Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
In the Case of:
S. Khalid Hussain, M.D.,
Petitioner,
- v. -
The Inspector General.
DATE: June 11, 1992
Docket No. C-330
DECISION
On October 4, 1990, the Inspector General (I.G.) notified Petitioner that he
was being excluded from
participating in Medicare and any State health care program 1/ for a period
of five years. The I.G. advised
Petitioner that his exclusion was authorized by section 1156 of the Social Security
Act (Act) because the
I.G. agreed with the recommendation of the Peer Review Organization of New Jersey
(NJPRO), which
concluded that Petitioner had grossly and flagrantly violated his obligation
under section 1156(b)(1)(B) to
provide care to patients that meets professionally recognized standards of health
care. 2/ The I.G.
concluded that, while there was no specific evidence to support the conclusion
that Petitioner was
unwilling to comply with his obligations under section 1156 of the Act, Petitioner
had demonstrated an
inability to substantially comply with such obligations. The I.G. based his
conclusion on Petitioner's
treatment of seven patients, to whom I shall refer as Patients 268001, 8601866M,
854914, 86-0935,
277259, 8617854M, and 632365. The I.G. informed Petitioner that in arriving
at the decision to exclude
Petitioner for a period of five years, the I.G. had considered specific factors
in accordance with 42 C.F.R.
1004.90(d) (1989). 3/
In the notice letter, the I.G. informed Petitioner that he was entitled to
a hearing before an administrative
law judge (ALJ) to contest the I.G.'s determination to exclude him for five
years. Petitioner timely
requested a hearing, and the case was assigned to me for hearing and decision.
I held hearings in Camden,
New Jersey on September 13-14, 1991, and on November 14, 1991. I have considered
the evidence and
exhibits and the parties' briefs and arguments. I conclude that the evidence
establishes that on three
occasions Petitioner grossly and flagrantly violated his obligation to provide
care which meets
professionally recognized standards. I further conclude that Petitioner has
demonstrated an inability to
comply with his obligation. Therefore, the I.G. had the authority to exclude
Petitioner under section 1156
of the Act. Although there is a remedial need for an exclusion in this case,
a five-year exclusion would not
serve a remedial purpose. Thus, the five-year exclusion imposed and directed
by the I.G. is unreasonable.
Accordingly, I modify the exclusion to an exclusion of three years.
ISSUES
The issues in this case are whether:
1. the I.G. must prove his case by the preponderance of evidence or by clear
and convincing
evidence;
2. Petitioner grossly and flagrantly violated his obligation to provide health
care which meets
professionally recognized standards and demonstrated an unwillingness or inability
to substantially comply
with such obligation; and
3. the five year exclusion imposed and directed against Petitioner by the I.G. is reasonable.
FINDINGS OF FACT AND CONCLUSIONS OF LAW 4/
Petitioner
1. Petitioner is a physician practicing in the specialty of neurological surgery,
or neurosurgery, in
Vineland, New Jersey. Tr. II/258-59. 5/
2. Neurosurgery is the surgical treatment of disorders and diseases of the
brain, spine, spinal cord, and
nerves. Tr. I/131-32.
3. Petitioner is licensed to practice medicine in the States of New Jersey and New York. Tr. II/262.
4. At the time of his exclusion, Petitioner was on the staffs of Newcomb Medical
Center, Vineland, New
Jersey; Millville Hospital, Millville, New Jersey; Bridgeton Hospital, Bridgeton,
New Jersey; and Elmer
Community Hospital, Elmer, New Jersey. T. II/263.
5. Petitioner graduated first in his medical school class of approximately
250 students at Liaqat Medical
College in Sind, Pakistan. Tr. II/260; P. Ex. 21.
6. Petitioner completed an internship at St. Elizabeth's Hospital in Chicago, Illinois. Tr. II/260; P. Ex. 21.
7. Petitioner completed a residency in general surgery at Long Island College
Hospital in Brooklyn, New
York. Tr. II/260-61; P. Ex. 21.
8. Petitioner completed a residency in neurosurgery at several New York hospitals
during the period July
1975 to June 1980. Tr. II/260-61; P. Ex. 21.
9. Petitioner was certified by the American Board of Neurological Surgery in 1983. Tr. II/262; P. Ex. 21.
10. To become board certified in neurosurgery, a physician must successfully
complete an accredited
neurosurgical training program in the United States and must successfully complete
a two part
examination, encompassing a written and an oral component. Tr. I/48-49; Tr.
II/262-63.
11. The process of board certification is intended to establish that a physician
has mastered at least the
minimum body of knowledge required of a neurosurgeon and is able to apply this
knowledge on a clinical
level. Tr. I/131.
Procedural History
12. By letter dated September 30, 1988, NJPRO notified Petitioner that it had
concerns about Petitioner's
management of seven identified cases. The letter informed Petitioner that the
cases would be presented to
the Quality Assurance Committee and that he could submit an explanation of his
management of the cases.
I.G. Ex. 1.
13. Petitioner provided written responses to NJPRO. I.G. Ex. 2.
14. By letter dated January 9, 1989, NJPRO informed Petitioner that his written
responses failed to resolve
its concerns. The letter stated that, based on his unacceptable responses, NJPRO
would institute an
intensified review of Petitioner's medical records of Medicare admissions occurring
after January 1, 1988,
for a three month period or 30 records. I.G. Ex. 3.
15. By letter dated August 9, 1989, NJPRO notified Petitioner that it had concluded
that there was a
reasonable basis to determine that Petitioner had violated his obligation to
assure that services provided to
Medicare beneficiaries were of a quality that met professionally recognized
standards of health care in six
cases. I.G. Ex. 4.
16. Petitioner met with the Sanctions Committee of NJPRO on March 5, 1990. I.G. Ex. 6/1.
17. At the March 5, 1990, meeting, Petitioner was represented by counsel and
offered the testimony of Dr.
Najum Kazmi, a neurosurgeon practicing in New Jersey. I.G. Ex. 6/1, 177.
18. The Sanctions Committee was assisted at the March 5, 1990, meeting by Dr.
Ira Kasoff, a
neurosurgeon and consultant to NJPRO. I.G. Ex. 6.
19. Dr. Kasoff was not a voting member of the Sanctions Committee. I.G. Ex. 8/14.
20. At the conclusion of the March 5, 1990, meeting, the Sanctions Committee
voted to recommend that
Petitioner be excluded from participating in Medicare and State health care
programs, based on its
conclusion that Petitioner had grossly and flagrantly violated his obligation
to provide health care that met
professionally recognized standards and that he had demonstrated an unwillingness
and inability to comply
with his obligation. I.G. Ex. 6/179-80.
21. By letter dated February 15, 1990, NJPRO notified Petitioner that it had
identified another instance in
which it had reason to believe Petitioner had violated his obligation to provide
health care that met
professionally recognized standards. I.G. Ex. 5/1.
22. On April 30, 1990, Petitioner met with the Sanctions Committee of NJPRO
regarding the case
identified in the letter of February 15, 1990. I.G. Ex. 7/1.
23. Petitioner was represented by counsel at the April 30, 1990, meeting. I.G. Ex. 7/1.
24. At the conclusion of the April 30, 1990, meeting, the Sanctions Committee
voted to recommend that
Petitioner be excluded from participating in Medicare and State health care
programs, based on its
conclusion that Petitioner had grossly and flagrantly violated his obligation
to provide health care that met
professionally recognized standards and that he had demonstrated an unwillingness
and inability to comply
with his obligation. I.G. Ex. 7/56-58.
25. By letter dated October 4, 1990, the I.G. notified Petitioner that he was
being excluded from
participating in Medicare and State health care programs for a period of five
years. The I.G. agreed with
NJPRO's conclusion, expressed in a letter dated June 19, 1990, that, in the
seven cited cases, Petitioner had
grossly and flagrantly violated his obligation to provide health care of a quality
that met professionally
recognized standards. The I.G. concluded that there was no specific evidence
that Petitioner was unwilling
to comply with his obligation, but it agreed with NJPRO that Petitioner had
demonstrated an inability to
comply. I.G. Exs. 8, 9.
Burden of Proof
26. Petitioner, as a practitioner who is dissatisfied with the determination
made by NJPRO, has a right to a
hearing. 42 U.S.C. 1320c-4; Section 1155 of the Act.
27. Petitioner's right to a hearing is a right to a de novo hearing. Section
205(b) of the Act; Charles J.
Barranco, M.D., DAB CR187, (1992).
28. Under the Administrative Procedure Act (APA), the standard to be used by
an agency in making its
determination on the evidence received at a hearing is preponderance of the
evidence. Section 7 of the
APA, 5 U.S.C. 556.
29. The preponderance of the evidence standard, as provided in section 7 of
the APA, 5 U.S.C. 556, is
applicable to adjudicatory proceedings. Section 5(b) of the APA, 5 U.S.C. 554(c)(2).
30. The instant proceedings are adjudicatory in nature and are subject to the
provisions of the APA.
Sections 5 and 7 of the APA, 5 U.S.C. 554, 556; see Steadman v. S.E.C., 450
U.S. 91 (1981).
31. The appropriate standard of evidence in this case is preponderance of the
evidence. Sections 5 and 7
of the APA, 5 U.S.C. 554, 556; see Steadman.
Neurosurgical treatment of increased intracranial pressure
32. A craniectomy is a surgical procedure in which the surgeon makes a 3/8
inch diameter burr hole in the
patient's skull with a particular drill bit. Tr. I/57.
33. A craniotomy is a surgical procedure in which the surgeon turns a bone
flap, to create a "window" of
some size in the patient's skull to perform a formal operation. Tr. I/57.
34. Both craniotomies and craniectomies are usually performed in an operating
room under general
anesthesia. Tr. I/57.
35. The terms infarct and stroke are synonymous. They indicate that a portion
of the brain has been
deprived of its blood supply. Tr. I/55.
36. Another category of stroke disease is characterized by hemorrhage, or bleeding
into the brain. Tr.
I/55.
37. Various diseases of the brain are accompanied by increases in intracranial
pressure (ICP). Because the
skull is a tight compartment, expanding lesions within the brain may be accompanied
by increased ICP.
Tr. I/58; Tr. II/269; P. Ex. 23/1.
38. Increased ICP may cause damage to a patient's brain because the swelling
of the injured portion of the
brain may put pressure on, or compress, previously undamaged portions of the
brain. Increased ICP, if
uncontrolled, can lead to death. Tr. II/269, Tr. III/36, 127.
39. The article Lehman, Intracranial Pressure Monitoring and Treatment: A Contemporary
View, 19
Annals of Emergency Medicine 295 (1990)(Intracranial Pressure Monitoring), is
authoritative medical
literature. Tr. II/274; P. Ex. 23.
40. Intracranial Pressure Monitoring states that to alleviate the potential
damage to the brain from
swelling, most treatment measures have attempted to reduce the volume of cerebrospinal
fluid (CSF),
blood, or water in the brain without removing or manipulating viable brain tissue.
P. Ex. 23/2.
41. The ventricles are structures deep in the brain, close to the midline, where CSF is produced. Tr. I/59.
42. A ventriculostomy is a procedure whereby a shunt or catheter is inserted
into one of the ventricles of
the brain in order to relieve pressure on the brain by draining excess CSF.
Tr. I/59, 136.
43. The text Neurological Surgery (J. Youmans, M.D., 3d ed. 1990) (Youmans'
Neurological Surgery), is
an authoritative medical reference. Tr. II/271.
44. Youmans' Neurological Surgery states that severe brain infarction may be
accompanied by swelling
due to cerebral edema or hemorrhagic infarction and that the result may be increased
ICP. P. Ex. 22/2.
45. Edema is another term for swelling of the brain. Tr. II/325.
46. Youmans' Neurological Surgery states that fatal outcome in massive cerebral
or cerebellar infarction
within the first week can be directly related to acute brain swelling and its
secondary effects. P. Ex. 22/3.
47. ICP monitoring (ICPM) was introduced in the early 1970's to measure the
pressure within the confines
of the skull. Tr. I/58.
48. Youmans' Neurological Surgery states that ICP monitoring of patients with
severe brain swelling due
to infarction has been beneficial in titrating medical measures and predicting
the need for operative
decompression. P. Ex. 22/3.
49. One method for recording and monitoring ICP is to insert a catheter into
the ventricle, as for a
ventriculostomy, and connect it to a transducer so that pressure waves transmitted
through the CSF may be
transformed into electrical impulses and plotted on a graph or converted to
numerical values by digital
means. Tr. I/59.
50. Employing a ventricular catheter as an ICPM device permits the treating
physician to drain CSF as a
therapeutic measure if ICP is elevated. Tr. I/137-38.
51. Another method for recording and monitoring ICP is to place a hollow conical
screw in a 1/4 inch drill
hole in the patient's skull. The screw is attached to a transducer, pressure
waves are transformed to
electrical impulses and recorded in the same manner as with the ventricular
catheter. Tr. I/58-59.
52. Insertion of the bolt or screw type of ICPM device is usually performed
at bedside under local
anesthetic. Tr. I/60.
53. A ventriculostomy or insertion of a ventricular catheter also can be performed
under local anesthetic.
Tr. I/61.
54. In the cases cited by the I.G., Petitioner performed ICP monitoring using
the ventricular catheter
method and not the bolt or screw method. Tr. I/136.
55. Dr. Samuel J. Hassenbusch, III is a staff member of the Department of Neurosurgery
at the Cleveland
Clinic Foundation (Cleveland Clinic). Dr. Hassenbusch obtained his M.D. and
Ph.D. degrees from the
Johns Hopkins University in Baltimore, Maryland, where he also served his internship
and residency. Dr.
Hassenbusch successfully completed the written examination phase of his board
certification in
neurosurgery in 1987. At the time he testified, Dr. Hassenbusch was awaiting
a date for the administration
of the oral examination phase of the board certification process. P. Ex. 19;
Tr. III/6.
56. Dr. Hassenbusch is a qualified expert in neurosurgery.
FFCL 55.
57. Dr. Hassenbusch testified that an estimated 30 to 50 percent of practicing
neurosurgeons would
perform ICPM in selected stroke patients or would consider it a reasonable alternative.
Tr. III/47-48.
58. Dr. Hassenbusch testified that neurosurgeons at the Cleveland Clinic currently
perform ICPM in
selected stroke patients and that neurosurgeons at Johns Hopkins Hospital did
so at the time he was in
training there. Dr. Hassenbusch testified that ICPM was done at those institutions
for therapeutic purposes,
rather than for research. Tr. III/47-48, 126-27.
59. Both Dr. Hassenbusch and Dr. Kasoff testified that ICPM was done more frequently
in the 1970's and
1980's than it is done currently. Tr. I/61-64; Tr. III/127.
60. The use of a ventricular catheter to relieve and monitor ICP is a reasonable
procedure to perform in
certain stroke cases where there are indications of increased ICP. Tr. II/271;
Tr. III/48; FFCLs 50, 54, 57,
58.
61. To be within professionally recognized standards of care, a procedure need
not be endorsed by the
majority of the professional community; the procedure is within professionally
recognized standards if it
has substantial support within the professional community.
62. Insertion of a ventricular catheter for drainage and ICPM in a patient
who is exhibiting clinical signs of
increased ICP is within professionally recognized standards of neurosurgery.
FFCL 60.
63. Clinical signs of increased ICP include decreased level of consciousness;
lowered heart rate; elevated
blood pressure; and impaired motor function, such as hemiparesis. Tr. II/288;
Tr. III/165; I.G. Ex. 19/3-4.
64. Hemiparesis is a weakness on one side of the body. Tr. I/79.
65. The article, Ropper and Shafran, Brain Edema After Stroke, 41 Archives
of Neurology 26 (1984)
(Brain Edema After Stroke), is authoritative medical literature. T. III/143;
194.
66. The article Brain Edema After Stroke states that routine monitoring of
ICP in patients with brain
edema after stroke cannot be recommended. I.G. Ex. 20/4.
67. Dr. Ira Kasoff is a board certified neurosurgeon and clinical assistant
professor at the Robert Wood
Johnson School of Medicine at Rutgers University. Dr. Kasoff is a consultant
to the NJPRO. Additionally,
Dr. Kasoff was recently appointed a consultant to the Super-PRO a national body,
the function of which is
to arbitrate conflicts that may arise between individuals and State PROs. Tr.
I/48-53; I.G. Ex. 17.
68. Dr. Kasoff is a qualified expert in neurosurgery. FFCL 67.
69. Dr. Kasoff testified that the routine use of ICPM in the treatment of stroke
patients is a violation of
professionally recognized standards of neurosurgical care. Tr. I/63-64.
70. Dr. Kasoff's testimony that routine use of ICPM in stroke patients is a
violation of professionally
recognized standards of neurosurgical care is not inconsistent with Dr. Hassenbusch's
testimony that use of
ICPM in selected stroke patients is within professionally recognized standards
of neurosurgical care.
FFCLs 60, 62.
71. The I.G. proved that it is a violation of professionally recognized standards
of neurosurgical care
routinely to perform ICP monitoring on stroke patients. FFCLs 60, 61, 69, 70.
72. Dr. Kasoff testified that his review of the records in this case led him
to conclude that Petitioner was
prepared to use ICPM on a routine basis. Tr. III/196.
73. Dr. Kasoff acknowledged that he reached the conclusion that Petitioner
was prepared to use ICPM on
a routine basis without knowing how many similar patients Petitioner had treated
during the relevant
period. Tr. III/196.
74. During the period July 1985 to July 1986, Petitioner treated over 100 patients
for stroke, brain
hemorrhage, and brain tumors. Tr. II/267.
75. Of the more than 100 patients suffering from stroke, brain hemorrhage,
or brain tumor whom
Petitioner treated from July 1985 to July 1986, only approximately seven or
eight were treated by inserting
an ICPM device and drain. Tr. II/268.
76. The I.G. did not prove that Petitioner routinely performed ICPM on his stroke patients. FFCLs 73-75.
77. Dr. Kasoff stated at the NJPRO meeting that the risk of mortality and morbidity
associated with the
use of general anesthesia is approximately one percent. I.G. Ex. 6/42.
78. Dr. Kasoff also testified that patients suffering from stroke disease may
be placed at risk by the
administration of general anesthesia because the inhalation anesthetic might
cause blood to be diverted into
the area of the brain that has experienced the stroke. This diversion, according
to Dr. Kasoff, could convert
the stroke into a hemorrhage, resulting in greater brain damage to the patient.
Tr. I/73.
79. The I.G. did not introduce any evidence as to the magnitude of the risk
that a stroke patient would
experience a cerebral hemorrhage as a result of receiving general anesthesia.
80. The only quantifiable evidence before me as to the magnitude of the risk
presented by the
administration of general anesthesia proves that the risk is approximately one
percent. FFCLs 77-79.
81. Dr. Kasoff testified that there is a risk of infection associated with
surgery and with insertion of an
ICPM device. Tr. I/71.
82. The I.G. did not introduce any evidence quantifying the risk of infection
associated with surgery to
insert an ICPM device.
83. A gross and flagrant violation within the meaning of section 1156(b)(1)(B)
of the Act is one that
involves "an especially dangerous deviation from medical norms." Varadani
v. Bowen, 824 F.2d 307, 312
(4th Cir. 1987).
84. Placing a patient who faces a near certain risk of death from his or her
underlying disease process at a
one percent risk of mortality from general anesthesia does not constitute an
especially dangerous violation
of medical norms because the patient is not placed at greater risk than that
resulting from the underlying
condition. FFCLs 80, 82, 83.
Patient 268001 (Case # 1)
85. Patient 268001 was an 81 year old male who was brought to the emergency
room at Newcomb
Hospital in Vineland, New Jersey, on August 23, 1985, after suffering a sudden
weakness on the right side
and becoming unconscious. I.G. Ex. 10/5.
86. In the emergency room, Patient 268001 was comatose and was not breathing
effectively on his own.
I.G. Ex. 10/5.
87. Patient 268001 was intubated in the emergency room. I.G. Ex. 10/5.
88. After examining the patient in the emergency room, Dr. Ilyas Rajput, the
attending physician, listed his
impressions as: 1) cerebrovascular accident with right hemiparesis; 2) increased
blood pressure by history;
and 3) history of irregular heart beats. I.G. Ex. 10/5.
89. Patient 268001 was admitted to the hospital and transferred to the Intensive
Care Unit (ICU). I.G. Ex.
10/2.
90. On admission to the ICU, the patient was able to squeeze his left hand
to commands and responded to
his name by opening his eyes and turning his head toward the speaker. I.G. Ex.
10/57.
91. Petitioner saw the patient as a consultant on August 23, 1985. I.G. Ex. 10/18, 57.
92. On August 24, 1985, a computerized axial tomography (CAT) scan of the patient's
head was
performed. I.G. Ex. 10/97.
93. A CAT scan is similar to an x-ray except that it permits the physician
to visualize soft tissue, in this
case the brain, rather than just the bone. Tr. III/20.
94. According to the radiologist's report, the CAT scan revealed an area of
decreased attenuation in the left
temporal and parietal lobe consistent with a recent infarct with mass effect.
The report also noted minimal
compression of the left lateral ventricle. The radiologist's impression was
that the patient had suffered an
infarct involving the left temporal and parietal lobes. I.G. Ex. 10/97.
95. Dr. Hassenbusch testified that compression of the left lateral ventricle
could indicate increased
pressure within the brain. Tr. III/11.
96. On August 24, 1985, Dr. Rajput noted that Patient 268001 remained stuporous
and occasionally
responded to verbal commands. I.G. Ex. 10/18.
97. A nurse's note of 15OO hours (3:00 p.m.) August 24 reports the patient's
neurological status as
stuporous, pupils sluggish, right side flaccid, grips weakly with left hand.
I.G. Ex. 10/58.
98. The nurse's note of 1500 hours August 24 further reports that at 1130 hours
(11:30 a.m.) Patient
268001 became bradycardic with sinus arrest. I.G. Ex. 10/58.
99. Bradycardia means that the patient's heart rate was low. Tr. II/290.
100. In a note also dated August 24, 1985, Petitioner described Patient 268001's
condition as unconscious,
no verbal response; withdraws mainly to pain; pupils sluggish. Petitioner wrote
that the patient's CAT scan
showed shift and mass effect and concluded that, in view of the mass effect
and decreased heart rate,
Patient 268001 was probably experiencing increased ICP. I.G. Ex. 10/19; Tr.
II/286.
101. Petitioner reported that he had discussed the patient's condition and
treatment options with the
patient's wife and that the patient's family agreed to proceed with a ventriculostomy
and ICPM. I.G. Ex.
10/19; Tr. II/286.
102. The patient was taken to the operating room for surgery at 1920 hours
(7:20 p.m.), August 24, 1985.
I.G. Ex. 10/59.
103. Petitioner performed a ventriculostomy on the patient under general anesthesia. I.G. Ex. 10/19.
104. There is no indication in the record as to what anesthetic agent or agents
were administered to the
patient.
105. In the operative record of the procedure, Petitioner stated that when
the catheter entered the ventricle,
fluid came out under pressure. I.G. Ex. 10/9.
106. In a note dated August 25, 1985, Dr. Robert D. Fazzaro, who was covering
for Dr. Rajput (see I.G.
Ex. 10/59), reported that the patient was more awake and that his heart rate
was increased. I.G. Ex. 10/20.
107. Petitioner's note of August 25 also reported: "Patient is more awake.
Started to follow verbal
commands. Pre-op [patient] was completely unresponsive. His ICP WNL [within
normal limits]. Pupils
are reacting. Still has gaze preference to [left symbol]. . .His HR [heart rate]
is up. Started to move [right
symbol] leg more." I.G. Ex. 10/21
108. Throughout the remainder of Patient 268001's stay at Newcomb Hospital,
the physicians' notes reflect
fairly consistently that the patient was more awake and was able to follow verbal
commands. I.G. Ex.
10/21-34.
109. Petitioner removed the ICPM device on August 27, 1985. I.G. Ex. 10/22.
110. The values for recorded for ICP were all within normal limits except for
one notation that readings
were "as high as 25 [mm/Hg] when pt [patient] is being suctioned."
I.G. Ex. 10/64.
111. A consistent reading of greater than 15 mm/Hg indicates increased ICP. P. Ex. 23/6.
112. Efforts to wean Patient 268001 from the respirator were unsuccessful. I.G. Ex. 10/2.
113. At the family's request, Patient 268001 was transferred by ambulance to
a Philadelphia hospital on
September 11, 1985, so that he could be cared for by the family physician. I.G.
Ex. 10/2.
114. Patient 268001 exhibited symptoms consistent with increased ICP. Those
symptoms included a
decrease in level of consciousness, an episode of bradycardia, or low heart
rate, and right hemiparesis. The
patient's CAT scan also suggested the possibility of increased ICP. FFCLs 63,
88, 94-100.
115. In light of Patient 268001's symptoms, it was reasonable for Petitioner
to conclude that the patient
might be suffering from increased ICP, and to perform surgery to insert a ventricular
catheter for ICPM
and drainage of CSF. FFCL 114.
116. Dr. Hassenbusch testified that performing the surgery under general anesthesia
was an appropriate
alternative because the Patient 268001 was unable to follow verbal commands
and thus might have been
unable to cooperate if the procedure had been done under local anesthesia. Tr.
III/14; 88-89; P. Ex. 18/1.
117. Dr. Joseph Arico, a board certified neurosurgeon, stated in a written
report, prepared at Petitioner's
request, that Petitioner's treatment approach was the best approach to both
monitor and treat increased ICP.
P. Ex. 1/1.
118. Dr. Hassenbusch testified that insertion of the ICPM device in Patient
268001 was within
professionally recognized standards of neurosurgery. Tr. III/15.
119. The I.G. did not prove by a preponderance of the evidence that Petitioner
violated his obligation to
provide Patient 268001 with care that met professionally recognized standards
of neurosurgery. FFCLs
114-118.
120. Because I have concluded that Petitioner did not violate his obligation
to provide Patient 268001 with
care that met professionally recognized standards of neurosurgery, I need not
reach the question of whether
Petitioner placed Patient 268001 in imminent danger or unnecessarily in a high
risk situation. FFCLs 83,
119.
Patient 8601866M (Case # 2)
121. Patient 8601866M was a 74 year old female who was admitted to Millville
Hospital in Millville, New
Jersey, on January 17, 1986, after she suddenly developed confusion, slurred
speech, and marked weakness
of the left side. I.G. Ex. 11/4.
122. Patient 8601866M was seen in the emergency room by Dr. Fazzaro, who noted
that her blood
pressure was 240/110, that she was comatose with pupils pinpoint and nonreactive,
and that she had severe
left hemiparesis. Dr. Fazzaro's impression was that the patient had suffered
a cerebrovascular accident
(CVA), probable hemorrhage. I.G. Ex. 11/17.
123. Dr. Fazzaro ordered a CAT scan and requested a neurosurgical consultation
on an emergency basis.
I.G. Ex. 11/2.
124. The report of the CAT scan described a large hemorrhagic lesion throughout
the right basal ganglia
extending into the adjacent right frontotemporal and parietal lobes as well
as into the right lateral ventricle.
The report also noted significant right to left shift of the midline structures.
I.G. Ex. 11/21.
125. The radiologist's impression of the CAT scan was that Patient 8601866M
had suffered a large
hemorrhagic lesion on the right side of the brain with right to left shift,
most likely representing a
hemorrhagic infarction in the basal ganglia with extension into the ventricular
system and adjacent brain.
The radiologist stated that a neoplasm [tumor] with hemorrhage could not entirely
be excluded. I.G. Ex.
11/21.
126. On January 17, 1986, Petitioner performed surgery to evacuate the hematoma. I.G. Ex. 11/17-18, 30.
127. Petitioner's operative record of the surgery describes a large intracerebral
hematoma which extended
from the surface of the brain, postero-medially to the basal ganglia. The hematoma
was completely
removed. I.G. Ex. 12/14.
128. After evacuating the hematoma, Petitioner inserted a catheter into the
ventricle for monitoring and
draining of intracranial pressure. I.G. Ex. 12/14.
129. The patient did not improve after surgery. She passed into a deep coma
and was pronounced dead on
January 20, 1986. I.G. Ex. 11/13, 20.
130. Dr. Fazzaro's expiration summary reflects the opinion that Patient 8601866M's
only chance for
survival was to perform surgery to evacuate the clot. I.G. Ex. 11/13.
131. Petitioner testified that Patient 8601866M had no chance for recovery
without surgery, while with
surgery, she might have had a 10 percent chance of recovery. Tr. II/296-97.
132. Dr. Hassenbusch testified that there was a 99 percent likelihood that
Patient 8601866M would have
died without surgery, whereas with surgery, he estimated her chances for survival
at 3 to 10 percent. Tr.
III/28-29.
133. Dr. Hassenbusch opined that the surgery to remove the hematoma was within
professionally
recognized standards of neurosurgical practice. Tr. III/25.
134. Dr. Arico stated in his written report, "had some aggressive treatment
program not been undertaken,
[the patient] would have gone on to demise. Dr. Hussain's effort to decompress
her was aggressive, but
held out the only chance that this patient would have had for survival whatsoever."
