The Issue The issue in these cases is whether disciplinary action should be taken against Respondent's license to practice medicine, No. ME 0046170, based upon the alleged violations of Section 458.331(1), Florida Statutes, set forth in the Administrative Complaint dated April 6, 1989, (the "First Administrative Complaint") which has been assigned DOAH Case No. 89-3723 and/or the Administrative Complaint dated August 16, 1990, (the "Second Administrative Complaint") which has been assigned DOAH Case No. 91-3864.
Findings Of Fact Based on the evidence adduced at the hearings on October 3, 1990, and March 10, 1992, and the entire record in this proceeding, the following findings of fact are made: Respondent is, and has been at all times material hereto, a licensed physician, having been issued license number ME 0046170 by the State of Florida. Respondent was initially licensed to practice medicine in the State of Florida in approximately April of 1985. No evidence was presented of any prior disciplinary action against Respondent. Respondent's last known address is 10611 N.E. 11th Avenue, Miami Shores, Florida 33138. Sometime around 1986, Respondent became affiliated with EMSA which is an emergency room provider. EMSA contracts with hospitals to staff emergency rooms. Thus, Respondent has been working as an emergency room physician since 1986. The evidence did not establish the extent of Respondent's obligations with EMSA since 1986. As discussed in more detail below, since 1986, Respondent has also been affiliated with at least two other entities, the Institute of Specialized Medicine and the Immunology Allergy Institute, Inc. Facts Regarding the First Administrative Complaint Respondent was employed as a salaried employee of the Institute of Specialized Medicine (the "Institute") for at least several months during the year 1987. Although the evidence regarding Respondent's affiliation with EMSA was not entirely clear, it appears that he retained his affiliation with that company during the time that he worked at the Institute. In June of 1987, Respondent was associated with the Institute. In June of 1987, J.P. was a 36 year old female who saw an advertisement in a newspaper for the Institute of Specialized Medicine. That advertisement suggested that weight loss could be accomplished through adjusting a person's metabolism. J.P. called the Institute and scheduled an appointment for June 30, 1987. J.P. had been seriously overweight all of her adult life and had previously tried almost every possible method of weight loss. Shortly before her visit to the Institute, J.P. had been able to lose 80 pounds by diet and exercise alone. On June 30, 1987, J.P. visited the Institute and was told that she needed to provide certain information to determine her eligibility for the Institute's program. J.P. was advised that the Institute charged a $925 fee for testing and consultation. That fee included her first two visits, after which she was to be charged $40 per visit. The Institute's staff told J.P. that she had to pay $285 and that the rest would be billed to her insurance company. J.P. paid $285 on this first visit. On her first visit, J.P. filled out various questionnaires regarding her health, background and other general information. She was given a "blood test," a spirometric test, an EKG, and she provided a urine sample. J.P. did not see a physician or dietician during this visit. On July 6, 1987, J.P. returned to the Institute and was seen for about ten minutes by Respondent, who listened to her heart and lungs. Her height, weight, blood pressure, and pulse rate were noted, but no other physical examination was performed and Respondent did not inquire regarding any of the matters disclosed in the questionnaire filled out by J.P. during her first visit. During the July 6, 1987 visit, Respondent informed J.P. of his interpretation of her test results. He told J.P. that her tests showed she had an irregular thyroid, that her metabolism was below normal range, and that her body retained fluid. In his records of J.P.'s July 6, 1987 visit, Respondent diagnosed J.P. as having "Euthyroid Sick Syndrome." Euthyroid Sick Syndrome is a condition which may arise in a patient seriously ill from another cause. In such a situation, there are abnormal findings in blood tests for thyroid function, but these findings do not indicate the true thyroid status which is normal. The evidence established that this was an incorrect diagnosis for J.P. based upon the test results and history provided. Respondent did not provide a cogent explanation for his written diagnosis of Euthyroid Sick Syndrome