NOT FOR PUBLICATION WITHOUT THE
APPROVAL OF THE APPELLATE DIVISION
SUPERIOR COURT OF NEW JERSEY
APPELLATE DIVISION
DOCKET NO. A-6357-00T1
DAVID L. ROSENBERG, deceased, by
RITA B. ROSENBERG, Executrix and
Administratrix ad Prosequendum
of the Estate of DAVID L.
ROSENBERG, deceased, and RITA B.
ROSENBERG, individually,
Plaintiffs-Appellants,
v.
RANJANA TAVORATH, M.D., MEMORIAL
SLOAN-KETTERING CANCER CENTER AT
NORTHWEST COVENANT MEDICAL CENTER,
NORTHWEST COVENANT MEDICAL CENTER,
and MEMORIAL SLOAN-KETTERING
PHYSICIANS AT NORTHWEST COVENANT
MEDICAL CENTER,
Defendants-Respondents.
..............................
Argued: June 5, 2002 - Decided: June 27, 2002
Before Judges Newman, Fall and Axelrad.
On appeal from the Superior Court of New
Jersey, Law Division, Essex County, ESX-L-
6783-98.
Adrian I. Karp argued the cause for
appellants.
Peter L. Korn argued the cause for respondents
(McDonough, Korn & Eichhorn, attorneys; Mr.
Korn of counsel; William S. Mezzomo, on the
brief).
The opinion of the court was delivered by
AXELRAD, J.T.C. (temporarily assigned).
Plaintiff, Rita B. Rosenberg, the executrix and administratrix
ad prosequendum of the estate of her deceased husband, David L.
Rosenberg, appeals from the grant of an involuntary dismissal of
the complaint at the close of plaintiff's case. The judge ruled
that plaintiff's expert failed to delineate a standard of care or
a departure from any standard, or that any alleged deviation of
care was a proximate cause of decedent's death.
Decedent, a former smoker, suffered from laryngeal cancer,
specifically stage III squamous cell carcinoma, which is treatable.
In November 1997, he was referred to Dr. Elliot Strong, a cancer
surgeon specializing in head and neck surgery, at Memorial Sloan-
Kettering Cancer Center ("MSKCC") in New York City. Dr. Strong
recommended treating the disease with two to three cycles of
chemotherapy, a few weeks apart, and then determining what the
results were in terms of shrinking the cancer which could then be
radiated, as an alternative to surgery, in order to preserve the
patient's larynx and ability to speak. In the event the prescribed
course of treatment was not effective, Mr. Rosenberg would have the
option of undergoing surgery for the removal of his larynx and the
placement of a prosthetic voice box.
As Dr. Strong did not have anything to do with determining
which chemotherapy drugs were used or the dosage, and he did not
manage patients on chemotherapy, he referred Mr. Rosenberg to Dr.
Karen Schupak, a radiation therapist who practiced at MSKCC's
"satellite facility" at Northwest Covenant Medical Center
("Northwest") in Denville, New Jersey, which was closer to
decedent's home. Dr. Schupak referred Mr. Rosenberg to defendant,
Ranjana Tavorath, M.D., a board-certified medical oncologist also
practicing at MSKCC's Northwest satellite facility.
In accordance with MSKCC's larynx preservation protocol ("LP
protocol"), which sets forth the dosages and schedules for
administering the chemotherapy, Dr. Tavorath's plan of treatment
involved administering two cycles of chemotherapy, containing a
combination of cisplatin and fluorouracil, over a three-to-four-
week schedule. Every record of treatment by Dr. Tavorath was sent
to both Drs. Strong and Schupak. Mr. Rosenberg was administered
out-patient chemotherapy treatment over a five-day period beginning
on December l7. Thereafter, he experienced complications including
nausea, high fever, severe diarrhea, low blood count, and
dehydration requiring his hospitalization from December 28 through
January 2, 1998. During this hospitalization, he was treated by
Dr. Ephraim S. Casper, Dr. Tavorath's supervisor and the Chief of
MSKCC's site at Northwest.
On January 6, 1998, Dr. Tavorath evaluated Mr. Rosenberg for
his second cycle of chemotherapy. She determined he was
substantially recovered from the prior toxicities and administered
an identical second round of chemotherapy beginning the next day
through January ll, 1998.