P. Ex. 1/2.
135. The unidentified neurologist who reviewed the case of Patient 8601866M
for NJPRO concluded that,
while the surgery held out little hope for recovery, "[o]ne certainly can't
fault Dr. Hussain under the
circumstances for trying to evacuate the hemorrhage." I.G. Ex. 4/8.
136. The unidentified neurosurgeon who reviewed the case of Patient 8601866M
for NJPRO opined that
the majority of neurosurgeons would consider the surgery unnecessary, although
he conceded that there
were those that would differ. I.G. Ex. 4/8.
137. Dr. Kasoff testified that there was no benefit to be gained by surgery
to evacuate the hematoma
because Patient 8601866M had descended into a very deep level of coma from which
he would not
anticipate recovery. Tr. I/89-90.
138. Dr. Kasoff testified that there are neurosurgeons who would consider surgery
to remove the
hematoma an appropriate alternative. Tr. I/161-62.
139. Dr. Kasoff testified that there were neurosurgeons who would proceed with
surgery if there was the
slightest chance that the surgical procedure could benefit the patient. Dr.
Kasoff stated that, in his view,
such surgery would be a "viable option." Tr. III/206.
140. By performing surgery to remove the hematoma from Patient 8601866M's brain,
Petitioner did not
violate his obligation to provide care that met professionally recognized standards
of neurosurgery. FFCLs
133-136, 138, 139.
141. During the surgery to remove the hematoma, Petitioner also inserted a
ventricular catheter for ICPM
and drainage of cerebrospinal fluid. I.G. Ex. 11/14.
142. Petitioner testified that the primary purpose of performing the surgery
was to evacuate the hematoma.
Tr. II/300.
143. Petitioner testified that it is normal neurosurgical procedure to insert
an ICP monitor after surgery to
remove a hematoma. Tr. II/301-02.
144. Dr. Hassenbusch opined that placing the catheter was within accepted standards
of neurosurgical
care. Tr. III/26-27; P. Ex. 18/2.
145. Petitioner did not violate his obligation to provide care that met professionally
recognized standards
of neurosurgery by placing a ventricular catheter in Patient 8601866M to monitor
and regulate ICP.
FFCLs 143, 144.
146. The only risk posed by the ICP monitor independent of the surgery to evacuate
the hematoma is that
of infection. Tr. I/71.
147. The I.G. presented no evidence as to the magnitude of this risk.
148. The I.G. failed to prove that the insertion of the ICP monitor placed
the patient in imminent danger or
unnecessarily in a high risk situation. FFCLs 146, 147.
149. Even if insertion of a ventricular catheter for ICPM and drainage did
represent a violation of
Petitioner's obligation to provide care that met professionally recognized standards
of neurosurgery,
Petitioner did not commit a gross and flagrant violation of that obligation.
FFCLs 146-148.
150. Petitioner testified that stroke patients who present a "fixed deficit,"
such as those suffering
hemorrhages of the basal ganglia, are not helped by surgical means, because
they have already damaged a
particular part of the brain. Tr. II/268.
151. I understand Petitioner's testimony to mean that patients who have suffered
irreversible brain damage
due to strokes of the basal ganglia are not helped by surgical means.
152. The I.G. did not prove that Patient 8601866M had suffered irreversible
brain damage at the time
Petitioner performed surgery.
Patient 854914 (Case # 3)
153. Patient 854914 was an 80 year old male with a history of prior strokes
(transient ischemic attacks or
TIAs) and myocardial infarctions (heart attacks), who presented to the emergency
room at Bridgeton
Hospital in Bridgeton, New Jersey, on July 25, 1985, complaining of nausea and
vomiting since the
previous evening. Tr. I/91; I.G. Ex. 12/2.
154. Dr. Gladwyn Baptist, the attending physician, examined the patient in
the emergency room. His
neurological examination revealed minimal weakness over the left side but no
significant sensory or motor
deficits. Dr. Baptist listed his initial impressions as gastroenteritis with
mild dehydration and rule out the
possibility of myocardial infarction. I.G. Ex. 12/2, 3.
155. Patient 854914 was admitted to Bridgeton Hospital on July 25, 1985, after
abnormal
electrocardiogram (EKG) findings and an episode of nausea in the emergency room.
I.G. Ex. 12/2.
156. On July 29, 1985, Patient 854914 exhibited slurred speech and complained
of mild chest and
epigastric discomfort. I.G. Ex. 12/3.
157. On July 30, 1985, Patient 854914 became increasingly somnolent, his speech
became further slurred,
and his respiratory processes became depressed such that he required intubation.
I.G. Ex. 12/3.
158. Dr. Sharan Rampal, a neurologist, was consulted and saw the patient on
July 31, 1985. His initial
impression indicated he was to rule out the possibility of a cerebellar infarct.
I.G. Ex. 12/3.
159. A CAT scan was ordered. According to the discharge summary, the CAT scan
showed a right
parietal infarct encroaching on the occiput as well as acute right cerebellar
infarction, with severe atrophy
and moderate ventricular dilation. I.G. Ex. 12/3, 33.
160. On August 1, 1985, Dr. Rampal noted that Patient 854914 exhibited decerebrate
posturing to deep
pain and was unresponsive to verbal commands. Dr. Rampal's impression was that
the patient was
decerebrate secondary to cerebellar infarct and that the prognosis was grave.
I.G. Ex. 12/35.
161. Decerebrate posturing refers to a position of the patient's arms and legs,
in which the arms and legs
are extended. The presence of decerebrate posturing indicates pressure upon
or damage to the basic areas
of the brain, specifically the brain stem and the mid-brain. Tr. III/32.
162. Dr. Rampal ordered Mannitol to reduce ICP and requested a repeat CAT scan.
Tr. II/307; I.G. Ex.
12/5, 35.
163. Technical difficulties prevented a print of the follow up CAT scan. However,
the CAT scan was
described in Dr. Rampal's notes as showing increased ventricular dilation suggesting
obstructive
hydrocephalus. Dr. Rampal noted that he would request urgent neurological evaluation
for a possible
shunt. Tr. I/171-72; Tr. II/35; I.G. Ex. 12/36.
164. The term shunt is a broad term for a device, usually similar to a catheter,
which is used to drain fluid
so that ICP can be reduced. The term shunt would include a ventriculostomy.
Tr. II/305-06.
165. On August 2, 1985, Dr. Baptist described Patient 854914's condition as
deteriorating, showing
decerebrate posturing and unresponsiveness. Dr. Baptist also noted multiple
CVAs with cerebral edema.
I.G. Ex. 12/36.
166. Petitioner did not become involved with the treatment of Patient 854914
until he was consulted by
Dr. Rampal on August 2, 1985. Tr. II/304.
167. On August 2, 1985, Petitioner performed a right frontal craniotomy, decompression,
and
ventriculostomy under general anesthesia and set up and calibrated an ICPM device
on Patient 854914.
I.G. Ex. 12/5, 37.
168. The ventriculostomy that Petitioner performed on Patient 854914 on August
2, 1985, was for the
purpose of decompressing or draining the ventricular system. I.G. Ex. 12/83-84,
90.
169. Petitioner's contention that the procedure performed was a craniectomy,
not a craniotomy, is not
persuasive given the numerous references in the hospital records and in Petitioner's
own notes, which refer
to the procedure performed as a craniotomy. I.G. Ex. 12/3, 5, 37.
170. On August 3, 1985, Petitioner noted that Patient 854914 was comatose and
decerebrating bilaterally,
with withdrawal responses to deep painful stimuli. Petitioner also noted posterior
fossa swelling and
hydrocephalus, and indicated that if the patient failed to improve in the next
two to three days he would
consider a posterior fossa decompression. I.G. Ex. 12/38.
171. Dr. Rampal and Petitioner both indicated on August 3 and 4, 1985, that
Patient 854914's neurological
condition remained the same and stated that a repeat CAT scan would be performed.
I.G. Ex. 12/40.
172. On August 6, 1985, Petitioner noted the patient was "unchanged"
and noted a need for
electroencephalogram (EEG) results. I.G. Ex. 12/41.
173. In a note also dated August 6, 1985, Dr. Baptist stated that the patient's
prognosis was "very poor".
I.G. Ex. 12/41.
174. Petitioner noted no change in Patient 854914's neurological status in
his note of August 7, 1985. I.G.
Ex. 12/43.
175. A repeat CAT scan done on or about August 8, 1985, showed increased mass
effect, compression in
the posterior fossa, and compression of the brain stem. I.G. Ex. 12/3; P. Ex.
20/31; Tr. III/34.
176. An EEG was performed on August 8, 1985, and revealed pronounced cortical
(brain stem) function
in Patient 854914. I.G. Ex. 12/45, 82.
177. On August 9, 1985, Petitioner performed a posterior fossa craniotomy,
a posterior fossa
decompression, and a ventriculostomy on Patient 854914, using general anesthesia.
I.G. Ex. 12/6, 45-46.
178. On August 13, 1985, Petitioner removed the ICPM device, noting that the
patient's ICP was within
normal limits. I.G. Ex. 12/49.
179. Patient 854914 did not improve after the surgery of August 9, 1985. Dr.
Baptist noted that the
prognosis appeared extremely poor. On August 16, 1985, the patient was extubated
and allowed to expire
with the consent of the family. I.G. Ex. 12/4.
180. A cerebellar stroke is a stroke which occurs in the part of the brain
known as the cerebellum, and
which may produce a mass effect on the brain stem. Tr. I/93.
181. In the case of cerebellar strokes, it is necessary and vital to decompress
the cerebellum very quickly.
Failure to do so may cause irreversible devastation to the brain stem and possibly
death to the patient. Tr.
I./93-94.
182. It was necessary and vital for Petitioner to act quickly to avoid total
compromise of Patient 854914's
brain stem function. FFCLs 159, 160, 170, 175, 181.
183. A posterior fossa decompression is an appropriate procedure to perform
in the early stages of a
cerebellar stroke (also called a cerebellar infarct). It serves to relieve intracranial
pressure and alleviate
mass effect, in turn protecting the vital brainstem. After the patient has suffered
irreversible brainstem
damage (a symptom of which may be decerebration) a posterior fossa decompression
cannot remedy the
condition. After a relatively short time, the brain stem is damaged and there
is very little hope of the
patient surviving. Tr. I/99-100, 173, 175.
184. The medically appropriate treatment for an acute cerebellar infarction
with compression of the
brainstem is prompt posterior fossa decompression. I.G. Ex. 4/9-10.
185. When Petitioner operated on Patient 854914 on August 2, 1985, he did not
believe he was dealing
with a cerebellar infarct; he believed the patient had acute hydrocephalus.
I.G. Ex. 12/84-86.
186. Had Petitioner thought, on August 2, 1985, that he was dealing with a
cerebellar infarct, he would
have performed a posterior fossa decompression. I.G. Exs. 6/72-73; 12/87-88.
187. Petitioner's contention that the CAT scans of July 31 and August 1, 1985,
showed only
hydrocephalus is not credible, in light of the discharge report stating the
July 31 CAT scan showed a right
parietal infarct encroaching on the occiput, as well as acute right cerebellar
infarction, with severe atrophy
and moderate ventricular dilation. I.G. Ex. 12/3, 33.
188. Petitioner became convinced, several days after the August 2, 1985, surgery,
that he was dealing with
a cerebellar infarct in Patient 854914. I.G. Ex. 12/90.
189. Despite Petitioner's realization that he was dealing with a cerebellar
infarct in Patient 854914, he did
not perform a posterior fossa decompression until August 9, 1985. FFCLs 177,
185, 186, 188.
190. Petitioner was satisfied with the quality of the CAT scan that was performed
on August 1, 1985. I.G.
Ex. 6/85.
191. It was the responsibility of Petitioner, when he was consulted in the
case of Patient 854914, to ensure
that all diagnostic procedures were performed that were necessary to diagnose
the cause and severity of the
patient's condition. I.G. Ex. 6/96, 98.
192. Petitioner noted that Patient 854914 was comatose and decerebrating on
August 3, 1985. Petitioner
also noted posterior fossa swelling and hydrocephalus in the patient on August
3. I.G. Ex. 12/38.
193. Petitioner did not perform a posterior fossa decompression on Patient
854914 until August 9, 1985,
six days after he noted posterior fossa swelling and decerebration in the patient.
I.G. Ex. 12/38.
194. When Petitioner performed a posterior fossa decompression on Patient 854914
on August 9, 1985,
the patient's condition was unsalvageable and irreversible. To have been of
any benefit in this case, a
posterior fossa decompression would have to have been done by August 2, 1985.
Tr. I/99-100, 173, 175.
195. Petitioner's performance of a posterior fossa decompression on Patient
854914 on August 9, 1985,
was unnecessary. FFCLs 181-184, 193, 194.
196. Petitioner violated his obligation under the Act by failing to diagnose
and treat Patient 854914 for an
acute cerebellar infarction (stroke). FFCLs 181-195.
197. Petitioner violated his obligations under the Act by failing to recognize
a cerebellar stroke in Patient
854914 and by failing promptly to perform a posterior fossa decompression to
alleviate the compression of
the patient's brain stem. FFCLs 181-196.
198. Petitioner violated his obligations under the Act when he failed to diagnose
the cause of Patient
854914's hydrocephalus. FFCLs 185-188, 191, 194.
199. Petitioner's failure to obtain a repeat CAT scan to verify the nature
of Patient 854914's condition was
a violation of Petitioner's obligation under the Act. FFCLs 171, 175, 181-188,
190, 191.
200. Petitioner's failure timely to diagnose Patient 854914's condition placed
the patient in imminent
danger and unnecessarily in a high risk situation. FFCLs 181-189, 193-199.
201. Petitioner's failure promptly to perform a posterior fossa decompression,
in light of clear evidence of
compromised brain stem function and the deterioration of the patient, placed
patient 854914 in imminent
danger and unnecessarily in a high risk situation. FFCLs 177, 181-186, 193-199.
202. Petitioner's failure timely to obtain another CAT scan placed Patient
854914 in imminent danger and
unnecessarily in a high risk situation. FFCLs 171, 175, 181-188, 190, 191, 199.
203. Petitioner committed gross and flagrant violations of his obligation under
the Act when he failed
timely to obtain a repeat CAT scan, failed timely to diagnose that Patient 854914
was suffering from a
cerebellar infarct, and when he failed promptly to perform a posterior fossa
decompression. FFCLs 200-
202.
204. Petitioner failed to diagnose and treat Patient 854914's medical condition properly. FFCL 196, 197.
205. Petitioner's treatment of Patient 854914 manifests an inability promptly
to diagnose and treat patients
for cerebellar infarcts. FFCLs 181-193.
206. Petitioner demonstrated poor judgment in failing to order a repeat CAT
scan. FFCLs 187, 191, 202.
207. Petitioner's treatment of Patient 85914 demonstrates a lack of appreciation
for the need to act very
quickly to diagnose a cerebellar infarct and to perform a posterior fossa decompression
to prevent brain
stem compression. FFCLs 182, 193, 197, 200, 201, 204.
208. Petitioner lacks knowledge vital to the prompt diagnosis and treatment
of cerebellar strokes
impacting on the brainstem. FFCLs 193-207.
209. Petitioner lacks the ability to comply with his obligation to provide
care that meets professionally
recognized standards, because he lacks knowledge basic to the diagnosis and
treatment of cerebellar stroke
patients. FFCL 208.
Patient 86-0935 (Case # 4)
210. Patient 86-0935 was an 83 year old female, who was admitted to Elmer Community
Hospital in
Elmer, New Jersey on April 11, 1986, with complaints of confusion, unsteadiness,
and fever. I.G. Ex.
13/4.
211. Dr. J. A. LaCavera, the admitting physician, found that Patient 86-0935
was able to move her upper
and lower extremities fairly well and noted equal reflexes and no hemiparesis.
His impression was a
urinary tract infection, possible CVA, possible hypokalemia, and organic brain
syndrome. I.G. Ex. 13/5.
212. Dr. LaCavera noted that, on April 11, 1986, the date of admission, the
patient was unable to answer
any questions, and was disoriented as to time, place, and year. I.G. Ex. 13/8.
213. On April 15, 1986, four days after her admission, a CAT scan was performed
on Patient 86-0935.
According to the radiologist's report, the CAT scan showed a high density area
indicative of an acute
hematoma and evidence of previous infarctions. The scan showed no shift in the
midline structures of the
brain. I.G. Ex. 13/31.
214. Petitioner was consulted and became involved with the treatment of Patient
86-0935 on April 16,
1986. I.G. Ex. 13/6.
215. Petitioner was not responsible for the unusual delay between Patient 86-0935's
admission to the
hospital on April 11, 1986, and the performance of the CAT scan on April 15,
1986. Tr. I/104; Tr. II/317.
216. Petitioner conducted an examination of Patient 86-0935 on April 16, 1986.
Petitioner noted the
patient's history and described her as stuporous, not following verbal commands.
Tone was described as
equal, symmetrical; however, Petitioner also noted a slight hemiparesis on the
right side. Tr. II/318; I.G.
Ex. 13/6.
217. Petitioner concluded on April 16, 1986, that Patient 86-0935's level of
consciousness had decreased,
that the hematoma was causing significant pressure on the brain, and that the
patient was exhibiting a
deterioration in her level of consciousness and weakness such that surgery was
indicated. I.G. Ex. 13/10,
Tr. II/319.
218. On April 17, 1986, Petitioner performed a surgical craniotomy on Patient
86-0935 under general
anesthesia. Petitioner evacuated the hematoma and inserted a catheter (drain)
type of ICPM. I.G. Ex. 13/7,
10.
219. On April 18, 1986, Petitioner removed the ICPM device, without recording
any ICP values in Patient
86-0395's chart. Tr. II/379-80.
220. Patient 86-0935 was released from the hospital to a nursing home, via
ambulance, on April 29, 1986.
Upon her release, she still exhibited confusion and disorientation and did not
exhibit marked improvement.
I.G. Ex. 13/90, 91.
221. In the instance of a small intracerebral hematoma, with no shift in the
midline structures, the
preferred form of treatment is conservative, namely to treat it with steroids
and to let the body reabsorb it.
Tr. I/180.
222. Surgery may be indicated for intracerebral hemorrhages where there is
a deterioration in the
neurological condition coupled with disordered motor function. Tr. I/180-181;
Tr. III/165; P. Ex. 14.
223. Neurologic deterioration, by itself, is not an automatic signal to perform
neurosurgery on a stroke
patient. Tr. III/86.
224. Organic brain syndrome is a condition that is also known as Alzheimer's
disease. I.G. Ex. 6/110-11;
Tr. II/175.
225. Patient 86-0935 exhibited behavior patterns consistent with Alzheimer's disease. Tr. III/117.
226. Confusion is not necessarily indicative of a decreasing level of consciousness.
Increasing
somnolence, optundation, or stupor are indicative of a decreasing level of consciousness.
Tr. III/165.
227. A CAT scan showing no shift in midline structures is indicative of a small
intracerebral hemorrhage.
Tr. III/109.
228. Possible risks from postsurgical increases in intracranial pressure can
be expected to occur, if at all,
within three days following the surgery. Tr. I/111.
229. The nurse's notes in the record do not support Petitioner's conclusion
that Patient 86-0935 was
deteriorating neurologically. I.G. Ex. 13/52, 53; Tr. II/377-78.
230. The nurse's notes indicate that on the morning of April 16, 1986, Patient
86-0935 was aroused by
verbal stimuli. I.G. Ex. 13/53.
231. Dr. LaCavera's notes do not support Petitioner's contention that patient
86-0935 was deteriorating
neurologically. I.G. Ex. 13/8, 9.
232. Petitioner's notes in the patient's progress records that patient 86-0935
was deteriorating are
inconsistent with Petitioner's consultation report, which does not mention that
the patient was deteriorating
or that surgery was a possible option. I.G. Ex. 13/6, 10.
233. Petitioner noted that the patient was basically unchanged neurologically
upon her release, and that the
patient still exhibited poor communication. I.G. Ex. 13/16.
234. Surgery to remove the hematoma was not indicated in the case of Patient
86-0935 because the patient
had tolerated the small intracerebral hematoma for five days, because there
was no shift in midline
structures, and because the patient did not exhibit signs of neurological deterioration.
FFCLs 217, 221-
225, 227, 229, 231, 232.
235. Petitioner's insertion of an ICPM device and ventricular drain in Patient
86-0935 was not medically
indicated, given that the patient did not exhibit signs of increased ICP. FFCLs
63, 219, 221, 222, 227, 234,
267.
236. Petitioner's insertion of an ICPM device and ventricular drain in Patient
86-0935 was a violation of
Petitioner's obligations under the Act. FFCL 235.
237. Petitioner's removal of the ICPM device after only one day, when the patient
was still at risk for
swelling and edema, and without recording any pressure readings, was contrary
to Petitioner's stated
purpose in inserting the ICPM and was a violation of Petitioner's obligations
under the Act. FFCLs 218,
219, 228, 235.
238. Petitioner subjected this patient unnecessarily to a high risk situation
by performing surgery under
general anesthesia, which was not medically indicated in this instance. FFCLs
218, 234.
C\MA Petitioner committed a gross and flagrant violation of his obligations
under section 1156 by
performing a surgical craniotomy and evacuation of hematoma under general anesthesia
on patient 86-
0935. FFCL 238.
240. Petitioner failed to recognize that Patient 86-0935 was tolerating her
small intracerebral hematoma
and that surgical intervention to remove the hematoma was not medically indicated.
FFCLs 221, 222, 227,
234, 238.
241. Petitioner inappropriately inserted an ICPM device and ventricular drain
in Patient 86-0935, when the
patient's hematoma was unlikely to cause increased ICP. FFCLs 213, 221, 222,
234, 235.
242. If Petitioner's purpose in inserting the ICPM device was to monitor any
swelling caused by the
surgery to remove the hematoma, Petitioner inappropriately removed the ICPM
device from Patient 86-
0935 when the patient remained at risk from edema and swelling of the brain
secondary to the surgery.
FFCLs 219, 237.
243. Petitioner's treatment of Patient 86-0935 demonstrates a lack of knowledge
of the indications for
surgical intervention, as opposed to medical management in cases of small intracerebral
hemorrhages.
FFCLs 234, 242.
Patient 277259 (Case # 5)
244. Patient 277259 was a 74 year old female who was admitted to Newcomb Medical
Center on April 7,
1986, complaining of weakness in her left leg, difficulty walking, and a facial
droop on the left side. I.G.
Ex. 14/2.
245. Patient 277259 was examined by the admitting physician, Dr. Pasquale A.
Ruggieri, a specialist in
internal medicine and cardiology. Dr. Ruggieri's examination of the patient
revealed a left central facial
weakness associated with weakness of the left arm and left leg. Dr. Ruggieri's
initial impression was a
stroke in progress with left hemiparesis. I.G. Ex. 14/2.
246. Dr. Dirk E. Skinner, a neurologist, was called in for consultation on
April 7, 1986. His impression
was that Patient 277259 was suffering from a frontoparietal lesion, most likely
a CVA, and rule out the
possibility of a tumor. Tr. II/322; I.G. Ex. 14/2, 6.
247. A CAT scan performed on April 8, 1986, on Patient 277259 revealed a tumor
in the right frontal lobe
attached to the falx with large edema surrounding the tumor and a shift in the
midline structures. Tr. I/12;
Tr. II/323; I.G. Ex. 14/16.
248. The falx is the membrane which connects the two hemispheres of the brain. Tr. II/324-25.
249. Petitioner was called for a neurosurgical consultation on April 8, 1986.
His consultation noted that
the patient was lethargic, not following verbal commands, and had vomited. Petitioner
concluded that the
patient was deteriorating from awake to lethargic in 1-2 hours and that it would
be wise to monitor ICP and
stabilize and then consider surgery for removal of the lesion. I.G. Ex. 14/7.
250. Petitioner discussed his recommendation for surgery with the family of
Patient 277259 and noted that
the family was indecisive about pursuing a surgical option. I.G. Ex. 14/11.
251. Petitioner informed the patient's family of the risks of delay. On the
morning of April 9, 1986,
Patient 277259's husband and daughter decided to proceed with treatment. I.G.
Ex. 14/11.
252. On April 9, 1986, Petitioner performed a surgical craniectomy and inserted
a ventricular catheter for
drainage and an ICPM device. Upon insertion of the ventricular catheter, fluid
came out under pressure.
I.G. Ex. 14/4.
253. Petitioner performed the ventriculostomy for the dual purposes of monitoring
Patient 277259's ICP
and for relieving the patient's increased ICP. I.G. Ex. 14/3, 12, 26.
254. After the surgery, Dr. Ruggieri noted that the patient was neurologically
stable, and Dr. Skinner noted
that the patient was awake and alert. I.G. Ex. 14/14.
255. During the two days following the surgery of April 9, 1986, Patient 277259's
ICP ranged from 8 to
20 mm/Hg, with several readings of 15 or above, indicative of increased ICP.
P. Ex. 23/6; I.G. Ex. 14/24-
26; FFCL 111.
256. Petitioner ordered anti-swelling medications to be administered to Patient
277259 after the April 9
surgery. I.G. Ex. 14/19-20.
257. Petitioner tentatively scheduled Patient 277259 for surgery to remove
the tumor on April 11, 1986.
I.G. Ex. 14/14, 24.
258. Patient 277259's daughter was a nurse at St. Luke's Hospital in New York
City. The daughter
contacted a neurosurgeon at St. Luke's and made arrangements to have the patient
transferred there. The
patient was transferred to St. Luke's on April 11, 1986. I.G. Ex. 14/3, 14
259. Petitioner was unable to perform surgery to remove Patient 277259's brain
tumor because the patient
was transferred to another hospital. FFCLs 257, 258.
260. Petitioner testified that the neurosurgeon in New York, to whose care
Patient 277259 was transferred,
concurred with Petitioner's plan to stabilize the patient by inserting the ventricular
catheter for drainage and
ICPM. Tr. II/330-31.
261. Advances and Technical Standards in Neurosurgery, H. Krayenbuhl ed. (Advances
and Technical
Standards in Neurosurgery) is an authoritative reference on neurosurgical procedure.
Tr. I/190; P. Ex. 24.
262. Advances and Technical Standards in Neurosurgery endorses the practice
of inserting an ICPM
device into a patient several days before surgery to remove a brain tumor to
lower and monitor the patient's
ICP. P. Ex. 24/2.
263. Dr. Maurice M. Davidson, a board certified neurosurgeon who prepared a
written report at
Petitioner's request, stated that it was appropriate neurosurgical practice
to lower ICP for several days prior
to surgery to remove certain brain tumors and that this would be enhanced by
ICPM. P. Ex. 15.
264. Dr. Hassenbusch testified that an ICPM device may be indicated in brain
tumor cases where the
patient experiences severe brain swelling. Tr. III/123.
265. ICPM of patients with certain types of brain tumors is within professionally
accepted standards of
neurosurgery. FFCLs 262-264.
266. Petitioner's decision to insert an ICPM device and ventricular catheter
was based on his determination
that Patient 277259 was deteriorating due to increased ICP. Petitioner determined
that Patient 277259 was
deteriorating based on her decreased level of consciousness, her vomiting, and
her increased left
hemiparesis. I.G. Ex. 14/11.
267. Decreasing level of consciousness, vomiting, and increased hemiparesis
are clinical signs that a
patient may be experiencing increased ICP. Tr. I/180-181; Tr. III/165; FFCL
63.
268. The admission note of April 7, 1986, describes Patient 277259 as exhibiting
some left side weakness.
The nurse's notes of April 8, 1986, indicate severe left side weakness and an
episode of vomiting. I.G. Ex.
14/28
269. The nurse's notes confirm Petitioner's observation that Patient 277259
was deteriorating. FFCLs 267,
268.
270. Petitioner's decision to insert an ICPM device to stabilize and monitor
Patient 277259 was within
professionally accepted standards of neurosurgery. FFCLs 265-269.
271. The I.G. did not prove by a preponderance of the evidence that Petitioner
failed to consider removal
of Patient 277259's brain tumor. FFCLs 250, 257, 258, 259.
272. The I.G. did not prove by a preponderance of the evidence that Petitioner
violated his obligation
under the Act to provide care to Patient 277259 in accordance with generally
recognized standards of
neurosurgery. FFCL 271.
273. Because I have concluded that Petitioner did not violate his obligation
to provide Patient 277259 with
care that met professionally recognized standards of neurosurgery, I need not
reach the question of whether
Petitioner placed Patient 277259 in imminent danger or unnecessarily in a high
risk situation. FFCL 272.
Patient 8617854M (Case # 6)
274. Patient 8617854M was a 70 year old male who was admitted to Millville
Hospital on June 21, 1986,
following weakness and paralysis of the left extremities. I.G. Ex. 15/3-4, 15.
275. Patient 8617854M had previously had a myocardial infarction and arteriosclerotic
disease. I.G. Ex.
15/3.
