The Issue Should Respondent Patricia Dee G. Stehpenson's license to practice medicine in the State of Florida be revoked, suspended or otherwise disciplined based on the allegations contained in the Administrative Complaint filed herein?
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant findings of fact are made: At all times material to this proceeding, the Respondent was a licensed physician in the State of Florida, having been issued license number ME 0051453. The patient, a 73 year old female, presented to Respondent on July 11, 1991, with complaints of flashes of light over the past ten years which had increased over the past two years. The patient also complained of seeing halos around street lights at night. During this visit, Respondent diagnosed the patient as having 20/30 corrected vision in her right eye and 20/40 plus 2 corrected vision in her left eye, and that the patient had cataracts. However, Respondent did not recommend cataract surgery at this time. In January, 1992, the patient took the State of Florida driver's license test, including the eye test, and received her driver's license. However, the examiner notice that the patient was having trouble with the eye test and, although the examiner gave the patient her driver's license, the examiner suggested that the patient see an opthalmologist. At the time the patient received her driver's license in January, 1992, the patient was enjoying golf, bowling and driving. Although the patient did not immediately follow the driver's license examiner's advice concerning her eyes, the patient did visit with Respondent on May 8, 1992. At this visit, the patient advised the Respondent that the flashes and floaters had improved but that her vision was interfering with her golfing and driving. Again, Respondent did not recommend removal of the cataract. The patient's vision continued to interfere with her golfing and driving, notwithstanding the patient's testimony to the contrary which I do not find to be credible. The patient's next visit with Respondent was on October 16, 1992. At this visit, the patient advised Respondent that her vision had "lessened a lot" in the left eye. Visual acuity testing indicated corrected vision of 20/30 in the right eye and 20/40 plus 2 in the left eye. However, while the level of vision at which the patient was able to perceive letters (20/40 plus 2) did not change, the refraction (stronger glasses) required to achieve that level indicated more myopia, indicating that the cataract had progressed which supports the patient's complaint that her vision had "lessened a lot". Also at the October 16, 1992, visit, Respondent tested the patient's vision using brightness acuity testing (glare test) and measured the patient's vision as 20/70, with glare in the left eye. The glare test is a method whereby the doctor shines a light in the person's eye to determine the effect of glare on the person's vision. Although some ophthalmologists consider the glare test of no value, other ophthalmologists consider the glare test as another tool to assist the surgeon in making a decision concerning the necessity for cataract surgery. During the October 16, 1992, office visit, Respondent discussed with the patient: (a) the effect the cataract was having on the patient's activities (life-style); (b) the patient's complaint that her vision had lessened; (c) the results of the glare test showing the patient's vision as 20/70 with glare and; (d) other visual acuity testing; and (e)advised the patient that cataract surgery was indicated. Also, Respondent explained the cataract surgery procedures and discussed with the patient the risks and the benefits of the surgery. The patient had no reservations or objections to the surgery and consented to the surgery in hopes of improving her eyesight as well as her life- style. For a person with cataracts, a corrected vision of 20/40 or worse is the vision level where some cataract surgeons will recommend cataract surgery, while other cataract surgeons consider a corrected vision of 20/50 or worse, with or without glare, as the vision level where cataract surgery should be recommended. However, because the vision as determined by visual acuity testing (the ability of the person to perceive letters) does not always accurately reflect the person's quality of vision (the quality of perception on a day to day basis), neither vision level referred to above when considered alone can be used as a hard and fast rule to form a basis for cataract surgery. Since the quality of vision can only be described by the person with the cataract(s), the cataract surgeon must also determine, after consultation with the person, that the cataract(s) are interfering with the person's life-style. Therefore, a person with corrected vision of somewhat better than 20/40 or 20/70 with or without glare, may be a candidate for cataract surgery, provided the cataract is causing a reduction in the person's quality of vision beyond what is indicated by visual acuity testing and thereby interfering with the person's life-style. Furthermore, there are no written standards or guidelines which set a particular vision level for the cataract surgeon to follow when making a decision to recommend cataract surgery. The surgeon must take into consideration all factors and make a decision based on the surgeon's judgment as to what is best for that person. The patient's vision level and the interference the patient was experiencing with her life-style because of the cataracts in her left eye justified Respondent's decision to recommend and perform the cataract surgery on the patient, notwithstanding any of the testimony of Dr. Leslie Monroe to the contrary. On November 3, 1992, Respondent performed phacoemulsification (removal of cataract) with posterior chamber intracular lens implant (implantation of lens) on the patient's left eye. While the patient was in the holding area being prepared for surgery there were complications with the anesthesia. The anesthesiologist, Robert Dienes, M. D., first gave the patient a retrobulbar block which was repeated apparently due to Dr. Dienes' conclusion that the first retrobulbar block was ineffective. Apparently, Dr. Dienes also concluded that the second retrobulbar block was ineffective and gave the patient a superior lid peribulbar block. After giving the peribulbar block, Dr. Dienes noticed a dissecting subconjunctival hemorrhage and notified Respondent. Upon examining the patient's eye, Respondent found the globe (whole eye) to be soft with no active bleeding, indicating the eye was not full of blood and that there was no retina tear or rupture of the globe. Respondent also noticed that "the conjunctiva was real chemotic or it had blood behind it". Respondent also measured the patient's eye pressure with a Schiotz tonameter because there was no slit-lamp in the holding area. The patient's eye pressure was 5, with a 5.5 gram weight, which was normal. The patient's medical records do not reflect an indirect ophthalmoscopy being performed by Respondent on the patient's left eye between Respondent being advised of the dissecting subjunctival hemorrhage by Dr. Diemes and the Respondent performing surgery on the patient's left eye to remove the cataract and implant the lens. Furthermore, Respondent has no independent recollection of performing an indirect ophthalmoscopy during the above period of time before surgery. Respondent's normal practice under conditions and circumstances similar to those in this case has been to perform an indirect ophthalmoscopy during the above period of time before surgery. Therefore, it is assumed that Respondent performed an indirect ophthalmoscopy on the patient after being advised of the subconjunctival hemorrhage but before surgery, notwithstanding the fact that patient's medical records do not reflect such procedure being performed or the fact that Respondent has no independent recollection of performing such procedure during the above period of time. However, assuming arguendo that Respondent did not perform the indirect ophthalmoscopy before surgery, the Agency has failed to establish facts to show that under the conditions and circumstances of this case that such failure amounted to the failure of Respondent 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. After considering the conditions and circumstances surrounding the complication that arose while the patient was being anesthetized, Respondent made a decision that it was in the best interest of the patient to go forward with the removal of the cataract and implantation of the lens. The operation was completed without any further incident and there was a successful removal of the cataract and lens transplant. Respondent's decision to go forward with the surgery had no adverse effect on the subsequent treatment of the complication that arose while the patient was being anesthetized. In fact, the result of the treatment subsequent to the cataract surgery would have been the same even if Respondent had not gone forward with the surgery. Respondent, using a ophthalmoscope, was able to see the inside of the eye more clearly and assess the complication that arose while the patient was being anesthetized. While performing this indirect ophthalmoscopy, Respondent noted undulation of the vitreous with pigmented blood cells present and that the anesthesia needle had penetrated the globe. The patient was seen the next morning, November 3, 1992, by Respondent. After assessing the condition of the patient's left eye, Respondent referred the patient to Keye Wong, M. D., a retina specialist. Upon examining the patient's left eye on November 4, 1992, Dr. Wong noted vitreous hemorrhaging and retinal detachment. Dr. Wong performed an operation on the patient's left eye in an attempt to correct the damage and attach the retina. The patient's vision is not as good as it was before the operation, and still effects the patient's life-style. The patient has difficulty tolerating sunlight, which may or may not be a result of the complication experienced while the patient was being anesthetize. Respondent's action of going forward with the surgery after becoming aware of the complication that arose while the patient was being anesthetized did not cause, complicate, aggravate or result in any of the problems the patient has suffered postoperatively. Respondent did not fail to recognize, identify or treat properly the complications that arose before, during or after the surgery. The Agency has failed to establish facts to show that Respondent failed 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 at anytime while Respondent was treating the patient, including both preoperative and postoperative treatment.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Petitioner Agency for Health Care Administration enter a final order dismissing the Administrative Complaint filed herein against Respondent Patricia Dee G. Stephenson, M. D. DONE and ENTERED this 23rd day of January, 1996, at Tallahassee, 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 of Administrative Hearings this 23rd day of January, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-1560 The following constitutes my specific rulings, pursuant to Section 120.59(2), Florida Statutes, on all of the proposed findings of fact submitted by the Petitioner and the Department in this case. Agency's Proposed Findings of Fact. Proposed findings of fact 1-2 are adopted in substance as modified in Findings of Fact 1 and 2. The first sentence of proposed finding of fact 3 is adopted in Finding of Fact 3. The second and third sentence are not supported by evidence in the record. Proposed finding of fact 4 is adopted in substance as modified in Finding of Fact 5, otherwise not supported by evidence in the record. Proposed finding of fact 5 is adopted in substance as modified in Finding of Fact 7, otherwise not supported by evidence in the record. Proposed finding of fact 6 is adopted in substance as modified in Findings of Fact 12, 13, and 14, otherwise not supported by evidence in the record. Proposed findings of fact 7 and 8 are adopted in substance as modified in Findings of Fact 21 and 22, otherwise not supported by evidence in the record. Proposed finding of fact 9 is a restatement of Dr. Monroe's testimony and is not a finding of fact. However, see Findings of Fact 16 and 17. 8, Proposed findings of fact 10, 16, 17 and 19 are adopted in substance as modified in Findings of Fact 15, 16, 10, 8 and 9. Proposed finding of fact 11 is adopted in substance as modified in Finding of Fact 16, otherwise not supported by evidence in the record. Although proposed findings of fact 12, 13 and 15 are findings of fact, they are neither material nor relevant to this proceeding. See Finding of Fact 9. Proposed finding of fact 14 is a restatement of Dr. Grabow's testimony and is not stated as a finding of fact, but see Finding of Fact 10. Dr. Grabow's testimony was 20/50 vision with or without glare which is different than just 20/50 vision. 11. Proposed findings of Fact 18 and 20 are not supported by evidence in the record. Respondent's Proposed Findings of Fact. 1. Proposed findings of fact 1 through 27 are adopted in substance as modified in Findings of Fact 1 through 25. COPIES FURNISHED: Marm Harris, M. D., Executive Director Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0770 Jerome W. Hoffman, Esquire Agency for Health Care Administration Fort Knox Building Number Three 2727 Mahan Drive Tallahassee, Florida 32308 Steve Rothenburg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 William E. Partridge, Esquire Lutz, Webb, Partridge, BoBo, and Baitty One Sarasota Tower 2 North Tamiami Trail, Suite 500 Sarasota, Florida 34236
The Issue The issue for determination at formal hearing was whether Respondent committed the offenses set forth in the administrative complaint, and, if so, what action should be taken.