On January 17, 1998, due to a 104° fever, Mr. Rosenberg was
treated in the emergency room and placed on a respirator, before
being admitted to the intensive care unit for management of what
appeared to be a sepsis syndrome. He was diagnosed as suffering
from "chemotherapy-induced neutropenic fever . . . complicated by
dehydration" and septic shock. Despite treatment, his condition
worsened. On January 19, 1998, decedent died as a result of septic
shock, induced by chemotherapy neutropenia and toxicity, which
caused multiple organ failure.
Plaintiff brought the instant medical malpractice action
against Dr. Tavorath, MSKCC and Northwest, and fictitiously
pleaded MSKCC doctors, seeking to recover damages for her
husband's injuries, pain and suffering, and wrongful death, among
other things, arising from the alleged malpractice of defendant
Tavorath in failing to properly monitor decedent's response to
chemotherapy and in failing to properly treat the complications
which resulted from the treatment.
Plaintiff's theory at trial, as presented by her expert, Luis
Villa, M.D., was that Tavorath's negligence in failing to modify
the second course of chemotherapy caused decedent's death.
Plaintiff also asserted that Dr. Tavorath violated MSKCC's LP
treatment protocol which required a "team approach" by Drs. Strong,
Schupak and Tavorath in evaluating her husband's condition after
each cycle of chemotherapy, and that such violation was evidence of
negligence. The claims against MSKCC and Northwest were brought
under the theory of respondeat superior. The first three counts
alleged a wrongful death and survival action against Tavorath,
MSKCC, and Northwest, respectively. The fourth count sought
damages for decedent's pain and suffering. The fifth count alleged
the negligence of various fictitiously pleaded tortfeasors pending
amendment of the complaint to reflect their true identities. The
sixth count sought damages for loss of consortium.
A jury trial was conducted before the Law Division on several
dates between June 5 and June 11, 2001. Plaintiff and her adult
son Stuart testified, along with Dr. Villa and an economist, Dr.
Marcus. Plaintiff's counsel also read into the record the
deposition testimony of Drs. Strong, Tavorath, and Casper.
Following the close of plaintiff's evidence on liability, but
prior to testimony on damages, defendants moved for an involuntary
dismissal on the ground that Dr. Villa's testimony was insufficient
to establish a prima facie case of medical malpractice because: (1)
he offered only his net opinion on the appropriate standard of care
unsupported by reference to any medical literature or case studies;
(2) he testified that there was no standard of care regarding dose
modification, or, that it ranged from a 5% to 25% modification and,
therefore, his testimony was too imprecise and lacking in
parameters to assist the jury; and (3) his testimony on proximate
cause was lacking because he did not supply "some percent . . . in
reasonable medical probabilities" demonstrating that a dose
reduction would have influenced the outcome.
Following oral argument, the trial court granted defendants'
motion. A judgment dismissing the complaint was entered in
accordance with the court's decision on June 25, 2001.
On appeal, plaintiff alleges that the court erred in
dismissing the complaint because: (1) the testimony of her expert
was sufficient to make out a prima facie case of medical
malpractice for submission to the jury; and (2) the court failed to
rule on plaintiff's "preserved claim" that Tavorath's violation of
MSKCC's treatment protocol constituted negligence.
I.
As to the first issue on appeal, plaintiff argues that the
court erred in finding that Dr. Villa: (1) failed to establish a
standard of care because he did not specify the basis of his
opinion that dose modification was required and, by implication,
that he offered only a "net opinion;" (2) failed to establish
proximate cause because he did not precisely quantify the
appropriate dose reduction and its corresponding effect on
toxicity; and (3) exceeded the scope of his written report and
deposition testimony in testifying that even a 5% reduction would
have satisfied the standard of care. According to plaintiff, Dr.
Villa established a standard of care, a deviation therefrom, and
proximate cause, premised upon his own training and experience as
an oncologist, and supported by reference to decedent's hospital
records and articles authored by Dr. Marshall Posner, defendants'
expert. In addition, plaintiff asserts that Dr. Villa did not
testify outside his area of expertise or exceed the scope of his
report or deposition testimony. Plaintiff further argues that Dr.
