The Issue In an administrative complaint dated July 3, 1990, the Department of Professional Regulation (DPR) alleges that Respondent violated Section 458.331(l)(m) and (t), F.S., by failing to keep written medical records justifying a course of treatment, and by gross or repeated malpractice or the failure to practice medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. More specifically, the complaint alleges that in his treatment of "Patient #1", Nabil Hilwa, M.D. failed to document in his patient's records the patient's difficulty urinating and the need for a transurethral resection of the prostate (TURP), and that he mislabeled patient #1's adenocarcinoma. The complaint also specifically alleges that Dr. Hilwa inappropriately diagnosed patient #1's condition because the emphasis in March 1985 should have been on the patient's nodule and a diagnosis of prostate cancer, either by transrectal or transperineal biopsy, and not on the TURP, and that Respondent should have performed an acid phosphatase and a prostatic specific antigen on patient #1. The issues for disposition are whether those violations occurred and, if so, what discipline is appropriate.
Findings Of Fact Except for two conclusory paragraphs, Respondent has admitted all factual allegations of the amended administrative complaint. These facts are thus established: Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.30, Florida Statutes, Chapter 455, Florida Statutes, and Chapter 458, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME 0032104. Respondent's last known address is 6388 Silver Star Road, Orlando, Florida 32818-3235. From on or about March 5, 1985, to on or about April 22, 1985, and from on or about February 8, 1988, to on or about April 10, 1989, Respondent provided medical care and treatment to patient #1. On or about March 6, 1985, patient #1 was admitted to the hospital, with a complaint of difficulty urinating, for evaluation of prostatism, and Respondent subsequently performed a cystoscopy and found a one hundred percent obstruction of the prostatic urethra. On or about March 7, 1985, Respondent performed a Transurethral Resection of the Prostate (TURP). The pathology report revealed nodular hypoplasia without any evidence of malignancy. Respondent did not perform a prostate biopsy, an acid phosphatase, or a prostatic specific antigen. On or about April 22, 1985, patient #1 made his last postoperative visit after the TURP. On or about February 8, 1988, patient #1 presented to Respondent for evaluation of a prostatic nodule on the left prostatic lobe. Respondent advised patient #1 to have a prostatic sonogram with biopsy. On or about March 7, 1988, Respondent performed a transrectal sonography, which revealed a hypoechoic area, and a transrectal biopsy, which revealed a small focus of moderately differentiated adenocarcinoma of the prostate, on patient #1. Respondent did not perform an acid phosphatase or a prostatic specific antigen. On or about July 25, 1988, patient #1 was admitted to the hospital and Respondent performed a repeat prostatic biopsy, which revealed that adenocarcinoma of the prostate was present on all needle biopsy segments taken, in contrast to the biopsy performed on or about March 7, 1988. A sonogram was not repeated. On or about August 3, 1988, patient #1 was admitted to the hospital and Respondent performed a bilateral pelvic lymphadenectomy and a retropubic radical prostatectomy, which revealed the prostate had cancer up to the margin of resection. Respondent referred patient #1 to a radiation oncologist for a consultation. On or about August 3, 1988, Respondent's records indicate Respondent discussed the postoperative complications of impotence and urinary incontinence with patient #1. On or about March 23, 1989, patient #1 presented to Respondent with a complaint of gross hematuria. Respondent performed a cystoscopy which revealed hemorrhagic cystitis secondary to radiation. On or about April 10, 1989, patient #1 was doing well with no gross hematuria, and a repeat urinalysis was negative. 1985 -- First Referral of Patient to Dr. Hilwa for Evaluation and Treatment Don Buswell-Charkow (Dr. "B-C") is a physician who has practiced in the Orlando, Florida area since 1981. His field of practice is internal medicine. He is not and does not consider himself an expert in urology. A.C. (described as "patient #1" in DPR's Administrative Complaint and Amended Administrative Complaint) was a patient of Dr. B-C from March 10, 1983 to August 25, 1989. During the time period of 1983 to 1985, A.C. complained to Dr. B-C of urinary difficulty. On February 14, 1985, Mr. C. saw Dr. B-C for a sore throat and coughing. In the course of discussions, he mentioned that he was having difficulty with his bowels. Dr. B-C performed a rectal exam and felt an area which he described in his records as follows: "the left lobe of the prostate has a nodule." (Pet. Ex. 2) On March 1, 1985, Dr. B-C, by letter, referred Mr. C. to Dr. Hilwa for evaluation of his prostate. The letter stated: Would you please evaluate Mr. [C.'s] prostate. I felt the left lobe of his prostate had a nodule. A sigmoidoscopy was negative, a barium enema was negative, and an IVP showed enlargement of the prostate, though was otherwise normal. (Pet. Ex. #2) Including his training, Dr. Hilwa has specialized in the fields of urology and urological surgery for over 19 years. His specialty training includes post-graduate work in urology and urological surgery at Washington Hospital Center in Washington, D.C., a teaching facility affiliated with George Washington University; the University of Cincinnati Medical Center, a teaching facility; and Wayne State University, a teaching institution. Dr. Hilwa began his private practice in Orlando, Florida in 1978. The majority of his patients come from referring physicians. Approximately 25-30 physicians refer patients to Dr. Hilwa for speciality evaluation and treatment. Dr. Hilwa serves on the active medical staffs of AMI Hospital and West Orange Hospital. At AMI he is Chief of the Urology Department which consists of nine urologists. At West Orange Hospital, he is the Chief of Surgery (made up of approximately 15-20 physicians) and Chairman of the Surgical Practice Committee which addresses cases related to quality assurance matters. Dr. Hilwa has worked with the American Cancer Society as a Clinical Fellow at the University of Cincinnati where he performed research on cancer of the prostate and the significance of their serum acid phosphatase. He has also lectured for the American Cancer Society concerning cancer of the prostate. In addition, he has appeared on T.V. to discuss cancer of the prostate. In his practice, Dr. Hilwa sees approximately 1,000 patients a year for urological problems. Approximately 10% or 100 patients a year fall within the category of males with potential cancer of the prostate. He performs approximately 600 surgical procedures a year, of which approximately 60% fall within the category of major cases and 40% fall within the category of minor cases. To Dr. Hilwa's knowledge, he has never been (a) investigated by DPR (other than this case); (b) investigated or complained against by Medicare; (c) disciplined by any licensing agencies dealing with the practice of medicine; or (d) disciplined by any hospital with respect to hospital privileges. Dr. Hilwa has never had a patient with a diagnosis or suspected diagnosis of prostate cancer, other than A.C., complain to him with respect to his care and treatment. Neither has he had a referring physician tell him that someone had complained against him with respect to his care and treatment. On March 5, 1985, Dr. Hilwa first saw Mr. C. He personally took a history from him and documented in his