Forge Drive-in Theater, Inc., 246 A.2d 875, 878 (Pa. 1968), for

the proposition that the type of foreseeability required for imposition of a

duty of care is “the likelihood of the occurrence of a general type of risk

rather than the likelihood of the precise chain of events leading to the

injury[,]” as distinguished from the foreseeability employed in proximate

cause analysis that is specific to the particular plaintiff.   Plaintiffs contend

that the general type of risk presented by Kwiatkowski’s conduct met the

foreseeability requirement for imposition of a duty.

       Neither UPMC nor Maxim squarely addresses Plaintiffs’ arguments

regarding the foreseeability of the harm created by Kwiatkowski’s unchecked

drug diversion and substitution and the public interest in imposing a duty.

Rather, Maxim focuses on the first factor, the lack of a special relationship

between itself and Plaintiffs, as dispositive of the duty question.     It relies

heavily upon our decision in J.E.J. v. Tri-County Big Bros./Big Sisters,

Inc., 692 A.2d 582, 584 (Pa.Super. 1997), where this Court declined to

impose a duty upon Tri-County to plaintiffs based on a statutory failure to

report suspected sexual misconduct by one of its Big Brothers upon his Little

Brother.9 Thereafter, in circumstances unrelated to Tri-County Big Brothers

____________________________________________


9
  Pennsylvania's Child Protection Services Law, 23 Pa.C.S. § 6301 et seq.,
requires individuals who, in the course of their employment, come into
(Footnote Continued Next Page)


                                          - 19 -
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activities, the abuser molested the plaintiffs’ minor son.        The parents

asserted that the Big Brothers national organization was independently and

vicariously liable for their son’s physical injury and emotional harm, as well

as their own emotional distress, due to its failure to report the suspected

prior abuse involving the Big Brother.

      Noting the absence of any special relationship between Tri-County and

the plaintiffs, this Court found the only duty owed by the defendant to the

plaintiffs was the general duty imposed on all persons not to expose others

to reasonably foreseeable risks of injury. Furthermore, we relied upon the

principle that a person is not liable for the criminal conduct of another in the

absence of a special relationship imposing a pre-existing duty.        Feld v.

Merriam, 485 A.2d 742, 746 (Pa. 1984); T.A. v. Allen, 669 A.2d 360

(Pa.Super. 1995) (same).10 Since no relationship was alleged between the

                       _______________________
(Footnote Continued)

contact with children to make a report to the local children and youth agency
when they have reasonable cause to suspect, on the basis of their medical,
professional, or other training and experience, that a child who has come
before them in their professional or official capacity is an abused child. 23
Pa.C.S. § 6311.
10
   Neither UPMC nor Maxim asserts the principle that, generally, one is not
liable for the physical harm caused by a third party’s criminal conduct, even
if the actor’s negligent conduct created the situation which afforded the
opportunity for the third person to commit the tort or crime, as that
intentional tort or crime is a superseding cause of harm. The exception to
that rule, however, is the situation where the actor at the time of his
negligent conduct realized or should have realized the likelihood that such
a situation might be created, and that a third person might avail himself of
(Footnote Continued Next Page)


                                           - 20 -
J-A07013-16



plaintiffs’ child and Tri-County National Organization, the latter only owed

the general duty imposed on all persons not to place others at risk of

reasonably foreseeable harms and did not include a duty to report the

abuser.    See Schmoyer v. Mexico Forge, Inc., 649 A.2d 705, 708

(Pa.Super. 1994) (Absent a special relationship, the duty that one person

owes to another is "the general duty imposed upon all persons not to expose

others to risk of injury which are reasonably foreseeable[."])

      Maxim argues that, as in Tri-County, it had no relationship with either

Plaintiffs or Kwiatkowski at the time Plaintiffs were exposed to Kwiatkowski

and, hence, no duty.          Furthermore, it alleges that the consequences of

holding it liable for Kwiatkowski’s conduct go far beyond the cost of making

a telephone call.        It characterizes Plaintiffs’ position as seeking to hold

Maxim liable in perpetuity for injuries caused by any former employee. It

advances the same position found persuasive by the trial court: that in the

                       _______________________
(Footnote Continued)

the opportunity to commit such a tort or crime. See Restatement (Second)
of Torts § 448 (1965) (Intentionally Tortious Or Criminal Acts Done Under
Opportunity Afforded By Actor's Negligence) (emphasis added).            Other
exceptions include situations where “(a) a special relationship exists between
the actor and the third person's conduct, or (b) a special relationship exists
between the actor and the other that gives the other a right to protection.”
See Emerich v. Phila. Ctr. for Human Dev., Inc., 720 A.2d 1032, 1036
(Pa. 1998) (holding that the special relationship between a mental health
professional and his patient may, in certain circumstances, give rise to an
affirmative duty to protect and warn patient’s intended victim); see Feld v.
Merriam, 485 A.2d 742, 746 (Pa. 1984) (holding landlord has duty to
protect tenants from the foreseeable criminal acts of third persons).



