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EFiled: Jan 23 2019 05:19P! iE
Transaction ID 62891801
Case No. N16A-11-001 JAP pi)
IN THE SUPERIOR COURT OF THE STATE OF DELAWARE Qa
BRUCE GROSSINGER, D.O.
Appellant,
Vv. C.A. No. N16A-11-001 JAP
DELAWARE BOARD OF
MEDICAL LICENSURE
AND DISCIPLINE,
Appellee.
MEMORANDUM OPINION
This is an appeal from a Final Order (“Order”) of the Board of
Medical Licensure and Discipline (the “Board”) imposing disciplinary
sanctions on Dr. Bruce Grossinger! for alleged violations of several
its regulations relating to the treatment of patients with pain
medications. The court reverses the Board on all but one of its
holdings that Dr. Grossinger violated the regulations, affirms the
remaining holding and remands the case for a determination as to
what, if any, discipline is appropriate for the affirmed violation.
i For purposes of this opinion, “Dr. Grossinger” refers to Dr. Bruce Grossinger.
With two exceptions, the regulations as applied to Dr.
Grossinger did not provide him with constitutionally adequate notice
of what was required of him under the facts of this case. To cure this
vagueness, it is necessary to superimpose the standard of care onto
the regulations in order to give them meaning. According to the
State, the Board relied upon its own expertise to supply evidence of
the standard of care.? Yet, standard of care evidence must be proven
by an expert evidence which was not offered by the State and cannot
otherwise be gleaned from the record.? By determining the standard
of care on its own (and thus imbuing the regulations with meaning)
the Board deprived Dr. Grossinger of his constitutional right to
confront the evidence against him. Therefore, the findings that Dr.
Grossinger violated these particular regulations will be reversed.
Of the two remaining Board decisions, one must be reversed
since the regulation was misinterpreted by the Hearing Officer and
the Board. The other violation -- finding that Dr. Grossinger violated
a regulation relating to informed consent -- is affirmed, as the
2 State’s Answering Br., D.I. 23, at 24.
3 See United Water Del., Inc. v. PSC, 723 A.2d 1172, 1176 (Del. 1999) (“[AJn administrative
agency may apply its institutional expertise in the evaluation of conflicting evidence but may
not under that guise, create evidence.”) (citing Turbitt v. Blue Hen Lines, 711 A.2d 1214, 1216
(Del. 1998).
2
Hearing Officer’s conclusion in this regard is supported by
substantial evidence.
PROCEDURAL HISTORY
Appellant Dr. Bruce Grossinger is a physician employed in a
three-physician practice known as Grossinger Neuropain Specialists
(“GNS”) which specializes in pain management. In January 2014, a
patient referred to as “Michael” began treatment of chronic pain with
GNS. Regrettably Michael died, on December 12, 2014, from a heroin
overdose.
Three days after Michael’s death, his mother filed a complaint
against GNS and its three physicians with the Division of Professional
Regulation (the “Division”), which then investigated the matter. After
the investigation was complete, the State filed separate formal
complaints against all three physicians at GNS with the Board and
with the Secretary of State (the “Secretary”).4 Because the matters
were largely based on the same facts, the parties agreed to a
consolidated evidentiary hearing in front of a Hearing Officer.5 The
4 The complaint fell within the jurisdiction of two regulatory agencies: (1) the Board, and (2) the
Secretary — the latter of which is charged with enforcing certain regulations relating to the
prescription of controlled substances. Separate complaints were filed with each regulatory
agency against each of the three physicians.
8 Grossinger’s Opening Br., D.I. 21, at 1.
Hearing Officer conducted an evidentiary hearing spanning two days
and received substantial written submissions from the parties.6 In
his opinions, the Hearing Officer found that all three respondents
were guilty of regulatory violations in both the Board and the
Secretary matters, and recommended discipline for all three.7 In his
Recommendation in the Dr. Bruce Grossinger matter before the
Board (the “Recommendation”), the Hearing Officer found Dr.
Grossinger violated several of the Board’s regulations and
recommended that the doctor be disciplined:
Bruce Grossinger, D.O. failed to comply with Board rules and
regulations when he failed to document the patient’s history of
substance abuse, he failed to discuss the benefits and risks of
controlled substance treatment in the absence of record of such
discussion with the patient, he failed to order urine samples or
require pill counts from the patient prior to prescribing substances
over a period of six months when no record of such provision was
present in the patient’s file, Dr. Bruce Grossinger failed to
periodically review the course of the patient’s pain treatment and
any new information on the etiology of his pain and the state of his
health, and he failed to keep accurate and complete records
pertaining to the patient.’
The Board adopted the findings that Dr. Grossinger violated its
regulations, but reduced the discipline recommended by the Hearing
Officer.
6 Inthe Matter of Bruce Grossinger, Recommendation of Chief Hearing Officer at 3, Case No. 10-
168-14 (July 13, 2016) (hereinafter, “Recommendation’).
7 The Hearing Officer opined separate recommendations for the Board and the Secretary.
8 Bd. Order at 1 (Oct. 4, 2016).
4
Only Dr. Bruce Grossinger has appealed from the Board’s
judgment.? During the course of the appeal the parties made several
written submissions at the court’s request and the parties appeared
for multiple oral arguments, including the final one in which the
court advised counsel in advance of the topics it wished to discuss.
This is the court’s ruling.
FACTS
This appeal is about the care provided to a 38-year-old patient
by the name of Michael in 2014 by Grossinger Neuropain Specialists
which, as the name suggests, specializes in the treatment and
management of pain. Three physicians employed by GNS during this
period - Dr. Jason Brajer, Dr. Steven Grossinger and Dr. Bruce
Grossinger - each played a role in the treatment of Michael.
The matter has its roots in 2008 when Michael injured his neck,
shoulder, and right arm in a motor vehicle accident.!° In 2011, he
was in a second car accident which aggravated his 2008 injuries and
caused new injuries to his left side.1!_ Michael sought treatment for
9 Appeals from the Secretary’s ruling are addressed in a separate opinion of the court. Bruce
Grossinger, et. al. v. Jeffrey W. Bullock, Delaware Secretary of State, appeal docketed, No. N17A-
02-004 (Del. Super. Ct. 2017).
10 Recommendation at 31-32.
Id.
these injuries from several physicians between 2008 and 2014. He
initially treated with Dr. Ross Ufberg, who discharged Michael in
March 2011 due to inconsistencies in his drug urine screen.!2
Michael then began treatment with others and at some time became
addicted to opioids., and in December 2013, he began treatment with
Dr. Irwin Lifrak for opioid detoxification.!* Opioids were not Michael’s
only problem, however; he told Dr. Lifrak that he used heroin daily
and that he had done so for the past six years with only intermittent
periods of sobriety.14 Dr. Lifrak prescribed Suboxone to Michael, who
began taking the medication on December 2013.15 This treatment
was short-lived -- Dr. Lifrak discharged Michael as a patient just one
month after the treatment began because Michael’s toxicology screen
report had produced “dirty urine.”1!6
Michael’s Initial Treatment with GNS
When Dr. Lifrak discharged Michael as a patient, his primary
care physician referred Michael to GNS for further treatment.!”? As
12 Id. at 32.
13 Recommendation at 33.
14 Id.
15 Id.
16 Id. at 34. During his testimony at the hearing, Dr. Steven Grossinger defined a “dirty
toxicology screen result” as “one which is inconsistent with prescribed medications, or one which
may disclose the use of illicit drugs.” Id. at 22.
17 Id. at 8.
an incoming patient at GNS, Michael was evaluated by Dr. Allen
Silberman, an independent psychologist, who then provided a
“Psychotherapy Initial Evaluation” for GNS.!8 Dr. Silberman noted
in his evaluation report that Michael “suffers from an opiate addiction
that started five years ago as the result of Oxycodone and Morphine
prescriptions from his physician, and mentioned that Dr. Lifrak
“manages [Michael’s] Suboxone which is used for opiate
dependence.”!9 Dr. Silberman recommended continued
psychotherapy and treatment for Michael’s ongoing chronic pain.?°
The Hearing Officer found that GNS’s referral of Michael to Dr.
Silberman was a legitimate effort to treat Michael:
I find that Dr. Silberman’s “psychotherapy initial evaluation” was
not prepared gratuitously or to “paper” the GNS file. Rather, I find
that it was requested by GNS and was prepared to inform the care
offered to Michael by all GNS physicians, including Dr. Bruce
Grossinger. 2!