Findings Of Fact The Department of Professional Regulation (now, the Agency for Health Care Administration), Board of Medicine (Petitioner), is the state agency charged with regulating the practice of medicine pursuant to Section 20.30, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times material hereto, Arthur J. Schatz, M.D. (Respondent), has been a licensed physician in the State of Florida, having been issued license number ME 0024745. On or about September 7, 1988, Patient A. H., a 61-year-old female, presented to her internist with complaints of left pelvic pain. The internist ordered a pelvic sonogram and an MRI. Both procedures revealed a five centimeter mass on the left side of Patient A. H.'s pelvis. The internist referred Patient A. H. to Respondent. On or about September 16, 1988, she presented to Respondent who performed an examination by palpation, which revealed a mass on the left side of her pelvis. Respondent diagnosed Patient A. H. as having a left ovarian tumor. Respondent scheduled Patient A. H. for exploratory laparotomy and probable total abdominal hysterectomy and bilateral salpingo-oophorectomy. Exploratory laparotomy is a surgical procedure in which a patient's abdomen is opened to explore the abdominal cavity in order to determine whether there is any pathology present. Exploratory laparotomy was indicated, and Respondent was qualified and credentialed to perform the surgical procedure. Because of the location of the mass and because of Patient A. H.'s history, especially her age, pre-operatively, Respondent believed that the mass was highly suggestive of a malignancy. Respondent did not perform or order any other diagnostic test or seek any consultation with any other physician or any specialist. Such conduct by Respondent was within the acceptable standard of care, skill, and treatment in the practice of medicine. On or about September 25, 1988, Respondent admitted Patient A. H. to Parkway Regional Medical Center for the surgical procedure to be performed. On or about September 26, 1988, Respondent performed the exploratory laparotomy. Upon entering Patient A. H.'s abdomen, Respondent took washings. Respondent then proceeded to examine her female organs and discovered that they were normal. Continuing, Respondent palpated the mass on the left side of Patient A. H.'s pelvis in the retroperitoneal area, behind a very thin layer of tissue called the peritoneum. Pre-operatively, Respondent could not have known that the mass was retroperitoneal. The overwhelming majority, ninety-eight percent, of gynecologic surgery is performed on the intra-peritoneal structures, while only two percent is performed retroperitoneally. General gynecologists are trained to and do perform surgical procedures retroperitoneally. Respondent appropriately elected to open the peritoneum and entered the retroperitoneal space to identify and surgically address the area of suspected pathology. He found a somewhat soft mass, approximately five centimeters in diameter, on the pelvic side wall with a white structure running through the middle of the mass. The mass, a tumor, which was encapsulated was round in shape and yellowish in color. Encapsulation is more commonly associated with benign tumors than malignant tumors. Unsuccessfully, Respondent attempted several times to dissect the mass off the white structure. Respondent recognized the white structure as the obturator nerve which was later identified as such. Respondent observed that the mass had the general appearance of a lymphoma which is a benign, fatty, slow-growing tumor. However, he was unable to precisely identify the nature of the mass which could also have been lymphosarcoma, malignant, since no analysis had been performed on the mass. Respondent believed that the tumor was more likely benign than malignant. Confronted with a most unusual situation in that the tumor was in a very unusual location and the obturator nerve was within the mass itself, Respondent requested that the entire hospital be paged for a gynecologic oncologist. He was informed that neither of the two gynecologic oncologists on the hospital staff were in the hospital or scheduled to be in the hospital. Respondent's act of not having a gynecologic oncologist present or on call during the scheduled surgery was not practicing medicine below the acceptable standard of care, skill, and treatment. Respondent then requested the paging of a general surgeon. A board certified general surgeon responded and entered the operating suite where Respondent was operating on Patient A. H. The general surgeon did not scrub to assist Respondent but came into Respondent's operating suite and viewed the operating field. He advised Respondent that he had never seen a condition like that of Patient A. H. and could offer no suggestions. Getting no assistance from the general surgeon, Respondent requested that a neurosurgeon or orthopedist be called. A board certified orthopedist was in surgery in an adjacent operating suite. Respondent broke scrub, left his operating suite and entered the orthopedist's operating suite. He questioned the orthopedist regarding the function of the obturator nerve and the anticipated effect of sacrificing the nerve, if that were necessary, in order to remove the tumor in its entirety. The orthopedist advised Respondent that the obturator nerve was a major nerve which governs the muscles involved in the adduction of the thigh and affects the ability to walk. He further advised Respondent that sacrificing the nerve should result in only a minimal disability which could be adequately addressed with physical therapy. Generally, a general gynecologist, including Respondent, has a cursory understanding of the function of the obturator nerve. Arising from the lumbar section of the spinal column, the obturator nerve is a major nerve and is extremely important in allowing a person's legs to move to the midline for the purpose of walking. After being advised by the orthopedist, Respondent re-scrubbed and returned to his operating suite. He again attempted, without success, to dissect the tumor from the obturator nerve. Thereupon, Respondent decided that Patient A. H. would benefit from a complete resection of the tumor even though it would mean sacrificing the obturator nerve in order to remove the tumor in its entirety. He had no experience in the removal of lymphomas from nerves. Respondent appropriately decided against performing a frozen section on the tumor, prior to removal, because such a procedure might expose Patient A. H. to the risk of cancer cells being spread through the retroperitoneal space if the tumor was malignant. His action was within the acceptable standard of care, skill, and treatment in the practice of medicine. A frozen section is a procedure in the intraoperative period 2/ in which a surgeon attempts to remove a piece of a tumor or mass to send to a pathologist to determine whether the mass is malignant or benign. The procedure is important because it provides the surgeon with direction as to how to proceed in terms of treatment and care of a patient while the patient is under anesthesia and in the operating room. Furthermore, Respondent appropriately decided against removing only portions of the tumor, thereby leaving some of it behind, because such a procedure could result in the tumor re-growing, and possibly as a malignancy. His action was within the acceptable standard of care, skill, and treatment in the practice of medicine. Respondent removed the tumor in its entirety which included removing the portion of the obturator nerve to which the tumor was attached to and incorporated within the tumor. Respondent sent the specimen to the pathology lab for analysis which revealed that the tumor was a fatty, benign lymphoma and that the white structure incorporated within the tumor was nerve tissue. Prior to removing the tumor in its entirety, there was no acceptable method available to Respondent for him to definitively know that the tumor was benign. Respondent failed to record his contacts with the general surgeon and the orthopedic surgeon in his operative notes for the surgery but recorded the contacts in his discharge summary. It is customary and appropriate to record intra-operative consultations in an operative report. Neither the general surgeon nor the orthopedist considered their contact with Respondent as a consultation. Patient A. H.'s postoperative recovery was not as anticipated in that she suffered severe, instead of minimal, disability which has affected her ability to walk. She is unable to walk without the assistance of either a cane or a leg brace. No literature or authority exists which supports the sacrifice of the obturator nerve for a benign tumor or a tumor which appears to be benign. Patient A. H.'s condition was a rare case because of the location of the tumor and because the tumor was attached to the obturator nerve which was incorporated within the tumor. Neither the expert for Petitioner nor for Respondent had ever experienced, or heard or read of such a situation. Furthermore, because of Respondent's experience with Patient A. H. and her resulting condition, both experts have greater knowledge of the obturator nerve. Respondent's removal of the tumor in its entirety, including removing a portion of the obturator nerve, was within the acceptable standard of care, skill, and treatment in the practice of medicine.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency For Health Care Administration, Board of Medicine, enter a final order dismissing the administrative complaint. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 2nd day of December 1994. 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 2nd day of December 1994.
The Issue An Administrative Complaint dated May 22, 1990, alleges that Respondent violated Section 458.331(1)(t), F.S. 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, Petitioner alleges that Respondent undertook certain surgical procedures on patient, R.M., without conducting necessary pre-surgery work up and testing. At the hearing Petitioner voluntarily dismissed remaining allegations in the Complaint, related to a subsequent hospitalization of the same patient. (transcript, pp 13 & 14) The issue for determination is whether Respondent committed the alleged violation, and if so, what discipline is appropriate.
Findings Of Fact Respondent, Irving L. Colvin, M.D., is and has been at all times material hereto, a licensed physician, having been issued license number ME0008095 by the State of Florida. He has practiced in the Central Florida area since 1958, and is a Board-certified surgeon. R.M., a 35 year old male, became a patient of Dr. Colvin in 1985, when he complained of right upper quadrant pain. Gallbladder x-rays were obtained at that time, and several months later when the complaints persisted. In August 1985, Dr. Colvin obtained a sonogram (echo test) of the gallbladder and an upper gastrointestinal series. Blood tests were also taken. The results of these tests did not, in Dr. Colvin's opinion, indicate a need for surgery, and the patient was treated symptomatically. R.M. continued to complain of pain in 1986 and was treated symptomatically. He was seen by another internist and a gastroenterologist and was placed on several medications. None of the medications appeared to relieve his pain, and he visited Dr. Colvin again in June 1988, with the same complaints: recurring episodes of right upper quadrant pain radiating to the back. Laboratory tests were done and some jaundice was found. His serum bilirubin was elevated and was treated symptomatically for a couple of weeks, until the patient was admitted to AMI Medical Center in Orlando for exploratory surgery in July 1988. None of the tests conducted prior to the surgery revealed the existence of gallstones. Three gallbladder x-rays were performed between 1985 and 1988. At least one sonogram was conducted, as well as blood tests and upper gastrointestinal series. Dr. Colvin considered that the tests ruled out other bases for the recurring complaints and clinically concluded that the patient had chronic cholecystitis (gallbladder disease) with bile duct obstruction and possibly intermittent stones. By the time of the surgery, the patient indicated he was tired of putting up with the pain and wanted something done other than the medications. At Dr. Colvin's request, the morning of surgery, Dr. Talal Hilal, a gastroenterologist, conducted an endoscopy to rule out other causes of the intermittent jaundice. This consisted in the insertion of a tube through the mouth and esophagus, down to the stomach and to the small intestine where the gallbladder is found in the duodenum. Dr. Hilal's findings were essentially normal, and he recommended that Dr. Colvin proceed to surgically explore the common bile duct. The surgery conducted by Dr. Colvin included exploration of the duct with a choledoscope and removal of the gallbladder. The surgery was appropriate as the gallbladder was diseased. Post operative diagnoses were: chronic acalculus cholecystitis, chronic pancreatitus and stenosis (constriction) of the distal common bile duct and sphincter of odi. None of the experts claims that the surgery should not have been performed. Rather, the agency's two experts, who reviewed the medical files only, claim that insufficient work-up was completed prior to the surgery. The original function of the gallbladder was to store bile in lower animals, which has carried over into a gallbladder in human beings and which may or may not have very much function. Still, invasive procedures should be avoided unless they are necessary, as they can be life-threatening. The agency's experts claim that less invasive procedures should have been tried prior to surgery. More specifically, they suggest that an operative cholangiogram should have been done. That is a procedure wherein a small tube is inserted through a small nick in the part of the gallbladder that joins the common bile duct. Dye is injected, and x-rays of the duct are taken. They also suggest other procedures, including sonography or ultrasound, hiatiscan, CAT scan, a study of the bilirubin, and ERCP (endoscopic retrograde cholangiopancreatogram). At least two of these procedures, sonography and bilirubin tests, were obtained by Dr. Colvin prior to surgery. By the time that he performed surgery on R.M., Dr. Colvin surmised through his clinical observations that the patient's gallbladder disease was not likely caused by stones. Chronic acalculus cholecystitis is a specific disease characterized by the absence of stones but still caused by an inflammatory reaction. From five to ten percent of gallbladder cholecystitis exists without the presence of stones. Diagnosis of the disease is made clinically, through the elimination of possibilities of other diseases, by skillfully feeling the patient and by listening to his complaints. Typically, the symptoms of chronic acalculus cholecystitis are upper abdominal pain, sometimes radiating to the back, digestive disturbances and low grade fever. The disease recurs chronically, with subsidence of the symptoms from time to time. There is substantial difference of opinion on the utility of the multiple tests suggested by the agency's experts. A cholangiogram is helpful when stones are strongly suspected, as it indicates how many stones exist, so that surgery will remove them all. While not as life-threatening as the exploratory surgery, this procedure also has risks, including inflamation of the pancreas, and it still involves opening the abdomen. Dr. Colvin already had the advantage of several sonagrams and X-rays indicating that stones did not exist. He had the laboratory tests revealing fluctuating bilirubin levels and strongly indicating the need for bile duct exploration. The hiatiscan, involving a nuclear radiation determination of obstructions, is most commonly used in cases of acute, rather than chronic cholecystitis. If the ERCP needed to have been done, Dr. Hilal would have performed it at the time that he did the pre-surgery endoscopy. He did not feel it was necessary and recommended that Dr. Colvin follow his plan for the surgery. A CAT scan would have been very costly and is an inaccurate means of detecting gallstones, detecting less than ten or fifteen percent of existing stones. From his review of the records, Dr. Corwin, an expert witness for the agency, conceded that R.M. probably had chronic cholecystitis. He has never treated a patient with chronic acalculus cholecystytis and stated that he does not consider it an acceptable diagnosis. Dr. Corwin admitted that some people might consider the laboratory tests and endoscopy ordered by Dr. Colvin to be an adequate work-up, and he stated that he would "hedge a little bit" on his own opinion. All of the remaining witnesses, including Dr. Goggin, the agency's other expert, have heard of the disease and consider it a valid diagnosis. This is a case of reasonably prudent physicians disagreeing as to appropriate pre-surgery work-up of a patient. Other than Dr. Colvin, only one witness was personally familiar with the patient. That witness, Dr. Hilal, the gastroenterologist, unequivocally supported Dr. Colvin's handling of the case. Once Dr. Colvin determined clinically that surgical exploration was necessary through his treatment of the patient and through the process of elimination of alternative diagnoses, the other available tests suggested by Drs. Goggin and Corwin were redundant. Petitioner failed to prove that the means by which Respondent reached his clinical diagnosis violates the applicable standard of care.
