The Issue The issue for determination is whether respondent committed the offenses set forth in the administrative complaint and, if so, what action should be taken.
Findings Of Fact Craig William Herman, M.D. (Respondent) is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME0043959. Respondent has been licensed in Florida since 1984. Respondent is Board certified in urology. On March 27, 1992, Patient E. G., a forty-five year old male, presented to Respondent for a male fertility evaluation. When a patient presents for an infertility evaluation, it is appropriate for a urologist to obtain a urologic history and to evaluate urologic problems. Patient E.G.'s history was consistent with his chief complaint of infertility. His history includes that, during his seven years of marriage to his first wife no children were conceived even though no contraceptives were used and that, after remarrying, Patient E.G.'s second wife was not able to conceive even though she had a child from her previous marriage. Respondent's further evaluation of Patient E.G. on March 27, 1992, revealed that Patient E.G. suffered from urinary hesitancy and nocturia two to four times per night. The nocturia and urinary hesitancy are symptoms of an outlet obstruction. Additionally, on March 27, 1992, Respondent performed a physical examination including a digital rectal examination. The examination revealed, among other things, that Patient E.G. had a firm 2+ prostate and bilateral varicoceles. A firm 2+ prostate indicates an enlarged and suspicious prostate. Respondent also performed various tests on this first visit. He took a urine culture and performed a urinalysis, a bladder ultrasound scan (echography) and a prostate ultrasound scan (transrectal ultrasound). Respondent had a concern for possible prostate infection and outlet obstruction. The bladder ultrasound, which is a non-invasive procedure, was performed to address this concern and was medically indicated. Because of the abnormality of the prostate, the prostate ultrasound was performed to evaluate the prostate and was medically indicated. The prostate ultrasound or transrectal ultrasound of the prostate revealed a hypoechoic region of the prostate. Such a result was positive and Respondent interpreted it as suggestive of a lesion or carcinoma of the prostate. Patient E.G.'s urine culture, urinalysis, and bladder ultrasound scan produced normal results. Included as a procedure on this first visit was a semen analysis. Respondent sent Patient E.G. to Holy Cross Hospital for the analysis. The results of the analysis, which were received on March 30, 1992, reported a low sperm count and low motility. On April 3, 1992, Patient E.G. returned to Respondent for a follow-up appointment. On this second visit, Respondent performed or ordered several tests on Patient E.G.: repeat urinalysis, repeat urine culture, repeat prostate ultrasound, a prostate biopsy, renal and scrotal ultrasound, SMAC-25, free testosterone, prolactin, prostate specific antigen (PSA) blood test, and uroflometry. The prostate biopsy was medically indicated due to Patient E.G.'s firm prostate discovered during the digital rectal examination and due to the observation of the hypoechoic region. Respondent performed the biopsy, using the transrectal prostate ultrasound as guidance. The biopsy revealed an abnormal, benign growth known as hyperplasia. As Patient E.G.'s transrectal biopsy procedure was performed in Respondent's office, Respondent was not required to prepare a biopsy operative report. A copy of the pathology report for the biopsy procedure was in Respondent's medical records for Patient E.G. The scrotal ultrasound, as an evaluative procedure for a fertility patient, was medically indicated. The ultrasound was used as an objective procedure to review Patient E.G.'s bilateral varicoceles. The hormonal tests, consisting of testosterone and prolactin, were medically indicated as part of the fertility evaluation. An evaluation of Patient E.G.'s hesitancy was medically indicated, using the uroflometry as the evaluative procedure. The results were abnormal which suggested obstructive uropathy or bladder outlet syndrome. Because of Patient E.G.'s abnormal uroflow results and enlarged prostate, Respondent determined that Patient E.G.'s upper and lower urologic tract should be examined. The renal ultrasound was medically indicated to assist in determining whether an obstruction existed within the upper urologic tract. The results from the renal ultrasound revealed a suspicious cyst or mass in Patient E.G.'s left kidney. A follow-up ultrasound on the left kidney was medically indicated. The second ultrasound was performed on April 13, 1992. The results of all the remaining tests were within normal limits. Subsequently, on April 13, 1992, Patient E.G. returned to Respondent for another follow-up appointment. On this third visit, Respondent performed the following procedures: repeat urinalysis, repeat urine culture, and repeat ultrasound scan of the left renal unit (kidney). Bilateral renal ultrasounds are more common than an ultrasound of only the left kidney. However, no cost evidence was presented regarding the cost of a bilateral ultrasound versus a unilateral renal ultrasound. Patient E.G.'s ultrasound scans and tests performed on April 13, 1992, all produced normal results. All of the ultrasound examinations, except for one renal examination, conducted during Patient E.G.'s three visits were performed in Respondent's office. On all three visits, Respondent ordered Patient E.G.'s urine to be tested. The tests consisted of a urinalysis, culture, and sensitivity which are diagnostics procedures used to detect infection. If there is a concern about an infection, it is medically indicated to order these tests during each visit. Respondent had a concern regarding infection on each office visit. Patient E.G.'s infertility, his exhibited urologic symptomatology and his low semen volume are indicators of infection. Furthermore, after the biopsy, which is an invasive procedure, testing is appropriate to determine the presence of an infection. The urinalysis, culture and sensitivity were all medically indicated tests for each of Patient E.G.'s visits. Respondent's medical records included the specific laboratory results of each test which was performed on Patient E.G. As to the ultrasounds, Respondent is not required to prepare an independent written evaluation of an ultrasound film when the films are present in the chart unless a formal reading is requested. The ultrasound films were present in the chart, and no formal reading of the films was requested. Respondent practiced medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar Board certified urologist as being acceptable under similar conditions and circumstances. Respondent's medical records justify the course of treatment of Patient E.G. Respondent did not exploit Patient E.G. for financial gain.
Recommendation Based on the foregoing Findings of Fact and Conclusions of law, it is RECOMMENDED that the Board of Medicine dismiss Counts One, Two and Three of the administrative complaint. DONE AND ENTERED this 5th day of April, 1996, in Tallahassee, Leon County, Florida. ERROL H. POWELL, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 5th day of April, 1996. APPENDIX The following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact Partially accepted in finding of fact 1. Partially accepted in finding of fact 2. Partially accepted in finding of fact 3. Partially accepted in finding of fact 3. Partially accepted in finding of fact 5. Partially accepted in finding of fact 9. Partially accepted in finding of fact 13. Partially accepted in finding of fact 12. Partially accepted in finding of fact 14. Partially accepted in finding of fact 14. Partially accepted in finding of fact 15. Partially accepted in finding of fact 15. Partially accepted in finding of fact 17. Partially accepted in finding of fact 25. Partially accepted in finding of fact 25. Partially accepted in finding of fact 27. Rejected as being argument, or a conclusion of law. Partially accepted in finding of fact 3. Rejected as being contrary to the greater weight of the evidence. Partially accepted in finding of fact 7. Partially accepted in findings of fact 7, 13, and 24. Partially accepted in findings of fact 15 and 24. Partially accepted in findings of fact 7 and 8. Rejected as being contrary to the greater weight of the evidence. Rejected as being contrary to the greater weight of the evidence. Rejected as being contrary to the greater weight of the evidence. Partially accepted in finding of fact 28. Rejected as being contrary to the greater weight of the evidence. Rejected as being contrary to the greater weight of the evidence. Rejected as being contrary to the greater weight of the evidence. Respondent's Proposed Findings of Fact Partially accepted in finding of fact 1. Partially accepted in finding of fact 2. Rejected as being unnecessary, argument, or conclusion of law. Rejected as being unnecessary, argument, or conclusion of law. Rejected as being unnecessary, argument, or a conclusion of law. Rejected as being unnecessary, argument, or a conclusion of law. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in finding of fact 3. Partially accepted in finding of fact 4. Partially accepted in finding of fact 5. Partially accepted in finding of fact 7. Partially accepted in finding of fact 8. Partially accepted in findings of fact 6, 8, 10 and 11. Partially accepted in finding of fact 6. Partially accepted in findings of fact 6, 9 and 10. Partially accepted in finding of fact 10. Partially accepted in findings of fact 9 and 11. Rejected as being unnecessary, argument, or a conclusion of law. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in finding of fact 12. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in findings of fact 15 and 16. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in finding of fact 16. Partially accepted in finding of facts 12 and 17. Partially accepted in finding of facts 15 and 19. Partially accepted in finding of fact 19. Partially accepted in findings of fact 15 and 20. Partially accepted in findings of fact 15 and 21. Partially accepted in finding of fact 22. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in findings of fact 15 and 22. Partially accepted in finding of fact 23. Partially accepted in finding of fact 26. Partially accepted in finding of fact 29. Partially accepted in finding of fact 29. Partially accepted in finding of fact 30. Partially accepted in finding of fact 30. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in finding of fact 34. Partially accepted in finding of fact 34. Partially accepted in findings of fact 10, 11, 16, 20, 21, 22, 23, 29, 30, and 34. Rejected as being unnecessary, argument, or a conclusion of law. Partially accepted in finding of fact 32. Partially accepted in finding of fact 33. Partially accepted in finding of fact 31. Partially accepted in finding of fact 18. Partially accepted in finding of fact 33. NOTE: Where a proposed finding has been partially accepted, the remainder has been rejected as being irrelevant, unnecessary, cumulative, contrary to the greater weight of the evidence, argument, or a conclusion of law. COPIES FURNISHED: Hugh R. Brown Staff Attorney Agency for Health Care Administration, Board of Medicine 1940 N. Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Mark A. Dresnick, Esquire Grand Bay Plaza, Suite 201 2665 South Bayshore Drive Miami, Florida 33130 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32309 Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308
The Issue The issue in this case is whether the Board of Medicine should discipline the Respondent, Carlos C. Soriano, M.D., on allegations contained in an Administrative Complaint filed against the Respondent in DPR Case No. 89-05941: namely, allegations that the Respondent practiced medicine below the acceptable level of care, skill and treatment, in violation of Section 458.331(1)(t), Fla. Stat. (1993), by failing to offer one of his patients the option of radiation therapy or chemotherapy for cancer of the rectum and by inappropriately delaying treatment for the condition.
Findings Of Fact The Respondent, Carlos C. Soriano, M.D., is a physician licensed in the State of Florida, holding license number ME 0024149. In late 1988 and early 1989, the Respondent, Carlos C. Soriano, M.D., was the medical director of a health maintenance organization called Gold Plus. On or about October 24, 1988, a physician at Gold Plus examined the patient in question, a 90 year-old female in apparent good health for her age, and made a preliminary diagnosis of suspected cancer of the rectum. She referred the patient to the Respondent, a surgeon, for further evaluation and treatment. The Respondent examined the patient on October 31, 1988. He confirmed his associate's preliminary diagnosis of cancer of the rectum but pointed out that a flexible sigmoidoscopy with biopsy would be necessary to make a final diagnosis and to determine the kind of cancer involved. The diagnostic procedure was scheduled for November 17, 1988. The Respondent also discussed with the patient that, due to her age and the size and extent of the tumor, surgical removal of the tumor may not be appropriate. The Respondent suggested that the best course might be to perform a palliative colostomy, if necessary, and "let nature take its course." The patient was not pleased with the Respondent's attitude and consulted a nephew, who was a physician, for advice. The nephew referred the patient to another physician, who was a gastroenterologist, for a second opinion. The gastroenterologist examined the patient on or about November 8, 1988, prepared a report for the referring physician, with copies also sent to the patient and to the Respondent. The gastroenterologist's report recommended: a colonoscopy and biopsies like those already scheduled by the Respondent; a complete work-up preliminary to surgical removal of the tumor (including CEA levels, a liver/spleen scan, chest X-ray, and CT scan of the pelvis) to determine whether the cancer had metastasized; and (3) radiation therapy if there was no evidence of metastasis, or palliative radiation prior to snare polypectomy or laser fulguration, to avoid the necessity of a colostomy in the future if there was evidence of metastasis. The Respondent performed the flexible sigmoidoscopy and three biopsies as scheduled on November 17, 1988. He told the patient he would discussed the results with her as soon as they were received from the pathology laboratory. The Respondent received the pathology report and scheduled an appointment to discuss the results with the patient and her family (another nephew, and his wife) on November 30, 1988. The pathology report on the biopsies confirmed that the tumor was malignant. The report stated that the cancer was coacogenic. At the time, and to this day, radiation therapy and chemotherapy is not considered effective curative treatment for coacogenic carcinomas. Assuming the accuracy of the report, the only course of possible effective curative treatment for the patient was surgical removal. Whether or not the cancer had spread, the Respondent did not think surgical removal was appropriate for the patient, due to her age and the size and extent of the tumor. He did not think she would tolerate the kind of surgery that would be required. The decision whether to perform a particular surgery on a particular patient requires the exercise of the physician's professional medical judgment. Such a judgment cannot be made without a knowledge of the patient, through history and physical examination. It is found that, based on all of the evidence, including the Respondent's knowledge of the patient, through history and physical examination, the Respondent's medical judgment not to recommend surgical removal of the patient's tumor was not below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. During the meeting with the patient and her family on November 30, 1988, the Respondent explained the results of biopsies and what he considered to be the treatment alternatives. He told them that he would not recommend surgical removal, due to the patient's age and the size and extent of the tumor. He mentioned but did not elaborate on the possibility of radiation therapy because he did not know much about it. He suggested that the patient consider a colostomy to bypass the tumor and to "let nature take its course." He informed the patient and her family that he would be out of the country on vacation for the next four weeks but that she should make an appointment to see him after the holidays. Meanwhile, he would have someone research for him whether radiation or other alternative treatment modes were appropriate. It is found that the Respondent's failure to recommend radiation therapy or chemotherapy was not below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Radiation therapy and chemotherapy is not considered effective curative treatment for coacogenic carcinoma. Assuming the accuracy of the pathology report on the biopsy, the only course of possible effective curative treatment for the patient was surgical removal. Subsequent events revealed that the patient's cancer was not coacogenic but rather squamous cell carcinoma. (It is not uncommon for biopsy reports to make such an error due to the relatively small size of the biopsy sample.) But even if the biopsy report had shown that the patient suffered from squamous cell carcinoma, it could not be found that the Respondent's failure to recommend radiation therapy or chemotherapy was below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. In 1988 and 