records: "FREQUENCY 3X", "NYCTURIA [sic] 1-2X", decreased potency, "DRIBBLING YES", decreased stream force and caliber, and "HESITANCY YES". Upon physical examination of Mr. C.'s prostate, he found, according to his notes, that the prostate is 1+ enlarged; asymmetrical; and left prostatic nodule semi-firm. (Pet. Ex. #6, p. 70) Dr. Hilwa's use of the term "semi-firm" was not descriptive of "a cancerous feeling". "Semi-firm" is not a term he normally uses to refer to something that he would be suspicious of as cancer. His definition of a prostatic nodule that is cancerous is usually "firm or stoney-hard" -- not "semi-firm". The term "nodule" is a very broad term which signifies an aggregation of cells that may be anatomical or may be pathological. This definition is consistent with medical dictionary definitions of "nodule", e.g., Taber's Medical Dictionary. Dr. Hilwa's use of the term "nodule" in A.C.'s records referred to the left lobe of his prostate which was semi-firm and larger than the right. This is what he perceived as a "nodule". He did not feel an isolated, discrete, or raised surface on Mr. C.'s prostate gland. The term "induration" is a different feeling in the substance of the prostate than the surrounding tissue felt. Dr. Hilwa did not feel any induration on the surface of Mr. C.'s prostate in 1985. In Dr. Hilwa's practice, if he does find an induration he customarily draws a picture of it so that he will have a reference for himself. No such picture was drawn in 1985 in the case of Mr. C.'s prostate. The significance of finding an induration is that it provides a specific target towards which a biopsy needle may be directed. According to Dr. Hilwa, there was no discrete, isolated induration on the surface of A.C.'s prostate in 1985 to which he could have guided a biopsy needle. If he had performed such a procedure, it would have been a "blind biopsy". Following examination of A.C., Dr. Hilwa's initial clinical impression was "benign prostatic hypertrophy" which refers to a nonmalignant enlargement of cells of the prostate. His plan was to do a cystoscopy examination and a TURP if obstruction is present. Cystoscopy means looking inside the bladder through the urethra to determine whether or not there is obstruction. A TURP or transurethral resection of the prostate is a surgical procedure which involves cutting the interior tissue of the prostate gland. Prostatic stones are a hard, stoney substance. They can mimic a cancer or prostatic nodule. The finding of 100% obstruction upon cystoscopy examination of Mr. C. was consistent with documented symptoms in the medical records. In performing the TURP on Mr. Carty on March 7, 1985, Dr. Hilwa removed tissue and stones weighing a total of 13 grams. Following the cystoscopy and TURP, a pathology report was presented to Dr. Hilwa. It confirmed: (1) that he had dissected 13 grams by weight; (2) that the tissue removed was benign, and (3) that stones were present in Mr. C.'s prostate. On the basis of these findings, Dr. Hilwa's final diagnosis was benign prostatic hypertrophy. His hospital discharge summary, included in his office records for A.C., includes this statement: "...In view of the obstruction present and the patient's symptoms, it was felt that a TURP of the prostate is indicated rather than doing a biopsy of the prostate...". (Pet. Ex. #6, p. 115) Dr. Hilwa did not order a prostatic specific antigen test on Mr. C. because such was not available to him in 1985. The reason he did not do a serum acid phosphatase is that his diagnosis was benign prostatic hypertrophy. He had no reason to add this test, which often reveals false positives and false negatives. The TURP eliminated the obstruction found, as well as the multiple prostatic stones. Potential complications, if the prostatic obstruction and stones had not been removed by the TURP procedure, include worsening of the obstruction, irritation, recurring infection and surgery. A TURP is an accepted procedure in the field of urology for the elimination of prostatic stones and the elimination of an obstruction in the prostate. Dr. Hilwa saw Mr. C. on two occasions post-operatively in 1985: March 27, 1985 and April 22, 1985. He advised Mr. C. to come see him whenever he had any problems or needs. Otherwise he referred him back to his family physician, Dr. B-C. Dr. Hilwa had no further contact with Mr. C. from April 22, 1985 until February, 1988 -- approximately three years later. 1986 Re-evaluation of Patient By Dr. B-C On June 26, 1986, Dr. B-C examined Mr. C. and made the following notation in his records: "The rectal has a firm left lobe and normal right." (Petitioner's Exhibit #2) Dr. B-C was specifically looking for a prostatic nodule in Mr. C. in June of 1986. However, he did not palpate a nodule. He did not feel the same thing that he felt in 1985. On February 2, 1988, in his annual physical check up of Mr. C., Dr. B-C found the patient's prostate enlarged on the left and quite firm without a definite nodule. The right side was normal. 1988 -- Second Referral of Patient to Dr. Hilwa For Evaluation & Treatment Mr. C. was again referred by Dr. B-C to Dr. Hilwa for prostatic evaluation on February 8, 1988. Upon physical examination, Dr. Hilwa felt a one by one centimeter firm, left prostatic nodule. A picture was drawn on his medical records. It was not the same nodule that he felt in 1985 in Mr. C.'s prostate. It was a discrete, raised, distinct nodule surrounding prostatic tissue on the surface of the left lobe that he could measure with his finger. Dr. Hilwa's plan was to proceed with prostatic sonogram and biopsy. Mr. C. was scheduled for a sonogram on February 22, 1988, but did not show up. Two weeks later, the procedure was conducted. It revealed a hypoechoic area, which is an area that is usually characteristic of cancer of the prostate. The pathology report came back on March 9, 1988. It indicated that the vast majority of tissue was benign, except for a very small microscopic focus of moderately differentiated adenocarcinoma. Dr. Hilwa had Mr. C. come to his office where he explained his findings. Because Mr. C. asked a lot of questions and had a history of emotional illness, Dr. Hilwa pulled one of his textbooks, sat with him, went through all phases of cancer of the prostate, and described what he felt his situation was. Dr. Hilwa next commenced a metastatic workup involving x-rays of the abdomen and pelvis to determine whether the prostatic cancer was contained in the prostate or had spread outside. It was contained and had not spread. Next, Dr. Hilwa explained to Mr. C. the plan to repeat sonogram of the prostate with biopsy in two to three months. Another biopsy of Mr. C.'s prostate was performed on July 25, 1988. At that time, Dr. Hilwa felt clinically that Mr. C.'s cancer was stage B. The decision was made to proceed with a radical prostatectomy. On August 3, 1988, a radical prostatectomy was performed. The cancer was removed from A.C.'s prostate. According to the pathology report there was no indication that the cancer had spread beyond the surgical capsule of the prostate. With respect to the "labeling" of Mr. C.'s adenocarcinoma, the description "stage B" appears throughout Dr. Hilwa's notes and transcriptions in the hospital records. (See, for example Pet. Ex. #8, pages 195, 204, 210 & 260). DPR's Expert Testimony Dr. Richard H. Lewis is a physician practicing in Jacksonville who specializes in urology. He is Board certified. At DPR's request, Dr. Lewis examined medical records concerning Dr. Hilwa's case and predicated his opinions on portions of Dr. Hilwa's records. Dr. Lewis opined that a transurethral resection of the prostate ("TURP") is not an adequate method of evaluating a patient for prostate cancer; that