The opinion of the court was delivered by: LEINENWEBER
Donna Santucci has been diagnosed with chronic myelogenous leukemia. Leukemia is cancer of the blood. Chronic myelogenous leukemia is a slowly progressing cancer that affects granulocytes which are white blood cells. Although an individual can live with this condition for many years, the disease will eventually reach the acute (or blast crisis) stage, in which immature granulocytes (or blast cells) are affected by the disease. Death usually follows shortly after the blast crisis.
Plaintiff, an employee of Hyatt Corporation, was a participant in the Hyatt Corporation Medical/Dental Plan, which was established and maintained pursuant to ERISA. Under the plan, Hyatt was designated as the plan administrator and, as administrator, was given "sole and exclusive discretion, authority and responsibility for administering, construing, and interpreting the provisions of the plan and making all determinations thereunder." Hyatt was further given authority to appoint an entity, here Prudential, to serve as the claim administrator with authority to review and pay claims. The plan excludes payment for "charges that are not . . . medically necessary." The words "medically necessary" were defined to exclude services that are "educational, experimental, or investigational in nature." Investigational procedures are considered experimental. "Experimental or investigational services" includes any services
under study or in a clinical trial to evaluate its toxicity, safety or efficacy for a particular diagnosis or set of indications. Clinical trials include bur are not limited to phase I, II and III clinical trials.
The Summary Plan Description, given to plaintiff and other Hyatt employees, contains language similar to that of the plan.
The plaintiff was initially treated with alpha interferon but she could not tolerate this treatment. She was then treated with an alternative drug therapy. She was a potential candidate for high dose chemotherapy with allogeneic stem cell rescue. This procedure involves killing the diseased bone morrow with high dose chemotherapy and replacing it with non-diseased marrow of a donor. However allogeneic stem cell rescue requires a suitable match, usually from a sibling. Unfortunately no suitable match was found for plaintiff.
It has been proposed that plaintiff receive autologous stem cell replacement at Northwestern University where she would be participating in a clinical or "research" trial. Her trial would be monitored by the hospital's Institutional Review Board which is a federally mandated organization intended to protect the participants in clinical trials. Treatment must be in accord with a protocol approved by the board.
Clinical trials are divided into three phases. Phase I which is designed to determine the largest tolerable dose of chemotherapy that can be tolerated with out unacceptable toxic side affects. Phase II studies evaluate the safety and efficacy of the dosage determined in Phase I through a study of a group of similarly situated patients. Phase III occurs if Phase II shows promise and involves a random comparison of treatment results of patients receiving various types of treatment including the one under study. If at the conclusion the results equal or exceed alternative treatments, the procedure is approved and is no longer experimental.
One of the conditions for participation in the Northwestern study was that the patient be able to pay the cost, either through insurance or private funds. Accordingly, plaintiff made a claim under her insurance plan for pre-certification. Prudential, the claim administrator, denied pre-certification. In reviewing the claim Prudential obtained the opinions of two expert oncologist through the Medical Care Ombudsman Program, an independent organization owned by an attorney in Washington, D.C., named Grace Powers Monaco. Neither Prudential or Hyatt had any role in selection of medical reviewers. One of the experts was Dr. Bruce D. Cheson, Chief of the National Cancer Institute's Medical Section, which supervises cancer research world-wide. He is a national and international authority in the treatment of leukemia. The other expert was Dr. Raymond B. Weiss. Dr. Weiss is board certified in internal medicine and medical oncology and is Chief of Medical Oncology at Walter Reed Army Medical Center. He is a professor of medicine and as chaired groups involved in cancer and leukemia treatment. He has personally treated patients with the autologous stem cell rescue treatment proposed for plaintiff.
Both concluded in written reports prepared in April, 1995, that the treatment was not standard therapy and should only be performed in an investigational setting. They further concluded that until randomized studies have been completed no one can say whether the treatment is as good as or better than the alternative treatments available. Based on these reports, Prudential denied pre-certification.
In June, 1995, as a result of an appeal taken by the plaintiff under the Prudential insurance policy of Prudential's denial of pre-certification, each doctor was again asked for opinions and each reaffirmed his definite opinion that the procedure was indeed experimental. Prudential, on the basis of these opinions, denied plaintiff's appeal.
The court conducted an emergency hearing for a preliminary injunction in July, 1995. At that hearing the plaintiff called Dr. Patrick Stiff, Associate Professor of Medicine and Director of the Bone Marrow Transplantation Program at Loyola University Medical Center; Dr. Philip Barton McGlave, Chief of the Adult Bone Marrow Transplantation Program at the University of Minnesota; Dr. Donald Sweet, a hematologist/oncologist at Northwestern University, who practices privately in Hinsdale, Illinois; and Dr. Ann Elizabeth Traynor, an oncologist at Northwestern Memorial Hospital. Prudential called Dr. Weiss.