nor did he explain the verbal diagnosis given to J.P. Respondent's records do not include the results of the spirometric test or the EKG. In addition, the urinalysis was incomplete and, while the doctor's notes and billing records reflect a chest x-ray was taken, there is no evidence of such an x-ray in the records. The results of J.P.'s blood tests reflect all normal values with the exception of a slightly low "total iron." At the conclusion of the July 6, 1987 visit, Respondent prescribed Cytomel, 25 micrograms BID, and Maxzide for J.P. No directions were given regarding the administration of Maxzide. Cytomel is a prescription drug containing the active ingredient of the secretions of the thyroid gland. Cytomel is used to replace the hormone in cases of thyroid underactivity (hypothyroidism). There is no indication from the medical records that J.P. was suffering from Euthyroid Sick Syndrome, that her thyroid was malfunctioning, that her metabolism was below normal, or that she required any hormonal replacement therapy. Respondent now admits that the test results indicate J.P. was not hypothyroid. Respondent claims that if he had actually believed that the patient had been hypothyroid, the dosage prescribed would have been approximately three times greater. He contends that he prescribed Cytomel to increase oxygen consumption. To justify his prescription of Cytomel, Respondent cited to two medical texts which he claims were in wide circulation in 1987. He says those texts support his prescription of Thyroid hormone to encourage weight reduction. Only one of the two cited references even marginally supports Respondent's contention. In any event, the more persuasive evidence established that, before the advent of thyroid testing (approximately twenty years ago), Cytomel was occasionally used in an attempt to encourage weight loss in patients. However, the prescription of Cytomel for weight loss in 1987 was below the standard of care expected of a reasonably prudent physician under similar conditions and circumstances. Respondent also attempted to justify his prescription of Cytomel by claiming that J.P. had advised him that she had previously been taking a thyroid supplement. Respondent contends that some patients who stop taking thyroid supplements have a "rebound effect where their metabolic rate decreases." During her testimony, J.P. denied having ever been on thyroid medication. The questionnaires filled out by J.P. during her first visit to the Institute do not reflect that she had ever taken thyroid medication in the past. Furthermore, there is no notation in the medical records indicating that J.P. had been on thyroid medication in the past. Respondent's testimony that J.P. advised him that she had previously been on thyroid supplements but was no longer taking them is not credited. Maxzide is a prescription drug, a diuretic appropriate for patients with high blood pressure. Maxzide should not be used as initial therapy for fluid retention. Maxzide can have deleterious effects on a patient and should not be used in a weight reduction program unless other reasons indicating its use are present. Respondent's medical records do not justify the prescription of Maxzide to J.P. There is no indication that the patient had high blood pressure. Furthermore, J.P. denied having any previous problems with fluid retention and no such problems are noted on the medical history that she filled out. While Respondent noted "++edema" as part of his examination on July 6, 1987, the notation is not consistent with Respondent's other notes of his exam or J.P.'s testimony regarding her condition. Moreover, J.P.'s weight loss of only three pounds between July 6 and July 30, 1987, indicates that she had no edema on July 6, 1987. During the July 6, 1987 visit, J.P. saw the Dietitian at the Institute of Specialized Medicine for about 20 minutes. The only thing the Dietitian did was to give J.P. a 1,000 calorie per day diet which she was told to follow. On July 30, 1987, J.P. returned to the Institute to see Respondent because she thought she was suffering nausea from the effects of the medications Cytomel and Maxzide. Respondent did not document in his notes any treatment for her nausea. J.P.'s health insurance claim form, submitted under Respondent's signature, reflects a diagnosis of "Euthyroidism" and a corresponding insurance code number of 244.9. Euthyroidism means normal thyroid function. An insurance company will not pay for a diagnosis of a normal condition. Insurance code number 244.9 indicates a condition of hypothyroidism or thyroid insufficiency which Patient J.P. did