Recommendation Based on the foregoing, it is hereby, RECOMMENDED: That the Board of Medicine enter its final order dismissing the Administrative Complaint against Irving L. Colvin, M.D. DONE AND RECOMMENDED this 28th day of February, 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 Divisionof Administrative Hearings this 28th day of February, 1991. APPENDIX The following constitute specific rulings on the findings of fact proposed by the parties. Petitioner's Proposed Findings Adopted in paragraph 1. Adopted in paragraph 7. Adopted in substance in paragraph 5. Adopted in relevant part in paragraph 4. Rejected as irrelevant. Rejected as contrary to the weight of evidence. Rejected as contrary to the weight of evidence. What comprises a "complete history and physical" is not explained, nor is this failure alleged as a violation of Section 458.331, F.S., in the Administrative Complaint. Rejected as immaterial. Rejected as contrary to the weight of evidence. Rejected as cumulative, immaterial (as to elevated alkaline phosphatase level) and contrary to the weight of evidence (as to no evidence of need for exploration). Adopted in substance in paragraph 9. Rejected as immaterial, and contrary to the weight of evidence. Rejected as contrary to the weight of evidence. and Adopted in relevant part in paragraph 5. Adopted in paragraphs 3 and 4. 17.and 18. Rejected, as to the persuasiveness of the two experts' opinion. Respondent's Findings of Fact The Respondent's proposed findings consist of 2 numbered paragraphs. The first is adopted in Recommended finding #1; the second is argument and commentary on the testimony, rather than proposed findings. COPIES FURNISHED: Francesca Small, Esquire Larry G. McPherson, Esquire DPR 1940 N. Monroe St., Ste. 60 Tallahassee, FL 32399-0792 Gary Siegel, Esquire 6500 S. Highway 17-92 Fern Park, FL 32730 Jack McRay, General Counsel DPR 1940 N. Monroe St., Ste. 60 Tallahassee, FL 32399-0792 Dorothy Faircloth Executive Director DPR-Board of Medicine 1940 N. Monroe St., Ste. 60 Tallahassee, FL 32399-0792
Findings Of Fact The Respondent, Charles P. Shook, M.D., is a medical doctor having been issued license number 0020414, pursuant to Chapter 458, Florida Statutes. He is board certified in the areas of general and peripheral vascular surgery and practices in those specialty areas in Fort Myers, Lee County, Florida. He has been practicing in Lee County since 1973. The Petitioner is an agency of the State of Florida, charged with enforcing the licensure and practice standards embodied in Chapter 458, Florida Statutes and related statutes and rules and imposing disciplinary measures for departure from those standards by physicians licensed in Florida when such are proven. Mrs. Betty A. Fiore, at times pertinent hereto, was an obese, 47-year old female, with a history of thrombo-phlebitis and progressively enlarging and painful bilaterial varicosities of the veins in her right and left legs. She was admitted to Fort Myers Community Hospital on January 28, 1979, by the Respondent, for performance of a bilateral "vein-stripping" surgical procedure. Her medical history reflected that she had had a similar vein-stripping procedure performed over 20 years previously. The patient was operated on by the Respondent on January 29, 1979, beginning at approximately 9:25 a.m. The procedure was quite lengthy due to certain complications and lasted until 1:25 p.m. that day. After normal preparations, under general anesthesia, the Respondent began the operation by performing an oblique groin incision on the left leg just below the inquinal liagment, approximately ten centimeters in length. The incision penetrated the subcutaneous tissue and, as the "fossa-ovalis" was approached, the Respondent noted a significant amount of scar tissue, apparently related to the earlier surgical procedure, which obliterated and concealed much of the normal anatomy and structure in the area of surgery. It was of such a dense nature that only a faintly palpable pulse could be felt in the vessel. The Respondent dissected out the various venous branches in the area and individually ligated them. During his dissection process, the distal common femoral artery was injured by being slightly nicked with the surgical instrument. Repair procedures for the injury to the artery were carried out as will be described below. In any event, the "codman stripper" was employed in carrying out the stripping operation on the vein in question and additionally, several incisions were made around the calf of the leg to alleviate smaller varicosities. One large perforating vein in the malleolar area had to be ligated after the superficial portion had been stripped away. The Respondent then began to perform a similar procedure on the right leg, in spite of the initial difficulties he had had on the left leg, because he did not expect such severe scar tissue involvement with the anatomical structures in the area of incision on both legs. When he carried out the incision on the right leg however, he found that the anatomy of the right leg was essentially the same as that of the left and that substantial scar tissue reaction had occurred, related to prior surgery, with obliteration of much of the normal anatomy, including concealment of the femoral artery. Due in large part to these anatomical changes and complications involved in dissecting out the various venous branches involved in the stripping procedure, the right femoral artery was also slightly nicked by the scalpel. The Respondent attempted to suture the femoral arteries nicked in both legs at the time these injuries occurred, but the sutures would not hold in the arteries due to some then unknown, medical condition. After the same failure to hold sutures was encountered with regard to both femoral arteries, the Respondent sent samples of the arteries to the pathologist for evaluation. The pathologist report indicated that the arteries were "normal." Parenthetically it should he noted that the "complaining witness," Mrs. Fiore, has been found to exhibit symptoms of diabetes mellitus. Her testimony was somewhat evasive concerning the degree to which she may suffer from this malady, which can have a detrimental effect on the vascular system. In any event, when working first on the left leg, the Respondent elected to resect back along the artery for approximately a half-inch on each side of the wound and after that resection, to repair the femoral artery with the insertion of a 6 millimeter gortex graft. Likewise, with regard to the right leg, the Respondent found the sutures would not hold in the damaged artery (which was of a "cheese-like" consistency). He therefore performed a similar resection and insertion of a 6 millimeter gortex graft to repair the injury. The surgical procedure was then successfully concluded. Post-operatively the patient encountered some complications involving infection in the groin area, requiring two additional admissions to Fort Myers Community Hospital. Subsequently, she was transferred to Methodist Hospital in Houston, Texas, where she underwent two additional surgical procedures. The Petitioner presented the opinions of two expert witnesses, Dr. Alexander Braze and Dr. E. William Reiber. Dr. Braze's expert opinion is predicated on the review of Mrs. Fiore's office records from the Respondent's office, the hospital charts for her three admissions to Fort Myers Community Hospital, and summaries of her two admissions to the Methodist Hospital in Houston, Texas. His opinion is not based on any examination of the patient involved. Dr. Braze thus opined that because of the previous surgery on the greater saphenous vein, bilaterally, there would be obvious and considerable scarring and scar tissue in the subcutaneous area which would distort and conceal the individual anatomical structures. He himself has never nicked a femoral artery while doing a vein-stripping operation but, although he acknowledges it is an "uncommon complication, he has heard of it occurring. He was unable to render an opinion concerning whether or not the operation was performed properly because this was not a typical vein ligation and stripping procedure, due to the presence of extensive scar tissue, and resulting difficulty involved. The dense scar tissue precluded identification of the structures in the area of the surgical incision and meant that the Respondent had to proceed slowly and very meticulously with a careful dissection, deviation from which careful procedure could cause difficulty. The doctor's procedure was slow and meticulous. The procedure (for both legs) took approximately four hours. Although the Respondent proceeded with care, he nicked the arteries anyway. Dr. Braze could not state that such a complication, albeit uncommon, constituted a departure from standards normally recognized in the medical community. With regard to the doctor's judgmental decision to proceed to the right leg after nicking and repairing the artery in the left leg and completing the vein stripping procedure in the left leg. Dr. Braze opined that he was acting as a reasonable physician in proceeding to the other leg since he had already corrected the initial injury, especially since it was the leg in which she was having her chief complaints. In any event, Dr. Braze was unable to render an opinion as to whether or not the procedure up to the point of nicking the artery was properly or improperly done, although he acknowledged that the lengthy time taken to perform the total procedure indicates that the doctor was proceeding slowly and with greater than normal difficulties. In any event, after the arteries were nicked, the procedure followed by the Respondent was excellent and the repair work was competently and efficiently performed. Dr. Reiber, Petitioner's other expert witness, testified by deposition, which was stipulated into evidence. His expert opinion was based on a review of the deposition of the Respondent, the Fort Myers Community Hospital records of the patient, and the depositions of the patient, Betty Fiore, Arnold Flare and Quillen Jones. Additionally, he reviewed the records dealing with Mrs. Flare's treatment in Houston, Texas. He thus opined that the Respondent made two technical errors when he injured the arteries in each leg and he felt that it was an error in judgment to have performed the procedure on the right leg after having encountered difficulty in the initial procedure on the left leg. He was unable to opine however, that the treatment rendered the patient by Respondent fell below the appropriate standard of care accepted by similar physicians in the community. Moreover, he also opined that the Respondent's treatment after nicking the arteries affirmatively met the standard of care for reasonably prudent physicians in such circumstances. The expert witnesses presented on behalf of the Respondent were Drs. Peter M. Sidell and Luis A. Ruilova. Both witnesses opined, in effect, that, given the obesity of the patient and the difficult surgical process that alone entailed, coupled with the significant involvement of scar tissue in the area of the incision, that the complications associated with this procedure could occur in the hands of even the most renowned surgeon. The fact that the Respondent experienced these complications does not render his practice in this regard to be below the standard of care for vascular surgeons in that community or area of practice. They further opined that it is a matter of personal judgment on whether to proceed to the other leg after encountering these difficulties. A reasonable judgment would have been to explore the groin area on the other side, after accomplishing repair of the first injured artery, which was done. The initial arterial injury having been repaired in a successful manner, both of the Respondent's experts opined that, the patient then being stabilized, the Respondent was justified in proceeding to the other leg and performing the procedure on that side. The main purpose of the operation was to remove the veins of the patient since the patient was symptomatic with varicosities. It therefore would be poor judgment to simply repair the nicked artery and proceed no further, since the symptomatic vein would remain uncorrected. In short, both experts for Respondent opined that neither the vein-stripping procedure, the repair of the damaged arteries nor post-operative management for which Respondent was responsible were performed in a manner below the appropriate standard of care of reasonably prudent physicians in the community. Thus, although the patient unfortunately experienced difficulties during a procedure involving the accidental nicking of her femoral arteries and, after the grafts repairing those injured arteries were performed, later suffered an infection at the operative site necessitating further hospitalization, no expert witness could describe the treatment and care afforded this patient as being below the appropriate standard of care exercised by a reasonably prudent physician performing such vascular surgical practice in the Fort Myers community or area. The Respondent has never encountered this difficulty either before or since this occasion in his practice, which is characterized by frequent vascular surgical procedures. Additionally, Dr. Ruilova established that the nicking of the femoral arteries during such a procedure, although not a common occurrence, is well documented in the literature and not at all unheard of. Indeed, Dr. Ruilova, when assisting a distinguished surgeon who was chief of surgery at the Mayo Clinic at the time, observed that expert surgeon nick a femoral artery in a vein- stripping procedure on two occasions. Finally, it is noted that the Respondent's practice has been characterized by a high level of professional expertise, competence and compassion in caring for his patients, both before and since the occasion in question. He has never before been subjected to disciplinary action.