1989, the medical community did not recognize radiation therapy or chemotherapy as an acceptable curative treatment for squamous cell carcinoma of the anus. Once again, the patient became anxious that the Respondent was not offering any curative treatment plan. She asked whether the Respondent should not at least have a liver/spleen scan done to see if the cancer had metastasized. Since the Respondent was not recommending surgery (the only possible curative treatment), he did not think a liver/spleen scan would serve any useful purpose. But to satisfy the patient, and because it was one of the gastroenterologist's recommendations, he agreed to schedule one for the patient before he left for vacation. The patient scheduled a follow-up appointment for January 9, 1989. Meanwhile, the Respondent left for vacation, and the liver/spleen scan was performed on December 8, 1988. In the Respondent's absence, Gold Plus delayed giving the patient the results of the scan. She became more and more anxious as time went by. When the patient called for the results, she initially was told that Gold Plus could not give her the results until the Respondent returned. It took an angry telephone call from the wife of the patient's nephew on the day before Gold Plus closed for the Christmas holiday for Gold Plus to agree to allow another of its physicians discuss the results of the scan. The patient was promised that the physician would call the next day. Still, no call came, and the wife of the patient's nephew called again just hours before the office closed for Christmas. The patient and her family were told that the results of the scan were negative. This distasteful experience further soured the patient's relationship with Gold Plus and, by extension, with the Respondent, and they lost faith in the Respondent and his medical practice. Instead of seeing the Respondent on January 9, 1989, as scheduled, the patient cancelled the appointment and made another appointment to see the gastroenterologist again. By this time, the tumor had grown to some extent and, along with it, the patient's discomfort. It was difficult to even examine the patient's rectum either digitally or by flexible sigmoidoscopy. The gastroenterologist agreed to refer the patient to another surgeon for possible surgical removal of the tumor. The patient initiated disenrollment from Gold Plus so that her Medicare could be reinstated to cover the anticipated surgery. The gastroenterologist asked the Respondent for the patient's medical records. The Respondent's care of the patient and responsibility for the care of the patient effectively ended when the patient cancelled her appointment on January 9, 1989. Another appointment with the gastroenterologist was scheduled for February 1, 1989, in anticipation of imminent surgery. Surgery was scheduled for February 14 but, after the patient's admission, was postponed to February 17, 1989. Initially, the patient's recovery from surgery was slow, and she remained hospitalized until March 14, 1989. Subsequent events raise questions whether the surgery was effective or worth the trauma. It is debatable how well the patient tolerated the surgery. It appears that she did not ever recover the level of physical vigor and energy she had before surgery. During the summer of 1989, the cancer reappeared on her coccyx and had to be treated by radiation. By the fall of 1989, another abdominal perineal resection was necessitated by the reappearance of the cancer in her rectum. Based on the best expert testimony available at the hearing, it cannot be found that the time that went by during the Respondent's treatment of the patient was "substantial," i.e., that it contributed to the spread of the patient's cancer. Notwithstanding the results of the liver/spleen scan, which was not definitive or even very useful in evaluating the patient's cancer for metastasis, it is probable that the patient's cancer already had metastasized by the time the Respondent first saw the patient. The Respondent clearly did not inordinately delay the flexible sigmoidoscopy with biopsy or his discussion of the results and treatment alternatives with the patient. The only questionable delay was the four-week delay caused by the Respondent being out of the country on vacation; by the time he was scheduled to see the patient on his return, she had terminated his care and treatment. There was no evidence on which it could be found that this delay was below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order dismissing the Administrative Complaint against the Respondent. RECOMMENDED this 21st day of March, 1994, in Tallahassee, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of March, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-5068 To comply with the requirements of Section 120.59(2), Fla. Stat. (1991), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1.-4. Accepted and incorporated to the extent not subordinate or unnecessary. 5.-6. The date of the procedure was November 17, not November 11. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 7.-10. Accepted and incorporated to the extent not subordinate or unnecessary. "[A]pproximately four (4) weeks after the Christmas holidays" rejected as not proven and as contrary to the greater weight of the evidence. (He said "in four weeks, i.e., after the Christmas holidays.") Accepted and incorporated. Rejected as not proven and as contrary to the greater weight of the evidence that it was just "for a second opinion." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 14.-15. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven and as contrary to the greater weight of the evidence that the gastroenterologist made such a determination; rather, the subsequent surgeon did. Also, rejected as not proven and as contrary to the greater weight of the evidence that the surgery was "successful." In some senses it was, in other senses it was not. Rejected as not proven and as contrary to facts found. 18.-19. Accepted but subordinate to facts contrary to those found, and unnecessary. 20. Both as to the growth of the tumor and as to the evidence of metastasis, rejected as not proven and as contrary to the greater weight of the evidence. (The liver/spleen scan was negative, but the best expert testimony presented as the hearing indicated that subsequent events showed prior metastasis.) 21.-22. Rejected as not proven and as contrary to facts found. (The evidence was that those treatments were not alternative curative treatments. The Respondent was not given an opportunity to use them palliatively.) 23. Rejected as not proven and as contrary to facts found. Respondent's Proposed Findings of Fact. For purposes of these rulings, the Respondent's unnumbered paragraphs of proposed findings of fact are assigned consecutive numbers. 1.-3. Accepted but subordinate and unnecessary. 4.-6. Accepted and incorporated to the extent not subordinate or unnecessary. 7. As to the second sentence, a "transverse colostomy" was discussed, not a "transverse colonoscopy." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 8.-9. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to facts found and to the greater weight of the evidence that there was no delay. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. Subordinate and unnecessary. COPIES FURNISHED: Barbara Makant, Esquire Steven A. Rothenburg Senior Attorney Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792 Hugh Smith, Esquire P. O. Box 3288 Tampa, Florida 33601 Dr. Marm Harris Executive Director Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, Esquire Acting General Counsel Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether the medical services prescribed for the Petitioner are experimental or investigative under terms of the state insurance contract, and excluded from coverage.
Findings Of Fact The Petitioner, John M. Compton, is 55 years of age, and has been an employee of the State of Florida for 21 years and 2 months. Mr. Compton is a participant in the State of Florida Employees' Group Health Self Insurance Plan (Group Plan), and entitled to coverage in accordance with the provisions of the Group Plan. The Respondent is the Division of State Employees' Insurance, Department of Management Services (Department) which is charged with the administration of the Group Plan. BCBS is the contract administrative agency for the Group Plan, and makes recommendations to the Administrator regarding covered procedures. In February 1992, the Petitioner was diagnosed by Dr. Mark Currie, a physician who specializes in treatment of diseases of the blood and cancer, with multiple myeloma, a form of cancer which attacks the blood and bone marrow. Dr. Currie treated the Petitioner using chemotherapy with good results; however, recognizing that the prescribed chemotherapy would be effective for a finite, but unknown period of time, Dr. Currie suggested intensive chemotherapy treatment with stem cell support upon relapse. Stem cell support is another term for bone marrow transplants which today includes withdrawing the blood from the donor, extracting the stem cells which form bone marrow cells, freezing these cells, and reintroducing them into the donor. This would be done after the Petitioner had had high dose chemotherapy which would kill his existing bone marrow. Chemotherapy utilizing the drugs which would be used in this procedure has been conducted for many years and the maximum dosages, maximum toxicity, and similar information have been investigated and studied in trials which have been concluded. This therapy is standardized treatment of the type administered by Dr. Currie and presumably covered by the plan. Bone marrow transplants using the procedure described above is a relatively new procedure, compared with the chemotherapy, but has been performed for four to five years and has been accepted as a standard treatment. Dr. Currie referred the Petitioner to Dr. Robert Joyce at Baptist for assessment as a subject for treatment upon relapse using a combination of the two procedures described in paragraphs 5, 6, and 7, above. Dr. Joyce is a physician experienced in bone marrow research and the treatment of diseases of the blood and bone marrow using chemotherapy and bond marrow transplants. Dr. Joyce was the principal investigator and primary physician in the program to which the Petitioner was referred. After examination, testing and an initial series of chemotherapy using the drugs used in the high dose therapy, Dr. Joyce determined that the Petitioner is an excellent candidate for this procedure because he does not have many of the diseased cells in his system and they are destroyed by the drugs used in the chemotherapy. For the maximum benefit, the procedure must be undertaken before the number of diseased cells increase in the Petitioner's system. This is what creates the urgency in these proceedings. Dr. Joyce requested a predetermination of coverage for the proposed procedure from the Group Plan's administration, BCBS, which recommended to the Group Plan's Administrator that the coverage was excluded as investigative or experimental. See Subsection G.28 of the Insurance Plan Benefit Document, Respondent's Exhibit 3. By letter dated March 15, 1995, the administrator denied coverage. The denial letter states erroneously that the proposed procedure is a Phase II investigation, which gave rise to efforts at hearing to show that the proposed procedure was not a Phase I, II or III investigation or experiment. The benefit document, Respondent's Exhibit 3, defines "Experimental or Investigative" as meaning: . . . any evaluation, treatment, therapy, or device which involves the application, admin- istration or use, of procedures, techniques, equipment, supplies, products, remedies, vaccines, biological products, drugs, pharmaceuticals, or chemical compounds if, as recommended by the Servicing Agent and determined by the Administrator: such evaluation, treatment, therapy, or device cannot be lawfully marketed without approval of the United States Food and Drug Administration or the Florida Department of Health and Rehabi- litative Services and approval for marketing has not, in fact, been given at the time such is furnished to the Insured; such evaluation, treatment, therapy, or device is the subject of an ongoing Phase I, II, or III clinical investigation or under study to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as compared with the standard means for treatment or diagnosis of the condition in question; that the consensus of opinion among experts is that further studies, research, or clinical investigations are necessary to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as compared with the standard means for treatment or diagnosis of the Condition in question; that such evaluation, treatment, therapy, or device has not been proven safe and effective for treatment of the condition in question, as evidenced in the most recently published medical literature in the United States, Canada, or Great Britain, using generally accepted scientific, medical, or public health methodologies or statistical practices; there is no consensus among practicing Physicians that the treatment, therapy, or device is safe and effective for the condition in question; or such evaluation, treatment, therapy, or device is not the standard treatment, therapy or device utilized by practicing Physicians in treating other patients with the same or similar condition. The testimony of Dr. Currie and of Dr. Joyce established that this procedure was not a Phase I, II, or III investigation; that this procedure is safe and effective within the acceptable limits of such therapies; and that there is a consensus that the procedure is safe and effective for the condition. The testimony of Dr. Joyce established that under the protocols under which the Petitioner would received the proposed treatment, information would be gathered on toxicity and on the efficacy of this treatment compared with current treatments. Deposition of Dr. Joyce, Page 113, line 9. The evidence also establishes that the treatment proposed is not the "standard" treatment for this disease. See Petitioner's Exhibit 8, Letter of September 28, 1994, Dr. Joyce to Dr. McLear attached to letter dated October 13, 1994, Dr. McLear to Dr. Joyce. Although these conditions do not define the treatment as even a Phase IV investigation, it does place the treatment within the exclusions (b) and (c) cited in Paragraph 11, above.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is, RECOMMENDED: That the proposed procedure be excluded under the terms of the State Group Plan. DONE and ENTERED this 13th day of April, 1995, in Tallahassee, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 13th day of April, 1995. APPENDIX TO RECOMMENDED ORDER Petitioner's Proposed Findings Paragraphs 1-9 Adopted and subsumed in paragraphs 1-8. Paragraphs 10-15 Adopted and subsumed in paragraphs 9-11. Paragraph 16 True, the plan does not name any specific procedure. Paragraph 17,18 There is no presumption regarding the proposed procedure as experimental. Paragraph 19,20 True, but unnecessary to resolve the legal and factual dispute. Paragraph 21-37 Subsumed in paragraph 12. Paragraph 38 Subsumed in paragraph 8. Paragraph 39 The study shows that the treatment is accepted as safe and effective, but does not address the issue of whether it is experimental. Further, the exclusion is not based upon the experimental nature of the procedure, but upon the fact that it would be excluded under specific language of the benefit plan. Paragraph 40,41 See comments to Paragraph 21. Paragraph 42-43 See comments to Paragraph 39. Paragraph 44 Subsumed in paragraphs 6,7. Paragraph 45-49 True, but not required for a determination of the issue. Paragraph 50 Subsumed in paragraph 8. Paragraph 51 Rejected as contrary to best evidence. Paragraph 52 Subsumed in paragraph 12. Paragraph 53-55 Rejected as argument. Paragraph 56 0True, but not required for a determination of the issue. Respondent's Proposed Findings Paragraphs 1-5 Paragraphs 1-4. Paragraphs 6,7 Not necessary for determination of the issue. Paragraphs 8-13 Paragraphs 3-8. Paragraphs 12 Deleted by Respondent. Paragraphs 14,15,16 Paragraphs 9-11. Paragraph 17 Paragraph 8. Paragraph 18 True, but not necessary for determination of the issue. The evidence tends to show that, notwithstanding the newness of the procedure, it is rapidly being accepted as the procedure of choice in treatment of this type of disease. Paragraph 19-23 Irrelevant. Paragraph 24 The information quoted is quoted from another source attributable to Dr. Joyce. Paragraph 25 Supports finding that the treatment is not standard, but is rejected for the purpose that it was apparently offered. Paragraph 26-29 Irrelevant. Paragraph 30,31 Conclusion of Law. Paragraph 32 Subsumed in findings that proposed procedure in not the standard treatment. Paragraph 33-39 Irrelevant. Paragraph 40 See comments to paragraph 32. Paragraph 41,42 Irrelevant. COPIES FURNISHED: Robert D. Newell, Jr., Esquire 817 North Gadsden Street Tallahassee, FL 32303 Augustus D. Aikens, Jr., Chief Benefit Programs and Legal Services Division of State Employees' Insurance 2002 Old St. Augustine Road, B-12 Tallahassee, FL 32301-4876 William H. Lindner, Secretary Department of Management Services Knight Building, Suite 307 Koger Executive Center 2737 Centerview Drive Tallahassee, FL 32399-0950 Paul A. Rowell, General Counsel Department of Management Services Knight Building, Suite 312 Koger Executive Center 2737 Centerview Drive Tallahassee, FL 32399-0950