a biopsy of the prostate, either through a transrectal or transperineal approach is the appropriate standard of care for evaluating or ruling out this particular diagnosis. Such biopsies are performed " . . . by guiding the needle to the area that you are concerned about so that you can actually feel the nodule and the needle and so you can be sure the needle is entering the area that you are concerned about." (Pet. Ex. #13, pages 10-11). Dr. Lewis stated that the key issue is that Dr. Hilwa did not "aggressively seek" to prove whether the patient did or did not have prostate cancer. (Pet. Ex. #13, page 16). Dr. Lewis further testified that about 50% of the time when you are biopsying a nodule you are going to miss it. He further conceded that a stone in the prostate is relatively common and if the physician is comfortable that he felt a stone he would be justified in not doing a biopsy. Dr. Lewis agreed that it was reasonable for Dr. Hilwa to not order the acid phosphatase and prostatic specific antigen tests in 1985. It would not be appropriate to draw those tests until a diagnosis of prostate cancer had been made. Dr. Lewis agreed that in this case the available evidence suggests that the patient had no spread of the prostate cancer outside the prostate and that a radical prostatectomy was an appropriate treatment option. Dr. Lewis believes Dr. Hilwa's records are logical and appropriate in terms of his thought patterns once the diagnosis of cancer was made. He conceded that records is an area where he may be "a little confused." "The medical record is there to document what was done so that you can look back at it in retrospect." His criticism of Dr. Hilwa's records was: So to me where he fell below the standard of care is that he didn't do what needed to be done. His records did not explain why he did that. (Pet. Ex. #13, pages 40-41) This conflicts with his opinion in his earlier written report of May 9, 1990, which stated: The physician does state the reasons for his treatment and course of actions in the records. (Attached Exhibit 2 to Pet. Ex. #13, page 4). Dr. Lewis believed that there was a "discrete nodule" in 1985. It was his further assumption that the "nodule" palpated in 1988 was the same "nodule" palpated in 1985. Such assumptions are inconsistent with the facts proven in this case. Dr. Lewis did not hear the final testimony of Dr. B-C wherein he stated that he did not palpate a nodule in or on Mr. C.'s prostate in 1986. He also did not hear the final hearing testimony of Dr. Hilwa describing what he, the clinician actually performing the evaluation, perceived. Dr. Lewis conceded that the practice of medicine is not a precise science; that there is room for clinical judgment based upon a physician's experience in his field; and that how a physician documents matters in a medical record may vary from physician to physician. Dr. Wajsman's Expert Testimony Dr. Zev Wajsman is a Professor of Surgery in the Division of Urology, and Chief of Urologic Oncology, at the University of Florida, College of Medicine, University of Florida, Gainesville, Florida. Dr. Wajsman is Board certified in urology and licensed in Florida and New York. He has published more than 112 articles in his field and gives presentations and lectures on an ongoing basis. In preparation for giving testimony for Dr. Hilwa in this case, Dr. Wajsman reviewed all medical records of Mr. C. pertaining to Dr. Hilwa's treatment of him in 1985 and 1988. In addition, he reviewed the depositions taken in this case, the transcript of the final hearing, and Dr. B-C's office records. Dr. Wajsman opined that Dr. Hilwa did not fall below the accepted standard of care in his care and treatment of Mr. C. in 1985 and 1988. He further testified that no acts or failures to act by Dr. Hilwa in treating Mr. C. caused any injury to him. Dr. Wajsman testified that on the basis of all the information he reviewed, there is no evidence that the patient had clinical evidence of prostate cancer in 1985. He found no evidence in the charts to suggest that Dr. Hilwa should have done a biopsy at the time. Many patients are referred to urologists as experts because of abnormal prostatic findings. A biopsy will not be done just because someone else believed that he felt an abnormal prostate. Quite often, in Dr. Wajsman's experience, his response to the referring physician will be that he didn't find or feel any abnormality. He consequently does not feel that he "has to do" a biopsy. It is Dr. Wajsman's understanding that the reason Dr. Hilwa did not do a biopsy was because in his clinical judgment there was no suspicious finding to perform a biopsy upon. So based on this finding and the fact that on the subsequent transurethral resection the specimen did not contain any cancer, Dr. Wajsman believed that there was no evidence of cancer at that time and therefore there was no substandard care by Dr. Hilwa. Dr. Wajsman believes the testimony of Dr. B-C describing an examination that he performed one year later on Mr. C. (1986) was significant in that he did not palpate a nodule at that time. In '85 this Dr. B-C referred this patient to Dr. Hilwa because of abnormal rectal findings. Then a year later, after TUR was done the same physician did not find any abnormality. So the question is what happened during this year, and the only explanation I can find out is that at the time of surgery, I mean transurethral resection, stones were removed from the prostate during the section, and it is possible that what the Dr. B-C felt the year prior to is that he felt a stone or hardened tissue around the stone which disappeared after transurethral resection. That enforced the reason Dr. Hilwa didn't do a biopsy because what he felt probably at the time, the referring physician felt was an abnormality not cause by cancer but by a stone or inflammatory reaction or whatever. (Resp. Ex. #1, page 12). Dr. Wajsman further opined that the records do not reveal that Dr. Hilwa in any fashion acted in bad faith or without due regard for the prevailing standard of care in treating Mr. C. Dr. Wajsman is unaware in the context of 1985 or even today of any requirement in the field of urology for a clinician in documenting a medical record to record a "degree of difficulty urinating," for example, 10 degrees or 50 percent or some fixed number, in order to conform to the standard of care. The notes described in paragraph 9, above, adequately document the difficulty. With respect to DPR's allegations that Dr. Hilwa should have performed prostatic specific antigen and acid phosphatase tests in 1985, Dr. Wajsman confirmed that the prostatic specific antigen test was not available on the market in a majority of places in 1985. The acid phosphatase test was available, but is done for patients who actually have prostate cancer. It was not necessary in 1985 or 1988. 1/ By not performing the two tests, no damage was done to the patient and such did not affect the ultimate treatment for this patient. With respect to the radical prostatectomy performed by Dr. Hilwa, it was done properly, and it successfully removed the cancer. The patient became incontinent, a very unfortunate, but accepted and known risk of complication with this type of surgery. With respect to DPR's allegations concerning the adequacy of Dr. Hilwa's records, Dr. Wajsman testified that while the records could be better, he believes that anyone's records can be better. He does not believe that Dr. Hilwa's records fall below the standard of care. The records do properly document why a biopsy was not done in 1985, and they do properly refer to the cancer as level B, which according to Dr. Wajsman, is a nodule or abnormality, confined to one lobe, usually less than 1 1/2 centimeters.