Dr. Bruce Grossinger’s Role in Michael’s Treatment
According to the Hearing Officer, out of the three GNS
physicians, Dr. Bruce Grossinger “was least involved in Michael’s
18 Recommendation at 8, 35. “Though his name appears on the GNS letter head, Dr. Allen
Silberman is an ‘independent’ psychologist who performs psychosocial studies and evaluates
pain status with respect to certain GNS patients and provides reports of his findings to the GNS
physicians.” Id. at 35.
19 Id. at 36.
20 Id.
21 Id. at 36-37.
care”22 as his role was limited to writing refill prescriptions on three
occasions:
The record in this case establishes that Dr. Grossinger’s only
involvement in Michael’s care was to write refill prescriptions for him
in July, September, and November 2014. . . . In signing the refill
scripts, Dr. Grossinger did not alter the type of drug or amount or
schedule of dosing reflected on scripts signed by his colleagues
previously. 2°
Notably the Hearing Officer found no evidence that Dr. Bruce
Grossinger was involved in planning or executing the course of
Michael’s pain treatment at GNS.24 At no time did Dr. Grossinger
have any physical encounter with Michael.
The Hearing Officer’s conclusion about the limited scope of Dr.
Bruce Grossinger’s role is confirmed by the summary of the course
of GNS care for Michael provided in the Recommendation.?5 The
court has included this summary and provided emphasis in bold to
highlight the encounters which involved Dr. Grossinger:
Feb, 26, 2014 Dr. Steven Grossinger performs
second EMG test; Dr. Bajer performs
cervical epidural injection
22 Id, at 53.
23 Id, at 44.
24 Bd. Order at 4. The evidence shows that Michael’s pain treatment was primarily pursued by
Dr. Steven Grossinger and Dr. Brajer. Both Dr. Steven Grossinger and Dr. Brajer were the
physicians who: attended the encounters with Michael, developed his medication regimen, and
performed his injection procedures; purportedly discussed pain etiology with him and his then-
current state of health; and assessed the appropriateness of Michael’s treatment plan, including
whether progress was satisfactory. Recommendation at 52-53.
25 Recommendation at 38-39.
8
March 18, 2014 Dr. Brajer performs second cervical
epidural steroidal injection; due to
acute low back pain, Meloxicam,
Tizandine and Tramadolprescribed
April 9, 2014 Dr. Brajer performs third cervical
epidural steroidal injection;
Thamadol discontinued;
Hydrocodone 5/325mg prescribed
April 17, 2014 Meloxicam and Tizandine refilled
April 30, 2014 Dr. Brajer performs first cervical
selective root injection; low back
issues “worsening”
May 8, 2014 Hydrocodone 5/325mg refilled
May 28, 2014 Dr. Brajer performs first cervical
facet injection; Dr. Brajer prescribes
Morphine Sulfate 15mg at nighttime;
Hydrocodone dosing reduced from
twice daily to once daily; Esgic
prescribed for headache
June 9, 2014 Hydrocodone 5/325mg dosing
adjusted; Morphine Sulfate 15mg
added
June 18, 2014 Appointment with Dr. Brajer
canceled due to “lapse in insurance”;
urine drug screen was to be
performed but sample could not be
collected
July 9, 2014 Hydrocodone 5/325mg and
Morphine Sulfate 15mg refilled by
Dr. Bruce Grossinger
July 30, 2014 Follow-up visit scheduled with Dr.
Brajer; injection cancelled because
coverage denied by insurance carrier;
Dr. Brajer increase Hydrocodone
dosing to twice daily and Morphine
Sulfate 15mg to once every 12 hours
9
Sept. 3 2014 Michael cancels appointment due to
illness
Sept. 11, 2014 Hydrocodone 5/325mg and
Morphine Sulfate scripts refilled
by Dr. Bruce Grossinger
Oct. 27, 2014 Appointment with Dr. Brajer
canceled by Michael
Nov. 12, 2014 Dr. Bruce Grossinger refills scripts
for Hydrocodone 5/325mg and
Morphine Sulfate 15mg. Dr.
Grossinger notes that Michael
must make and keep next
appointment to receive further
refill scripts
Dec. 8, 2014 Michael seen by Dr. Steven
Grossinger; urine sample provided
for screening; medications refilled
Dec.15, 2014 Michael discharged after receipt of
UDS results
Michael’s Death
On December 8, 2014, Michael presented to GNS for an
appointment with Dr. Steven Grossinger and gave a urine sample for
drug screening.26 One week later, on December 15, GNS received the
laboratory report which indicated that Michael tested positive for
heroin and negative for his prescribed medications.2” As a result,
GNS mailed a letter to Michael that day discharging him as a patient
26 Recommendation at 39.
27 Id.
10
of GNS.28 Tragically, Michael died on December 12, 2014 as a result
of a heroin overdose.?° Both the Hearing Officer and the Board found
that GNS’s treatment of Michael did not cause his death.9°
THE STATE’S CLAIMS
The Board of Medical Practice derives its authority to discipline
physicians from 24 Del. C. sec. 1731.31 Subsection (b) of that statute
provides 23 nonexclusive definitions of “unprofessional conduct.” At
present, the court is faced with the State’s claims arising under
subsection (b)(3),32 which defines “unprofessional conduct” as “[a]ny
dishonorable, unethical, or other conduct likely to deceive, defraud,
or harm the public.”33 Although not precisely articulated in its
professional complaint against Dr. Grossinger,*+ it appears the State
contended that he violated the Board’s regulations relating to
28 Id. at 38-39.
29 Id, at 40-41.
30 See supra note 5.
31 24 Del. C. § 1731 provides, in part: “A [physician] may be disciplined by the Board for
unprofessional conduct, as defined in subsection (b) of this section . . . ”
32 The State cited to subsections (b)(3) and (b)(11) of 24 Del. C. § 1731 in its complaint before
the Board. See State’s Compl., Case No. 10-168-14, at 2-3 (Oct. 15, 2015); App. To Appellee’s
Answering Br., D.I. 23, at B-180. The court need concern itself, however, with only subsection
(b)(3) because the Hearing Officer and the Board found no violation of subsection (b)(11) - which
defines “unprofessional conduct” to include a “pattern of negligence in the practice of medicine”
- because the State failed to prove a pattern of negligence by Dr. Grossinger. See
Recommendation at 57. The State did not take a cross-appeal from this finding and has not
otherwise argued to this court that the Board erred.
33 24 Del. C. § 1731(b)(3).
34 State’s Compl., Case No. 10-168-14 (Oct. 15, 2015); App. To State’s Answering Br., D.I. 23,
at B-180.
11
controlled substances which amounted to “other conduct [which
would] likely . . . harm the public.” The only regulations actually
cited in the Complaint in connection with the (b)(3) claims are
Regulations 8.1.12 and 8.1.13.35 Elsewhere in its Complaint, the
State alleged misconduct by Dr. Grossinger, but did not identify
specific regulations this alleged conduct supposedly violated.%° In his
Recommendation, the Hearing Officer was careful to link the conduct
alleged in the Complaint to specific regulations. Seeing as his
correlations are reasonable, and neither side has challenged them in
this appeal, the court will use them.
Turning to the factual allegations in this appeal, the State
contends that Dr. Bruce Grossinger’s alleged failure to do the
following amounts to unprofessional conduct:
1 Obtain the prior treatment records from Dr. Lifrak or otherwise
communicate with Dr. Lifrak regarding Michael’s care [Regulation 18.1.1];
2 Discuss and/or document that he had discussed risks and benefits
of the use of controlled substances with the patient [Regulation 18.3];
35 App. To State’s Answering Br., D.I. 23, at B-181.
36 ©The State also charged that Dr. Grossinger violated Regulation 18.2 because he failed to
utilize a written treatment plan addressing goals and objectives of treatment. The Hearing Officer
found there was insufficient evidence to support this finding, and the State has not cross-
appealed or otherwise challenged the Hearing Officer’s finding. No further discussion is therefore
needed.