Villa was not required to quantify his opinion that a dose
reduction would have lessened the severity of the toxic effects of
the chemotherapy since he explained why it was not possible to do
so. Based on our review of the record and applicable law, we
conclude that Dr. Villa's testimony was sufficient to submit the
case to the jury. Furthermore, the trial judge did not rule on
plaintiff's "preserved claim" that Tavorath's violation of MSKCC's
treatment protocol constituted negligence. Accordingly, we reverse
the judgment and remand the case for a new trial on all issues.
The trial court accepted Dr. Villa as a qualified expert in
oncology. Dr. Villa opined that, based upon his review of
decedent's hospital records, Dr. Tavorath deviated from the
accepted standards of oncology in treating decedent by failing to
reduce the dosage of the second round of chemotherapy. Plaintiff's
expert maintained that decedent's death from the complications of
chemotherapy was entirely avoidable had the second cycle been
modified. According to Dr. Villa, the deviation occurred when Dr.
Tavorath failed to recognize that the significant toxicity suffered
by decedent following the first cycle of chemotherapy warranted a
dose modification for the second cycle. Dr. Villa opined that a
dose modification of about 10% to 25% would have avoided or
lessened the severity of some of the complications decedent
experienced after his first cycle; however, without having examined
decedent, he could not say what the precise dose modification
should have been.
Dr. Villa further testified that the initial dose of any
chemotherapeutic drug is determined by reference to protocols which
take into account a patient's height, weight, and body area, but
that any subsequent dosage must be determined based upon the
individual patient's response and the doctor's experience, taken
together with the protocols. Where a patient has a response that
is "far too toxic," an adjustment must be made where there are
unacceptable or life-threatening side-effects.
Dr. Villa testified as to several toxic reactions and
complications suffered by decedent following the first cycle,
including neutropenia, which was confirmed by the drop in his white
blood cell count from normal levels to very low levels, and left
the patient with no protection against bacterial infection;
reduction in appetite and significant weight loss; severe diarrhea;
mucositis, which causes sores to develop in the protective mucus
linings of the nose, mouth, and anus, thereby allowing bacteria to
enter the body; and bowel "ileus," a chemotherapy-induced injury
to the electrical mechanism of the bowel interfering with bowel
movements. According to Dr. Villa, based upon the totality of all
these toxicities, Dr. Tavorath should have realized that
administration of a second identical course of chemotherapy was
likely to cause a greater toxicity resulting in more serious
complications or even death, and then used her judgment as an
oncologist to modify the dose appropriately. Dr. Villa concluded,
within a reasonable degree of medical probability, that the
administration of the second cycle of chemotherapy at the identical
dosage as the first cycle, proximately caused decedent's death.
When pressed by defense counsel on cross-examination to
quantify the appropriate dose reduction in decedent's case, Dr.
Villa stated that the purpose of his testimony was not to establish
the exact dosage or to prove that Tavorath was not well-qualified,
but simply to demonstrate that "a change should have been made . .
. and if . . . Tavorath had made a five percent change," Dr. Villa
would not have testified on plaintiff's behalf even if decedent had
died.
Dr. Villa testified regarding his familiarity with the
chemotherapy drugs administered to decedent. However, he admitted
that he was not familiar with the details of MSKCC's protocol
regarding "the measurements that are used to make certain clinical
decisions." Dr. Villa, however, maintained that given the
"significant toxicity" suffered by decedent as a result of the
first cycle of chemotherapy, the "majority of clinical oncologists"
would have modified the second dose based upon decedent's clinical
presentation evincing a "severe toxicity" after the first course of
chemotherapy.
In granting defendants' motion, the trial court stated in
pertinent part:
A fair reading of the doctor's [Villa's]
testimony, giving all inferences to the
plaintiff, suggests that the doctor found that
Dr. Tavorath deviated because she failed to do
something in connection with reduction of
dosage following Mr. Rosenberg's
hospitalization between the first and second
doses of chemotherapy.
When it came to quantification, the
doctor had testified in his depositions on one
occasion that the standard would require a
dosage modification of ten to 15 percent with
a higher dosage modification if there were
problems between the second and the third
rounds of chemotherapy.
And at another point in his testimony at
deposition -- and this was all brought out at
trial -- he said that one should start on the
second round at a 25 percent reduction. And
then if there was a good reaction, then
perhaps there could be a lesser reduction in
the third round to the ten to 15 percent
level.