Findings Of Fact Introduction At all times relevant hereto, respondent, Raul Romaguera, held physician license number ME 0010347 issued by petitioner, Department of Professional Regulation, Board of Medical Examiners (DPR). Romaguera has been licensed by the State since 1962. He now resides at 7810 South Flagler Drive, West Palm Beach, Florida. The initiation of this proceeding represents the first occasion on which he has been the subject of disciplinary action. Respondent is a graduate of Havana University where he received a degree in medicine in 1952. At that time, a medical degree required the completion of a seven year program. Between 1955 and 1962, Romaguera completed five years of residency in pathology at three hospitals in Tennessee and Florida. In 1962 he successfully completed the examination for licensure in Florida, and began working as a pathologist at a hospital in Boynton Beach. In 1973 respondent and certain other physicians founded Doctors' Hospital of Lake Worth, Inc. (DHLW). The hospital was eventually sold to Hospital Corporation of America in 1980. However, Romaguera has continued working as a pathologist at the facility. He is a board certified pathologist, having passed the board examinations in 1962. When the events herein occurred in 1979 and 1980, Romaguera was chief of the pathology department and director of the pathology laboratory at DHLW. In addition to supervising department and laboratory personnel, Romaguera also actively performed pathology services. The Discipline of Pathology and Its Use Pathology is a branch of medicine which studies diseases. This involves the clinical diagnosis of disease through the examination of tissues and organs by various laboratory methods. The discipline of pathology comes into play when tissue specimens are removed from a patient's body by a surgeon and then sent by the requesting physician to a pathologist for examination. This tissue is more commonly referred to as the gross specimen. Upon receipt at the laboratory, a histologist assigns it a number, records it in a book, and then refers it to the pathologist for the initial or gross examination. The pathologist examines the specimen, describes it for his records, and then cuts several small sections from the gross specimen. After the gross examination is completed, the sections are processed in formal in to dehydrate the tissue cells and make them firm. They are then injected with hot paraffin wax. The next morning the histologist prepares a "paraffin block" and places the blocks into a machine (microtome) where microscopic slides are cut. Thereafter, the sections are placed in a water bath to remove the paraffin and the tissue is then placed on glass slides. These slides are given to the pathologist for microscopic scrutiny. After reviewing them, the pathologist prepares a report, signs it, and returns the same to the requesting physician. In 1979 and 1980, Romaguera's department was handling between 6,000 and 7,000 cases per year. At that time, there were no more than four or five full and part-time pathologists in the department. Under then-existing DHLW procedures, the requesting physician filled out a form to be sent with the specimen. The form contained the patient's name, age, sex, hospital identification number (if any), clinical impression, radiological findings (if any), and the size and location of the lesion. If any other pertinent clinical information was known, it was the surgeon's responsibility to convey this to the pathologist. However, unless something out of the ordinary was present, no other communication between the pathologist and requesting physician took place. Lipoma or Liposarcoma? There are two types of soft-tissue tumors: lipoma and liposarcoma. The distinction between a lipoma and liposarcoma is not insignificant. A lipoma is a benign tumor while a liposarcoma is a malignant or cancerous growth. If a liposarcoma is diagnosed as being well-differentiated, it has a low malignant potential and is not growing rapidly. In this case, the controversy lies over a soft tissue tumor of a patient examined by respondent in 1980, and whether it was a lipoma or a well-differentiated myxoid liposarcoma. In September, 1980 a patient by the name of R.C. visited the offices of Dr. Nat Stephens, then a West Palm Beach family practitioner. R.C., a 42 year old male, was complaining of a lump which had formed just above his right knee. R.C. related to Stephens that the mass had formed some two years earlier, and had grown in size over that period of time. By September, 1980 it measured around 20x10cm, or 4"x8" by more commonly known measurements, had a feeling of "soft, fatty mass," and had a tumorous shape. Dr. Stephens' original impression was that the mass was a lipoma. Nonetheless, he promptly referred R.C. to Dr. Charles Matuszak, a local surgeon, with a recommendation that the tumor be excised and then examined by a pathologist. Dr. Matuszak is a board certified orthopedic surgeon. He admitted R.C. to DHLW on September 21, 1980. After admission, Matuszak had a right femoral arteriogram performed on R.C. on September 23. The radiologist made the following impression: There is an avascular soft tissue mass which does not show any evidence for malignant vessels or neoplastic change, radiographically. Additional X-rays revealed no erosion of the bone, and produced normal readings. It is noted West Palm Beach had no CT scan in 1980. R.C. was discharged on September 24 with a final diagnosis of "probable lipoma, pending pathology report." He was scheduled for elective surgery within the next few months to remove the mass. On December 7, 1980 R.C. was readmitted to DHLW for surgery. This was performed the next day. Matuszak described the surgery as "routine" and "a fairly straight forward procedure." He was able to "shell out" most of the mass although one part of the tumor had adhered to the periosteum over the right distal femur and required tying off a vessel. However, this was not unusual since even a benign tumor can adhere to the bone. The size of the mass was described in the hospital records as being 15x17cm. R.C. was later discharged on December 13. Although a surgeon can excise tissue from the patient, freeze it, and send it to pathology for immediate evaluation before the wound is closed, Matuszak elected not to do so since he did not suspect the tumor was malignant based on his own evaluation and a corresponding finding in the radiology report. Matuszak's final diagnosis was "lipoma of right thigh." A specimen of the tissue was forwarded by Matuszak to DHLW on December 8 with a request that an examination be made. The request contained R.C.'s name, age, admission number to hospital, room number, doctor and the following clinical impressions: Nature of specimen and clinical data: SOFT TISSUE MASS, RIGHT THIGH Pre-op Dx: Soft tissue mass, right thigh Post-op Dx: pending pathology This was the normal amount of information provided to a pathologist by a requesting physician. Romaguera does not specifically recall the R.C. specimen since he has handled thousands of specimens since that time. However, through the use of R.C.'s records, he again concluded there was nothing unusual about the request, or anything that required further consultation with Matuszak. In fact, neither Matuszak or respondent recall conferring about the case. When R.C.'s specimen arrived at the laboratory, respondent first made a gross inspection of the R.C. specimen along with 25 or 30 others, and then forwarded them to the histology section for entry into the log book. Records indicate the R.C. specimen was logged in on December 8, 1980, given surgical pathology number 2980, and assigned to respondent for examination. According to the pathology report, Romaguera's gross examination revealed the following: The specimen consists of an encapsulated tumoral mass measuring 11cm in diameter. The capsule is composed of thin transparent and translucent membrane. The tumor on sections shows a multilobulated fat undergoing focal degeneration. In other words, Romaguera observed a fatty tissue with a degeneration of the fat in certain areas. That is, some areas were "softer" than others, and had different colors. These were typical characteristics of a lipoma. Although there is no record of the number of sections made, Romaguera believes there were two or three. After the sections were processed that evening, the next morning Romaguera performed his microscopic examination of the specimen and concluded as follows in his report: Sections are of adipose tissue undergoing in certain places myxomatous degeneration and also exhibiting fibrous septation. Focal fresh hemorrhage is also seen. The tumor is encapsulated by fibrocollageneous tissue. The "focal fresh hemorrhage" was caused by the surgery and was not unusual. The fibrous septation was not indicative of malignancy while the mucoid like substances that were observed were not dispositive of a cancerous tumor. Romaguera accordingly reached a final diagnosis of "lipoma, right thigh." The pathology report was returned to Matuszak on December 9 with a lipoma diagnosis. Matuszak informed R.C. of these findings but told him there was a chance of recurrence even though the tumor was benign. After discharge, R.C. returned to Matuszak's office for several follow-up visits and was discharged in May, 1981. Had a diagnosis of malignancy been received, Matuszak would have referred R.C. to Shands Teaching Hospital and Clinics in Gainesville, Florida, a facility which specializes in the treatment of tumors. On November 27, 1984 R.C. returned to Matuszak's office with a recurrence of swelling and pain in his right thigh. A CT scan was ordered which revealed a well-encapsulated soft tissue mass anterior to the distal femur. Matuszak diagnosed this as a probable recurrent lipoma and admitted R.C. to DHLW on January 7, 1985. After a pathology report revealed the tumor was a low-grade malignancy, Matuszak referred R.C. to Shands for further treatment. At Matuszak's request, the DHLW pathology department was requested to review R.C.'s 1980 slides to determine if the original diagnosis was correct. This review resulted in different findings by other pathologists. Armed with this information, R.C. filed a malpractice suit against respondent, the first in respondent's career, and also turned the matter over to DPR. The agency's administrative complaint was thereafter issued which prompted this proceeding. The Experts' Opinions To determine if Romaguera's examination in 1980 was right or wrong, and whether his examination conformed with then prevailing standards, a number of experts were assembled by both sides to again review the slides in question. For DPR, they included an assistant medical examiner for Palm Beach County (Dr. Benz) who last did surgical pathology in the early 1970s, but who reviewed literature to become reacquainted with the specialty, a Boynton Beach board certified pathologist (Dr. Bickel) who once worked for respondent in 1974, and the video deposition testimony of a Daytona Beach board certified pathologist (Dr. McCann) who worked at DHLW from 1982 until October, 1986. Finally, depositions of three physicians who testified for R.C. in his malpractice suit against respondent were offered. In addition to his own testimony, Romaguera offered the testimony of the senior attending pathologist in surgical pathology and the chief of the cyto pathology department at Memorial Sloan Kettering Cancer Center in New York City (Dr. Hajdu). Of the four to five thousand soft tissue sarcomas diagnosed each year in the United States, around twenty five to thirty percent are referred to Hajdu's facility for consultation. Also having particular significance is Hajdu's membership on the American Joint Committee, a three person committee which sets the criteria to be used by pathologists throughout the nation in making evaluations such as the one being questioned. He has been a member of that committee for fifteen years. Finally, Hajdu is also a full professor at Cornell University Medical College. According to Dr. Benz, who is now a county medical examiner and specializes in forensic pathology, R.C.'s slides indicated immature fat cells, an increased number of blood vessels and areas of degeneration, all being characteristics that are indicative of a liposarcoma. In addition, the location of the tumor was a "favorite" place for a liposarcoma to occur. Benz conceded a soft tissue diagnosis is "extremely difficult" to make, but opined that the immature cells, richer vascular configuration and degeneration should have alerted respondent to suspect a malignancy and to obtain additional sections for examination and to obtain a second opinion. Although Benz has not been active in this area since the early 1970s, and had to review textbooks to refresh his recollection on the subject, he stated he knew after two minutes that the tissue was cancerous. He conceded he had been given other expert reports in advance which reached a similar diagnosis. Dr. Bickel, a practicing pathologist in Palm Beach County, also reviewed the slides in question on behalf of DPR and reached a conclusion that, in hindsight, he would have diagnosed the tissue as "suspected cancerous." He stated he would do so because of the "myxoid changes," individual cells that were more densely arranged, and the abnormal vascular pattern, all of which are signs calling for further investigation. However, he acknowledged that this was done in hindsight, and that it would have been "extraordinarily difficult" to determine if the tumor was malignant or benign in 1980. He also acknowledged having the benefit of the other DPR reports before making his examination. Dr. McCann, also a DPR expert, reached the conclusion that R.C.'s tissue was a well-differentiated liposarcoma. In doing so, he admitted he was "prejudiced" in the sense he already knew the diagnosis from other reports. He also conceded that there have been "significant advances in surgical pathology since 1980" when the slides were first examined. McCann noted the presence of lipoblast (or immature) cells on R.C.'s slides. Since males of R.C.'s age should not have immature adipose tissue, he concluded this was a sign of malignancy. He also noted that "statistically" the right thigh is the most likely place for a male to have a malignant tumor, but was not sure if these statistics were available in 1980. Finally, he pointed out that in the general practice of pathology at hospitals such as DHLW the occurrence of this type of malignant tumor was "rare." After McCann reviewed the slides, he forwarded his conclusions and the slides to the Armed Forces Institute of Pathology (AFIP), a military-operated organization in Washington, D.C., that performs pathology services for doctors throughout the nation. The AFIP diagnosis dated January 28, 1985 was as follows: Well differentiated liposarcoma with myxoid foci, low grade, right thigh. We fully agree with your diagnosis. This tumor displays both well-differentiated lipoma-like areas and prominent foci of myxoid change. These tumors may recur locally but have virtually no metastatic potential. Therapeutic considerations should include wide local excision and careful follow-up for recurrent growth. The AFIP report was prepared by Dr. Sharon A. Weiss, a well-known institute pathologist. Of the three depositions taken in the civil malpractice case and offered in evidence in this proceeding, two focused primarily on whether there was a metastasis as opposed to independent primary tumors in R.C.'s case, a matter irrelevant to this proceeding. The third (Dr. Kime) did not directly criticize respondent, but simply had a difference of opinion on respondent's diagnosis of the slides. He believed Romaguera had deviated from the prescribed standard of care. Dr. Steven I. Hajdu, who testified for respondent, is recognized by the medical community as a leading authority on the diagnosis and treatment of tumors. His testimony is found to be the most credible and persuasive in this case. He too examined R.C.'s original slides on behalf of respondent, as well as the depositions of Benz, Bickler and McCann. According to Hajdu, there is a grey area between a benign and a malignant tumor, and pathologists frequently do not make the proper distinction. If one diagnoses a benign tumor as cancer, it is a "major mistake" and can result in the patient losing his leg when in fact no cancer exists. Conversely, it is far less serious for a pathologist to incorrectly diagnose a low-grade malignancy as benign. Hajdu acknowledged that Romaguera made an error in his 1980 diagnosis. However, using the standards and knowledge that existed in 1980, Hajdu stated that he too would have probably erred. Indeed, Hajdu stated that in 1980 eight or nine out of every ten pathologists would have made the same diagnosis as Romaguera. Today, with more knowledge and skill, and under present standards, Hajdu said only two or three out of every ten pathologists would make the wrong diagnosis. Given the prevailing standards and knowledge at that time, Hajdu concluded, and the undersigned so finds, that Romaguera did not deviate from the standard of care, skill and :treatment expected of a pathologist in 1980.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a final order be entered finding respondent did not violate Subsection 458.331(1)(t), Florida Statutes, and that the complaint be dismissed, with prejudice. DONE AND ORDERED this 12th day of May, 1987, in Tallahassee, Leon County, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of May, 1987.
The Issue Whether Respondent, Steven A. Magilen, M.D., violated Sections 458.331(1)(m) and (t), Florida Statutes, as alleged in an Administrative Complaint signed April 2, 2001, and filed with the Department of Health on April 3, 2001, and, if so, the penalty that should be imposed.