276. Dr. Dominic Diorio, a medical internist, was both the admitting and attending
physician for Patient
8617854M. On admission, Dr. Diorio noted that Patient 861754M was able to converse
when spoken to
and noted no problems other than weakness of the left arm and left leg and lethargy.
Dr. Diorio's initial
impression was a CVA involving the right hemisphere with left sided manifestations.
I.G. Ex. 15/3, 15.
277. Dr. Diorio ordered an EEG and CAT scan on June 21, 1986. The EEG and CAT
scan were not
performed until June 23, 1986. I.G. Ex. 15/6, 33.
278. According to the radiologist's report, the CAT scan revealed a large acute
infarction in the right
parietal and temporal lobes. The radiologist noted mass effect with a shift
of the lateral ventricles. I.G. Ex.
15/33.
279. A shift of the lateral ventricles of the brain indicates a shift in the midline of the brain.
280. The EEG performed on June 23 showed an abnormal disturbance of the right
hemisphere. I.G. Ex.
15/29.
281. On June 24, 1986, Patient 8617854M developed respiratory complications
and had to be transferred
to the ICU and intubated. I.G. Exs. 15/15, 25.
282. On June 24, 1986, Dr. Skinner, a neurologist, saw Patient 8617854M as a consultant. I.G. Ex. 15/21.
283. On June 26, 1986, Dr. Skinner noted that Patient 8617854M was exhibiting
increased stupor. I.G.
Ex. 15/16.
284. On June 27, 1986, the patient was having respiratory difficulties and
Dr. Diorio noted the need for a
neurosurgical consultation for an ICPM device. I.G. Ex. 15/16.
285. Petitioner was first consulted regarding Patient 8617854M on June 27,
1986. On examination,
Petitioner found the patient comatose and decerebrate to pain. I.G. Exs. 6/163,
15/18, 22.
286. Petitioner's impression was that Patient 8617854M was suffering from brain
edema with closed right
ventricle, mass effect, and increased ICP. I.G. Exs. 6/164, 15/22.
287. Petitioner recommended that Patient 8617854M undergo a ventriculostomy
and monitoring of ICP.
Tr. II/336-38; I.G. Exs. 6/164, 15/22.
288. On June 27, 1986, Petitioner performed a right frontal craniectomy and
a ventriculostomy, and
inserted an ICPM device to monitor ICP. I.G. Ex. 15/17-18, 24-25, 28.
289. During the procedure, Petitioner noted the patient's brain was edematous
with increased pressure.
Petitioner noted that cerebrospinal fluid came out of the ventricular catheter
under pressure. Tr. III/58; P.
Ex. 1/3, 16; I.G. Ex. 15/28.
290. Petitioner testified at the NJPRO proceedings that no general anesthesia
was used when he performed
surgery on Patient 8617854M. He further testified that, because the patient
was comatose at the time of the
surgery, only oxygen was administered. I.G. Ex. 6/166.
291. Generally, anesthesia is not administered when performing surgery on comatose
patients, because
there is no need to put a comatose patient to sleep since that patient cannot
experience pain. Tr. II/340-43.
292. The I.G. offered insufficient evidence from which I could reasonably conclude,
by a preponderance
of the evidence, that Petitioner used anything other than oxygen when he performed
surgery on Patient
8617854M. I.G. Ex. 15/17.
293. I am unable to conclude from the evidence in the record that Patient 8617854M
had, at the time of
surgery, lost all signs of cerebral activity and suffered herniation of the
brain. I.G. Exs. 6/163-64, 15/16,
22-23.
294. Petitioner's examination of Patient 8617854M on June 28, 1986, one day
after surgery, revealed no
brain function. I.G. Ex. 15/18.
295. EEGs performed on June 30 and July 1, 1986, confirmed the absence of brain
function. I.G. Ex.
15/19-20, 30-31.
296. After consultation with the family and the Ethics Committee, the physicians
removed Patient
8617854M from life support systems on July 1, 1986, and the patient died. I.G.
Ex. 15/20, 24-25.
297. Petitioner's rationale for performing surgery on Patient 8617854M was
that the patient had suffered
rapid deterioration due to massive brain swelling and edema. Petitioner thought
that drainage of CSF and
ICPM might improve the patient's condition. I.G. Ex. 6/164.
298. Patient 8617854M was severely compromised and close to brain death when
Petitioner undertook
surgical intervention. The surgical procedure undertaken by Petitioner on Patient
8617854M at best
increased the patient's chances of survival by 5 to 10 percent. Tr. II/346.
299. The surgical procedure undertaken by Petitioner on Patient 8617854M represented
the patient's only
and best hope for survival. Tr. III/59-61; P. Exs. 1/3; 16/2.
300. I am unable to conclude that Petitioner subjected Patient 8617854M to
an unnecessary high risk from
general anesthesia, because the I.G. has failed to show by a preponderance of
the evidence that general
anesthesia was used. FFCLs 290-292.
301. I am unable to conclude that Petitioner subjected Patient 8618754M to
an unnecessary operative
procedure, because that procedure was a reasonable treatment to alleviate the
condition of the patient, and
because it represented the patient's only hope of survival. FFCLs 297-299.
302. I am unable to conclude that Petitioner's use of ICPM in Patient 8618754M
was an unnecessary
operative procedure, because the ICPM device was also used to reduce ICP, and
because reduction of ICP
was clinically indicated. FFCLs 286, 288, 289.
303. The I.G. failed to prove by a preponderance of the evidence that Petitioner
violated his obligation to
provide services to Patient 8618754M in accordance with professionally recognized
standards of
neurosurgery. FFCLs 299-302.
304. Because I have concluded that Petitioner did not violate his obligation
to provide Patient 8618754M
with care that met professionally recognized standards of neurosurgery, I need
not reach the question of
whether Petitioner placed Patient 8618754M in imminent danger or unnecessarily
in a high risk situation.
FFCL 303.
Patient 632365 (Case # 7)
305. Patient 632365 was an 84 year old female who was brought to the emergency
room of Millville
Hospital on August 5, 1989 after being found unresponsive on the floor of her
home. I.G. Ex. 16/4-5; Tr.
II/346-48.
306. On August 4, 1989, the day prior to her admission, Patient 632365 had
complained of a cold and
headache and overall weakness, but had been ambulating, feeding herself, and
been doing well. I.G. Exs.
7/13, 16/4, 5; Tr. II/346-48.
307. Petitioner was the admitting physician. On admission, he initially diagnosed
Patient 632365 as
having a left CVA, test to rule out the possibility of an intracranial hemorrhage.
I.G. Ex. 16/4-5.
308. In the emergency room, Patient 632365 received a number of diagnostic
procedures, including a
chest x-ray, an EKG, and blood chemistry tests. I.G. Ex. 16/28, 33-34, 57-58.
309. The chest x-ray showed the patient's heart as enlarged with pulmonary
venous congestion present.
I.G. Ex. 16/28.
310. Enlarged heart and pulmonary venous congestion are symptomatic of congestive
heart failure. I.G.
Ex. 16/28.
311. Both the chest x-ray and the radiologist's report confirm that Patient
632365 had congestive heart
failure. A written declaration by Dr. Joseph C. Spagnuolo, who is board certified
in internal medicine, also
confirms this diagnosis. I.G. Exs. 16/28, 19/9, 13.
312. Petitioner testified to the NJPRO that the radiologist orally reported
that Patient 632365's chest x-ray
did not reveal any acute condition. I.G. Ex. 7/26.
313. Even if Petitioner received an oral report from the radiologist indicating
that the chest x-ray did not
show anything acute, Petitioner had a duty to inquire further or to order a
follow-up chest x-ray when he
received a written report from the radiologist that indicated that Patient 632365
was suffering from
congestive heart failure. I.G. Exs. 7/26, 16/28.
314. The EKG performed on Patient 632365 was normal. I.G. Ex. 16/33, 34; Tr. II/352.
315. On the date of admission, August 5, 1986, Patient 632365's blood chemistry
tests revealed that her
creatine phosphokinase (CPK) level was 525, and her MB isoenzyme level was 20.
I.G. Exs. 16/57-58;
19/10.
MAIL CPK level is normal within a range of 60-270 units per liter; MB isoenzyme
is normal below 15
units per liter. I.G. Exs. 16/57-58; 19/10.
317. It is frequently a signal of cardiac damage when MB isoenzyme is approximately
four percent or
greater of total CPK. The initial test result for MB isoenzyme in Patient 632365
indicated a MB isoenzyme
level of 20, which was four percent of the total CPK level of 525. I.G. Ex.
19/10.
318. The test result which revealed a CPK level of 525 and an MB isoenzyme
level of 20 noted that the
result was not obtained by the electrophoresis method and stated that the results
might not have the same
predictive value as results obtained with the electrophoresis method. I.G. Ex.
16/57.
319. Electrophoresis is a very accurate method of chemically analyzing blood. Tr. III/68.
320. The CPK test was repeated August 5, 1986, using the electrophoresis method.
The results were as
follows: CPK level was 61; MB isoenzyme level was 0. The pathologist who read
this report interpreted it
as normal. Tr. III/68; I.G. Ex. 16/56.
321. On the date of admission, August 5, 1986, Patient 632365's blood chemistry
tests revealed that her
serum sodium level was 122 milliequivalents per liter.
322. A patient's serum sodium level is normal within a range of 136-153 milliequivalents
per liter. I.G.
Exs. 16/57, 19/10.
323. Petitioner recognized that Patient 632365's serum sodium was relatively
low, but did not consider that
it required correction. I.G. Ex. 7/17.
324. Patient 632365's serum sodium level was 127 milliequivalents per liter
on August 9, 1989. Patient
632365's serum sodium was 117 milliequivalents per liter on August 24, 1989.
I.G. Ex. 16/57.
325. A decreased serum sodium level can be indicative of an increase in water
as a percentage of body
weight, which can be a complication in cases of congestive heart failure. Increased
body water content can
alter a person's mental status and serve to mimic the symptoms of neurological
deterioration. I.G. Ex.
19/10-11.
326. A serum sodium level that is below the normal range is medically unrelated
to an intracerebral
hematoma. I.G. Ex. 19/9.
327. In the face of an abnormal serum sodium level, normal medical practice
is to repeat the test for serum
sodium at least every 24 hours until the serum sodium level is within normal
limits. I.G. Ex. 19/10-11.
328. In the face of a decreased serum sodium level, proper medical treatment
usually consists of diuretics
or restriction of fluids, but the specific problem should be isolated before
any treatment is begun. I.G. Ex.
19/10-11.
329. Petitioner did not believe that Patient 632365 showed any signs of cardiac symptoms. I.G. Ex. 7/24.
330. If a patient exhibits cardiac symptoms, it is Petitioner's practice to
consult an internist or cardiologist
to co-manage the patient. I.G. Ex. 7/28.
331. If Petitioner had recognized that Patient 632365 was exhibiting any symptoms
of a serious cardiac
condition, he would have immediately consulted a cardiologist or internist to
assist him. I.G. Ex. 7/53.
332. Petitioner did not recognize that Patient 632365 was exhibiting cardiac
symptoms and needed to be
treated accordingly. FFCLs 309-312, 315-317, 321-330.
333. Petitioner violated his obligations under the Act to provide care in accordance
with professionally
recognized standards when he failed to recognize the chest x-ray was symptomatic
of congestive heart
failure and further failed to treat the patient according to the symptoms shown
to be present by the x-ray.
FFCLs 309-312, 329-332.
334. Petitioner violated his obligation under the Act to provide care within
professionally recognized
standards when he failed to repeat the serum sodium test until August 9, when
he failed to repeat the serum
sodium test every 24 hours, and when he failed to isolate the cause of and treat
Patient 632365's
abnormally decreased serum sodium levels. FFCLs 321-332.
335. A CAT scan performed on Patient 632365 on August 7, 1989, showed a normal
head without any
evidence of intracerebral hematoma. I.G. Ex. 16/37; P. Ex. 20/103-4.
336. Patient 632365 was initially placed in ICU on August 5, 1989, but was
transferred to neurological
service within one or two days. I.G. Ex. 7/14.
337. A diagnosis of cerebrovascular event or intracerebral hematoma or hemorrhage
is medically
inconsistent with a CAT scan that shows a normal head. I.G. Ex. 16/37; Tr. III/62-64.
338. On August 9 and 10, 1989, Patient 632365 was alert, but shaky and complained
of neck pain,
stiffness, and discomfort. X-rays of the patient's cervical spine showed degenerative
disease with
encroachment on the neural foramina. Tr. II/350; I.G. Ex. 16/17.
339. Based on the results of the x-rays of the cervical spine and his examination
of Patient 632365,
Petitioner diagnosed her symptoms as being caused by an arthritic condition
known as cervical
spondylosis. Petitioner began the patient on a course of physical therapy that
commenced on or about
August 14, 1989. Tr. II/350-51; Tr. II/151; I.G. Ex. 7/15, 16/19.
340. On August 15, 1989, Petitioner noted no neurological deficits in Patient
632365's condition. I.G. Ex.
16/19.
341. Cervical x-rays taken of Patient 632365 on August 16, 1989, confirmed
Petitioner's initial findings of
degenerative joint disease of the cervical spine. I.G. Ex. 16/30.
3 :\ From the period of August 16 through August 23, 1989, Petitioner noted
that Patient 632365's
symptoms of pain and weakness persisted and noted that the patient appeared
confused at times. I.G. Ex.
16/20-22.
343. On August 23, 1989, Petitioner recommended that Patient 632365 undergo
a myelogram to rule out
the possibility of compression of the spinal cord. I.G. Ex. 16/22.
344. A myelogram is an injection of medical dye into the spinal cord to note
any irregularities or
deformities.
345. On August 24, 1989, Patient 632365 suffered cardiac arrest and went into
an irreversible coma. It
was determined that the patient was brain dead. Patient 632365 died on August
30, 1989. Tr. II/151-52,
Tr. III/65; I.G. Exs. 7/16-17, 16/22-26.
346. Petitioner placed Patient 632365 in imminent danger and unnecessarily
in a high risk situation by
failing to recognize, diagnose, and treat her cardiac symptoms. FFCLs 332-334.
347. Petitioner placed Patient 632365 in imminent danger and unnecessarily
in a high risk situation by
failing to consult an internist or cardiologist. FFCLs 330-332.
348. Petitioner placed Patient 632365 in imminent danger and unnecessarily
in a high risk situation by
failing to order or administer conclusive follow up tests of serum sodium levels
and chest x-rays, where
initial tests had indicated the patient was experiencing cardiac difficulties.
FFCLs 333, 334.
349. Petitioner grossly and flagrantly violated his obligation under the Act
to provide medical care in
accordance with professionally recognized standards by failing to recognize,
diagnose, or treat Patient
632365's cardiac symptoms. FFCL 346.
350. Petitioner grossly and flagrantly violated his obligation under the Act
to provide medical care in
accordance with professionally recognized standards by in failing to consult
an internist or cardiologist
regarding Patient 632365. FFCL 347.
351. Petitioner grossly and flagrantly violated his obligation under the Act
to provide medical care in
accordance with generally accepted standards by failing to order or administer
conclusive follow up tests
for Patient 632365's electrolytic abnormalities and by failing to properly monitor
or treat the patient's
electrolytic abnormalities. FFCL 348.
352. Petitioner's treatment of Patient 632365 demonstrates a lack of knowledge
of the clinical signs and
symptoms that may indicate the presence of cardiac damage or disease. FFCLs
346, 349.
353. Petitioner's treatment of Patient 632365 demonstrates a lack of appreciation
of specific cardiac signs
or symptoms that would indicate the need to consult with an internist or cardiologist
in the management of
a patient. FFCLs 347, 350.
354. Petitioner has demonstrated an inability to recognize, diagnose, and treat
cardiac symptoms. FFCLs
351, 352.
355. Petitioner has demonstrated an inability to know when to consult with
an internist or cardiologist in
the management of a patient. FFCL 353.
Willingness and Ability to Comply
356. Petitioner has demonstrated an inability to comply with his obligations
under the Act. FFCLs 204,
205, 207, 208, 209, 240, 243, 353-355.
357. Petitioner has demonstrated a willingness to comply with his obligations
under the Act. Tr. II/359-
62.
Length of Exclusion
358. The I.G. has demonstrated by a preponderance of the evidence that Petitioner
has violated his
obligation to provide health care in accordance with professionally recognized
medical standards with
regard to Patient 632365 (Case # 7). FFCLs 333, 334.
359. The I.G. has demonstrated by a preponderance of the evidence that Petitioner
violated his obligation
to provide health care in accordance with professionally recognized standards
of neurosurgery with regard
to Patient 854914 and Patient 86-0935 (Cases # 3 and # 4). FFCLs 196-199, 236,
237.
360. The I.G. has demonstrated by a preponderance of the evidence that Petitioner
violated his obligation
to provide health care in accordance with professionally recognized standards
of medical care with regard
to Patient 632365 (Case # 7). FFCLs 333, 334.
361. The I.G. has demonstrated by a preponderance of the evidence that Petitioner
has committed gross
and flagrant violations of his obligation within the meaning of section 1156(b)(1)(B)
of the Act with regard
to Patients 854914, 86-0935, and 632365 (Cases # 3, # 4 and # 7). FFCLs 203,
239, 349-351.
362. The I.G. has failed to demonstrate by a preponderance of the evidence
that Petitioner violated his
obligation to provide health care in accordance with professionally recognized
standards of neurosurgery
with regard to Patients 268001, 8601866M, 277259, and 8617584M (Cases # 1, #
2, # 5, and # 6). FFCLs
119, 140, 145, 272, 303.
363. Under Section 1156 of the Act, the Secretary of the Department of Health
and Human Services
(Secretary) may exclude a physician from participating in Medicare and Medicaid
where the Secretary
determines, based on a recommendation by a PRO, that the physician has grossly
and flagrantly violated
the obligation to provide health care of a quality which meets professionally
recognized standards of care
and has demonstrated an inability or unwillingness to substantially comply with
the obligation to provide
such care. Social Security Act, sections 1156 (a)(2), (b)(1).
364. A "gross and flagrant violation" is defined as the violation
of an obligation to provide care in one or
more instances which presents an imminent danger to the health, safety, or well-being
of a Medicare
beneficiary or places the beneficiary unnecessarily in a high risk situation.
42 C.F.R. 1004.1(b) (1989).
365. The I.G. proved that Petitioner committed gross and flagrant violations
of his obligation to provide
health care in accordance with professionally recognized standards of care.
FFCLs 203, 239, 349-351.
366. Although Petitioner has demonstrated a willingness to meet his obligations
under the Act, he has not
demonstrated the ability to do so. FFCLs 356, 357.
367. The I.G. had the authority to exclude Petitioner from participating in
Medicare and Medicaid. FFCLs
20, 24, 25, 360, 363-366.
368. The purpose of section 1156 of the Act is remedial.
369. Section 1156 is intended to enable the Secretary to protect federally
funded health care programs and
their beneficiaries and recipients from health care providers who have demonstrated
by their conduct that
they are not trustworthy. Evelyn Reyes, M.D., DAB CR131 at 37 (1991)
370. The medical records in this case exhibit poor documentation by Petitioner.
I.G. Ex. 6/179; Tr.
III/161-162.
371. Petitioner has engaged in conduct that endangered the health and safety
of program beneficiaries.
FFCL 365.
372. Petitioner has demonstrated by his gross and flagrant violations that
he is not trustworthy to treat
program beneficiaries and recipients. FFCLs 356, 357, 365, 366.
373. The I.G. excluded Petitioner from participating in Medicare and Medicaid
for a period of five years.
I.G. Ex. 9; FFCL 25.
374. The I.G. has not proven that there exists a remedial purpose to exclude Petitioner for five years.
375. The remedial purpose of section 1156 will be served by excluding Petitioner
from participating in
Medicare and Medicaid for three years.
RATIONALE
1. The I.G. must prove his case by the preponderance of evidence.
Petitioner contends that the sanction imposed by the I.G. must be sustained
by clear and convincing
evidence. Petitioner acknowledges that "[P]reponderance of the evidence
is the standard of proof to be
applied in adjudicatory proceedings before and administrative agency if those
proceedings are governed by
7(c) of the Administrative Procedure Act (APA)." 5 U.S.C. 556(d); Steadman
v. S.E.C., 450 U.S. 91,
(1981); P. Br. 31. However, Petitioner argues that the preponderance of the
evidence standard as
articulated by section 7(c) of the APA does not apply to this case. The appropriate
standard for me to
apply, according to Petitioner, is that of clear and convincing evidence. Petitioner
cites Woodby v.
Immigration Serv., 385 U.S. 273 (1966), in support of his contention.
In Woodby, the Court held that while deportation was not a criminal sanction,
it did amount to a "drastic
deprivation" of rights, and therefore a higher standard of proof than the
mere preponderance standard was
appropriate and necessary. Id. at 32- 33. Petitioner acknowledges that Steadman
is a more recent
articulation of the Court's view than Woodby. Petitioner also acknowledges that,
in Steadman, the Court
rejected the argument that the agency should have applied a clear and convincing
standard of proof because
of the severity of the sanction. However, Petitioner reasons that because the
Court did not explicitly
overrule Woodby in the Steadman decision, it left open the issue of whether
the clear and convincing
standard could be applied to cases where: 1) Congress has not spoken as to the
standard of proof in
Medicare exclusion hearings and 2) the sanction involves important individual
interests.
The I.G. argues that the appropriate standard of proof to apply in this case
is the preponderance of the
evidence standard. The I.G. states that in Steadman, the Court explicitly rejected
the application of the
clear and convincing standard in administrative hearings involving civil sanctions.
Moreover, the I.G.
argues that Petitioner's potential exclusion in this case is a civil sanction
and is therefore distinguishable
from Woodby, because it does not involve Petitioner's personal liberty or infringe
on any of Petitioner's
protected property rights or entitlements 6/. I.G. Br. at 2-3. Lastly, the I.G.
argues that the new regulations
published on January 29, 1992 (new regulations), unequivocally state that the
I.G. bears the burden of
persuasion by preponderance of the evidence; whereas the respondent bears the
burden of proof as to any
affirmative defenses or mitigating circumstances. 57 Fed. Reg. 3298, 3352-53
(1992)(to be codified at 42
C.F.R. 1005.15).
I hold that preponderance of the evidence is the correct standard to be applied
in the case before me.
Petitioner's right to an administrative hearing in this case is contained in
section 1155 of the Act, codified
at 42 U.S.C. 1320c-4, which provides in relevant part:
. . . any practitioner or provider, who is dissatisfied with a determination
made by a contracting
peer review organization in conducting its review responsibilities under this
part, shall be entitled to a
reconsideration of such determination by the reviewing organization. Where the
reconsideration is adverse
to the beneficiary and where the matter in controversy is $200 or more, such
beneficiary shall be entitled to
a hearing by the Secretary (to the same extent provided in section 205(b).
Section 205(b) of the Act provides that Petitioners subject to exclusions imposed
by the I.G. are entitled to
de novo hearings. Charles J. Barranco, M.D., DAB CR187, (1992). The Act does
not specify the standard
of review to be used in adjudications of Peer Review Organization (PRO) review
cases before the
Departmental Appeals Board (DAB). Section 5 of the APA, 5 U.S.C. 554, "applies
in every case of
adjudication required by statute to be determined on the record after opportunity
for an agency hearing."
Section 5(b) of the APA, 5 U.S.C. 554(c)(2), makes the provisions of section
7, 5 U.S.C. 556, applicable
to adjudicatory proceedings. Steadman at 96-97. The standard to be used by the
agency in making its
decision is the preponderance of the evidence. Section 7 of the APA, 5 U.S.C.
556; Steadman at 100-01;
Fischer and Porter Co. v. U.S. Int'l Trade Comm'n, 831 F.2d 1574, 1580-81 (1987).
Petitioner's reliance on Woodby is misplaced, as Woodby was a decision of very
narrow application.
Specifically, the Court adopted the clear and convincing standard in Woodby
because:
deportation proceedings were not subject to the APA, and the Immigration and
Nationality Act
(INA) did not prescribe a standard of proof, only the judicial scope of review.
. . . The language, purpose
and history of these sections of the INA differ in language, purpose, and legislative
history of 7(c).
Steadman at 102, n.22.
The Woodby decision is not controlling here, where the administrative hearings
of the DAB are subject to
the APA.
Moreover, while Steadman did not explicitly overrule Woodby, it is a more recent
decision and one closely
analogous to the situation before me. Moreover, Woodby applied only to proceedings
that were outside the
scope of the APA, and not proceedings, such as this one, that are subject to
the APA's procedures.
The I.G. correctly asserts that the new regulations resolve this matter by
stating the I.G. bears the burden of
persuasion by preponderance of the evidence. 57 Fed. Reg. at 3352-53. However,
I cannot conclude the
new regulations are binding on me where their effective date is after the date
the I.G. made his
determination to exclude Petitioner. Behrooz Bassim, M.D., DAB 1333 at 5-9 (1992).
While I do not
believe the new provision changes the burden of proof from the standard used
in the past, I am reluctant to
use the new regulations as support for that rationale.
Additional support for the application of the preponderance of the evidence
standard to exclusion cases is
found in Michael Burditt, DAB CR35 (1989), aff'd DAB 1167 (1990). In Burditt,
ALJ Charles Stratton
stated that the applicable standard for the burden of proof in a section 1867
"anti-dumping" case, where no
specific statutory guidance existed, was "preponderance of the evidence."
Burditt at 30. This
preponderance of the evidence standard was reiterated by an appellate panel
of the DAB in affirming Judge
Stratton's decision. Burditt, DAB 1167 at 8.
In Evelyn Reyes, M.D., DAB CR131 (1991), ALJ Steven Kessel used a preponderance
of the evidence
standard both in determining that a petitioner had grossly and flagrantly violated
her obligation under
section 1156 to provide health care that met professionally recognized standards,
and in determining that
the petitioner in that case was unable to comply with her obligation under the
Act. Reyes was not
challenged on appeal.
Based on the Supreme Court's decision in Steadman and the inapplicability of
Woodby, as well as the
guidance contained in the APA and in DAB decisions, I find that the correct
standard to be applied in the
case before me is one of preponderance of the evidence. In the following sections
of this decision, I
conclude that the I.G. has proven by a preponderance of the evidence that Petitioner
grossly and flagrantly
violated his obligation to provide care which met professionally recognized
standards under section 1156
in three instances. I further conclude that the I.G. proved by a preponderance
of the evidence that
Petitioner is unable substantially to comply with his section 1156 obligation
and that Petitioner's exclusion
is remedially necessary to protect Medicare beneficiaries.
2. Petitioner grossly and flagrantly violated his obligation under section
1156 to provide professionally
recognized standards of health care in three instances.
Section 1156 of the Act imposes on physicians and other health care providers
an obligation, among other
things, to provide services "of a quality which meets professionally recognized
standards of health care."
Section 1156(b)(1)(B) authorizes the Secretary to exclude from participation
in Medicare and Medicaid
practitioners who have been determined by a Peer Review Organization (PRO) to
have "grossly and
flagrantly" violated their obligations in one or more instances. To justify
an exclusion, the PRO must
further conclude that the practitioner has demonstrated an unwillingness or
inability substantially to
comply with his or her obligations under the Act. I first turn to an analysis
of the specific instances in
which the I.G. alleges that Petitioner committed gross and flagrant violations
of his statutory obligation,
after which I discuss generally the nature of Petitioner's obligation to provide
care that meets professionally
recognized standards, and the definition of a gross and flagrant violation of
that obligation.
Neither section 1156 of the Act nor the applicable regulations define the term
"professionally recognized
standards of health care." 7/ Petitioner argues that this standard is equivalent
to a common law malpractice
standard. P. Br. 34. I do not agree. As the I.G. points out, medical malpractice
is a common law tort,
intended to compensate patients who suffer injury caused by a physician's failure
to meet a duty of care.
See I.G. R. Br. 4. By contrast, section 1156 is intended to protect Medicare
beneficiaries from the risk of
harm by identifying practitioners whose care fails to meet the standards of
practice of their professions.
See Reyes at 37. Thus, the different purposes of section 1156 and the common
law of medical malpractice
argue against a wholesale importation of medical malpractice standards into
litigation arising under section
1156.
Moreover, while I have stated that the present case is not governed by the
new regulations, I find
persuasive support for my conclusion that "professionally recognized standards
of health care" are not
synonymous with a medical malpractice standard in the preamble to those regulations.
The preamble
rejects the suggestion of a commenter that the regulations adopt a medical malpractice
standard, stating:
[T]he proposed definition of "professionally recognized standards of
health care" does not provide
a litmus test which can easily be applied in every case. It would be very difficult
to formulate a wholly
objective standard in the area of medical practice, where a certain amount of
subjectivity in judgment is
inevitable.
57 Fed. Reg. at 3301.
The perspective of the preamble is consistent with that of Varadani v. Bowen,
824 F.2d 307 (4th Cir.
1987). In holding that "professionally recognized standards of health care"
was not unconstitutionally
vague, the Court of Appeals for the Fourth Circuit stated:
The definition of adequate medical care cannot be boiled down to a precise
mathematical formula;
it must be grounded in what, from time to time, other health professionals consider
to be acceptable
standards of health care.