                                           - 21 -
J-A07013-16



event of a simple employee error in failing to report, it could be subject to

potentially limitless liability.

      UPMC, like the trial court, relies upon Seebold in refuting the

establishment of a new affirmative duty of care on UPMC to protect unknown

third parties.   It cites Seebold for the proposition that it had “no duty to

protect or rescue someone who is at risk on account of circumstances the

defendant had no role in creating.” Seebold at 655 (citing e.g., Yania v.

Bigan, 155 A.2d 343, 346 (Pa. 1959) and Section 314 of the Restatement of

Torts for the proposition that a mere observer has no duty to rescue).

      In Seebold, a corrections officer sued Prison Health Services (“PHS”),

the contractor who provided medical care at the prison, when she contracted

a contagious bacterial infection after strip-searching a dozen infected

inmates.    She alleged that PHS knew or should have known the inmates

were infected and should have warned staff and taken precautionary

measures. The trial court sustained preliminary objections, finding PHS did

not owe a duty to protect the health of a prison staff member; it owed a

duty only to its patients.

      This Court reversed. We held that physicians treating a patient with a

communicable disease had a duty to warn third persons who would be

foreseeably likely to contract the contagious skin disease.    The Supreme

Court reversed this Court, finding first that the standard of care for a

physician treating a patient with a communicable disease was to advise the

                                    - 22 -
J-A07013-16



patient about the nature of the disease, treat the disease, and inform the

patient how to prevent its transmission to others. The Court continued that

a physician had no duty to third persons outside the doctor-patient

relationship.   The Court concluded that there was no special relationship

between PHS and the plaintiff, and “no duty to protect or rescue someone

who is at risk on account of circumstances the defendant had no role in

creating” in the absence of such a special relationship. Seebold, 57 A.3d at

1246.

        According to UPMC, in order to proceed, Plaintiffs’ theory of liability

would either have to fall either within an exception to the no-duty rule in

rescue scenarios, or the application of the Althaus factors would have to

militate in favor of creating a new affirmative duty. Appellee UPMC’s brief at

10.   Since there was no special relationship between UPMC and Plaintiffs,

UPMC maintains there is no applicable exception to the no-duty rule. As to

the Althaus factors, UPMC argues that the lack of a special relationship

between the parties militates against the imposition of a new affirmative

duty. Additionally, UPMC takes the position that the social utility of imposing

a duty to report upon a health care provider is outweighed by the lack of

foreseeability. In response to Plaintiffs’ contention that foreseeability in the

duty context need only be of the general type of harm, UPMC downplays the

importance of foreseeability in our duty determination.         See Seebold,

supra at 1249 (finding foreseeability alone not determinative of duty).

                                     - 23 -
J-A07013-16



UPMC characterizes Plaintiffs’ attempt to impose a duty to protect all health

care patients as “entirely unworkable and overarching.”      Appellee UPMC’s

brief at 16.

      As to the fourth Althaus factor, UPMC argues that the cost of

imposing a duty to report includes the consequences: open-ended and

limitless liability “unchecked by the passage of time, proximity or scope of

harm.” Appellee UPMC’s brief at 17 (quoting Trial Court Opinion, 6/20/13, at

14). It reiterates the trial court’s assumption that, although UPMC intends to

comply with all federal reporting regulations, the inevitable employee error

could result in onerous consequences.