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, therefore RECOMMENDED that a Final Order be entered by the Board of Medical Examiners dismissing the complaint in its entirety. DONE and ENTERED this 11th day of October, 1984, in Tallahassee, Florida. P. MICHAEL RUFF 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 11th day of October, 1984. COPIES FURNISHED: Barbara K. Hobbs, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Patrick Geraghty, Esquire HENDERSON, FRANKLIN, STARNES & HOLT Post Office Box 280 Fort Myers, Florida 33902 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issue to be resolved in this proceeding concerns whether the licensure examination taken by the Petitioner qualifies him under Section 459.007(3), Florida Statutes, for licensure as an osteopathic physician in the State of Florida.
Findings Of Fact The Petitioner, Lawrence Edward Suess, is an osteopathic physician licensed by the Boards of Medical Examiners in Texas, Alabama, and Kentucky. He seeks licensure in Florida, pursuant to Section 459.007(3), Florida Statutes. He is also licensed in Arizona and Texas as a registered nurse, holds BS and MS degrees in child development and nursing and a Ph.D. in nursing. The Respondent, the Board of Osteopathic Medicine (Board), is an agency of the State of Florida, charged with regulating the admission to practice and the practice and licensure standards of osteopathic physicians licensed or seeking to be licensed in the State of Florida. The Board issued an order, as corrected, on November 9, 1995, granting application of licensure to the Petitioner upon the condition that within one year, he successfully complete Part III of the NBOME examination for purposes of licensure in the State of Florida, and not for diplomate status. The Board found in that order that the Petitioner had not passed all three parts of the NBOME examination and had submitted certification of passage of only Parts I and II. The Board found that the “FLEX” examination was not a substantially-similar examination to the required NBOME examination since the FLEX examination did not contain an osteopathic medicine component. The Board also found that the completion by the Petitioner of a Board certification examination was not substantially similar to the NBOME examination because it tested only a single subject matter and not the broad principles contained in Part III of the NBOME examination. On November 13, 1995, a Petition for Formal Hearing was filed by the Petitioner disputing the decision of the Board which precluded him from obtaining licensure to practice medicine in the State of Florida because of failure to complete Part III of the NBOME examination. He contended that he was outside the time period in which he would be allowed to take Part III. He further contended that the FLEX examination was a substantially-similar examination to the NBOME examination. The Petitioner contends that taking the FLEX examination should be sufficient to justify licensure, although he also acknowledged that Part III of the NBOME examination tests osteopathic philosophy and principle; and he acknowledged that the FLEX examination does not, although he was attempting to testify and argue that the FLEX examination was substantially similar to the NBOME examination. He provided no testimony or evidence, however, to establish that the FLEX examination tests osteopathic philosophy and principle. The Respondent presented the testimony of Joseph Smoley, Ph.D. by deposition. Dr. Smoley holds a Ph.D. in educational measurement and has served for ten of the last eleven years as Executive Director of the NBOME. The NBOME is an organization that develops an examination that is independent of the osteopathic medical schools to evaluate osteopathic physicians who are either currently in undergraduate or in graduate medical programs. The NBOME’s main mission is to provide state licensing examinations with an independent assessment of the knowledge base of candidate osteopathic physicians. Dr. Smoley oversees NBOME policy and supervises educational measurement within the osteopathic profession. His oversight responsibilities include the examination section of the NBOME. He provides a constant review of the process of testing for the Board of Directors. The NBOME developed its examination by having questions drafted by faculty members and osteopathic physicians in independent practice. Faculty members may be D.O.’s or Ph.D.’s in the various basic sciences, and there is a multi-tiered process for preparing and reviewing questions. A copy of the bulletin of information concerning the NBOME examinations was attached to and made part of the deposition. Dr. Smoley testified that typically the candidates take Part I as a sophomore during medical school, Part II as a senior, and Part III as an intern in their first post-graduate year. He established that the purpose behind that examination is “the integration of osteopathic principles and practices as well as the philosophy of osteopathic medicine.” No allopathic physicians are involved in the grading process of that examination. Some allopathic physicians associated with osteopathic colleges may submit questions that, after the review process, may be used on the examination. The purpose of the NBOME examination, as shown by Dr. Smoley, is to make sure that each question integrates osteopathic principles and practices in some way and that the entire examination is reflective of the practice of osteopathic medicine. Dr. Smoley is also familiar with the FLEX examination, as well as the current licensure examination for allopathic physicians, the USMLE. The Federation of State Medical Boards (FSMB) does not prepare any complete examination or any additional components for its regular examination concerning manipulation or osteopathic practice and principles. According to Dr. Smoley, there has never been an official comparison or analysis between the NBOME examination and the FLEX examination. Based upon his experience and educational measurement, he has determined that if one examination, the NBOME, contains osteopathic principles and practice and the other examination, the FLEX, does not incorporate those principles and practices, then the two examinations could not be considered equivalent. The NBOME examination is more extensive because it integrates osteopathic principles and practice throughout its content. This osteopathic examination is not simply one that tests manipulation. Therefore, it is not asserted to be appropriate for chiropractors or M.D.’s who have been trained in manipulation but only for persons who have received an osteopathic medical education. The Respondent also presented the testimony by deposition of James R. Winn, M.D. He is Executive Vice President of the FSMB. The FSMB assists state medical boards in conducting their evaluation of physicians regarding their fitness to practice medicine. The FSMB developed examinations which are administered by state boards. Dr. Winn serves as the supervisor for the examination services section of the FSMB. Those examinations are developed in cooperation with the National Board of Medical Examiners. The current examination available from the FSMB is the United States Medical Licensing Examination (USMLE) used since 1992. Prior to that time, the FSMB administered the FLEX examination, which was for the evaluation of all physicians requesting licensure. The FLEX examination did not have a section on osteopathic practice, as shown by Dr. Winn. The FSMB allows all physicians seeking licensure in the United States to take that examination, including graduates of osteopathic medical schools and graduates of foreign medical schools. With the FLEX examination, unlike the NBOME examination, medical students are not eligible, only graduates of medical schools are eligible to take the examination. Dr. Winn is familiar with the examination of the NBOME and its purpose. He is not aware of any side-by-side comparison between the two examinations to determine equivalency. In his expert opinion, there would have to be such an evaluation in order to determine whether the examinations are equivalent. The testimony of Drs. Smoley and Winn was elaborated upon and corroborated by Dr. Morton Morris. Dr. Morris is a licensed osteopathic physician in the State of Florida and is board certified in osteopathic surgery by the American Osteopathic Board of Orthopedic Surgery. He is also certified by the American Board of Quality Medical Assurance and is a fellow of the American College of Legal Medicine. He is Vice-Chancellor for academic affairs in the health professions division at Nova Southeastern University, a Florida osteopathic medical school. Additionally, Dr. Morris is a licensed, practicing attorney in the State of Florida. He practices in the areas of medical malpractice, general health law and administrative law. Dr. Morris is familiar with the NBOME examination, having served as a test item writer for the NBOME. He recognizes Dr. Smoley as one who helps develop the philosophy of the examinations in question. The philosophy of the NBOME is that content concerning osteopathic practice and principles permeates the entire examination. Even when certain questions on their face are not osteopathically oriented, the evaluation and the grading of the responses is carried out from an osteopathic viewpoint and philosophy. The test item writers are directed to draft test questions which include osteopathic philosophy. In the past, the NBOME has agreed to allow a candidate to take only Part III or an equivalent examination and receive the score from the NBOME. In fact, Dr. Morris represented that person in his capacity as an attorney. He worked out the arrangements whereby that candidate could take and pass Part III of the NBOME examination in order to obtain a Florida osteopathic medical license, as the Petitioner seeks herein, even though, since he would not have taken Part III within the required seven years, he could not receive diplomate status with the NBOME. The Board’s order in this case specifically requires passage of Part III of that examination, but it does not require diplomate status. Such an arrangement would thus seem to provide a means to alleviate the Petitioner’s predicament in the instant situation. The Petitioner, in questioning Dr. Morris upon cross- examination, inquired about the possibility of a person taking all three parts of the NBOME examination, even if he had already taken Parts I and II. Dr. Morris stated that that was possible. Page 7 of the Bulletin of Information, in evidence in Respondent’s Exhibit 1, although stating that the candidate cannot take the examination “to attempt to improve his score”, states nothing to indicate preclusion of a candidate taking the entire examination for any other purpose. Dr. Morris stated that the Petitioner could take Part III of the examination and that the NBOME would make arrangements to allow him to do that, with the understanding that if he passed Part III, he would not be able to receive diplomate status from the NBOME (because of passage of time before taking Part III). In making comparisons between osteopathic medical education and allopathic medical education, Dr. Morris acknowledged that in some cases, osteopathic medical colleges use the same textbooks as used by allopathic medical schools. That does not, however, make them similar professions. Although anatomy and physiology may not be different, the philosophy of treating the whole patient is different. Responding to the Petitioner’s contention that having obtained board certification in his specialty area should count as equivalency to the entry level examination, Dr. Morris pointed out that all that the board certification accomplishes is to show that an osteopathic physician is recognized by his or her peers as competent to practice a specialty. It does not mean that the person is osteopathically oriented enough to be eligible for licensure and to be able to pass a minimum competency examination. The Petitioner contends that having passed Parts I and II of the NBOME examination, FLEX should quality him for osteopathic licensure in the State of Florida, in lieu of taking Part III of the NBOME examination, because anything of an osteopathic nature would have already been tested on Parts I and II. Dr. Morris established to the contrary, however, that Part III is the clinical testing, the testing of how the individual puts to use his clinical evaluation in treatment of patients. It is the ultimate test of whether an individual has developed and is able to apply a philosophy of practice sufficient to show that he is competent to be an osteopathic physician. Parts I and II of the NBOME examination do not test clinical skills. The FLEX does test clinical skills, but it does not test for osteopathic practices as to clinical skills. The NBOME requires that a person take Part III within seven years of having taken Part I, if that person wishes to be a diplomate of the NBOME. There is no apparent preclusion, however, in a person arranging to take only Part III, simply for purposes of state licensure. The record is not clear whether a person could take Parts I, II and III within the period of one year. It does seem apparent, however, that the Petitioner could take Part III within a one-year time period, which is all that is required in the Board’s order. Further, the statute requires that a person take all parts of the NBOME examination or a substantially-equivalent examination. What the Petitioner attempts to do is to take two parts of the NBOME examination and then substitute a different examination (FLEX) for Part III. This does not constitute a substantially-equivalent examination for the above reasons. A substantially-equivalent examination would have to be equivalent to all three parts of the NBOME examination. During discussion of the difference between osteopathic and allopathic schools of medicine, Dr. Morris pointed out that many osteopathic physicians use the same modalities that allopathic physicians use. It is just that they also use osteopathic modalities. He gave the example of a cardiac patient whom an osteopathic physician would treat just as a medical doctor would treat the basic condition with appropriate drugs but then would incorporate osteopathic philosophy, such as the “lymphatic pump”, meaning that the osteopathic physician would incorporate muscle techniques of stretching and passive manipulation in order to help the patient. The osteopathic physician would possibly use manipulative techniques on the lymphatic system and not just use drugs or other allopathic techniques. In the context of the NBOME examination, a question might reference a cardiac patient. Although the question would not mention the lymphatic pump, a proper answer might entail a clinical response that would consider that modality of treatment. In orthopedics, Dr. Morris’ specialty, an osteopathic physician can make significant use of manipulative techniques, as well as general surgery, casting and other modalities normally used by allopathic physicians. Use of the FLEX examination, rather than the NBOME examination, would not lower standards for osteopathic physicians. Rather, the FLEX examination simply embodies a different standard than the one used to test for competency in osteopathic principles and medicine. The Petitioner acknowledged that he could have taken Part III of the NBOME examination but chose not to because it was then more convenient for him to take the FLEX examination to continue his training in the State of Texas which required passage of the FLEX examination for osteopathic licensure. The Petitioner contended that if he applied for a Florida osteopathic medical faculty certificate (MFC), the FLEX examination would be acceptable and he would be eligible. That fact, he contends, by analogy, establishes that he is qualified to practice osteopathic medicine in the State of Florida. He has never applied for such a certificate nor has he been offered an osteopathic medical faculty position in the State of Florida. Thus, determination of that issue is not before this tribunal. Even if it were, there are significant differences between a full license to practice osteopathic medicine indefinitely and a medical faculty certificate. With the MFC, the Petitioner would not be allowed to be engaged in private practice of osteopathic medicine and the MFC would only allow him to practice in the academic realm for only two years. Finally, the statutory requirements for an MFC do not require the passage of any licensure examination. Accordingly, to the extent that the Petitioner’s argument and testimony implies some analogy or equivalency between eligibility for the MFC and eligibility for full licensure, such equivalency is not borne out by the greater weight of the evidence.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the application of the Petitioner, Lawrence Edward Suess, D.O., for licensure as an osteopathic physician, without conditions, is denied on the basis that the FLEX examination has not been shown to be substantially similar to the NBOME examination.DONE AND ENTERED this 28th day of February, 1997, in Tallahassee, Florida. P. MICHAEL RUFF Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 28th day of February, 1997. COPIES FURNISHED: Lawrence E. Suess, D.O., Ph.D. Owensboro Psychiatric Institute 1700 Frederica Street, Suite 106 Owensboro, Kentucky 42301 M. Catherine Lannon, Esquire Department of Legal Affairs The Capitol, Room PL-01 Tallahassee, Florida 32399-1050 William H. Buckhalt, Executive Director Board of Osteopathic Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0757 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32309
The Issue Whether Petitioner's request for authorization for the autologous chondrocyte implantation procedure should be approved pursuant to worker's compensation laws and rules.