Id. at 312.
From the court's decision in Varadani, I infer that "professionally recognized
standards of health care"
describes treatment which the professional peers of a physician would regard
as acceptable.
My interpretation of the standard would not require unanimity of opinion among
physicians as to the
acceptability of a given treatment. Petitioner cites a decision which is persuasive
as to this point. In the
case of Scheuler v. Strelinger, 43 N.J. 330, 204 A.2d 577 (1964), the Supreme
Court of New Jersey stated:
[W]hen a surgeon selects one of two courses, . . . either one of which has
substantial support as
proper practice by the medical profession, a claim of malpractice cannot be
predicated solely on the course
pursued.
204 A.2d 577 at 585; 43 N.J. 330 at 346.
While the case addresses medical malpractice, it illustrates an important point
-- in many instances, it may
be impossible to identify one course of treatment as the only acceptable standard.
For purposes of this
case, I conclude that a physician does not violate his obligation to provide
health care that meets
professionally recognized standards if the physician pursues a course of treatment
that has substantial
support as proper practice among his or her professional peers. The parties
agree, and I hold that the
relevant professional peers in this case are neurosurgeons practicing in the
United States.
Just as "professionally recognized standards" are not defined by
statute, section 1156 also does not define
the term "gross and flagrant violation." However, that term has been
defined by regulation to mean a
violation "which presents an imminent danger to the health, safety or well-being
of a Medicare beneficiary
or places the beneficiary unnecessarily in high-risk situations." 42 C.F.R.
1004.1(b) (1989).
The I.G. asserts that Petitioner grossly and flagrantly violated his obligation
to provide services which meet
professionally recognized standards of quality in each of the seven cases cited.
The I.G. has made
substantially similar arguments in a number of the cases. For this reason, I
discuss these common
arguments as a preliminary matter before proceeding to the specific facts of
each case.
As to the first six patients, the I.G. contends, among other things, that Petitioner
committed gross and
flagrant violations by performing surgery under general anesthesia for ventriculostomy
and ICPM. These
cases primarily involved patients suffering from either stroke or cerebral hemorrhage.
The terms infarct
and stroke are synonymous. They indicate that a portion of the brain has been
deprived of its blood supply.
Tr. I/55.
Youmans' Neurological Surgery, an authoritative medical reference, states that
severe brain infarction may
be accompanied by swelling due to cerebral edema or hemorrhagic infarction and
that the result may be
increased ICP. P. Ex. 22/2. Increased ICP occurs because the skull is a tight
compartment which limits the
range in which a brain lesion can expand. Tr. I/58; Tr. II/269; P. Ex. 23/1.
Increased ICP may cause
damage to a patient's brain because the swelling of the injured portion of the
brain may put pressure on, or
compress, previously undamaged portions of the brain. Tr. II/269. Youmans' Neurological
Surgery states
that fatal outcome in massive cerebral or cerebellar infarction within the first
week can be directly related
to acute brain swelling and its secondary effects. P. Ex. 22/3.
The article Lehman, Intracranial Pressure Monitoring and Treatment: A Contemporary
View, 19 Annals of
Emergency Medicine 295 (1990)(Intracranial Pressure Monitoring), states that
to alleviate the potential
damage to the brain from swelling, most treatment measures have attempted to
reduce the volume of CSF,
blood, or water in the brain without removing or manipulating viable brain tissue.
P. Ex. 23/2. One
method of alleviating potential damage to the brain from swelling is to perform
a ventriculostomy. A
ventriculostomy is a procedure whereby a shunt or catheter is inserted into
one of the ventricles of the brain
in order to relieve pressure on the brain by draining excess CSF. Tr. I/59,
136. The ventricles are
structures deep in the brain, close to the midline, where CSF is produced. Tr.
I/59.
ICPM was introduced in the early 1970's to measure the pressure within the
confines of the skull. Tr. I/58.
One method for recording and monitoring ICP is to insert a catheter into the
ventricle of the brain, as in a
ventriculostomy, and connect it to a transducer so that pressure waves transmitted
through the CSF may be
transformed into electrical impulses and plotted on a graph or converted to
numerical values by digital
means. Tr. I/59. Employing a ventricular catheter as an ICPM device permits
the treating physician to
drain CSF as a therapeutic measure to control and relieve elevated ICP. Tr.
I/137-38.
Another method for recording and monitoring ICP is to place a hollow conical
screw in a 1/4 inch drill
hole in the patient's skull. The screw is attached to a transducer, pressure
waves are transformed to
electrical impulses and recorded in the same manner as with the ventricular
catheter. Tr. I/58-59. Insertion
of the bolt or screw type of ICPM device is usually performed at bedside under
local anesthetic. Tr. I/60.
A ventriculostomy or insertion of a ventricular catheter also can be performed
under local anesthetic. Tr.
I/61. In the cases cited by the I.G., Petitioner performed ICPM using the ventricular
catheter method and
not the bolt or screw method.
The I.G.'s expert, Dr. Ira Kasoff, a board-certified neurosurgeon and consultant
to NJPRO, testified that the
routine use of ICPM in the treatment of stroke patients violates professionally
recognized standards of
neurosurgical care. Dr. Kasoff's view is supported by an article from the journal
Archives of Neurology,
dated January 1984, which states:
Routine monitoring of ICP in this situation [brain edema after stroke], however,
cannot be
recommended at this time since it has not yet been demonstrated that treatment
based on ICP measurement
improves outcome, only that persistently raised ICP is associated with brain
death.
I.G. Ex. 20/4 (emphasis added).
Based on this evidence, I conclude that performing ICPM in stroke patients
on a routine basis is a violation
of the obligation to provide health care which meets professionally recognized
standards.
The I.G. appears to argue, in his post-hearing brief, that any use of ICPM
in stroke patients is not an
accepted medical practice. I.G. Br. 15. I interpret this as an assertion that
ICPM is never indicated in the
treatment of stroke patients. This assertion is not supported by the record.
Even the I.G.'s expert, Dr.
Kasoff, acknowledged that ICPM could be done in selected stroke cases. However,
he testified that this
was not the practice in the neurosurgical community in New Jersey. Tr. III/197.
Petitioner introduced the expert testimony of Dr. Samuel Hassenbusch, a neurosurgeon
practicing at the
Cleveland Clinic, 8/ who testified that a significant percentage of neurosurgeons
(30 to 50 percent
according to his estimate) would do the procedure in selected stroke cases,
or would consider it a
reasonable alternative. Tr. III/47-48. Dr. Hassenbusch's testimony that ICPM
in certain stroke cases meets
professionally recognized standards of care is supported by several learned
treatises offered by Petitioner,
including the aforementioned Neurological Surgery, which Petitioner testified
is the only text
recommended in all neurosurgery training programs. Tr. II/271; see also P. Ex.
22; P. Ex. 23.
At the meeting of the NJPRO, Dr. Kasoff conceded that the author of the Youman's
chapter cited by
Petitioner is a reputable neurosurgeon. I.G. Ex. 6/157. However, Dr. Kasoff
noted that the author
practiced at the Mayo Clinic and asserted that standards of care practiced at
the Mayo Clinic may not be
appropriate in private practice. Id. at 157-58. 9/ Dr. Kasoff stated that physicians
at academic or research
institutions such as the Mayo clinic are employing ICPM in stroke cases only
when conducting research
intended for publication. I.G. Ex. 6/157-58. The testimony of Petitioner's expert,
Dr. Hassenbusch,
directly contradicts Dr. Kasoff's assertion. Dr. Hassenbusch testified that
ICPM of selected stroke patients
is currently being done at the Cleveland Clinic and that it was also done at
Johns Hopkins Hospital, where
he served his residency. He specifically stated that ICPM was being performed
at those institutions for
therapeutic rather than research purposes. Tr. III/127. Dr. Hassenbusch and
Dr. Kasoff both testified that
ICPM was done more frequently in the 1970's and 1980's than it is done currently.
Tr. I/61-64, Tr. III/127.
Petitioner has introduced authoritative treatises and the testimony of an expert
witness in support of his
contention that ICPM is accepted by the neurosurgical community in the treatment
of selected stroke
patients. Based on this evidence, I find that the use of ICPM in a patient diagnosed
with stroke disease is
not a per se violation of professionally recognized standards of neurosurgery.
For this reason, I must
determine, as to each individual case, whether Petitioner's insertion of a catheter
for ICPM violated his
obligation to provide treatment which comports with professionally recognized
standards.
Petitioner does not dispute that routine ICPM of stroke patients violates professionally
recognized
standards of neurosurgery. Instead, he argues that the cases cited by the I.G.
in fact represent the
nonroutine use of ICPM in selected patients who, in addition to having suffered
some brain insult such as a
stroke or hemorrhage, showed clinical signs for increased ICP. Petitioner testified
that he does not
routinely insert ICP monitors in stroke patients. According to Petitioner's
estimate, he treated over 100
patients for stroke, brain hemorrhage, or hematoma, and brain tumors during
the period 1985 to 1986. Tr.
II/267-68. Of those cases, Petitioner estimated that he used ICPM in seven or
eight. Id. I find that
Petitioner did not routinely use ICPM in treating his stroke patients.
I have concluded as a general matter that Petitioner did not violate his section
1156 obligations by routinely
performing ICPM of stroke patients. I must next consider, as to each individual
case, whether Petitioner's
insertion of an ICPM device violated his obligation to provide care in accordance
with professionally
recognized standards. However, even a finding that the treatment provided failed
to meet professionally
recognized standards, without more, will not justify an exclusion. An exclusion
under section
1156(b)(1)(B) is only justified if Petitioner's failure to comply with professionally
recognized standards
was gross and flagrant--that is, if it placed the patient in imminent danger
or unnecessarily in a high risk
situation--and if he is unwilling or unable substantially to comply with such
obligation. 10/
The I.G.'s contention that Petitioner's treatment placed the patients in unnecessarily
high risk situations
generally stems from the view that in these cases the surgical procedure to
insert an ICPM device was
unjustified. Thus, according to the I.G., the usual risks of surgery, such as
the risk of death from
anesthesia, or the risk of infection, were unnecessary in these cases. The I.G.
contends that Petitioner
performed surgery in cases where there was either no clinical indication or
deterioration that would justify
surgical intervention or where the patient was so devastated that surgery offered
no meaningful chance of
recovery.
Petitioner contends that, in his judgment, the patients did deteriorate or
show clinical signs of increased
ICP. Petitioner testified, and the I.G.'s experts confirm, that the clinical
indications for increased ICP
include: decreased level of consciousness; lowered heart rate; elevated blood
pressure; and impaired motor
function, such as hemiparesis. Tr. II/288; Tr. III/165; I.G. Ex. 19/3-4. Thus,
in the cases involving ICPM
alone, a determination that Petitioner violated his obligation to provide care
that meets professionally
recognized standards of neurosurgery initially turns on the question of whether
the medical records support
Petitioner's clinical judgment that the patients suffered neurological deterioration
consistent with increased
ICP. Assuming the records reflect no neurological deterioration or deterioration
to a degree that does not
warrant ICPM, then a determination that a gross and flagrant violation occurred
must be based on a
showing that the patient was in imminent danger or placed in an unnecessarily
high risk situation by the
use of ICPM.
The I.G. alleges that Petitioner grossly and flagrantly violated his section
1156 obligations in several cases
where Petitioner performed surgery to insert ICPM devices for drainage and monitoring
in patients who
had suffered very serious strokes or hemorrhages and were at grave risk of dying
from the brain injury
regardless of whether they underwent surgery. In these cases, the I.G. asserts
that the surgical procedures
placed the patients in unnecessarily high risk situations because, in the I.G.'s
view, the patients were
unnecessarily exposed to the risks inherent in the use of general anesthesia
and to the risks of infection
associated with surgery.
Dr. Kasoff stated at the PRO meeting that the risk of mortality and morbidity
associated with the use of
general anesthesia is approximately one percent. I.G. Ex. 6/42. At the hearing
before me, Dr. Kasoff also
testified that patients suffering from stroke disease may be placed at risk
by the administration of general
anesthesia because the inhalation anesthetic might cause blood to be diverted
into the area of the brain that
has experienced the stroke. Tr. I/73. This diversion, according to Dr. Kasoff,
could convert the stroke into
a hemorrhage, resulting in greater brain damage to the patient. Id. Dr. Kasoff
did not testify, and the I.G.
did not introduce any other evidence, as to the magnitude of this risk. Thus,
the only quantifiable evidence
before me as to the magnitude of the risk presented by the administration of
general anesthesia indicates
that the risk is approximately one percent. Similarly, although Dr. Kasoff testified
that there is a risk of
infection associated with surgery and with insertion of an ICPM device, the
I.G. did not introduce any
evidence quantifying these risks.
The court in the Varadani case explained that a gross and flagrant violation
involves "an especially
dangerous deviation from medical norms." 824 F.2d at 312. I conclude that
placing a patient who already
faces a near certain risk of death from his or her underlying disease process
at a one percent risk of
mortality from general anesthesia does not constitute an especially dangerous
deviation from medical
norms. I reach this conclusion because the patient in such a case is not placed
at greater risk than that he or
she already faces as a result of the underlying condition. 11/
As a preliminary matter, I have concluded that Petitioner did not violate his
obligation to provide care that
met professionally recognized standards of neurosurgery by routinely monitoring
ICP in stroke patients. I
have also concluded that administering general anesthesia to a severely compromised
patient does not place
the patient in imminent danger or in an unnecessarily high risk situation within
the meaning of the
regulation. With these general observations as background, I now turn to an
examination of the individual
cases in which the I.G. alleges that Petitioner committed gross and flagrant
violations of his obligation to
provide services that met professionally recognized standards of health care.
As to each case, I first
analyze the question of whether Petitioner violated his obligation to provide
care of the requisite quality.
Where I find such an obligation, I proceed to determine whether the violation
placed the patient in
imminent danger or unnecessarily in a high risk situation, that is, whether
the violation was gross and
flagrant.
a. Petitioner's treatment of Patient 268001 (Case # 1) did not violate section
1156 of the
Act.
Patient 268001 was an 81-year-old male who was admitted to Newcomb Hospital
in Vineland, New Jersey,
on August 23, 1985. The patient had apparently suffered a sudden weakness on
the right side and became
unconscious. He was comatose on admission and was intubated in the emergency
room because he was
not breathing effectively on his own. I.G. Ex. 10/5. On admission, Dr. Rajput,
the attending physician,
listed his impressions as: 1) cerebrovascular accident with right hemiparesis;
2) increased blood pressure
by history; and 3) history of irregular heart beats. Id. The patient was transferred
to the ICU.
The nurse's notes on admission to the ICU indicate that the patient's level
of consciousness was somewhat
improved. The nurse noted that the patient was able to squeeze his left hand
to commands and responded
to his name by opening his eyes and turning his head toward the speaker. I.G.
Ex. 10/57. Petitioner saw
the patient as a consultant on August 23. I.G. Ex. 10/18, 57.
On August 24, 1985, Dr. Rajput noted that the patient remained stuporous and
occasionally responded to
verbal commands. I.G. Ex. 10/18. On that date, a computerized axial tomography
(CAT) scan of the
patient's head was performed. I.G. Ex. 10/97. A CAT scan is similar to an x-ray
except that it permits the
physician to visualize soft tissue, such as the brain, rather than just the
bone. Tr. III/20. According to the
radiologist's report, the CAT scan revealed an area of decreased attenuation
in the left temporal and parietal
lobe consistent with a recent infarct with mass effect. Id. The report also
noted minimal compression of the
left lateral ventricle. The radiologist's impression was that the patient had
suffered an infarct involving the
left temporal and parietal lobes. Id.
The nurse's note of 15OO hours (3:00 p.m.) August 24 reported the patient's
neurological status as
stuporous, pupils sluggish, right side flaccid, grips weakly with left hand.
I.G. Ex. 10/58. That note further
reported as to the patient's cardiovascular status that at 1130 hours, the patient
became bradycardic with
sinus arrest. Id. Bradycardia means that the patient had decreased heart rate.
Tr. II/290.
In a later note, also dated August 24, Petitioner stated that the patient was
deteriorating neurologically. He
described the patient as unconscious, no verbal response; withdraws mainly to
pain; pupils sluggish.
Petitioner indicated the CAT scan showed shift and mass effect. Petitioner believed
that, in view of the
mass effect and decreased heart rate, there was a probability of increased ICP.
Petitioner discussed the
patient's condition and possible treatment options with his wife and family.
They agreed to allow
Petitioner to proceed with a ventriculostomy and ICP. I.G. Ex. 10/19; Tr. II/286.
The patient was taken to the operating room for surgery at 1920 hours (7:20
p.m.), August 24. I.G. Ex.
10/59. Petitioner performed a ventriculostomy on the patient under general anesthesia.
I.G. Ex. 10/19.
There is no indication in the record as to what anesthetic agent or agents were
administered to the patient.
In the operative record of the procedure, Petitioner stated that when the catheter
entered the ventricle, fluid
came out under pressure. I.G. Ex. 10/9.
In a note dated August 25, 1985, Dr. Robert Fazzaro, who was substituting for
Dr. Rajput (see I.G. Ex.
10/59), reported that the patient was more awake and that his heart rate was
increased. I.G. Ex. 10/20.
Petitioner's note of August 25 also reported: "Patient is more awake. Started
to follow verbal commands.
Pre-op pt [patient] was completely unresponsive. His ICP WNL [within normal
limits]. Pupils are reacting.
Still has gaze preference to [left symbol]. . .His HR [heart rate] is up. Started
to move [right symbol] leg
more." I.G. Ex. 10/21
Thereafter, the physicians' notes reflect fairly consistently that the patient
was more awake and was able to
follow verbal commands. I.G. Ex. 10/21-34. Petitioner removed the ICPM device
on August 27. I.G. Ex.
10/22. The values recorded for ICP were all within normal limits except for
one notation that readings
were "as high as 25 when pt is being suctioned." I.G. Ex. 10/64. There
were no further significant changes
in the patient's neurological condition. Efforts to wean him from the respirator
were unsuccessful. At the
family's request, the patient was transferred by ambulance to a Philadelphia
hospital on September 11,
1985, so that he could be cared for by the family physician.
In its letter of June 19, 1990, NJPRO notified Petitioner that it had concluded
that he had grossly and
flagrantly violated his obligation to provide care that met professionally recognized
standards in his
treatment of Patient 268001 in the following respects: (1) inappropriate use
of an intracranial pressure
monitoring devise [sic] to treat a stroke; (2) subjecting the patient to the
risks and hazards of general
anesthesia; (3) increasing the risk of infection by subjecting the patient to
an unnecessary invasive
operative procedure: i.e., the insertion of an intracranial pressure monitoring
catheter; and (4) inappropriate
management of a stroke. I.G. Ex. 8/1.
In determining to exclude Petitioner, the I.G. accepted NJPRO's conclusion
that the conduct cited
represented a gross and flagrant abuse of Petitioner's obligations under section
1156 of the Act.
The I.G. argues that Petitioner grossly and flagrantly violated his obligations
to this patient by performing a
ventriculostomy and ICP monitoring when the patient was diagnosed with an acute
stroke. I have
concluded above that it is not a per se violation of Petitioner's obligations
to perform ICP monitoring in
stroke cases. However, the I.G. contends that ICP monitoring of this patient
was unjustified, because this
case involved an acute stroke without any clinical signs of increased ICP. Such
clinical signs would
include a decreased level of consciousness; lowered heart rate; elevated blood
pressure; and impaired
motor function, such as hemiparesis. Tr. II/288; Tr. III/165; I.G. Ex. 19/3-4.
I conclude that there were
clinical signs from which Petitioner could reasonably have concluded that Patient
268001 may have been
experiencing increased ICP. For this reason, I conclude that the I.G. failed
to prove that Petitioner violated
his obligation to provide care that met professionally recognized standards
of neurosurgery to Patient
268001.
Dr. Kasoff testified that, in his view, the patient did not deteriorate further
beyond his condition on
admission, which was described as comatose and unable to breathe on his own.
Therefore, Dr. Kasoff
concluded that Petitioner's pre-operative note, which described the patient
as deteriorating, was not
supported by the record. Tr. I/148-149. I disagree. It is true that the patient
was described as unconscious
on admission and that he was placed on a respirator. However, the nurse's notes
on the patient's condition
on admission to the ICU indicate that he had regained some level of consciousness.
For example, he
opened his eyes and turned his head in response to his name. Further, while
Dr. Rajput's note of August 24
describes the patient as "stuporous," he also notes that the patient
was occasionally able to follow verbal
commands. In contrast, Petitioner's note of August 24 describes the patient
as unconscious and "no verbal
response."
Additionally, the nurse's notes describe an episode of bradycardia, or low
heart rate, on August 24. Finally,
from the time of admission, the patient had been experiencing right hemiparesis.
Thus, the record contains
evidence that three clinical parameters for increased ICP were present in this
case, namely: decreasing level
of consciousness, lowered heart rate, and motor dysfunction. Moreover, according
to Dr. Hassenbusch, the
CAT scan report, which described compression of the left lateral ventricle,
also raised the possibility of
increased ICP. Tr. III/11.
Petitioner's operative report indicates that CSF came out under pressure when
the catheter entered the
ventricle. Dr. Hassenbusch testified that this was an indication that the patient
was, in fact, experiencing
increased ICP. Tr. III/12. Dr. Hassenbusch also testified that performing the
surgery under general
anesthesia was a reasonable alternative, because performing a burr hole under
local anesthetic requires a
cooperative patient. Patient 268001 was experiencing altered mental status and
was unable to follow
verbal commands, and thus may have been unable to cooperate. Tr. III/14; 88-89;
P. Ex. 18/1. Finally, the
patient's status seems to have improved somewhat after the surgery. The physicians'
notes from August 25
through September 11, when the patient was transferred, generally indicate that
the patient was more
awake and responsive. Based on this evidence, I conclude that the I.G. failed
to prove that by performing a
ventriculostomy and ICPM on Patient 268001, Petitioner violated his obligation
to provide care that met
professionally recognized standards of neurosurgery.
Because I have concluded that the I.G. did not prove that Petitioner violated
his obligation to provide
treatment that met professionally recognized standards, I do not reach the question
of whether the treatment
placed the patient in imminent danger or placed him unnecessarily in a high
risk situation.
b. Petitioner's treatment of Patient 8601866M (Case # 2) did not violate section
1156 of the
Act.
The Patient 8601866M was a 74-year-old female who was admitted to Millville
Hospital in Millville, New
Jersey, on January 17, 1986. Apparently, she had been in excellent health until
she suddenly became
confused and rapidly developed slurred speech and marked weakness of the left
side. I.G. Ex. 11/4. The
patient was seen in the emergency room by Dr. Fazzaro, who noted that her blood
pressure was 240/110,
that she was comatose with pupils pinpoint and nonreactive, and that she had
severe left hemiparesis. I.G.
Ex. 11/17. Dr. Fazzaro's impression was that the patient had suffered a CVA
(cerebrovascular accident),
probable hemorrhage. Id. Dr. Fazzaro ordered a CAT scan and requested a neurosurgical
consult on an
emergency basis. I.G. Ex. 11/2.
The report of the CAT scan describes a large hemorrhagic lesion throughout
the right basal ganglia
extending into the adjacent right frontotemporal and parietal lobes, as well
as into the right lateral ventricle.
I.G. Ex. 11/21. The report also notes significant right to left shift of the
midline structures. Id. The
radiologist's impression was
Large hemorrhagic lesion on the right side of the brain with right to left
shift, most likely
representing a hemorrhagic infarction in the basal ganglia with extension into
the ventricular system and
adjacent brain. A neoplasm [tumor] with hemorrhage cannot entirely be excluded.
Id.
Dr. Fazzaro's expiration note states, "It was felt that [the patient's]
only chance was for evacuation of clot."
I.G. Ex. 11/13. Therefore, on the same day, January 17, Petitioner performed
surgery to evacuate the
hematoma. Petitioner's operative record of the surgery describes a large intracerebral
hematoma which
extended from the surface of the brain, postero-medially to the basal ganglia.
I.G. Ex. 12/14. The
hematoma was completely removed. Id. After evacuating the hematoma, Petitioner
inserted a catheter into
the ventricle for monitoring and draining of intracranial pressure (ventriculostomy).
Id. The patient did
not improve after surgery. I.G. Ex. 11/13. She passed into a deep coma and was
pronounced dead on
January 20, 1986. I.G. Exs. 11/13, 20.
The I.G. and NJPRO concluded that Petitioner grossly and flagrantly violated
his obligation to provide
health care that met professionally recognized standards by 1) subjecting the
patient to unnecessary
intracranial operative procedures, i.e., the evacuation of a clot and insertion
of an intracranial pressure
monitoring catheter; 2) failing to acknowledge the poor prognosis of the patient
and proceeding with an
operative procedure; and 3) subjecting an already moribund and compromised patient
to the risks and
hazards of general anesthesia and operative procedure. I.G. Exs. 8/2; 9/2.
The essence of the I.G.'s argument as to this patient is that the extent of
the hemorrhage which she suffered
was so great that there was little hope of her recovery. For this reason, the
I.G. argues, Petitioner violated
his section 1156 obligations by intervening surgically, rather than simply rendering
supportive care. The
I.G.'s expert, Dr. Kasoff, testified that the patient had descended into a very
deep level of coma, from
which he would not anticipate recovery. Tr. I/89. He stated that there was no
benefit to be gained by
evacuating the hematoma and that ICP monitoring in such a case was "irrelevant."
Tr. I/90-91. Dr. Kasoff
testified that the accepted course of treatment in such a case would be supportive
medical management. Tr.
I/89.
Petitioner does not dispute that the patient was severely compromised, nor
that the prognosis was grave.
Instead, Petitioner asserts that the patient had no chance for recovery without
surgery, while with surgery,
she might have had a 10 percent chance of recovery. Tr. II/296-97. Petitioner's
expert, Dr. Hassenbusch,
similarly testified that, in his opinion, there was a 99 percent likelihood
that the patient would have died
without surgery, whereas with surgery, he estimated her chances for survival
at 3 to 10 percent. Tr. III/28-
29. Dr. Arico, a board certified neurosurgeon who prepared a report at Petitioner's
request, stated:
"Certainly, had some aggressive treatment program not been undertaken,
[the patient] would have gone on
to demise. Dr. Hussain's effort to decompress her was aggressive, but held out
the only chance that this
patient would have had for survival whatsoever." P. Ex. 1/2.
Even the summaries prepared by the neurologist and neurosurgeon who reviewed
the records for NJPRO
are somewhat supportive of the course of treatment pursued by Petitioner. The
neurologist stated:
One certainly can't fault Dr. Hussain under the circumstances for trying to
evacuate the
hemorrhage. Although with signs of mid-brain compression and an increased intracranial
pressure, i.e.
decreased pupillary reaction, the chances that such a procedure would improve
the patient's condition was
very small indeed.
I.G. Ex. 4/8. The neurosurgeon concluded that the surgery was unnecessary,
and opined that this would be
the conclusion of the majority of neurosurgeons, although he noted, "there
are those that would differ." Id.
Even Dr. Kasoff conceded that there are neurosurgeons who would consider surgery
an appropriate
alternative. Tr. I/161-62. Dr. Kasoff also testified that there were neurosurgeons
who would proceed with
surgery if there was the slightest chance that the surgical procedure could
benefit the patient. Tr. III/206.
Dr. Kasoff stated that, in his view, such surgery would be a "viable option."
Id.
Based on the testimony of Dr. Kasoff and Dr. Hassenbusch, as well as the written
reports of Dr. Arico and
the NJPRO consultants, I conclude that a reasonable body of neurosurgical opinion
would support surgery
to remove the hematoma as an acceptable alternative as a last-ditch effort to
save the patient's life. I view
the statutory standard "professionally recognized standards of health care"
to require a consensus of
opinion. Where reasonable physicians differ as to the appropriate treatment
in a given case, a physician
does not violate his obligations by pursuing a course of treatment which has
the support of a respectable
body of physicians. There is no evidence from which I could quantify the percentage
of neurosurgeons
who would advocate surgery as opposed to those who would advocate medical management
alone.
However, all of the neurosurgeons in the present case recognized that there
was a body of support for
surgical intervention. For this reason, I conclude that Petitioner did not violate
professionally recognized
standards of neurosurgical practice in performing surgery to evacuate the hematoma.
Petitioner testified that the primary purpose of performing the surgery was
to evacuate the hematoma. Tr.
