The opinion of the court was delivered by: CONNER
This action is presently before the Court on Thelma Elsroth's ("Ms. Elsroth's" or "plaintiff's") motion for a preliminary injunction ordering Consolidated Edison Company of New York ("Con Ed") and Empire Blue Cross and Blue Shield ("Blue Cross") (together, "defendants") to pre-certify a high-dose chemotherapy, peripheral stem cell support treatment ("HDC-PSCT") recommended by her treating oncologist. The Court has original jurisdiction over the action pursuant to the Employee Retirement and Insurance Security Act ("ERISA"), 29 U.S.C. § 1132(a)(1)(B), and supplemental jurisdiction over plaintiff's state law claim pursuant to 28 U.S.C. § 1367(a). For the reasons stated, the motion is denied.
Ms. Elsroth is a fifty-nine-year-old woman who suffers from ovarian cancer, which has metastasized to her liver. Her husband is an employee of defendant Con Ed, and a retired employee of New York state, and thus, she is a beneficiary of two health insurance plans, one, the "Con Ed Plan," which is insured solely by Blue Cross, and governed by ERISA, 29 U.S.C. § 1001, et seq., the other, the "Empire Plan," which is co-insured by Blue Cross and United HealthCare,
in connection with the New York State Health Insurance Program, N.Y. Civ. Serv. Law § 160 et seq. (McKinney 1983). See Pl.'s Ex. D.
Ms. Elsroth was diagnosed with stage IV epithelial ovarian cancer in June 1996, when a laparotomy revealed a large ovarian mass and multiple metastatic tumors or lesions in her liver. Beginning in November 1996, Ms. Elsroth was treated with paclitaxel and platinum, specifically, cisplatin and then with carboplatin.
However, by October 1997, Ms. Elsroth had developed new lesions. In December 1997, three of these lesions measured 6 centimeters, 4 centimeters and 5 centimeters in size. By January 1998, after further chemotherapy, the 6 and 4 centimeter lesions had shrunk to 4 and 3 centimeters, respectively, while the 5 centimeter lesion remained the same size.
Plaintiff's treating physician, Dr. Tauseef Ahmed, Chief Oncologist and Professor of Medicine at New York Medical College, Westchester County Medical Center, now recommends that Ms. Elsroth undergo sequential or "tandem" administration of HDC in three cycles of ifosfamide, carboplatin and etoposide with peripheral stem cell rescue ("HDC-PSCR" or "HDC-PSCT").
Dr. Ahmed asserts that this treatment offers Ms. Elsroth the best opportunity for sustained health and life, in light of her condition. Moreover, he states that if Ms. Elsroth does not begin the treatment promptly, the cancer will probably spread to her other vital organs, and she will become physically unable to withstand the treatment. If she continues to receive standard therapy, according to Dr. Ahmed, the cancer cells will become physically resistant to the proposed treatment. Dr. Ahmed claims that he is unable to provide Ms. Elsroth with this treatment unless she is either pre-certified by defendants or makes an initial payment of $ 25,200 to the hospital -- an amount which she states she cannot afford.
Ms. Elsroth sought pre-certification for HDC-PSCR from Blue Cross in mid-January of 1998. She provided Blue Cross with her medical records and a copy of the proposed treatment protocol. Upon reviewing these materials, Dr. Chowdhary, a Blue Cross physician, denied pre-certification on January 20, on the ground that the proposed treatment was "investigational" and "unlikely to benefit Ms. Elsroth."
Ms. Elsroth appealed this decision on January 21, pursuant to instructions provided by Blue Cross. Dr. Steven Wolinsky, Blue Cross's "medical policy" director, then reviewed her medical records, the protocol, and the medical literature provided to him by Dr. Ahmed. He concluded that the proposed treatment was investigational and therefore excludable under both health plans. However, before contacting Dr. Ahmed, and pursuant to Blue Cross policy, he arranged to have the file reviewed by an expert who was not affiliated with Blue Cross, through the Medical Care Ombudsman Program ("MCOP").
MCOP referred the file to Dr. Maurie Markman, Director of the Cleveland Cancer Clinic. The file was sent directly to Dr. Markman and was accompanied by a letter from Blue Cross, instructing him to determine whether "the scientific evidence supports a result of improvement in health outcomes; the technology of which would improve health outcomes; . . . is as beneficial as any established alternatives; . . . is attainable outside the investigational setting; . . . and is a well-designed study for which [Ms. Elsroth] is a good candidate." Accordingly, Dr. Markman reviewed Ms. Elsroth's file, as submitted by Blue Cross, on January 21-23. He determined that the proposed treatment was "highly experimental" and "of absolutely no known clinical benefit in [Ms. Elsroth's] setting." Defs.' Ex. C. He reasoned that Ms. Elsroth "has extensive and highly chemo resistant ovarian cancer . . . . [with] minimal shrinkage," and that any response to the therapy would be "of short duration," and concluded that "there [was] no evidence [that chances of] survival or quality of life [would be] improved compared to far less intensive and far less morbid treatment approaches," and thus, that the proposed treatment was not "a reasonable therapeutic option" for Ms. Elsroth. Id. On the basis of Dr. Markman's opinion, Blue Cross denied plaintiff's appeal.