12
3 Routinely order urine/serum medication level screening or utilize
other controls for evaluating prescription compliance [Regulation 18.4];
4 Periodically review the course of pain treatment and any new
information about the etiology of the pain and patient’s state of health
including an assessment of the appropriateness of the current treatment
plan if progress is unsatisfactory [Regulation 18.5]; and
5 Keep accurate, complete and accessible patient records including
documentation of etiology; treatment objectives; discussion of risks and
benefits; informed patient consents; treatments; medications including the
date, type, dosage and quantity prescribed; instructions to the patient;
agreements with the patient; and periodic reviews with interim histories,
physical examinations, assessments of progress and medication plans
[Regulation 18.7].37
PRELIMINARY MATTERS
Before beginning the analysis, it is necessary to devote brief
attention to some preliminary matters which are discussed below.
What is Being Reviewed?
One preliminary matter is a determination as to precisely what
is being reviewed here. The State asserts “[i]t is the Board’s Order
that is under review, not the Recommendation of the hearing
37 See State’s Answering Br., D.I. 23, at 29-32.
13
officer.”38 This is too narrow a view; both the Hearing Officer’s
Recommendation and the Board’s Order are subject to review
because the Board itself incorporated the Hearing Officer’s
Recommendation as part of its order, writing in part: “the hearing
officer report and recommendation is entered as an Order of the
Board.”39 Moreover, the Hearing Officer, not the Board, was the fact-
finder here.*° It is therefore impossible to judge whether there was
substantial evidence supporting the findings without reference to the
Hearing Officer’s Recommendation. Consequently, the court deems
that the decisions of the Hearing Officer, as well as the Board are
both proper subjects of review for the present appeal.*!
State’s Answering Br., D.I.23, at 35.
39 Bd. Order at 5 (Oct. 4, 2016).
40 Id. at 4.
41 Upon such review, the court determines:
[W]hether the Board’s decision is supported by substantial evidence and free from
legal error. Substantial evidence is such relevant evidence that a reasonable mind
would accept as adequate to support a conclusion. This Court does not act as the
trier of fact, nor does it have authority to weigh the evidence, decide issues of
credibility, or make factual conclusions. In reviewing the record for substantial
evidence, the Court must consider the record in the light most favorable to the
party prevailing below. The Court’s review of conclusions of law is de novo. Absent
an error of law, the Board’s decision will not be disturbed where there is
substantial evidence to support its conclusions.
Bilski v. Bd. of Med. Licensure & Discipline of Del., 2014 WL 3032703 (Del. Super. Ct. June 30,
2014), rearg. denied 2014 WL 5282115 (Del. Super. Ct. Oct. 16, 2014), aff'd, 115 A.3d 1214 (Del.
2015).
14
Must the State Prove Harm to the Patient?
Another preliminary matter is whether the State must show
harm in order to prove a violation of the medical regulations.*2 The
parties tacitly agree that the State need not do so, and the court
likewise agrees, primarily because none of the regulations are
conditioned upon a bad outcome. The issue is not entirely free from
doubt, however. The preamble to the regulations suggests that the
outcome of the treatment plays a significant role in the Board’s
assessment, declaring: “The practitioner's conduct will be evaluated
to a great extent by the outcome of pain treatment.”*3 This portion
of the preamble is at odds with the language of the regulations
themselves, which, as mentioned, are completely devoid of any
reference to the outcome of the treatment. The court will not imbue
the content of the regulations with a policy not supported by the
regulations themselves. For the same reasons the Supreme Court
held in Delaware Board of Nursing v. Francis*+ that the Board of
Nursing regulations did not require proof of harm. And former Chief
Justice Steele wrote, the “broad public policy statements in a
42 Both the Hearing Officer and the Board found that Dr. Grossinger’s conduct did not play a
role in Michael’s death. See supra note 5.
43 24 Del. Admin, C. § 1700.
44 195 A.3d 467 (Del. 2018).
15
statute's preamble do not govern the specific and explicit text of
unambiguous statutory provisions.”45 Therefore, the court holds that
any injury (or lack thereof) resulting from Michael’s treatment is
immaterial to the issues presented here
Does the APA Apply?
The court is presented with the question of whether the
Administrative Procedures Act (“APA”) is applicable to the instant
case. Though the parties cite to it for support of various propositions,
the APA plainly did not apply at the time of the hearing or at the time
of the board’s decision.*6 The hearing took place in April 2016 and
the Board’s decision was issued on October 4, 2016, but the APA was
43 Progressive N. Ins. Co. v. Mohr, 47 A.3d 492 (Del. 2012) (Steele J., dissenting).
46 “The State cannot merely allege that an act or omission violated the standard of care and
shift the burden to the physician to prove otherwise. See 29 Del. C. § 10125(c).” Grossinger’s
Opening Br., D.I. 21, at 17.
This Court has jurisdiction to entertain appeals from an administrative board’s
final order pursuant to the Delaware Administrative Procedures Act (“APA”). See
29 Del. C. §§ 10142 and 10102(4). A reviewing court must affirm an
administrative board’s order so long as the record below provides substantial
evidence to support the board’s decision and the board’s ruling is free from legal
error. See 29 Del. C. §10142(d) ... . “The Court, when factual determinations are
at issue, shall take due account of the experience and specialized competence of
the agency of the purposes of the basic law under which the agency has acted.”
29 Del. C. § 10142(d).... The Board’s decision to impose discipline on a licensee
should be affirmed so long as it is supported by substantial evidence and free from
legal error. 29 Del. C.§ 10142(d)....
State’s Answering Br., D.I. 23, at 18-32.
16
not made applicable to medical board hearings until July of 2017.47
The court will therefore disregard the citations to the APA.
Do the regulations apply in their entirety to a physician who merely
renews a prescription first written by a colleague?
The Hearing Officer went to great effort to distinguish the roles
each of the GNS physicians played in Michael’s care when
considering their respective culpability under the regulations:
Licensure cases such as this one, in my view, are directed at
the conduct of individual licensees. In other words, if three
physicians are employed in a pain management practice but only
two have assumed primary responsibility for the management of a
give patient’s chronic pain, the third is not liable for most
shortcomings in the planning by the other two under some sort of
vicarious liability theory. To my knowledge the law if professional
licensure does not provide for such blanket professional liability
across the entire practice. I can foresee cases in which such a rule
would be illogical and create mischief. Liability should only attach
to the license of the third physician if he took some form of active
role in structuring, approving or implementing a treatment plan.
There is no evidence in this case that Dr. Bruce Grossinger was
involved with Michael’s care of planning other than to write follow-
on scripts for Michael in accordance with the approach taken by his
GNS partners.*8
The Board seems to have taken the opposite view. In a terse,
isolated sentence buried in the penultimate paragraph of its opinion,
the Board wrote that “all three doctors should be treated the same
a7 The Board’s procedures were at one time governed by 24 Del. C. § 1734; however, the 2017
amendment struck virtually all of that section and substituted in its place the following:
“Hearings shall be conducted pursuant to the Administrative Procedures Act.” 24 Del. C. §
1734 (i) (effective July 21, 2017); 2017 Del. ALS 97, 81 Del. Laws 97, 2017 Del. SB 39.
48 Recommendation at 46-47.
17
because a covering doctor who merely refills a prescription is as
responsible as the treating doctors.”49 The Board cited no authority,
made no reference to the regulations to support this notion and
provided no analysis to support its conclusion. Indeed, it gave no
basis at all for its holding. Because of the manner in which this
appeal has been analyzed and resolved, it is unnecessary for the
court to reach the question whether this is a matter of regulatory
interpretation vested in the Board’s authority or whether it is a
question of law. The court believes, however, it is important to stress
that it expresses no opinion concerning this aspect of the Board’s
holding or any precedential effect it may have in future cases.
What does the court mean by “medical evidence”?
Throughout this opinion the court uses the term “medical
evidence.” That term is used advisedly. As discussed below, in some
cases before the Board, the standard of care becomes relevant. This
is one of them. In this court, the standard of care must ordinarily be
proven by an expert. But, evidentiary standards are relaxed in
hearings before the Board, and the court will not speculate as to
49 Bd. Order at 4 (Oct. 4, 2016).
18
whether something less than expert testimony is required by the
Board in order to prove the standard of care. This issue was never
litigated before the Board, nor, understandably, did the parties
address it in this appeal. The court will not decide the issue, but
save it for a later day when it is fully litigated. Suffice it to say for
now the court will used the deliberately vague term “medical
evidence.”
ANALYSIS
There is no dispute that due process requires a regulation must
give reasonable notice as to what it requires and what it prohibits.