Findings Of Fact The Department of Health, Board of Medicine, is the state agency charged with regulating the practice of medicine in Florida. Section 20.43; Chapters 456 and 458, Florida Statutes. Steven A. Magilen, M.D., is, and was at the times material to this proceeding, a physician licensed to practice medicine in Florida, having been issued license number ME 002082. Dr. Magilen received his medical degree from the University of Brussels in Belgium in June 1972. He received his license to practice medicine in Florida in 1973 and completed a residency in general surgery at Mount Sinai Medical Center, Miami, Florida, in June 1976. He has maintained a private practice in Florida since 1976. Dr. Magilen is board certified in general surgery. His general surgical practice focuses on colorectal surgery and proctology. He is experienced in the use of colonoscopy, having performed an average of between 250 and 300 colonoscopies per year since approximately 1979. Dr. Magilen's address is 21150 Biscayne Boulevard, Suite 400, Aventura, Florida 33180. Dr. Magilen has not previously been the subject of a disciplinary proceeding.1 D. M., a female, was initially seen by Eugene Eisman, M.D.,2 an internist, who has continued to see D. M. for at least the past ten years. As early as 1991, D. M. related a five-year history of intermittent abdominal pain. D. M. was referred by Dr. Eisman to Dr. Magilen in June 1995,3 complaining of years of constipation, which she indicated was becoming worse. She also complained of rectal bleeding. D. M. was in her mid-60's in 1995. Rectal bleeding is one of the most common problems seen by Dr. Magilen, who sees primarily older patients. Rectal bleeding can be caused by colonic (relating to the colon) disorders or anal disorders. The typical anal disorder found in adults which results in bleeding is hemorrhoids. Colonic disorders which cause rectal bleeding include polyps, colon carcinoma (cancer), inflammatory bowel disease, ulcerative colitis, Crohn's Disease, diverticulosis, diverticulitis, and appendicitis. While rectal bleeding may occur with diverticulitis, it is less likely than with only diverticulosis.4 The disorder which is most threatening to a patient of the disorders that can cause rectal bleeding is colon cancer. If not timely identified, colon cancer can spread to an extent that surgical intervention will be ineffective and the patient will ultimately die. The typical signs of colon cancer include a change in bowel pattern, such as diarrhea or constipation, rectal bleeding, abdominal pain, and, in later stages, weight loss. Because D. M. had reported rectal bleeding, Dr. Magilen first looked for signs of hemorrhoids. After finding no such signs, Dr. Magilen recommended to D. M. that she undergo a colonoscopy to explore whether she was suffering from a colonic disorder. A colonoscopy is one of the diagnostic tools available to determine whether polyps or colon cancer are present in a patient experiencing rectal bleeding. A colonoscopy allows the physician to visually evaluate subtleties of mucosal changes of the colon by visually inspecting the lumen, or inside lining of the colon. Any problematic or suspicious tissue can be collected during the colonoscopy for later biopsy. The colonoscopy is performed by inserting a flexible tube with fiber optic capabilities into the rectum and up through the colon. The colon is the lower six to eight feet of the gastrointestinal tract, which runs from the mouth to the anus. The colon consists of a muscular wall with an inner lining of mucosa and an outer layer of serosa tissue. Typically, approximately 50% of the colon is attached to the inside of the belly cavity (the abdomen) by a suspensory fibrous tissue. Colon cancer typically is found in the mucosal surface of the colon and is most prevalent in the left colon (the rectum, sigmoid colon, the descending colon, and the distal transverse colon). Because a colonoscopy is an invasive procedure, it is not without risks. Among the risks of performing a colonoscopy is the possibility that the patient's colon will be perforated. Despite Dr. Magilen's concern over D. M.'s rectal bleeding, D. M. ignored Dr. Magilen's recommendation and declined to undergo a colonoscopy in 1995. D. M. was next seen by Dr. Magilen in April 1996. D. M. complained of constipation and bright red bleeding on the toilet paper in the bowl. At Dr. Magilen's urging, D. M. agreed to and did undergo a colonoscopy on April 23, 1996. As a result of the procedure, Dr. Magilen found and removed a 3 millimeter benign sessile polyp5 and noted the presence of a small amount of diverticuli in her sigmoid colon.6 The sigmoid colon, which makes up the last portion of the colon and attaches to the rectum, is so-named because of its "S" shape. The sigmoid colon is more mobile and, therefore, has more variability in its position. It is, however, usually located on the lower left side of the abdomen. Diverticuli are "out-pockets" or bulges in the intestine. Their presence is referred to more specifically as "diverticulosis." In adults over the age of 65 years, approximately 75% have diverticuli somewhere in the colon. A finding of diverticulosis in older adults is, therefore, not an uncommon finding. D. M. next presented to Dr. Magilen on July 14, 1997. She was 68 years of age. She complained of upper and lower abdominal pain, a change in bowel habits, occasional bright red blood from her rectum, and nausea (without vomiting). The abdominal pain, which she reported had started approximately a week and a half prior to July 14th, was reported to be mainly in the upper abdomen. D. M.'s change in bowel habits were reported to be constipation despite an increase from one bowel movement a day to four to five bowel movements per day. She was considered constipated, even with the increased number of bowel movements, because she had also reported a sensation of incomplete evacuation, that her stool consisted of hard balls, and she had witnessed bright red blood on occasion. Dr. Magilen obtained D. M.'s medical history and conducted a physical examination on July 14th. D. M.'s pertinent medical history included the following: (a) she was a heavy smoker for 26 years (3 1/2 packs a day until she quit in 1981); (b) she consumed alcohol regularly (at least 3 glasses of wine per day); (c) she had previous lumpectomies of her breasts for benign tumors; (d) she had a cavernous hemangioma on her right thigh that was treated with radiation therapy and for which she suffered a recurrence and malignancy; (e) she had cancer removed from her toe; (f) she had several D & C's of her uterus; (g) she had a sessile polyp removed from her colon in 1996; and (h) she has diverticulosis. Dr. Magilen's physical examination of D. M. revealed that she had diffuse, non-localized abdominal tenderness with no masses or organomegaly. A vaginal and rectal examination of D. M. revealed uterine tenderness with no masses. An anoscopic examination of her rectum revealed internal hemorrhoids. Dr. Magilen found no indication of acute blood loss or bowel obstruction, and no signs, symptoms, or indications of acute decompensation from a colonic malignancy. Dr. Magilen's impression of D. M. on July 14th was that she was suffering from acute abdominal pain and that uterine pathology needed to be ruled out as the source of her problem. Dr. Magilen, therefore, planned to obtain a pelvic ultrasound, admit D. M. to the hospital for 23 hours, and obtain a gynecological consult. The pelvic ultrasound, which was performed outpatient on July 14th, revealed the presence of an ovarian cyst on D. M.'s left ovary and no masses in her uterus.7 No other abnormalities, malignancies, or uterine pathology were revealed by the ultrasound. At approximately 4:30 p.m. of July 14th, D. M. presented and was admitted to Aventura Hospital. A blood chemistry profile, a complete blood count, abdomen X-rays, abdomen and pelvis Computed Axial Tomography ("CAT" or "CT") Scans and a gynecological consult with Dr. Gross, a gynecologist, were ordered. A complete blood count was also ordered for July 15, 1997. D. M. was placed on "NPO" (nothing by mouth), meaning that she was allowed no food or liquids by mouth. She was also given Vistaril, a common relaxant, to help with her complaints of pain. D. M. was not suffering from fever at the time of her admission. Her blood chemistry and the complete blood count failed to reveal any increase in her white blood cell count or an increase in immature white blood cells, commonly referred to as a "shift to the left." D. M. was found to be evidencing signs of anemia, based upon a drop in her hemoglobin. D. M.'s hemoglobin as of April 1996 had been 12.7. As of her admission to Aventura in July 1997, D. M.'s hemoglobin had fallen to 11.4. D. M.'s X-rays were unremarkable. No significant distention or the presence of free air, soft tissue masses, or abnormal calcifications were indicated. The CT Scan was produced on July 14, 1997. The image of the CT Scan was transmitted to an on-call radiologist, Dr. Maria Rodriguez, for a preliminary interpretation. Although Dr. Rodriguez issued a preliminary fax report of her findings, Dr. Magilen did not receive the report. Dr. Magilen was, therefore, unaware of the findings made by Dr. Rodriguez when he made the decision at issue in this case. The CT Scan image was also reviewed by Karl Drehobl, M.D. Dr. Drehobl's findings and impressions were provided to Dr. Magilen in a written report. That written report was received and considered by Dr. Magilen. With regard to D. M.'s colon, Dr. Drehobl's report included the following findings and impression as a result of his review of the CT Scan image: . . . . THERE IS SIGMOID DIVERTICULOSIS PRESENT. THERE IS EVIDENCE OF SIGMOID WALL THICKENING. THERE IS INCREASED DENSITY IN THE REGION OF THE SIGMOID MESENTERY. NO DISCRETE FLUID COLLECTION OR ABSCESS IS NOTED. FINDINGS ARE SUGGESTIVE OF SIGMOID DIVERTICULITIS. NO FREE AIR OR FREE FLUID IS IDENTIFIED. THE REMAINDER OF THE BOWEL AND MESENTERY ARE NORMAL. IMPRESSION: FINDINGS SUSPICIOUS FOR SIGMOID DIVERTICULITIS. NO FREE AIR OR DISCRETE ABSCESS COLLECTION. . . . . Dr. Drehobl's findings8 were consistent with those reported by Dr. Rodriguez. Dr. Drehobl's finding of "increased density in the region of the sigmoid mesentery" meant that the fat adjacent to the colon was swollen or inflamed. Dr. Drehobl's finding of sigmoid wall thickening meant that there was an abnormal thickening of the wall of the colon and small bowel. Dr. Drehobl's impression of D. M., taking into account his findings from reading the CT Scan, the fact that there were diverticuli present in the same area, D. M.'s age, and her history of abdominal pain, was that there was a "strong possibility" that D. M. was suffering from "diverticulitis or inflammation of the diverticuli in that region." See page 20, lines 12-14, Petitioner's Exhibit 2. "Diverticulitis" is the inflammation of one or more diverticuli. The diverticuli become inflamed when an out-pocket becomes blocked. Fluid from the mucosal lining of the intestine becomes captured in the blocked out-pocket. Infection and/or inflammation then occurs. If untreated, in the later stages of diverticulitis, a blocked diverticuli can rupture into the pericolonic fat and/or form an abscess.9 CT Scans can be 85 to 90% accurate in diagnosing diverticulitis. Even so, the results of a CT Scan are only a guide, one of a number of tests available to the physician, which must be correlated by the treating physician with all the clinical findings concerning the patient, including the results of the physical examination, the patient's clinical symptoms and history, the results of other diagnostic tests, and the results of laboratory studies. Dr. Drehobl's findings and impression were, therefore, not dispositive. Dr. Magilen was required to take Dr. Drehobl's findings into consideration along with his clinical findings. Dr. Magilen, after speaking with Dr. Drehobl personally about his report, did just that. Dr. Magilen was not convinced that D. M. was suffering from diverticulitis. This conclusion was based upon a number of factors: Dr. Drehobl did not find any of the more specific signs of diverticulitis which CT Scans can show such as marked edema around the colon, abscesses within the mesentery, or segmental thickening. Dr. Drehobl's findings of increased density in the region of the sigmoid mesentery and sigmoid wall thickening were equivocal findings. Persons with diverticulosis, which D. M. was known to have, almost consistently evidence some thickening of the wall of the sigmoid colon; Because the results of the CT Scan were equivocal, the findings, in addition to supporting an impression of diverticulitis, also supported an impression of a number of other disorders, in and outside the colon, which Dr. Magilen had not yet been able to rule out: inflammation in another organ, such as the appendix or an adjacent loop or intestine; inflammation in a fallopian tube or an ovary; colon neoplasm, colitis, or other tumor of the colon; ischemic colitis, Crohn's disease, and inflammatory bowel disease; D. M. was not evidencing the classic symptoms of diverticulitis: Left-lower quadrant pain; Fever; and Increased white blood cells and a "shift to the left." The presence or absence of any one or more of these symptoms alone does not reasonably support a finding of diverticulitis or the absence thereof. But the absence of all three significantly reduced the possibility that D. M. was suffering from diverticulitis; and D. M.'s symptoms, including rectal pain, bright-red rectal bleeding (which is less likely to occur with diverticulitis) associated with bowel passage, vague abdominal discomfort that was not localized to any particular quadrant of the abdomen, and her sensation of incomplete evacuation could not all be explained by diverticulitis and were suggestive of other diagnosis which Dr. Magilen had not been able to rule out. D. M.'s hemoglobin, which had dropped from 12.7 in April 1996 to 11.4 upon her admission to the hospital, indicated some loss of blood which her body was not able to replace, could also have been symptomatic of the other problems suggested by the results of the CT Scan. Based upon the foregoing, and following a consult with Dr. Gross, Dr. Magilen's impression was that D. M.'s pathology was coming from her uterus and ovarian tubes. Between the evening of July 14, 1997, and the morning of July 15, 1997, D. M.'s condition improved. She exhibited minimal abdominal tenderness, she had a normal white blood cell count, she had no fever, and she was able to eat. Dr. Magilen decided to increase her diet and to discharge her home with directions to follow-up with Dr. Magilen and her gynecologist. Dr. Magilen prescribed Cipro, a broad spectrum antibiotic, to address what he believed was her pelvic inflammatory process. The day after she was released from the hospital, July 16, 1997, D. M. presented to Dr. Eisman. She complained that the abdominal pain had returned during the night of July 15th. Dr. Eisman conducted a physical examination of D. M. Dr. Eisman found an increase in pain on palpation of the cervix and generalized mild tenderness of the abdomen. Because the pain in D. M.'s abdomen was not located in the lower left- quadrant and in light of the pain on palpation of her cervix, Dr. Eisman was of the opinion that the likely cause of her pain was pelvic inflammatory disease. The etiology of her pain was, however, still unknown. Dr. Eisman had D. M. readmitted to Aventura and notified Dr. Magilen of the change in her condition. D. M. was readmitted with orders for blood chemistry and complete blood count, ultrasound of the pelvis, X-rays of the abdomen, CT Scan of the abdomen and pelvis, and NPO (except ice chips). She was given Phenergan and Demerol for pain and nausea. Dr. Magilen examined D. M. upon her admission to the hospital. He found that her abdomen was soft with minimal tenderness. A vaginal and rectal examination revealed uterine tenderness with no masses. These findings were consistent with those of Dr. Eisman and Dr. Gross. D. M. was still not experiencing fever. Flat and upright X-rays of D. M.'s abdomen revealed no significant abnormalities. D. M.'s blood chemistry studies and complete blood count indicated the presence of anemia, a significantly elevated sedimentation rate with no increase in white blood cell count and no "shift to the left." The CT Scan revealed some evidence of diverticulosis and slight edematous changes within the fat adjacent to the sigmoid colon consistent with diverticulitis. Dr. Magilen again discussed the CT Scan findings with the radiologist. Dr. Magilen was still concerned about those findings for most of the reasons indicated in Finding of Fact 41, supra. The radiologist's findings were still equivocal; the findings were still consistent with other disorders, which the radiologist acknowledged to Dr. Magilen, including a carcinoma or other inflammatory process inside or outside the colon; D. M. was not evidencing the three classic signs of diverticulitis; and her symptoms continued to support other findings. The ultrasound of D. M.'s pelvis was performed on July 17, 1997. The following findings and impressions were made as a result of the ultrasound: . . . . THERE IS A FIBROID LESION WITHIN THE LOWER UTERINE SEGMENT ADJACENT TO THE CERVIX MEASURING 2.7 X 2.3 X 2.6 CM. NORMAL ENDOMETRIAL STRIPE IS NOTED. NO ADDITIONAL UTERINE MASSES ARE NOTED. BOTH OVARIES ARE UNREMARKABLE IN APPEARANCE. THE RIGHT OVARY MEASURES 1.6 X .9 X 1.1 CM AND THE LEFT OVARY MEASURES 1.8 X 1 X 1 CM. NO ADNEXAL MASSES ARE NOTED. SMALL AMOUNT OF FREE FLUID IS NOTED WITHIN THE CUL-DE-SAC. IMPRESSION: LOWER UTERINE FIBROID LESION MEASURING 2.7 X 2.3 X 2.6 CM. NO ADNEXAL MASSES. SMALL AMOUNT OF FREE FLUID. The July 17, 1997, ultrasound found that the cyst which had been disclosed by