HIV AIDS Resource Guide/HIV-AIDS Resource Guide.iso/STAT/CASES/BRADLEY.ASC

Text File | 1993-01-14 | 10KB | 214 lines

/* This case is reported in 562 N.Y.S.2d 908 (Sup. 1990). In this
rather unusual case, a health insurance company is required to
cover an "experimental" treatment for HIV. This court finds that
although a hospital may for liability purposes label a treatment
"experimental" that it must cover the treatment as a one that is
accepted, EVEN if not accepted for treatment of a particular
disease. That is, if chemotherapy is no-experimental, the fact
that it is used for an illness which it is not usually used for
does not take it outside of its insurance coverage. A recent
$70,000,000 verdict in a California case with an HMO refusing to
pay for treatment in a similar factual circumstance, involving
breast cancer is a further extension of this ruling. */

Thomas J. Bradley, Plaintiff,

v.

Empire Blue Cross and Blue Shield, Defendant.

Supreme Court, New York County, Individual Assignment part 6.

August 1, 1990



ELLIOT WILK, Judge.



This is an action to compel Empire Blue Cross and Blue Shield to
provide insurance coverage to Thomas Bradley for a medical
procedure to be performed at Johns Hopkins  Hospital in
Baltimore, Maryland. Plaintiff has moved to enjoin defendant from
refusing coverage.  Although the courts are generally disinclined
to favor preliminary injunctions which mirror the ultimate relief
sought, because of the unique circumstances of this case, it is
appropriate that this motion be granted. On the return date of
the motion, counsel agreed that the cross motion to dismiss would
also be treated as its opposition to Mr. Bradley's motion.  An
expedited hearing was ordered, at the conclusion of which I make
the following findings.

     Plaintiff, Thomas J. Bradley, is a 47 year old male who is
infected with Human Immunodeficiency Virus (HIV), which is a
principal cause of Acquired Immunodeficiency Syndrome (AIDS). As
a result, has a dangerously low T-cell lymphocyte count which
compromises his immune system which compromises his immune system
and exposes him to severe opportunistic infections which afflict
AIDS victims. He has experienced numerous symptoms associated
with HIV infection.

     Mr. Bradley's treating physician, Dr. James D. Lax, referred
him to Dr. H. Kent Holland, who is affiliated with Johns Hopkins
Hospital, to evaluate his candidacy for a bone marrow transplant.
Both doctors believe Mr. Bradley to be terminally ill.

     After a thorough examination of Mr. Bradley's medical and
emotional condition and with the approval of the Hospital, Dr.
Holland and his staff concluded that Mr. Bradley is a suitable
candidate for treatment.

     The procedure contemplated by Dr. Holland is the
administration of high doses of chemotherapy and whole body
radiation to destroy the cells in the bone marrow. Mr. Bradley's
immune system will then be reconstituted by the introduction of
bone marrow donated by his identical twin brother. After the
transplant, to protect donor cells from infection, Mr. Bradley
will continue with the antiviral drug AZT, which will be
administered intravenously.

     The pre-transplant treatment of heavy doses of highly toxic
drugs requires that Mr. Bradley be reasonably healthy. Should he
develop any of the more severe opportunistic infections
associated with AIDS, which could happen at any time, he would
become ineligible for this treatment.

     The proposed bone marrow transplant is to be followed by
long term hospitalization and extensive follow-up with antibiotic
treatment, transfusion, parenteral nutrition and monitoring of
organs for toxic effects.

     Empire Blue Cross and Blue Shield has moved to dismiss the
complaint on the ground that the treatment described is outside
of the scope of its contractual obligation to Mr. Bradley.

     The "Empire Plan" provides that "Blue Cross will not pay for
services which are deemed experimental or investigative according
to guidelines established jointly for the Empire Plan by the
State of New York, Blue Cross and Metropolitan Life Insurance
Company."  Apparently, the guidelines have never been drawn.

In an affidavit submitted in support of the cross motion, Dr.
Arthur Levin, associate medical director of Empire, states that
"[a]s an aid in determining whether a new procedure not
previously evaluated by the Empire Plan is experimental or
investigative in treating a particular diagnosis, Empire uses the
criteria established by the Blue Cross and Blue Shield
Association." He concludes that the proposed treatment meets none
of the criteria.

     Dr. David M. Eddy is a professor at Duke University, who
specializes in the evaluation of medical practices. He, too, is
affiliated with Empire Blue Cross and Blue Shield.  He has done
an analysis of the literature concerning the use of high-dose
chemotherapy with autologous bone marrow transplant for the
treatment of metastatic breast cancer.  He is not an oncologist,
a hematologist or a bone marrow transplant expert and has no
expertise in the treatment of HIV or AIDS infected people. At the
hearing, he was unable to provide an opinion about the potential
benefits of the treatment proposed by Dr. Holland.