Many of the regulations in question did not give Dr. Grossinger
reasonable notice as to what the Board ultimately found they
required. For example, the regulations dictate that a physician must
obtain the medical history of a new patient.5° From this, the Hearing
Officer and the Board extrapolated that the regulation, requires in
some but not all instances a physician to obtain medical records from
some unspecified previous providers, even though the regulation
makes no mention of such a requirement.5! Nor does it provide any
50 See 24 Del. Admin. C. § 1700-18.1.1.
51 Recommendation at 45; see Bd. Order at 4 (“The Board is bound by the findings of fact made
by the hearing officer”).
19
guidance as to when a physician must obtain prior records (and
which prior records) in order to comply with the rule.
The parties urge, and the court agrees, that it is impossible to
draft regulations which address every conceivable circumstance
arising during the course of medical treatment.52 The only way to
cure this is to interpret and apply the regulations in light of the
standard of care. These standards serve to supply the information
missing from the regulations. Presumably, all licensed physicians
are familiar with the standard of care and, therefore, they are charged
with knowledge of the standard of care as applied to the regulations.
The standard of care has long been held to be a factual issue
and an unbroken line of opinions have decided that, in almost all
instances, it must be proven by expert evidence.5? The State offers
no such expert evidence here nor can it be gleaned from the record;
instead, the State argues that it was not required to do so because
52 See Tr. of Oral Arg., D.I. 44, at 9-12 (Aug. 17, 2018); see Grossinger’s Opening Br., D.I. 21,
at 27.
83 See Ridgeway v. Acme Mkts., Inc., 194 A.3d 372 (Del. 2018) (holding that when the standard
of care requires resort to technical or other complex principles, the plaintiff must establish
the standard of care through expert testimony); Robinson v. J.C. Penney Co., 977 A.2d 899, 2009
WL 2158106, at *1 (Del. 2009) (TABLE) (holding that an expert was required to show
the standard of care owed by a security guard to a suspected shoplifter since "the standard of
care applicable to a professional can be established only through expert testimony"); Abegglan v.
Berry Refrigeration Co., 2005 WL 6778336, at *2-3 (Del. Super. Ct. 2005) (holding that the
plaintiff needed an expert to establish the standard of care because a tradesman repairing an ice
machine is a professional).
20
the Board, relying upon its own expertise, could alone determine the
appropriate standard of care.5+ But, Dr. Grossinger has a
constitutional right to hear and confront any evidence against him
concerning the standard of care. Allowing the Board to determine
the standard of care based on its own expertise deprives him of that
fundamental right.
An early preliminary word about the void for vagueness doctrine
is appropriate here. The constitutional vagueness doctrine has two
faces—facially void and void for vagueness as applied. In facial
vagueness cases “the challenger must show that the statute is invalid
in all respects.”55 In other words, the challenger must show there no
possible notice which can be drawn from a regulation. This is not
the case here. Rather the issue is whether the Board has
constitutionally applied the regulations to Dr. Grossinger. The court
understands that the Regulations here have been adopted in one
form or another by almost every jurisdiction in the state. The Court
emphasizes therefore that it does not find the regulations vague on
their face.
54 State's Answering Br., D.I. 23, at 20.
88 Copeland v. Vance, 893 F.3d 101 (274 Cir. 2018)
21
A. The Due Process Clause Requires Fair Notice to a Reasonable
Person as to what Conduct is Required or Prohibited
There is no doubt that citizens whose activities are regulated by
the government are entitled to fair notice of what the regulations
prohibit them from doing and what they are required to do.5°
According to the United State Supreme Court, “[a] fundamental
principle in our legal system is that laws which regulate persons or
entities, must give fair notice of conduct that is forbidden or
required.”5” “Living under a rule of law” according to the Court,
“entails various suppositions, one of which is that all persons are
entitled to be informed as to what the State commands or forbids.”58
Thus, “[a] statute can be impermissibly vague . . . if it fails to provide
people of ordinary intelligence a reasonable opportunity to
understand what conduct it prohibits.”59
36 F.C.C. v. Fox Television Stations, Inc., 567 U.S. 239 (2012).
37 A fundamental principle in our legal system is that laws which regulate persons
or entities must give fair notice of conduct that is forbidden or required. See
Connally v. General Constr. Co., 269 U. S. 385, 391, 46 S. Ct. 126, 70 L. Ed. 322
(1926) (“{A] statute which either forbids or requires the doing of an act in terms
so vague that men of common intelligence must necessarily guess at its meaning
and differ as to its application, violates the first essential of due process of law”)[.]
Id. at 253.
88 Papchristou v. City of Jacksonville, 405 U.S. 156, 162, 92 S. Ct. 839, 843 (1972) (internal
quotation and editing marks omitted).
89 Hill v. Colorado, 530 U.S. 703, 732 (2000).
22
Because of the principle’s constitutional roots, the Delaware
Supreme Court echoes the same view:
A statute is void for vagueness if it fails to give a person of ordinary
intelligence fair notice that his contemplated behavior is forbidden
by the statute, or if it encourages arbitrary or erratic enforcement.
The test to be applied in determining whether a criminal statute is
void for vagueness is:
that the terms of a penal statute creating a new offense
must be sufficiently explicit to inform those who are
subject to it what conduct on their part will render them
liable to its penalties ; and a statute which either
forbids or requires the doing of an act in terms so vague
that men of common intelligence must necessarily
guess at its meaning and differ as to its application
violates the first essential of due process of law.©°
The opinion of the United States Supreme Court in Rabe v.
Washington®! illustrates the workings of the rule. In that case, the
defendant was convicted in the Washington state courts of obscenity
because he presented an X-rated film at an outdoor drive-in
theater.62 The Washington courts did not find that the film itself was
obscene under the then-prevailing legal standards, but rather found
that it violated a Washington statute because of “the context” [a drive-
in movie] in which it was displayed. The Washington courts did so
60 State v. Baker, 720 A.2d 1139, 1146 (Del. 1998) (citation omitted) (citing State v. J.K., 383
A.2d 283, 291 (Del. 1977), cert. denied, 435 U.S. 1009 (1978)); see also Connally v. General
Construction Co., 269 U.S. 385 (1926).
61 405 U.S. 313 (1972) (per curiam).
62 Id. at 313-14.
23
even though the applicable statute said nothing about “context.”
Rabe appealed to the Supreme Court, arguing that the statute, as
applied to him, was unconstitutionally vague because it gave him no
warning that it prohibited him from showing the film at a drive-in.
The United States Supreme Court agreed with Rabe. In
reversing Rabe’s conviction, the it found nothing in the statute which
put Rabe on notice that showing the film at a drive-in might expose
him to an obscenity charge.®* According to the Court:
To avoid the constitutional vice of vagueness, it is necessary,
at a minimum, that a statute give fair notice that certain conduct is
proscribed. The statute under which petitioner was prosecuted,
however, made no mention that the ‘context’ or location of the
exhibition was an element of the offense somehow modifying the word
“obscene.” .. . The statute, so construed, is impermissibly vague as
applied to petitioner because of its failure to give him fair notice that
criminal liability is dependent upon the place where the film is
shown. 6
By the same token the regulations in this case make no mention of
matters such as ordering prior records from some, but not all
physicians; how often records must be “periodically” be reviewed; or
when or how often urine tests must be ordered. In short, the
63 Id. at 315.
64 Id. at 315.
65 Jd. at 315-16 (emphasis added).
24
regulations provide no information about these matters for Dr.
Grossinger, just as the Washington statute did for Rabe.
B. Some of the Regulations as Applied Are Unconstitutionally
Vague Because They Did Not Give Dr. Grossinger Fair Notice His
Conduct Was Prohibited
“It is well established” according to the Supreme Court “that
vagueness challenges to statutes which do not involve First
Amendment freedoms must be examined in the light of the facts of
the case at hand.”66 As this appeal does not implicate First
Amendment rights, the analysis must be conducted in light of the
facts at hand. A review of the facts indicates that most of the
regulations at issue omit vital information which would have served
to inform Dr. Grossinger (or any other practitioner for that matter) of
the steps necessary to comply with them.
With commendable candor, the State conceded at one of the oral
arguments that nothing in the language of the regulations expressly
provided notice to Dr. Grossinger of most of the things the Board
ultimately found was required of him:®7
THE COURT: Let’s go through . . . the violations and point to
me. . in the regulations where it specifically puts Dr. Grossinger
on notice.