the July 14, 1997, ultrasound was now gone. This fact, coupled with the fluid found in D. M.'s cul-de-sac (located in the rectal-uterine space, between the rectum and the posterior wall of the uterus and the vagina), could mean that the cyst had ruptured. The ultrasound also indicated that the uterus was 20 percent larger and that there was a two to three centimeter myoma or tumor in the lower uterine segment. These changes, which apparently took place over a two to three day period, and the results of D. M.'s physical examination (uterine tenderness and tenderness in the cul-de-sac), are consistent with pelvic inflammatory disease. The findings of the July 17, 1997, ultrasound could also explain the findings of edema and the change in sigmoid mesentery found by the CT Scan. Both Dr. Gross10 and Dr. Magilen concluded that it was likely that D. M. was, at least in part, exhibiting signs of pelvic inflammatory disease. Dr. Gross also concluded that, if her condition did not soon improve, a laproscopy11 would probably be required to determine the specific cause of D. M.'s complaints. Dr. Magilen was still concerned about the possibility of colon cancer or some other colonic disorder which the CT Scan and the ultrasound did not explain. Dr. Magilen's concern was based upon the following factors, which his conclusion about pelvic inflammatory disease and the CT Scans of July 14th and July 16th had not ruled out: The findings of the CT Scans and the impressions of the radiologists concerning diverticulitis had not ruled out the possibility that D. M. was suffering from some other colonic disorder, as explained in findings of fact 41 and 52; D. M. had undergone at least some treatment with antibiotics upon her release from the hospital on July 15th and undergone some bowel rest while in the hospital between July 14th and July 15th, and yet her complaints had persisted; and D. M.'s history (she is at some risk of cancer) and her complaints: she had unexplained or undefined abdominal and pelvic pain that had lasted for a week or two; she had been bleeding from the rectum and had rectal pain; she had had a change in her bowel pattern; and she had shown signs of anemia. Dr. Magilen decided to perform a colonoscopy on D. M. to be sure that D. M. was not suffering from a colonic disorder in addition to what he suspected was a pelvic inflammatory disease. The procedure was performed on July 18, 1997. It was performed easily and without apparent complication at the time. Dr. Magilen found uncomplicated diverticulosis but no other pathology, including colonic neoplasm, lesions, or malignancy. Subsequent to the completion of the colonoscopy on July 18th, D. M.'s condition rapidly deteriorated. D. M. experienced an acute abdomen, which is consistent with a possible perforation of the colon as a result of the colonoscopy. An abdominal X-ray, however, failed to reveal a perforation or the presence of free air in D. M.'s abdomen. D. M.'s condition did not improve on July 19th. Therefore, on July 20, 1997, Dr. Magilen performed exploratory surgery on D. M.'s abdomen. Dr. Magilen observed inflammation and abscesses on the outside of D. M.'s colon. Dr. Magilen also reported observing two perforations of her sigmoid colon. Dr. Magilen also found inflammation of the right ovary and tube and the presence of pus in the cul-de-sac. The pus was sampled for culture. Because of the two perforations Dr. Magilen believed he had observed, Dr. Magilen removed a large portion of the colon; he resected and placed a colostomy. Pathology of the resected portion of D. M.'s colon determined that the colon evidenced focal fibrinous hemorrhagic exudate, numerous deep diverticuli, and no neoplasm. Culture of the pus did not produce bacteria that would be expected from ruptured diverticuli. The culture was, however, consistent with a gynecologic origin. Pathology also failed to confirm Dr. Magilen's belief that there were two perforations in D. M.'s colon. These findings suggest that D. M. was suffering from a pelvic inflammatory disease, in particular, a tube and ovary on the right side; and that the inflammation may have adhered the tube and ovary to the sigmoid colon causing the symptoms evidenced by D. M. as opposed to diverticulitis. Conducting a colonoscopy in a patient with diverticulitis is generally considered counterindicated and may under certain circumstances constitute a deviation from the standard of care. A colonoscopy is counterindicated because it poses a greater risk of perforation by mechanical trauma-- disruption of the inside of the bowel wall by the scope used to perform the colonoscopy--for a patient suffering from diverticulitis. The colonoscopy also requires the injection of air into the colon which results in the colon being firmer and, thus, more prone to damage, especially if the patient is suffering from diverticulitis. A perforation of the colon can result in serious complications and can lead to death. Under normal circumstances, the preferred treatment of diverticulitis is to prescribe antibiotics, serial clinical examinations, and bowel rest. Absent some reasonable basis for deviation, the most prudent treatment of a patient suffering from acute diverticulitis who may also be suffering from a colonic disorder would be to treat the patient for the diverticulitis first and then, if deemed medically necessary, perform a colonoscopy after the diverticulitis has been resolved. Usually, the four to days it takes for antibiotics to be effective in treating diverticulitis, will not make any difference in a patient's oncologic situation. Even where it is suspected that there is another pathology in the colon, it may be prudent to calm the bowel and address the diverticulitis first before performing a colonoscopy. Despite the foregoing, if it is questionable whether a patient is in fact suffering from diverticulitis as opposed to some other process, the need for additional information concerning the patient must be weighed against the risk of performing a colonoscopy. Under these circumstances, clinical judgment concerning whether the colonoscopy should be performed must be exercised. The evidence in this case failed to prove that Dr. Magilen did not have a reasonable basis for proceeding with a colonoscopy of D. M. on July 18, 1997, despite the "suspicion" of diverticulitis reported as a result of the CT Scans of July 14th and July 16th. The normal course of treatment for diverticulitis was not followed in D. M.'s case by Dr. Magilen because Dr. Magilen was not convinced that D. M. was suffering from diverticulitis. As found, supra, Dr. Magilen concluded that D. M.'s clinical picture was unclear at best. In light of D. M.'s unclear clinical picture and Dr. Magilen's conclusions concerning the CT Scan findings, the evidence failed to prove that Dr. Magilen failed to realize that D. M.'s history, physical examination, and radiologic studies were consistent with a diagnosis of probable diverticulitis. In addition to D. M.'s unclear clinical picture and Dr. Magilen's reasonable conclusions concerning the CT Scan findings, Dr. Magilen was faced with the knowledge that Dr. Gross would in all probability perform a laproscopy on D. M. It was, therefore, reasonable for Dr. Magilen to proceed with the colonoscopy on July 18th without first treating D. M. with antibiotics and bowel rest. Dr. Magilen reasonably decided that it would be better to determine if there was any colonic disorder before the laproscopy was performed. Dr. Magilen wanted to avoid D. M. being placed under a general anesthesia and having some surprise problem with her colon discovered after the laproscopy was begun. The evidence, therefore, failed to prove that Dr. Magilen failed to practice medicine with the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances because Dr. Magilen failed to treat D. M. for diverticulitis with intravenous antibiotics and serial clinical examinations before performing the colonoscopy on July 18, 1997. Finally, the evidence failed to prove that Dr. Magilen failed to document justification for proceeding to perform a colonoscopy on D. M. on July 18, 1997.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered dismissing the Administrative Complaint against Steven A. Magilen, M.D. DONE AND ENTERED this 29th day of October, 2001, in Tallahassee, Leon County, Florida. LARRY J. SARTIN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 29th day of October, 2001.
The Issue Whether Respondent performed a wrong-site procedure in violation of section 456.072(1)(bb), Florida Statutes; if so, whether (and what) disciplinary measures should be taken against Respondent's license to practice medicine.
Findings Of Fact At all times relevant to this case, Dr. Lior, M.D., was licensed to practice medicine in the State of Florida, having been issued license number ME 74061, and was board-certified by the American Board of Dermatology. The Department has regulatory jurisdiction over licensed physicians such as Dr. Lior. In particular, the Department is authorized to file and prosecute an administrative complaint against a physician, as it has done in this instance, when a panel of the Board of Medicine has found that probable cause exists to suspect that the physician has committed a disciplinable offense. Here, the Department alleges that Dr. Lior committed one such offense. In the one-count Complaint, the Department charges that Dr. Lior violated section 456.072(1)(bb), "by performing or attempting to perform health care services on the wrong patient, a wrong-site procedure, a wrong procedure, or an unauthorized procedure or a procedure that is medically unnecessary or otherwise unrelated to the patient's diagnosis or medical condition." Dr. Akhtar's Examination On January 11, 2010, Patient S.L., a 74-year-old gentleman, presented to Asfa Akhtar, D.O., a general dermatologist employed by the Cleveland Clinic Florida, for an evaluation of a lesion inside his left ear. It was noted on that date that S.L. had a positive history for skin cancer. Dr. Akhtar performed a physical examination of S.L., and his contemporaneous note provides, in pertinent part, as follows: "Exam of the face, ears and hands reveal a pearly papule with rolled borders on the right helix."1/ On that date Dr. Akhtar's assessment included "R/O BCC-right helix." In other words, Dr. Akhtar wanted to rule out basal cell carcinoma on S.L.'s right helix. Dr. Akhtar's plan was to conduct a "shave biopsy." Prior to performing the biopsy, the location was marked with a pen and photographed. Dr. Akhtar then performed the biopsy by scraping skin cells of the surface skin of the suspicious area. The subsequent surgical pathology report provides, in pertinent part, as follows: Final Pathologic Diagnosis SKIN BIOPSY, RIGHT HELIX: NODULAR BASAL CELL CARCINOMA WITH SURFACE ULCERATION. TUMOR EXTENDS TO THE DEEP AND PERIPHERAL MARGINS OF BIOPSY. In correspondence dated January 20, 2010, Dr. Akhtar advised S.L. that the pathologic findings from the biopsy specimen of S.L.'s right helix confirmed a basal cell carcinoma. Dr. Akhtar recommended that it "be treated by a technique called Mohs Surgery to be certain as possible that it is completely removed." January 26, 2010 Consultation On January 26, 2010, S.L. presented to Dr. Lior for a Mohs surgical consultation. In addition to being board-certified in dermatology, Dr. Lior is qualified as a Mohs surgeon. On that date, Dr. Lior, who is also employed at the Cleveland Clinic, had access to the records of Dr. Aktar's office visit, the biopsy photograph, and the pathology report. Additionally, Dr. Lior's nurse, Diane Donner, LPN, obtained additional history from the patient. Specifically, Ms. Donner noted that, "[p]atient states he has surgery in the area approximately 3 years ago. It has been present for 3 YEAR(S)." Dr. Lior then performed an examination of S.L.'s right helix; however, her examination did not include the entire right helix. Specifically, Dr. Lior did not examine the top of the helix of S.L.'s ear. Instead, Dr. Lior conducted a "focused examination" on an observed scarred pearly papule on the helix of the right ear just superior to (above) the mid-line of the ear. Dr. Lior explained the methodology utilized in limiting her examination to a specific location on the helix, as follows: Q. . . . What information from those records would indicate where on that right helix that you just described that either the biopsy was taken or that there was biopsy- proven carcinoma? A. Right. So when we get that information, patient participation is expected. We ask the patient. We get a history. Then we also need to look at the area and see what looks consistent with the biopsy site as well. And so all of these things, when you actually see a cancer and you see a scar and you see the skin graft area, and the patient tells you that that's the site, you put it together with your biopsy pathology report, as well as your office notes. It's what we use all together. Based on Dr. Lior's experience, the observed papule was consistent with the clinical appearance of basal cell carcinoma. Dr. Lior credibly testified that S.L. pointed to the same area she was palpating and advised her that he had previously undergone Mohs surgery and that the cancer had returned. Dr. Lior discussed treatment options with S.L. and advised that Mohs surgery would be appropriate, to which S.L. agreed. Dr. Lior's record of the consultation provides in pertinent part, as follows: Physical Exam: Right superior helix: There is a 1 cm scarred, crusted, pearly papule. Impression: Biopsy-proven basal cell carcinoma. Patient notes this is recurrent. Plan: Therefore indicated for Mohs surgery. February 11, 2010 Mohs Surgery S.L. returned to Dr. Lior for the scheduled Mohs surgery on February 11, 2010. Upon entering the surgical room, S.L. was engaged in a conversation with Ms. Donner concerning the location of the site. Dr. Lior greeted and approached S.L., obtained the prior photograph, approached S.L.'s ear, and stated, "let's take a look." As she was attempting to match the photograph with the area of the ear, S.L. stated to Dr. Lior, "Don't you see the scar?" while simultaneously pointing to the location of the scar tissue. Dr. Lior indeed observed the scar tissue from the prior skin graft and again, like the January 26, 2010, consultation, noted the area was consistent with recurrent basal cell carcinoma. The location was noted to be just above the scar. Dr. Lior proceeded to palpate or touch the suspicious area. Thereafter, Dr. Lior proceeded to mark the intended surgical location on S.L.'s ear with a marker pen. Subsequently, a photograph of the marked location was obtained, the patient's informed consent was obtained, and an informed consent document was executed by S.L. A time-out was then performed where Dr. Lior and her assistant agreed upon the procedure and location. The surgical site was then sterilized and injected with lidocaine. At no time prior to the surgery did S.L. voice any concerns or objections related to the proposed surgical site. S.L. was not, however, provided a mirror to examine the proposed marked location. Additionally, there was no evidence that S.L. was shown a copy of the photograph obtained by Dr. Lior prior to surgery. Dr. Lior then proceeded to perform the Mohs surgery without incident. After completing the procedure, S.L.'s ear was bandaged and S.L. waited in a separate room while the excised portion of the ear was examined to determine whether there were "clear margins"--the absence of basal cell carcinoma. After completing the examination, Dr. Lior requested that S.L. return to the operating area to discuss the findings. When S.L. returned, Dr. Lior stated, "Good news, it's all clear, the margins are clear, there's no cancer, we're going to repair the area." In response, S.L. replied that, "[t]he site was not here, it was here." S.L. then bent the top of his ear down, and Dr. Lior observed--for the first time--a papule consistent with basal cell carcinoma.2/ It is undisputed that this newly-observed papule was the site of biopsy-proven basal cell carcinoma. Dr. Lior conceded that it was her plan, at the conclusion of the January 26, 2010, consultation, to perform a Mohs surgery on the site of the biopsy-proven basal cell carcinoma. She further conceded that, on February 11, 2010, she performed the Mohs surgery on a location of S.L.'s right helix different from the location that was the subject of the biopsy performed by Dr. Akhtar.3/ Dr. Lior offered to perform a Mohs surgery on the newly-observed/previously-biopsied location; however, S.L. elected to defer the procedure for a later date. Accordingly, Dr. Lior closed the existing excision site and performed a skin graft in the area. Dr. Lior provided S.L. with her contact information and informed S.L. that she would attempt to arrange for the Cleveland Clinic to withhold the charges for the surgical procedure performed. The Cleveland Clinic reversed the charges, as requested. S.L. declined to return to the Cleveland Clinic for suture removal or for any additional procedures.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of performing a wrong-site procedure and, therefore, violating section 456.072(1)(bb); and imposing the following penalties: a $1,000.00 fine, a letter of concern, five hours of risk management education, and a one-hour lecture on wrong-site surgery. DONE AND ENTERED this 20th day of May, 2013, in Tallahassee, Leon County, Florida. S TODD P. RESAVAGE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of May, 2013.
The Issue Whether Respondent, a licensed physician, violated the applicable standard of care by diagnosing prostate cancer in four patients, and recommending and participating in a course of treatment for these patients, without confirming prostate cancer through tissue biopsy results; and, if so, what is the appropriate penalty?
