a "significant response" would indicate a 50% reduction in
disease; a "complete response" would indicate a 100% reduction
in disease. Because, however, some treatments reduce disease
but kill the patient, a treatment must be evaluated in terms
of both response and Patient Quality of Life ("PQL"). PQL
takes into account not only the results of a treatment,
including the prolongation of life, but also the way in which
it affects a patient during treatment by weakness, nausea,
disfigurement, extended hospitalization, etc. An analysis of
a treatment for its response and PQL in turn determines the
"efficacy" of such treatment.
Dr. DiPersio admitted that most oncologic treatment is not
curative; it is merely efficacious, aimed at reducing disease
as much as possible while maintaining the highest level of
quality of life. Dr. DiPersio stated that the
efficacy of conventional chemotherapy in the treatment of
patients like Mrs. Kulakowski with advanced, metastatic breast
cancer is not disputed. It is equally undisputed that such
treatment will not cure her; that conventional chemotherapy
presents Mrs. Kulakowski with a treatment regimen which will
require extended and repeated hospital stays and visits, will
present her with an array of side effects, including nausea and
weakness, and which will, some months or perhaps even a few
years down the road, cease to be effective until her cancer
"overwhelms" her and she dies.
Dr. DiPersio stated that HDC/ABMT is equally, if not more,
efficacious, in the treatment of Mrs. Kulakowski's cancer.
Treatment with HDC/ABMT would just as likely, if not more
likely, lead to a remission of her cancer; the treatment would
involve significantly less hospitalization and a shortened
term of chemotherapy with its unavoidable side effects. Dr.
DiPersio estimated, based on research results currently
reported in the medical literature, that, in achieving a
remission in metastatic breast cancer, conventional
chemotherapy is 30-60% effective and HDC/ABMT is 70-90%
effective. Dr. DiPersio admitted that the toxicity connected
with high dose chemotherapy involves some risk of death, but
that such risk has been reduced from 20% under older HDC/ABMT
protocols to 3-5% under newer treatment methods. He
acknowledged that there are also questions of safety and
toxicity about conventional chemotherapy (slightly lower than
for HDC/ABMT), and that protocols for both types of treatment
are continually subject to change. Dr. DiPersio defined a
protocol as a treatment regimen set up for an individual
patient whose medical outlook, given any other available
courses of treatment, is dismal, and effectively disputed that
a protocol is necessarily experimental.
With respect to Mrs. Kulakowski's treatment, Dr. DiPersio
stated that her history and present condition make her a "good
candidate" for HDC/ABMT; she is young, strong, otherwise
healthy, and presently presents with minimal disease. He also
stated that the decision to transplant Mrs. Kulakowski is not
irreversible; if, after receiving high dose chemotherapy she
did not remain medically stable, she would not be
According to Dr. DiPersio, Mrs. Kulakowski is presently
faced with three treatment options: She may elect no further
treatment, in which case her disease will progress quickly; or
she may elect conventional chemotherapy, which will result in
a slower but inexorable progression of her disease; or, if
coverage is available to her under the Contract, she may elect
HDC/ABMT, which will, in all likelihood, at least match the
efficacy of conventional chemotherapy, may exceed its efficacy,
and may offer a chance for a cure. Of these three options, only
HDC/ABMT offers any hope of a cure; only HDC/ABMT offers a
treatment which may both extend the span of Rebecca
Kulakowski's life and ensure a modicum of comfort to the time
allotted to her.
Dr. Richard Cooper was defendants' first witness. A medical
oncologist, Dr. Cooper is a member of the faculty of the
University of Buffalo Medical School; 95% of his practice
concerns the treatment of patients with metastatic breast
cancer. Dr. Cooper had never seen Mrs. Kulakowski, or examined
her records. He had, however, spoken
to Dr. Stankaitis, in the past, about the use of ABMT in
connection with the treatment of breast cancer. It was Dr.