The doctor then went further -- and this
was clearly beyond anything that he said in
his deposition -- to say that if Dr. Tavorath
had reduced the dosage of chemotherapy . . .
[by] five percent that he would not have been
there, that there would be no negligence under
the circumstances regardless of whether Mr.
Rosenberg had died or had not died. By doing
so, Dr. Villa set up a standard of care that
had no precise quantification and, in essence,
was that so long as some form of modification
occurred, that would be sufficient.
For that reason, the standard of care
established by Dr. Villa is not one that can
be easily followed in any respect because it
is not one that establishes for a clinician
what it is that needs to be done, or what
signs and symptoms would allow a person to
make a reasoned choice between various [chemo]
therapeutic modification[s] . . . .
In addition to not establishing a standard for
the dose modification, the doctor did not in
any sense specify what the criteria were that
would permit a doctor to determine [by] how
much a dose should be modified. He gave the
opinion that because Mr. Rosenberg had been
hospitalized and had suffered significant
toxicity leading to that hospitalization,
there must be a modification.
He said further that the modification
needed to be based on an assessment of the
individual as a whole person, that he
[decedent] was the book . . . . But he did not
say, for instance, that a combination of white
blood cells at a certain rate and a certain
amount of diarrhea, and a certain amount of
vomiting, if that occurred, or a certain
amount of mucositis would permit a doctor to
conclude that . . . it was necessary to have a
five percent reduction or a ten percent
reduction or a 15 or 20 percent reduction.
And in that respect, he did not provide any
clinical correlation to the sliding scale that
he presented for dose modification . . . .
[H]e, likewise, did not establish any
basis on which one could determine that his
undefined clinical assessment and sliding
scale dose modification was based either on
his own experience or on the experience of
practitioners with whom he had consulted. He
did not testify in any respect with regard to
his own patients.
And he acknowledged during voir dire that
he had seen relatively few patients who had
laryngeal cancer and had been treated with
larynx sparing chemotherapy and radiation. He
did not testify in any respect to
conversations with people outside his own
practice. And he testified with respect to
his own practice that there was no standard
among doctors that he practiced with as to
what signs and symptoms would lead to the need
for a particular dose modification.
On that basis, I find not only that an
inadequate standard was set, but also that the
standard that was utilized was not
demonstrated to be one that was accepted
within the medical community. Indeed, what
the doctor appears to have done is some form
of post-hoc analysis saying that because he
died, something should have been done.
Even if I were to find the standard
adequate, and if I were to find that it was
sufficient under these circumstances to say
that because a person has been hospitalized
for four days in an era in which
hospitalizations are increasingly rare, that a
dose modification was required, and so long as
some modification took place that no deviation
would occur . . . I still cannot find that Dr.
Villa has established a factual basis for a
jury to determine that the conduct of Dr.
Tavorath was a proximate cause of the death of
Mr. Rosenberg.
In that regard, I would note that by
concession of the plaintiff's attorney, what
we're dealing with is a but for causation
situation. What I have on causation is . . .
Dr. Villa's testimony that if the dose had
been reduced [by] 25 percent, there would have
been a significant reduction in toxicity, and
anything less than that would have been . . .
risky.
He testified further that a dose
reduction of ten to 15 percent would have had
substantial toxicity, but he felt that it
would not be . . . lethal. He did not express
that opinion with any great certainty and, in
fact, said that there was considerable
guesswork involved in stating what he did say.
Giving the plaintiff the benefit of the doubt,
he said in the trial testimony that that would
be educated guesswork. In his deposition, he
simply said that he was guessing.
There was no testimony whatsoever with
respect to the consequences of a five percent
reduction in the dosage of the
chemotherapeutic agents utilized in this case.
And for that reason, the jury would have no
basis on which to conclude that . . . a
failure to reduce chemotherapy by five percent
was a proximate cause of Mr. Rosenberg's
death.
. . . .
My determination is based on the science as I
see it to have been presented to me through an
expert.
And . . . the science was
insufficient.