Findings Of Fact Petitioner is responsible for the investigation and prosecution of complaints against medical doctors licensed in the state of Florida, who are accused of violating chapters 456 and 458 of the Florida Statutes. Respondent is licensed as a medical doctor in Florida, having been issued license number ME 46625. Respondent is not board-certified in any specialty recognized by the Florida Board of Medicine. Respondent has never had disciplinary action against his license to practice medicine. Respondent's Practice Since his residency concluded in 1985, Respondent has practiced urology. For more than 20 years, the focus of his practice has been prostate disease, its diagnosis, and treatment. In 2006, Respondent became the lead investigator for a General Electric study regarding its 3-Tesla magnetic resonance spectroscopy imaging machine (3T MRI-s) as part of an Institutional Review Board measuring the heat generated by the machine to ensure the safety of patients. Between 2006 and 2010, 1,600 prostates were scanned with a 3T MRI-s as part of the study. Respondent reviewed the results of each radiology report associated with these scans and compared them to the clinical data he had for each patient. Respondent also completed a double-blind study of 200 of these patients who had prostate biopsies during 2008 and 2009, as well as the 3T MRI-s, correlated the results of the biopsies and the scans, and became convinced that the 3T MRI-s technology alone is a positive predictor of prostate cancer 95 percent of the time. According to both parties' experts, as well as Respondent, the standard of care in Florida and throughout the United States is to use a needle tissue biopsy to identify prostate cancer. As admitted by Respondent, medical schools teach that needle biopsy is "the way" to diagnose prostate cancer. Absent a biopsy showing malignant tissue, it is not possible for a reasonably prudent physician to diagnose or treat prostate cancer. Biopsies are usually performed to diagnose prostate cancer if a man has a combination of risk factors, such as family history, an abnormal digital rectal exam, and/or increasing levels of Prostate Specific Antigen (PSA). However, needle biopsies for prostate cancer carry a false negative rate of 20 to 50 percent, which means that a standard 12-point needle biopsy (where 12 samples of tissue from different locations in the prostate are sampled) often misses cancerous tissue. Prostate needle biopsies are sometimes painful and carry a risk of complications, including common complications such as bleeding and infection, and the unlikely complications of septic shock and death. Respondent is convinced that there is a significant risk from a prostate needle biopsy to spread prostate cancer cells outside the prostate capsule, which is referred to as "seeding" or "needle tracking." Respondent's belief is founded upon a one-page 2002 article published in the American Urological Association, Inc.'s Journal of Urology (Journal), which refers to two cases in which a tumor was discovered in the rectal wall after prostate biopsies and cryoblation.1/ The tumors were suspected of being the result of needle tracking from prostate cancer biopsies. Significantly, this article makes clear that needle tracking resulting from prostate biopsies are rare and "exceedingly uncommon." Respondent's concern, regarding prostate biopsies spreading prostate cancer, is also in part founded upon a one-paragraph 1991 Journal abstract reporting a Johns Hopkins University School of Medicine study of 350 patients in which needle tracking was suspected in seven patients (two percent).2/ According to Respondent, his belief that prostate biopsies spread prostate cancer is "intuitive," although he acknowledges this is not the prevailing view in Florida. Respondent argues that doctors do not want to believe needle tracking takes place with prostate biopsies and suggests there is a financial motivation for doctors to require a positive biopsy before definitively diagnosing prostate cancer. Respondent is so convinced of the dangers of needle biopsies for prostate cancer that he published a book, Men at Risk: the Dirty Little Secret – Prostate Biopsies Really Do Spread Prostate Cancer Cells, in 2012, which he provides to all his patients. In his book, Respondent states: For me, a 3T MRI scan is the best objective marker to a diagnosis of prostate cancer. To summarize, patients must answer one question. Should I agree to a prostate biopsy procedure where it has been proven to spread prostate cancer cells or do I keep my fingers and toes crossed, hoping for the best? In two words, . . . "absolutely not." To me, the decision is easy – the literature validates avoiding random biopsies and supports imaging with a 3 T magnet. There is no other organ in the human body where diagnosis is dependent on sticking needles randomly and blindly into a delicate organ in an attempt to find cancer. This practice is archaic, patently barbaric, unacceptable and preferentially favored by virtually all urologists. Beyond the obvious benefit to being able to see a cancer and its pattern of invasion with the 3.0 Tesla MRI scan, there is no other exam or scan that competes in terms of diagnostic accuracy or predictability. The discerning patient will soon recognize that guessing where cancer is located, through random biopsies, is for the less informed.[3] Respondent refers to the use of 3T MRI-s as the "truth serum" of prostate cancer diagnosis. During all times material hereto, Respondent held himself out as a urologist who could diagnose and treat prostate cancer without a needle biopsy. In fact, the four patients at issue in this case found Respondent through an Internet search. Respondent defines his office, the Diagnostic Center for Disease (DCD) as, "A comprehensive prostate cancer diagnostic center in Sarasota, Florida specializing in non-invasive diagnostics (MRI/MRIS) without biopsy as an integral part of the diagnostic evaluation of prostate cancer."4/ Respondent also advertised himself as "a world expert in High Intensity Focused Ultrasound (HIFU), having diagnosed and treated more patients for prostate cancer from more countries than any other treating doctor in the world."5/ HIFU is a treatment alternative to brachytherapy (the insertion of radioactive seeds into the prostate), radiation, and prostatectomy (the surgical removal of the prostate gland) for prostate cancer and uses highly focused ultrasound waves in a small area to create intense heat, which destroys prostate cancer tissue. HIFU was not an approved treatment for prostate cancer in the United States until October 9, 2015, at which time the Food and Drug Administration (FDA) approved the use of the Sonablate machine for prostate tissue ablation. Prior to that time, Respondent referred his patients to treatment facilities in Mexico and the Caribbean where he performed HIFU treatments. The standard of care in Florida precludes treating prostate cancer with HIFU in the absence of a tissue biopsy confirming the presence of cancer. In order to be eligible for HIFU treatment, in addition to a positive diagnosis, the patient's prostate gland must be less than 40 grams. HIFU is not appropriate on patients with multiple calcifications in their prostate because they interfere with the treatment. Because a smaller prostate gland is easier to work with, prior to undergoing HIFU treatment, patients are often prescribed Bicalutamide (also known by its brand name, Casodex) and Trelstar. Bicalutamide suppresses the uptake of testosterone and Trelstar suppresses the production of testosterone, with both drugs having the effect of shrinking the prostate gland. Side effects of these drugs include hot flashes, weakness, and a sense of a loss of well-being. Facts Related to Patient G.P. Patient G.P., a 69 year-old retiree, had a prostate biopsy performed in December 2005 after a rise in his PSA level. This biopsy was negative for prostate cancer, but Patient G.P. was diagnosed with an enlarged prostate and benign prostate hyperplasty (BPH). In May 2008, Patient G.P. learned through a physical exam for a life insurance policy that his PSA level was elevated. After another check of his PSA level in November 2008, Patient G.P. was advised to undergo another prostate biopsy. Because his first prostate biopsy was painful, Patient G.P. searched the Internet for alternatives to biopsy and learned of Respondent and his use of the 3T MRI-s at the DCD in Sarasota for diagnosing prostate cancer. Patient G.P. traveled to Florida from Michigan to meet with Respondent on January 5, 2009. Patient G.P. underwent a 3T MRI-s scan at Respondent's office. Respondent told Patient G.P. that he was unsure of the results because they were consistent with BPH and not prostate cancer. However, Respondent advised Patient G.P. was considered "high risk" because his father died from prostate cancer in 2002. Rather than undergoing any treatment at that time, Patient G.P. was prescribed Avodart for his BPH and agreed to active surveillance (A.S.) whereby he would receive regular PSA screening. When Patient G.P.'s December 2009 PSA level went up after being on Avodart for most of the year, he was concerned and telephoned Respondent's office. Respondent prescribed Casodex based upon his telephone call with Patient G.P. on January 15, 2010. By February 2010, G.P.'s PSA level decreased significantly, but not as much as he believed it should have after taking Casodex for several weeks. Patient G.P. also experienced urinary frequency problems and pain. He returned to Respondent's office where Respondent performed an ultrasound and digital rectal exam. Respondent told Patient G.P. it was likely he had prostate cancer, but that he could not be sure without a biopsy. However, Respondent's medical records reflect that Respondent diagnosed Patient G.P. as having prostate cancer without a tissue biopsy.6/ Respondent offered to do a targeted biopsy based on an MRI scan. Respondent also discussed his concerns regarding needle tracking from biopsies with Patient G.P. Patient G.P. made it clear he did not want a biopsy, and he wanted to proceed to HIFU. Respondent advised Patient G.P. of the risk of erectile dysfunction following HIFU, but did not discuss the possibility of urinary stricture problems. In April 2010, Patient G.P. traveled to Mexico where the HIFU procedure was performed by Respondent. In March 2011, Patient G.P. saw a urologist in Michigan about his diminished urinary stream and pain. The urologist used a reamer to open Patient G.P's urethra, but on April 15, 2011, he went to the emergency room because he was completely unable to urinate. Patient G.P. was catheterized and subsequently underwent electro-vaporization on April 25, 2011, to relieve the urinary stricture. In August 2011, Patient G.P. also underwent hydro- dilating in an attempt to relieve the symptoms of his urinary stricture. In September 2011, Patient G.P. saw board-certified urologist Dr. Joel Gelman, who specializes in urethral reconstruction. At that time, Patient G.P. was advised that his urinary stricture, caused by the HIFU treatment, was a significant problem because his urethra was closed off almost to the bladder neck. Dr. Gelman performed a transurethral resection of the prostate (TURP). As part of the TURP procedure, Dr. Gelman took samples of Patient G.P.'s prostate tissue and no evidence was found of prostate cancer. Although Patient G.P. had no complaints regarding his course of treatment from Respondent, Dr. Gelman filed a complaint against Respondent because he was concerned that Respondent prescribed medications and performed HIFU on Patient G.P. for prostate cancer without a tissue biopsy. Facts Related to Patient J.W. Patient J.W., a 74 year-old retired dentist, had two biopsies performed in 2005 and 2007 ordered by his urologist in Alabama in response to elevated PSA levels. No evidence of malignancy was found. Patient J.W.'s PSA level was again elevated when tested in March 2012. He was reluctant to have another biopsy because the first two were painful. Patient J.W. was told about Respondent by a friend, and he viewed Respondent's website. Patient J.W. was interested in consulting with Respondent because Respondent advertised he had an MRI machine that could detect cancer cells, and Respondent believed prostate biopsies spread cancer. Patient J.W. traveled from Alabama to meet with Respondent at the DCD on May 14 and 15, 2012. After a sonogram and MRI, Respondent diagnosed Patient J.W. with prostate cancer. Respondent discussed a treatment plan which included what Respondent called "chemical castration" for a period of six months, to be followed with a trip to Mexico for HIFU treatment at the cost of $32,000.00. Respondent did not suggest any other treatment options to Patient J.W. or recommend a tissue biopsy. The idea of "chemical castration" scared Patient J.W., who sought a second opinion in June 2012 from another urologist, Dr. M. Eric Brewer. Dr. Brewer told J.W. that HIFU was not an accepted treatment in the United States for prostate cancer. Patient J.W. declined to go forward with treatment by Respondent. Dr. Brewer recommended A.S. and, as recommended by Dr. Brewer, Patient J.W. has his PSA level checked every six months. Patient J.W.'s PSA levels have decreased without any treatment. Dr. Brewer discussed Patient J.W.'s case with his partners, the tumor board, the president of the Southeastern Urological Association, and the president of the American Board of Urology, who unanimously advised Dr. Brewer to file a complaint with Petitioner against Respondent for cancer diagnosis and recommending treatment in the absence of a pathologic specimen. Facts Related to Patient K.S. Patient K.S. is a 62-year-old video producer and editor from Tennessee. He has no family history of prostate cancer. Patient K.S. had his PSA level tested in 2005 and 2009, at which time it was considered elevated. Patient K.S. was referred to a urologist by his primary care physician. After again showing elevated PSA levels, Patient K.S. underwent a prostate biopsy in 2011 and 2012. Neither biopsy was positive for prostate cancer. However, Patient K.S. and his wife were concerned about his rising PSA level and sought a second opinion. Patient K.S.' wife was concerned that if her husband had prostate cancer, his local urologist would recommend removal of the prostate. She researched alternative treatments on the Internet and found Respondent's website. On October 15, 2012, Patient K.S. and his wife traveled to the DCD in Sarasota to meet with Respondent. Respondent initially performed an ultrasound on Patient K.S. and then told Patient K.S. he was "concerned" Patient K.S. had prostate cancer. He recommended HIFU treatment to Patient K.S. Respondent made it clear to Patient K.S. that Respondent would not perform a needle biopsy because it pushes cancer further into the prostate. Respondent told Patient K.S. that the MRI would make it clear whether Patient K.S. had prostate cancer. Later that same day, Patient K.S. had an MRI performed at the DCD. Approximately a week later, Patient K.S. received a telephone call from Respondent with the MRI results who told Patient K.S. that based on the MRI, he had Gleason 7 prostate cancer, a fairly aggressive form of prostate cancer that could be treated with HIFU in Mexico the following month. This was followed up with an e-mail from the DCD to Patient K.S. demanding a payment of $32,000.00 within three days to schedule the HIFU procedure in Mexico. Patient K.S.' wife immediately secured a bank loan for the $32,000.00 Due to the seriousness of the diagnosis and the rush for payment for HIFU, Patient K.S. visited his primary care doctor for another opinion. Patient K.S' primary care doctor, Dr. Jeffrey Jump, told him that no one can diagnose prostate cancer as a Gleason 7 without a tissue biopsy. Further, it was a "red flag" to Dr. Jump that a cash payment of $32,000.00 was expected in such a short time frame to schedule treatment. After speaking to Dr. Jump, Patient K.S. decided not to have HIFU and instead opted for A.S. Subsequent PSA level tests for Patient K.S. have shown a decrease in his PSA level. Patient K.S.' wife filed a complaint with the Petitioner against Respondent. Facts Related to Patient V.P. Patient V.P. is a 63-year-old construction worker and guide from Alaska. He has no family history of prostate cancer. In August 2013, at age 60, Patient V.P. had his first physical examination. As part of the exam, he took a PSA test, which showed an elevated PSA level of 6.3. As a result, Patient V.P. was referred to a urologist who recommended a biopsy. Patient V.P. heard from friends that prostate biopsies are painful, so he looked on the Internet for alternatives. Patient V.P. found Respondent's website, which claimed Respondent could diagnose prostate cancer without a biopsy by using new MRI technology. Patient V.P. traveled to Sarasota to meet Respondent on September 11, 2013. Respondent performed a digital rectal exam and told Patient V.P. that his prostate was much enlarged. Respondent next performed a prostate ultrasound on Patient V.P. Immediately after the ultrasound, Respondent told Patient V.P., "I'm telling you right now you have prostate cancer." Respondent provided Patient V.P. with a prescription for Bicalutamide and Trelstar, which Respondent said would wipe out Patient V.P.'s testosterone and slow the growth of the cancer. Respondent told Patient V.P. that prostate biopsies are dangerous and metastasize cancer cells. Respondent said that even though he knew Patient V.P. had cancer, he wanted an MRI to see the amount of cancer. Respondent also offered Patient V.P. the opportunity to participate in a private placement offering for a HIFU company he was forming for a minimum investment of $50,000.00. The following day, Patient V.P. had an MRI and then met with Respondent to review the results. Respondent showed Patient V.P. his MRI images and pointed to areas of concern. Respondent told Patient V.P. he had extensive prostate cancer and that Patient V.P. did not have much time to decide whether to have HIFU because the cancer was about to metastasize. Respondent told Patient V.P. to take the Bicalutamide