II/300. Petitioner inserted an ICP monitor as a secondary procedure to monitor
the patient's ICP post-
surgery. Petitioner testified that it is normal neurosurgical procedure to insert
an ICP monitor after surgery
to remove a hematoma. Tr. II/301-02. Dr. Hassenbusch opined that placing the
catheter was within
accepted neurosurgical standards of care. Tr. III/25-27; P. Ex. 18/2. However,
even were I to accept that
ICP monitoring was "irrelevant," as Dr. Kasoff concluded, I would
nevertheless conclude that insertion of
the monitor did not represent a gross and flagrant violation of Petitioner's
section 1156 obligations. This is
because the insertion of the ICP monitor did not pose any significant additional
risk to the patient beyond
that posed by the surgery to evacuate the hematoma. The only risk posed by the
ICP monitor independent
of the surgery to evacuate the hematoma is that of infection. Tr. I/71. The
I.G. presented no evidence from
which I can assess the magnitude of this risk. I therefore must conclude that
the I.G. did not meet his
burden of proving that the insertion of the ICP monitor placed the patient in
imminent danger or in an
unnecessarily high risk situation.
The I.G. points out that Petitioner himself testified that hemorrhages of the
basal ganglia are not helped by
surgical means. I.G. Br. 21; Tr. II/268. Petitioner testified that stroke patients
who present a "fixed deficit"
are not helped by surgical means. Tr. II/268. I take this to mean that patients
who have suffered
irreversible brain damage due to strokes of the basal ganglia are not helped
by surgical means. As noted
above, the radiologist's report of the CAT scan gave as the most likely diagnosis
a hemorrhage of the basal
ganglia. However, there is considerable dispute in the record as to whether
this patient had suffered
irreversible brain damage at the time Petitioner performed surgery. Therefore,
I have no basis to conclude
that Petitioner's operative procedures in this patient's case were unnecessary
and contrary to his obligations
under section 1156 of the Act.
c. Petitioner committed gross and flagrant violations of his section 1156
obligation in his
treatment of Patient 854914 (Case # 3).
Patient 854914, an 80 year old male with prior strokes/transient ischemic attacks
(TIAs) and myocardial
infarctions (heart attacks), presented to the emergency room (ER) at Bridgeton
Hospital on July 28, 1985
with complaints of nausea and vomiting. He was admitted after an abnormal EKG.
A neurological
examination revealed minimal weakness over the left side but no significant
sensory or motor deficits.
Initial impression was gastroenteritis with mild dehydration and rule out myocardial
infarction. On July
29, 1985, his family reported that his speech had become slurred. By July 30,
1985, his speech had
become markedly slurred, he had difficulty opening his eyes, and his respiratory
process was depressed and
required intubation. I.G. Ex. 12/3, 32-33.
A neurologist, Dr. Sharan Rampal, was consulted and his initial impression
included rule out cerebellar
infarction. He ordered a CAT scan 12/ which showed right parietal infarct encroaching
on the occiput, an
acute right cerebellar infarction, severe atrophy and moderate ventricular dilation.
I.G. Ex. 12/3. By
August 1, 1985, the patient's neurological condition continued to deteriorate
-- he was showing signs of
decerebration (reduction of brain stem function). Dr. Rampal's impression of
that date indicated:
Unresponsive to verbal commands. Decerebrate posturing to deep pain. Eyes
deviated to the left.
Some spontaneous [illegible] movement to the left. Pupils pinpoint. Imp. Decerebrate
[secondary] to
cerebellar infarct; prognosis grave.
I.G. Ex. 12/35; Tr. I/174-75, Tr. II/307. Dr. Rampal ordered a steroid (Mannitol)
to reduce intracranial
pressure and a repeat CAT scan. I.G. 12/35.
Apparently for technical reasons, a print of the scan was not obtainable. Dr.
Rampal did offer the
following description of the CAT scan on August 2, 1985:
For technical reasons, radiologist unable to print CT yesterday, [illegible]
measurement of ventricles.
On reviewing films today there appears to be [increased symbol] ventricular
dilatation suggesting
obstructive hydrocephalus. [Therefore symbol] will request urgent neurosurgical
eval. for possible shunt.
Imp. cerebellar infarct with IV [four] ventricular obstruction.
I.G. Ex. 12/36, Tr. I/171-72.
Dr. Gladwyn D. Baptist, the attending physician on this case, indicated on
August 2, 1985 that the patient's
neurological status continued to deteriorate -- he showed "decerebrate
posturing and unresponsiveness".
He further indicated multiple CVAs with cerebral edema. I.G. Ex. 12/36.
Petitioner was consulted on August 2, 1985. On that day, he performed, with
the patient under general
anesthesia, a "right frontal craniotomy, decompression and ventriculostomy"
and as part of the operative
procedure he "hooked up for intracranial pressure monitoring and calibration."
13/ I.G. Ex. 12/5, 37.
On August 3, 1985, Petitioner noted:
patient is comatose, decerebrating bilaterally. Has withdrawal response to
deep painful stimuli.
His symptoms are [illegible] post fossa swelling [and symbol] hydrocephalus.
If no improvement - next 2 -
3 days will consider post fossa decompression.
I.G. Ex. 12/38. On August 3 and 4, 1985, both Dr. Rampal and Petitioner indicated
that the patient's
neurological condition remained essentially the same and a repeat CAT scan would
be done. I.G. Ex.
12/40. Again on August 6, 1985, Petitioner noted similar neurological findings
as previously, and a need
for electroencephalogram (EEG) results. I.G. Ex. 12/41-42. That date, Dr. Baptist
indicated no clinical
improvement, EEG to assess brain function and prognosis "very poor".
I.G. Ex. 12/41. There was no
change in the patient's neurological status as reflected in Petitioner's note
of August 7, 1985. I.G. Ex.
12/43.
The EEG examination was performed on August 8, 1985 and showed pronounced cortical
function on the
left side. I.G. Ex. 12/45. Apparently based on the continued lack of neurological
improvement, a CAT
scan showing evidence of increased mass effect compression in the posterior
fossa with compression of the
brain stem and the indication of some brain stem function by the EEG examination,
Petitioner performed
under general anesthesia a posterior fossa craniotomy, posterior fossa decompression
and ventriculostomy
on August 9, 1985. 14/ I.G. Ex. 12/6, 45-46. Petitioner noted on August 13,
1985 that the intracranial
pressure monitor showed the patient's pressure to be within normal limits and
the monitor was removed.
I.G. Ex. 12/49. There was no improvement in the patient's condition post surgery.
I.G. Ex. 12/4, 47-54. In
fact on August 14, 1985, it was noted that the patient "has received all
the possible options that might result
in improvement, and his failure to do so implies irreversible sequelae of cerebellar
infarction with brain
stem compression". I.G. Ex. 12/49. By August 16, 1985 with continued poor
prognosis, the patient was
extubated and he died that day. I.G. Ex. 12/4.
The I.G. and the NJPRO argue that the following findings represent gross and
flagrant violations of
Petitioner's obligation to provide care that meets professionally recognized
standards of health care: (1) the
operative procedure (craniotomy and insertion of an intracranial pressure monitoring
catheter) on August 2,
1985 was not necessary since the patient had an acute brain stem infarct; (2)
a repeat CT scan was needed
to verify the diagnosis prior to determining the type of surgery to perform;
(3) the posterior decompression
surgery on August 9, 1985 should not have been performed; and (4) the patient
was exposed to the
unnecessary risk of general anesthesia on two occasions. I.G. Ex. 9/2.
In assessing the need for the surgery performed by Petitioner on August 2,
1985, it is important to reflect
on the patient's clinical signs and findings as of that date and determine whether
Petitioner acted in a
manner consistent with the existing standards of practice in neurosurgery. Considering
that Petitioner was
dealing with several CVA's, including a stroke involving the cerebellum of the
brain, it was necessary for
him to act promptly to avoid total compromise of the patient's brain stem function.
As stated by Dr.
Kasoff, this portion of the brain is an "extremely sensitive and vital
structure of the brain." Tr. I/93. He
further indicated that due to
the possibility of rapid deterioration in the face of a swollen cerebellar
hemisphere, because of stroke, it
is often necessary to decompress [the] cerebella with great rapidity before
impact has had a chance to cause
devastation to the brain stem, which would be irreversible.
Tr. I/93.
Moreover, considering the extent of neurological damage that had occurred by
August 2, 1985 (the patient
was decerebrate), Dr. Kasoff opined that while a posterior fossa decompression
procedure was appropriate
in the early stages of a cerebellar stroke, the patient's brain stem was irreversibly
damaged and that even
decompression would not result in the patient's recovery. Tr. I/99-100, 173,
175.
Dr. Kasoff opined that the procedure that Petitioner performed on August 2,
1985 -- a craniotomy in order
to insert a ventricular drain was proper when done in connection with a posterior
fossa decompression. Tr.
I/99-100. But he further opined that the use of ICP monitoring catheter was
"irrelevant", nor could he find
any record that pressure was recorded. Tr. I/96. In fact the only reference
Petitioner made to the patient's
ICP was when he removed the monitor on August 13, 1985, after the second operation.
I.G. Ex. 12/49. At
that point, even though the patient's pressure was normal, his condition was
"unsalvageable". Tr. I/99.
Since neither surgical procedure performed by Petitioner on this patient was
necessary, based on the
application of existing standards of neurological surgical practice, Dr. Kasoff
opined that the general
anesthesia used in the two operations placed the patient in a "considerable
unnecessary risk". Tr. I/100 -
101. Considering that Dr. Kasoff has expressed his opinion that the patient
was beyond hope of recovery
when the two surgeries were performed, a question arises whether any risk from
a general anesthesia would
have any impact on this patient. What is evident, according to Dr. Kasoff, is
that Petitioner's failure to
perform the posterior fossa decompression surgery timely when it might have
had a positive impact on the
patient placed the patient in imminent danger and unnecessarily in a high risk
situation. Moreover,
assuming that on August 2, 1985 the patient's brain stem compression could be
reversed, Petitioner's choice
of a ventricular drain and ICPM placed the patient in imminent danger and unnecessarily
in a high risk
situation. His delay of the posterior fossa decompression until August 9, 1985,
even with some indication
of brain stem activity by EEG, eliminated any realistic hope that the patient
had for recovery.
In response to Dr. Kasoff and the NJPRO's assertions, Petitioner contends that,
when he was consulted on
August 2, 1985, his judgment as to the need to relieve the ventricular pressure
was based on Dr. Rampal's
belief that the patient's hydrocephalus required drainage. Tr. II/306. Petitioner
acknowledged that the lack
of a dispositive CT scan as of August 2, 1985 complicated his choice of surgical
procedures, since the
extent of the cerebellar infarct was not known. I.G. Ex. 6/72. He explained
his rationale for the first
surgery as follows:
My impression was, that likely, we're dealing with cerebellar infarct, but
it could have been something
associated with that, and the only objective evidence we saw, was obstructive
hydrocephalus from the CAT
scan. And based on his rapid deterioration from being awake to coma and responses,
we did a
ventriculostomy at this point, and monitored the pressure, and I continued to
follow and review the films
again.
I.G. Ex. 6/72.
The need for the subsequent posterior fossa decompression was explained as follows:
[After the patient did not improve after the first surgery], at this point,
it was, you know, obvious or
clear after this, that we are dealing with cerebellar infarct, and maybe he
may benefit by posterior fossa
decompression.
I.G. Ex. 6/72-73.
Petitioner admitted that if the CAT scan or other studies showed that the obstructive
hydrocephalus was
caused by the cerebellar infarct then "the treatment o[f] choice at that
time, is posterior fossa
decompression and a ventriculostomy at the same time." I.G. Ex. 6/74, 80-81.
It would appear that Dr.
Kasoff and Petitioner and his experts all agree that the decompression surgery
was needed. The apparent
conflict is that Dr. Kasoff argues there was sufficient information to demonstrate
its need by August 2,
1985. Petitioner argues differently.
Petitioner indicated that in the case of Patient 854914, as of August 2, 1985,
the CAT scan showed only
hydrocephalus. I.G. Ex. 6/80. He opined that in such situations
the simplest and easiest procedure was just ventriculostomy to put the drainage,
shunting, to relieve the
pressure, until you determine really what is going on, and at least give them
a chance to recover some of
his function.
I.G. Ex. 6/75.
In short, Petitioner explains his choice of surgery on August 2, 1985 on the
inability of himself, Dr.
Rampal, and the radiologist to be certain that the cause of the hydrocephalus
was the cerebellar infarct and,
therefore, it would have been incorrect to do a decompression because he was
not sure of the cause of the
pressure. I.G. Ex. 6/81 - 83. When the NJPRO pointed out to Petitioner that
the CAT scans of July 30 and
August 1, 1985 were reflective of a cerebellar stroke, and Dr. Rampal's impression
prior to the first surgery
was cerebellar infarct, Petitioner indicated such evidence was uncertain. I.G.
Ex. 6/84. When asked to
identify the types of strokes that cause hydrocephalus, Petitioner admitted
"any posterior fossa strokes" or
"brain stem infarct . . ." I.G. Ex. 6/85. Although Petitioner admitted
the August 1, 1985 CAT scan was
"not the best quality", he considered it "reasonable" and
he "was satisfied with the study." I.G. Ex. 6/85.
He did not do a decompression on August 2, 1985 because he 1) was not convinced
that the patient had a
brain stem infarct, 2) did not want to "put [the patient] through such
a major procedure", and 3) thought the
cause of the hydrocephalus was possibly a "small tumor in the posterior
fossa." I.G. Ex. 6/87 - 88.
This explanation is unsatisfactory. When Petitioner is consulted as he was
in this patient's case, his
responsibility as a neurosurgeon is first to ensure that all diagnostic procedures
have been performed which
reflect the cause and severity of the patient's condition. Dr. Kasoff expressed
that such an obligation was
reflective of professionally recognized standards of neurological practice.
I.G. Ex. 6/96, 98. Moreover,
Petitioner cannot defer responsibility for his own actions by pointing to others
who were involved in the
patient's treatment. He was the person who by skill and training as a neurosurgeon
had to make the
ultimate decision on the timing and type of surgery needed. By August 2, 1985,
the patient's neurological
condition was already severely compromised -- he was decerebrate and unresponsive.
I.G. Ex. 12/36.
CAT scans of July 30, 1985 and August 1, 1985 were indicative of a cerebellar
infarct. I.G. Ex. 12/3, 36.
Dr. Rampal's impression prior to the surgery was hydrocephalus secondary to
a cerebellar infarct and the
possible need of a shunt to relieve the cerebral pressure. I.G. Ex. 12/36. But
Dr. Rampal sought a
neurosurgical evaluation for guidance. Id. Petitioner's obligation at this point
was to independently assess
the patient's condition based on his signs and symptoms and available diagnostic
studies. It is evident that
the CAT scans were strongly suggestive of a cerebellar infarct. If Petitioner
had doubts about the cause of
the cerebral pressure, he should have repeated the CAT scan. He admits that
a posterior fossa
decompression is necessary when the brain stem is compressed. I.G. Ex. 6/72,
73.
Moreover, the record is clear that a significant delay in performing the decompression
will eliminate any
realistic possibility of the patient's recovery. Tr. I/93, 94. I agree with
Dr. Kasoff that the hospital record
reflecting the patient's neurological status supports that the decompression
surgery was needed either on
August 2, 1985 or earlier. Petitioner had sufficient information that the patient
had suffered a cerebellar
infarct. He may have not known the exact dimensions of that infarct based on
the CAT scans available, but
that could have been remedied by a prompt repeat scan. I.G. Ex. 6/96. 15/ Such
a scan was not done until
the earliest August 8, 1985. Tr. III/34; I.G. Ex. 12/3; P. Ex. 20/31. He did
not perform the posterior fossa
decompression until August 9, 1985. I.G. Ex. 12/6, 46. Such a delay is inexcusable
considering: 1) the
serious, irreversible and potentially devastating effect of continued brain
stem compression; 2) the absence
of improvement in the patient's neurological status since the first surgery;
and 3) Petitioner's own note, on
August 3, 1985, that such surgery will be performed in the next two or three
days. Tr. I/93, 94; I.G. Ex.
12/38, 40. By August 9, 1985, the decompression surgery was essentially irrelevant,
since the patient's
brain stem was so severely compromised that reduction of the cerebral pressure
would have no effect on
his recovery. Tr. I/99-100, 173-75. In fact, subsequent to such surgery, the
patient's cerebral pressure was
normal and the ICP monitor was removed. I.G. Ex. 12/49. There is no indication
in the record that either
the ventriculostomy performed on August 2, 1985, or the posterior fossa decompression
performed on
August 9, 1985 had any impact on the patient's neurological status or in any
way improved his chances of
recovery. It is evident that such surgeries were unnecessary, but considering
that the patient was beyond
any realistic hope of recovery I am unable to conclude that Petitioner's use
of general anesthesia on these
two occasions placed the patient in imminent danger or in a unnecessarily high
risk situation. His
condition was such that any risk from surgery would have no impact on his outcome.
I emphasize here that
I am not condoning unnecessary surgery on unsalvageable patients. Section 1156(b)(1)(A)
proscribes such
a procedure when it occurs in a substantial number of cases without the need
to show gross and flagrant
conduct. The I.G. has not alleged such a violation in this case. 16/
Petitioner relies on Drs. Kazmi, Hassenbusch, Arico, and Davidson to support
his actions. Dr. Kazmi is
supportive of the first procedure because of the absence of clear evidence of
the extent of the cerebellar
infarct on the CAT scan. I.G. Ex. 6/103. I would agree except that, in this
case, the remedy for a lack of
complete information is a repeat CAT scan. Delaying the decompression, especially
as done here, seven
days, is not acceptable, since brain stem compression is acknowledged to quickly
lead to the patient's non-
salvageability. Similarly, Dr. Hassenbusch's opinion is equally suspect. He
bases his opinion of the need
for the first surgery on the August 2, 1985 CAT scan results, and the second
surgery on the patient's
worsening condition and the August 8, 1985 CAT scan showing continuing brain
stem pressure. Tr. III/34
- 37. But such opinion fails to properly consider that any significant delay
in decompressing the brain stem
will make recovery unlikely. Neither Dr. Hassenbusch nor Dr. Davidson provide
a reasonable basis for
Petitioner's delay of the decompression for seven days. Whatever chances the
patient had for recovery,
meager at best, were eliminated by the delay in performing surgery. Finally,
Dr. Arico admits that the
ventriculostomy was conservative and the decompression surgery is a recognized
procedure to reduce brain
stem pressure. P. Ex. 1/2. However, he fails to provide Petitioner with any
basis to delay such surgery. In
sum, Petitioner's experts do not justify Petitioner's actions in diagnosing
and treating this patient in light of
the information available to him or which could have been available with more
aggressive diagnostic
studies. While they have expressed their views that the decompression surgery
was necessary to alleviate
brain stem compression, an EEG showing minimal function does not support the
need for surgery when the
patient's brain stem has been compressed for over one week and his neurological
status was severely
compromised and beyond any realistic hope of recovery.
Petitioner also presented an affidavit and report written by Dr. Rampal reflecting
his opinion that both
surgeries performed by Petitioner were necessary. P. Ex. 11. Here, again, Dr.
Rampal fails to explain
Petitioner's delay in performing the posterior fossa decompression -- the only
surgery all experts agree
could result in alleviation of brain stem compression. Moreover, Dr. Rampal's
belated report, written in
1990, is suspect, due to his personal involvement in this patient's case and
to the fact that Petitioner was the
subject of a quality review by the hospital where the surgeries were performed.
17/ Indirectly, Dr.
Rampal's conduct was also placed in question by Petitioner's actions.
The record supports the following conclusions that: 1) Petitioner failed to
obtain a repeat CAT scan to
verify the precise nature of the patient's condition prior to performing the
surgery on August 2, 1985; 2)
Petitioner's performance of a craniotomy and insertion of ICP monitoring on
August 2, 1985 was
unnecessary; and 3) Petitioner's performance of a posterior fossa decompression
on August 9, 1985 was
also unnecessary. Since Petitioner did not obtain a repeat CAT scan and perform
the decompression
surgery timely, he placed the patient in imminent danger and at unnecessarily
high risk. I do not find that
subjecting this patient, who had severe brain stem compression and was unsalvageable,
to general
anesthesia on two occasions was a gross and flagrant violation of Petitioner's
obligation under section 1156
of the Act.
d. Petitioner's treatment of Patient 86-0935 (Case # 4) was a gross and flagrant
violation of
section 1156 of the Act.
This patient, an 83 year-old female, was admitted to Elmer Community Hospital
(ECH) on April 11, 1986.
The patient had a history of organic brain syndrome, a condition equivalent
to Alzheimer's disease. I.G.
Ex. 13/4; Tr. I, 102. She was admitted because she was unable to stand, had
a 102 degree fever, and,
according to her son, had become increasingly confused. The cause of the patient's
fever was later found
be a urinary tract infection. Dr. J. LaCavera was the physician who initially
treated and admitted this
patient to ECH. This patient had previously been admitted to ECH on two separate
occasions. The first
occasion, December 22, 1984 through January 3, 1985, she was admitted and treated
for a subendocardial
myocardial infarction, arteriosclerosis, and Alzheimer's disease. The patient
was also admitted to ECH on
a second occasion, January 7 through January 9, 1986, during which she was treated
for angina pectoris,
arteriosclerotic cardiovascular disease, and organic brain syndrome. I.G. Ex.
13/4.
A CAT scan was performed on this patient on April 15, 1986, four days after
her admission. The CAT
scan revealed a left intracerebral hematoma in the frontal region, with some
edema but with no shift in the
midline structures. Previous old multiple infarcts were noticed and remarked
upon. Petitioner was
consulted and became involved with the treatment of this patient on April 16,
1986. I.G. Ex. 13/6. There
is no explanation as to why the CAT scan was not done at an earlier point in
time, but I am convinced that
the delay is not attributable in any way to Petitioner. Tr. I/104; Tr. II/317.
On April 17, 1986, Petitioner
performed a craniotomy on this patient to remove the intracerebral hematoma.
Petitioner also inserted a
ventricular drain and an intracranial pressure monitor, which were removed on
April 18, the day after the
surgery. The patient was ultimately released from the hospital.
The NJPRO and the I.G. concluded that Petitioner grossly and flagrantly violated
his obligations in this
particular case, by failing to provide services of a quality that meets professionally
recognized standards of
health care, in that Petitioner: 1) inserted an ICPM device that was not indicated
(NJPRO's conclusion was
based on the fact that the device was removed twenty-four hours after the procedure;
if consideration was
given to the purpose of ICPM, the device would have remained, until maximum
edema occurs - three to
five days after the operation); 2) performed a craniotomy with evacuation of
a hematoma which is not
justified in the record (NJPRO's conclusion was based in part on the nurse's
notes of 4/11 - 4/29; according
to NJPRO, the notes document no changes in the patient's mental status before
the operation); 3) subjected
this patient to the hazards of general anesthesia and the risk of infection
by the performance of the
unnecessary cranial procedure. I.G. Exs. 8/4; 9/(sanction report).
Petitioner testified that he was not consulted by the admitting physician until
April 16, 1986. On April 16,
1986, Petitioner examined the CAT scan and remarked that the CAT scan showed
a high density area with
surrounding edema in the left frontal region thought to represent an acute hematoma.
He further remarked
that the right frontal region also shows a considerable low density, as does
the left, probably reflecting a
previous infarct. Petitioner noted an infarct over the right convexity. Tr.
II/317. Petitioner stated that he
reviewed the patient's history prior to operating on her and had noted the patient's
level of consciousness
had decreased. Tr. II/317; I.G. Ex. 13/10. On April 16, Petitioner examined
the patient and noted: "On
examination, patient is stuporous at times, awake, not following verbal commands.
Tone is equal,
symmetrical, except decrease on the right side and right side hemiparesis."
Tr. II/318; I.G. Ex. 13/6.
On April 17, 1986, Petitioner operated on the patient. Petitioner used general
anesthesia in performing the
operation. I.G. Ex. 13/7. Petitioner performed a frontal craniotomy, evacuated
the hematoma, and inserted
an ICP monitor. I.G. Ex. 13/7,10. Petitioner's stated purpose in performing
surgery was to relieve the
pressure by removing the clot, which, if successful, would allow the patient
to recover her impaired
functions. Tr. II/319-20. Petitioner testified that deterioration, along with
the weakness exhibited by the
patient, was a consideration for performing the surgery. Tr. II/319.
Petitioner removed the ICPM on April 18, 1986, the day after surgery. Petitioner
admitted that he had
recorded no pressure values on the patient's chart. Tr. II/379-80. Petitioner
testified that, by inserting the
ICP monitor, he was not adding any extra insult to the patient because the patient
already was having
surgery for the hematoma. Tr. II/379-80. When questioned why he took the ICPM
out on April 18,
Petitioner stated "Because she had improved ... to a point that her paralyzed
side was also moving, which is
an improvement. Her mental status was improved. Pressure was normal. All was
going along with the
same thing that she was doing better. We decided at that point to take it out."
Tr. II/320. Petitioner stated
that the patient had right hemiparesis before surgery and that this condition
was improved after the surgery.
Id.
Dr. Kasoff, the neurosurgeon appearing on behalf of the I.G., examined the
CAT scan used by Petitioner.
He testified that the lack of shift in midline structures is indicative that
the hematoma in this patient was of
small size and was not posing a significant threat to the brain. He stated that
such a hematoma would not
pose a significant threat for clinical deterioration. Tr. I/103. He testified
that the lack of midline shift in
this patient's brain indicates that if there were increases in intracranial
pressure, they would be very small.
Id. Dr. Kasoff further testified that the CAT scan given to this patient showed
multiple old infarcts of the
brain, and that multiple old infarcts can produce an picture very much like
Alzheimer's disease, as appears
in this CAT scan. He further testified that when a mass effect from hematoma
occurs in a patient with
previous multiple infarcts, that patient may be better able to tolerate those
effects, because the previous
infarcts have reduced the mass of brain tissue, and this would allow the brain
to better accommodate a new
mass effect. Tr. I/103.
Dr. Kasoff concluded:
Based on the CAT scan findings, and based upon the hospital course and the
condition of the patient,
the appropriate treatment would have been strictly conservative, certainly supporting
the patient medically,
probably, the institution of decadron, that is a steroid medication that has
the capacity of stabilizing a brain
edema, and that is probably is the basis of the treatment for this patient.
Tr. I/104.
Dr. Kasoff also concluded that there was no basis for surgical intervention in this case stating:
A hematoma of this size and under this circumstance, will resolve on its own.
I am convinced,
without any neurological sequela beyond what has already been in this patient's
background, simply with
time and the use of steroids, one of which being decadron. I think there are
certainly cases of intracerebral
hemorrhages that need to be evacuated. Those that are relatively superficial
and those that have the
potential to cause neurological deterioration. This was neither a large enough
hemorrhage to consider
removing, nor did it cause any neurological deterioration. Furthermore, the
date at which the operation
was performed was on the seventh hospital day. Presumably, this hemorrhage had
already been there for at
least a week and was well tolerated by the patient. This patient would have
survived this without surgery
and done as well as the patient did with the surgery. Without the risks of surgery.
Tr. I/105.
Dr. Kasoff, while acknowledging that Petitioner was not consulted until April
16, stated that performing
surgery on the seventh day after this patient was admitted to the hospital was
not appropriate:
When intracerebral hemorrhages of this nature, when they are compelling, or
when they require
surgery, it is usually acute, and it is much earlier in the course of the process,...
we would declare itself
within the first two or three days. Surgery would be most appropriate either
acutely on day one or
following neurological deterioration, within the first two or three days. In
a patient with a hemorrhage of
this nature, it would be highly unusual for such a patient to have survived
this hemorrhage for six or seven
days, to then develop neurological deterioration. It would be almost unheard
of.
Tr. I/106-7.
Dr. Kasoff agreed with Petitioner that this patient had a hematoma. Dr. Kasoff
also agreed that assuming
the attending physicians correctly concluded there was a deterioration in the
patient's neurological
condition, surgery was appropriate. Tr. I/181. However, the NJPRO and the I.G.
dispute Petitioner's
contention that there was any deterioration in the condition of this patient.
Petitioner points to the
attending physician's notes on April 14, 1986, to support his argument that
the patient was deteriorating.
The note states "[p]atient is confused, doesn't wish to be examined. Definite
change for the worse."
During the course of these proceedings, Dr. Kasoff was asked about the notes
and responded:
We know the lady was confused, she has a dementia syndrome that is chronic.
I would expect this
patient to be confused. The fact that she doesn't want to be examined indicates
to me that she has the
presence of mind and the physical abilities to push someone away or tell people
that she didn't want to be
examined.
Tr. I/177.
Dr. Kasoff's conclusion was that the patient's condition was not deteriorating,
but that she was merely
exhibiting symptoms consistent with her organic mental disorder.
Petitioner states that he was aware of this patient's history of Alzheimer's.
Tr. II/375. Petitioner
acknowledged that the admitting physician's report showed the patient's reflexes
to be equal. Tr. II/376.
However, he states that he examined this patient and concluded she was deteriorating.
Petitioner's notes on
April 16 state that the patient's level of consciousness had decreased and that
the son had been informed of
all of the risks of the surgery and consented to the surgery for his mother.
