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Note: In consideration of the privacy of
the patient, her name has been replaced by "Jane Doe" and the court case number
has been suppressed. In photographs of documents, the name of the patient, the
pathology accession numbers, and direct reference to the identity of the patient
have been suppressed or blacked out.
Facts Relevant to the Case of
Doe vs. WCP Laboratories
Case Summary:
Case #[case number suppressed],
Div [suppressed]
Saint Louis County, MO
Plaintiff:
Jane Doe, born 1974
Defendants:
Emmett Bentley, D.O.
Weldon
Schott, D.O.
WCP Laboratories
The Hospital
Expert witnesses for the plaintiff:
Arthur J.
Sober, M.D.
Dermatologist, Boston, MA, Harvard University, Massachusetts
General Hospital
George F. Murphy, M.D.
Dermatopathologist,
Jefferson Medical College, Philadelphia, PA
Louis P. Dehner,
M.D.
Pathologist/Dermatopathologist, Saint Louis, MO, Washington University,
Barnes/Jewish Hospital
Pond R. Kelemen, M.D.
Surgical Oncologist, Saint
Louis, MO, Saint Louis University School of Medicine
Expert witnesses for the defense:
Leon H.
Dragon, M.D.
Medical Oncologist, Highland Park, IL
Mark A. Hurt, M.D.
Dermatopathologist and
material witness, Saint Louis Co., MO, WCP Laboratories, Cutaneous
Pathology
A. Bernard Ackerman, M.D.
Dermatopathologist,
New York, NY, Ackerman Academy of Dermatopathology
All depositions were taken in 2002 and the trial
also was held in 2002.
*Dr. Ackerman is Director emeritus of the Ackerman
Academy of Dermatopathology in New York City where he continues to serve as
consultant and mentor.
Sequence of Events Leading to Trial
Original biopsy, 12/21/1999
Surgeon performing
biopsy: James E. Nahlik, M.D., Board certified in Family Practice (certificate
current through 12/2005)
Original diagnosis clinical:
Preoperative
diagnosis: "Suspicious mole"
Postoperative diagnosis: "Pigmented
nevus"
Type of procedure: "Shave biopsy"
~~~~~~~~~~~~~~~~~~
Findings and diagnosis histopathologic,
12/23/1999
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Fig.
1A-F: This is a series of photomicrographs of sections from the
original biopsy specimen of Jane Doe, which was performed on 12.22.1999. The
diagnosis of Drs. Bentley and Schott was "compound nevus." The findings are
those of a very superficial primary melanoma, i.e., 0.41 mm in thickness, that
indicating an excellent prognosis. |
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Fig.
2: This is the original biopsy report issued by Emmett Bentley, D.O.,
on 12/23/1999, concerning what the referring clinician deemed to be a
"suspicious mole / pigmented nevus" on the mid back of Jane Doe. The diagnosis
of Dr. Bentley was "compound nevus," which was agreed on by his associate,
Weldon Schott, D.O., to whom the sections were shown in
consultation. |
~~~~~~~~~~~~~~~~~~
The pigmented lesion persisted at the local
site.
~~~~~~~~~~~~~~~~~~
Follow-up excision,
1/29/2001
Surgeon: Anne T. Riordan, M.D., Board certified in
Dermatology (certificate current through 12/2007)
Clinical data: "R/O recurrent nevus. Check
margins"
~~~~~~~~~~~~~~~~~~
Findings and diagnosis
histopathologic, 2/5/2001
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Fig.
3A-B: These two photomicrographs are of a section from the second
excision of the lesion on the back of the patient performed on 1/29/2001. The
specimen came from the very same site as the original one. The diagnosis by Dr.
George Nahass was "Superficial Spreading Malignant Melanoma, Breslow Thickness
1.07 mm, Clark's Level 4." The findings are those of a persistent melanoma in
conjunction with scar, not a metastasis (i.e., "local recurrence"); the melanoma
grew at the original biopsy site because it had not been removed in toto by the
original surgical procedure. |
Diagnosis histopathologic: "Mid Back: Superficial
Spreading Malignant Melanoma, Breslow Thickness 1.07mm, Clark's level 4", issued
by George T. Nahass, M.D., Board certified in Internal Medicine, Dermatology,
and Dermatopathology (St. Louis University accession # [pathology number
suppressed]).