Pursuant to Rule 4:37-2(b), "[a]fter having completed the
presentation of the evidence on all matters other than the matter
of damages . . . the defendant . . . may move for a dismissal of
the action . . . on the ground that upon the facts and upon the law
the plaintiff has shown no right to relief." "[S]uch motion shall
be denied if the evidence, together with the legitimate inferences
therefrom, could sustain a judgment in plaintiff's favor." Ibid.
In determining a motion for an involuntary dismissal, the
trial court must accept as true all the evidence which supports the
plaintiff's position and must accord that party the benefit of all
legitimate inferences which can be deduced therefrom; if reasonable
minds could differ the motion must be denied. Dolson v. Anastasia,
, 5-6 (1969). The court is not concerned with the "worth,
nature or extent (beyond a scintilla) of the evidence, but only
with its existence . . . ." Ibid.
To establish a prima facie case of negligence in a medical
malpractice action, a plaintiff usually must present expert
testimony to establish the relevant standard of care, the doctor's
breach of that standard, and a causal connection between the breach
and the plaintiff's injuries. Estate of Chin v. St. Barnabas Med.
Ctr.,
, 469 (1999). Absent competent expert proof of
these three elements, the case is not sufficient for determination
by the jury. Sanzari v. Rosenfeld,
, 134-35 (1961);
Parker v. Goldstein,
, 484 (App. Div.) certif.
denied,
(1963).
The court qualified Dr. Villa as an expert in oncology
following an extensive voir dire. However, in granting defendants'
motion for an involuntary dismissal after Dr. Villa testified, the
court determined that Dr. Villa's opinion was suspect because he
acknowledged, among other items, that "he had seen relatively few
patients who had laryngeal cancer and had been treated with larynx
sparing chemotherapy and radiation." In reaching this conclusion,
the trial judge intruded on the function of the jury to determine
the credibility and probative value of the expert's testimony.
A physician has a duty to exercise in the treatment of his or
her patient the degree of care, knowledge and skill ordinarily
possessed and exercised in similar situations by the average member
of the profession practicing in his or her field. Schueler v.
Strelinger,
, 344 (1964). In Sanzari, supra, 34 N.J. at
136, the Supreme Court stated that "the license to practice imports
the minimal technical training and knowledge essential to the
expression of a meaningful and reliable opinion." While it is true
that "mere possession of a license to practice medicine does not
without more conclusively establish the physician's competency to
testify in a malpractice case . . . [h]is license to practice at
least imports some general competency to testify on all medical
subjects." Carbone v. Warburton,
, 424-25 (1953).
Having graduated from Harvard Medical School in 1970, and having
obtained board certifications in six subspecialties, including
oncology, Dr. Villa clearly possessed the minimum training and
knowledge essential to the expression of an opinion on the subject
of the professional standards applicable to chemotherapy treatment
sufficient to withstand a motion for involuntary dismissal.
In addition to what is implied by a license to practice, Dr.
Villa was qualified to offer his expert opinion on the basis of
occupational experience or knowledge acquired over a period of
years. Bellardini v. Krikorian,
, 463 (App.
Div. 1988); Correa v. Maggiore,
, 282 (App. Div.
1984). As it is said, "[a] witness may be qualified to testify as
an expert either 'by study without practice or by practice without
study.'" State v. Chatman,
, 41 (App. Div.),
(quoting State v. Smith,
, 334 (1956), certif. denied,
(1978)). Although Dr. Villa treated only about six or
seven patients for "head-neck" cancer, he saw sixty to seventy
oncology patients in his office per week and treated oncology
patients with chemotherapeutic drugs for twenty years. Plaintiff
demonstrated Dr. Villa's competence to offer an opinion concerning
the standard of care in treating a patient with laryngeal cancer
who had experienced chemotherapy toxicity. "Any [perceived]
deficiencies in his qualifications should have been left to the
consideration of a jury 'to determine the credibility, weight and
probative value of the expert's testimony.'" James v. City of East
Orange,
, 563 (App. Div. 1991) (quoting Rubanick
v. Witco Chem. Corp.,
, 48 (App. Div. 1990),
modified on other grounds,
(1991)).
In addition to determining whether a witness is qualified to
testify as an expert, the trial court must also decide the closely
related issue as to whether the expert's opinion is based on facts
and data. Biunno, Current N.J. Rules of Evidence, comment 2 on
N.J.R.E. 702 (2002). As construed by applicable case law, N.J.R.E.