Findings Of Fact Petitioner's Injury At all times, the Petitioner has been employed as a Ladies Wear Department Manager for K-Mart Corporation. On July 21, 1998, Petitioner, while in the course and scope of her employment, was injured when she fell on a metal ladder as she attempted to hang clothes on a rail. Her left knee struck a metal bar on the second step of the ladder, causing immediate pain. On August 26, 1998, Petitioner consulted Dr. Jeffery Friedman, M.D., an orthopedic surgeon, who specializes in knee and shoulder surgery. Dr. Friedman was recognized as an expert in the field of orthopedic surgery. On or about September 4, 1998, Petitioner underwent arthroscopic surgery performed by Dr. Friedman to remove a loose body from the knee. Dr. Friedman found grade III chondromalacia and debrided the area using an arthroscopic shaver. He also found loose articular cartilage at the patella. Dr. Friedman's records describe the area of grade III chondromalacia as "fairly large" and involving " the apex of the patella." However, neither the size nor the shape of the injury is disclosed. Dr. Friedman also debrided flake of articular cartilage from the tibial plateau and removed a calcific loose body from the posteromedial compartment. His post-operative diagnosis was left knee loose body, chrondromalacia, and intracruciate ligament strain. Petitioner returned to work with K-Mart after the arthroscopic surgery, and was placed on light duty. While performing her duties, Petitioner is required to stand most of the time, and is unable to sit. Prior to her injury, Petitioner worked 40 hours per week. After her injury, due to her physical limitations resulting from the accident, Petitioner is only able to work 24 hours per week. Petitioner's pain limits her ability to work 40 hours per week. Petitioner cannot put her full weight down on the left knee while going up steps or a ladder or it causes sharp shooting pains. In addition, continuous walking results in continuous aching pain. The reduction in Petitioner's work hours was due to her injury. Petitioner is now unable to perform all of the duties that were required of her before the injury. Dr. Friedman found Petitioner to have reached maximum medical improvement in December 1998. In early 1999, Petitioner sought treatment for continued pain. An MRI was performed on or about March 5, 1999, which suggested a small defect in the articular cartilage, thinning of the patellar cartilage, and narrowing of the medical femoral tibial joint consistent with the early stages of osteoarthritis. In June, 1999, Petitioner underwent steroid injections for continued pain. In September, 1999, Petitioner returned to Dr, Friedman because of continued pain. Dr. Friedman reviewed a video tape that he had made of the arthroscopic surgery and fount that the Petitioner had a fairly large chondral defect of the patella. Dr. Friedman determined that Petitioner was a candidate for ACI, also known as the Genzyme Carticel Procedure (Genzyme Procedure). Dr. Friedman believed that the ACI procedure would benefit Petitioner by providing long-term symptomatic relief with joint pain and mechanical disturbances and improved joint motion function, eliminating the complaints of grinding and catching, and furthering the goal of returning the patient to regular and even strenuous activity. Petitioner then requested authorization for the ACI procedure. The Employer/Carrier denied the request and referred it to the Agency for Health Care Administration for review in accordance with Florida law. The Agency consulted with the University of Florida Faculty Practice Group, and Dr. B. Hudson Berrey, Chair of the Department of Orthopaedics and Rehabilitation, rendered an opinion that the procedure is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. Dr. Berrey further opined that there was not reliable evidence that ACI would provide significant benefit to the recovery and well-being of the injured employee within the meaning of Rule 59B-11.004(3), Florida Administrative Code. The documents and information forwarded to Dr. Berrey by Respondent included Petitioner's medical records provided by Intervenor, K-Mart carrier. Dr. Berrey did not review any actual MRI films, did not review any films taken at the time of the arthroscopic procedure, and in fact only reviewed certain documentation that was supplied to him by the agency. Petitioner was denied her right to present information to Dr. Berrey prior to his forming his opinion for the agency. This was a violation of Rule 59B-11.003, Florida Administrative Code. The agency rendered a decision based upon Dr. Berrey's opinion, declining to order the Employer/Carrier to provide ACI to Petitioner. Autologous Chondrocyte Implantation The ACI procedure was initially developed in Sweden by Dr. Lars Peterson. ACI is a surgical procedure whereby a sample of cartilage is harvested from another area of the joint. The harvesting of the cartilage is performed during an arthroscopic surgical operation. The sample is sent to Boston to the laboratory of Genzyme Tissue Repair, Inc. ("Genzyme"), the owner of the process. Genzyme uses its proprietary process to culture the cells into an estimated 12 million chondrocytes over a period of approximately two months. Genzyme then returns the cultured chondrocytes to the surgeon. The surgeon then performs an open surgical operation. The surgeon creates a periosteal flap. In addition, the injury is debrided and the chondrocytes are implanted on the wounded cartilage and covered with the periosteal flap. The ACI procedure thus requires two surgical operations, one arthroscopic procedure and one open procedure. The claimed benefit of ACI is that the cartilage that is generated and implanted onto the knee will be hyaline cartilage or hyaline-like cartilage rather than fibrocartilage. Hyaline cartilage is composed both of the cartilage cells of an extra-cellular matrix. It has greater ability than fibrocartilage to withstand compression and shearing forces. ACI has been shown to produce "hyaline-like" cartilage in some patients. However, it does not reproduce the extra- cellular matrix in which the chondrocytes are found in naturally occurring hyaline cartilage. Alternative Treatments Other available treatments for a defect in articular cartilage of the knees include abrasion chondroplasty, arthroscopic microfracture, and arthroscopic drilling. Many patients get relief with one or more of these alternative procedures and do not need another operation. In addition, a surgical procedure to elevate the tibial tubercle and remove some of the weight from the patella might also alleviate the Petitioner's pain and improve her functioning. Dr. Friedman performed an abrasion chondroplasty during the arthroscopic surgery of September 4, 1998. Dr. Friedman did not offer Petitioner either the microfracture or the drilling procedures. Dr. Friedman had considered performing a tibial tubercle elevation but has not recommended that the Petitioner undergo that procedure either before the ACI is approved or independently of the ACI. Dr. Friedman views the primary purpose of this procedure as assuring the best possible results from the ACI. Dr. Friedman indicated there were no appropriate alternative medical procedures, other then the ACI procedure, available for Petitioner's injury. Dr. Friedman opined that the only viable option of putting back normal articular cartilage underneath the kneecap would be with the ACI procedure. In this opinion, the alternative procedures are not appropriate for and would not benefit Petitioner, as they were merely temporary procedures. Moreover, he emphatically stated that the ACI procedure is the procedure which is appropriate for an would benefit Petitioner. The Evidence That ACI Remains Investigative The Agency for Health Care Administration has not promulgated, endorsed, or approved any particular treatment for injuries to the articular cartilage of the knee in accordance with Sections 440.13(15) or 408.02, Florida Statutes; therefore, there was no Agency-approved protocol for Dr. Berrey to consider in rendering his opinion. Dr. Berrey testified that he could find no articles or publications describing controlled studies in which the effectiveness of ACI compared to any other procedure. Dr. Berrey further testified that he could find no articles about the ACI procedure in peer-reviewed journals in which the authors used objective measures of outcome which compared the patients' condition before and after treatment. The use of blinded or controlled studies is important so that possible confounding factors or variables can be controlled or accounted for and the results measured objectively. Dr. Berrey found that the publications cited by the proponents of the procedure discussed research which was funded by Genzyme, the owner of the process by which the chondrocytes were cultured. The funding of the research by the owner of the process was an additional factor in his determination that the evidence supporting the efficacy of the procedure was not reliable. The Cartilage Repair Registry and the results reported therein do not constitute reliable evidence of the benefits of ACI when compared to other available procedures for two reasons. First, the potentially confounding variables are neither controlled nor accounted for. Second, each surgeon evaluates his or her own work, so that there is no objective, independent measurement or assessment of the condition of each patient before and after surgery. Although the premise on which ACI is based is that the patient's implant will consist of hyaline cartilage rather than fibrocartilage, the available data does not indicate that the results are comprised only, or even primarily, of genuine hyaline cartilage. Rather, the evidence is that some patients develop "hyaline-like" cartilage, or cartilage composed partly of hyaline tissue. It cannot be determined whether hyaline or hyaline- like cartilage has filled a patient's defect without performing a biopsy and a histological evaluation of the tissue. The published reports described in the testimony contain discussions of post-surgical histological performed on very small numbers of patients. The published reports concerning the use of ACI to treat defects of the patella show that the results are not as favorable as those claimed for treatment of the femoral condyle. After the proponents of the procedure began to perform other procedures with the ACI to assure that any defects in the alignment of the patella are repaired, improved results were reported. Dr, Friedman testified about the published results of histological evaluations of 37 patients. Of those, seven underwent ACI to treat defects of the patella. Only one of the seven showed the development of hyaline-like tissue. Further, only two of the seven patella patients reported surgical results classified as good or better. Dr. Friedman opined that the histological data resulting from treatment of defects of the patella had improved since the study described in the preceding paragraph. However, he could not give any reference to the basis for his opinion. Dr. Friedman further testified that the more recent articles discussed the results of patients who had been followed from nine to 15 years. However, the articles and presentations from 1997 to 2000 report on follow-up of the first hundred patients between two and nine years after their surgery. Dr. Billings testified that Dr. Peterson's presentation discussed follow-ups of ACI patients occurring as long as 15 years after surgery. Yet, the March 2000 presentation to the American Academy of Orthopedic Surgeons focused on 40 patients who had been evaluated three or more years after their surgery. The FDA granted an accelerated approval of the Carticel product in 1997. The original accelerated FDA approval was granted for defects of the femoral condyle, the trochlear groove, and the patella. The terms of the approval require that controlled studies be conducted which compare the procedure to other procedures available for the treatment of focal chondral defects, specifically, microfracture and the creation of a periosteal flap without the injection of the cultured chondrocytes. None of the expert witnesses had found in their literature search any published reports of the progress of the controlled studies required under the terms of the accelerated FDA approval. In February, 2000, the FDA approval was modified. Genzyme is no longer permitted to market the ACI procedure or its Carticel product for treatment of defects to the patella. The requirements of Rule 59B-11.004, Florida Administrative Code, differ significantly from those of the accelerated FDA approval process, so that the granting of accelerated approval does not determine the answer to the question whether a treatment is investigative under that rule. The FDA's inquiry addresses the issues of safety and efficacy. However, the accelerated FDA approval process does not address the issues of whether a particular product is more effective than currently existing treatments or is equally cost-effective. Based upon all the evidence, the performance of the ACI procedure on the defects located in the patella is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. The Probability That ACI Would be of Significant Benefit in Returning Petitioner to Work Both of Petitioner's expert witnesses testified that if she does not undergo ACI, it is likely that she will need a total knee replacement. However, neither witness testified that Petitioner currently requires a total knee replacement. No testimony