Cooper's expert opinion that the use of HDC/ABMT in connection
with breast cancer is investigational, but not experimental. He
also rendered his expert opinion that HDC/ABMT and conventional
chemotherapy are equally efficacious in the treatment of such
cancer. Dr. Cooper acknowledged that there has been "no
significant change" in the long-term prognosis for metastatic
breast cancer over the last decade and that, even in the
treatment program using the most aggressive conventional
chemotherapy and having the best statistical outcome, only 9%
of the patients enjoyed longterm remission. In choosing to give
more weight to the opinion of Dr. DiPersio, I am persuaded by
the decisions of a number of other district courts which, in
considering this very issue, and relying upon expert testimony,
have stated without qualification that conventional
chemotherapy cannot cure metastatic breast cancer. See, e.g.,
White v. Caterpillar, Inc., 765 F. Supp. 1418 (W.D.Mo. 1991);
Pirozzi v. Blue Cross, 741 F. Supp. 586 (E.D.Va. 1990).
Because I found much of the remainder of the testimony
elicited by defendants neither remarkable nor relevant to the
outcome of this motion, I will address it only summarily. Dr.
Hoffman testified concerning an experimental program to
provide HDC/ABMT to breast cancer patients which is currently
in the final planning stages and which will be funded, in
part, by health care insurers, including Blue Choice. It is
undisputed that treatment under the program is not yet
available and that, in any event, Mrs. Kulakowski would not be
accepted into the program because of the advanced stage of her
cancer. That program will only be available to Stage II and
Stage III breast cancer patients; Mrs. Kulakowski suffers from
Stage IV breast cancer, the most serious form recognized.
Dr. Stankaitis testified concerning the steps he took prior
to declining coverage for Mrs. Kulakowski: he reviewed her
records; he reviewed the literature in the field; he conferred
with other Blue Choice employees; he spoke to Dr. Hoffman
concerning a relevant seminar which Dr. Hoffman had attended;
and he spoke to other medical doctors, including surgeons.
Based on the information he received, he determined that the
HDC/ABMT protocol proposed for Mrs. Kulakowski is an
experimental treatment for cancer such as the plaintiff
presents and is, therefore, an excluded procedure under the
Contract. In making that determination, Dr. Stankaitis relied
upon the "experimental" nature, not only of the combination of
chemotherapy and bone marrow transplant to treat the
plaintiff, but also of the drug regimen proposed by Dr.
DiPersio: a previously untested combination of etoposide
(VP-16), carboplatin (Cb), and intravenous L-phenylalanine
mustard (L-PAM) ("Melphalon"). The defendants have, however,
failed to provide any testimony, expert or otherwise, that a
protocol involving the administration of such new combinations
of drugs — each a recognized efficacious chemotherapeutic drug
— constitutes "experimental" treatment. As the court
recognized in Pirozzi v. Blue Cross-Blue Shield, 741 F. Supp. 586,
593 (E.D.Va. 1990):
[T]he use of protocols in connection with
HDC/ABMT treatment is [not] an indication that
the treatment is experimental. . . . . . . Use of
a protocol does not, by itself, indicate that a
procedure is experimental. (footnote omitted)
Were this not so, much of medicine might be swept
within the ambit of the experimental exclusion. .
Thus, I must decide, under the applicable legal standard,
whether Blue Choice erred in determining that Mrs.
Kulakowski's proposed treatment is experimental and therefore
excluded under the Contract.
It is undisputed that Mrs. Kulakowski is a covered
beneficiary under a benefits plan which is subject to ERISA.
Thus, she may challenge the denial of coverage for her
HDC/ABMT treatment under 29 U.S.C. § 1132(a)(1)(B), which
provides that a civil action may be brought by such a
to recover benefits due to him under the terms of
his plan, to enforce his rights under the terms
of the plan, or to clarify his rights to future
benefits under the terms of the plan[.]
The Supreme Court has expressly held that a denial of
benefits challenged under Section 1132(a)(1)(B) is to be
reviewed under a de novo standard
unless the benefit plan gives the administrator
or fiduciary discretionary authority to determine
eligibility for benefits or to construe the terms
of the plan. Firestone Tire and Rubber Co. v.
Bruch, 489 U.S. 101, 109 S.Ct. 948, 956, 103
L.Ed.2d 80 (1989).
In this case, the Contract expressly provides that the
determination whether a procedure is experimental, and
therefore, excluded, rests solely with the Medical Director.
See fn. 2, supra. Thus, under Firestone, the denial of coverage
to Mrs. Kulakowski is reviewable only to determine whether such
denial was arbitrary or capricious. See, e.g., Reichelt v.