      We find Seebold distinguishable as we are not dealing with a

physician-patient relationship.   Seebold presented the issue of whether

PHS, a health care provider, owed a duty of reasonable care to warn or

otherwise protect a prison guard charged with strip-searching inmates from

the dangers of the transmission of MRSA from its patients.      Our Supreme

Court declined to impose a duty upon a health care provider involved in a

physician/patient relationship to warn at-risk third parties, finding that

considerations such as physician-patient confidentiality and protection of the

physician-patient relationship outweighed considerations favoring imposition

of a duty to warn. Our High Court acknowledged that it had imposed a duty

upon a health care professional to convey information to a third party that

he obtained within the confines of the physician-patient relationship in

                                    - 24 -
J-A07013-16



Emerich v. Phila. Ctr. for Human Dev., Inc., 720 A.2d 1032 (Pa. 1998)

(therapist had a duty to warn his patient’s intended victim of the harm but

duty limited to readily-identifiable individuals).           The Court declined,

however, to use Emerich, “unique in many respects,” as “a springboard for

the imposition of new and broader duties upon health care providers vis-à-

vis third party non-patients.” Id. at 1233.

       While the Seebold Court noted other considerations independent of

the physician-patient relationship, such as prison order and security, the

difficulty in identifying persons at risk in the prison, and access to and the

ability to disseminate the information, which weighed against imposition of a

duty on the facts therein, the decision turned on the physician-patient

relationship. Our High Court refused to impose on physicians engaged in a

physician-patient relationship “some non-specified affirmative obligation

to   third-party non-patients        relative   to   communicable   diseases,”   with

individual juries deciding what the duty would be.11          Herein, UPMC echoes

PHS’s argument that policy considerations counteract such an overly

expansive exposure of health care providers to unlimited liability.

       The fact that Kwiatkowski was an employee of UPMC and Maxim, not a

patient, sharply distinguishes the instant case from Seebold.             Absent a
____________________________________________


11
   In his dissenting opinion, then-Justice McCaffrey took the position that
any alleged failure to warn was the result of the physicians’ failure to
properly diagnose MRSA.



                                          - 25 -
J-A07013-16



physician-patient relationship, we need not be concerned with the policy

considerations of privilege and confidentiality flowing from that relationship,

and which create a tension with any duty to report, warn, or protect third

parties at risk. See DiMarco v. Lynch Homes-Chester County, Inc., 583

A.2d 422 (Pa. 1990) (physician owed duty to his patient, not her boyfriend,

to warn and advise about avoiding spread of communicable disease);

compare e.g., Troxel v. A.I. Dupont Inst., 675 A.2d 314 (Pa.Super.

1996) (injured third party could maintain action against physician who failed

to advise his patient of the dangers of spreading her disease to unborn

children of others); Emerich, supra.

      Secondly, while we agree with UPMC and Maxim that they had no

special relationship with Plaintiffs, our inquiry does not end there.   Where

the defendant stands in some special relationship with the person whose

conduct needs to be controlled, a duty may be imposed.           Brezinski v.

World Truck Transfer, Inc.,         755      A.2d 36, 40   (Pa.Super. 2000).

Kwiatkowski was allegedly an employee of UPMC and Maxim when the duty

to report arose.   A special relationship may include a master's duty to

control a servant. See Restatement (Second) of Torts, § 317 (recognizing

master is under a duty in certain circumstances “to exercise reasonable care

so to control his servant while acting outside the scope of his employment as

to prevent him from intentionally harming others or from so conducting

himself as to create an unreasonable risk of bodily harm to them”).         In

                                    - 26 -
J-A07013-16



addition, we have imposed a duty upon those in charge of individuals with

dangerous propensities to control those individuals. See Restatement

(Second) of Torts § 319 (“One who takes charge of a third person whom he

knows or should know to be likely to cause bodily harm to others if not

controlled is under a duty to exercise reasonable care to control the third

person to prevent him from doing such harm.”);12 see also Goryeb v.

Commonwealth, Dep't of Public Welfare, 575 A.2d 545, 549 (Pa. 1990)

(finding duty to protect "others" who could foreseeably be affected by a

wrongful discharge of a mental patient consistent with Section 319 of the

Restatement (Second) of Torts and our own prior case law).

       UPMC is quick to point out that the master’s duty with regard to a

servant only exists where the servant is upon the master’s premises, using

the master’s chattel, or upon premises he is privileged to enter only due to

his status as the master’s servant, circumstances that it contends are not

applicable herein. It does not address a duty under the principles espoused

in § 319.


____________________________________________


12
   Generally, one is not liable for the physical harm caused by the criminal
conduct of a third party unless a special relationship exists between the
actor and the third person’s conduct or a special relationship exists between
the actor and the other that gives the other a right to protection. Emerich
v. Phila. Ctr. for Human Dev., Inc., 720 A.2d 1032 (Pa. 1998); see Feld
v. Merriam, 485 A.2d 742 (Pa. 1984) (landlord has duty to protect tenants
from the foreseeable criminal acts of third persons).



