1 Fla. L. Weekly Supp. 15a
Insurance — Health — Coverage — Experimental treatment — Treatment of stage IV, metastatic breast cancer with procedure known as high-dose chemotherapy with autologous rescue is experimental in nature and not “medically necessary” as defined by policy at issue
WINONA CALKINS, Plaintiff, vs. MUTUAL OF OMAHA INSURANCE COMPANY, Defendant. 9th Judicial Circuit, in and for Orange County, FL. Case No. CI 91-4181. May 5, 1992. Rom W. Powell, Judge. James P. Kelaher, Orlando, FL, for Plaintiff. John L. Sewell, Orlando, FL, and Thomas E. Johnson, Omaha, NE, for Defendant.
OPINION AND FINAL SUMMARY JUDGMENT
THIS CAUSE, having come on for hearing April 27, 1992, on Defendants Motion for Summary Judgment, and the Court, having heard the arguments of counsel, upon consideration of the pleadings, depositions and affidavits on file, and being otherwise fully advised in the premises, makes the following findings of material fact, each of which is demonstrated to exist without genuine dispute:
1. Plaintiff is an individual and a resident of the State of Florida. She suffers from stage IV, metastatic breast cancer. Defendant is a foreign corporation engaged in the insurance business. Defendant has conducted business within the State of Florida.
2. At all times material to this action, Plaintiff was insured under a contract of insurance issued by Defendant.
3. The insurance contract at issue provides for
reimbursement only for services or supplies which are “medically necessary.” Said contract further provides that, in order for a service or supply to be “medically necessary,” three conditions must be met, to wit: (1) it must be appropriate and consistent with the diagnosis (here, stage IV, metastatic breast cancer) in accord with accepted standards of community practice, and (2) it must not be considered experimental, and (3) it must be such that it could not have been omitted without adversely affecting the insured person’s condition or quality of medical care.
4. Between August and November of 1991 Plaintiff underwent a procedure known as high-dose chemotherapy with autologous rescue (“HDC-AR”) at the University of Chicago Medical Center under the direction of Dr. Stephanie Williams, an Assistant Professor of Medicine at that institution. HDC-AR is a procedure involving, essentially, three steps: (1) a component of the bone marrow known as “stem cells” is collected from the patient by either withdrawing a small portion of the patient’s bone marrow or by collecting a quantity of stem cells from a series of blood samples withdrawn from the patient’s veins; the stem cells are processed and frozen for preservation, then (2) the patient is given chemotherapy at doses substantially higher than standard or conventional doses; at such doses, the patient’s remaining bone marrow is substantially destroyed, then (3) the stem cells previously collected from the patient’s own (“autologous”) marrow or blood is reinjected. If all goes well, the reinjected stem cells will repopulate the patient’s bone marrow system over the next several weeks. During that time, the patient is at risk of life threatening infections or bleeding.
5. The Plaintiff contends that she is due benefits from Defendant for HDC-AR. The Defendant contends that HDC-AR is not “medically necessary” under the contract of insurance issued to Plaintiff. There exists a justiciable controversy between the parties as to their respective rights or obligations under the subject contract.
6. The delivery of HDC-AR at the University of Chicago Medical Center was, at all relevant times, subject to supervision by that institution’s Institutional Review Board (“IRB”). The primary function of the IRB was to protect the rights and welfare of human subjects involved in biomedical research. The IRB was organized pursuant to regulations promulgated by the United States Food and Drug Administration and the United States Department of Health and Human Services (see, 21 C.F.R. §§ 50.1 et seq.; 45 C.F.R., §§ 46.101, et seq.).
7. Pursuant to the regulations, Dr. Williams and others prepared a detailed, written description of the HDC-AR procedure which was delivered to the IRB. Such a written description is called a “protocol.” The protocol was approved by the University of Chicago Medical Center IRB. Dr. Williams and her collaborators were under a duty to make no misrepresentation of fact in the protocol document. The protocol under which Plaintiff was treated stated, among its objectives, determination of the activity and toxicity of HDC-AR in persons with stage III or IV breast cancer.
8. Pursuant to the regulations, Dr. Williams and others submitted to the University of Chicago IRB an informed consent document. The informed consent document was approved by the IRB together with the protocol under which Plaintiff was treated. Dr. Williams and her collaborators were under a duty to make no misrepresentation of fact in the informed consent document. One of the requirements imposed upon Dr. Williams and her collaborators by the University of Chicago IRB was that they identify, in the informed consent document, any and all experimental procedures. Plaintiff was required to execute the approved informed consent document as a precondition to receipt of HDC-AR. The informed consent document which Plaintiff executed identified HDC-AR as an “experimental” procedure.
9. The University of Chicago Medical Center is engaged in research to determine whether HDC-AR can treat breast cancer more effectively than is possible with conventional therapies. The answer to that question is not yet known scientifically.
10. Within the authoritative medical literature there appear numerous statements indicating that, as applied to breast cancer, HDC-AR is considered experimental, investigational or nonstandard. Plaintiff has produced no authoritative medical literature containing statements indicating that, as applied to breast cancer, HDC-AR is considered standard or conventional treatment.
11. The use of HDC-AR in breast cancer is substantially confined to academic research institutions pursuant to protocols approved and supervised by IRB’s.
12. Plaintiff’s breast cancer got neither better nor worse as a result of HDC-AR.
13. Plaintiff’s and Defendant’s expert witnesses agree that HDC-AR could have been omitted from Plaintiff’s treatment without adversely affecting her condition or the quality of her medical care.
14. HDC-AR is considered experimental as applied to breast cancer. HDC-AR could have been omitted from Plaintiff’s treatment without adversely affecting her condition or the quality of medical care. HDC-AR is not appropriate and consistent with a diagnosis of stage IV, metastatic breast cancer in accord with accepted standards of community medical practice.
Having so found, the Court further determines that the material facts defining the controversy between Plaintiff and Defendant are not in dispute and that construction of the relevant portions of the contract of insurance is a matter of law for the Court. Epstein v. Hartford Casualty Insurance Co., 566 S.2d 331 (Fla. 1st D.C.A. 1990); Jaar v. University of Miami, 474 S.2d 239 (Fla. 3rd D.C.A. 1985); Ellenwood v. Southern United Life Insurance Co., 373 S.2d 392 (Fla. 1st D.C.A. 1979). Given the contract language here, its reasonable, practical and sensible interpretation, it is the Court’s determination, as a matter of law, that the procedure at issue was not “medically necessary” as the contract defines that term. See, Allstate Insurance Co. v. Shofner, 573 S.2d 47 (Fla. 1st D.C.A. 1990); Saha v. Aetna Casualty and Surety Co., 427 S.2d 316 (Fla. 5th D.C.A. 1983).
IT IS, THEREFORE, ORDERED AND ADJUDGED that Defendant’s Motion for Summary Judgment be, and same hereby is, GRANTED. The Court hereby enters this Final Summary Judgment in favor of Defendant, Mutual of Omaha Insurance Company. It is further ordered that Plaintiff take nothing from this action and that Plaintiff and Defendant each bear their own costs and fees.
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