was presented as to when Petitioner might require a total knee replacement. Despite the testimony that ACI has been studied for 20 years, the published reports follow patients only for nine years after surgery. From the current state of the research, it is not possible to conclude that patients who undergo ACI avoid the need for subsequent surgery in ten or more years. The published studies of the results of ACI going out nine years from the date of surgery do not state the number of procedures performed on the patella. No witnesses testified regarding any published studies of the effectiveness of ACI that addressed the extent to which patients had been able to return to work as a result of the procedure. There is insufficient evidence from which to conclude that the ACI is more likely to enable the Petitioner to return to her duties that other available procedures. The Likelihood That the Benefits of ACI Would Outweigh the Risks and the Costs The testimony compared the cost and benefit of ACI with chondroplasty, microfracture or drilling, and, to some extent, a Macquet procedure or tibial tubercle elevation. Each of the other procedures requires only one surgical operation. ACI requires an arthroscopic surgical procedure to harvest cartilage, culturing of the chondrocytes at the Genzyme laboratory in Boston, and followed by an open surgical procedure to create a periosteal flap and to implant the chondrocytes. Petitioner's expert testified that the cost of culturing the chondrocytes alone was between $8,000 and $10,000, in addition to the two surgical procedures. Petitioner's expert compared the cost of ACI to that of a total knee replacement. However, that comparison is not appropriate under the rule because there is no evidence that Petitioner currently needs a knee replacement or that a knee replacement is the treatment generally used to treat her current condition. The cost of the abrasion chondroplasty, the microfracture or drilling procedure would approximate the cost of the first stage of ACI, approximately $2,300. Dr. Billings testified that the cost of the second stage of ACI was greater than that of the first stage. The second stage is an open surgical operation rather than an arthroscopic one. The total cost of the ACI procedure, including therapy, is probably close to the $30,000 required for a total knee replacement, including the therapy required for the total knee replacement. Dr. Berrey testified that published reports of the cost of ACI are as high as $37,000. The ACI requires extensive physical therapy; Petitioner presented no evidence as to the extent to which the cost of this aspect of treatment was included in the total cost of ACI. ACI has been established to be safe, so that the benefits of the procedure outweigh the risks. However, there is insufficient evidence from which to conclude that the benefits of ACI outweigh the additional costs.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order denying approval of the autologous chondrocyte implantation for Petitioner Rebecca Crane. DONE AND ENTERED this 27th day of November, 2000, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE 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 27th day of November, 2000. COPIES FURNISHED: Jeffrey J. Bordulis, Esquire 570 Crown Oak Centre Drive Longwood, Florida 32750 Lisa J. Hurley, Esquire Pyle, Jones, Hurley & Hand, P.A. 1069 West Morse Boulevard Winter Park, Florida 32789 Michelle L. Oxman, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308 Ruben J. King-Shaw, Jr., Director Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3116 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308
The Issue The issue is whether Respondent, Department of Health, Board of Medicine (“Department”), was “substantially justified” under section 57.111(3)(e), Florida Statutes, in initiating the underlying action against the electrolysis license of Petitioner, Claudia Patricia Orozco-Fandino, E.O. (“Petitioner” or “Ms. Orozco”).
Findings Of Fact Case No. 18-3899PL was initiated by the Department, a “state agency” for purposes of section 57.111(3)(f). Ms. Orozco qualifies as a “small business party” as defined in section 57.111(3)(d). Because the Final Order in Case No. 18-3899PL was entered in her favor, Ms. Orozco is a “prevailing small business party” under section 57.111(3)(c)1. The Department has stipulated that the $55,185.50 in attorneys’ fees and $2,226.53 in costs claimed by Ms. Orozco are reasonable. The only issue remaining at hearing was whether the Department was substantially justified in bringing the initial action against Petitioner’s electrolysis license. Section 57.111(3)(e) states that a proceeding is “substantially justified” if “it had a reasonable basis in law and fact at the time it was initiated by a state agency.” Starting in or around 2003, Ms. Orozco owned and operated Orozco Medical Center (“OMC”), a facility that is no longer in operation. OMC provided a range of cosmetic surgical procedures, including liposuction, Brazilian butt lifts, fat transfers or fat grafting, and vampire facials. Since 2013, Ms. Orozco has been the president of Orozco Surgical Center (“OSC”), which remained in operation as of the hearing date. OSC currently provides only facials and acupuncture services.1 The Board of Medicine’s probable cause panel decides whether there is a sufficient legal and factual basis for the Department to move forward with formal charges in license discipline cases. In Ms. Orozco’s case, Department Case No. 2017-13921, the information presented to the probable cause panel included an investigative report prepared by the Department’s investigator, 1 Ms. Orozco is a licensed electrologist, acupuncturist, facial specialist, and body wrapper. Cynthia Demetrovich. This 743-page report served as the basis for the probable cause determination made by the probable cause panel on April 20, 2018. As described in the investigative report, the investigation in Department Case No. 2017-13921 began on August 9, 2017, and was triggered by Ms. Orozco’s arrest by officers of the Hillsborough County Sheriff’s Office. She had been charged with four felony counts of aggravated battery, four felony counts of practicing medicine without a license, and four felony counts of fraud.2 Between August 24, 2017, and October 16, 2017, Ms. Demetrovich and Christopher Heuerman, another Department investigator, interviewed 15 OMC patients. Patients K.H., S.H., L.H., C.W., A.M., D.A., C.P., and M.A. underwent a surgical procedure known as a “Brazilian butt lift” (“BBL”) at OMC. A BBL is a specialized fat transfer procedure that augments the size and shape of the buttocks without implants. Excess fat is removed from the hips, abdomen, lower back, or thighs with liposuction, and a portion of this fat is then strategically injected into the buttocks. All eight of the patients stated that they witnessed Ms. Orozco perform their BBL procedures. Patients K.H., S.H., L.H., C.W., and A.M. expressed their willingness to testify in court about their experiences at OMC. Patients K.H., S.H., W.P., C.W., O.H., A.M., and C.P. stated that Ms. Orozco represented herself as a doctor when they met with her at OMC. Patient P.J. stated that Ms. Orozco treated her for weight loss by injecting her with HCG and vitamin B12 at OMC. HCG, or human chorionic 2 The criminal case against Ms. Orozco was resolved by a Pre-trial Intervention Agreement. gonadotropin, is a hormone produced during pregnancy that is sometimes used as a weight loss medication. Patients T.M. and L.H. stated that Ms. Orozco gave them phentermine as an appetite suppressant at OMC. Phentermine is a prescription drug. Patient K.O. stated that she was treated by Ms. Orozco at OMC for weight loss. Ms. Orozco administered HCG injections and personally gave an appetite suppressant to Patient K.O., who could not recall the name of the suppressant. Patient O.H. stated that Ms. Orozco injected dermal fillers into her face at OMC. Patients N.M. and K.B. stated that Ms. Orozco administered vampire facials to them at OMC. A “vampire facial,” or “platelet-rich plasma facial,” is a procedure in which blood is drawn from a patient’s arm and placed in a centrifuge. The resulting platelet-rich plasma is then injected into the patient’s face. “Electrolysis or electrology” is defined by section 478.42(5) as “the permanent removal of hair by destroying the hair-producing cells of the skin and vascular system” using equipment and protocols approved by the Board of Medicine. An electrologist is not competent to perform surgical procedures such as BBLs; to treat a patient for weight loss; to prescribe or administer weight loss drugs; to inject dermal fillers; or to perform vampire facials. On August 10, 2017, the Department mailed a letter to Ms. Orozco advising her that a case had been opened against her and that she had 20 days from receipt of the letter to submit a response or schedule an interview. Ms. Orozco’s counsel responded by letter dated August 28, 2017, addressed to Ms. Demetrovich. The letter enclosed a copy of Ms. Orozco’s curriculum vitae and stated that she intended to “vigorously defend the criminal allegations which were the subject of her arrest.” Counsel noted that formal charges had yet to be filed against Ms. Orozco and concluded by requesting the Department “to refer to my correspondence in the related Department of Health Investigation No. 2016-16104.” The referenced correspondence included two letters from Ms. Orozco’s attorneys. Both letters were addressed to Ms. Demetrovich and addressed an earlier Department investigation of Ms. Orozco. The first letter, dated July 7, 2016, included a three-page chart identifying the names of patients, their dates of surgery, and the names of the physicians who performed the surgeries. The chart listed 46 patients whose procedures were stated to have been performed by Mark Kantzler, D.O., and 12 patients whose procedures were stated to have been performed by Amina Edathodu, M.D. The second letter, dated August 26, 2016, asserted that Ms. Orozco was a “certified Surgical First Assistant,” and set forth the job description and duties of a surgical assistant as defined by the American Board of Surgical Assistants and the Association of Surgical Assistants. The letter stated that all surgical procedures at OMC were performed by licensed physicians with assistance from certified surgical assistants, including Ms. Orozco. The August 28, 2017, letter from Ms. Orozco’s counsel was included in Ms. Demetrovich’s investigative report. However, the referenced letters of July 7, 2016, and August 26, 2016, were not included in the investigative report and therefore were not placed before the probable cause panel. Ms. Demetrovich testified that she is not allowed to “share cases,” i.e., to mix materials from separate investigations into a single file. Because the letters dated July 7, 2016, and August 26, 2016, were in reference to Department Case No. 2016-16104, Ms. Demetrovich did not include them in her investigative report for Department Case No 2017-13921. The investigative report included the complete medical records, including before and after photographs, received from OMC for Patients K.H., S.H., C.W., O.H., N.M., K.B., T.M., A.M., D.A., A.B., K.O., P.J., C.P., and M.A. The investigative report also included the Hillsborough County Sheriff’s Office criminal report affidavit and arrest report for Ms. Orozco. The criminal report affidavit named four additional patients who told detectives that Ms. Orozco performed their BBL or liposuction procedures at OMC. All four patients named in the criminal report affidavit stated that Ms. Orozco led them to believe she was a medical doctor who could perform the surgical procedures offered by OMC. The patients variously stated that Ms. Orozco referred to herself as “doctor,” conducted the preoperative consultations, or showed them pictures of previous surgeries she had performed. Patient N.M. stated that another non-physician, Marlon Barcelo, performed the fat removal in her procedure. Mr. Barcelo was a surgical assistant employed by Ms. Orozco. Patient N.M. stated that Ms. Orozco performed the fat injection portion of the procedure. Patients U.L., A.B., and H.P. stated that their liposuction procedures were performed entirely by Ms. Orozco. The criminal report affidavit stated that on April 22, 2016, a Hillsborough County Sheriff’s detective interviewed Dr. Edathodu, who stated that she had worked at OMC. Dr. Edathodu referred to Ms. Orozco as a “doctor” and stated that Ms. Orozco had performed fat removal and injection procedures at OMC. Dr. Edathodu reviewed the medical records for Patient N.M., which indicated that Dr. Edathodu performed her procedure. Dr. Edathodu denied to the detective that the signatures and handwriting on N.M.’s medical records were hers. The criminal report affidavit stated that on May 5, 2017, a Hillsborough County Sheriff’s detective interviewed Dr. Kantzler, who stated that he would be present in the OMC facility while liposuction procedures were performed, but that the surgical assistants performed them. The criminal report affidavit stated that Patient A.B. reported that about two weeks before she met with the detective, she received a text message from Ms. Orozco. The text message stated that if Patient A.B. got a phone call from anyone, she should tell them that Dr. Kantzler had performed her surgery. On December 27, 2017, counsel for the Department provided Ms. Orozco’s counsel with a CD copy of the Department’s complete investigative file for Department Case No. 2017-13921. In