                                          - 27 -
J-A07013-16



      Although there was no relationship between UPMC and Plaintiffs

herein, Plaintiffs have pled facts that, if proven, could support a finding of a

special relationship between UPMC and Maxim and Kwiatkowski. At the time

the alleged duty arose, Kwiatkowski was the employee/agent of Maxim and

UPMC, and both entities knew that Kwiatkowski was diverting intravenous

drugs that he accessed on UPMC’s premises. Kwiatkowski injected himself,

replaced the drugs with saline, and placed the contaminated needles and

syringes back on the shelf to be used on unsuspecting patients.           UPMC

communicated the nature of Kwiatkowski’s criminal conduct to Maxim, and

banned him from its facilities. While Kwiatkowski was in the charge of UPMC

and Maxim, both entities knew he was dangerous and likely to cause bodily

harm to others if not controlled.    Reasonable care, according to Plaintiffs,

entailed reporting Kwiatkowski to law enforcement.

      We find that Plaintiffs pled facts that could conceivably support

imposition of a duty of care upon both UPMC and Maxim to others based on

their special relationship with Kwiatkowski.   Additionally, application of the

Althaus factors on the facts as gleaned from the pleadings weigh in favor of

imposing a duty to report. Duty is predicated upon the relationship existing

between the parties at the relevant time. Althaus, at 1169. There was a

special relationship between Kwiatkowski and UPMC and Maxim when the

alleged duty to report arose, i.e., when Kwiatkowski’s theft and substitution

of controlled substances were exposed. Additionally, UPMC and Maxim knew

                                     - 28 -
J-A07013-16



that Kwiatkowski’s addiction, diversion, and substitution of drugs presented

a danger to patients at facilities where he worked, not just UPMC’s patients.

      As to the social utility of UPMC and Maxim’s conduct, the second

Althaus factor, it is indisputable that UPMC provides critical health care

services and Maxim plays a role in providing the necessary staffing to

perform those services.     However, imposing a duty to report upon health

care providers and staffing agencies will not unduly hinder such entities from

performing their vital functions, and in fact, would operate to their benefit in

protecting   these   entities   from    unwittingly   hiring   drug-impaired   and

unreasonably dangerous health care workers. Furthermore, reporting is not

such an arduous task as to divert attention or resources from the mission of

providing quality health care.         UPMC is already required to report the

diversion of controlled substances under both federal and state law.

Pursuant to 63 P.S. § 422.4, hospitals are required to report impaired

physicians to the state board of medicine.            See Cooper v. Frankford

Health Care Sys., 960 A.2d 134 (Pa.Super. 2008).

      The third factor, the risk presented by the diversion, adulteration, and

substitution of medications, weighs heavily in favor of imposing a duty. The

risk was a serious and foreseeable one to UPMC and Maxim.             As Plaintiffs

correctly state, foreseeability in the context of duty “means the likelihood of

the occurrence of a general type of risk rather than the likelihood of the

occurrence of the precise chain of events leading to the injury.” Charlie v.

                                        - 29 -
J-A07013-16



Erie Ins. Exch., 100 A.3d 244, 256 (Pa.Super 2014). Plaintiffs pled that,

due to the failure of UPMC and Maxim’s failure to report Kwiatkowski to the

DEA or other law enforcement agencies, he gained access to other health

care facilities, exposing the patients in those facilities to the same risk of

contaminated      needles,    and    the   transmission   of   life-threatening

communicable diseases such as HIV and hepatitis C.

       As to the fourth Althaus factor, we are not persuaded that the

imposition of a duty to report is so onerous as to be “entirely unworkable or

overarching” as UPMC contends. Appellee UPMC’s brief at 16. Nor do we

cower from claims of exposure to “limitless liability unchecked by the

passage of time, proximity, or scope of harm” for what could be a mere

clerical error.   Id.   Imposition of a duty is but the first step in imposing

liability.   Recovery hinges on proof of breach and causation, and we

recognize that it becomes more difficult to prove the latter with the

intervening circumstances that come with the passage of time.