not have. The health insurance claim form submitted under Respondent's signature reflects overlapping billings for a hemogram and WBC, includes charges for an x- ray and spirometry of which there is no record, and contains a coded diagnosis of Hypothyroidism which conflicts with the results of the tests performed on J.P. and also conflicts with the Respondent's recorded diagnosis of Euthyroid Sick Syndrome. The insurance claim form also includes charges for a complete history and physical. After J.P. filed a complaint with Petitioner, Respondent attempted to justify this billing by telling Petitioner's investigator that he gave J.P. a complete physical examination and a "full workup". However, the evidence established that Respondent did not perform a complete physical examination of J.P. Respondent did not examine J.P.'s breasts, recommend a mammogram, perform or refer J.P. for a gynecological examination, examine her throat, eyes, ears, or abdomen; address her familial history of diabetes, kidney disease, hypertension or obesity; question her about her listed allergies, past anemia, abnormal stomach x-rays, or changing moles; consider her serious depressions and emotional problems; interpret her EKG; or address the basic causes of her obesity. Respondent contends that he did not handle the billing for the Institute and did not himself submit any diagnosis to the insurance carrier. In addition, he claims that he has subsequently learned that the Institute forged his name on some insurance documents. These contentions do not provide a defense to the charges in this case. It is clear that the billings to the insurance company were submitted under Respondent's signature. There is no evidence that the health claim form in this case was forged. The insurance company directed an inquiry to Respondent regarding his diagnosis of J.P. and Respondent did little or nothing to clarify the situation. Furthermore, when J.P. complained to Respondent about the treatment and costs, there is no indication that Respondent took any steps to investigate the situation or correct the problems. In the original billings submitted to J.P.'s insurance company, the Institute sought payment of $925 for the treatment and tests rendered to J.P., even though the patient had already paid $285 of that agreed upon fee. Respondent's records reflect that ultimately the insurance company paid $670 for the services rendered to J.P. Respondent's treatment of J.P. failed to meet that level of care, skill and treatment expected of a reasonably prudent similar physician under similar conditions and circumstances because Respondent inappropriately prescribed Cytomel and Maxzide to J.P. when the need for those drugs was not indicated by the results of the tests performed and because his final diagnosis of "Euthyroid Sick Syndrome" was incorrect and unsupported by any tests or physical findings. Respondent failed to keep written medical records justifying his course of treatment of J.P. because the records (1) do not justify his diagnosis of Euthyroid Sick Syndrome, (2) do not justify his prescription of Cytomel for the patient who had no evidence or history of hypothyroidism, (3) do not justify his prescription of Maxzide for the patient who had no fluid retention and who presented with normal findings other than her obesity, (4) do not justify the extensive and inappropriate tests performed, (5) do not appropriately reflect J.P.'s EKG, do not report on results of her x-ray (if it was made) or spirometry, and (6) do not indicate that Respondent either advised or treated J.P. on July 30, 1987, when she complained that the medications were making her nauseous. By prescribing medications for J.P. which were medically unnecessary, by filing conflicting diagnoses, by charging for a complete physical examination when one was not performed, and by signing off on duplicative billing on J.P.'s health insurance claim form, Respondent has made deceptive, untrue and/or fraudulent representations in the practice of medicine. Facts Regarding the Second Administrative Complaint Respondent quit working at the Institute in approximately November of 1987. As noted in the Preliminary Statement above, Respondent was indicted in October of 1988 in connection with his affiliation with the Institute of Specialized Medicine. While the circumstances and facts surrounding that indictment were not fully explained at the hearing in this cause, it appears that Respondent was indicted with several other individuals for allegedly participating in a scheme to defraud insurance companies by billing for tests and treatments that were unnecessary