66 United States v. Mazurie, 419 U.S. 544, 550 (1975).
67 ‘Tr. of Oral Arg., D.I. 44, at 20 (Aug. 17, 2018).
25
THE STATE: I’m happy to engage Your Honor in that exercise
but... I don’t know if it will be fruitful for you because I think I’m
going to just wind up reading the plain language of the regulation.
I can agree and stipulate that the regulations do not put
practitioners on notice of every factual scenario for treatment of a
patient.
A review of most of the alleged infractions in fact shows that the plain
language of the regulations, by itself, did not provide fair notice to
Dr.
Preview
sol, EFiled: Jan 23 2019 05:19P! iE Transaction ID 62891801 Case No. N16A-11-001 JAP pi) IN THE SUPERIOR COURT OF THE STATE OF DELAWARE Qa BRUCE GROSSINGER, D.O. Appellant, Vv. C.A. No. N16A-11-001 JAP DELAWARE BOARD OF MEDICAL LICENSURE AND DISCIPLINE, Appellee. MEMORANDUM OPINION This is an appeal from a Final Order (“Order”) of the Board of Medical Licensure and Discipline (the “Board”) imposing disciplinary sanctions on Dr. Bruce Grossinger! for alleged violations of several its regulations relating to the treatment of patients with pain medications. The court reverses the Board on all but one of its holdings that Dr. Grossinger violated the regulations, affirms the remaining holding and remands the case for a determination as to what, if any, discipline is appropriate for the affirmed violation. i For purposes of this opinion, “Dr. Grossinger” refers to Dr. Bruce Grossinger. With two exceptions, the regulations as applied to Dr. Grossinger did not provide him with constitutionally adequate notice of what was required of him under the facts of this case. To cure this vagueness, it is necessary to superimpose the standard of care onto the regulations in order to give them meaning. According to the State, the Board relied upon its own expertise to supply evidence of the standard of care.? Yet, standard of care evidence must be proven by an expert evidence which was not offered by the State and cannot otherwise be gleaned from the record.? By determining the standard of care on its own (and thus imbuing the regulations with meaning) the Board deprived Dr. Grossinger of his constitutional right to confront the evidence against him. Therefore, the findings that Dr. Grossinger violated these particular regulations will be reversed. Of the two remaining Board decisions, one must be reversed since the regulation was misinterpreted by the Hearing Officer and the Board. The other violation -- finding that Dr. Grossinger violated a regulation relating to informed consent -- is affirmed, as the 2 State’s Answering Br., D.I. 23, at 24. 3 See United Water Del., Inc. v. PSC, 723 A.2d 1172, 1176 (Del. 1999) (“[AJn administrative agency may apply its institutional expertise in the evaluation of conflicting evidence but may not under that guise, create evidence.”) (citing Turbitt v. Blue Hen Lines, 711 A.2d 1214, 1216 (Del. 1998). 2 Hearing Officer’s conclusion in this regard is supported by substantial evidence. PROCEDURAL HISTORY Appellant Dr. Bruce Grossinger is a physician employed in a three-physician practice known as Grossinger Neuropain Specialists (“GNS”) which specializes in pain management. In January 2014, a patient referred to as “Michael” began treatment of chronic pain with GNS. Regrettably Michael died, on December 12, 2014, from a heroin overdose. Three days after Michael’s death, his mother filed a complaint against GNS and its three physicians with the Division of Professional Regulation (the “Division”), which then investigated the matter. After the investigation was complete, the State filed separate formal complaints against all three physicians at GNS with the Board and with the Secretary of State (the “Secretary”).4 Because the matters were largely based on the same facts, the parties agreed to a consolidated evidentiary hearing in front of a Hearing Officer.5 The 4 The complaint fell within the jurisdiction of two regulatory agencies: (1) the Board, and (2) the Secretary — the latter of which is charged with enforcing certain regulations relating to the prescription of controlled substances. Separate complaints were filed with each regulatory agency against each of the three physicians. 8 Grossinger’s Opening Br., D.I. 21, at 1. Hearing Officer conducted an evidentiary hearing spanning two days and received substantial written submissions from the parties.6 In his opinions, the Hearing Officer found that all three respondents were guilty of regulatory violations in both the Board and the Secretary matters, and recommended discipline for all three.7 In his Recommendation in the Dr. Bruce Grossinger matter before the Board (the “Recommendation”), the Hearing Officer found Dr. Grossinger violated several of the Board’s regulations and recommended that the doctor be disciplined: Bruce Grossinger, D.O. failed to comply with Board rules and regulations when he failed to document the patient’s history of substance abuse, he failed to discuss the benefits and risks of controlled substance treatment in the absence of record of such discussion with the patient, he failed to order urine samples or require pill counts from the patient prior to prescribing substances over a period of six months when no record of such provision was present in the patient’s file, Dr. Bruce Grossinger failed to periodically review the course of the patient’s pain treatment and any new information on the etiology of his pain and the state of his health, and he failed to keep accurate and complete records pertaining to the patient.’ The Board adopted the findings that Dr. Grossinger violated its regulations, but reduced the discipline recommended by the Hearing Officer. 6 Inthe Matter of Bruce Grossinger, Recommendation of Chief Hearing Officer at 3, Case No. 10- 168-14 (July 13, 2016) (hereinafter, “Recommendation’). 7 The Hearing Officer opined separate recommendations for the Board and the Secretary. 8 Bd. Order at 1 (Oct. 4, 2016). 4 Only Dr. Bruce Grossinger has appealed from the Board’s judgment.? During the course of the appeal the parties made several written submissions at the court’s request and the parties appeared for multiple oral arguments, including the final one in which the court advised counsel in advance of the topics it wished to discuss. This is the court’s ruling. FACTS This appeal is about the care provided to a 38-year-old patient by the name of Michael in 2014 by Grossinger Neuropain Specialists which, as the name suggests, specializes in the treatment and management of pain. Three physicians employed by GNS during this period - Dr. Jason Brajer, Dr. Steven Grossinger and Dr. Bruce Grossinger - each played a role in the treatment of Michael. The matter has its roots in 2008 when Michael injured his neck, shoulder, and right arm in a motor vehicle accident.!° In 2011, he was in a second car accident which aggravated his 2008 injuries and caused new injuries to his left side.1!_ Michael sought treatment for 9 Appeals from the Secretary’s ruling are addressed in a separate opinion of the court. Bruce Grossinger, et. al. v. Jeffrey W. Bullock, Delaware Secretary of State, appeal docketed, No. N17A- 02-004 (Del. Super. Ct. 2017). 10 Recommendation at 31-32. Id. these injuries from several physicians between 2008 and 2014. He initially treated with Dr. Ross Ufberg, who discharged Michael in March 2011 due to inconsistencies in his drug urine screen.!2 Michael then began treatment with others and at some time became addicted to opioids., and in December 2013, he began treatment with Dr. Irwin Lifrak for opioid detoxification.!* Opioids were not Michael’s only problem, however; he told Dr. Lifrak that he used heroin daily and that he had done so for the past six years with only intermittent periods of sobriety.14 Dr. Lifrak prescribed Suboxone to Michael, who began taking the medication on December 2013.15 This treatment was short-lived -- Dr. Lifrak discharged Michael as a patient just one month after the treatment began because Michael’s toxicology screen report had produced “dirty urine.”1!6 Michael’s Initial Treatment with GNS When Dr. Lifrak discharged Michael as a patient, his primary care physician referred Michael to GNS for further treatment.!”? As 12 Id. at 32. 13 Recommendation at 33. 14 Id. 15 Id. 16 Id. at 34. During his testimony at the hearing, Dr. Steven Grossinger defined a “dirty toxicology screen result” as “one which is inconsistent with prescribed medications, or one which may disclose the use of illicit drugs.” Id. at 22. 17 Id. at 8. an incoming patient at GNS, Michael was evaluated by Dr. Allen Silberman, an independent psychologist, who then provided a “Psychotherapy Initial Evaluation” for GNS.!8 Dr. Silberman noted in his evaluation report that Michael “suffers from an opiate addiction that started five years ago as the result of Oxycodone and Morphine prescriptions from his physician, and mentioned that Dr. Lifrak “manages [Michael’s] Suboxone which is used for opiate dependence.”!9 Dr. Silberman recommended continued psychotherapy and treatment for Michael’s ongoing chronic pain.?° The Hearing Officer found that GNS’s referral of Michael to Dr. Silberman was a legitimate effort to treat Michael: I find that Dr. Silberman’s “psychotherapy initial evaluation” was not prepared gratuitously or to “paper” the GNS file. Rather, I find that it was requested by GNS and was prepared to inform the care offered to Michael by all GNS physicians, including Dr. Bruce Grossinger. 