the accompanying letter, counsel for the Department reminded Ms. Orozco’s counsel that he had 20 days in which to file a written response to the information contained in the investigative file, pursuant to section 456.073(10). On April 20, 2018, the Department’s probable cause panel met to review and discuss the investigative report. The panel found probable cause for both counts of the Administrative Complaint. At the hearing in the instant fee case, Ms. Orozco contended that the probable cause panel’s determination was based on an incomplete record. She argued that the Department’s investigative report omitted exculpatory material and that Ms. Demetrovich failed to make inquiries that might have led the probable cause panel to a different decision. Ms. Orozco noted that Ms. Demetrovich began investigating OMC in 2016, well before the investigative report in Department Case No. 2017- 13921 was prepared. Ms. Orozco testified that Ms. Demetrovich visited the offices of OMC on August 11, 2016, in the guise of accompanying a Department dispensing practitioner inspector. While at OMC, Ms. Demetrovich interviewed Ms. Orozco directly and took photographs of every room in the building. She photographed the surgical suite and the equipment therein. Ms. Demetrovich testified that she did not interview Ms. Orozco on August 11, 2016. She testified that if any photographs were taken during the visit, they were taken by the other inspector. Ms. Orozco contended that at the time she submitted her investigative report, Ms. Demetrovich was aware that the OMC surgical suite contained a drape between the patient’s head and the surgical field that wholly obstructed the patient’s view of who was performing their surgery. Ms. Orozco contended that if this information had been provided to the probable cause panel, the panel would have discounted the numerous patient statements attesting that Ms. Orozco performed their surgeries. Ms. Orozco also questioned why Ms. Demetrovich did not ask the patients how they could possibly know Ms. Orozco was performing their procedures when they could not see the surgical field. Ms. Orozco noted that the 2016 investigation prompted her counsel to submit the July 7, 2016, and August 26, 2016, letters referenced above. Ms. Orozco questioned why the contents of those letters were not included in the investigative report. Ms. Orozco pointed out that the medical records that were included in the investigative report were replete with indications that the surgeries were performed by Dr. Edathodu and Dr. Kantzler, including the consent forms in which the patients expressly acknowledged the name of the physician who would perform the procedure. Ms. Orozco contends that Ms. Demetrovich was obliged to confront the patients with this evidence and ask them to reconcile it with their statements that Ms. Orozco performed their procedures. Ms. Orozco argued that Ms. Demetrovich should have interviewed Dr. Edathodu, Dr. Kantzler, and other members of the OMC staff before completing her investigative report. Ms. Demetrovich testified that Dr. Edathodu evaded several attempts to interview her. Ms. Demetrovich stated that she interviewed Dr. Kantzler in another case, but did not include a summary of that interview in the investigative report of this case. Ms. Demetrovich testified that neither Dr. Edathodu nor Dr. Kantzler submitted affidavits in relation to this case. Ms. Demetrovich testified that her role in the investigation of Ms. Orozco and OMC did not include evaluating records obtained from the subjects of the investigation, or their attorneys, apart from checking for completeness. She testified that the determination as to whether to pursue disciplinary action based on the investigation rested with the Department’s attorneys. Ms. Demetrovich’s testimony as to the limits of her job responsibilities is credited. The investigative report included an identification key with the full names of the patients. Ms. Demetrovich acknowledged that she neglected to include the full names of Patients W.P. and L.H. in the identification key. It is found that the information before the probable cause panel was sufficient to support the panel’s decision to pursue an Administrative Complaint against Ms. Orozco. The investigative report included interviews with eight OMC patients who stated to the Department’s investigators that Ms. Orozco had performed BBLs on them. All eight patients stated that they witnessed Ms. Orozco perform the procedure. Five of the eight stated their willingness to testify against Ms. Orozco in any future court proceeding. Seven patients stated that Ms. Orozco had presented herself to them as a physician. Four other patients interviewed by the Department’s investigators stated that Ms. Orozco had provided them with injections of medications. Two patients stated that Ms. Orozco had performed vampire facials on them. One patient stated that Ms. Orozco administered dermal fillers to her. Four patients interviewed by detectives from the Hillsborough County Sheriff’s Office stated that Ms. Orozco presented herself as a medical doctor. Three of the four stated that Ms. Orozco performed their liposuction procedures. The patient statements alone justified a finding of probable cause. Ms. Orozco pointed to contrary evidence in the investigative report, such as the patient consent forms that clearly indicated the surgeries were performed by Dr. Edathodu and Dr. Kantzler. Such documentation might weigh against the patient statements, but is insufficient to support a finding that the probable cause panel should have disregarded the word of 19 patients that Ms. Orozco performed procedures on them that exceeded the scope of her professional licensure. Further, the probable cause panel would have been justified in discounting the patient consent forms in light of the statements the two physicians gave to the Hillsborough County Sheriff’s detectives that surgical procedures were in fact performed by Ms. Orozco and/or Mr. Barcelo. None of the items that Ms. Orozco claims were omitted from the investigative report would change this finding. The July 7, 2016, letter from her counsel naming the patients and their respective physicians was of no more significance than the signed consent forms that were included in the report. The August 26, 2017, letter setting forth the definitions of “surgical assistant” and stating that licensed physicians performed all surgeries at OMC merely contradicted the patients’ statements. It did not disprove or invalidate the patients’ statements in such a way as to justify their disregard by the probable cause panel. Finally, it was a matter of dispute whether Ms. Demetrovich had in her possession photos of the OMC surgical suite that she declined to include in the investigative report. Nothing prevented Ms. Orozco from submitting such photos on her own if she believed they would help her case. Such photos might raise questions, but again would not disprove or invalidate the statements of 19 patients to the degree that the probable cause panel could reasonably disregard the patients’ statements to the investigators and detectives.3
Findings Of Fact Petitioner, Peter P. McKeown, is a graduate of the University of Queensland Medical School in Brisbane, Australia. He holds the degrees of Bachelor of Medicine and Bachelor of Surgery. Doctorates of Medicine, under the British system, are reserved for specialists. Nonetheless, the medical training Petitioner received equates to that leading up to the award of the degree of Doctor of Medicine in the United States, and he is a physician and licensed as such in several states. He has completed residencies in general and thoracic surgery in Australia and the United States and has taken advanced training in cardiovascular and thoracic surgery at Emory University. Immediately before coming to the University of South Florida, (USF), Dr. McKeown was an Assistant Professor of Surgery at the University of Washington. In mid to late 1988, Dr. McKeown responded to an advertisement USF had placed in the Journal of the American Medical Association seeking applicants qualified for appointment at the Associate Professor level "... to join the Department of Surgery at the University of South Florida College of Medicine as the Chief of Cardiothoracic Surgery." He was selected for the position and joined the faculty effective May 1, 1989. All the correspondence leading up to Petitioner's joining the University faculty referred not only to his appointment as Associate Professor but also his assignment as Chief of the Cardiothoracic Surgery Division. Only the actual state employment contract described his employment exclusively as Associate Professor and made no mention of the Chief position. Under these circumstances, Petitioner did not gain any proprietory interest in the position of Chief of the Cardiothoracic Surgery Division. Dr. McKeown held the position of Chief of the Cardiothoracic Surgery Division until April, 1994, when, as a result of a decision made by the Chairman of the school's Department of Surgery, he was replaced as Chief and that position was filled, on a temporary basis, by the Department Chair. Petitioner claims that when he arrived at USF to assume the directorship, an administrative position, he saw an opportunity to develop the position into something significant. He contends he would not have come to USF unless he was to be the Chief of the Division as there was no appeal to him in a position as a general faculty member. He wanted an opportunity to budget, hire people, and develop plans and programs, and in order to advance in academic medicine, one must, at some point, hold an administrative position. Apparently the Department of Surgery had experienced a rapid turnover in faculty. It is not clear whether this caused or was the result of a dispute with administrators and medical staff at Tampa General Hospital, (TGH), where much of the clinical medical school activity is carried on. However, the program was recognized as being weak in cardiothoracic surgery, and this condition offered Petitioner the challenge he wanted. In his five years as Chief, Petitioner increased both the number and quality of personnel and revenues considerably. He developed affiliations with several foreign universities and recruited qualified people, built up the laboratory, secured more grants, developed a program of continuing medical education and raised the examination scores of the school's graduates. He opened new clinical programs and built up both billings and collections to the point where the program revenues were increased at least 2 to 5 times. By 1992- 1993, the Division was making money and generating a surplus and still used clinic funds to support research. During his tenure as Chief of the Division, Petitioner served under two Department of Surgery chairmen. The first was Dr. Connar, the individual who recruited him; and the incumbent is Dr. Carey, the individual who removed him. Petitioner asserts that at no time during his tenure in the position of Chief of the Cardiothoracic Surgery Division was he ever told, by either Department Chairman, that his performance was unsatisfactory. All Division heads within the Department were, from time to time, counseled about personnel costs, and Petitioner admits he had some differences with Dr. Carey about that subject and some other financial aspects of the job, but nothing different than anywhere else in academia. Petitioner was removed by Dr. Carey based in part upon his alleged inability to get along with people. Though he claims this is not true, he admits to three areas of conflict. The first related to his objection to transplants being accomplished by unqualified surgeons which, he alleges, Dr. Carey permitted to further his own ends. The second related to the pediatric heart transplant program for which Petitioner supported one candidate as chair and Dr. Carey supported another. The third related to Petitioner's reluctance to hire a physician whom Dr. Carey wanted to hire but to whom Petitioner purportedly objected. Of the three areas of dispute, only the first two came before his removal, but he contends at no time was he advised his position was a problem for the Department. By the same token, none of Petitioner's annual performance ratings reflected any University dissatisfaction with his performance. At no time was he ever rated unsatisfactory in any performance area; and prior to his removal, he had no indication his position as Chief of the Division was in jeopardy. Dr. Carey indicates he did counsel with Petitioner often regarding his attitude but did not rate him down because he hoped the situation would improve. Dr. McKeown was called to meet with Dr. Carey in his office on April 12, 1994. At that meeting, Dr. Carey was very agitated. He brought up the "Norman" incident and indicated he was going to remove Petitioner as Chief of the Division. Dr. McKeown admits to having made an inappropriate comment regarding Dr. Norman, another physician, to a resident in the operating room while performing an operation. He also admits that it was wrong to do this and apologized to Dr. Norman both orally and in writing shortly thereafter. Dr. Norman accepted his apology and Petitioner asserts that after his removal, Dr. Norman called him and assured him he, Norman, had not prompted the removal action. Dr. Norman did not testify at the hearing. Dr. Carey removed Petitioner from his position as Chief because of the comments he had made regarding Dr. Norman. Almost immediately after the meeting was concluded, Dr. Carey