703 requires that an expert's opinion be based on facts, data, or
another expert's opinion, either perceived by or made known to the
expert, at or before trial. Buckelew v. Grossbard,
,
524 (1981); Nguyen v. Tama,
, 48-49 (App. Div.
1997). Under the "net opinion" rule, an opinion lacking in such
foundation and consisting of bare conclusions unsupported by
factual evidence is inadmissible. Johnson v. Salem Corp.,
, 91 (1984); Buckelew, supra, 87 N.J. at 524. The rule requires
an expert "to give the why and wherefore" of his or her opinion,
rather than a mere conclusion. Jimenez v. GNOC, Corp.,
cite=286%20N.J.Super.%20533">286 N.J.
, 540 (App. Div.), certif. denied,
(1996).
In this regard, the trial court found:
[Villa] did not testify in any respect to
conversations with people outside his own
practice. And he testified with respect to
his own practice that there was no standard
among doctors that he practiced with as to
what signs and symptoms would lead to the need
for a particular dose modification.
Thus, the court concluded that "the standard that was utilized was
not demonstrated to be one that was accepted within the medical
community," the implication being that Dr. Villa offered a net
opinion, or an opinion that was personal to him.
We disagree. Dr. Villa was competent to testify and offer an
opinion regarding treatment of laryngeal cancer with chemotherapy.
Accepting as true all of the evidence and legitimate inferences
drawn therefrom, Dr. Villa offered adequate, particularized
testimony sufficient to establish a standard of care, a deviation
from that standard, and a causal link between that deviation and
the injury. He had personally administered the chemotherapy drugs
in question numerous times over a twenty-year period. He studied
and trained in oncology for nearly a decade before becoming board
certified, and he served as chief of oncology at two hospitals. He
was certainly familiar with the subject of his testimony and he
repeatedly stated that the majority of oncologists would concur
with his opinion regarding dose modification.
Throughout the trial, and on appeal, defendants repeatedly
pointed to Dr. Villa's failure to cite and apply the National
Cancer Institute's ("NCI") CTC grading system. The failure of an
expert to give weight to a factor thought important by an adverse
party does not reduce his testimony to an inadmissible net opinion
if he otherwise offers sufficient reasons which logically support
his opinion. State v. Freeman,
, 115-16 (App.
Div. 1988), certif. denied,
(1989). Rather, such an
omission merely becomes a proper "subject of exploration and cross-
examination at a trial." Rubanick, supra, 242 N.J. Super. at 55.
Given the level of Dr. Villa's competency, the trial court
attributed undue significance to the physician's acknowledgment
that his oncology group had not adopted a numerical grading system
for rating chemotherapy toxicities.
Moreover, Dr. Villa's acknowledgment that the numerical
grading system was not employed by his group was an insufficient
basis, on an involuntary dismissal motion, for the trial court to
conclude that "there was no standard among doctors that he
practiced with." Dr. Villa provided a plausible explanation, which
a jury could weigh and determine whether to accept or disregard.
Dr. Villa explained that his group did not employ the CTC ratings
because they were primarily used by teaching institutions, such as
MSKCC, for purposes of uniform reporting of data to the NCI. He
also testified at great length to the fact that standards of care
in oncology do not vary from community to community, and that his
oncology group adhered to the same standards of care as did the
majority of oncologists throughout the nation. Rather than
adopting a "number system" for grading toxicity criteria, Dr.
Villa's group relied upon their "experience and knowledge" in
assessing toxicities and making appropriate dose modifications.
Nor does the fact that Dr. Villa failed to cite any treatises,
articles, protocols or the like in support of his opinion render it
a net opinion as claimed by defendants. Evidential support for an
expert opinion is not limited to treatises or any type of
documentary support, but may include what the witness has learned
from personal experience. Bellardini, supra, 222 N.J. Super. at
463. "The requirements for expert qualifications are in the
disjunctive. The requisite knowledge can be based on either
knowledge, training or experience." Ibid. Of course, "'the weight
to which an expert opinion is entitled can rise no higher than the
facts upon which the opinion is predicated.'" Ibid. (quoting
Johnson, supra, 97 N.J. at 91) (other citations omitted).