~~~~~~~~~~~~~~~~~~
Reassessment of sections from the original biopsy
specimen of 1999 and comparison to those of the specimen of the excision from
2001
Evaluation of sections of tissue from the original
biopsy from 1999 by Mark A. Hurt, M.D., Board Certified in Anatomic Pathology
and Dermatopathology, on 2/5/2001: ". . . this lesion is not a nevus, but is
melanoma" (in a letter to Emmett Bentley, D.O. at the request of A. Weldon
Schott, D.O.).
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Fig.
4: Letter of consultation of 2/5/2001 from Mark A. Hurt, MD, to Emmett
Bentley, DO, informing that the original neoplasm of Jane Doe was a very thin
primary melanoma, one that measured 0.41 mm in thickness and, therefore, was
indicative of an excellent prognosis. |
Mark A. Hurt, MD, wrote a letter of follow-up on
2/12/2001 to Dr. Nahass after having reviewed sections from the 2001 excision
and stated, "I completely agree with you that this is malignant melanoma . .
."
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Fig.
5: Letter of 2/12/2001 from Mark A. Hurt, MD, to George T. Nahass, MD,
informing that the neoplasm of Jane Doe was a persistence of melanoma that, like
the melanoma as it presented itself originally, still was "thin," measuring 1.07
mm in thickness, thereby indicating a very favorable
prognosis. |
Dr. Hurt wrote a letter on 2/23/2001 to Dr. Schott
in follow-up after having studied additional sections of tissue in the paraffin
block that housed the original biopsy specimen. He informed that the melanoma
had not been removed completely in 1999.
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Fig.
6: Letter of 2/23/01 from Mark A. Hurt, MD, to Weldon Schott, DO, to
the effect that the original melanoma was present at margins at the periphery of
the specimen resected, establishing thereby the reason that the original
melanoma had persisted at the local site, not having been removed completely by
the first surgical procedure. |
~~~~~~~~~~~~~~~~~~
The Issue Fundamental to this
Case
"Recurrence" of melanoma: Persistence vs.
metastasis
"Recurrence" in regard to melanoma is used in two
entirely different ways as follows:
1) Persistence of the primary
neoplasm at the local site consequent to its not having been removed completely
(i.e., it still remains a primary melanoma whose prognosis
turns on various factors, the most important one today being the thickness of
the neoplasm; the prognosis may be very favorable if the persistent melanoma is
"thin," even if there has been a delay in diagnosis as a consequence of an error
in diagnosis by conventional microscopy).
2) Metastasis of melanoma (i.e.,
neoplastic cells have disseminated through lymphatic or blood vascular channels,
or both) signals a poor prognosis. "Local recurrence" refers to
a metastasis within a few centimeters of a primary melanoma; it is a
metastasis, not a persistence, of melanoma.
Ms. Doe had a persistent primary
melanoma that measured 1.07 mm in thickness, which is
considered, universally, to be a thin melanoma associated with a highly
favorable prognosis.
Testimony of Arthur J. Sober, MD
Arthur J. Sober, MD
Professor of
Dermatology
Vice Chair, Department of Dermatology
Harvard Medical
School
Boston, MA
Testimony at deposition on
[September – exact date suppressed] 2002
Defendants' Attorney: In this
scenario with Jane Doe is this recurrence or persistence [of
melanoma]?
Dr. Sober: I think she represents
persistence of tumor[.] [T]he original biopsies indicated that there was tumor
in the margins and they regrew. (page 45 of the transcript)
Defendants' Attorney: Is it fair
to say they are two scenario[s that] are in fact medically indifferent [sic,
different] though [sic] local recurrence versus persistence?
Dr. Sober: I'm not sure what you
mean by medically different. (page 46-47)
Defendants' Attorney: Maybe it was
my misunderstanding. Doesn't local recurrence represent a situation where the
disease is actually metastasized?
Dr. Sober: Local recurrence
usually is in [sic] event with disease tracking towards the lymph
nodes.
Defendants' Attorney: Is that,
yes?
Dr. Sober: Yes. That's a yes.
(page 47)
Defendants' Attorney: Where as
[sic, whereas] persistence would be the disease that has actually re-grown at
the primary sight [sic, site] as opposed to metastasizing from the primary sight
[sic, site] to some other location?