       Finally, we find that the fifth Althaus factor, consideration of the

overall public interest, favors the imposition of a duty of care.      It was

foreseeable that Kwiatkowski’s conduct, if unchecked, would place other

hospital patients such as the Plaintiffs at risk for the transmission of an

infectious blood-borne disease. The public health interest in preventing the

transmission of blood-borne pathogens, especially HIV and hepatitis C, is

evidenced by the many statutes and regulations requiring health care

                                      - 30 -
J-A07013-16



providers to report incidences of these and other communicable diseases.

This Commonwealth imposes criminal liability upon a health care practitioner

or facility “who treats or examines a person who is suffering from, or who

the health care practitioner or health care facility suspects, because of

symptoms or the appearance of the individual, of having a reportable

disease, infection or condition,” but who fails to report that fact to the Health

Department. See 28 Pa. Code § 27.21a. “Hepatitis, viral, acute and chronic

cases” are among the infections/conditions reportable within five days of

being identified. Id. at (b)(2); see The Disease Prevention and Control Law

of 1955, 35 P.S. § 521.1.

      UPMC banned Kwiatkowski from its facilities and informed Maxim of his

conduct.     Such action evidences UPMC’s appreciation of the danger

Kwiatkowski posed to its patients.     Maxim, despite being fully informed of

the danger Kwiatkowski presented, did not report Kwiatkowski to law

enforcement.    Plaintiffs contend herein that Maxim placed Kwiatkowski at

other health care facilities, knowingly and intentionally exposing other

patients to the possibility of contagion.         The risk of not reporting

Kwiatkowski to law enforcement and licensing agencies was that he would

seek employment and access to controlled substances to support his

addiction at other health care facilities and endanger patients in those

settings.   His practice of injecting himself and substituting saline for the

diverted substances presented an increased risk of serious infection to

                                     - 31 -
J-A07013-16



patients elsewhere due to contaminated needles and substances.            The

inference Plaintiffs ask us to draw is that the nature of Kwiatkowski’s

addiction, as well as his preferred mode of satisfying that addiction, made it

both foreseeable and highly likely that patients elsewhere would be exposed

to the unreasonable risk of contagion if he was not reported and stopped.

The unacceptable health risks involved, the likelihood of transmission of

blood-borne pathogens to compromised hospital patients, support the

finding of a duty to report.

      Were this but a simple drug diversion scenario, where a healthcare

professional stole drugs, injected himself, and properly disposed of the

needle and syringe, our primary concern would be for the welfare of patients

receiving diluted medications followed by overdoses, or being treated by an

impaired health care provider. See Cassella v. State Board of Medicine,

547 A.2d 506 (Pa.Cmwlth. 1988) (recognizing that drug-impaired medical

practitioners present a clear and obvious danger to the public).    The facts

herein certainly demonstrate that danger, as well as an even more perilous

scenario with far-reaching public health consequences.

      Kwiatkowski was engaged in criminal behavior that constituted a

serious public health risk. In light of Kwiatkowski’s occupation as a health

care worker, his addiction to fentanyl, his known diversion and substitution

of drugs to conceal his habit, we agree with Plaintiffs that it was highly

foreseeable to UPMC and Maxim that, left unchecked, Kwiatkowski would

                                    - 32 -
J-A07013-16



seek employment and access to drugs at other health care facilities and

continue that practice.   UPMC and Maxim had a special relationship with

Kwiatkowski when his drug diversion and substitution was detected, and

they knew and appreciated the danger he presented to patients generally.

In these circumstances, we find that Plaintiffs pled facts that could support

imposition of a common law duty of care upon both UPMC and Maxim to

report Kwiatkowski’s criminal conduct to the DEA and/or other law

enforcement agencies for prosecution.        See 21 C.F.R. § 1301.76(b)

Supplementary Information (“Lack of prompt notification could prevent

effective investigation and prosecution of individuals involved in the

diversion of controlled substances.”).

                   II. Negligence per se against UPMC

      Plaintiffs advance a second theory of liability against UPMC, which was

rejected by the trial court. They pled that UPMC is a registrant permitted to

possess and dispense controlled substances under the Controlled Substances

Act (the “CSA”).    Registrants under the CSA have a duty pursuant to 21

C.F.R. § 1301.76(b), to report the diversion of controlled substances to the

Drug Enforcement Agency (“DEA”) within forty-eight hours of discovery to

facilitate investigation and prosecution. Plaintiffs contend that UPMC failed

to report Kwiatkowski’s diversion of its controlled substances to the DEA and




                                    - 33 -
J-A07013-16



that the violation of the reporting statute constitutes negligence per se.13

The trial court disagreed, finding there was “nothing in the legislation or

accompanying regulations suggesting that drug diversion by healthcare

employees and its risks to patients are specific subjects that the Controlled

Substances      Act   addressed.”        Trial     Court   Opinion,   6/20/13,   at   6.