or unrelated to patients' true conditions. The indictment was pending through out the time of the incidents alleged in the Second Administrative Complaint. Respondent ultimately entered into a pretrial diversion program as a result of those charges. Sometime in 1988, Respondent became associated with the Immunology Allergy Institute, Inc., (the "Allergy Clinic"). Respondent claims that he was seeking to establish a private family practice and associated with the Allergy Clinic as part of an office sharing arrangement. The Allergy Clinic was owned by Frank Seedarnee and his ex-wife. Respondent contends that in return for office space, he was to serve as the "medical director" for the office and would be responsible for examining and diagnosing all medical problems and prescribing necessary controlled substances. Respondent contends that he never discussed cases with Seedarnee and did not rely on any recommendations from him because Seedarnee was not a doctor. Respondent further contends that Seedarnee's only function was to recommend diet changes, vitamins, or other products to help patients keep their homes free from allergies. However, the evidence presented in this case established that the Allergy Clinic did not always function in this manner, at least with respect to the patient S.L. and her son A.L. In March of 1989, S.L. was experiencing sinus problems and had a cough. In addition her son, age 10 months at the time, had been coughing for a few months. S.L. had previously been diagnosed as having allergies. S.L. was told of the Allergy Clinic by a friend who recommended "Dr. Seedarnee" as a allergist. She assumed from this conversation that Dr. Seedarnee was a medical doctor. She made an appointment at the Allergy Clinic for herself and her son for March 30, 1989. On March 30, 1989, S.L. arrived at the Allergy Clinic with her son as scheduled. She did not see a sign at the Allergy Clinic or any indication as to who the doctors were. During her initial visit, S.L. filled out an extensive health questionnaire form on herself and her son, A.L. S.L. and her son were escorted by a woman who appeared to be a nurse into an office. The nurse stated "Dr. Seedarnee will see you now." This nurse also mentioned that Respondent was not in because he was out on an emergency. The office contained a large microscope and a TV-like screen. A man in a white coat introduced himself as Dr. Seedarnee. Seedarnee reviewed S.L.'s health history forms and discussed with her the reasons why she wished to see an allergist. He told S.L. that he had developed an immune booster to help immune systems, that he would be taking blood from S.L. and A.L. so he could diagnose their problems, and that he had invented a microscope capable of evaluating the blood that same day. Seedarnee did not physically examine S.L. or A.L. or inquire if anyone else in the office had examined them. Seedarnee ordered a nurse to draw blood from S.L. and A.L. The blood was drawn as requested without question or surprise by the nurse. S.L. also provided a urine sample at the nurse's request. After the samples were obtained, S.L. and A.L. returned to Seedarnee's office where an enlarged picture of two slides of blood were shown to S.L. on the TV-like screen. Seedarnee took photographs of the blood slides and gave them to S.L. Those photographs were introduced as Petitioner's Exhibits 2 and 3. Seedarnee told S.L. that the white cell in the middle of her blood slide was an "allergy cell" and the other figures in the picture were iron- deficient cells. He also told her that she had a "low immune system." Seedarnee told S.L. that A.L.'s blood slide had clumped-together cells because he had a sluggish immune system. Seedarnee indicated that his conclusions were based on the blood pictures. He recommended that S.L. receive one of his "immune boosters" once a month for the next few months and one yearly thereafter. He also indicated that A.L. needed an immune booster and should get one yearly thereafter. Seedarnee specifically used the words "diagnosis" and "treatment" and stated that he was going to run further tests in order to make his final diagnosis. Seedarnee's statements to S.L. on March 30 constituted a diagnosis and the practice of medicine. The evidence presented at the hearing established that the diagnosis made by Seedarnee on March 30 could not validly be made on the basis of the blood slides. Moreover, the pictures of S.L.'s and A.L.'s blood appear normal. The "allergy cell" was simply a white blood cell and the clumping of A.L.'s blood was due to an artifact. S.L. did not see Respondent or any other person