Dr. Sober: That's correct. (page
47)
Dr. Sober: I believe she falls
into patients with recurrent melanoma and her outcome is based on this Exhibit
24 (Figure 7 and Figure 8) from the Balch book would indicate that people with
recurrent tumors that grow back with a delay in definitive therapy. That has a
substantially unfavorable prognosis and the ten years survival for these
patients is in the twenty to thirty percent range. (page 27)
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Fig.
7: This is the cover of the second edition, published in 1992, of
Cutaneous Melanoma by Balch, Houghton, Milton, Sober, and Soong. This second
edition houses figure 23-5 that pertained to metastasis of melanoma in regard to
prognosis, which Dr. Sober told the jury was relevant to the case of Jane Doe.
But the patient had a persistence of a primary melanoma, not a metastasis of
melanoma. In his testimony, Dr. Sober did not utilize the more recent third
edition of Cutaneous Melanoma, published in 1998, despite his being an editor of
that volume. |
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Fig.
8: This graph on page 292 of the second edition of Cutaneous Melanoma
by Balch, Houghton, Milton, Sober, and Soong, published in 1992, was introduced
repeatedly by Dr. Sober as evidence of Jane Doe having a grim prognosis.
However, the graph pertains solely to prognosis for a patient with metastasis of
melanoma and Ms. Doe had persistence of a primary melanoma, not metastasis of
melanoma. Moreover, that persistence was "thin," an indication of her prognosis
being excellent. |
Comment: Dr. Sober acknowledges that the
melanoma in the second biopsy specimen of 2/5/2001 is "persistence of tumor,"
that is, persistence at the local site of the primary melanoma that was removed
on 12/22/1999, but, at the same time, he avers that the "persistence" is a
"local recurrence," by which he states that he means a metastasis of melanoma,
even though he admitted, again and again, that there was no evidence,
whatsoever, of metastasis of melanoma. By this maneuver, Dr. Sober was able to
"transform" a primary melanoma with a highly favorable prognosis into a
metastatic melanoma with a grim prognosis.
Testimony at trial on
[October - exact date suppressed] 2002 (pages 51-55 of the
transcript):
Plaintiff's Attorney: Is that your
judgment within reasonable medical certainty as to the situation as it applies
to Jane and the Breslow measurements?
Dr. Sober: If you were just going
to use the tumor thickness measurements directly, the observations that I just
made were valid. However, I regarded the second tumor as a tumor that was a
recurrent tumor. One that had been clinically removed, a portion of it left
behind at the edge, and that regrew.
Comment: Dr. Sober makes clear that he considers
the "recurrent tumor" to be a persistence of a primary melanoma at the original
site of it ("a portion of it left behind at the edge, and that regrew"), not a
metastasis of melanoma. A "thin" persistent melanoma like that of Jane Doe is
associated with a very good prognosis.
Dr. Sober: The best chance of
curing melanoma is the first chance you get at diagnosing it. You do not want to
leave tumor behind to regrow. So the best chance for cure is the first chance
you encounter the tumor. This tumor was clinically removed, regrew several
months later, was removed thirteen months later. And so I regard this as a tumor
that falls into the category of a recurrent tumor. And the five-year survival
for patients with recurrent tumors is actually down to in the 40 percent range.
And the ten-year survival is 20 to 30 percent. So there's a substantial
diminishment in survival associated with recurrent tumors.
Plaintiff's Attorney: Seventy to
80 percent die within --
Dr. Sober: Ten
years.
Comment: Dr. Sober reverses course and now uses
"recurrent" to mean "metastatic" rather than "persistent," and, by that
maneuver, transforms the "thin" persistent melanoma of Jane Doe, with a very
favorable prognosis, into a metastatic melanoma with a poor prognosis, all of
this being derived from Figure 8 [Figure 23.5 of the 2nd edition of the Balch
book, Cutaneous Melanoma, see above], that figure pertaining to "survival" of a
patient with "local recurrence" of melanoma, the term "local recurrence," in
that setting, meaning metastasis of melanoma and not persistence of melanoma,
which, in fact, was the actual nature of the "recurrent" lesion in Jane Doe. By
this ploy, i.e., a play on the word "recurrence," Dr. Sober converted the
prognosis of Jane Doe from very good, which, in actuality, it is, to very bad,
which it is not.
Plaintiff's Attorney: What is
your foundation for that opinion?