Furthermore, the court found the statute was intended to protect the

interests of the general public rather than a specific group of persons

encompassing Appellants.

       Negligence per se is defined as “conduct, whether of action or

omission, which may be declared and treated as negligence without any

argument or proof as to the particular surrounding circumstances.” Wagner

v. Anzon, Inc., 684 A.2d 570, 574 (Pa.Super. 1996) (quoting Black's Law

Dictionary, p. 933 (5th ed. 1979)).            We start with the premise that, since

ordinances and statutes regulate conduct, they also may impose legal

obligations on individuals.       McCloud v. McLaughlin, 837 A.2d 541, 545

(Pa.Super. 2003). As this Court stated in McCloud, “[n]egligence per se is

____________________________________________


13
   Pennsylvania has the Controlled Substance, Drug, Device and Cosmetic
Act, 35 P.S. § 780-101 et seq., which like the federal statute classifies
substances such as fentanyl as Schedule II substances with a high potential
for abuse and dependence. Regulations promulgated pursuant to that
legislation require “Persons maintaining stocks or having controlled
substances in production areas or on hand for distribution shall provide
effective controls and procedures to guard against theft and diversion of
substances.” 28 Pa.Code § 25.61(a).



                                          - 34 -
J-A07013-16



the law's acknowledgement that through an individual's violation of a statute

or ordinance, it is possible to show that the individual breached his duty to

behave as a reasonable person, i.e., that the individual was negligent.” Id.

      However, a court will not use a statute or regulation as the basis of

negligence per se where the purpose of the statute is to "secure to

individuals the enjoyment of rights or privileges to which they are entitled

only as members of the public."    Centolanza v. Lehigh Valley Dairies,

635 A.2d 143, 150 (Pa.Super. 1993), aff'd, 658 A.2d 336 (Pa. 1995)

(quoting Restatement (Second) of Torts, § 288(b) (1965)).       Furthermore,

before an individual can be held to be negligent per se, his violation of the

statute or ordinance must “cause harm of the kind the statute was intended

to avoid and to a person within the class of persons the statute was intended

to protect."   See Dan B. Dobbs, The Law of Torts § 134 (2000).        These

requirements are calculated to ensure that the policy behind the legislative

enactment will be appropriately served by using it to impose civil liability.

Lutz v. Chromatex, Inc., 718 F. Supp. 413, 428 (M.D. Pa. 1989). Even

then, negligence per se only supplies the first two elements of negligence:

duty and breach.     J.E.J. v. Tri-County Big Brothers, supra at 585;

Cabiroy v. Scipione, 767 A.2d 1078, 1079 (Pa.Super. 2001). There can be

no recovery absent proof that negligence was the cause of the injury.

Schemberg v. Smicherko, 85 A.3d 1071, 1074 (Pa.Super. 2014) (citing

Mahan v. Am-Gard, Inc., 841 A.2d 1052, 1058-1059 (Pa.Super. 2003).

                                   - 35 -
J-A07013-16



      Thus, to proceed on a negligence per se theory, a plaintiff must prove

the purpose of the statute, at least in part, was to protect the interest of a

specific group of individuals, as opposed to the general public, and that the

statute or regulation clearly applied to the defendant’s conduct. In order to

recover, the plaintiff must also prove that the defendant violated the statute

or regulation and that the violation was the proximate cause of injury.

      The application of negligence per se is illustrated in several recent

decisions in this Court.   In Cabiroy, supra, we affirmed the trial court’s

reversal of its grant of a non-suit on a negligence per se theory where the

plaintiff offered proof that the defendant administered liquid silicone

injections that were never approved by FDA, which resulted in harm to the

plaintiff. This Court found that the statute that was violated was “designed

to protect an individual such as plaintiff from being administered a non-

labeled, non-sterile unapproved drug to avoid unexpected negative results.”

Cabiroy, supra at 1082. Proof of violation of the statute constituted proof

of duty and breach thereof, and it was up to the factfinder to determine if

that negligence was the cause of the injury.