announced in writing his assumption of the Chief's position, in which position he remained until he hired Dr. Robinson as Chief in April, 1995. Petitioner found out that Carey's threat to remove him had been carried out the following day when his nurse told him his removal had been announced at the Moffett Cancer Center. He thereafter heard other reports of his removal from other sources, and based on what had happened, concluded his removal was intended to be and constituted a disciplinary action for his comment regarding Dr. Norman. He was not advised in advance of Carey's intention to impose discipline nor given an opportunity to defend himself before the action was taken. He claims he was not given any reason for his removal before or at the time of his dismissal. It is found, however, that the removal was not disciplinary action but an administrative change in Division leadership. Dr. McKeown at first did nothing about his removal, believing it would blow over. However, after he heard his removal had been publicized, he called several University officials, including a Vice-President, the General Counsel and the Provost, to see how the matter could be handled. He claims he either got no response to his inquiries or was told it was a Medical College problem. He then met with the Dean of the College of Medicine who indicated he could do nothing. After he was removed as Division Chief, Petitioner's salary remained the same as did his supplement from his practice. He claims, however, his removal has had an adverse effect on his reputation in the medical and academic communities. It is his belief that people now feel something is wrong with him. Dr. Carey's blunt announcement of his assumption of the Chief's position, without any reasons being given for that move or credit being given to Petitioner for his past accomplishments has had an impact on his ability to work effectively. After his removal, he received calls from all over the world from people wanting to know what had happened. The removal has, he claims, also made it more difficult for him to get grants and has, thereby, adversely impacted his ability to do productive research. In addition, his removal made it difficult for him to carry out his academic duties. His specialty is still presented in student rotations, only in a different place in the medical curriculum. Dr. McKeown has sought reinstatement to the administrative position of Chief of the Division. He is of the opinion that Dr. Carey's action in removing him from his position as Division Chief was capricious and damaging to the University as well as to his career. Petitioner admits he could have been less confrontational in the performance of his duties as Division Chief, but he knows of no complaints about him from TGH, All Children's Hospital or the VA Hospital. There are, however, letters in the files of the Department Chairman which indicate some dissatisfaction with Petitioner's relationships in some quarters and, as seen below, there were signs of dissatisfaction from both TGH and All Children's Hospitals. Petitioner admits he may have been somewhat overbearing or abrasive, but neither his alleged inability to properly steward finances nor his alleged inability to get along with people were mentioned to him at the time of dismissal or before. After Dr. Carey assumed the Chairmanship of the Department of Surgery in July, 1990, he saw Dr. McKeown frequently on an official basis at first. A Chief, as Petitioner was, has many and varied functions such as administration, teaching, fiscal, research, clinic administration and the like. People skills are important because of the necessary interface with colleagues, faculty, administrators and the public. When Dr. Carey came to USF, Dr. McKeown had not been in place very long, and the Division of Cardiothoracic Surgery was not doing well financially. There were contract negotiations going on with the VA Hospital which were not going well, at least partly because, Dr. Carey asserts, Dr. McKeown had made some major unacceptable demands. As a result, Dr. Carey stepped in, along with Dr. Benke, who was very effective in dealing with the VA, and as a result, an agreement was reached which resulted in somewhere between $275,000 and $300,000 per year coming in which put the Division in the black. Dr. Carey recalls other instances indicating Dr. McKeown's inability to get along with others. One related to the relationship with TGH previously mentioned. TGH had made a decision to use a particular physician as head of its transplant program because, allegedly, Dr. McKeown had so angered private heart patients they would not let him be appointed even though Dr. McKeown was Dr. Carey's choice. As it turned out, Dr. Carey convinced the TGH Director and another physician to agree to a plan whereby Dr. McKeown would be head of the program 50 percent of the time. This would have been good for the University, but Dr. McKeown refused indicating that if he could not be in charge all of the time, he would not be in charge at all. Another incident relates to All Children's Hospital. That institution wanted to initiate a pediatric heart transplant program and a meeting was set up to which Dr. McKeown was invited. Petitioner so infuriated the community surgeons attending that meeting they would not work with him, and without his, Carey's, efforts, Dr. Carey claims the program was doomed to failure. As a result, Carey asked Dr. Nevitsky to help get the program started. This gave the USF an opportunity to participate in the program, but when Nevitsky left, they lost it. Still another example, according to Dr. Carey, is the fact that some surgeons on staff have called to complain about Dr. McKeown's attitude and unwillingness to compromise and negotiate and about his demands for service and staff, all of which creates friction among the hospital staff. A few days before Dr. Carey removed Petitioner as Chief, he spoke with the Dean of the College of Medicine, a Vice-president of the University, and others who would be impacted, about his concern regarding the Cardiothoracic Surgery Division and, in fact, he had had discussions with other officials even before that time. Long before making his decision to remove Petitioner, Carey spoke of his consideration of possibly shifting the emphasis within the Division to non-cardiac thoracic surgery in place of the cardiac program which Dr. Carey felt was not very successful. He believed the program did not do enough procedures to support the medical school affiliation. Dr. Carey chose to dismiss Dr. McKeown as Chief of the Division on April 12, 1994, after learning of McKeown's destructive attack on another surgeon before a junior physician in a public place, an operating room, (the Norman incident). He notes that over the years there was a building concern regarding Dr. McKeown's abilities as an administrator, and this incident with Dr. Norman was the last straw. Dr. Carey had received complaints about Petitioner from other physicians, all of which he discussed with Dr. McKeown. Finally, with the Norman incident, it became abundantly clear that Dr. McKeown's capabilities as a leader had diminished to the point where a change was necessary. Before he dismissed Petitioner, and during the investigation which led up to the dismissal, Dr. Carey admits, he did not give Dr. McKeown any opportunity to give any input to the decision. By the time Carey met with McKeown on April 12, 1994, his mind was made up. The Norman incident was demonstrative of what Carey perceived as McKeown's lack of supervisory ability, and it was that factor which led Carey to the ultimate decision to remove McKeown. He felt it necessary to act then and not leave Dr. McKeown in place during the search for a replacement. Petitioner cites alleged comments made by Carey to others that he would have relieved anyone for doing what Petitioner did in the Norman incident. Dr. Carey cannot recall having made such a statement. He claims he considered disciplinary action against Petitioner for the Norman comments but decided against it. However, it was the last in a series of incidents which caused him to question the propriety of McKeown's placement in the Chief's position, and which ultimately cemented his decision to replace him. Dr. Carey met with Dr. McKeown several times before the dismissal and counseled him about administrative deficiencies in his performance, but he never told Dr. McKeown that unless he improved, he would be dismissed. This is consistent with Petitioner's testimony that he was not warned of his shortcomings or of the administration's dissatisfaction with his performance. Disagreements in conversations between superior and subordinate, meant by the former to be corrective in nature, are not always taken as such by the latter. Dr. Carey did not document any of this in Dr. McKeown's personnel files but put some of the information he received by way of communications from others in the files. These are the letters submitted by the University, pursuant to agreement of the parties, subsequent to the hearing. They contributed to Carey's increasing concern about Dr. McKeown's ability to lead the Division. At no time, however, though he questioned Dr. McKeown's leadership, did Dr. Carey ever question his good faith and sincerity, nor does he do so now. When he finally decided action was necessary, on April 12, 1994, Dr. Carey wrote a memorandum to the Medical College faculty concerning his assumption of the position as Chief of the Cardiothoracic Surgery Division. He also advised Dr. McKeown of his removal. Dr. Carey remained in the Chief's position, holding that title in an administrative capacity and not from a clinical standpoint, for approximately one year, intending to stay in the position only until he could find a fully qualified thoracic surgeon to take the job. After Carey removed Petitioner, he was contacted by the Medical College Dean who asked that he get with McKeown and try to work something out. He thereafter offered Dr. McKeown the position of Chief of the cardiac section of the Division but McKeown declined. Dr. Carey also, on April 26, 1994, wrote to TGH recommending that Dr. McKeown be allowed to have more impact on the hospital's transplant program, pointing out that the change in McKeown's position at the University was occasioned by a need for a change in leadership. According to Dr. Tennyson J. Wright, Associate Provost of the University, disciplinary action against nonunion faculty members is governed by Rule 6C4-10.009, F.A.C., and requires notice of proposed action be given before such disciplinary action is taken. The contract which Dr. McKeown holds and has held since the inception of his tenure at the University, is a standard USF/State University System contract. It reflects Petitioner was hired as an Associate Professor, which is one of the three types of personnel classifications used within the system. These are faculty, administration and support. Petitioner's contract does not refer to his holding the Division Chief position and it is not supposed to. Such a position is an administrative appointment within a Department and a working title used to define the holder's duties, and service in such a position is at the pleasure of the Department Chair. Appointment to or removal from a Chief position is an administrative assignment. The position of Department Chairperson, on the other hand is a separate position and subclassification within the University classification system and is different.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Petitioner, Peter P. McKeown's, grievance against the University of South Florida School of Medicine arising from his removal as Chief, Cardiothoracic Surgery Division in the Department of Surgery be denied. DONE AND ENTERED this 19th day of January, 1996, in Tallahassee, Florida. ARNOLD H. POLLOCK, 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 19th day of January, 1996. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 95-1832 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. - 7. Accepted and incorporated herein. Though the documents in question refer to appointment, in actuality the personnel action was an appointment to the faculty with an administrative assignment to the position of Director of the Division. & 10. Accepted. 11. & 12. Accepted and incorporated herein. 13. & 14. Accepted and incorporated herein. - 19. Accepted and incorporate herein. Accepted and incorporated herein. Accepted. Rejected as inconsistent with the better evidence of record. Accepted. Accepted and incorporated herein. Rejected as inconsistent with the better evidence of record. & 27. Accepted. & 29. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. 32. - 34. First sentence accepted. Second sentence rejected as inconsistent with the better evidence of record. 35. - 37. Accepted. 38. Rejected as argument. 39. Accepted. FOR THE RESPONDENT: - 9. Accepted and incorporated herein. Accepted. - 14. Accepted and incorporated herein. 15. & 16. Accepted and incorporated herein. COPIES FURNISHED: Benjamin H. Hill, III, Esquire William C. Guerrant, Jr., Esquire Danelle Dykes, Esquire Hill, Ward & Henderson, P.A. Post Office Box 2231 Tampa, Florida 33601 Thomas M. Gonzalez, Esquire Thompson, Sizemore & Gonzalez 109 North Brush Street, Suite 200 Post Office Box 639 Tampa, Florida 33601 Olga J. Joanow, Esquire University of South Florida 4202 East Fowler Avenue, ADM 250 Tampa, Florida 33620 Noreen Segrest, Esquire General Counsel University of South Florida 4202 East Fowler Avenue, ADM 250 Tampa, Florida 33620-6250