Dr. Sober: It's based on two
things. First of all, the definition for local recurrence. And there are a
number of different definitions out there for local recurrence. So this is an
area where there is still some both uncertainty and confusion. But in any event,
the information that I'm relying on for my opinion comes from a chapter in a
monograph that I edited, the Second Edition of the Balch Cutaneous Melanoma,
published in 1992. And there's a chapter in this book dealing with local
recurrence. In this chapter local recurrence is defined as tumor that has come
back in the scar or within five centimeters of the scar. Now, that includes
patients who have had tumor incompletely removed so that some tumor was left
behind.
Comment: Here Dr. Sober states that by "local
recurrence" he means "metastasis," which, in fact, was not at all pertinent to
the situation of Jane Doe
Plaintiff's Attorney: That's
Jane's case?
Dr. Sober: That's Jane's case,
correct. And also that includes patients who have had metastasis from the
original tumor tracking down the lymphatics. The definition that I gave you was
the one that was used for the table in that chapter of ninety-five patients that
represented data from the Sydney Melanoma Group, which is a large melanoma study
group in Sydney, Australia, and a group of patients from the University of
Alabama. Local recurrence is not a common problem. So there is not a lot of data
to base opinions on one way or another. But in this study of ninety-five
patients, and I don't know what the distribution of them are in terms of which
ones are like Jane and which ones had metastasis within the specimen, that is
the group that the five-year survival was about 40 percent, and the ten-year
survival was 10 to—excuse me, 20 to 30 percent. And that's the basis of my
opinion.
Plaintiff's Attorney: And that's
within a reasonable degree of medical certainty?
Dr. Sober: Yes.
Plaintiff's Attorney: What was
your reasoning process—share with us your thought process as to why you chose to
use that table in the Balch book?
Dr. Sober: I believe that Jane is
a person who has had a local recurrence of one of the definitions. And at the
present time I'm not aware of studies that have separated out people who have
had a tumor incorrectly diagnosed, incompletely removed, allowed to recur, and
then you see what happens to them. Since local recurrence is not a frequent
phenomenon, these were two very large groups, this is their combined experience.
And based on the definition as used in the chapter, I would feel that patients
like her would fall into this group that they analyzed. But I recognize that the
majority of the patients in this group are actually patients that had met—tumor
that was actually growing metastatically in the lymphatics and recurred in and
around the scar.
Plaintiff's Attorney: Do you think
that it's reasonable to use that study to offer a prognosis on Jane's
case?
Dr. Sober: I do until we have
better data.
Comment: Once again Dr. Sober deliberately employs
"local recurrence" as a synonym for "metastasis," even though he has admitted
that the "recurrence" in Jane Doe is a persistence, not a metastasis. That
tactic accomplishes the aim of the plaintiff's case, namely, to confirm that the
error in diagnosis by Drs. Bentley and Schott would likely cost Jane Doe her
life. But there was not a jot of evidence that the patient had metastatic
melanoma, and Dr. Sober agreed with that in sworn
testimony.
Pages
70-79
Defendants' Attorney: Let's talk
about Jane Doe today, because you reviewed the medical records,
correct?
Dr. Sober: Yes, I did.
Defendants' Attorney: As she sits
here today, she does not have any metastatic cancer, does she?
Dr. Sober: Not as far as I
know.
Defendants' Attorney: In fact, she
didn't have that back in December of 1999. It was not metastatic melanoma, was
it?
Dr. Sober: No, it was
not.
Defendants' Attorney: There's
never been any evidence she's ever had any metastatic melanoma,
correct?
Dr. Sober: That's
correct.
Defendants' Attorney: She had the
definitive procedure in February 2002 [sic 2001], correct?
There was a pause for clarification of
dates.
Dr. Sober: Correct.
Defendants' Attorney: She's not
had a relapse since then, has she?
Dr. Sober: She has not.
Defendants' Attorney: I want to
talk a little bit about how this all works. As I understand, the idea is, if
there's a tumor, a melanoma, the idea is to do the definitive procedure and get
the tumor out before it metastasizes, correct?
Dr. Sober: Correct.
Defendants' Attorney: And by
metastasis, we're talking about, this is laymen's language, [the melanoma] sends
out cells throughout the body, [and] those are called metastasis [sic,
metastases], correct?
Dr. Sober: That's
correct.
Defendants' Attorney: And they can
land in the lungs or they can be in the liver or they can actually move through
the body and come back and end up at the same spot they were taken out,
correct?
Dr. Sober: That can occur. Much
more rare event than the other possibilities, but yes it can occur.