Recommendation Based on the foregoing, it is hereby, RECOMMENDED That the Department of Professional Regulation, Board of Medicine, enter its Final Order dismissing the Amended Administrative Complaint against the Respondent. DONE AND RECOMMENDED this 2nd day of May, 1991, in Tallahassee, Leon County, Florida. MARY CLARK 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 2nd day of May, 1991.
The Issue The issue to be resolved in this proceeding concerns whether the Respondent's medical licensure should be subjected to discipline for the reasons asserted in the Administrative Complaint, involving his alleged malpractice concerning patient, E.L.
Findings Of Fact The Respondent at all times material hereto has been a licensed physician in the State of Florida, having been issued License No. ME0030859. The Respondent practices at 1800 N.E. Street, Suite 521, Pensacola, Florida 32501. The Petitioner is an agency of the State of Florida. It is charged by the Legislature, as pertinent hereto, with enforcing the provisions of Chapter 458, Florida Statutes, and related rules, pertaining to the regulation of licensure and the quality of practice of medical doctors within the State of Florida. The Respondent is a board-certified dermatologist, practicing that specialty in the State of Florida in excess of 15 years. There is no evidence of any prior disciplinary action against the Respondent's licensure nor of any prior instance when his practice failed to conform to appropriate professional standards. In the course of his practice, the Respondent sometimes does his own microscopic pathological examination of tissue samples taken from patients (biopsies) on occasions when he deems it appropriate and that a consulting opinion is not required. It is undisputed by the parties that a dermatologist such as the Respondent, who had extensive training in dermatopathology during his medical education, can appropriately do such biopsy work within the standard of care of a reasonable physician practicing under similar conditions and circumstances. If he does so, however, he is held to the standard of a dermatopathologist in the course of his professional practice. The Respondent treated E.L. (an 80-year-old male patient at times pertinent hereto) since approximately 1982 for various problems involving pathology of the skin, including skin carcinoma. On November 21, 1991, E.L. presented as a patient of the Respondent showing a crusty area measuring approximately 1 x 2 centimeters on the vertex of his scalp or the back of his head. The lesion in question appeared on the skin with a hard crust, whitish or yellowish in color, and the Respondent diagnosed it as hypertrophic actinic keratosis. This is sometimes a pre-cancerous condition of the skin. Upon making his diagnosis, which he did clinically, without biopsy, the Respondent performed a curettage, or scraping of the tissue, to remove and destroy it. He did this by injecting the area with lidocaine as an anesthetic before performing the curettage. The Respondent had previously treated the same sort of condition on E.L. with liquid nitrogen but chose, this time, to treat the lesion with extension cautery and curettage. He did this because he was attempting to lessen the discomfort in his 80-year-old patient, who had already undergone a number of procedures to remove pre-cancerous or cancerous lesions of the skin on his head. The use of liquid nitrogen and the associated burning of the tissues involved would cause more difficult healing and discomfort for the patient. The treatment which the Respondent accorded the actinic keratosis condition, by curettage, is an acceptable, appropriate treatment for such a condition. It is undisputed by either the Petitioner's or the Respondent's expert witnesses, as well as the Respondent in his testimony, that such a clinical diagnosis and the following treatment by curettage is within the professional standard of care and practice by dermatologists practicing under similar conditions and circumstances. A biopsy is not a necessary prerequisite to such treatment. After the November 21, 1991 destruction of the skin lesion, the patient did not return for approximately one month. On December 19, 1991, he returned to the Respondent concerned about possible infection at the removal site. The Respondent, however, detected only granulation tissue, which are normal granular projections on the surface of a normally-healing wound. Consequently, there was no reason within the bounds of reasonable medical treatment standards for the Respondent to have biopsied the lesion area on that office visit occasion, either. Patient E.L. returned on January 3, 1992, at which point the Respondent noted a minor area of "dermatitis" or a non-cancerous inflammation of the skin, for which he prescribed a cortisone ointment. The Respondent did no biopsy at that time, either, and the clear and convincing evidence does not demonstrate that a biopsy was required under those conditions and circumstances within acceptable, reasonable bounds of the Respondent's professional practice. Patient E.L. returned to the Respondent on January 23, 1992 complaining of unsatisfactory progress with the healing of the lesion. The lesion by that time had become a rounded, raised growth with central cratering, characteristic of a keratoacanthoma. The Respondent examined the lesion or tumor clinically and determined that it appeared to be a keratoacanthoma. A keratoacanthoma is a rapidly-growing nodule with a central "crater", which then fills with a crusty material. It usually remains localized and most often resolves itself spontaneously, even if untreated. On very rare occasions does it become an aggressively-growing tumor. The Respondent biopsied the suspected keratoacanthoma by performing an excision of the area. He excised the nodule, taking a narrow margin of several millimeters around it and then performed a suture closure of the wound. He performed a biopsy of the tissue thus taken himself and interpreted the biopsy results approximately one week later as confirming his clinical diagnosis of a keratoacanthoma. Keratoacanthoma is regarded as a "low-grade" form of squamous cell carcinoma. The diagnosis is based upon a clinical observation with the naked eye, based upon history, as well as by pathological diagnosis. Conservative treatment is appropriate for a keratoacanthoma since they often resolve themselves spontaneously. Simple observation, surgical excision, curettage with or without electro-desiccation, radiation therapy, intra-lesional injection, and topical application of 5-fluorouracil and methotrexate are all acceptable forms of treatment for keratoacanthoma and can be reasonably expected to cure the condition. On rare occasions, keratoacanthoma can recur, even with such treatment. The diagnosis and treatment of keratoacanthoma is a matter of good- faith differences of opinion among reasonable dermatologists and pathologists, based upon their clinical judgment and experience. Some diagnose it as keratoacanthoma, which is a low-grade form of squamous cell carcinoma; and some diagnose it as squamous cell carcinoma with varying degrees of "differentiation". The photograph of the lesion as it was seen by the Respondent prior to the January 23, 1992 surgery shows a lesion consistent with the clinical appearance of a keratoacanthoma. The Respondent has been properly trained as a dermatologist in dermatopathology, and he commonly reviews biopsy and pathology slides. He is not required, under pertinent practice standards, to seek consultation when he believes that he has made a proper diagnosis. It was proper for him to read and review the pathology slide of the biopsy specimen, even though he himself acknowledges, as do the two expert witnesses, that he would be held to a dermatopathologist's professional practice standard by doing so. The Respondent opined that actinic keratosis developed into the keratoacanthoma. Dr. Breza, the