      In Mahan, supra, plaintiff, a bank teller was shot and injured by an

off-duty private detective perpetrating a robbery. She sought and obtained

recovery on a negligence per se theory against the private detective’s

employer based on its admitted violation of the fingerprinting requirement of

the Private Detective Act, 22 P.S. § 23, in its hiring of the detective.   On

                                    - 36 -
J-A07013-16



appeal, the detective agency argued that the trial court erred first, in

admitting evidence that it violated the fingerprinting requirement as a basis

for finding negligence per se, and second, in permitting the jury to consider

whether the violation was the cause of harm to the teller, since the detective

had not committed any criminal acts in the past that would have been

discovered through fingerprinting.    This Court held that the evidence was

relevant and properly admitted, but that the agency’s failure to abide by the

statute was not the proximate cause of the plaintiff’s injuries.             We

acknowledged, based on Ford v. Jeffries, 379 A.2d 111, 115 (Pa. 1977),

that the agency could be liable for its negligence despite the detective’s

superseding criminal acts if, at the time of its negligent conduct, it realized

or should have realized the likelihood that such a situation might be created

and that the detective might avail himself of the opportunity to commit such

a tort or crime.   However, the detective’s impending criminal conduct was

not foreseeable since fingerprinting would not have disclosed any prior

criminal acts evidencing that the detective had a criminal propensity.

      Appellants   contend   that    the   purpose   of   the   CSA’s   reporting

requirement is, “at least in part, to prevent the harms associated with drug

diversion from befalling” its likely victims.   Appellants’ brief at 44.    They

direct our attention to the Code of Federal Regulations, specifically 21 C.F.R.

§ 1301.76(b), and the DEA’s “Supplementary Information” regarding the




                                     - 37 -
J-A07013-16



regulations, which addresses the requirement that registrants report drug

diversion:

             The purpose of immediate notification is to provide an
      opportunity for DEA, state, or local participation in the
      investigative process when warranted and to create a record that
      the theft or significant loss was properly reported. It also alerts
      law enforcement personnel to more broadly based circumstances
      to provide an opportunity for DEA, state, or local participation in
      the investigative process when warranted and to create a record
      that the theft or significant loss was properly reported. It also
      alerts law enforcement personnel to more broadly based
      circumstances or patterns of which the individual registrant may
      be unaware. This notification is considered part of a good faith
      effort on the part of the regulated industries to maintain
      effective controls against the diversion of controlled substances,
      as required by Sec. 1301.71(a). Lack of prompt notification
      could prevent effective investigation and prosecution of
      individuals involved in the diversion of controlled
      substances.

(emphasis added). Plaintiffs maintain that drug diversion affects them and

others like them, and UPMC’s violation of that reporting requirement was a

proximate cause of their injuries.

      UPMC counters that none of the statutes or regulations cited by

Plaintiffs is intended to protect a group of persons, rather than the public as

a whole.     Furthermore, the statutes and regulations are not designed to

protect against the specific harm at issue: the diversion and substitution of

controlled substances by healthcare workers to patients.       See McCloud,

supra (violation of statute must cause harm of the type statute was

intended to prevent for negligence per se to apply).        UPMC directs our

attention to Gonzales v. Oregon, 546 U.S. 243, 250-51 (2006), where the


                                     - 38 -
J-A07013-16



United States Supreme Court construed the main objectives of the CSA as

“combatting drug abuse and controlling the legitimate and illegitimate traffic

in controlled substances.”

      Congress enacted the CSA as Title II of the Comprehensive Drug

Abuse Prevention and Control Act of 1970, Pub. L. No. 91-513, 84 Stat.

1236 (1970) (codified at 21 U.S.C. §§ 801-904).          As the United States

Supreme Court noted in United States v. Moore, 423 U.S. 122, 132 (U.S.

1975), “the Act was intended to ‘strengthen,’ rather than to weaken,

‘existing law enforcement authority in the field of drug abuse.’    (citing 84

Stat. 1236 (1970) (Preamble); see also H. R. Rep. No. 91-1444, p. 1. ("This

legislation is designed to deal in comprehensive fashion with the growing

menace of drug abuse in the United States[.]").

      In enacting the statute, Congress recognized that “(1) Many of the

drugs included within this title have a useful and legitimate medical purpose

and are necessary to maintain the health and general welfare of the

American people.” 21 USCS § 801. Nonetheless, it required “[e]very person

who dispenses, or who proposes to dispense, any controlled substance,” to

“obtain from the Attorney General a registration issued in accordance with

the rules and regulations promulgated by him.” 21 USCS § 822(a)(2).