Defendants' Attorney: That's
referred to as true local recurrence when you've got the original tumor and for
some reason it comes back at the same site, correct?
Dr. Sober: Actually we're going to
probably, you and I, have a problem with the definition of local recurrence
because there were different people using true local recurrence in different
ways. Some people use true local recurrence to mean the situation like Jane Doe,
where tumor was least [sic, left] behind, [and] tumor regrew. That's a true
local recurrence. It wasn't from a metastatic event. And other people call that
persistent tumor and not true local recurrence, and use true local recurrence to
suggest a—either a satellite in[-]transient metastasis, which is tumor going up
the channel from the original tumor, or this really rare tumor which you were
indicating where the tumor went through the bloodstream and came back and
lodging in the scar, which is a very uncommon event, but thought to occur
because the scar itself is an area where there's vulnerability, called locus
minoris resistentiae. So you guys know Latin, so you tell them what it
means.
Comment: Dr. Sober makes clear the distinction
between what he calls "a true local recurrence," which is persistence of a
primary melanoma at the original site, and "not true local recurrence," which is
metastasis of melanoma. Dr. Sober acknowledges, repeatedly, that Jane Doe had a
"persistence," not a metastasis, but, nonetheless, he bases his judgment about
her prognosis on a graph shown in Figure 8 [Figure 23.5 of the 2nd edition of
the Balch book, Cutaneous Melanoma, see above] that deals with the effects of
metastatic melanoma, not persistence of a primary melanoma. That maneuver was
essential to the plaintiff's case; without it there was no case against Drs.
Bentley and Schott because there was no causation, i.e., no injury was done to
the patient by virtue of an error in diagnosis because the prognosis of the
patient was good.
Dr. Sober: As best we can tell,
this is regrowth from tumor left behind at the edge of the excision in
1999.
Defendants' Attorney: It was that
primary tumor, and that's what I'm getting to, the primary tumor that regrew as
opposed to a tumor that came because metastasis went through the body and ended
up back at the same spot?
Dr. Sober: You and I agree a
hundred percent.
Defendants' Attorney: So the
problem is sometimes true local recurrence equals metastasis and sometimes it
doesn't, correct?
Dr. Sober: That's
correct.
Defendants' Attorney: And we know
that patients who have metastasis, that's not a good thing, correct?
Dr. Sober: That's
correct.
Defendants' Attorney: And patients
that have persistence like Jane Doe have not had metastasis, correct?
Dr. Sober: They have not had
metastases that have been demonstrated.
Defendants' Attorney: As far as we
know?
Dr. Sober: As far as we
know.
Defendants' Attorney: And that's
why they did the operation to take out these sentinel nodes on either arm was to
assure, as best medical science can, that she doesn't have metastasis,
correct?
Dr. Sober: That's
correct.
Comment: Dr. Sober could not be more clear: Jane
Doe had a persistent melanoma, not a metastatic melanoma, yet he predicated his
prognosis for her on a graph that concerns metastatic melanoma, which Jane Doe
did not have and Dr. Sober acknowledged she did not
have.
Defendants' Attorney: Doctor,
this is page – I think it's 282. And it's not as focused as I'd like it to be.
But -- 292 in your book, correct?
Dr. Sober: That's
correct.
Defendants' Attorney: And so the
jury—I want the jury to understand what you did in rendering your opinions here
today. And I want to do a little compare and contrast. First of all, we're
talking about ninety-five patients, that's it, correct?
Dr. Sober: That's
correct.
Defendants' Attorney: Not exactly
what we call a big sample of patients, fair statement?
Dr. Sober: Fair
statement.
Defendants' Attorney: In fact,
we've talked about the AJCC, the American Joint Commission on Cancer,
correct?
Dr. Sober: Correct.
Defendants' Attorney: That had
over seventeen thousand patients in it, fair statement?
Dr. Sober: Fair
statement.
Defendants' Attorney: Medical
thought or scientific thought that the larger the group sampling, the more
likely the results are to be accurate?
Dr. Sober: That's
correct.
Defendants' Attorney: Well, let's
talk about these ninety-five patients. Of these ninety-five patients, I think
you said on direct some may be like Jane Doe and some may not be like Jane Doe,
correct?
Dr. Sober: That's
correct.
Defendants' Attorney: All right.
Dr. Sober: May I make a
suggestion? I think for the jury's benefit we ought to tell them what's—what's
on this graph.