Petitioner's expert witness, opined that actinic keratosis does not develop into keratoacanthoma but, rather, into squamous cell carcinoma. Even he acknowledged, however, that good pathologists have trouble making the diagnosis of keratoacanthoma and prefer generally to diagnosis such conditions as simply "low-grade" squamous cell carcinoma. Dr. Hanke, in his testimony, established that keratoacanthoma and squamous cell carcinoma are different gradients of diagnosis on the same continuum or range describing squamous cell carcinoma. That is, in lay terms, a keratoacanthoma is a "low-grade" squamous cell carcinoma. They are not precisely the same diagnosis, but both diagnoses describe the same general type of cells. As shown by Dr. Breza, squamous cell carcinoma tumors or lesions generally tend to appear somewhat flatter than that characteristic of a keratoacanthoma. Squamous cell carcinomas tend to be more indurated or firm on the outer edges and to have more inflammation on the outer edges, including occasional ulceration. The Respondent's description in E.L.'s medical record seems more consistent with squamous cell carcinoma, but the photographic images of the growth or lesion at issue, made at the time the biopsy and excision was performed, appear also consistent with keratoacanthoma. Based upon the information, including clinical appearance, that the Respondent had to consider in making his diagnosis and given that reasonable pathologists can differ concerning the gradients of diagnosis of squamous cell carcinoma (which includes keratoacanthoma), as shown by the expert testimony, the Respondent's diagnosis does not constitute a departure from appropriate, professional standards. The deficiency in the Respondent's practice in this instance began with the excision made on January 23, 1992. The Respondent took the tissue material from the excision for biopsy and, after pathological examination of the sample, diagnosed the nodule as keratoacanthoma. The Respondent, however, did not establish a "negative margin" for the excision. That is, the tissue removed had positive margins, especially the deep margin, which means that carcinoma cells could be observed on the surface of the piece of tissue removed. This means that the Respondent could not be assured that carcinoma cells did not remain in the tissue area surrounding the walls of the excision site because the margin of the excision around the nodule to be removed was not wide enough. The same slide and tissue sample which the Respondent used for biopsy in January 1992 was examined by a dermatopathologist, but not until some six months later, in July 1992. The dermatopathologist reported his opinion that the biopsy showed an "infiltrating squamous cell carcinoma with involvement of the lateral and deep margins." An infiltrating carcinoma implies that it is a more aggressive tumor than would be the case with a normal keratoacanthoma. The Respondent did not report those positive margins from the results of his excision and biopsy in January 1992. His testimony indicates that he may have seen them or been aware of them but did not make a larger incision in order to achieve a negative margin because of his concern about the complicated closure techniques that would be necessary. He was concerned with attendant additional discomfort to this elderly patient, as might be entailed with the possible use of grafting in order to make closure of the wound. He also seemed to discount the need to excise a larger margin because of his belief that he was dealing with a non-aggressive keratoacanthoma. In fact, however, the clear and convincing evidence shows that a larger margin wound could have been excised without the necessity for more elaborate techniques of closure and attendant discomfort to the patient. Moreover, it was established that even this elderly patient, with his attendant heart problems, could have tolerated a more elaborate excision of the tumor in question, since the procedure could still be done under low-risk local anesthesia in the Respondent's office. An infiltrating carcinoma is one which is more aggressive. It can move from its original location and infiltrate the skin and blood vessels, which can, in some cases, result in the tumor spreading via the blood stream or by infiltrating the lymphatic system, with migration to regional lymph nodes. The squamous cell carcinoma is not known for being a readily metastasizing form of cancer. It is known on some occasions to metastasize, however. The finding of positive margins on the pathological examination in July 1992 means that the tumor extended to the cut surface of the excision at the time of the January excision procedure from which that biopsy sample was taken. Thus, tumor cells remained in the patient's scalp after the January 1992 excision procedure. The finding of a positive margin requires that another margin be established, meaning that the physician must cut another level of tissue until normal skin (a negative margin) is revealed. This can be done by conventional surgery, by just a larger excision area being removed, or by "MOHS" surgery, which involves freezing sections of the excision area, with small portions of the suspicious area removed at a time and with attendant pathology examinations so that each "thread" of cancer cells can be removed with minimal damage to surrounding tissues and less attendant discomfort and healing problems associated with the resulting surgical wound. The patient could have tolerated either type of procedure in January 1992. The Respondent did not establish a negative margin, however. He only excised the carcinoma once. He stated that he was really seeking only a biopsy sample and that he considered the treatment by excision of the nodule itself and attendant scraping of the wound to be adequate as conservative treatment, to take care of what he believed to be a non-aggressive keratoacanthoma. This may be a correct assessment if the physician is certain that he is confronted with a non-aggressive, non-infiltrating keratoacanthoma. However, if positive margins to the excisional wound result, the patient is better served, and a successful treatment result much more likely, if all suspected carcinoma cells are removed at that time. If the Respondent knew of the positive margins to the excision and had made an additional excision to remove all positive margins, the provision of additional, more elaborate treatment techniques would not have been delayed for nearly six months and likely would have been unnecessary. The determination of the existence of positive margins, after the January 1992 excision procedure, should have caused him to remove additional tissue to obtain a safe, negative margin. That failure of care, in his capacity as a dermatopathologist, resulted in a six-month delay before the dermatopathologist, at Sacred Heart Hospital, identified the positive margins. He identified them on the Respondent's same January 1992 pathological slide, when he examined it in July 1992, after which radiation and further more radical treatment was attempted. Thus, the delay in treatment action, resulting from the delay in acting on the existence of positive margins by the Respondent, resulted in a six-month delay in appropriate treatment being provided the patient, which is a deviation from the accepted standard of care, as established by the testimony of Dr. Breza, which is accepted in this regard. Earlier determination (or acting on a determination) of the positive margins, after the January 1992 excision procedure would have alerted the Respondent that the excision procedure was unsuccessful and that further treatment was necessary. The patient's lesion occurred on a sun-damaged scalp. The Respondent had treated the patient repeatedly for sun-damaged skin problems, including carcinomas, in the past. Squamous cell carcinomas can be susceptible to mestastases, either regional or systemic when they are