I.G. Ex. 13/10. Petitioner's
notes on the patient's chart, also dated April 16, state that the patient was
stuporous at times and was not
following verbal commands, and note that her tone is equal except for a slight
right side hemiparesis. I.G.
Ex. 13/6. He concluded on April 16 that the patient's level of consciousness
had decreased and performed
surgery the following day. I.G. Ex. 13/10. Petitioner testified that this patient's
deterioration and weakness
were considerations for performing the surgery. Tr. I/319. He testified further
that her condition indicated
that the hematoma was causing significant pressure to the brain. Id.
I do not find Petitioner's position on this issue persuasive in light of contradictory
evidence. The admitting
physician's notes do not support Petitioner's assertion that the patient had
deteriorated. Specifically, on
April 11, 1986, the day of admission, this patient was unable to answer any
questions and was disoriented
as to time, place, and date. I.G. Ex. 13/8. On April 12, 1986, the admitting
physician describes the patient
as "confused and refuses to eat," and notes the patient was lethargic.
Id. There is also a mention that he
would obtain a CAT scan for the patient. Id. His notes of April 13, 1992 list
the patient as "[c]onfused as
ever today, but less lethargic." I.G. Ex. 13/9. On April 14, 1992, he indicates
that the patient was refusing
to eat, was confused, and did not want to be examined. Additionally, he notes
a definite change for worse
in her personality, and mentions cortical infarct as a possible cause. Id. On
April 15, he notes that the
patient was confused. On April 16, he notes "confusion same." Id.
While the admitting physician does note a change for the worse in her personality,
he does not note any
change in either her level of consciousness or her confusion or disorientation.
Similarly, the nurse's notes
on April 15 indicate that the patient's appetite was good and that she was fed
65 percent of her lunch. I.G.
Ex. 13/52. Also, the notes show that the patient's appetite was good and that
she ate 70 percent of her
breakfast on the morning of April 16. I.G. Ex. 13/53; Tr. II/377-78. The notes
also indicate that the
patient got out of bed and walked to a chair with assistance. I.G. Ex. 13/53;
Tr. II/378. The note for lunch
on April 16 says appetite fair, for lunch ate 50 percent, returned to bed with
assistance. Tr. II/378. The
nurse's notes of April 16 indicate that, at 7:00 a.m., the patient was aroused
by verbal stimuli, lethargic,
confused, and disoriented. I.G. Ex. 13/53. There is nothing in the nurse's notes
that this patient was in any
way deteriorating. Indeed, that the patient's appetite remained good and that
she got out of bed, albeit with
assistance, do not support Petitioner's assertion that this patient was deteriorating.
Moreover, that the
patient was aroused by verbal stimuli on April 16 is a clear indication that
she was not stuporous.
I find Dr. Kasoff's testimony regarding this patient particularly persuasive.
Dr. Kasoff disagrees with
Petitioner's assertion that this patient was deteriorating. Tr. I/182. Dr. Kasoff
testified that a combination
of two specific findings in this case would support surgical intervention. The
first is a compromise in the
level of consciousness and the second is disordered motor function. Tr. III/165.
In evaluating the motor
function, the factors to look for are hemiplegia or hemiparesis, weakness, and
unilateral weakness. In the
area of cerebral function, higher cerebral function or level of consciousness,
the factors to look for are
optundation (increasing somnolence). Dr. Kasoff discounted Petitioner's conclusion
that the patient was
confused. He stated that, due to her condition (Alzheimer's), the patient was
probably confused most of the
time. Tr. III/165. Dr. Kasoff testified that the patient had moments of regular
lucidity and other, less lucid,
moments. His conclusion was that "perhaps at some time the patient is a
bit more oriented than at other
times, but I think she fades in and out as her base line. And I don't believe
that this lady veered very far
from her baseline at any point in her hospitalization." Tr. III/165.
I am not persuaded that this patient's condition was deteriorating in such
a way that this surgery was
necessary or clinically indicated. There is undisputed testimony, from Petitioner
and experts on both sides
of this case, that in the instance of a small cerebral hematoma, with no shift
in the midline structures, the
best approach is a conservative one, that is, to treat it medically using steroids,
such as Decadron, and to let
the body reabsorb it. Petitioner specifically stated that his decision to operate
on this patient was based on
her deterioration. However, the record does not support Petitioner's contention
that the patient was
deteriorating. Petitioner merely makes assertions, unsupported by any tests,
data, notes, or specific
recollections, that this patient deteriorated. Petitioner noted on the progress
records that the patient's level
of consciousness had deteriorated and that surgery was discussed with the patient's
son. I.G. Ex. 13/10.
However, Petitioner's own notations in his consultation report, written the
day before surgery, make no
mention that the patient had deteriorated or that surgery was a possible option.
I.G. Ex. 13/6. Lastly, the
progress note of April 29, written by Petitioner just before the patient's release,
indicates that the patient
was basically unchanged neurologically and that she still exhibited poor communication.
I.G. Ex. 13/16.
Petitioner intervened in this case fully five days after the patient was admitted.
I realize the late
intervention was not the fault of the Petitioner, as it does not appear that
Petitioner was consulted until
April 15. However, I find Dr. Kasoff's testimony persuasive that surgery is
not indicated in the case of a
hematoma that the patient has tolerated well for several days. Even Dr. Hassenbusch,
the expert who
testified on behalf of Petitioner, stated that the preferred treatment for small
hemorrhages, as in this case, is
medical management as opposed to surgery. Tr. III/110. Petitioner's expert also
agreed with Dr. Kasoff
that neurologic decline is not an automatic signal to perform neurosurgical
procedure. Tr. III/86.
Petitioner's expert conceded that the CAT scan showed no shift in midline structures
and that is consistent
with a small hemorrhage. Tr. III/109. Petitioner's expert also conceded that
the patient's behavior patterns
of confusion and not wanting to be examined is consistent with Alzheimer's disease.
Tr. III/117.
In light of this testimony, I do not find that Petitioner's documentation of
the patient's condition and
supposed deterioration and his rationale for performing surgery on this patient
were adequate. I also do not
find Dr. Hassenbusch's testimony regarding this patient to be credible, since
his assertion that this surgery
was appropriate is in direct conflict with his statement that medical treatment
is the preferred method of
treatment for small hemorrhages, the type present in this case.
NJPRO and the I.G. also contend that Petitioner's insertion of an intracranial
pressure monitoring device
was inappropriate in this instance. Dr. Kasoff testified throughout this hearing
that he believed that ICPM
was not a medically indicated procedure in stroke patients, because there is
not generally an increase in the
intracranial pressure of these patients. Moreover, in this particular instance,
Dr. Hussain admitted
removing the ventricular drain the day after surgery. Surgery was performed
on April 17 and the
ventricular was removed on April 18, one day after surgery. I.G. Exhibit 13/65.
No pressure values were
recorded in the patient's chart between April 17 and 18. The I.G. argues that
this demonstrates a lack of
consistency on the part of Petitioner.
Dr. Kasoff testified, "If the pressure monitor were put in to identify
any increases in intracranial pressure, it
should have then been left in for the period of time where we anticipate possible
increases in intracranial
pressure following the surgical procedure, which would have been a minimum of
three days or so." Tr.
I/111. Dr. Hassenbusch directly contradicted Dr. Kasoff when he testified that
the use of the catheter and
monitor were within professionally recognized standards of health. Dr. Hassenbusch
stated:
Removal of the catheter one day after the surgery was reasonable. The catheter
was placed
essentially for immediate postoperative management to rule out any massive swelling
on the first day after
the operation. With low pressures being found in this catheter, it served I
think little benefit in continuing
it after that period.
Tr. III/44.
I find that Dr. Kasoff's testimony on this issue persuasive. If indeed Petitioner
was concerned with ICP in
this patient, he should have left the monitor on for the entire time during
which he could have reasonably
expected such increased pressures. That Petitioner removed the monitor, without
waiting the entire three
day period, undermines his contention that the insertion of the ICPM was performed
because the patient
was at risk from ICP. Also, Petitioner conceded that there were no pressure
readings recorded on the
patient's chart. I find it unlikely that, if Petitioner had been concerned with
ICP in this patient, he would
not have recorded the pressure readings himself or directed someone to record
them.
I conclude that, in performing a craniotomy and insertion of an ICPM in this
patient, Petitioner violated his
obligations under the Act to provide health care in accordance with generally
accepted professional
standards. This stroke patient, with a small intercerebral hematoma, exhibited
no shift in the midline
structures of her brain and had been tolerating the stroke for over five days
before Petitioner decided to
operate on her. Both Petitioner and his expert conceded that the accepted method
of treatment of small
intercerebral hemorrhages was medical management. Petitioner deviated from that
standard and from
generally accepted medical procedure by performing surgery on this patient,
who had a small intercerebral
hemorrhage. The craniotomy and insertion of an intracranial pressure monitor
were not medically
supportable, given that this patient's condition had not deteriorated.
There is evidence in the record to support that this patient exhibited symptoms
similar, if not identical, to
Alzheimer's disease. But there is no evidence from which I could reasonably
conclude that the patient
deteriorated neurologically. Indeed, the nurse's and attending physician's notes
seem to indicate
specifically that the patient was not deteriorating. Petitioner's notes mention
the patient's deterioration in
only one place and do not even mention deterioration in the consulting report
dated April 16, the day
before the patient was taken into surgery. Further persuasive evidence to support
my conclusion was
provided when Dr. Kasoff testified that this patient was merely exhibiting her
baseline behavior and was
not deteriorating.
I also conclude that, as to this patient, Petitioner violated his obligations
under the Act by insertion of an
ICPM in this patient and in removing it the day after surgery. Petitioner's
insertion of an ICPM in this case
is not in accordance with professionally recognized medical standards. Dr. Kasoff
testified that there is
generally no indication of increased intracranial pressure in stroke patients.
Both Dr. Kasoff and Dr.
Hassenbusch testified that, based on their review of the CAT scan, there was
no shift in the midline
structures. This patient exhibited no symptoms of increased intracranial pressure,
and no indications
existed that would warrant the insertion of an ICPM device.
Even if I were to agree with Petitioner's contention that the insertion of
an ICPM device was indicated in
this case, I cannot agree that the removal of the ICPM device on the day after
surgery was in compliance
with generally accepted medical practice. On this issue, there was conflicting
expert testimony from Dr.
Hassenbusch and Dr. Kasoff. Dr. Hassenbusch stated that the removal of the catheter
and ICPM device
one day after surgery was reasonable and appropriate, whereas Dr. Kasoff stated
that the removal of the
ICPM was medically inappropriate. I am more persuaded by Dr. Kasoff's testimony
on this issue. It is
logically inconsistent for Petitioner to insert an ICPM device in this patient
and then remove it before three
days, the period of time the patient was at risk from increased ICP due to swelling.
Neurosurgery is obviously a very complicated and delicate procedure. It should
be performed only when
clinically indicated. I conclude that, in this case, Petitioner violated professionally
recognized standards
when he performed surgery on this patient. This patient had a small hematoma,
had been tolerating it well
for five days with no shift in midline structures, had a greater ability to
tolerate mass effect due to a history
of previous infarcts, and showed no signs of neurologic or clinical deterioration.
I further conclude that, in
this case, performing a craniotomy and evacuating a hematoma on this patient
violates recognized medical
standards and is a gross and flagrant violation of Petitioner's obligations
under the Act. In this instance,
Petitioner subjected an otherwise healthy patient to the risks associated with
surgery, general anesthesia,
and infection from surgery that was not clinically indicated. Therefore, Petitioner
placed this patient
unnecessarily in a high risk situation. I realize that the testimony at the
hearing was that there was a serious
risk of one percent emanating from such a procedure. However, I hold that even
a one percent risk of
death or serious injury is unnecessarily high where, as here, the surgery is
not clinically indicated, the
patient is not neurologically deteriorating, and the patient is likely to recover
absent the surgical
intervention.
I further conclude that there was no indication, given the previous infarcts,
the lack of shift in the midline,
and the small size of the hematoma, for Petitioner to insert an ICPM device.
As there was no clinical
indication that this patient had increased intracranial pressure, it was a violation
of Petitioner's obligations
under the Act to insert a device to monitor ICP. The removal of the ICPM device
in this patient, after only
one day, and before any risk of swelling and increased ICP subsided was also
a violation of Petitioner's
obligations under the Act. As there was no clinical indication for the insertion
of an ICPM device or for its
removal merely one day after surgery, Petitioner violated his obligation under
the Act to provide medical
care in accordance with professionally recognized standards. However, in making
these findings with
regard to the ICPM device, I cannot conclude that the insertion and removal
of the ICPM device subjected
the patient unnecessarily to a high risk situation. The reason I am not able
to reach that conclusion is
because the I.G. has not introduced any evidence that the insertion and removal
of the ICPM device
subjected the patient to additional risk over and above the risks of general
anesthesia and infection incurred
in the craniotomy and removal of the hematoma. Therefore, while I find that
Petitioner, in inserting the
ICPM device and removing it after only one day, violated his obligation under
the Act to provide medical
care in accordance with professionally recognized standards, I cannot conclude
that, in inserting and
removing the ICPM device, he committed a gross and flagrant violation of his
obligation under the Act
e. Petitioner's treatment of Patient 277259 (Case # 5) did not violate section
1156 of the Act
as contended by the I.G.
This patient was a 74-year-old female who was admitted to Newcomb Medical Center
on April 7, 1986,
complaining of weakness in her left leg, difficulty walking, and a facial droop
on the left side. I.G. Ex.
14/2. Additionally, the patient's daughter reported some changes in the patient's
mentation and personality
over the preceding two weeks. Id. Dr. Ruggieri, the attending physician, noted
that his initial examination
revealed a left central facial weakness associated with weakness of the left
arm and left leg. Dr. Ruggieri's
impression at that time was of stroke in progress with left hemiparesis. Id.
Dr. Skinner, a neurologist, saw the patient as a consultant on the day of her
admission, April 7. His
impression was that the patient had a frontoparietal lesion, most likely a cerebrovascular
accident, with a
tumor to be ruled out. Id.; see also I.G. Ex. 14/6. A CAT scan was performed
on April 8, 1986. I.G. Ex.
14/16. The CAT scan revealed a tumor in the right frontal lobe, with edema surrounding
the tumor, and
shift of the midline structures. Id. The tumor measured 5 1/2 cm. x 4 cm. x
4 cm. Id.
Petitioner was called in for consultation on April 8, 1986. I.G. Ex. 14/7.
His consultation report states that
the patient was lethargic, not following verbal commands very well, and notes
that the patient had vomited.
Id. The consultation concludes: "As pt is deteriorating from awake to lethargic
in 1-2 hours will be wise to
monitor ICP and stabilise and then consider surgery for removal [of] lesion."
Id.
Petitioner discussed his recommendation with the patient's family, and noted
that the family was indecisive
about giving their consent to surgery. I.G. Ex. 14/11. In the morning of April
9, 1986, after further
discussion of the risks of delay, Petitioner noted that the patient's husband
and daughter decided to proceed
with treatment. Id. Later that day, Petitioner performed surgery to insert a
ventricular catheter for
decompression and monitoring of ICP. I.G. Ex. 14/3, 12, 26. Petitioner's post-operative
orders include the
medication Decadron, and if ICP readings exceeded 25 mm/Hg, Mannitol. I.G. Ex.
14/20. During the next
two days, the patient's ICP ranged from 8 to 20 mm/Hg, with several readings
of 15 or above. I.G. Ex.
14/24-6.
Petitioner tentatively scheduled the patient for surgery to remove the tumor
on April 11, 1986. I.G. Ex.
14/14, 24. However, the patient's daughter, who was a nurse at St. Luke's Hospital
in New York City,
contacted a neurosurgeon there, and arranged to have the patient transferred
to St. Luke's. I.G. 14/3, 14.
The patient was transferred on April 11, 1986.
The I.G. and NJPRO concluded that Petitioner grossly and flagrantly violated
his obligations to this patient
in the following regard:
1. Subjecting this patient with a brain tumor to an inappropriate intracranial
operative procedure,
i.e., the insertion of an intracranial pressure monitoring catheter;
2. Failure to consider removal of the brain tumor rather than the insertion
of an intracranial
pressure monitoring catheter.
I.G. Ex.9; FFCL 25.
As an initial matter, I reject the allegation that Petitioner violated his
obligation by failing to consider
removal of the tumor, because that allegation is completely unsupported in the
record. From Petitioner's
first consultation, his notes indicate that he considered and, in fact, recommended
removal of the tumor.
Petitioner had scheduled the patient for surgery to remove the tumor on April
11, and the only reason that
appears in the record for his failure to perform the surgery on that date was
that the patient's family insisted
that the patient be transferred to St. Luke's Hospital in New York to have the
surgery there. Certainly,
Petitioner could not have performed the surgery without the family's consent.
I also conclude that the I.G. failed to prove that Petitioner violated his
obligation to provide care in
accordance with recognized standards of neurosurgery by inserting an ICPM catheter
in this patient. In this
regard, I am particularly persuaded by the discussion found in the treatise,
Advances and Technical
Standards in Neurosurgery, an excerpt of which is in evidence as P. Ex. 24.
Dr. Kasoff indicated that this
reference is considered authoritative. Tr. I/190. According to the author of
the cited portion of the treatise,
ICPM is used in tumor cases:
In tumor cases the following routine is usually employed: The recording is
started one or two
days before a planned operation. Urgency sometimes necessitates the immediate
drainage of fluid;
otherwise the pressure is recorded for at least two hours to obtain information
on the intracranial dynamics.
In some patients it may be appropriate to keep the pressure at a low level for
some days before operation
e.g. in order to relieve the brain stem or optic nerves from stress.
P. Ex. 24/2.
I recognize that this article was written in the mid 1970's. Tr. I/192; I.G.
Ex. 6/156. However, the
treatment plan contained in the treatise was also endorsed by Dr. Davidson,
one of Petitioner's experts, who
stated in his written report, dated February 20, 1990:
[A] very reasonable treatment for meningiomas is to lower the brain pressure
for several days
first, prior to removing the tumor. In a meningioma, the general thought is
that the better the patient is
going in, the better the patient is when surgery is finished. Thus, it is well
worth a course of steroids for
several days prior to removing a large meningioma. This would be enhanced by
using an Intracranial
Pressure Monitor.
P. Ex. 15.
Dr. Hassenbusch stated that in his practice he does not routinely insert an
ICPM device in patients with
brain tumors two days before a planned operation to remove the tumor, "except
in a situation where there's
severe swelling and in those situations, a pressure monitor as well as appropriate
anti-swelling measures
would be indicated." Tr. III/123. Moreover, another article introduced
by Petitioner, "Intracranial Pressure
Monitoring and Treatment: A Contemporary View," which was published in
the March 1990 edition of
Annals of Emergency Medicine, cites tumors as among the indications for ICPM.
P. Ex. 23/4-5.
Dr. Kasoff testified that he was unaware of any neurosurgeon in the United
States who used ICPM before
removing a brain tumor, except for research purposes. Tr. I/192. However, the
I.G. did not introduce any
medical literature or treatises to support the view expressed by Dr. Kasoff,
namely that ICPM of patients
with brain tumors has been discredited in the neurosurgical community. For this
reason, I conclude that the
authoritative medical literature introduced by Petitioner, combined with the
testimony of two practicing
neurosurgeons, demonstrates that ICPM of patients with certain types of brain
tumors is within
professionally accepted standards of neurosurgery. This conclusion is further
reinforced by Petitioner's
testimony that the neurosurgeon in New York to whose care the patient was transferred
concurred with the
plan of treatment. 18/ Tr. II/330-331. Of course, this physician's agreement
is not a justification for
Petitioner's decision to insert the ICPM device. However, it does indicate that
another practicing
neurosurgeon at a large urban medical center apparently considered ICPM to be
within professionally
recognized standards of neurosurgical treatment for a patient with this type
of brain tumor.
Petitioner based his decision to insert the ICPM device on his assessment that
the patient was deteriorating
in her level of consciousness, and that she had vomiting and had increasing
left hemiparesis. I.G. 14/11. In
his view, these symptoms, when combined with the CAT scan showing a large tumor
with massive edema,
or swelling, indicated that increased ICP was a likely cause of the patient's
symptoms. Id. This assessment
would accord with Dr. Hassenbusch's view that ICPM would be appropriate in cases
of severe swelling. I
note that Petitioner did order anti-swelling medications for the patient. I.G.
Ex. 14/19, 20.
The nurse's notes do not appear to document a clear deterioration of the patient's
level of consciousness
prior to the insertion of the ICPM device. For example, a nursing note on the
evening of April 8 indicates
that the patient had a Glasgow Coma Scale score of 15, which indicates a patient
who is fully conscious
and aware of her surroundings. I.G. Ex. 14/27; see Tr. I/112-113; Tr. II/382-83;
Tr. III/119-20. However,
the nursing notes do indicate "severe" left side weakness on April
8, which suggests a deterioration from
the admission note which describes "some" left sided weakness. I.G.
Ex. 14/28. The notes also confirm an
episode of vomiting, which Dr. Hassenbusch testified is an important clinical
sign for markedly increasing
ICP. I.G. Ex. 14/27; see Tr. III/50. Finally, the nursing notes after insertion
of the ICPM device reflect
several readings above 15 mm/Hg, which would indicate increased ICP.
The nursing notes also repeatedly refer to a "neuro check sheet"
for a detailed description of the patient's
neurological condition. See, e.g., I.G. Ex. 14/26, 27. These "neuro check
sheets" were not part of the
exhibit introduced by the I.G., however. Dr. Hassenbusch testified that these
sheets would be "critical" to a
full understanding of the patient's condition. Tr. III/131.
As is true of most of the hospital records in this case, the documents which
are in evidence do not appear to
be complete. Moreover, as I have noted, the documentation by Petitioner which
is present is often
inadequate. Nevertheless, I conclude that the records before me as to this patient
sufficiently support
Petitioner's identification of clinical signs of increased ICP to demonstrate
that he did not violate his
obligations to provide care that met professionally recognized standards of
neurosurgery. Accordingly,
there is no issue of gross and flagrant conduct regarding this patient.
f. Petitioner's treatment of Patient 8617854M (Case # 6) did not violate section
1156 of the
Act as contended by the I.G.
This patient, a 70 year old male, with a diagnosis of a CVA involving the right
hemisphere with left sided
manifestations and arteriosclerotic cardiovascular disease, was admitted to
Millville Hospital on June 21,
1986 by Dr. Dominic A. Diorio, the attending physician, following weakness and
paralysis of the left upper
and lower extremity. I.G. Ex. 15/3 - 4, 15. Other than the left sided involvement
and lethargy, the patient
was noted in no acute distress and responsive . I.G. Ex. 15/3, 15. In order
to evaluate the severity and
extent of the CVA, a CAT scan and EEG were ordered that day. I.G. Ex. 15/6.
As of June 23, 1986, he
improved somewhat but his paralysis remained the same. I.G. Ex. 15/15. The CAT
scan was performed
on June 23, 1986 and showed a "large acute infarction in the right parietal
and temporal lobes . . . with a
shift of the lateral ventricles towards the left". I.G. Ex. 15/15, 33.
The EEG performed the same day
showed an abnormal disturbance of the right hemisphere. I.G. Ex. 15/29. On June
24, 1986, he developed
respiratory complications and was transferred to ICU where he was intubated.
I.G. Ex. 15/15, 25. That
day Dr. Dirk E. Skinner completed a neurological consultation. I.G. Ex. 15/21.
He recommended, among
other things, supportive care. Id. By June 26, 1986, Dr. Skinner noted that
the patient had increased
"stupor". I.G. Ex. 15/16. The patient's respiratory situation became
acute on June 27, 1986 and Dr. Diorio
noted the need for a neurosurgical consultation for measurement of intracranial
pressure. I.G. Ex. 15/16,
23.
Petitioner examined the patient on that day and found him comatose and decerebrate
to pain. I.G. Exs.
6/163, 15/22. His impression was brain edema with closed right ventricle, mass
effect, and increased
intracranial pressure. I.G. Exs. 6/164, 15/22. He recommended ventriculostomy
and the monitoring of
intracranial pressure. Id. Prior to surgery, an anesthesiology note reflects
that there was uncertainty
whether a general anesthetic or local would be used with IV sedation. I.G. Ex.
15/17. 19/ Petitioner
performed a right frontal craniotomy and used a ventricular catheter to drain
fluid (ventriculostomy) and to
monitor intracranial pressure. 20/ I.G. Ex. 15/17-18, 28. Petitioner noted that
the patient's brain was
"edematous with increased pressure". I.G. Ex. 15/28.
There is a suggestion in the expiration summary prepared by Dr. Diorio that
at the time of surgery the
patient "had begun to herniate his brain stem and lost all signs of cerebral
activity" from an intravascular
hemorrhage. I.G. Ex. 15/26. However, as indicated above, other medical records
prepared before or on
the day of surgery do not support such brain devastation.
On the day after the surgery, the patient upon examination showed the absence
of brain function. I.G. Ex.
15/18. This was confirmed by EEG on June 30 and July 1, 1986. I.G. Ex. 15/19-20,
30-31. After
consultation with the Ethics Committee, the patient was removed from life support
systems on July 1,
1986, and died. I.G. Ex. 15/20, 24-25.
At a hearing before the NJPRO, Petitioner explained his rationale for performing
surgery as follows:
basically [due to the] massive brain swelling with edema, rapid deterioration
. . . [I] suggested [that]
monitoring of the pressure [might] improve the [patient's] status." I.G.
Ex. 6/164. He also indicated
because the patient was comatose at the time of surgery, no general anesthesia
was used and the only thing
the patient required was oxygen. I.G. Ex. 6/166.
The NJPRO and the I.G. assert that Petitioner grossly and flagrantly violated
his quality of care obligations
toward this patient by subjecting him, when he was experiencing an acute CVA,
to an unnecessary
operative procedure, i.e., ICPM catheter insertion. I.G. Ex. 9/3.
Dr. Kasoff, as stated in other cases, opined that intracranial monitoring was
unnecessary in this case. Tr.
I/123-124, 126; I/169-170, 180. He based his opinion on the fact that, when
Petitioner inserted the ICPM
device, the possibility for ICP was remote, since ICP would rise within the
first three days of the stroke,
and by the seventh day there would be little or no risk of increased pressure.
Tr. I/124. The absence of the
recording of abnormal ICP values subsequent to the surgery confirmed his opinion.
Tr. I/124-125.
Moreover, Dr. Kasoff asserted that, to the extent that such pressure should
be monitored, it should be done
under local anesthesia to avoid the risks associated with general anesthesia.
Tr. II/123. Again, he offered
his opinion that general anesthesia places stroke victims at risk and, in the
case of Patient 8617854M, it
could convert this patient's stable, bland infarct to a hemorrhage infarct,
having more mass effect and
pressure than the original stroke. Tr. I/123. In contrast to Petitioner's surgical
intervention, Dr. Kasoff
indicated his suggestive course would have been limited to only supportive care.
Tr. I/125. Lastly, Dr
Kasoff was insistent that even evidence of neurological deterioration does not
justify surgical intervention.
Tr. I/200-201.
This patient suffered a large infarct in the right parietal and temporal lobes
causing a mass effect which
shifted the midline portion of the brain to the left. I.G. Ex. 15/33. Conservative
treatment measures were
initiated but they did not impact on his condition and he continued to slowly
deteriorate neurologically,
with increased somnolence, difficulty with respiration, and eventually became
comatose and decerebrate to
pain. I.G. Ex. 15/8, 15, 16. It was at this point, approximately one week after
the patient suffered the
infarct that Petitioner was consulted. I.G. Exs. 6/163; 15/18, 22.
It is evident that the patient was severely compromised and very close to brain
death at the time Petitioner
chose to intervene surgically. Even Petitioner conceded that his surgical procedures
at best increased the
patient's chances of survival by only 5 percent to 10 percent. Tr. II/346. Dr.
Kasoff, without seeing the
actual CAT scan film, could not predict that the patient would die from the
stroke. Tr. I/125 -126.
However, he did indicate that any attempt to reduce ICP from the infarct should
be within the first few
days after its occurrence. Tr. I/124. As in other cases, Dr. Kasoff's opinion
seems focused on Petitioner's
use of an ICPM device and does not give adequate credence to the possible ameliorating
effect that the
ventriculostomy may have had in reducing the damaging impact of the stroke.
While he may not favor use
of ICPM in his practice, its use has been accepted by at least a significant
minority of neurosurgeons and
advocated as a treatment option in many of the most prestigious teaching hospitals.
Tr. III/47-48.
Moreover, the monitoring was a secondary procedure done for the purpose of determining
whether the
draining of ventricular fluid would lead to reduced ICP. Credible evidence from
Petitioner's experts, Drs.
Arico, Davidson and Hassenbusch, demonstrated that the surgical procedures presented
the patients only
hope for survival. P. Exs. 1/3, 16/2; Tr. III/59-61.