Defendants' Attorney: I'm going to
get to that, Doctor, honest.
Dr. Sober: I'm sorry.
Defendants' Attorney: I want to do
it one step at a time. I'm concentrating right now on these ninety-five
patients. Of course this was done what, some time in the late '80's, these two
studies?
Dr. Sober: That's
correct.
Defendants' Attorney: And we know
some of these patients had metastasis, correct?
Dr. Sober: That's
correct.
Defendants' Attorney: And that
means that the tumor was removed after it had already sent these evil cells out
into the body, correct?
Dr. Sober: That's
correct.
Defendants' Attorney: We've got no
evidence of that in Jane's case, do we?
Dr. Sober: We do not.
Defendants' Attorney: It's your
testimony that some of these patients may have been like Jane,
correct?
Dr. Sober: That's
correct.
Defendants' Attorney: And I don't
mean to be too casual. I've been referring to Jane for a year. I don't mean to
be disrespectful to Miss Doe. Of that ninety-five, Doctor, how many were like
Jane Doe?
Dr. Sober: I do not
know.
Defendants' Attorney:
One?
Dr. Sober: I can't tell
you.
Defendants' Attorney: Equally
possible it could be zero, correct?
Dr. Sober: It is
possible.
Defendants' Attorney: In fact,
Doctor, of those ninety-five patients, if they all had metastatic disease, that
would not be comparable to what Jane Doe had, correct, or has?
Dr. Sober: No, it would
not.
Defendants' Attorney: It would not
be comparable or would be?
Dr. Sober: If all of these
patients had metastatic disease, then they would represent only one of the two
categories listed at the beginning of the chapter for local recurrence. The
definition at the beginning of this chapter includes patients like Jane Doe with
persistent tumor left behind.
Defendants' Attorney: I'm not
arguing about that. All right, Doctor. What I'm arguing about is some of these
people that have tumor left behind have a tumor that persists, they don't—it
didn't get into their system, correct?
Dr. Sober: That's
correct.
Defendants' Attorney: And that's
like Jane Doe. It didn't get into her system as best we know,
correct?
Dr. Sober: Correct.
Defendants' Attorney: Whereas,
these ninety-five patients, your opinion is the majority of them have had
metastatic disease, correct?
Dr. Sober: That's
correct.
Defendants' Attorney: Got into
their system, they got the tumor too late, is that correct?
Dr. Sober: That's
correct.
Defendants' Attorney: Unlike Jane,
correct, as best we know?
Dr. Sober: Correct.
Defendants' Attorney: So what this
basically says is, and I wanted to make sure we're fair, that graph is a
representation of what these ninety-five patients experienced,
correct?
Dr. Sober: That's
correct.
Defendants' Attorney: And you'll
tell this jury, being completely honest, you have no idea if even one person in
that cohort, in that group of ninety-five were like Jane Doe?
Dr. Sober: That's
correct.
Comment: Dr. Sober, yet again, acknowledges the
fact that Jane Doe's melanoma is a persistent primary, not a metastasis. He
admits further that the study he relied on as the basis for prognosis (the 2nd
edition of the Balch book) mixes apples and oranges, i.e., 95 patients, some
possibly with persistent primary melanoma but others surely with metastatic
melanoma—two entirely different situations, the first being associated at times
with a very favorable prognosis (as is the case for Jane Doe) and the second
being a sign of a grave prognosis. Moreover, Dr. Sober admits there is no way to
know, from the study cited in Figure 8 (Figure 23-5 of the 2nd edition of the
Balch book Cutaneous Melanoma, see above), how many melanomas of each type were
represented in the study that served as the basis for his opinion concerning the
prognosis of Jane Doe. In spite of this, Dr. Sober still concludes that her
prognosis is poor, his opinion being based on a study that is flawed
irreparably.
Page
94
Defendants' Attorney: And there's
no such publication to describe those ninety-five patients you relied on for
your opinions here today, is there?
Dr. Sober: That's
correct.
Defendants' Attorney: You're just
guessing at those ninety-five, aren't you, Doctor?
Plaintiff's Attorney: Object to
the question.
The Court: Overruled.
Plaintiff's Attorney: He's not
guessing at it.
Defendants' Attorney: I'll
rephrase. As to how many are like Jane and how many aren't, the best you can do
is guess?
Dr. Sober: That's
correct.