2! Dr. Bruce Grossinger’s Role in Michael’s Treatment According to the Hearing Officer, out of the three GNS physicians, Dr. Bruce Grossinger “was least involved in Michael’s 18 Recommendation at 8, 35. “Though his name appears on the GNS letter head, Dr. Allen Silberman is an ‘independent’ psychologist who performs psychosocial studies and evaluates pain status with respect to certain GNS patients and provides reports of his findings to the GNS physicians.” Id. at 35. 19 Id. at 36. 20 Id. 21 Id. at 36-37. care”22 as his role was limited to writing refill prescriptions on three occasions: The record in this case establishes that Dr. Grossinger’s only involvement in Michael’s care was to write refill prescriptions for him in July, September, and November 2014. . . . In signing the refill scripts, Dr. Grossinger did not alter the type of drug or amount or schedule of dosing reflected on scripts signed by his colleagues previously. 2° Notably the Hearing Officer found no evidence that Dr. Bruce Grossinger was involved in planning or executing the course of Michael’s pain treatment at GNS.24 At no time did Dr. Grossinger have any physical encounter with Michael. The Hearing Officer’s conclusion about the limited scope of Dr. Bruce Grossinger’s role is confirmed by the summary of the course of GNS care for Michael provided in the Recommendation.?5 The court has included this summary and provided emphasis in bold to highlight the encounters which involved Dr. Grossinger: Feb, 26, 2014 Dr. Steven Grossinger performs second EMG test; Dr. Bajer performs cervical epidural injection 22 Id, at 53. 23 Id, at 44. 24 Bd. Order at 4. The evidence shows that Michael’s pain treatment was primarily pursued by Dr. Steven Grossinger and Dr. Brajer. Both Dr. Steven Grossinger and Dr. Brajer were the physicians who: attended the encounters with Michael, developed his medication regimen, and performed his injection procedures; purportedly discussed pain etiology with him and his then- current state of health; and assessed the appropriateness of Michael’s treatment plan, including whether progress was satisfactory. Recommendation at 52-53. 25 Recommendation at 38-39. 8 March 18, 2014 Dr. Brajer performs second cervical epidural steroidal injection; due to acute low back pain, Meloxicam, Tizandine and Tramadolprescribed April 9, 2014 Dr. Brajer performs third cervical epidural steroidal injection; Thamadol discontinued; Hydrocodone 5/325mg prescribed April 17, 2014 Meloxicam and Tizandine refilled April 30, 2014 Dr. Brajer performs first cervical selective root injection; low back issues “worsening” May 8, 2014 Hydrocodone 5/325mg refilled May 28, 2014 Dr. Brajer performs first cervical facet injection; Dr. Brajer prescribes Morphine Sulfate 15mg at nighttime; Hydrocodone dosing reduced from twice daily to once daily; Esgic prescribed for headache June 9, 2014 Hydrocodone 5/325mg dosing adjusted; Morphine Sulfate 15mg added June 18, 2014 Appointment with Dr. Brajer canceled due to “lapse in insurance”; urine drug screen was to be performed but sample could not be collected July 9, 2014 Hydrocodone 5/325mg and Morphine Sulfate 15mg refilled by Dr. Bruce Grossinger July 30, 2014 Follow-up visit scheduled with Dr. Brajer; injection cancelled because coverage denied by insurance carrier; Dr. Brajer increase Hydrocodone dosing to twice daily and Morphine Sulfate 15mg to once every 12 hours 9 Sept. 3 2014 Michael cancels appointment due to illness Sept. 11, 2014 Hydrocodone 5/325mg and Morphine Sulfate scripts refilled by Dr. Bruce Grossinger Oct. 27, 2014 Appointment with Dr. Brajer canceled by Michael Nov. 12, 2014 Dr. Bruce Grossinger refills scripts for Hydrocodone 5/325mg and Morphine Sulfate 15mg. Dr. Grossinger notes that Michael must make and keep next appointment to receive further refill scripts Dec. 8, 2014 Michael seen by Dr. Steven Grossinger; urine sample provided for screening; medications refilled Dec.15, 2014 Michael discharged after receipt of UDS results Michael’s Death On December 8, 2014, Michael presented to GNS for an appointment with Dr. Steven Grossinger and gave a urine sample for drug screening.26 One week later, on December 15, GNS received the laboratory report which indicated that Michael tested positive for heroin and negative for his prescribed medications.2” As a result, GNS mailed a letter to Michael that day discharging him as a patient 26 Recommendation at 39. 27 Id. 10 of GNS.28 Tragically, Michael died on December 12, 2014 as a result of a heroin overdose.?° Both the Hearing Officer and the Board found that GNS’s treatment of Michael did not cause his death.9° THE STATE’S CLAIMS The Board of Medical Practice derives its authority to discipline physicians from 24 Del. C. sec. 1731.31 Subsection (b) of that statute provides 23 nonexclusive definitions of “unprofessional conduct.” At present, the court is faced with the State’s claims arising under subsection (b)(3),32 which defines “unprofessional conduct” as “[a]ny dishonorable, unethical, or other conduct likely to deceive, defraud, or harm the public.”33 Although not precisely articulated in its professional complaint against Dr. Grossinger,*+ it appears the State contended that he violated the Board’s regulations relating to 28 Id. at 38-39. 29 Id, at 40-41. 30 See supra note 5. 31 24 Del. C. § 1731 provides, in part: “A [physician] may be disciplined by the Board for unprofessional conduct, as defined in subsection (b) of this section . . . ” 32 The State cited to subsections (b)(3) and (b)(11) of 24 Del. C. § 1731 in its complaint before the Board. See State’s Compl., Case No. 10-168-14, at 2-3 (Oct. 15, 2015); App. To Appellee’s Answering Br., D.I. 23, at B-180. The court need concern itself, however, with only subsection (b)(3) because the Hearing Officer and the Board found no violation of subsection (b)(11) - which defines “unprofessional conduct” to include a “pattern of negligence in the practice of medicine” - because the State failed to prove a pattern of negligence by Dr. Grossinger. See Recommendation at 57. The State did not take a cross-appeal from this finding and has not otherwise argued to this court that the Board erred. 33 24 Del. C. § 1731(b)(3). 34 State’s Compl., Case No. 10-168-14 (Oct. 15, 2015); App. To State’s Answering Br., D.I. 23, at B-180. 11 controlled substances which amounted to “other conduct [which would] likely . . . harm the public.” The only regulations actually cited in the Complaint in connection with the (b)(3) claims are Regulations 8.1.12 and 8.1.13.35 Elsewhere in its Complaint, the State alleged misconduct by Dr. Grossinger, but did not identify specific regulations this alleged conduct supposedly violated.%° In his Recommendation, the Hearing Officer was careful to link the conduct alleged in the Complaint to specific regulations. Seeing as his correlations are reasonable, and neither side has challenged them in this appeal, the court will use them. Turning to the factual allegations in this appeal, the State contends that Dr. Bruce Grossinger’s alleged failure to do the following amounts to unprofessional conduct: 1 Obtain the prior treatment records from Dr. Lifrak or otherwise communicate with Dr. Lifrak regarding Michael’s care [Regulation 18.1.1]; 2 Discuss and/or document that he had discussed risks and benefits of the use of controlled substances with the patient [Regulation 18.3]; 35 App. To State’s Answering Br., D.I. 23, at B-181. 36 ©The State also charged that Dr. Grossinger violated Regulation 18.2 because he failed to utilize a written treatment plan addressing goals and objectives of treatment. The Hearing Officer found there was insufficient evidence to support this finding, and the State has not cross- appealed or otherwise challenged the Hearing Officer’s finding. No further discussion is therefore needed. 12 3 Routinely order urine/serum medication level screening or utilize other controls for evaluating prescription compliance [Regulation 18.4]; 4 Periodically review the course of pain treatment and any new information about the etiology of the pain and patient’s state of health including an assessment of the appropriateness of the current treatment plan if progress is unsatisfactory [Regulation 18.5]; and 5 Keep accurate, complete and accessible patient records including documentation of etiology; treatment objectives; discussion of risks and benefits; informed patient consents; treatments; medications including the date, type, dosage and quantity prescribed; instructions to the patient; agreements with the patient; and periodic reviews with interim histories, physical examinations, assessments of progress and medication plans [Regulation 18.7].37 PRELIMINARY MATTERS Before beginning the analysis, it is necessary to devote brief attention to some preliminary matters which are discussed below. What is Being Reviewed? One preliminary matter is a determination as to precisely what is being reviewed here. The State asserts “[i]t is the Board’s Order that is under review, not the Recommendation of the hearing 37 See State’s Answering Br., D.I. 23, at 29-32. 