While this is a close case, especially considering the expiration summary of
Dr. Diorio, I find performance
of the ventriculostomy and ICPM was arguably reasonable as a last resort for
a patient who had no other
possibility of recovery. Unlike the earlier case of patient 854914, there is
no suggestion that another
operative procedure was indicated. Nor is there any suggestion that Petitioner
failed to obtain clarifying
diagnostic tests or inappropriately delayed a needed surgical procedure. Here
the I.G. and NJPRO rely on
their argument that ICPM is unnecessary in stroke cases. As I have previously
found, use of the ventricular
catheter for monitoring after a ventriculostomy is not per se a violation of
Petitioner's obligations under
section 1156 of the Act. See, supra. at PAGE NUMBER HERE.
Moreover, even assuming I agreed with Dr. Kasoff that use of these surgical
procedures in this case was
violative of Petitioner's obligations, there is no evidence that performance
of such procedures in this
patient's case was "gross or flagrant". The I.G. has not established
that the patient was placed in "imminent
danger" or under "unnecessarily high risk". First, the I.G. has
failed to prove that a potentially harmful
anesthetic agent was employed when the patient was prepared for surgery. Petitioner
stated none were
used. I.G. Ex. 6/166. This is understandable, considering that the patient was
comatose and in need of no
agent to put him to sleep or to prevent him from feeling pain. Therefore, absent
such an agent, the
damaging consequences suggested by Dr. Kasoff, such as complications from further
hemorrhaging or
swelling of the brain, would not occur. Second, even assuming such consequences,
they increase
morbidity by only percent. Such a percentage is meaningless in this case. Here
the patient was close to
death, with, at best, a 5 percent to 10 percent chance of recovery, and the
surgical procedures were a last
desperate act to save him. I do not find, in such circumstances, that employing
surgical procedures that
imposed a 1 percent risk was a gross and flagrant violation of Petitioner's
obligation under section 1156.
g. Petitioner's treatment of Patient 632365 (Case # 7) was a gross and flagrant
violation of
section 1156 of the Act.
This patient was an 84 year old woman who was transported to the emergency
room (ER) of the Millville
Hospital on August 5, 1989, after being found on the floor and unresponsive
in her home. It was reported
by her daughter that the prior day the patient felt lightheaded, with generalized
weakness, and complained
of a cold and headache. A physical examination was uneventful except for a slight
right facial asymmetry
and a diminution of the withdrawal of the right arm to pain as compared to her
left arm. Petitioner, who
was the attending physician, made an admitting diagnosis of left cerebrovascular
accident, rule out
intracranial hemorrhage. I.G. Ex. 16/4-5.
A number of diagnostic procedures were performed on the patient in the ER to
assist in assessing her
medical problems. A portable x-ray of the patient's chest showed the patient's
heart as enlarged and
pulmonary venous congestion present. 21/ The radiologist's impression was congestive
heart failure
(CHF). 22/ I.G. Ex. 16/28. An electrocardiogram (EKG) was interpreted as negative.
I.G. Ex. 16/33-34;
Tr. II/352.
Several blood chemistry profiles were also performed. The results relevant
to this case are as follows: her
serum sodium level was 122 milliequivalents per liter, which is below the normal
range of approximately
136 - 146 milliequivalents per liter; her creatine phosphokinase (CPK) levels
were reported as 525 and 61
and her MB isoenzyme levels were reported as 20 and 0, (normal level for CPK
is approximately 60-270
units per liter (U/L) and for MB isoenzyme is below 15 U/L). I.G. Exs. 16/57-58,
19/10. The serum
sodium levels were tested again on August 9 and August 24, 1989, which indicated
these respective results:
127 milliequivalents per liter and 117 milliequivalents per liter. I.G. Ex.
16/57.
The MB isoenzyme level is significant in assessing cardiac function. Whenever
that level is reported to be
approximately four percent of the total CPK level or greater, there is an expectation
of cardiac damage. A
decreased serum sodium level can be reflective of an increase in the patient's
total body water, which can
be a complication if the patient suffers from congestive heart failure. The
increased body water content
can alter the patient's mental status and give an erroneous reflection of neurological
deterioration. I.G. Ex.
19/10-11.
The patient was placed in intensive care initially, but then was transferred
to neurological service. I.G. Ex.
7/14. By August 7, 1985, Petitioner noted that the patient was more "awake"
and "verbalizing". I.G. Ex.
16/17. A CAT scan done that day showed a normal head without evidence of intracerebral
hematoma.
I.G. 16/37. This test result placed in question Petitioner's admitting diagnosis
of left CVA and intracranial
hemorrhage. For the next several days, Petitioner noted that the patient was
weak, shaky, and dizzy. I.G.
Ex. 16/17. An x-ray of the patient's cervical spine revealed marked degenerative
changes with
encroachment on the neural foramina. I.G. Ex. 16/29. Apparently, based on this
examination finding and
the patient's complaints of neck pain, Petitioner began her on a course of physical
therapy on or about
August 14, 1989. I.G. Ex. 7/15, 16/19. Petitioner noted no neurological deficits
as of August 15, 1989.
I.G. Ex. 16/19. A repeat cervical x-ray on August 16, 1989 confirmed the existence
of degenerative joint
disease of the cervical spine. I.G. Ex. 16/30. Petitioner's notes for the period
of August 16 - 23, 1989
indicate that the patient's symptoms of pain and weakness continued, but she
appeared at times confused.
I.G. Ex. 16/20-22. On August 23, 1989 Petitioner recommended that she undergo
a myelogram to rule out
compression of the spinal cord. I.G. Ex. 16/22. Suddenly on August 24, 1989,
the patient suffered a
cardiopulmonary arrest, went into an irreversible coma, was transferred to intensive
care, and died on
August 30, 1989. I.G. Exs. 7/16-17, 16/22-26.
The I.G. and the NJPRO argue that Petitioner grossly and flagrantly violated
his quality of care obligations
toward this patient by 1) failing to follow-up the abnormal CPK and CK MB fractions
to rule out a
myocardial infarction, 2) failing to address and treat the patient's low serum
level with more frequent
laboratory studies to determine if improvement in the overall serum sodium was
occurring, and 3) failing
to appreciate the patient's overall cardiac and electrolyte abnormalities by
treating personally or by
obtaining a cardiac or internal medicine consultation. I.G. Exs. 8/3, 9/3.
Dr. Joseph C. Spagnuolo, the Associate Medical Director of the NJPRO and board
certified in internal
medicine, gave the following rationale for the NJPRO's findings of gross and
flagrant conduct by
Petitioner. Petitioner's admitting diagnosis of cerebral stroke was not borne
out by a subsequent CAT scan
which showed no evidence of an intracerebral hematoma. Petitioner was placed
on notice of the patient's
potential serious cardiac problems, based on the chest x-ray evidence of congestive
heart failure and the
abnormal/conflicting blood chemistry results. Dr. Spagnuolo noted the below
normal serum sodium levels
23/ and indicated that they were unrelated to an intracerebral hemorrhage. More
importantly, a decreased
sodium level is oftentimes a manifestation of an increase in the patient's total
body water content. Such an
increase can place a great strain on the patient's heart, especially when CHF
is compromising the patient's
heart. Moreover, an effect of decreased sodium levels can be an alteration of
the patient's mental state
which may resemble neurological deterioration. There are measures that can be
taken to reduce the
patient's water content, but since there may be several causes for this condition,
the problem should be
isolated by having the patient undergo diagnostic tests. The normal practice
is to repeat the test for serum
sodium levels at least every 24 hours until the level is within normal limits.
In this case, Petitioner did not
order additional tests nor attempt to treat this medical problem. When presented
with conflicting CPK and
MB levels, Dr. Spagnuolo indicated the proper standard of medical practice would
be to measure promptly
these levels again to confirm or deny any cardiac disease. 24/ Petitioner is
faulted for failing to recognize
this clinical sign and consult with an internist or cardiologist to address
the patient's cardiac status. In sum,
Dr. Spagnuolo indicated that the NJPRO determined that Petitioner had grossly
and flagrantly violated his
obligation to adhere to acceptable standards of medical practice by: 1) failing
to consider the patient's
abnormal chest x-ray, serum sodium, and CPK levels; and 2) failing to treat
these metabolic and
cardiorespiratory problems. I.G. Ex. 19/9-11.
In explaining his treatment of this patient, Petitioner explained that the patient
presented with an "acute
cerebral vascular stroke" and had "no cardiac symptoms." I.G.
Ex. 7/18. Since her initial EKG was
normal, Petitioner claimed he "kept on thinking o[f] the neurological aspect.
Never thought about the
cardiac part of it". I.G. Ex. 7/18. He indicated that there were no "symptoms
suggestive of cardiac
problem[s]" but he speculated that possibly an internal or cardiac consult
would have impacted on his
assessment. I.G. Ex. 7/19.
With regard to the patient's CPK and MB levels, Petitioner indicated that they
were reported as normal
levels. I.G. Ex. 7/18. He indicated that he could not recall when the abnormal
test results came or whether
he saw them, but that if he had been aware of it, he would "repeat it or
if I had a concern, I would ask some
of the internists to look at it and maybe manage the patient". Tr.II/353,
387-89; I.G. Exs. 7/25, 29.
Regarding the patient's serum sodium levels, Petitioner indicated that, after
the initial recording of 122, the
patient was started on "I.V. fluids" and when she was showing a level
of 127, five days later, her
"neurological status was completely intact" and while he recognized
that her serum sodium level was
"relatively low" he did not consider it as requiring "acute correction".
I.G. Ex. 7/17. He further admitted
that when she went into cardiac arrest on August 24, 1989, her serum sodium
level fell to 117 but at this
point she "had no brain stem function" and was "brain dead".
I.G. Ex. 7/17. He acknowledged that no
effort was made to correct the serum sodium level at this point, due to the
irreversibility of her clinical
condition. I.G. Ex. 7/17.
Petitioner was questioned by the NJPRO physicians concerning his failure to
follow-up on the serum
sodium level of 127 that was done on August 9, 1989. While acknowledging that
this was a "low" level,
and that a repeat test could have been done, Petitioner blamed his lack of follow-up
action on the patient's
absence of "symptoms" that were "causing her problem[s]".
I.G. Ex. 7/24. He did admit that, considering
the patient's serum sodium level, he "should have done [a repeat test]
sooner [than he did on August 24,
1989]". I.G. Ex. 7/24. In response to the question whether Petitioner,
knowing the patient has low serum
sodium, he would treat the patient himself, Petitioner acknowledged that "[s]ometimes
[he does it him]self,
but if [he] suspect[s] that there's some other medical problem, [he] always
get[s] the internist or
cardiologist, depending on what problem it is to co-manage the patient".
I.G. Ex. 7/28.
Petitioner was also questioned regarding the chest x-ray of August 5, 1989,
where the radiologist reported a
finding of congestive heart failure and the absence of any follow-up treatment
for that condition. He
claimed that the radiologist reported to him orally that the x-ray failed to
show "anything acute in the
chest". I.G. Ex. 7/26. However, Petitioner did acknowledge that, several
days later, he received a written
report which indicated that the patient had congestive heart failure. I.G. Ex.
7/26. When asked why he did
not review the x-ray film again or speak with the radiologist, Petitioner could
not provide an explanation
other than admitting that he "should have gone for another chest x-ray
and clear[ed] up that point once and
for all". I.G. Ex. 7/27, 35. Petitioner explained his not documenting in
the patient's record the findings
from the physical examinations regarding her cardiac condition by stating that
he only notes "positive
finding[s]". I.G. Ex. 7/35. It is evident that existing medical documentation
in the patient's record
indicative of a serious cardiac condition was not recognized by Petitioner since
he admitted that if he "had
at any time, any concern about it, [he] would have got a cardiologist or internist"
to assist him in
addressing the condition. I.G. Ex. 7/53.
To rebut the NJPRO findings concerning the abnormal/conflicting CPK and MB
blood chemistry results,
Petitioner relies on Dr. Hassenbusch, a neurosurgeon, for the proposition that
the first abnormal test on
August 5, 1989 triggered a more definitive study by electrophoresis which proved
to be negative, and this
second test resolved any conflict. Tr. II/67-68; P. Br. at 67. The I.G. argues
that such opinion is at best
hypothetical and apparently not shared by the two board certified internal medicine
physicians, one of
whom is a hematologist, who reviewed this patient for the NJPRO and reached
no such conclusion. I.G.
Br. at 47-48. However, the lab reports themselves tend to support Petitioner's
contention. The lab result
listing the abnormal CPK and MB readings states on its face that it was not
performed by the
electrophoresis method and thus may be less reliable. I.G. Ex. 16/57. The lab
report which shows normal
CPK and MB readings states on its face that it was obtained using the electrophoresis
method. I.G. Ex.
16/56. The report which shows normal CPK and MB readings also states that it
was read by a pathologist,
who interpreted it as normal. Id. Thus, it would be reasonable for Petitioner
to place greater weight on the
test result that was done by electrophoresis and read by a pathologist. Petitioner
also relies on the normal
EKG test done in the ER as a basis for not pursuing the conflicting test results.
P. Br. at 68.
However, the normal EKG and the arguably normal CPK result are not sufficient
justification for
Petitioner's failure to order further diagnostic studies to clarify the patient's
cardiac status. The x-ray
showing congestive heart failure and abnormal serum sodium levels were sufficient
indicators, by
themselves, of possible cardiac problems to justify further diagnostic procedures.
Petitioner concedes that
he should have repeated the chest x-ray. Even if Petitioner believed that the
initial CPK test was normal,
further CPK results may have been helpful in evaluating the patient's condition.
Again, when confronted
by NJPRO, Petitioner agreed that he should have repeated these tests as well.
With regard to the low serum sodium levels, Petitioner offers no acceptable
explanation other than he did
not believe that the patient showed signs of any cardiac problems and therefore
did not give these abnormal
test results much significance. This rationale is equally weak. Even accepting
Petitioner's assertion that
the radiologist orally told him the patient's chest x-ray was normal, the written
report showing congestive
heart failure should have alerted him to the need for further diagnostic tests,
including more timely and
repeated serum sodium evaluations. His assertion that the values were improving
and in the low normal
range is inconsistent with the assessment of the NJPRO physicians nd the recognized
normal values for
such blood chemistry fractions. I.G. Exs. 5/6-7; 7/18, 24; 16/57, 58; 19/9-11.
In assessing Petitioner's care and treatment of this patient, I note that he
was the admitting and attending
physician. I.G. Ex. 16/4, 5. In such a role, Petitioner was in sole charge of
the management of the patient
while she was in the hospital. Whatever her medical problems, whether within
Petitioner's specialty or not,
they were subject to his diagnosis and treatment. Unlike the usual situation
where Petitioner is called in as
a consultant and his role is limited to neurosurgery, here he was responsible
for the care of the patient for
all medical problems. Therefore, his obligation to meet the recognized standards
of medical care goes
beyond the care and treatment of neurosurgical problems. The NJPRO and the I.G.
can properly assess
him under such standards.
The record of Petitioner's treatment of this patient is that Petitioner initially
treated her for a stroke, which
assessment was subsequently proven incorrect by a CAT scan showing no intracranial
hemorrhage. I.G.
Ex. 16/37. At the approximate time of admission or shortly thereafter, Petitioner
was advised that this
patient's chest x-ray showed congestive heart failure and her blood chemistry
indicated abnormal serum
sodium, CPK, and MB levels. I.G. Exs. 16/28, 57, 58; 19/10. In such circumstances,
standard medical
protocol calls for diagnostic studies to evaluate the cause and severity of
the congestive heart failure, as
well as repeat blood chemistry to confirm or deny cardiac damage. I.G. Ex. 19/9-11.
Here, Petitioner failed to recognize the significance of the findings from
the chest x-ray and the blood tests.
Such findings warranted further action by Petitioner, even though the patient
had a negative EKG. He
ordered no repeat x-ray to assess the patient's congestive heart failure. I.G.
Ex. 7/27, 35. Nor did he
perform or order repeat blood chemistry tests to obtain comparative CPK and
MB results. He delayed
obtaining repeat serum sodium levels and did not follow the customary practice
of repeating the tests on a
daily basis until normal values were shown. I.G. Exs. 7/24; 19/10. Despite the
presence of signs of a
compromised cardiac system, Petitioner made no effort to evaluate and treat
this condition, limiting his
treatment exclusively to the patient's neurological complaints. I.G. Ex. 7/18,
19, 53. In fact, it is possible
that some of the patient's neurological complaints, such as confusion, were
the product of her untreated low
serum sodium level. I.G. Ex. 19/11. His suggestion that he was attentive and
saw the patient regularly is
of no merit since he failed to ascertain in such visits the potential seriousness
of the patient's cardiac
condition. See, P. Br. at 67-68. If anything, it reaffirms his lack of understanding
of cardiac problems,
their diagnosis and treatment.
His explanation for failing to treat this patient's cardiac signs was that
she had no apparent overt cardiac
symptoms when he examined her. 25/ But such an explanation is inadequate and
demonstrates Petitioner's
lack of knowledge and understanding of the significance of abnormal blood chemistry
results and their
relationship to possible cardiac disease. Particularly with regard to this patient,
such lack of understanding
and recognition of abnormal blood chemistry symptoms, combined with a x-ray
finding of congestive heart
failure, makes Petitioner's failure to assess and treat these cardiac signs
especially egregious. 26/ At the
very least, Petitioner should have realized that they warranted obtaining a
cardiac or internal medicine
consultation. He was responsible for the patient's care and treatment and should
have been aware that her
possible cardiac problems were beyond his area of expertise. It is customary
in such circumstances for
physicians to consult other specialists who regularly treat such conditions.
Petitioner did not do so in this
case.
Cardiac disease can be life threatening. Failure to diagnose, assess, and treat
signs of such a condition,
such as congestive heart failure and abnormal blood chemistry studies, have
an obvious implication on the
patient's health and welfare. Here, Petitioner did not follow customary medical
practice in repeating blood
tests which showed potential cardiac electrolytic abnormalities. Nor did Petitioner
follow accepted medical
practice when he failed to repeat the chest x-ray. This is true despite Petitioner's
explanation that the
written report was inconsistent with the radiologist's oral assessment, showing
congestive heart failure.
Petitioner obviously did not possess the necessary skill or acumen to realize
the importance of these
adverse cardiac findings and their relationship to the potential of severe cardiac
compromise. Not only did
Petitioner not know enough to begin assessment of the patient's cardiac status,
and treatment if necessary,
he failed to recognize that a medical consultation was needed. Such failures
clearly placed this patient in
imminent danger and placed her in an unnecessary high-risk situation. Consequently,
Petitioner's conduct
was a gross and flagrant violation of his obligation under section 1156 of the
Act.
3. The I.G. has demonstrated that Petitioner is unable substantially to comply
with his obligations under
section 1156 of the Act.
Section 1156 authorizes an exclusion where the Secretary, or his lawful delegate,
the I.G., agrees with the
PRO's findings that Petitioner has violated his obligations under the Act and
determines that Petitioner has
demonstrated an unwillingness or a lack of ability substantially to comply with
such obligations. Section
1156(b)(1) of the Act. 27/ The I.G. does not contend, nor is there any evidence,
that Petitioner is unwilling
to comply with his obligation under the Act to provide medical care in accordance
with professionally
recognized standards. Indeed, from the outset of the NJPRO proceeding and throughout
this hearing,
Petitioner has indicated a willingness to comply with his obligations. See Tr.
II/359-362.
It is the I.G.'s contention that Petitioner has demonstrated an inability to
comply with his obligations. I.G.
Br. 49. The I.G. cites the seven cases as evidence of a "consistent pattern
of gross and flagrant violations."
I.G. Br. 50. The I.G. contends that Petitioner's consistent use of ICPM despite
its lack of usefulness in the
treatment of patients indicates his inability to comply with his statutory obligations.
I.G. Br. 53. The I.G.
asserts that, with regard to Patient 63235 (Case # 7), Petitioner's failure
to correctly diagnose, treat, and
consult, also reflects Petitioner's inability to comply with his obligations.
According to the I.G., Petitioner's
consistent failure to comply with accepted standards of neurosurgery and medicine
is strong evidence of
Petitioner's inability to comply with his obligations.
Petitioner contends that he is both willing and able to comply with his obligations.
To support his claim,
Petitioner offered letters into evidence from eight neurosurgeons who attest
to his ability. Petitioner states
that he has modified his practice concerning ICPM; he now confers with another
neurosurgeon when a
question arises, and he is more careful in documentation. P. Br. 72. Petitioner
also points to the testimony
of Dr. Hassenbusch as evidence of his ability to comply with professionally
recognized standards as a
neurosurgeon. P. Br. 73.
I conclude that, while Petitioner has demonstrated a general willingness, he
has also demonstrated an
inability to comply with his obligations under the Act. 28/ Petitioner's inability
to comply with his
obligation is established by his pattern of gross and flagrant violations, along
with his pattern of errors in
judgment and lack of documentation. Evidence of these deficiencies is shown
in the three cases where I
found Petitioner engaged in gross and flagrant violations of his obligation
to follow professionally
recognized standards of neurosurgery and medicine as required by section 1156
of the Act.
In the case of Patient 854914 (Case # 3), Petitioner failed to timely perform
a posterior fossa
decompression. Petitioner also did not correctly diagnose the patient's condition,
despite the fact that the
CAT scans of July 30, 1985, and August 1, 1985, were indicative of a cerebellar
infarct. Instead of
proceeding with the medically indicated post fossa decompression at that point,
Petitioner demonstrated a
lack of understanding of fundamental neurological concepts when he operated
on this patient for
hydrocephalus, instead of cerebellar infarct. Petitioner should have recognized
that this patient's brain stem
was compromised and that there was a need for an immediate post fossa decompression.
The fact that
Petitioner failed promptly to perform a post fossa decompression after having
sufficient information that
the patient had a cerebellar infarct, evidences a lack of understanding of basic
neurological principles. It
also evidences a lack of the skills of diagnosis and analysis that are so critical
in the field of neurosurgery.
By waiting seven days to perform this critical operative procedure, Petitioner
ignored his own, but belated,
assessment that a decompression was necessary three days earlier and essentially
eliminated any slim hope
that this patient had for recovery. The I.G.'s contention that Petitioner is
unable to comply with his
obligations is well supported in this instance. The treatment of Patient 854914
demonstrates that Petitioner
lacks critical skills needed for analyzing a patient's condition and determining
the medically proper course
of action. His willingness to correct his actions is insufficient where Petitioner
is lacking in some of the
basic skills that are needed to perform neurosurgery in accordance with medically
recognized standards.
In the case of Patient 860935 (Case # 4), Petitioner performed a surgical craniotomy
and evacuation of a
hematoma when these procedures were not medically indicated. Petitioner admitted
that the treatment of
this type of hematoma was usually medical, but attempted to support his decision
to perform surgery on the
basis that the patient was deteriorating. However, the evidence in the record
does not support Petitioner's
contention. In this case, although Petitioner espoused that he was aware of
the standard treatment for this
type of condition and when it was indicated, his application of that knowledge
was shown to be lacking.
Petitioner did not take into account that this patient had endured previous
infarcts, which reflects an ability
of the patient to tolerate better a hematoma with conservative treatment only.
Petitioner overlooked that
there was no shift in midline structures. Petitioner did not seem to have a
proper concept as to what
constitutes neurologic deterioration, as he often confuses "stuporous"
-- a classic sign of neurologic
deterioration -- with "confused". Petitioner improperly failed to
consider that the patient had been
tolerating the stroke for seven days and had a chronic neurological condition,
Alzheimer's, which would
affect her mental status independent of the stroke. In this instance, Petitioner's
inability to assess properly
all relevant information regarding this patient, make an appropriate diagnosis,
or decide on a proper course
of action, leads me to conclude that he is unable to comply with his obligations
under the Act. This case
points to a defect in basic skills of analysis and information assessment that
are critical to doctors in
general, and especially to neurosurgeons.
In case of Patient 632365 (Case # 7), Petitioner failed to properly diagnose
and assess clear indicators that
the patient had a serious cardiac condition. Petitioner failed to consult with
a specialist and failed to take
proper action when confronted with a trifecta of symptoms, low serum sodium
level, abnormal CPK and
MB isoenzyme levels, and an abnormal chest x-ray. Admittedly, Petitioner is
not a cardiologist. However,
it was incumbent upon Petitioner, as the admitting and attending physician,
properly to assess and treat this
patient's medical conditions, and, if any condition is outside his area of expertise,
to consult with the
appropriate specialist who could properly assess and treat her. Instead of assessing
and treating this patient
for her cardiac condition, Petitioner focused his entire treatment on her neurological
complaints. This
conduct was particularly inappropriate, considering that some of the patient's
confusion may have
emanated from her cardiac condition rather than her neurological problems. Petitioner
should have been
aware that such symptoms oftentimes readily mimic neurological signs. Petitioner
did not possess the
necessary skill or acumen to realize the importance of these adverse cardiac
findings and the potential
threat these symptoms posed to his patient. Petitioner's failure to recognize
relatively common medical
signs of cardiac disease, to order additional diagnostic procedures to assess
her cardiac status, and to
provide treatment for any cardiac problems found, demonstrates that he lacks
the ability to comply with his
obligations under the Act. His lack of knowledge of basic cardiac signs, symptoms,
and findings was so
deficient that he failed to realize that a specialist should be consulted. Here,
again, a willingness to
conform to his obligations under section 1156 of the Act cannot make up for
his basic inadequacies in
medical knowledge of cardiac disease, diagnosis, and treatment.
Although Petitioner has frequently asserted that he is willing to do whatever
is necessary to comply with
his obligations under section 1156 of the Act, such willingness is inadequate
protection for program
beneficiaries and recipients when he lacks the basic medical knowledge to comply
with his obligations
under the Act. This point is graphically demonstrated in Petitioner's treatment
of Patient 632365, where
Petitioner demonstrated that he lacks the basic medical knowledge properly to
diagnose and treat cardiac
conditions, such as CHF. Petitioner's lack of understanding of signs and symptoms
of this disease was so
significant that he did not think to consult with another physician who had
expertise in cardiac disorders.
When asked what he had learned from this case at the NJPRO hearing, Petitioner
provided the following:
Because these questions have arisen, so maybe to correct it, maybe I've learned
something, I don't
know. I'm just -- at least if C.H.F. maybe would have been a concern, we might
have repeated a chest x-
ray, which I didn't do, I'm really not sure what it would have done in this
patient. It might help me at least
just to cover me up.
I.G. Ex. 8/42 (emphasis added).
My understanding of Petitioner's comment is that he still does not accept that
he may have misdiagnosed
this patient's cardiac condition. A repeat x-ray and additional blood tests
would have provided Petitioner
with information that could have led to a proper assessment of the patient's
cardiac disease and, if
necessary, to additional treatment measures. Rather than recognizing his deficiencies
in medical
knowledge and need for consultations in the future to assist in determining
the existence and severity of
cardiac conditions that his patients might present, Petitioner seems to be more
concerned about his
potential future liability than properly diagnosing, analyzing, and understanding
the patient's underlying
condition and providing proper patient care.
For the above reasons, I find that Petitioner is unable to comply with his
obligations under the Act.
Petitioner exhibited a consistent pattern of serious errors in the diagnosis
and assessment of patients, which,
in turn, indicates a lack of important, fundamental knowledge that is essential
in meeting his obligations
under the Act. An exclusion in this case is proper, as it will allow Petitioner
time to sharpen his diagnostic
skills, perhaps with the help of additional supervision or training. Petitioner
has demonstrated a
willingness to cooperate and learn, and hopefully will take the steps necessary
to ensure he gains the
experience and skills needed to become a provider who is able to fulfill his
obligations under the Act.
4. The five year exclusion imposed and directed against Petitioner is extreme
and excessive; a three year
exclusion is reasonable and comports with the remedial purposes of the Act.
The I.G. adopted the recommendation of the NJPRO and imposed a five year exclusion
against Petitioner.
Authorization for this exclusion was based on section 1156 of the Act. Essentially,
the following factors
must be established to provide the I.G. with the authority to impose an exclusion
under this section of the
Act. There must be proof that 1) Petitioner committed gross and flagrant violations
of his obligation to
provide care which meets professionally recognized standards of health care,
and 2) Petitioner is unwilling
or has an inability substantially to comply with such obligation. I have found
that the I.G. proved by a
preponderance of the evidence that he has the requisite authority to exclude
Petitioner. However, the
record demonstrates that the five year exclusion warrants modification, and
for the reasons set forth below,
I am reducing the exclusion imposed against Petitioner to three years.
Petitioner has a right pursuant to section 1156(b)(4) of the Act to a hearing
under section 205(b)(1) of the
Act for the purpose of reviewing the Secretary's decision (or in this case,
the I.G. as his delegatee) to
exclude him. Section 205(b)(1) provides for a de novo hearing and, based on
the record established at the
hearing, I have the authority to affirm, reverse, or modify the I.G.'s action
against Petitioner. In this case, I
have concluded that the remedy imposed against Petitioner is unreasonable.