Comment: Dr. Sober could not have been more clear;
his entire opinion is predicated on an unpublished study of 95 patients,
referred to only in a graph in the 2nd edition of Balch's text. That data mixed
patients with persistent primary melanoma and patients with metastatic melanoma,
but Dr. Sober treated the data as if the population of patients were one and the
same. This enabled him to allege a dismal prognosis for Jane Doe, whose
prognosis, in fact, is very good.
Page
98-99
Plaintiff's Attorney: Okay. Tell
the jury why you used the chart that you did use from the Balch book to offer
your opinions within reasonable medical certainty?
Dr. Sober: Local recurrence is a
[sic, an] uncommon event. And the reason there were only ninety-five cases from
two large centers is that they didn't have more data than that. I would love to
see a series on local recurrence with eight hundred and forty-four patients like
the Kelly paper that [the Defendant's Attorney] referred to. I would also like
to see a paper that separates out patients that have persistent tumor, that is,
tumor that's removed but a portion of the tumor is left behind and regrows. I
would like to see the outcome of a large series of patients with that set of
characteristics versus the ones where there is lymphatic and hematogenous
metastasis to know what the differences are, if there are differences, with the
highest degree of reliability that we can have. I don't think there's ever going
to be a series like that, because cases—patients like Jane Doe where a tumor has
been misdiagnosed and allowed to remain in the patient are fortunately rare. So
I don't think we're going to have that data. So my opinion is based on a chart
of ninety-five patients with local recurrence, admittedly, the majority of whom
have a metastatic event, but done by people who have defined local recurrence to
include both the persistence and the metastatic categories.
Plaintiff's Attorney: And Jane
falls into the persistent category?
Dr. Sober: She falls into the
group where tumor was left behind and regrew, correct.
Plaintiff's Attorney: And that's
why you used that table?
Dr. Sober: That is
correct.
Plaintiff's Attorney: You're
comfortable using that table?
Dr. Sober: As best I can
be.
Plaintiff's Attorney: Your
reputation you put behind it?
Dr. Sober: I have to.
Plaintiff's Attorney: And this is
within reasonable medical certainty?
Dr. Sober: Yes.
Plaintiff's Attorney: Thank you
very much.
Comment: The game is transparent. Dr. Sober knows
that the word "recurrence" is used in two completely different ways, to wit,
"persistence" and "metastasis." He is compelled to acknowledge that Jane Doe's
melanoma is a persistence because there is no evidence at all of metastatic
disease. But in order to prop-up the case for the plaintiff, he introduces the
concept of "local recurrence," used by Balch et. al., in the 2nd edition of
their text, as a synonym for metastasis, and then takes that confusing notion to
its illogical conclusion, namely, Jane Doe has metastatic melanoma and her
prognosis is grim. A jury might be fooled by this "fancy footwork," but
colleagues knowledgeable about melanoma are not. In this instance, the jury was
not deceived either.
Page
104-106
Plaintiff's Attorney: Do you have
an opinion within reasonable medical certainty as to whether that graph should
be used in Jane's case to predict her survivability?
Dr. Sober: As I indicated earlier,
I felt that because she had a recurrent tumor, that you could not simply use
that graph as it appeared. And I believe Dr. Hurt in his deposition is of the
same mind in that regard.
Comment: Dr. Hurt (defendant and expert witness for
the defense) never stated that Jane Doe had a grim prognosis, certainly not one
of near 40% survival for five years or 20%-30% survival for ten
years.
Plaintiff's Attorney: I don't
think I have anything else.
The Court: Anything
else?
Defendants' Attorney:
Yes.
Recross
Examination
Defendants' Attorney: So I
understand what you did then, instead of using the graph with all these patients
in it with the studies to back it up, you went to a study that you have no idea
if any of the patients are like Jane Doe. That's what you did, isn't it,
Doctor?
Dr. Sober: I don't believe I would
characterize it that way, no.
Defendants' Attorney: I'm sure you
wouldn't. But the fact of the matter is, you don't know if one of those patients
is like Jane Doe in that ninety-five—ninety patients you looked at?
Dr. Sober: That's
correct.
Redirect
Examination
Plaintiff's Attorney: How would
you characterize it?
Dr. Sober: How would I
characterize what?
Plaintiff's Attorney: You said in
response to [the defendants' attorney] question that's not how I would
categorize it—characterize it rather.