Among the acts and omissions of Dr. Tavorath which Dr. Villa
characterized as falling below accepted standards of care, were her
failure to (1) recognize the totality of the "very significant"
toxicities resulting from the first cycle; (2) recognize that
decedent's fever was attributable to his "severe" level of
neutropenia; (3) recognize that decedent's severe mucositis left
him vulnerable to bacteria; (4) appreciate the significance of
decedent's weight loss, his severely depleted protein levels, and
the prolonged period of dehydration and diarrhea; (5) consider the
totality of the foregoing toxicities in administering a second,
identical dose of chemotherapy; and (6) modify the second dose
despite having anticipated a re-occurrence of the severe
neutropenia as evidenced by the fact that she prescribed a hormone
to ameliorate the degree of anticipated neutropenia.
With respect to causation, Dr. Villa testified that an
appropriate dose modification would have resulted in less toxicity,
the complications would not have been to the same extent, the level
of toxicity would not have been lethal, and decedent would not have
died from the complications of chemotherapy. It was Dr. Villa's
opinion, within a reasonable degree of medical probability, that
the administration of the second cycle of chemotherapy at the
identical dosage as the first cycle caused decedent's death.
Further, it is undisputed that decedent in fact died from
chemotherapy toxicity.
The trial court incorrectly found that Dr. Villa's testimony
was insufficient to establish the standard of care, a deviation, or
causation, to allow plaintiff's case to be presented to a jury,
because the expert failed to correlate specific levels of
toxicities with quantified dose modifications. "An expert's
opinion need not be predicated on medical certainty." Greene v.
Memorial Hosp. of Burlington,
, 420 (App. Div.
1997). This is particularly important in a case such as the
present one where Dr. Tavorath did not reduce the dosage level at
all. Even though Dr. Villa's testimony may be "fairly susceptible
of divergent inferences," the court may not substitute its own
judgment for that of the jury by making findings of fact based only
on plaintiff's proofs, and then dismissing on the basis of adverse
findings. Lanzet v. Greenberg,
, 193, 197 (1991).
II.
As to the second issue, plaintiff maintains that the trial
court committed reversible error in dismissing the complaint
without first ruling on plaintiff's "preserved claim" that Dr.
Tavorath's violation of MSKCC's protocol requiring a "team
approach" constituted negligence. We agree.
Prior to plaintiff offering the deposition testimony of the
physicians to the jury, defense counsel moved to dismiss the claim
regarding violation of the "team approach" protocol, arguing that
there was no expert testimony to support plaintiff's theory that
the standard of care required Drs. Strong and Schupak to have input
or that any failure to follow a "team approach" had any bearing on
the issue of negligence. Plaintiff's counsel argued that under
Tobia v. Cooper Hospital University Medical Center,
(1994), Dr. Tavorath's violation of the hospital rule in
"prevent[ing] the other two members of her team from knowledge from
having the opportunity to see Mr. Rosenberg," constituted
negligence. The trial court dismissed plaintiff's protocol claim
"as they relate to the other doctors" because there was no evidence
"to suggest that they violated any duty that they had to this
particular patient." However, the court stated that it would
preserve [plaintiff's] argument that Dr.
Tavorath violated a duty as established by the
protocol.
. . . .
Permitting at this stage, but only at this
stage, an inference to be drawn that a
different result would have occurred if the
consultation had taken place. Obviously, that
is an inference that [defense counsel] is free
to shoot down should he choose to do so in the
defense case.
However, our review of the record indicates that the trial court
did not specifically address this claim when she granted
defendants' motion for an involuntary dismissal of plaintiff's
complaint.
Plaintiff also requests that we assume original jurisdiction
under Rule 2:10-5, and determine that violation of the protocol
established negligence. While plaintiff concedes that her expert
did not offer any testimony regarding this protocol, she maintains
that expert testimony was not required because such protocol
constitutes standards of care as a matter of law. We decline to
rule on this issue, due to the sparsity of the record before us.
We leave to plaintiff's counsel the trial strategy in presenting
this claim in the context of the new trial, with the following
brief comments.