On March 4, Ms. Elsroth again appealed Blue Cross's decision. She submitted a new CT scan to Blue Cross which showed that the lesions had shrunk to 3, 2.5 and 2 centimeters in size. Blue Cross once again contacted MCOP to request expedited review by a second, independent reviewer. Accordingly, Ms. Elsroth's file was reviewed by Dr. David Vesole, Associate Professor of Medicine and Clinical Director, Bone Marrow Transplant, at the Medical College of Wisconsin. Dr. Vesole concluded that the proposed treatment was investigational, as defined by the plan, and that Ms. Elsroth would "not benefit from [it]." See Defs.' Ex. E. He reasoned that
Ms. Elsroth has persistent bulky disease . . . . (at least 3 lesions greater [than] 1 cm) . . . . Based upon the [relevant] studies, she does not fit the profile of patients who would . . . benefit from the proposed treatment -- she is over 48, has received multiple prior therapies, has not achieved an excellent remission, [and] has small lesions which have not changed.
Id. After having received Dr. Vesole's review, Blue Cross again declined to pre-certify the treatment.
Ms. Elsroth requested further review on or about April 14 and May 5, 1998, when a new CT scan allegedly revealed that her liver lesions had further responded to chemotherapy. Dr. Markman reviewed the CT scan and again concluded that the treatment was "experimental." Defs.' Ex. F. Dr. Wolinsky conferred with Dr. Manion of United HealthCare, the co-insurer of the Empire Plan. Dr. Manion stated that in his opinion, coverage should be denied, because of "the large size of Ms. Elsroth's tumor." Wolinsky Aff. at P 18. Blue Cross again denied pre-certification on or around May 6, 1998.
Thereafter, having exhausted her administrative appeals, Ms. Elsroth filed this action, together with the instant motion for a preliminary injunction ordering defendants to grant pre-certification for the proposed HDC-PSCR treatment, and to clarify her rights to future benefits under the Con Ed and Empire Plans.
After fully briefing the issues, the parties appeared before the Court at a scheduled evidentiary hearing on June 23-24. At that time the Court heard testimony from Dr. Ahmed, and viewed Dr. Markman's videotaped deposition.
At the close of the proceedings, in view of the conflict in their testimony, the Court, with the concurrence of the parties, decided to appoint an independent expert, pursuant to Fed. R. Evid. 706, to advise the Court as to the value of the proposed treatment in this case. After receiving suggestions from the parties and others knowledgeable in the field, we selected Dr. David Spriggs, Chief of Developmental Chemotherapy Service, Memorial Sloan-Kettering Cancer Center. The Court received Dr. Spriggs's written opinion on July 6.
Plaintiff argues that defendants should be ordered to cover the proposed treatment on the ground that their denial of coverage was arbitrary and capricious. Her argument is two-part. First, she claims that defendants' reasons for the denial of coverage were beyond the terms of the contract and ambiguous, and that the contractual terms themselves are ambiguous. Second, she asserts that the proposed treatment is safe and effective, and generally accepted by the medical community, and is the best therapy for her. We will examine each of her arguments in turn, under both ERISA and New York law, after articulating the proper standards of review.
However, before reaching a detailed analysis of the issues, we summarize our conclusions. First, we conclude that plaintiff has not shown that the relevant plan terms were ambiguous under federal common law or state law, or that the language contained in the denial letters was misleading or insufficient under ERISA.
Second, we conclude that it is unlikely that plaintiff will be successful on her claim that Blue Cross wrongfully withheld pre-certification. Guiding that conclusion is the fact that all of the medical experts who have reviewed the case (excepting, of course, plaintiff's own treating oncologist) have emphatically opined that the proposed treatment is not likely to be of any benefit to Ms. Elsroth and is much more likely to cause her harm than the standard chemotherapy she has been receiving. Although the Court denies Ms. Elsroth the relief she seeks primarily for this reason, in the interest of completeness, we will consider each of the arguments made on her behalf.
Preliminary Injunction Standard
"It is by this time black-letter law that the party seeking a preliminary injunction must establish that: (1) absent injunctive relief, [she] will suffer an irreparable injury; and (2) either (a) a likelihood of success on the merits or (b) sufficiently serious questions going to the merits to make them a fair ground for litigation and the balance of hardships tips in favor of the movant." Alliance Bond Fund, Inc. v. Grupo Mexicano de Desarrollo, S.A., 143 F.3d 688, 696, 1998 WL 220954, at *9 (2d Cir. 1998); see also Jackson Dairy, Inc. v. H.P. Hood & Sons, 596 F.2d 70, 72 (2d Cir. 1979). For the following reasons, we conclude that ...