for ten days and then return for an injection of Trelstar to atrophy his prostate and make him ready for HIFU in 90 days. At Respondent's direction, Patient V.P. began the Bicalutamide and then returned to the DCD on September 20, 2013, for a three-month injection of Trelstar. During this visit, Patient V.P. questioned the cost if the HIFU was not successful in getting all the cancer and he needed further treatment. Respondent told Patient V.P. that he "doesn't miss," but an additional treatment of HIFU would cost another $10,000.00 to $12,000.00, in addition to the $32,000.00 for the initial treatment. Concerned about these costs, Patient V.P. asked about going to Loma Linda, California, for proton therapy as an alternative. Respondent told Patient V.P. that proton therapy would cause bladder cancer and any alternative to HIFU would require a needle biopsy first. Respondent actively discouraged Patient V.P. from any non-HIFU treatment for prostate cancer. As soon as Patient V.P. questioned Respondent about alternatives to HIFU, he was suddenly fast-tracked for HIFU scheduled October 24 through 26, 2013. He was told he needed to make a $10,000.00 deposit to hold the date and the total cost was $32,000.00. Despite his concerns regarding the expedited scheduling of his procedure and the cost of the HIFU treatment, Patient V.P. returned to the office with a check for $10,000.00 to cover the cost of the deposit to hold the October treatment date. While waiting to hand the check to Respondent's receptionist, Patient V.P. overheard Respondent on a speakerphone arguing with a radiologist concerning an MRI report. Respondent was insisting the radiologist include the word "cancer" on MRI reports and the radiologist insisted it was not possible for him to make such a diagnosis. After hearing this conversation, Patient V.P. immediately left Respondent's office with his check. Patient V.P. subsequently discussed his experience with a trusted friend who practiced as a nurse in a cancer clinic. She, too, expressed concerns about diagnosing and treating prostate cancer without a biopsy. Patient V.P. was referred by this friend to Dr. Vipul Patel, a physician specializing in urologic cancer in Orlando. Patient V.P. met with Dr. Patel on October 18, 2013. Dr. Patel advised Patient V.P. that it was not possible to diagnose prostate cancer without a biopsy. Dr. Patel also disputed that prostate biopsies can spread prostate cancer. Dr. Patel performed a digital rectal exam and found Patient V.P.'s prostate to be slightly enlarged (which is not abnormal for a man of Patient V.P.'s age), normal, and smooth. Dr. Patel told Patient V.P. that he doubted he had prostate cancer. Patient V.P. then underwent a prostate biopsy by Dr. Patel, which was negative for prostate cancer. This was surprising to Patient V.P. because Respondent led him to believe, based on the MRI, that his prostate was full of cancer. Patient V.P. experienced significant side effects as a result of taking the medications ordered by Respondent. The Bicalutamide caused Patient V.P. to experience overwhelming depression, shakes, hot flashes, tunnel vision, and headaches. The Trelstar caused erectile dysfunction, increased frequency of hot flashes, night sweats, and made Patient V.P. so weak he was unable to work for eight months. Standard of Care As discussed above, the experts who provided depositions or live testimony in this case were unanimous in their conclusions that the standard of care in Florida from 2008 through 2013 precluded diagnosis or treatment of prostate cancer in the absence of a tissue biopsy. A reasonably prudent physician would not tell a patient he had prostate cancer based upon an ultrasound and/or MRI. A reasonably prudent physician would not prescribe medication, suggest treatment, or participate in treating a patient for prostate cancer, based upon an ultrasound or MRI. Respondent claims that in each of these cases, he advised the patient that a needle biopsy was the definitive test for prostate cancer, but it was a method he did not favor due to the possibility of needle tracking. Respondent's testimony in this regard is not credible in light of the credible testimony of the three patients that Respondent made clear he would not perform a needle biopsy and actively discouraged them from anything other than diagnosis by MRI and subsequent HIFU treatment. Respondent's suggestion, that he offered needle biopsy as an option, is wholly inconsistent with the title, theme, and contents of his own book, and the manner in which he defined his method of diagnosing prostate cancer at the DCD in his book and on his website. It is self-evident that a patient's perceptions regarding the safety and efficacy of needle biopsies for prostate cancer detection are at least, in part, influenced by the discussion with the physician. Respondent's active efforts to dissuade these patients from having the one definitive test for prostate cancer, by dramatically over-inflating the infinitesimally small possibility of needle tracking, were wholly inconsistent with the standard of care. Respondent claims that these four patients insisted they did not want a needle biopsy, therefore, it was appropriate to diagnose them on the basis of "a preponderance of the evidence and concordance of data" and move forward with a treatment plan, including medications and HIFU. The standard of care in Florida during 2008 through 2013, for a situation in which a patient suspected of having prostate cancer refused a needle biopsy, was to prescribe a course of A.S., including regular and frequent PSA testing, and to offer no other treatment.7/ Ultimate Factual Determinations Petitioner established by clear and convincing evidence that Respondent committed medical malpractice in his treatment of Patients G.P., J.W., K.S., and V.P. by the following violations of the standard of care: failing to obtain and review prostate biopsy results before confirming the patient had, or diagnosing the patient with, prostate cancer (Patients G.P., J.W., K.S., and V.P.); prescribing Bicalutamide/Casodex to a patient without first confirming through a prostate tissue biopsy that the patient has prostate cancer (Patients G.P. and V.P); prescribing, injecting, or authorizing the injection of Trelstar to a patient without first confirming through biopsy results that the patient has prostate cancer (Patient V.P); recommending and/or attempting to facilitate HIFU treatment without first confirming through biopsy results that the patient has prostate cancer (Patients G.P., J.W., K.S., and V.P.); and participating in, and/or assisting with the performance of HIFU treatment for a patient without first confirming through biopsy results that the patient has prostate cancer (Patient G.P.). Accordingly, Respondent is guilty of the offense defined in section 458.331(1)(t), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Respondent violated section 458.331(1)(t), Florida Statutes, as charged in Amended Administrative Complaints; imposing a fine of $30,000.00; revoking Respondent's medical license; and imposing costs of the investigation and prosecution of this case. DONE AND ENTERED this 24th day of February, 2017, in Tallahassee, Leon County, Florida. S MARY LI CREASY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 24th day of February, 2017.
Findings Of Fact Based upon the oral and documentary evidence adduced at the final hearing and the entire record in this proceeding, the following findings of fact are made: At all time pertinent to this proceeding, Respondent, Jules G. Minkes, was licensed as an osteopathic physician in the State of Florida having been issued license No. OS 001516. There is no evidence that Respondent has ever been the subject of prior disciplinary action by the Petitioner, Department of Professional Regulation, and/or the Board of Osteopathic Medical Examiners. Respondent is certified by the American College of Osteopathic Internists, the American College of Osteopathic Board of Cardiology, the American Osteopathic Board of Nuclear Medicine and the American Board of Nuclear Medicine. Respondent has no advanced or specialized training in dermatology, however, he did complete courses in dermatology as a student and, as part of his primary care practice, he does provide some minor dermatological treatments. At all pertinent times, Respondent was the medical director of South Dade Osteopathic Medical Center d/b/a Suburban Medical Center ("Suburban"). Suburban was a primary care provider facility with International Medical Center ("IMC"), a health maintenance organization ("HMO"). Suburban contracted to become part of the IMC HMO system beginning in June of 1981. Under the IMC system, a patient's primary care physician was the "gatekeeper" four medical services. In the absence of an emergency, a patient was required to first see his primary care physician in order to be referred to other specialized medical care. Conflicting evidence was presented regarding the operation of the IMC program and the procedures for referring patients to specialized medical care and/or physicians who were not part of the HMO network. The IMC referral procedures and the manner of allocating the costs of specialized treatment were not the same at all IMC facilities and were changed several times during the early and mid 1980's. (Certain pertinent aspects of the referral process are explored in more detail in Findings of Fact 37 below.) IMC developed a network of physicians to whom primary care physicians could refer patients for specialized medical treatment. In accordance with its IMC contract, Suburban was expected to provide all primary medical care for all IMC patients assigned to the center. Respondent and Suburban agreed to refer IMC patients to specialists, hospitals, etc. within the IMC network "unless approval for a nonparticipating facility or a professional is specifically approved by the medical director or executive director of IMC." At all times pertinent to this proceeding, Respondent referred his HMO patients to the IMC specialist network with the expectation that those specialists would either treat the patient or further refer them as necessary. Some IMC affiliated providers entered into "risk" contracts with IMC and were responsible for paying specialists and/or directly negotiating arrangements for those specialists to be compensated. The evidence established that, during the time that the Patient was treated at Suburban, Suburban did not have a "risk" contract with IMC. As set forth on page 4 paragraph 23 of the contract between Suburban and IMC (Respondent's Exhibit 3) IMC paid the specialists attending to Suburban's HMO Medicare patients. In accordance with Suburban's contract, IMC allocated a specific amount per member per month to be deposited into an account and applied towards payments of the specialists. At the end of each quarter of the calendar year, IMC was supposed to distribute any sums remaining in the specialists' account to Respondent. However, during the time the contract was in effect, there were never any funds remaining in the specialists' account at the end of any calendar quarter. Therefore, no funds from this account were ever distributed to Respondent. IMC developed a plan for treating Medicare eligible patients. This program was known as the Gold Plus Plan and required the patient to essentially assign their Medicare benefits to the HMO. All patients who enrolled in the Gold Plus Plan executed an agreement acknowledging that all non-emergency medical treatment had to be provided or arranged for by IMC and that they would be limited to seeing doctors within the IMC network. All patients were advised that they could see a specialist at their own expense or could disenroll from the HMO at any time and return to their prior Medicare status. The Patient, T.G., enrolled in the IMC Gold Plus Plan in July of 1982 and executed the standard agreement. At the time she was first seen at Suburban, T.G. was approximately 68 years old. She was a somewhat difficult patient who frequently complained of numerous minor ailments. In approximately 1978, while she was living in New York, T.G. had a basal cell carcinoma removed from her forehead by a dermatologist. T.G. and her husband, C.G., moved to Florida in approximately 1978. Shortly thereafter, additional lesions appeared on her forehead. The Patient's family physician at the time, Dr. Kenneth Hertz, referred T.G. to a dermatologist, Dr. Darrell Blinski, who biopsied the lesions in August of 1981. The pathology report from the biopsy contained a diagnosis of "basal cell carcinoma; both side margins are involved. The deep margin is clear." Involvement of the surgical margins of a biopsy indicates the basal cell carcinoma has spread to the limits of the biopsy and perhaps beyond. On August 22, 1981, T.G. was admitted to coral Reef General Hospital where Dr. Blinski attempted to excise the basal cell carcinoma and performed a Limberg flap procedure to cover the skin defect on her forehead. As a result of the procedure, the Patient had a noticeable scar in the middle of her forehead. Dr. Blinski's admission notes in connection with this August 22, 1981 procedure indicate T.G. had: ... a history of multiple recurrences of basal cell carcinoma of the forehead under treatment in New Jersey and down here... incisional biopsy of a central forehead lesion was done and returned as a basal cell carcinoma, margins involved. The area in question wad in the central forehead. The physical examination revealed an ulcerated lesion measuring 2 mm x 5 mm in the central forehead with a scarred area to the left of that measuring 4 mm in diameter. Involved skin is within 1 cm. Examination of the rest of the facial skin was negative for lesions. A pathology report dated August 27, 1981 on tissue removed during the procedure performed by Dr. Blinski revealed basal cell carcinoma with the "left lateral margin free of tumor, all others surgical margins involved with tumor." In other words, not all of the tumor was removed during the surgery by Dr. Blinski. Dr. Blinski referred the Patient to Dr. Henry Menn for consultation. Dr. Menn was a professor of dermatology and head of the Mohs chemosurgery unit at the University of Miami. In a letter dated September 21, 1981, Dr. Menn advised Dr. Blinski that he thought: It would be best to initiate Mohs Chemosurgery excision of the residual basal cell carcinoma discovered by you in the surgical margins of your excised specimen performed on 27th of August, 1981, from tissue removed from the forehead. In approximately four weeks inflammation and irritation normally present after a surgical flap procedure will be reduced and the chemosurgical excision will be more easily accomplished. Dr. Menn apparently changed his treatment plan for the Patient because, instead of undertaking chemosurgery, he simply followed the patient clinically until the summer of 1982. During that time period, there were no clinical signs of regrowth of the basal cell carcinoma. While primary basal cell carcinoma typically grows in little mounds of cells, recurrent basal cell carcinoma can grow in a different, infiltrative fashion. This type of growth tends to be more subtle and the skin can appear normal for extensive periods of time. T.G. returned to Dr. Menn on December 17, 1981 and, in a letter dated December 21, 1981, Dr. Menn advised Dr. Blinski that: ... about four months have now passed since you excised the large basal cell carcinoma on her forehead. There is no clinical evidence of regrowth of tumor even though the surgical excision margins were involved by tumor after your treatment. Close clinical inspection and palpation do not reveal the evidence of basal cell carcinoma at this time... I will continue to follow the patient at periodic intervals. If there is any evidence of malignancy, I will do an excisional biopsy and initiate chemosurgical treatment as indicated. On March 15, 1982, Dr. Blinski examined the patient and advised Dr. Menn by letter that "there is no recurrence as of this time. She will be followed in four months." By letter dated May 19, 1982, Dr. Menn advised Dr. Blinski "I re- examined our patient [T.G.] on the 18th of May, 1982. I am pleased to report that there is no evidence of regrowth of the skin cancer were [sic] you performed plastic surgery on her forehead... I will continue to follow the patient." On July 22, 1982, T.G. and her husband joined the IMC Gold Plus Plan. Because the Gold Plus Plan required the enrollees to assign their Medicare benefits, T.G. stopped seeing Dr. Menn at this time. T.G. had an appointment with Dr. Menn on October 7, 1982. Dr. Menn's notes indicate that the patient did not appear for her appointment and there is a notation that the "patient wishes to continue care in her HMO." Suburban was the HMO affiliate center to which T.G. was assigned. T.G.'s first visit to Suburban took place on September 3, 1982. During that visit, T.G. advised the Respondent that she had a history of skin cancer. During the physical examination of the Patient, the Respondent noted the scar on her mid-forehead. At the time of the Patient's initial visit to Suburban, the medical records of her prior treatment by Dr. Blinski and Dr. Menn were not available. At some point, those records were obtained by the Respondent. However, it is not clear when the records were received. T.G.'s second visit to Suburban was on September 17, 1982. There is no indication in the medical records of that visit that her forehead was examined. On October 4, 1982, T.G. returned to Suburban and complained to Respondent that her "forehead always feels hot." The Respondent noted a "small left papular swelling 4mm at lower portion of scar-subcut." Under the "assessment" portion of his medical form, Respondent wrote "(1) follow possible recurrence basal cell carcinoma-left lower forehead (2) 1-2mm lesion on right forehead (3) keratotic lesion-right arm." During the October 4, 1982 visit, Respondent hyfercated the lesions on the Patient's right forehead and right arm. Hyfercation is an electrocauterization that burns or desiccates skin lesions by removing the water content of skin cells. Hyfercation destroys tissues and, as a result, the tissue cannot be