13 officer.”38 This is too narrow a view; both the Hearing Officer’s Recommendation and the Board’s Order are subject to review because the Board itself incorporated the Hearing Officer’s Recommendation as part of its order, writing in part: “the hearing officer report and recommendation is entered as an Order of the Board.”39 Moreover, the Hearing Officer, not the Board, was the fact- finder here.*° It is therefore impossible to judge whether there was substantial evidence supporting the findings without reference to the Hearing Officer’s Recommendation. Consequently, the court deems that the decisions of the Hearing Officer, as well as the Board are both proper subjects of review for the present appeal.*! State’s Answering Br., D.I.23, at 35. 39 Bd. Order at 5 (Oct. 4, 2016). 40 Id. at 4. 41 Upon such review, the court determines: [W]hether the Board’s decision is supported by substantial evidence and free from legal error. Substantial evidence is such relevant evidence that a reasonable mind would accept as adequate to support a conclusion. This Court does not act as the trier of fact, nor does it have authority to weigh the evidence, decide issues of credibility, or make factual conclusions. In reviewing the record for substantial evidence, the Court must consider the record in the light most favorable to the party prevailing below. The Court’s review of conclusions of law is de novo. Absent an error of law, the Board’s decision will not be disturbed where there is substantial evidence to support its conclusions. Bilski v. Bd. of Med. Licensure & Discipline of Del., 2014 WL 3032703 (Del. Super. Ct. June 30, 2014), rearg. denied 2014 WL 5282115 (Del. Super. Ct. Oct. 16, 2014), aff'd, 115 A.3d 1214 (Del. 2015). 14 Must the State Prove Harm to the Patient? Another preliminary matter is whether the State must show harm in order to prove a violation of the medical regulations.*2 The parties tacitly agree that the State need not do so, and the court likewise agrees, primarily because none of the regulations are conditioned upon a bad outcome. The issue is not entirely free from doubt, however. The preamble to the regulations suggests that the outcome of the treatment plays a significant role in the Board’s assessment, declaring: “The practitioner's conduct will be evaluated to a great extent by the outcome of pain treatment.”*3 This portion of the preamble is at odds with the language of the regulations themselves, which, as mentioned, are completely devoid of any reference to the outcome of the treatment. The court will not imbue the content of the regulations with a policy not supported by the regulations themselves. For the same reasons the Supreme Court held in Delaware Board of Nursing v. Francis*+ that the Board of Nursing regulations did not require proof of harm. And former Chief Justice Steele wrote, the “broad public policy statements in a 42 Both the Hearing Officer and the Board found that Dr. Grossinger’s conduct did not play a role in Michael’s death. See supra note 5. 43 24 Del. Admin, C. § 1700. 44 195 A.3d 467 (Del. 2018). 15 statute's preamble do not govern the specific and explicit text of unambiguous statutory provisions.”45 Therefore, the court holds that any injury (or lack thereof) resulting from Michael’s treatment is immaterial to the issues presented here Does the APA Apply? The court is presented with the question of whether the Administrative Procedures Act (“APA”) is applicable to the instant case. Though the parties cite to it for support of various propositions, the APA plainly did not apply at the time of the hearing or at the time of the board’s decision.*6 The hearing took place in April 2016 and the Board’s decision was issued on October 4, 2016, but the APA was 43 Progressive N. Ins. Co. v. Mohr, 47 A.3d 492 (Del. 2012) (Steele J., dissenting). 46 “The State cannot merely allege that an act or omission violated the standard of care and shift the burden to the physician to prove otherwise. See 29 Del. C. § 10125(c).” Grossinger’s Opening Br., D.I. 21, at 17. This Court has jurisdiction to entertain appeals from an administrative board’s final order pursuant to the Delaware Administrative Procedures Act (“APA”). See 29 Del. C. §§ 10142 and 10102(4). A reviewing court must affirm an administrative board’s order so long as the record below provides substantial evidence to support the board’s decision and the board’s ruling is free from legal error. See 29 Del. C. §10142(d) ... . “The Court, when factual determinations are at issue, shall take due account of the experience and specialized competence of the agency of the purposes of the basic law under which the agency has acted.” 29 Del. C. § 10142(d).... The Board’s decision to impose discipline on a licensee should be affirmed so long as it is supported by substantial evidence and free from legal error. 29 Del. C.§ 10142(d).... State’s Answering Br., D.I. 23, at 18-32. 16 not made applicable to medical board hearings until July of 2017.47 The court will therefore disregard the citations to the APA. Do the regulations apply in their entirety to a physician who merely renews a prescription first written by a colleague? The Hearing Officer went to great effort to distinguish the roles each of the GNS physicians played in Michael’s care when considering their respective culpability under the regulations: Licensure cases such as this one, in my view, are directed at the conduct of individual licensees. In other words, if three physicians are employed in a pain management practice but only two have assumed primary responsibility for the management of a give patient’s chronic pain, the third is not liable for most shortcomings in the planning by the other two under some sort of vicarious liability theory. To my knowledge the law if professional licensure does not provide for such blanket professional liability across the entire practice. I can foresee cases in which such a rule would be illogical and create mischief. Liability should only attach to the license of the third physician if he took some form of active role in structuring, approving or implementing a treatment plan. There is no evidence in this case that Dr. Bruce Grossinger was involved with Michael’s care of planning other than to write follow- on scripts for Michael in accordance with the approach taken by his GNS partners.*8 The Board seems to have taken the opposite view. In a terse, isolated sentence buried in the penultimate paragraph of its opinion, the Board wrote that “all three doctors should be treated the same a7 The Board’s procedures were at one time governed by 24 Del. C. § 1734; however, the 2017 amendment struck virtually all of that section and substituted in its place the following: “Hearings shall be conducted pursuant to the Administrative Procedures Act.” 24 Del. C. § 1734 (i) (effective July 21, 2017); 2017 Del. ALS 97, 81 Del. Laws 97, 2017 Del. SB 39. 48 Recommendation at 46-47. 17 because a covering doctor who merely refills a prescription is as responsible as the treating doctors.”49 The Board cited no authority, made no reference to the regulations to support this notion and provided no analysis to support its conclusion. Indeed, it gave no basis at all for its holding. Because of the manner in which this appeal has been analyzed and resolved, it is unnecessary for the court to reach the question whether this is a matter of regulatory interpretation vested in the Board’s authority or whether it is a question of law. The court believes, however, it is important to stress that it expresses no opinion concerning this aspect of the Board’s holding or any precedential effect it may have in future cases. What does the court mean by “medical evidence”? Throughout this opinion the court uses the term “medical evidence.” That term is used advisedly. As discussed below, in some cases before the Board, the standard of care becomes relevant. This is one of them. In this court, the standard of care must ordinarily be proven by an expert. But, evidentiary standards are relaxed in hearings before the Board, and the court will not speculate as to 49 Bd. Order at 4 (Oct. 4, 2016). 18 whether something less than expert testimony is required by the Board in order to prove the standard of care. This issue was never litigated before the Board, nor, understandably, did the parties address it in this appeal. The court will not decide the issue, but save it for a later day when it is fully litigated. Suffice it to say for now the court will used the deliberately vague term “medical evidence.” ANALYSIS There is no dispute that due process requires a regulation must give reasonable notice as to what it requires and what it prohibits. Many of the regulations in question did not give Dr. Grossinger reasonable notice as to what the Board ultimately found they required. For example, the regulations dictate that a physician must obtain the medical history of a new patient.5° From this, the Hearing Officer and the Board extrapolated that the regulation, requires in some but not all instances a physician to obtain medical records from some unspecified previous providers, even though the regulation makes no mention of such a requirement.5! Nor does it provide any 50 See 24 Del. Admin. C. § 1700-18.1.1. 51 Recommendation at 45; see Bd. Order at 4 (“The Board is bound by the findings of fact made by the hearing officer”). 