Dr. Eddy, in his affidavit, contends that the proposed treatment
is investigative. He states that:

[i]n order to be considered noninvestigational, two tests must be
met: (1) there must be evidence that the procedure causes
benefit, and (2) there must be evidence that, to patients, the
benefits of the procedure outweigh its harms.

According to Dr. Eddy, the first test is met when it is
determined that the treatment provides greater improvement in
health outcomes than alternative treatments.  He recognizes only
AZT as an alternative available to Mr. Bradley. He distinguishes
ultimate  from  intermediate health outcomes.  He then considers
(1) survival, (2) relief of symptoms, (3) prevention of
complications, (4) risks of treatment and (5) side effects of
treatment such as hair loss, nausea, vomiting, diarrhea and
anxiety.



The thrust of Dr. Eddy's testimony was that medical treatment may
not be considered non-investigative until controlled studies have
shown it to be effective and beneficial. Subjective clinical
judgments of practitioners do not determine whether a treatment
is investigative. Dr. Eddy maintains that because only six of
these procedures have been performed, all by Dr. Holland, the
proposed treatment must be viewed as investigative.

Dr. Holland is a well credentialed oncologist, hematologist and
bone marrow transplant expert who is a faculty member of Johns
Hopkins University School of Medicine and a staff member at Johns
Hopkins Hospital.  I found his testimony to be clear, informed,
insightful and persuasive. He testified that Dr. Eddy's
mechanical definition of "investigative" is inadequate and
inappropriate to the facts of this case. I agree.

The testimony made clear that both chemotherapy and bone marrow
transplants have a sufficient history to support the medical
community's conclusion that they are not investigative
treatments. This is true notwithstanding the severe side effects
of chemotherapy, the significant risk of death from bone marrow
transplants and the uncertainty of the results.  The consequences
of the absence of these treatments is more certain.

The combination of chemotherapy and bone marrow transplant is
also accepted by the medical community and has been used with
varying success to treat, among other things, metastatic breast
cancer, leukemia and aplastic anemia.

The third component of Dr. Holland's procedure, AZT, has gained
wide acceptance in the medical community for the treatment of
people infected with HIV and AIDS.

Dr. Holland believes that the chemotherapy, radiation, bone
marrow transplant combination will be just as effective in
treating Mr. Bradley's immunodeficiency as it has been with non-
HIV related medical problems.

The availability of the non-infected bone marrow of Mr. Bradley's
twin brother re moves the most serious obstacle to a successful
transplant-"graft-versus-host" disease and substantially
increases his chance of survival. Although Dr. Holland is no more
able to guarantee success or to predict results than are
physicians using similar methods to attack other diseases, I find
the logic of his analysis, which stands unrefuted, to be
compelling. The addition of AZT to the procedure provides another
guard against reinfection.  Its inclusion does not transform what
is already accepted medical protocol into experimental treatment.

     The only other witness called was Dr. Robert Geller, a well-
credentialed expert in oncology, hematology and bone marrow
transplants. He is a member of the faculty of the University of
Chicago School of Medicine and is affiliated with the University
of Chicago Medical Center.  His testimony confirmed that of Dr.
Holland. Dr. Geller stated that he expects to be performing
similar procedures at the University of Chicago Medical Center
within six to twelve months.



Hopkins will require that Mr. Bradley sign a "clinical
investigation consent form" which emphasizes the research aspect
of the procedure.  A similar consent form is required in every
bone marrow transplant procedure.  The defensive and cautionary
language of the form is, no doubt, the bar's contribution to the
defense of potential medical malpractice litigation.  I do not
believe that the form accurately characterizes the nature of the
treatment and I have given little weight to it.

In this motion for a preliminary injunction, Mr. Bradley must
demonstrate a likelihood of success on the merits, irreparable
harm in the absence of the injunction and a balancing of the
equities in his favor. W T. Grant Company v. Srogi, 52 N.Y.2d
496, 517, 438 N.Y.S.2d 761, 420 N.E.2d 953 (1981). The likelihood
of success is strong, the irreparable harm is, unfortunately,
obvious, and the equities lie in his favor. Accordingly, the
motion for injunctive relief is granted and Empire is directed to
discontinue its refusal to approve payment for the
hospitalization costs associated with Mr. Bradley's bone marrow
transplant at Johns Hopkins Hospital and is directed to notify
Hopkins forthwith that it will cover this procedure. Empire's
cross motion to dismiss is denied.