located on the scalp, although they are much less susceptible to such mestastases than if they are located on the lip or possibly the dorsal surface of the hand. The Respondent, as a board-certified dermatologist, knew or should have known that the scalp is an area of the body that can be susceptible to metastatic disease such as squamous cell carcinoma. The patient, as even acknowledged by the Respondent's expert, Dr. Hanke, was one with a high risk for developing skin cancer. In any event, after the excision procedure on January 23, 1992, the patient was seen on February 10, 1992 for removal of sutures and examination of the wound. It appeared to be healing nicely at the time, and the patient was advised to return to the Respondent in three months, unless a problem developed. The Respondent next saw the patient on April 6, 1992, when he complained of persistent pain at the excision and tumor site. This was treated by the Respondent by drainage, antibiotics, narcotic pain medications, and sleep- inducers. Later during the treatment regimen, in approximately May 1992, the Respondent felt that chemotherapy was indicated because apparently, the lesion had not been completely excised. Consequently, he prescribed injections of intralesional cortisone methotrexate and 5-fluorouracil. These, however, did not produce satisfactory healing or control of the pain. During April and May 1992, the Respondent saw the patient for complaints of persistent pain, poor healing, and drainage of the wound. On May 18, 1992, the Respondent performed a drainage of the lesion which had begun to show an abscess formation. An abscess formation is an indicator of squamous cell carcinoma, which should have been recognized by the Respondent. This should have alerted him that his diagnosis of simply keratoacanthoma was not correct, at least by that time. With the presence of these continuing and exacerbated problems with the wound site, the Respondent did not seek or perform further biopsy of the tumor site, despite continued complaints of persistent pain and further growth of the lesion between April and July 1992. The patient made 16 visits to the Respondent between April 1992 and July 14, 1992 for treatment and pain relief. During this time, little improvement occurred in the patient's condition, but no additional biopsy or consultation was requested or performed by the Respondent. The lack of improvement in E.L.'s condition during the period of April through July 1992 should have alerted the Respondent that something was incorrect about the patient's condition and that more extensive radical treatment would be necessary. In fact, the Respondent did respond to the continued complaints by, in addition to prescribing antibiotics and pain medication, prescribing the above- referenced intralesional injections of cortisone, methotrexate, and 5- fluorouracil. On July 9, 1992, another curettage procedure was performed and the pathology of the scrapings was sent for evaluation by a pathologist. The Respondent's interpretation of this tissue at the time apparently was a keratoacanthoma; well-differentiated squamous cell carcinoma. This was ultimately described by the pathologist to whom it was referred as a moderately- differentiated squamous cell carcinoma. Subsequently, after the C&D procedure, the patient was referred to Baptist Hospital in Pensacola, Florida, for radiation therapy. He received a full-course of radiation therapy with some booster therapy afterward and then, on his own volition, went for a second opinion to the University of South Alabama Medical Center in Mobile, Alabama. Five physicians at that facility recommended more extensive surgery, which ultimately the patient refused. There is no clear and convincing evidence that, at least at that point in the patient's progress, the persistent tumor had actually mestastized, although it was apparently growing locally. The fact that the lesion at issue was failing to heal and producing persistent pain by the visit of April 6, 1992 should have been interpreted so as to set in motion further investigative procedures, including an additional biopsy, to find out the reason for that condition and its persistence. Although a proper procedure involving excision and biopsy was done in January of 1992, the frozen sections of the lesion could have been interpreted to show that the tumor was an infiltrating carcinoma extending to the lateral and deep margins of the excision and something more aggressive could have been done to treat it at that time. It could have either been re-excised with frozen section control of the margins, referred to a "MOHS'" surgeon for a similar type of surgery or referred to a general surgeon. Radiation therapy could have been tried, at least by the time the persistence of the problem was determinable in April of 1992. The resultant reduction of delay in securing more extensive treatment of the lesion would have certainly benefited the patient. The persistence of the pain in the six-month period of time after the January 1992 excision of the tumor, until just before the time the patient was referred for radiation therapy indicates there was probably perineural invasion by the tumor (infiltration of the nerves), which produced pain. This should have alerted the Respondent that something more than a non-aggressive keratoacanthoma was involved, as well. In summary, it has been demonstrated that the Respondent failed to practice medicine within that level of care, skill and treatment recognized by reasonably prudent, similarly-situated physicians as acceptable under the circumstances, by failing to make an additional biopsy after the patient re- presented with problems associated with persistent pain and improper healing in April 1992; by failing to recognize and act on the presence of positive margins to the excision material taken in January 1992, to effect an additional excision at that time, so as to secure a safe, negative margin to the tumor. The failure to obtain consultation on the biopsy taken from a dermatopathologist was not in itself evidence of falling below appropriate professional levels of care, skill and treatment, but the Respondent, by doing his own interpretation of the biopsies was, as he agrees, creating a situation in which he would be held to the same standard as a dermatopathologist. The failure to correctly interpret the biopsy he took in January 1992, by failing to recognize the positive margins to the excised material and failing to act to remove those indicia of the continued presence of the tumor, at a time when it was thus easily excised, likely prevented an easily-effected cure.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is RECOMMENDED that the Respondent be found guilty of a violation of Section 458.331(1)(t), Florida Statutes, in the manner concluded above, and that the Respondent receive a private reprimand, a $2,000.00 fine, and that he be required to attend 20 additional hours of Category I continuing medical education in the area of diagnosis and treatment of skin cancer. DONE AND ENTERED this 30th day of October, 1995, in Tallahassee, Florida. P. MICHAEL RUFF, 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 30th day of October, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-3531 Petitioner's Proposed Findings of Fact 1-8. Accepted. 9-10. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted, but not itself materially dispositive. Rejected, as contrary to the clear and convincing evidence. The evidence does not reflect that one biopsy sample only showed one part of the lesion at issue but, rather, several parts were represented. Accepted. Accepted, but not itself materially dispositive. 15-21. Accepted. 22-24. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 25-26. Accepted. 27. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 28-36. Accepted. 37-41. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 42-44. Accepted. 