pathologically diagnosed unless a biopsy is first taken. No biopsy was taken prior to the hyfercation of either of the lesions. Although Respondent has no specialized training in dermatology, he regularly hyfercates skin lesions as part of his office practice. Respondent believes that he has the ability to differentiate between minor, obviously benign skin lesions and those that are more questionable and should be referred to a dermatologist. Respondent noted on the medical records from this visit to "follow for excisional biopsy." That comment was made with respect to the lesion on the Patient's lower left forehead. That lesion was not hyfercated. Instead, the Respondent decided to refer the Patient to a dermatologist in the IMC system for the treatment of that lesion. On October 14, 1982, the Respondent signed the referral form for T.G. to go to the IMC Dermatology Center at a facility known as the Westchester Clinic. An appointment with the IMC dermatologist was scheduled for October 21, 1982. On that day, the Patient was seen by Dr. Seymour Munzer, a dermatologist affiliated with IMC. The exact nature of Dr. Munzer's business relationship with IMC was not established, but he apparently traveled to various IMC Centers to treat patients. During the October 21, 1982 visit, Dr. Munzer noted the Patient's history of surgery for basal cell carcinoma with Dr. Blinski. He noted some nodular firmness above the left brow. His diagnostic impression was "(1) prob. [sic] scar tissue (2) r/o [rule out] recurrent basal cell carcinoma." Patient stated on several occasions that she did not like Dr. Munzer and wanted to see Dr. Menn, her options under the Gold Plus Plan were fully explained to her and she was advised that, under that plan, her treatment would have to be coordinated through the IMC dermatologist. She was also advised that she could see Dr. Menn at her own expense or disenroll from the program and continue her care under traditional Medicare procedures. The Respondent never completed any additional dermatological referral forms for the Patient. While Dr. Munzer claims that a written referral from the primary care physician was necessary every time a patient returned to see him, this testimony is rejected. The more creditable evidence established that Respondent was not required under the IMC system to issue a referral for each visit by a Patient to an IMC specialist. Dr. Munzer biopsied the lesion over the Patient's left brow and submitted it for pathological diagnosis. The pathology report was returned on October 26, 1982 and indicated "basal cell carcinoma, infiltrating. Surgical margins involved by the lesions." T.G. returned to Suburban on November 3, 1982. The records of that visit indicate that the Respondent was waiting for the pathology report. For his assessment, Respondent noted "r/o [rule out] basal cell carcinoma forehead." Respondent's plan was to "follow path report Westchester Center." During the November 3 visit, Respondent removed a 1mm keratotic lesion from the Patient's lower right chin. The Patient returned to Suburban on November 23, 1982. By that time, Respondent had received a copy of Dr. Munzer's report and the pathology report on the biopsy performed by Dr. Munzer. The Respondent discussed the results of the biopsy with the Patient and her husband and explained that she needed to follow up with the dermatologist. While the Patient and her husband have testified that the Respondent advised them that he could treat her basal cell carcinoma, this testimony is rejected. The more creditable evidence established that the Respondent advised the Patient of her need for follow-up by a dermatologist. The Respondent discussed the results of the biopsy with Dr. Munzer by phone and it was his understanding that Dr. Munzer would continue to follow the Patient and provide whatever additional treatment was necessary. The Respondent never received any additional reports or correspondence from Dr. Munzer regarding the Patient. Because the IMC specialists rotated between several hospitals, there was often alot of confusion regarding the paperwork for those patients referred to specialists. It was not unusual for there to be significant delays between the time an IMC specialist saw a patient and the time the specialist's report was sent to the primary care physician. In fact, in many instances such reports were never received. Thus, while Respondent did not receive any further reports from Dr. Munzer, Respondent thought Dr. Munzer and/or IMC was providing treatment for the Patient's basal cell carcinoma as diagnosed in the October 26, 1982 pathology report. No records of the treatment rendered by Dr. Munzer could be obtained from either Dr. Munzer or the Westchester Clinic where Dr. Munzer treated the Patient. It is not clear whether the Patient ever returned to Dr. Munzer for further evaluation or treatment. 1/ However, it is clear that Respondent and his office staff advised the Patient on several occasions that she needed to follow-up with the dermatologist. While the There is no evidence that Dr. Munzer ever developed a plan for treating T.G. Dr. Munzer could not specifically recall his treatment of this Patient except to review his report and the pathology report in Respondent's records. Dr. Munzer testified that he would not have attempted to treat a patient with recurrent basal cell carcinoma on the face, particularly in the area of scar tissue. Instead, he states that he would have recommended either Mohs chemosurgery, referral to a plastic surgeon or possibly radiation therapy. However, it does not appear that Dr. Munzer ever communicated his reluctance to treat such a condition to the Respondent. As far as the Respondent knew, Dr. Munzer and/or the IMC Dermatology Center were capable of treating this Patient. While Dr. Munzer claimed that he did not have authority to refer a patient from an affiliate center for further follow-up, at the very least his input and recommendation would have been essential to determine how to treat a patient with unique dermatological problems. In this case, it does not appear that he ever provided such a recommendation or opinion. Moreover, while Dr. Munzer contends that the Medical Director of an affiliate center was the only person who could make referrals outside the IMC network, Suburban's contract with IMC required such determinations to be made by the Medical Director of IMC. The evidence established that, under Suburban's contract, once a patient was referred to an IMC specialist for treatment, that specialist and IMC were responsible for determining whether to send the patient for additional consultation to a physician outside the IMC network. At no point during the treatment of this Patient did the Respondent attempt to treat the Patient's known basal cell carcinoma. The Patient was next seen by the Respondent on December 7, 1982. The Respondent noted "basal cell carcinoma left-forehead." There is no indication that the Respondent was attempting any treatment for this problem. The Patient was instructed to return in three months. The Patient was treated by the Respondent on February 1, 16, and March 7, 1983 for various ailments and complaints. There is no mention of the Patient's basal cell carcinoma in the medical records of these visits. On April 1, 1983, the Respondent excised a skin lesion on T.G.'s left shoulder. The Respondent submitted the excised lesion for biopsy and the pathology report stated that there was no evidence of malignancy. There is no evidence in the medical records of the April 1, 1983 report that Respondent treated or discussed the basal cell carcinoma on the Patient's forehead. The Patient returned to Suburban on April 4, 6, and May 2, 1983. She was seen by the Respondent during the April 4 and May 2, 1983 visits. The records of those three visits do not reflect any treatment or discussion of the Patient's forehead. The Patient's next visit to Suburban was on May 24, 1983. During that visit, Respondent noted a "2mm keratotic skin lesion, mid forehead." That lesion was high on the forehead near the hairline. It was not in the scar area or adjacent to the previously diagnosed basal cell carcinoma. The Patient wanted the lesion removed for cosmetic reasons and it was the Respondent's opinion that the lesion was not clinically related to the Patient's previous problems. The Respondent felt that the appropriate treatment was to obliterate the lesion and watch for any recurrence rather than to biopsy such a small lesion which appeared benign. His assessment was "keratosis, possible basal cell carcinoma." He hyfercated the lesion and noted to follow it for healing. Because no biopsy was done on this lesion, there is no pathology report available to establish whether or not this lesion was a basal cell carcinoma. Some of the expert witnesses in this proceeding have testified that the Respondent's failure to biopsy this lesion falls below the standard of care expected of a reasonably prudent physician under similar circumstances. However, that testimony presupposes that the lesions was contiguous or adjacent to the prior problem areas. Moreover, even Petitioner's experts admit that a primary care physician such as Respondent should be able to recognize and distinguish cosmetic skin problems from more questionable problems that need closer scrutiny. There is insufficient evidence to disregard Respondent's clinical diagnosis. Even though the Patient had a history of basal cell carcinoma, it was possible, indeed it is likely, that a patient with her history would develop unrelated cosmetic lesions. At the time that the lesion was hyfercated, the Respondent once again advised the Patient that she needed to continue seeing the dermatologist regarding the previously diagnosed basal cell carcinoma. Sometime during the Patient's visits in April or May of 1983, Respondent became aware that the Patient had not been returning to Dr. Munzer for follow-up care of the basal cell carcinoma of her forehead. Until this time, the Respondent had assumed that the Patient was being treated by Dr. Munzer. The Patient reiterated her dislike for Dr. Munzer and also indicated that she did not like the Westchester facility. The Respondent once again explained her options under the HMO plan and advised her of the need to seek specialized care for her basal cell carcinoma. The Patient did not exercise any of the options explained to her and continued to be treated at Suburban through at least March of 1984. During that time, she was treated for various ailments, but no attempt was made to treat the basal cell carcinoma. The Patient's next visit to Suburban took place on June 1, 1983. In addition to treating other unrelated complaints, the Respondent noted that the wound from the hyfercated forehead lesion was healing. The Patient was also treated at Suburban on June 16 and 21, July 7 and 25, August 1 and 9 and October 17, 1983. The Respondent saw the Patient on all of those visits except for the June 16, July 25, and October 17 visits when she was treated by other Suburban employees. There is no indication in the medical records of these visits that the Patient's forehead and/or basal cell carcinoma were treated. The Patient did not appear for scheduled appointments on June 6, July 18, and August 12, 1983. During a visit on November 1, 1983, the Respondent noted a lesion on the Patient's right forehead. This lesion was not contiguous to the Patient's scar nor was it adjacent to the area biopsied by Dr. Munzer. The Respondent hyfercated this lesion. As with the other lesions that Respondent hyfercated, the hyfercation was performed for cosmetic reasons and not because of any medical necessity. Each of the lesions that were hyfercated healed quickly and completely without any sign of regrowth. Because the lesions were hyfercated, biopsies were not possible. The absence of a pathology report precludes a conclusion that none of the hyfercated lesions were malignant. However, the Respondent's testimony that he only hyfercated lesions in areas where no previous problems had occurred and that appeared clinically benign is accepted. Therefore, there was no deviation from the standard of care expected of a reasonably prudent physician. The Patient returned to Suburban on November 8, and 28, and December 14, 1983 and January 13 and 30, 1984. There is no indication that the Respondent saw the Patient on those visits. The Patient was seen by other physicians employed by Suburban. None of those physicians attempted to treat any skin problems and/or the forehead area of this Patient. There is no indication that any of these physicians noted any abnormality on the Patient's forehead. During those visits when the Respondent saw the Patient, the Respondent would typically check her forehead to determine if there were any changes in the scar or the area that Dr. Munzer had biopsied. No changes were evident until the Patient's visit on February 6, 1984. During the February 6, 1984 visit, the Respondent noticed a slight nodularity on the Patient's forehead. Respondent did not attempt to treat that bump. He again recommended to the Patient that she see the dermatologist. The only notation in the medical records was "follow slight nodularity-forehead-hx [history] basal cell CA." The Patient was instructed to return in two weeks. The Patient returned to Suburban on February 7, 13, 27, and March 14, 1984. The Respondent only saw the patient on the February 13 visit. During these visits, she was treated for various unrelated matters and there is no notation regarding her basal cell carcinoma or the nodularity noted on February 6. On March 7, 1984, T.G. transferred to Dr. C.N. House's IMC affiliated provider center. On her first visit to Dr. House on April 6, 1984, T.G. was referred to a dermatologist, Dr. Kenneth Rosen, for a biopsy of her forehead. At the time of this visit, Dr. House did not have any of the Patient's prior records. Dr. Rosen took biopsies from three areas of the Patient's forehead: one from the "right forehead", one from the "mid-forehead", and one from the "mid-forehead above left side." The pathology reports on all three sections indicated basal cell carcinoma that had been incompletely excised. The multiple sites of carcinoma indicate that the tumor was infiltrating. Dr. Rosen advised Dr. House that he was not qualified to treat the Patient. He advised Dr. House that the Patient needed to be referred for Mohs chemosurgery. At the time, the only physician in Miami that Dr. House knew could perform that surgery was Dr. Menn. Mohs chemosurgery, now known as Mohs micrographic surgery, is the treatment of choice for recurrent basal cell carcinomas because of its high cure rate and conservation of healthy skin. Dr. House's contract with IMC was a "risk" contract. Under that contract, the fees for treatment by specialists were directly deducted from his payment from IMC. Dr. House arranged his own network of specialists to whom he would refer patients. As indicated above, the Respondent's contractual arrangement with IMC was different and, at least during the time this Patient was being treated, Respondent only referred patients to the network developed by IMC. Dr. House arranged for the Patient to be seen by Dr. Menn on May 15, 1984. In making this arrangement, Dr. House agreed to personally assume responsibility for Dr. Menn's fees. T.G. was treated by Dr. Menn at the University of Miami with the Mohs Chemotherapy technique in four stages over a period of three days, May 29, 30, and June 1, 1984. The Mohs Surgery revealed an extensive basal cell carcinoma that covered most of the Patient's forehead area. Extensive skin was removed during the surgery and, in some areas, the surgery penetrated to the underlying bone. The surgery reports indicate that all of the area was one continuous basal cell carcinoma of the forehead, the eyelids and the nasal dorsum. Dr. Garland believes that the basal cell carcinoma treated by Mohs Chemosurgery in May of 1984 was the same tumor present and growing at the time that Dr. Menn was seeing this Patient in 1981 and 1982. After the Mohs Surgery, the Patient was referred by Dr. House to Dr. Gary Zahler, an IMC Plastic Surgeon, for repair by skin grafting of the extensive wound to her forehead. After the surgery, the Patient was followed by Dr. Menn until his death in 1985. Dr. Larry Garland, a colleague of Dr. Menn at the University of Miami and a dermatologist specializing in Mohs Chemosurgery and cutaneous oncology, continued following the Patient after Dr. Menn's death. T.G. died from other causes in 1989. She had no recurrence of basal cell carcinoma following the Mohs surgery. The evidence established that the Respondent is a capable and dedicated physician. There is no evidence that the Respondent manipulated the Patient for his own financial gain. It is clear that at the time this case was initiated, there were some erroneous factual assumptions made by at least one expert retained by the Petitioner. Petitioner sent the Patient's medical records for review by Dr. Joseph Rosen. His opinion served as one of the grounds for the initial finding of probable cause in this case and the subsequent issuance of the Administrative Complaint. That opinion was premised on the erroneous assumption that the Respondent never referred the Patient to a dermatologist for treatment. At the hearing in this cause, Dr. Rosen amended his opinion and acknowledged that a referral did take place. However, he felt that the Respondent had still failed to meet the applicable standard of care because he failed to take adequate steps to ensure that the Patient's basal cell carcinoma was treated. This issue is addressed in the conclusions of law below.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Osteopathic Medical Examiners enter a Final Order finding the Respondent, Jules G. Minkes not guilty of the allegations contained in Count I of the Administrative Complaint and dismissing that Count, but finding Respondent guilty of Count II and III, issuing a letter of concern and imposing a fine of $500.00. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 13th day of December, 1990. J. STEPHEN MENTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 13th day of December, 1990.