      The   regulations require   registrants,   those   entities and persons

authorized to manufacture, possess, distribute or dispense controlled

substances, to physically secure controlled substances. In addition, they are

                                    - 39 -
J-A07013-16



not permitted “to employ, as an agent or employee . . . who has access to

controlled substances, any person who has been convicted of drug-related

felony offense.” 21 CFR § 1301.76(a). Furthermore, a registrant is required

to report the diversion of controlled substances to the DEA in certain

circumstances. 21 CFR 1301.76(b).

       It is apparent that the regulations in question are calculated to ensure

that controlled substances in the possession of registrants are properly

secured.      The prohibition against the employment of convicted drug

offenders indicates an awareness of the potential for drug abuse by health

care practitioners, workers, researchers, and pharmacists with lawful access

to drugs through their employment. The reporting requirement is intended

to alert the DEA when legitimately possessed controlled substances are

diverted so that it can investigate and prosecute the individuals responsible.

We are persuaded that the reporting requirement was intended to protect

the public from the dangers associated with the diversion, trafficking, and

abuse of controlled substances in the possession of registrants, i.e.,

hospitals and pharmacies and other licensed persons and entities, by

subjecting diverters to criminal prosecution.14

____________________________________________


14
    The CSA also authorizes the DEA to take administrative, civil, and
criminal action against any registrant that fails to maintain effective controls
against diversion. Administrative actions include a letter of admonition for
minor recordkeeping or reporting violations, or hearings for more serious
(Footnote Continued Next Page)


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      As a registrant under the Act, UPMC was allegedly required to report to

the DEA Kwiatkowski’s known diversion and substitution of its controlled

substances.     Its failure to do so in 2008 effectively foreclosed any DEA

investigation and prosecution of Kwiatkowski at that time.      Such reporting

was intended to protect against the harmful consequences of drug abuse,

including the type of harm that resulted herein.

      Nonetheless, we agree with the trial court that there is no indication in

the CSA or its regulations that the reporting requirement was intended to

protect a particular group to which Plaintiffs belonged.            The CSA’s

comprehensive enforcement scheme is calculated to protect the public from

the dangers resulting from the diversion of drugs and their abuse. We note

that the CSA does not expressly provide for a private right of action but that

fact is not dispositive of the statute’s use as the basis for negligence per se.

However, absent herein is any indication that the purpose of the statute is to




                       _______________________
(Footnote Continued)

violations. An order to show cause is usually reserved for a registrant’s
ongoing failure to maintain controls against diversion, and can result in
revocation of registration. The DEA is empowered to pursue civil actions
through the U.S. Attorney’s office for monetary penalties for violations of the
recordkeeping and reporting requirements of the CSA. Registrants are also
subject to criminal prosecution for knowing and intentional acts in the
unlawful manufacture and distribution of controlled substances. See 65
Food Drug L.J. 623, 627-628, for an expansive explanation of possible
liability of registrants for violations of the CSA and its regulations.



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J-A07013-16



protect a particular group of individuals encompassing Plaintiffs.15 See K.H.

ex rel. H.S. v. Kumar, supra at 1087-90 (citing J.E.J., supra at 586, for

proposition that while a violation of the Child Protective Services Law

(“CPSL”) could serve as the predicate for a negligence per se claim, the

minor-plaintiff fell outside the class of children protected by the statute as

he was not connected to the entity bearing the mandatory reporting

obligations). For this reason, we affirm the trial court’s order sustaining the

demurrer as to Plaintiffs’ negligence per se claim against UPMC.

       Order affirmed in part and reversed in part.       Case remanded for

further proceedings consistent with this opinion.    Jurisdiction relinquished.

       Judge Mundy Joins the Opinion

       Judge Jenkins files a Dissenting Opinion.




____________________________________________


15
   After a duty has been established, a statute or regulation may be
admissible evidence of the requisite standard of care. See Brogley v.
Chambersburg Engineering Co., 452 A.2d 743 (Pa.Super. 1982)
(sanctioning admission of evidence of OSHA regulation and its violation as
probative of employer’s negligence).



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J-A07013-16




Judgment Entered.




Joseph D. Seletyn, Esq.
Prothonotary



Date: 7/21/2016




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