45. Rejected, as contrary to the clear and convincing evidence and subordinate to the Hearing Officer's findings of fact on this subject matter. 46-53. Accepted, but not in their entirety materially dispositive. 54. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 55-56. Accepted. Rejected, as not in its entirety supported by clear and convincing evidence of record. Accepted. Accepted, to the extent of failing to practice medicine within the appropriate standard of care by not making earlier and more frequent biopsies only. Respondent's Proposed Findings of Fact 1-17. Accepted. 18. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. 19-20. Accepted. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter, and as not entirely in accord with the clear and convincing evidence of record. Accepted. Accepted, but not necessarily as to its material import and subordinate to the Hearing Officer's findings of fact on this subject matter, which contain additional findings of fact not contained in Proposed Finding of Fact No. 23 and which are material, relevant, and necessary to a clear picture of the patient's progress and treatment rendered during the period of April 6, 1992 through July 14, 1992. Accepted, but not as to its purported material import. Rejected, as contrary to the clear and convincing evidence of record, and as subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted, but not as to its purported material import. 27-31. Accepted. COPIES FURNISHED: Britt Thomas, Senior Attorney Mary Anne Davies, Certified Legal Extern Agency for Health Care Administration 1940 North Monroe St., Ste. 60 Tallahassee, FL 32399-0792 Donald Partington, Esq. CLARK, PARTINGTON, ET AL. Post Office Box 13010 Pensacola, FL 32591-3010 Dr. Marm Harris Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, FL 32399-0770 Jerome W. Hoffman, Esq. General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, FL 32309
The Issue Whether Petitioner's license as an Osteopathic Physician in the state of Florida should be revoked, suspended or otherwise disciplined under the facts and circumstances of this case.
Findings Of Fact Upon consideration of the oral and documentary adduced at the hearing, the following relevant facts are found: Respondent is, and has been at all times material hereto, a licensed osteopathic physician in the State of Florida, having been issued license number OS 0003822. Respondent's last known address is 1804 Nelson Street, No. 15, Ormond Beach, Florida 32074. From on or about July 17, 1985, until on or about April 28, 1987, Respondent diagnosed patient L.K. as suffering from, and rendered medical care and treatment for, juvenile fibromatosis or fibromatosis colli. Juvenile fibromatosis and fibromatosis colli are conditions characterized by the occurrence of multiple fibromas. Fribromas are benign (non- malignant) neoplasms. On or about July 17, 1985, Respondent executed a letter which was sent to the Exceptional Student Education Services section of the School Board of Volusia County (School Board) wherein Respondent represents that the patient L.K. "is being treated for a malignancy of the neck, etiology undermined." On or about August 22, 1986, Respondent executed a letter intended to allow the patient L.K. to avoid required immunization wherein Respondent represents that patient L.K. "...has a malignancy which was not identified by multiple biopsy." The representations made to the School Board in his letters of July 17, 1985, and August 22, 1986, were made in Respondent's practice of Osteopathic Medicine. Only one biopsy of the patient's neck mass was performed prior to Respondent's letter of August 22, 1986, to the School Board. This biopsy was performed during March of 1980 by Gary Horndeski, M.D. The pathology report concerning this biopsy was not received by Respondent until March 18, 1987. The patient's neck mass had not been subjected to multiple biopsy as represented by the Respondent on August 22, 1986. The Respondent's representations in the August 22, 1986 letter were deceptive, untrue, and fraudulent. The medical records of Respondent fail to document that Respondent performed multiple biopsies on the mass. Respondent has failed to keep written medical records justifying the course of treatment of the patient, including but not limited patient histories, examination results, and test results. Respondent prescribed, dispensed or recommended BHI Regeneration, Polyzyme 022 and Vitamin C 500 mg tablets to patient L.K. On or about November 21, 1986, Respondent executed three separate forms authorizing the administration of BHI Regeneration, Polyzyme 022 and Vitamin C to patient L.K. by school personnel of Volusia County, indicating that he had ordered the administration of these substances as a "part of scheduled med program." BHI Regeneration and Polyzyme 022 are "drugs" as defined by Section 499.003(8), Florida Statutes. Respondent failed to note in patient L.K.'s medical records his prescribing, dispensing or recommendation of BHI Regeneration and Polyzyme 022. Respondent's written medical records fail to document "informed consent" to the drug therapy initiated including medically acceptable alternative procedures or treatments. The preferred course of treatment for a mass of the size and location as existing on patient L.K. would be surgical intervention. Respondent's written medical records fail to adequately document the reason for not following the preferred course of treatment (surgery), that surgery was discussed with the patient's parents, or that the parents declined surgery. Respondent's entry for March 10, 1987, in the medical record of patient L.K. indicates "recommend to get physiotherapy in lieu of surgery." Respondent's medical records fail to justify the course of treatment of the patient, including but not limited to patient histories, examination results, and test results. A reasonably prudent similar physician under similar conditions and circumstances would have referred patient L.K. to a specialist or obtained a consultation with a specialist. Respondent failed to do so. A reasonably prudent similar physician under similar conditions and circumstances would not have recommended that patient L.K. not receive standard immunizations nor would such a physician have executed a school form allowing patient L.K. to be exempted from required immunizations. A reasonably prudent similar physician would have obtained and reviewed prior biopsy report or conducted a biopsy on patient L.K. soon after undertaking the care of the patient. Respondent has failed to practice osteopathic medicine with that level of care, skill and treatment which is recognized by a reasonably osteopathic physician as being acceptable under similar conditions and circumstances. On or about April 7, 1987, the Board of Osteopathic Medical Examiners issued a Subpoena Duces Tecum commanding Respondent produce for copying and inspection any and all medical records of patient L.K. On or about May 8, 1987, the aforementioned subpoena was served on Respondent to produce copies of any and all medical records of patient, L.K., on May 10, 1987, at 6501 Arlington Expressway, Jacksonville, Florida. Respondent did not file a challenge or object in any fashion to the subpoena. As a result of the Petitioner filing a petition for enforcement of the subpoena, Respondent furnished to Petitioner what was purported to be the medical records of patient L.K., and did not in any way advise Petitioner that there were certain records pertaining to L.K. that he did not consider medical records. The medical records of patient L.K. submitted by Respondent in response to the subpoena were incomplete. Respondent's license to practice osteopathic medicine in the state of Florida was disciplined by the Board of Osteopathic Medical Examiners (Board) by its final order issued on April 19, 1988, wherein Respondent's license was suspended for one year; to be followed by a three year period of probation.