The language of protocol 5.141 that "[r]esponse to
chemotherapy will be determined by agreement of all three
physicians involved" suggests an intent on the part of MSKCC that
there be an exchange of information and facilitation of
communication between specialists in a multi-disciplinary team
approach in managing a cancer patient's care. Since it appears
from the trial testimony, however, that protocols may be subject to
divergent inferences, expert testimony may be necessary to
explicate the protocols' terms and in order to understand their
significance in the context of this case. See, e.g., Morlino v.
Medical Ctr. of Ocean Cty.,
, 578-81 (1998) (holding
that Physicians' Desk Reference recommendations are not conclusive
evidence of the standard of care or accepted practice, and are
admissible on the issue of the standard of care only when they are
supported by expert testimony).
For example, throughout the voir dire and cross-examination of
Dr. Villa, defense counsel repeatedly suggested that the LP
treatment protocol, which employs the NCI "gradings of toxicities,"
constituted the accepted standard of care among oncologists
regarding dosages. Dr. Villa took the position that this protocol
was "not written in steel" but, rather, was a guideline subject to
modification by a physician depending on the patient's condition
and responses. Without explanation, plaintiff appears to take an
opposite position with regard to protocol 5.141. Plaintiff asserts
that Dr. Tavorath's failure to consult with Drs. Strong and Schupak
after each cycle of chemotherapy is a violation of the "team
approach" protocol and is evidence of negligence.
Thus, in the retrial, plaintiff may need to present factual
testimony from the scrivener or a promulgator of the protocols or
MSKCC's administrators as to their intent in adopting the
protocols, how they are monitored internally, and their
interpretation of whether they constitute a mandate or a guideline
may be necessary. Even were protocol 5.141 determined to reflect
a standard of care, plaintiff will still have to demonstrate a
causal connection between Dr. Tavorath's failure to affirmatively
consult with Drs. Strong and Schupak between the first and second
cycles of chemotherapy regarding Mr. Rosenberg's physical condition
and his health.
Reversed and remanded for a new trial on all issues.
1MSKCC states that it is incorrectly designated "Memorial
Sloan-Kettering Cancer Center at Northwest Covenant Medical Center"
and "Memorial Sloan-Kettering Physicians at Northwest Covenant
Medical Center." The proper designation is Memorial Sloan-
Kettering Cancer Center.
2According to counsel at oral argument, plaintiff did not
amend the complaint to add Drs. Strong and Schupak as defendants.
3Insofar as relevant here, the treatment protocol provides:
5.14 Response to chemotherapy will be
assessed prior to each cycle of chemotherapy.
. . . If there is unequivocal evidence of
disease progression . . . the patient will be
taken off study and standard treatment will be
recommended. If after two cycles of
chemotherapy there is no better than stable
disease, induction chemotherapy will be
discontinued and the patient will be referred
directly to concurrent chemotherapy and RT.
All other patients will proceed with the third
cycle of chemotherapy . . . .
5.141 Response to chemotherapy will be
determined by agreement of all three
physicians involved . . . .
. . . .
9.1 The probable or possible toxic
effects of this therapy include the following:
9.11 Cisplatin: Nausea, vomiting,
alopecia, myelosuppression, anorexia, auditory
dysfunction, renal dysfunction, and peripheral
neuropathy.
9.12 5-Fluorouracil: Nausea, vomiting,
alopecia, myelosuppression, anorexia,
diarrhea, stomatitus, dermatitis, neurologic
dysfunction, and hyperpigmentation of veins.
. . . .
9.2 Toxicity will be graded on a scale
of 0-4 according to the Common Toxicity Scale
. . . .
9.3 Treatment will be discontinued at
any time due to unacceptable or life-
threatening side effects not described in any
other section . . . .
4Dr. Marcus' testimony was not transcribed.
5The testimony of decedent's daughter-in-law was deferred
pending the ruling on defendants' motion for involuntary dismissal.
9The "common toxicity scale" is derived from a publication of
the National Cancer Institute (NCI) entitled Common Toxicity
Criteria (CTC). Although this publication was referred to
throughout the trial, it does not appear to have been admitted in
evidence (2T150-2T152). It is not one of the publications listed
on plaintiff's list of proposed exhibits (see uncollated
materials). On March 13, 2002, plaintiff provided the Appellate
Division Clerk's Office with copies of a segment of the NCI-CTC,
apparently adopted by MSKCC and bearing its logo (see uncollated
materials).