Dr. Sober: I believe that having
worked in this field for twenty-nine years and having taken care of a fairly
high number of patients with melanoma, I have come to the mind that having
disease left behind when you didn't get it out the first time is not a good
thing. And so it's hard for me to believe that those very high figures of
prognosis are the ones that are more correct than the figures that I presented
for local recurrence.
Plaintiff's Attorney: Thank
you.
Defendants' Attorney: I have no
other questions, Your Honor.
Comment: Dr. Sober averred that "having disease
left behind when you didn't get it out the first time is not a good thing" and
no one would disagree with that statement. However, that was not, and is not,
the issue. Dr. Sober concludes by declaring, "And so it's hard for me to believe
that those very high figures of prognosis [the figures set forth by all of the
expert witnesses who testified for the defense] are the ones that are more
correct than the figures that I presented for local recurrence." And neither is
that the issue. The core of the matter was the deception of Dr. Sober in
attempting to boggle a jury by making it believe that persistent melanoma was
metastatic melanoma and conning it into believing the patient likely was
doomed.
Verdict: In favor of the
defense.
Post
Script:
It should be noted here that the topic of "true
local recurrence" was not discussed in the 2nd edition of the Balch book, the
book on which Dr. Sober relied for his testimony. However, Dr. Sober should have
felt obligated to point out that in chapter 9 of the 3rd edition of the Balch
book on Cutaneous Melanoma, published in 1998, and of which he [Dr. Sober] also
was coeditor (Charles M. Balch, Alan N. Houghton, Arthur J. Sober, and Seng-jaw
Soong), there is a reference, on page 160 (Figure 9), to an article (reference
13 in the 3rd edition of the Balch book) by Brown and Zitelli in 1995 (Brown CD,
Zitelli JA. The prognosis and treatment of true local cutaneous recurrent
malignant melanoma. Dermatol Surg 1995 Apr;21(4):285-90). In that article, the
authors discussed the differences between a "true local recurrence" and a "local
recurrence," defining "true local recurrence" as "the reappearance of malignant
melanoma, bearing an in situ component, within or immediately adjacent to the
scar from excision of the primary tumor." In other words, those coworkers
studied persistent primary melanomas, not metastatic melanomas. The purpose of
their study was to "describe the prognosis and treatment of 50 patients with
local cutaneous recurrent melanoma due to retention of the primary tumor as a
result of incomplete excision." That was the situation of Jane Doe.
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Fig.
9: This is the definition of "true local recurrence" as set forth on
page 160 in Chapter 9 by Karakousis, Bartolucci, and Balch from the 3rd edition
of Cutaneous Melanoma, edited by Balch, Houghton, Sober, and Soong and published
in 1998. Note that "true local recurrence" is a synonym for persistent primary
melanoma and note also that the authors acknowledge an excellent prognosis for
it, in contrast with a dismal prognosis for metastatic melanoma. Jane Doe had a
persistence of melanoma, not a metastasis of
melanoma. |
Brown and Zitelli found that "The Kaplan-Meier
5-year overall and melanoma survival rates were 89% and 98%, respectively."
Figure 10 (Figure 1 from the article by Brown and Zitelli) is a graph of 5-year
survival that conveys, unmistakably, an excellent prognosis for patients with
persistent primary melanomas. That conclusion is drastically different (98%
versus 37% five year survival) from the one alleged by Dr. Sober based on Figure
8 (Figure 23-5 of the 2nd edition of the Balch book), the reason being that
whereas Brown and Zitelli addressed the matter of true persistence of melanoma,
Dr. Sober, improperly, dealt with the issue of metastatic melanoma. Jane Doe had
persistent melanoma, not metastatic melanoma.
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Fig.
10: This is Figure 1 from the article by Brown and Zitelli (Brown CD,
Zitelli JA. The prognosis and treatment of true local cutaneous recurrent
malignant melanoma. Dermatol Surg 1995 Apr;21(4):285-90). All of the patients
had persistent primary melanoma, i.e., "true local recurrence," and were
followed for a period of 5 years. The prognosis is excellent, 98% survival, not
37%, as was claimed to be the prognosis for Jane Doe by Dr. Sober. Res ipsa
loquitur! |
Invitation by the author: As a
matter of courtesy, professionally and academically, an offer is extended to Dr.
Sober to publish a comment or rebuttal by him in regard to the facts and
opinions expressed in this article.
Permission has been granted by publishers for
reproduction of materials that appear in this essay.
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