Recommendation Based on the foregoing Findings of Fact, Conclusions of Law, the evidence of record and the candor and demeanor of the witnesses, it is, therefore, RECOMMENDED that the Board enter a Final Order finding Respondent guilty of violating Section 459.015(1)(n), (p), (y) (cc), Florida Statutes (1989), as set forth in Counts I, III, IV and V of the Second Amended Administrative Complaint, as amended, and for such violation, considering the guidelines for imposing penalties set forth in Rule 2IR-19, Florida Administrative Code, and the aggravating or mitigating circumstances allowing the Board to deviate from those guidelines set forth in Rule 2IR-19, Florida Administrative Code, it is RECOMMENDED that Respondent's license to practice osteopathic medicine in the State of Florida be suspended for one year subject to the terms and conditions the Board deems appropriate for reinstatement. It is further RECOMMENDED that Count II be DISMISSED. Respectfully submitted and entered this 27th day of October, 1989, in Tallahassee, Leon County, Florida. WILLIAM R. CAVE 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 Administrative Hearings this 27th day of October, 1989. APPENDIX TO THE RECOMMENDED ORDER IN CASE NO. 88-0308 The following constitutes my specific rulings, pursuant to Section 120.59(2), Florida Statutes, on the proposed Findings of Fact submitted by the parties in this case. Specific Rulings on Proposed Findings of Fact Submitted by Petitioner 1-26. Adopted in Findings of Fact 1-26, respectively. Specific Rulings on Proposed Findings of Fact Submitted by Respondent Respondent filed a one page, two paragraph Proposed Findings of Fact and Proposed Conclusion of Law that was an argument consisting of facts and law. To the extent that there are facts contained in his argument, they are either not material or not relevant. COPIES FURNISHED: Bruce D. Lamb, Esquire Chief Trial Counsel 730 S. Sterling Street Suite 201 Tampa, Florida 32609 David L. Sturdivant, Sr. 1804 Nelson Street, #I15 Ormond Beach, Florida 32704 Rod Presnell Executive Director Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Kenneth E. Easley, Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issues in this case are whether Respondent violated Subsection 458.331(1)(t), Florida Statutes (2004),2 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state agency charged with the regulation of the practice of medicine pursuant to Chapters 20, 456, and 458, Florida Statutes. Dr. Roush is a licensed medical doctor in the State of Florida, having been issued license No. ME 83992. He is board- certified in general surgery by the American Board of Surgery. On February 8, 2005, V.R. presented to the emergency department at Winter Haven Hospital, Inc. Her chief complaint was “near syncope,” which means near fainting. She had fallen and hit her left ribs. She denied hitting her head and stated that she never “went completely out.” She complained of feeling dizzy when she stood. While in the emergency department, V.R. had a CT which indicated an abnormality. She was admitted to the hospital by Ernesto J. Perez, M.D., who was the attending physician. V.R.’s medical history included hypertension, osteoarthritis, osteoporosis, and gastroesophageal reflux disease. A brain magnetic resonance imaging (MRI) and a carotid magnetic resonance angiography (MRA) were ordered for V.R. After the MRI and MRA were completed, V.R. was seen by Juan L. Joy, M.D., who reviewed the test results. Dr. Joy found that both studies were “unremarkable.” Specifically, Dr. Joy found that the MRI showed no posterior fossa lesions. The radiographic report of the MRA showed that there was “approximately 70 to 80 percent luminal narrowing of the proximal left ICA." Because of the abnormal MRA, Dr. Perez consulted with Dr. Roush. Dr. Roush examined the patient and felt that V.R.’s symptoms were consistent with inner ear cochlear malfunction. However, he determined that V.R. had left-sided 70 to 80 percent carotid stenosis. His assessment of V.R. was that she was “a 66-year-old female with probable asymptomatic high-grade stenosis in the left carotid internal artery." He recommended a carotid endarterectomy, which is a procedure that removes plaque from the lining of the carotid artery. An MRA is used to diagnose blockages or stenosis in the carotid arteries. An MRA can overestimate the degree of blockage. Other studies such as ultrasound, carotid Doppler studies, and standard arteriography are used to diagnose carotid stenosis. Roush did not order or perform any additional diagnostic studies to confirm the results of V.R.’s MRA prior to making the surgical recommendation. Dr. Roush performed the carotid endarterectomy on V.R., but no carotid stenosis was found. An ultrasound of the right carotid artery was ordered to determine if the original MRA had been of the right carotid rather then the left. The ultrasound showed that there was “no hemodynamically significant stenosis” and “no plaque” in the right carotid. The Department presented Dr. Michael J. Cohen as its expert witness. Dr. Cohen is board-certified in vascular surgery. It was Dr. Cohen’s opinion that an MRA, alone, was not sufficient to diagnose carotid stenosis and that Dr. Roush fell below the standard of care by not ordering additional diagnostic tests prior to recommending surgical intervention. Dr. Cohen's opinion is credited. The MRA showed a blockage of 70 to 80 percent. Dr. Cohen credibly opined that most vascular surgeons would not have operated on an asymptomatic patient such as V.R. with that level of stenosis without additional testing. It was Dr. Cohen’s credible opinion that the carotid endarterectomy which Dr. Roush performed on V.R. was an unnecessary surgical procedure; thus, Dr. Roush fell below the standard of care when he performed the surgery.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Roush violated Subsection 458.331(1)(t), Florida Statutes; imposing an administrative fine of $10,000; requiring 25 hours of community service; requiring Dr. Roush to take no less than five hours of Risk Management Continuing Medical Education coursework; and issuing a reprimand. DONE AND ORDERED this 16th day of November, 2007, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL 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 16th day of November, 2007.
