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Stewart v. Cleveland Clinic Foundation

12/6/1999

Plaintiffs-appellants appeal from the trial court order granting summary judgment in favor of defendants-appellees. For the reasons adduced below, we affirm in part, and reverse and remand in part.


A review of the record on appeal indicates that Mr. Daniel Klais utilized the Cleveland Clinic Foundation ("Cleveland Clinic") as his medical care provider. During Klais' annual physical examination in March 1990, his primary family practice physician at the Cleveland Clinic, Dr. Cheryl Weinstein, diagnosed as a cyst two centimeter by two centimeter nodule found on his neck. During a subsequent visit on May 21, 1990, Weinstein observed further swelling on the patient's neck and two additional nodules. At this point, Weinstein suspected a cancerous condition and referred the patient to Cleveland Clinic Dr. Pierre LaVertu, who specialized in head and neck oncology. The biopsy of the suspect site ordered by LaVertu on Klais's neck indicated Stage IV squamous cell carcinoma originating at the base of the tongue (an oropharyngeal tumor). Stage IV of this type of cancer is considered an advanced stage of the disease. This test result was given to Klais and he was informed that he had a twenty-five percent chance of living five additional years.


LaVertu then referred Klais to Dr. Adelstein of the Cleveland Clinic's Oncology Department. Klais's first meeting with Adelstein was on June 4, 1990. During this meeting, Adelstein explained to Klais and his wife that there was a Phase III clinical trial at the Cleveland Clinic studying the treatment of squamous cell head and neck cancer using experimental preoperative chemotherapy in addition to the standard treatment of radiation and surgery. Research subjects within the clinical study were to be randomly assigned between two subject groups. The "Arm A" subjects were to receive only radiation therapy and surgery, the customary, standard treatment; no chemotherapy. The "Arm B" subjects were to receive preoperative chemotherapy coupled with radiation and surgery. Regardless of which Arm a subject was assigned, that subject was informed as to what treatment protocol they were to receive within the trial. Thus, it was not a blind study and it did not utilize placebos. Adelstein informed the couple that the patient was an ideal candidate to be included in the clinical study and sought the patient's consent to include him as a research subject. Adelstein, in addition to informing the patient of procedures, alternative therapies, and the risks and benefits of the clinical trial, informed the patient that he had two options. First, the patient could elect not to participate in the clinical trial and be treated with the standard treatment protocol of radiation and surgery or, second, the patient could elect to join the clinical trial where at least he had a fifty percent chance of receiving chemotherapy. Adelstein considered the effects of chemotherapy, at that point in time, to be speculative. Klais and his wife also met with Oncology Nurse Marjorie Larto, R.N., Adelstein's oncology research nurse, who further discussed the clinical trial and exchanged information and answers with the couple. While testifying about the treatment he received, Klais stated the following in response to questioning:


"Mr. Cunningham: Now, Dan, before you began your cancer treatment in 1990 did anyone at The Cleveland Clinic inform you about any studies that had already been done evaluating the effects of radiation and chemotherapy on persons having head and neck squamous cell cancer, like you were diagnosed with?


"MR. BONEZZI: Objection.


"THE WITNESS: No.


"MR. CUNNINGHAM: Now, before you began your cancer treatment in 1990 did anyone at

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