Based on my responsibilities in reviewing the I.G.'s determination, I am obliged
to modify the length of the
exclusion to comport with the minimum time period needed for Petitioner to demonstrate
that he can be
trusted to provide medical care to program beneficiaries and recipients in a
manner consistent with his
obligation to meet professionally recognized standards of health care. An exclusion
of three years will be
sufficient for Petitioner to satisfy his trustworthiness to be a program provider
and comports with the
remedial purposes of the Act. This time period will give Petitioner the opportunity
to rectify the
deficiencies, as established by the record, in his medical knowledge of the
management, including the need
for surgical intervention, of cerebral infarcts and hemorrhages and of the diagnosis
and treatment of cardiac
problems. At the end of this time period, Petitioner can seek reinstatement
into the program pursuant to 42
C.F.R. 1004.120, 57 Fed. Reg. 3350 (January 29, 1992).
In addition to ensuring that Petitioner can be trusted to be a program provider
and that the conduct which
led to his exclusion will not be repeated, his exclusion may have an ancillary
benefit of deterring other
providers of items or services from engaging in the same or similar misconduct.
Reyes at 37. However,
deterrence cannot be a primary purpose for imposing this exclusion. If deterrence
becomes the primary
purpose for this exclusion, then punishment becomes the objective, which is
inconsistent with the remedial
objectives of the Act. Hanlester Network, DAB 1275 at 51-52 (1991). Therefore,
where an exclusion
under section 1156 of the Act, a civil remedies statute, is essentially for
deterrence purposes rather than
remedial, the exclusion becomes punitive and is unconstitutional. Cf. United
States v. Halper, 490 U.S.
435 (1989).
Evidence which is relevant to the reasonableness of an exclusion is admissible
whether or not that evidence
was available to the I.G. at the time the I.G. made his exclusion determination.
Evidence which relates to a
provider's trustworthiness or to the remedial objectives of the exclusion law
is admissible at an exclusion
hearing even if that evidence is of conduct other than that which establishes
statutory authority to exclude a
provider.
However, I do not substitute my judgment for that of the I.G. An exclusion determination
will be held to
be reasonable where, given the evidence in the case, it is shown to fairly comport
with legislative intent.
"The word `reasonable' conveys the meaning that . . . [the I.G.] is required
at the hearing only to show that
the length of the [exclusion] determined . . . was not extreme or excessive."
(Emphasis added.) 48 Fed.
Reg. 3744 (1983).
The evidence of record establishes that some period of exclusion is warranted.
However, the five year
exclusion imposed by the I.G. must be modified. A major component of the I.G.'s
case has not been
sustained. The I.G. failed to prove by a preponderance of the evidence that
Petitioner engaged in a pattern
of misuse of ICPM in CVA and tumor cases. The I.G. also failed to prove by a
preponderance of the
evidence that Petitioner violated his obligation to provide care that met professionally
recognized standards
in the treatment of four of the seven patients cited.
Nevertheless, there is credible evidence that Petitioner failed in his obligation
to meet professionally
recognized standards of health care in three separate patient transactions in
which his conduct placed the
patients in imminent danger or unnecessarily in high risk situations. By regulatory
definition, a single
violation of this type constitutes a gross and flagrant violation which would
justify Petitioner's exclusion.
42 C.F.R. 1004(b). Here there were multiple instances of gross and flagrant
violations. Moreover, while
Petitioner has repeatedly expressed a willingness to comply with his requisite
obligations, I have concluded
that the record further establishes that he lacks an ability substantially to
comply with them. Petitioner's
multiple violations demonstrate that he cannot presently be trusted to provide
care to program beneficiaries
and recipients.
I have determined that a three year exclusion will adequately protect the Medicare
and Medicaid programs
and their beneficiaries and recipients. In reaching this conclusion, I have
considered the risks to which
Petitioner exposed three of his Medicare patients, and the likelihood that he
would continue to pose a risk
to program beneficiaries and recipients until his deficiencies in knowledge
and judgment are corrected. I
have also considered Petitioner's failure adequately to document in the medical
records his clinical
observations and rationale for choosing a particular course of treatment. Petitioner's
poor documentation
impacts on his trustworthiness as a program provider because it may impede the
peer review process,
which is intended to insure that beneficiaries and recipients receive competent,
medically necessary care.
Petitioner's treatment of Patient 854914 (Case # 3) departed significantly
from professionally recognized
standards of neurosurgical practice and demonstrates a lack of knowledge and
judgment that could
continue to place program beneficiaries and recipients at risk if not corrected.
He failed to order clarifying
diagnostic tests when an existing CAT scan did not define with proper clarity
the extent and location of the
patient's cerebral infarct. Considering the clinical presentation, accepted
neurosurgical practice required a
prompt posterior fossa decompression to eliminate pressure that was compromising
the patient's brain stem
which, if not alleviated, would lead to the patient's death. As a practicing
neurosurgeon, Petitioner is
rightfully expected to possess the necessary skill and experience to independently
evaluate the patient's
condition, and to employ existing diagnostic studies to determine the proper
surgical intervention and the
time frame in which it should be performed. Where the clinical picture is unclear,
Petitioner is expected to
know what additional tests are necessary to determine the proper course of treatment.
Upon completion of
such studies, he is to undertake a proper and medically correct surgical procedure
which will provide the
best chance for patient recovery. In this case, Petitioner undertook a preliminary
surgical procedure of a
ventriculostomy, with ICPM, and delayed performance of the urgently needed posterior
fossa
decompression. By the time Petitioner did the correct procedure, which was several
days after his own
specified time frame, he eliminated the acknowledged slim chance this patient
had for recovery.
Moreover, had Petitioner obtained a clarifying CAT scan on the day he first
operated, he may have been
able to avoid the performance of the initial, arguably unnecessary, surgical
procedures. The inappropriate
decisions he made were within his area of expertise and demonstrate a serious
deficiency in his knowledge
of accepted neurosurgical principles. It is obvious that continuation of such
action by Petitioner would
pose a significant risk to the Medicare and Medicaid programs.
As was true of the treatment of Patient 854914, Petitioner's treatment of Patient
86-0935 (Case # 4)
deviated in significant aspects from professionally recognized standards of
neurosurgery. Petitioner's
treatment of Patient 86-0935 also demonstrates failures of knowledge and judgment
that could expose
beneficiaries and recipients to a continuing risk of unnecessary surgery. This
patient's medical record also
demonstrates Petitioner's failure adequately to document his clinical findings
and treatment decisions. In
this case, Petitioner performed a surgical craniotomy and insertion of an ICPM
device in a patient who had
been tolerating a small intracerebral hemorrhage well for seven days. Petitioner
performed a surgical
craniotomy and evacuated a hematoma under general anesthesia despite the fact
that the patient exhibited
no mass effect, no shift in the midline structures of her brain, and no neurologic
deterioration. An
additional factor weighing against surgery was this patient's increased ability
to tolerate a small stroke,
given her history of previous infarcts. Accepted medical practice is to treat
small strokes conservatively,
i.e., with drugs, instead of surgery, unless the patient exhibits deterioration.
Petitioner deviated from
accepted medical practice and subjected this patient to risks from general anesthesia
and infection by
operating. This is especially true because the patient was tolerating the stroke
well for seven days and
exhibited no signs of neurologic deterioration. Moreover, Petitioner failed
in his diagnosis sufficiently to
take into account the fact that this patient had Alzheimer's disease. Petitioner,
in his notes, makes repeated
references that the patient was confused. Petitioner was unable to articulate
a clear and logically
supportable reason, either in his notes or in testimony at the hearing, as to
why he believed this patient was
suffering any neurologic deterioration. In making a decision to operate, Petitioner
failed to give sufficient
weight to the fact that this patient's baseline behavior was one which contained
periods of haziness and
confusion. Petitioner's stated rationale for performing surgery is not supported
by the notes of the
attending physician, nor is it supported by the nurses' notes. Petitioner's
stated rationale is not supported
even by his own sparse notes, which provide only conclusions and little supporting
rationale. Petitioner
disregarded the medically accepted and recognized treatment for small intracerebral
hemorrhages, based on
his mistaken assumption that the patient was deteriorating.
Petitioner also inserted an ICPM device into this patient when there was no
indication of increased
intracranial pressure. But, more importantly, he then removed the monitor one
day after the surgery, when
the patient was at risk from increased intracranial pressure from swelling for
three days. Removal of the
monitor in this instance is in direct conflict with Petitioner's stated purposes
for inserting it in the first place
and is a violation of Petitioner's obligations under the Act. In short, there
were no logical and supportable
clinical reasons for Petitioner to perform surgery on this patient or to remove
the ICP monitor after only
one day. These inappropriate decisions were within Petitioner's area of expertise
and demonstrate a serious
deficiency in Petitioner's knowledge of accepted neurosurgical and medical principles.
Perhaps more
importantly, these decisions demonstrate Petitioner's inability in this instance
to correctly analyze and
assess the medical needs of this patient and to proceed with the proper course
of treatment. As a result, this
patient was subjected unnecessarily to the risks of surgery under general anesthesia
and the accompanying
risk of infection. Continuation of such practices and actions by Petitioner
would pose a significant risk to
the Medicare and Medicaid programs.
The record of Petitioner's involvement in the management of the care and treatment
of Patient 632365
(Case # 7), also reveals serious deficiencies in recognized standards of health
care. As with the cases of
Patient 854914 and Patient 86-0935, Petitioner's treatment of this patient also
reveals serious gaps in
Petitioner's knowledge which could place program beneficiaries and recipients
at considerable risk. Here,
Petitioner failed to recognize clear indicators of potential cardiac problems
evidenced by low serum
sodium levels, inconsistent CPK and MB isoenzyme test results, and radiological
imagining showing CHF.
His narrow focus on the patient's neurological impairments, despite strong indications
of possible heart
disease and the obvious life threatening impact of such condition, is disturbing.
It suggests that Petitioner
is lacking in the knowledge of basic medical coronary diagnostic criteria. Even
more disturbing is
Petitioner's failure to recognize the need to seek consultation for a cardiac
or internal medicine specialist.
His expressions that he would utilize such consultive services in the future
is not very reassuring, especially
when he apparently lacks the basic knowledge of cardiac signs that would warrant
such involvement of
other medical specialties. Until Petitioner has the opportunity to refresh his
knowledge of cardiac diseases
and their care and treatment, he places program beneficiaries and recipients
at risk. The three year period
of exclusion will be an adequate time frame for Petitioner to demonstrate that
the programs are no longer at
risk from this past conduct.
While Petitioner, in appropriate cases, should solicit input from other attending
or consultative physicians,
the decision for surgical intervention, the type of surgery to be performed,
and its timing has to made
independently by him based on professionally recognized standards of health
care. Petitioner, in a number
of cases, asked me to review other physicians' opinions and tried to justify
his actions based on the fact it
was a joint decision of the doctors attending the patient. Such reliance on
others does not excuse Petitioner
where he did not follow professionally recognized standards of neurosurgical
care. He cannot justify his
surgical procedures on the fact that other physicians recommended them. He is
being consulted for his
neurosurgical skills and experience and should make an independent assessment
of the correct course of
action, especially when consulted by physicians who do not possess his level
of neurosurgical expertise. I
am disturbed that too often Petitioner showed a pattern of following others
and not exercising his own
independent assessment and judgment. Again, the period of exclusion that I am
imposing will allow
Petitioner time to demonstrate that this behavior no longer poses a risk to
program beneficiaries and
recipients.
In addition to the need for Petitioner to improve his medical knowledge and
judgment, a three year
exclusion will also allow Petitioner sufficient time to demonstrate that he
understands his responsibility to
adequately document the patient's hospital record so that the rationale and
basis for his determination of the
need for, and type and timing of, surgery can be assessed. Quality review is
an accepted part of the
medical community's efforts to reduce medical costs by eliminating unnecessary
procedures and weeding
out incompetent medical practices. Petitioner must be aware of this. Here, among
the other concerns I
have regarding Petitioner, I am disturbed about the absence of comprehensive
consultative notes explaining
the rationale for his actions. A number of the cases reviewed by the NJPRO were
complicated by the
absence of any rationale in the hospital record for Petitioner's surgical procedures.
Considering the
complexity, importance, and cost of such procedures, such lack of documentation
is indicative of an
unacceptable level of sloppiness and carelessness. Even acknowledging that in
most of these cases,
Petitioner was involved in an emergent situation, he still must take the time
to complete a reasonably
comprehensive rationale for his actions. In a number of instances, Petitioner's
notations were so poorly
worded that it was unclear whether the surgical procedure he performed was a
craniotomy or a
craniectomy. He should leave no doubt as to the type of surgery he performed.
Also of concern was the
frequent absence of a clear indication by Petitioner as to the precise reason
why a certain surgical
procedure was undertaken and what Petitioner was attempting to achieve by its
application in the patient's
case.
There seemed to be a consensus among experts that the patient files in issue
were poorly documented. I.G.
Ex. 6/179; Tr. III/161-62. Petitioner concedes this point and avers to change
his documentation practices
in the future. However, considering the consistency of this documentary lapse
and the length of its
duration from 1985 through 1989, it is apparent that an exclusionary period
is warranted to protect program
beneficiaries and recipients from a repetition of this activity in the future.
The I.G. argues for retention of the five year exclusion. The principal basis
for this period of exclusion is
the I.G.'s conclusion that Petitioner grossly and flagrantly violated his statutory
obligations and
demonstrated an inability to comply with those obligations in the care of seven
patients over a five year
period. I.G. Br. 49-57; I.G. R. Br. 13-14. As I have held in four of the patient
cases, the I.G. has failed to
meet his burden of proof in establishing violations under section 1156 of the
Act. A major component of
the I.G.'s case was Petitioner's alleged misuse of ICPM on a regular basis to
monitor and treat cerebral
infarcts, hemorrhages, and tumors. Contrary to the I.G.'s position, the record
demonstrates that Petitioner
used this procedure in exceptional cases only. Apparently, the NJPRO and the
I.G. concluded that
Petitioner was too aggressive in his use of ICPM when a more conservative and
less dangerous approach
was needed. In fact for the period of 1985 through 1986, Petitioner treated
approximately 100 patients
with CVAs, strokes, tumors, or hematomas and, of these patients, only in seven
or eight instances did he
insert an ICPM device.
Nor did the record support the I.G.'s assertion that a general anesthetic was
used to insert the monitoring
device in every patient's case. In at least one patient's case, the record supports
that no agent was used to
anesthetize the comatose patient. In all but one of the other patients, the
patients were either unsalvageable
and beyond any realistic hope of recovery or so severely compromised that the
only hope of recovery
emanated from Petitioner's surgical procedure. In such cases, a one percent
risk from the general
anesthesia does not meet the definition of gross and flagrant conduct. I did
find that, in the case of Patient
86-0935, the one percent risk of general anesthesia was significant, since the
surgery was unnecessary and
the patient would have recovered with the use of conservative measures. In this
case, the patient was
tolerating the stroke well, and surgery was not clinically indicated. For Petitioner
to subject the patient to a
one percent risk of serious injury or death, in that case, is a gross and flagrant
violation.
Moreover, the neurological literature does not support the I.G.'s assertion
that ICPM is universally
contraindicated. The I.G's assertion that you only find ICPM in nationally recognized
teaching institutions
is, on its face, without merit. There is no basis for a conclusion that such
monitoring is done only for
academic reasons as suggested by Dr. Kasoff. Its use in prestigious teaching
hospitals, such as the Mayo
Clinic and Johns Hopkins, suggests that an influential segment of the neurosurgical
community still
recognizes the need for such monitoring.
While it appears that, since the mid 1980's, practicing neurosurgeons have
begun to question the efficacy of
such monitoring based on studies reflecting that intracranial pressure is not
helpful in the treatment of
strokes and tumors, a significant minority of neurosurgeons still advocate its
use in such cases. Here, the
record shows Petitioner used such monitoring in specialized cases and only in
conjunction with another
procedure, such as a ventriculostomy or an evacuation of a hematoma, and was,
for the most part, based
on legitimate medical need. Furthermore, the I.G. failed to prove that use of
such monitoring in any of the
patient cases was a gross and flagrant violation of Petitioner's obligations
to comply with professionally
recognized standards of health care.
The I.G. failed, in four of the seven patients, to prove his case. The I.G.'s
case also suffered because a
major component of his case -- misuse of ICPM -- was shown to be invalid in
all but one patient. Thus, a
five year exclusion of Petitioner is unwarranted. Such a lengthy period of time
far exceeds the time needed
to establish Petitioner's trustworthiness based on the conduct that I have detailed
above. I am influenced by
Petitioner's recognition and apparent willingness in the future to: 1) obtain
second opinions of
neurosurgeons in close cases; 2) improve the quality of his documentation in
hospital records of patients
under his care; and 3) acquire increased medical knowledge in areas where he
may be deficient. The three
year period of exclusion will allow Petitioner time to improve his medical knowledge
and should be
sufficient time to make unlikely the repetition of the serious deficiencies.
Also in Petitioner's favor is that,
even after he was placed under intensive scrutiny by the NJPRO, only one additional
issue arose, and this
was unrelated to the quality of his care in the field of neurosurgery. Lastly,
I note that neither the NJPRO
nor the I.G. ever challenged Petitioner's surgical skills. The areas of Petitioner's
behavior placed into
disrepute by these cases are all subject to remedial action by him. Consequently,
in light of the above
analysis, any period of exclusion beyond three years is extreme or excessive
and fails to comport with the
remedial purposes of the Act.
CONCLUSION
Based on the applicable law and the evidence, I conclude that Petitioner, in
the cases of three patients,
grossly and flagrantly violated his obligation under section 1156 of the Act
to provide health care services
of a quality that met professionally recognized standards of health care and
demonstrated a lack of ability
substantially to comply with his obligation. I also conclude that Petitioner,
in the cases of four other
patients, did not grossly and flagrantly violate his obligation under section
1156 of the Act. I conclude that
the I.G. had the authority to impose and direct an exclusion against Petitioner
from participating in the
Medicare and Medicaid programs. Lastly, I conclude that the five year exclusion
imposed and directed by
the I.G. against Petitioner is not reasonable, but that a three year exclusion
will fully serve the remedial
purposes of the Act.
___________________________
Edward D. Steinman
Administrative Law Judge
1. "State health care program" is defined by section 1128(h) of the
Social Security Act to cover three
types of federally financed programs, including Medicaid. I use the term "Medicaid"
hereafter to refer to
all State health care programs from which Petitioner was excluded.
2. Section 1156(a) of the Act imposes on health care practitioners a number
of duties, among them the
duty to provide care of a quality that meets professionally recognized standards
of health care. Section
1156(b) authorizes the Secretary of the Department of Health and Human Services
to exclude practitioners
who commit certain types of violations of their statutory obligations. Section
1156(b)(1)(A) authorizes the
exclusion of practitioners who substantially violate their obligations in a
substantial number of cases.
Section 1156(b)(1)(B) authorizes the exclusion of practitioners who "grossly
and flagrantly" violate their
obligations on one or more occasions. In the present case, the I.G. has alleged
only that Petitioner's
exclusion is authorized pursuant to section 1156(b)(1)(B).
3. The I.G. must first determine that a violation (of Petitioner's obligation
under the Act) has occurred.
Once the I.G. has determined that a violation has occurred, he must consider
the specific factors contained
in 42 C.F.R. 1004.90(d) in arriving at an appropriate sanction. The factors
the I.G. is to consider are: (1)
the recommendation of the Peer Review Organization (PRO); (2) the type of offense;
(3) the severity of the
offense; (4) the previous sanction record of the practitioner or other person;
(5) the availability of
alternative sources of services in the community; (6) any prior problems the
Medicare carrier or
intermediary has had with the practitioner or other person; (7) whether the
practitioner or other person is
unable or unwilling to comply substantially with the obligations; and (8) any
other matters relevant to the
particular case. 42 C.F.R. 1004.90(d) (1989).
4. I have used headings in organizing my Findings of Fact and Conclusions of
Law (FFCLs). My
headings are not FFCLs and they do not alter the meaning of my FFCLs.
5. Citations to the record in this case are as follows:
Transcript Tr. [volume]/[page]
Petitioner's Exhibit P. Ex. [number]/[page]
I.G.'s Exhibit I.G. Ex. [number]/[page]
Petitioner's
Post-Hearing Brief P. Br. [page].
I.G.'s Post-Hearing
Brief I.G. Br. [page].
Petitioner's Reply Brief P. R. Br. [page].
I.G.'s Reply Brief I.G. R. Br. [page].
6. I do not agree with the I.G.'s assertion that Petitioner's expectation of
continued participation in the
Medicare program is not a property right. In Charles J. Barranco, M.D., DAB
CR187 at 23 (1992), I noted
that "Petitioner's expectation of continued participation as a program
provider is a property interest
protected by the due process clause of the Fifth Amendment," citing Ram
v. Heckler, 792 F.2d 444, 447
(4th Cir. 1986). Petitioner's property interest ensures that he will be afforded
due process of law.
However, Petitioner's property interest in being a program provider is distinguishable
from the rights of
individual liberty that are manifest in a deportation proceeding.
7. The new regulations promulgated and effective on January 29, 1992, define
the term "professionally
recognized standards of health care" to mean:
Statewide or national standards of care, whether in writing or not, that professional
peers of the
individual or entity whose provision of care is at issue, recognize as applying
to those peers practicing or
providing care within a State.
57 Fed. Reg. at 3330 (to be codified at 42 C.F.R. 1001.2). The parties do not
argue that the new
regulations are applicable to this case. P. R. Br. 3; I.G. R. Br. 6. Moreover,
I have previously held in
Barranco that the new regulations are not applicable to cases which were pending
before an administrative
law judge prior to their effective date. An appellate panel concurred with that
holding in Bassim. See
discussion supra.
8. Dr. Hassenbusch's Curriculum Vitae indicates that he completed Part I of
his board certification in
neurosurgery (written examination) in March 1987. P. Ex. 19/2. Dr. Hassenbusch
testified that he is
eligible for Part II of the board certification (oral examination), but had
not yet completed it as of the
hearing date. Tr. III/6. I found both Dr. Hassenbusch and Dr. Kasoff well qualified
and authoritative
witnesses as to the practice of neurosurgery.
9. If I were to follow the implications of Dr. Kasoff's testimony to their
logical conclusion, I would have
to conclude that a procedure which is performed by neurosurgeons at some of
the leading health care
institutions in the United States does not meet professionally recognized standards
because the procedure is
not routinely performed in private practice at local community hospitals. Such
a result would have the
effect of setting professionally recognized standards at the level of care rendered
at local community
hospitals without regard to the fact that standards of practice at local hospitals
may be different from those
at large teaching hospitals due to factors unrelated to the safety or efficacy
of the practice at issue.
Constraints such as lack of funds, unavailability of technology, or a lag in
dissemination of information
may explain why a given practice or procedure has not become standard in local
hospitals.
10. I will discuss my findings regarding Petitioner's unwillingness or inability
to substantially meet his
obligation under section 1156 of the Act in a separate section of my decision
which can be found at pages
[].
11. I would reach this conclusion even in a case where I concluded that the
surgery was unnecessary.
My conclusion that the patient is not placed unnecessarily in a high risk situation
does not mean that I
would condone unnecessary surgery simply because it is performed on a critically
ill patient. Section
1156(b)(1)(A) authorizes the Secretary to exclude practitioners who, among other
things, violate their
obligations in a substantial number of cases by providing services that are
not medically necessary, without
regard to whether patients are placed unnecessarily in high risk situations.
In the present case, however,
the I.G. did not seek to exclude Petitioner pursuant to section 1156(b)(1)(A),
but instead relied on section
1156(b)(1)(B) which, with 42 C.F.R. 1004.1, requires a finding that the patient
was placed in imminent
danger or unnecessarily in a high risk situation.
12. There were three CAT scans done on this patient. However, the record does
not contain copies of
the findings of the examinations. Determination of the findings of each examination
is based on the
physician notes of record.
13. There is some confusion in the record as to whether Petitioner performed
a craniotomy or
craniectomy. The operative note states craniotomy as the procedure done, but
the text refers to "burr hole"
and "direct craniectomy". I.G. Ex. 12/5 [the operative report is misdated
as August 9 rather than August 2,
1985]. Petitioner argues that he did a craniectomy. P. Br. 54. Considering the
numerous references in the
hospital records, including Petitioner's own notes, which refer to craniotomy
(I.G. Ex. 12/3. 37), I must
conclude that weight of the evidence suggests that the procedure done on August
2 was the more complex
craniotomy and not a craniectomy.
14. Although on August 4, 1985, Petitioner indicated a need for a repeat CAT
scan, there is no reference
to the findings of such examination until his operative note of August 9, 1985.
See I.G. Ex. 12/6.
15. I agree with Dr. Kasoff's opinion that Petitioner was obligated to determine
quickly the cause of the
patient's deteriorating neurological status and, if necessary, to obtain a repeat
CAT scan. I.G. Ex. 6/96, 98.
16. While such unnecessary surgery does not arise to a violation under section
1156 of the Act in this
case, I am able to consider Petitioner's performance of such surgeries in my
analysis of his trustworthiness
to be a program provider and its impact on the reasonableness of the length
of his exclusion.
17. I note that Dr. Rampal was the chairman of the quality review committee
that cleared Petitioner of
any wrongdoing. He clearly has personal involvement in this matter, and, therefore,
his views are given no
probative weight. See, Evelyn Reyes at 27.
18. I note that no record of Petitioner's conversation with the neurosurgeon
at St. Luke's appears in the
hospital records for this patient. This is another example of Petitioner's inadequate
documentation, an
occurrence which I observed throughout the hospital records.
19. It also apparent from this note that the anesthesiologist was uncertain
as to the type of procedure --
craniectomy or craniotomy, Petitioner was to perform.
20. In the operative report, Petitioner refers to a craniectomy, but the procedure
that he performed
reflects he opened the small flap of skull, which would be indicative of a craniectomy.
Also, other
physicians who referred to this surgery indicated it was a craniectomy. See,
I.G. Ex. 15/24-25.
21. The radiologist's report of the examination erroneously indicates the date
as August 4, 1989. I.G.
Ex. 16/28. However, a subsequent examination refers to the original examination
as being done on August
5, 1989. I.G. Ex. 16/31.
22. Congestive heart failure is a clinical syndrome in which the heart fails
to pump blood normally,
resulting in congestion in the pulmonary and/or systemic circulation and diminished
blood flow to the
tissues because of reduced cardiac output. Due to this condition's severity,
the cause of CHF should be
determined, correctable conditions searched for, and contributing factors eliminated.
The Merck Manual,
Fourteenth Edition (1982), at 413 - 428. Accord, Dorland's Illustrated Medical
Dictionary, Twenty-
seventh Edition (1988), at 237.
23. Low serum sodium levels is known as hyponatremia and occurs when the kidney
retains water and
dilutes the serum sodium.
24. Dr. Spagnuolo explained the significance of these fractions. CPK is an
enzyme present in skeletal
and cardiac muscle as well as in the brain. Whenever there is some injury to
a muscle, CPK level will rise.
Also, whenever the MB isoenzyme is reported to be approximate four percent of
the total CPK level or
greater, this signals the existence of cardiac damage. I.G. Ex. 19/9-11.
25. Petitioner's admission that he only records "positive findings"
in his examinations is troubling. Such
an incomplete recording of his findings are likely to create problems in patient
care, since other physicians
who may be consulted will not have a full and accurate understanding of the
patient's clinical condition.
The absence of such historical data may compromise the future treatment of the
patient.
26. The I.G. argues that Petitioner's conduct concerning the care and treatment
of this patient "led to the
patient's death". I.G. R. Br. at 28. While the record shows that his actions
did not comport with proper
standards of medical care and placed her in imminent danger or unnecessarily
high risk, there is no proof
that the patient's cardiac arrest and death occurred as a result of treatment
failures by Petitioner. Nor do I
need to make such a finding to conclude that his conduct was violative of section
1156 of the Act.
27. The I.G. correctly points out that this section of the Act was amended
in 1990 to clarify that the
period of time in which to evaluate Petitioner's willingness or inability to
substantially comply with his
obligation under section 1156 is the time period prior to the PRO's submission
of its report and
recommendations to the I.G. I.G. R. Br. 11-12. See Pub. L. No. 101-508, 4205,
104 Stat. 1388, 1388-
112 to 113. The I.G. further points out that this amendment to the Act occurred
after Petitioner was
excluded from the programs. Id. The I.G. does not suggest that this amendment
be applied retroactively.
For this reason, I have considered evidence as to Petitioner's willingness and
ability to comply with his
obligation both prior to the NJPRO proceedings and afterward. However, I note
that application of the
amended standard would not alter my conclusions on this issue, since Petitioner's
position before the
NJPRO and at the hearing were consistent. Also, there is no indication that
Petitioner took any corrective
action after the NJPRO issued its report and recommendations.
28. Petitioner has expressed his willingness to comply with his obligation
under section 1156, but as yet
he has not demonstrated that he has taken corrective actions to cure the deficiencies
noted in his obligations
under the Act. This may be due more to his failure to recognize his deficiencies
than to an unwillingness to
correct them.