19 guidance as to when a physician must obtain prior records (and which prior records) in order to comply with the rule. The parties urge, and the court agrees, that it is impossible to draft regulations which address every conceivable circumstance arising during the course of medical treatment.52 The only way to cure this is to interpret and apply the regulations in light of the standard of care. These standards serve to supply the information missing from the regulations. Presumably, all licensed physicians are familiar with the standard of care and, therefore, they are charged with knowledge of the standard of care as applied to the regulations. The standard of care has long been held to be a factual issue and an unbroken line of opinions have decided that, in almost all instances, it must be proven by expert evidence.5? The State offers no such expert evidence here nor can it be gleaned from the record; instead, the State argues that it was not required to do so because 52 See Tr. of Oral Arg., D.I. 44, at 9-12 (Aug. 17, 2018); see Grossinger’s Opening Br., D.I. 21, at 27. 83 See Ridgeway v. Acme Mkts., Inc., 194 A.3d 372 (Del. 2018) (holding that when the standard of care requires resort to technical or other complex principles, the plaintiff must establish the standard of care through expert testimony); Robinson v. J.C. Penney Co., 977 A.2d 899, 2009 WL 2158106, at *1 (Del. 2009) (TABLE) (holding that an expert was required to show the standard of care owed by a security guard to a suspected shoplifter since "the standard of care applicable to a professional can be established only through expert testimony"); Abegglan v. Berry Refrigeration Co., 2005 WL 6778336, at *2-3 (Del. Super. Ct. 2005) (holding that the plaintiff needed an expert to establish the standard of care because a tradesman repairing an ice machine is a professional). 20 the Board, relying upon its own expertise, could alone determine the appropriate standard of care.5+ But, Dr. Grossinger has a constitutional right to hear and confront any evidence against him concerning the standard of care. Allowing the Board to determine the standard of care based on its own expertise deprives him of that fundamental right. An early preliminary word about the void for vagueness doctrine is appropriate here. The constitutional vagueness doctrine has two faces—facially void and void for vagueness as applied. In facial vagueness cases “the challenger must show that the statute is invalid in all respects.”55 In other words, the challenger must show there no possible notice which can be drawn from a regulation. This is not the case here. Rather the issue is whether the Board has constitutionally applied the regulations to Dr. Grossinger. The court understands that the Regulations here have been adopted in one form or another by almost every jurisdiction in the state. The Court emphasizes therefore that it does not find the regulations vague on their face. 54 State's Answering Br., D.I. 23, at 20. 88 Copeland v. Vance, 893 F.3d 101 (274 Cir. 2018) 21 A. The Due Process Clause Requires Fair Notice to a Reasonable Person as to what Conduct is Required or Prohibited There is no doubt that citizens whose activities are regulated by the government are entitled to fair notice of what the regulations prohibit them from doing and what they are required to do.5° According to the United State Supreme Court, “[a] fundamental principle in our legal system is that laws which regulate persons or entities, must give fair notice of conduct that is forbidden or required.”5” “Living under a rule of law” according to the Court, “entails various suppositions, one of which is that all persons are entitled to be informed as to what the State commands or forbids.”58 Thus, “[a] statute can be impermissibly vague . . . if it fails to provide people of ordinary intelligence a reasonable opportunity to understand what conduct it prohibits.”59 36 F.C.C. v. Fox Television Stations, Inc., 567 U.S. 239 (2012). 37 A fundamental principle in our legal system is that laws which regulate persons or entities must give fair notice of conduct that is forbidden or required. See Connally v. General Constr. Co., 269 U. S. 385, 391, 46 S. Ct. 126, 70 L. Ed. 322 (1926) (“{A] statute which either forbids or requires the doing of an act in terms so vague that men of common intelligence must necessarily guess at its meaning and differ as to its application, violates the first essential of due process of law”)[.] Id. at 253. 88 Papchristou v. City of Jacksonville, 405 U.S. 156, 162, 92 S. Ct. 839, 843 (1972) (internal quotation and editing marks omitted). 89 Hill v. Colorado, 530 U.S. 703, 732 (2000). 22 Because of the principle’s constitutional roots, the Delaware Supreme Court echoes the same view: A statute is void for vagueness if it fails to give a person of ordinary intelligence fair notice that his contemplated behavior is forbidden by the statute, or if it encourages arbitrary or erratic enforcement. The test to be applied in determining whether a criminal statute is void for vagueness is: that the terms of a penal statute creating a new offense must be sufficiently explicit to inform those who are subject to it what conduct on their part will render them liable to its penalties ; and a statute which either forbids or requires the doing of an act in terms so vague that men of common intelligence must necessarily guess at its meaning and differ as to its application violates the first essential of due process of law.©° The opinion of the United States Supreme Court in Rabe v. Washington®! illustrates the workings of the rule. In that case, the defendant was convicted in the Washington state courts of obscenity because he presented an X-rated film at an outdoor drive-in theater.62 The Washington courts did not find that the film itself was obscene under the then-prevailing legal standards, but rather found that it violated a Washington statute because of “the context” [a drive- in movie] in which it was displayed. The Washington courts did so 60 State v. Baker, 720 A.2d 1139, 1146 (Del. 1998) (citation omitted) (citing State v. J.K., 383 A.2d 283, 291 (Del. 1977), cert. denied, 435 U.S. 1009 (1978)); see also Connally v. General Construction Co., 269 U.S. 385 (1926). 61 405 U.S. 313 (1972) (per curiam). 62 Id. at 313-14. 23 even though the applicable statute said nothing about “context.” Rabe appealed to the Supreme Court, arguing that the statute, as applied to him, was unconstitutionally vague because it gave him no warning that it prohibited him from showing the film at a drive-in. The United States Supreme Court agreed with Rabe. In reversing Rabe’s conviction, the it found nothing in the statute which put Rabe on notice that showing the film at a drive-in might expose him to an obscenity charge.®* According to the Court: To avoid the constitutional vice of vagueness, it is necessary, at a minimum, that a statute give fair notice that certain conduct is proscribed. The statute under which petitioner was prosecuted, however, made no mention that the ‘context’ or location of the exhibition was an element of the offense somehow modifying the word “obscene.” .. . The statute, so construed, is impermissibly vague as applied to petitioner because of its failure to give him fair notice that criminal liability is dependent upon the place where the film is shown. 6 By the same token the regulations in this case make no mention of matters such as ordering prior records from some, but not all physicians; how often records must be “periodically” be reviewed; or when or how often urine tests must be ordered. In short, the 63 Id. at 315. 64 Id. at 315. 65 Jd. at 315-16 (emphasis added). 24 regulations provide no information about these matters for Dr. Grossinger, just as the Washington statute did for Rabe. B. Some of the Regulations as Applied Are Unconstitutionally Vague Because They Did Not Give Dr. Grossinger Fair Notice His Conduct Was Prohibited “It is well established” according to the Supreme Court “that vagueness challenges to statutes which do not involve First Amendment freedoms must be examined in the light of the facts of the case at hand.”66 As this appeal does not implicate First Amendment rights, the analysis must be conducted in light of the facts at hand. A review of the facts indicates that most of the regulations at issue omit vital information which would have served to inform Dr. Grossinger (or any other practitioner for that matter) of the steps necessary to comply with them. With commendable candor, the State conceded at one of the oral arguments that nothing in the language of the regulations expressly provided notice to Dr. Grossinger of most of the things the Board ultimately found was required of him:®7 THE COURT: Let’s go through . . . the violations and point to me. . in the regulations where it specifically puts Dr. Grossinger on notice. 66 United States v. Mazurie, 419 U.S. 544, 550 (1975). 67 ‘Tr. of Oral Arg., D.I. 44, at 20 (Aug. 17, 2018). 25 THE STATE: I’m happy to engage Your Honor in that exercise but... I don’t know if it will be fruitful for you because I think I’m going to just wind up reading the plain language of the regulation. I can agree and stipulate that the regulations do not put practitioners on notice of every factual scenario for treatment of a patient. A review of most of the alleged infractions in fact shows that the plain language of the regulations, by itself, did not provide fair notice to Dr.