Dahl-Eimers v. Mutual of Omaha Life Ins. Co., 92-30254-RV.

• Decision Date: 29 July 1992
• Docket Number: No. 92-30254-RV.,92-30254-RV.
• Citation: 812 F. Supp. 1193
• Parties: Mary P. DAHL-EIMERS, Plaintiff, v. MUTUAL OF OMAHA LIFE INSURANCE COMPANY, Defendant.
• Court: U.S. District Court — Northern District of Florida

812 F. Supp. 1193

Mary P. DAHL-EIMERS, Plaintiff, v. MUTUAL OF OMAHA LIFE INSURANCE COMPANY, Defendant.

No. 92-30254-RV.

United States District Court, N.D. Florida, Pensacola Division.

July 29, 1992.

Miles Davis, Pensacola, FL, and Wm. Dennis Brannon, Ft. Walton Beach, FL, for plaintiff.

Thomas E. Johnson, Omaha, NE, Ralph A. Peterson, Beggs & Lane, Pensacola, FL, for defendant.

ORDER AND MEMORANDUM OPINION

VINSON, District Judge.

Plaintiff, Mary P. Dahl-Eimers, initiated this litigation for declaratory judgment, for injunctive relief, and for damages, against defendant, Mutual of Omaha Life Insurance Company. The plaintiff is insured under a policy of major medical expense coverage issued by the defendant. The plaintiff has Stage IV breast cancer, and desires to undergo a procedure identified generally as high dose chemotherapy with autologous bone marrow transplant ("HDC-ABMT"), utilizing three chemotherapy drugs known as Ifosfomide, Carboplatinum, and Etoposide ("I.C.E."). The issue presented is whether the HDC-ABMT treatment utilizing the I.C.E. drugs is "experimental" within the meaning of the policy's coverage.

(1) The preliminary injunction standard. In this Circuit, the four requisites for issuance of a preliminary injunction are well known: (a) a substantial likelihood that plaintiff will ultimately prevail on the merits; (b) that plaintiff will suffer irreparable injury unless the injunction issues; (c) that the threatened injury to the movant outweighs whatever damage the proposed injunction may cause to the opposing party; and (d) that the injunction, if issued, would not be adverse to the public interest. See, e.g., Sofarelli v. Pinellas County, 931 F.2d 718, 723-24 (11th Cir.1991). This matter was promptly set for hearing on the plaintiff's motion for a preliminary injunction because of the obvious need to deal quickly with the issue. For purposes of the preliminary injunction, only the first element needs to be considered, since the remaining three elements are established by the circumstances of the case.

(2) The plaintiff's cancer and course of treatment. Plaintiff is a forty-year-old female who resides in Destin, Florida. Her breast cancer was initially confirmed by biopsy on September 30, 1988. Following a right modified radical mastectomy, plaintiff embarked upon an initial course of chemotherapy and radiation treatments considered as standard or conventional therapy. At the end of that course of treatment, there was no clinical evidence that her disease was still existent. However, in August 1991, plaintiff developed pain in her right hip and was diagnosed with metastatic disease, for which she was treated with a drug called "Taxol" between September 1991 and March 1992. The cancer now appears to be in remission, although it is classified as "Stage IV metastatic breast cancer." Stage IV metastatic breast cancer is considered incurable by any known therapy. Plaintiff has now decided to explore the possibility of enrolling in the clinical trial of HDC-ABMT involving I.C.E. at the H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida in Tampa, Florida ("Moffitt").

(3) The terms of the policy. Under the major medical expense policy of insurance issued by the defendant, the insuring clause on page 4 specifies that the insurance company will reimburse the insured for "expenses" incurred. The expenses are defined as limited to "medically necessary" services or supplies. In turn, that is defined as follows:

A "Medically Necessary" service or supply means one which: (a) is appropriate and consistent with a diagnosis in accord with accepted standards of community practice; (b) is not considered experimental; and (c) could not have been omitted without adversely affecting the insured person's condition or the quality of medical care.

The critical term for purposes of this case is "experimental." The plaintiff contends that it is an ambiguous term, while the defendant says that it is not. Under Florida law, construction of the terms of an insurance contract is a question of law to be resolved by the court. Epstein v. Hartford Casualty Insurance Co., 566 So.2d 331, 332-33 (Fla. 1st DCA 1990). Further, courts are to give the language within an insurance policy a practical and sensible interpretation in accordance with the natural meaning of the words employed. Construction of the policy language must be:

... by the rule of reason and the principle that even insurance policies must be given practical, sensible interpretations in accordance with the natural meaning of the words employed. Obviously, the rule that ambiguities must be construed against the insurer applies only when a genuine inconsistency, uncertainty, or ambiguity in meaning remains after resort to ordinary rules of construction; it does not allow courts to rewrite the contracts, add meaning that is not present, or otherwise reach results contrary to the manifest intention of the parties.

Allstate Insurance Co. v. Shofner, 573 So.2d 47, 49 (Fla. 1st DCA 1990) (citations omitted).

(4) The HDC-ABMT treatment. Among cancer researchers, it is generally believed that higher doses of chemotherapy drugs may result in destruction of a greater portion of the cancer cells. However, since the chemotherapy drugs are extremely toxic, the dosage for each of these drugs is limited by the maximum that the human body can tolerate. A significant limiting factor is that very high doses substantially destroy the bone marrow which, ordinarily, is fatal since the bone marrow provides necessary red blood cells, white blood cells, and platelets.

Thus, a major research effort in recent years has been an attempt to increase the maximum tolerated dosage by means of protecting a small portion of the patient's own ("autologous") bone marrow. A major break through was being able to remove, freeze, and reuse the bone marrow. The first trials of this process, "HDC-ABMT," in cancer treatment involved patients with "diffuse" tumors such as leukemia or lymphoma. Through a series of laboratory and clinical experiments, researchers were able to determine what specific patients were benefitted by specific drugs or drug combinations at specific dose levels. As a result, HDC-ABMT for certain diffuse tumors is now recognized as standard therapy. There is no standard therapy recognized today, however, for a "solid" tumor such as breast cancer among women. Over the past few years, perhaps ten to twenty university-affiliated medical institutions have initiated active research programs for HDC-ABMT treatment of breast cancer. These programs involve a limited number of patients at various stages of the disease, and each program generally involves a testing of a particular combination of drugs at various dosage levels, with and without bone marrow purging. Despite high expectations from these clinical tests, the data available from the experiments conducted to date are inconclusive. The results of approximately 1,000 test patients using about six different combinations of chemotherapy drugs are now known to the medical community. For purposes of this case, it is important to note that there is no known published data for the I.C.E. combination of drugs on breast cancer, for which plaintiff seeks treatment at the Moffitt Center.

(5) Medical Research Requirements. The requirements of medical research involving human subjects is regulated by the federal government under regulations promulgated by the Department of Health and Human Services and the Food and Drug Administration. Medical experiments with human subjects are generally known within the profession as "clinical trials." Clinical trials are divided into "phases" which are defined in terms of the research objective and the methodology. Phase I clinical trials are the earliest stage of the testing of a drug or procedure, and follow test tube and animal research. The primary objective of a Phase I trial in the context of drug testing is to determine...