she thought was a physician on the March 30 visit. At this point, she still believed Seedarnee to be a physician. S.L. was told that she was required to pay 20% of the "total cost" for the treatment and her insurance company was to pay the remaining 80%. At the conclusion of the March 30, 1989 visit, S.L. wrote a check to the Allergy Clinic for $371.20. On April 4, 1989, S.L. returned without her son to the Allergy Clinic. She did not bring her son because her husband was skeptical that a proper diagnosis could be made from the blood slide picture. On April 4, S.L. was taken directly to Seedarnee's office where Seedarnee reviewed with her the results from her blood test and urinalysis, told her that she was allergic to dust and had a sensitivity to milk and yeast, and suggested to her that she needed his immune booster and B-12 injections. Seedarnee also reviewed with S.L. her son's test results. He told S.L. that A.L. had no allergy problems, but, because A.L. had a low immune system, he recommended an immune booster. During the April 4 visit, S.L. asked Seedarnee where he went to school. He told her India and England and said he had a Ph.D. and worked under a physician. Until this time, S.L. believed him to be a medical doctor. The office staff at the Allergy Clinic all referred to Seedarnee as "doctor." The medical records from the Allergy Clinic for S.L. and A.L. are captioned as follows: Patient: L, S. Physician: Seedarnee/Kunen and Patient: L, A. Physician: Seedarnee/Kunen After S.L. met with Seedarnee in his office on April 4, she was given two injections by a nurse. The medical records indicate the injections were (1) B-12 and Folic Acid and (2) "URT." There was no doctor's order for these injections. At the hearing, neither Seedarnee nor Respondent could, or would, identify "URT." Seedarnee's interpretation of tests, diagnosis of allergies and development of a treatment plan for S.L. on April 4 by ordering two injections for her which were given before S.L. ever saw a physician constitute the practice of medicine. After the injections, the nurse took S.L. to an examining room. Shortly thereafter, Respondent entered and introduced himself as Dr. Kunen. He asked S.L. what Dr. Seedarnee had recommended. Thus, it is clear that Respondent was aware that the patient had already seen Seedarnee and that he knew Seedarnee had at least developed some recommendations for her treatment. It is not clear whether Respondent knew that S.L. had already been given two injections. S.L. told Respondent that Seedarnee had diagnosed her allergies and told her that she needed B-complex, an immune booster and yearly immune boosters thereafter. Respondent's only response was something to the effect of "good, fine." He said nothing more about her treatment. S.L. was with Respondent for only about five minutes. Respondent briefly examined her. He listened to her heart and lungs and checked the glands in her neck. She was fully clothed during the exam. Respondent did not review with S.L. any of the items on her health form questionnaire. He did not inquire as to any of the items noted on the form such as the antibiotics she was taking, her sensitivity to perfume, her symptoms of fatigue and/or lethargy, her complaints of pressure in her head, muscle weakness and heart palpitations, or her notations of mucus in her stool or problems with urinary frequency. Her blood pressure was never taken. She was not asked about her history of rheumatic fever. Respondent did not discuss with S.L. her allergy symptoms, what she was allergic to, her test results or why she needed an immune booster and B-complex. Respondent did not ask about A.L. and S.L. did not tell Respondent that she wanted A.L. to be tested. Respondent's medical records regarding S.L. contain one undated page of notes indicating that Respondent requested allergy testing for S.L. and that S.L. wanted her son to be tested. S.L. denies telling Respondent that she wanted her son tested. Indeed, the evidence established that S.L. and her son had already been tested the week before by Seedarnee and that S.L. told Respondent of Seedarnee's diagnosis and treatment plan. Respondent's medical records for A.L. contain the boy's birth date rather than a current date. The notation in Respondent's handwriting states "patient here for testing, will return next week." Respondent claims that he saw the son otherwise he would not have filled out this medical note on the child. S.L. claims that her son was not with her on the April 4, 1989 visit and, therefore, Respondent never saw him. S.L.'s testimony is credited. In sum, it is concluded that Respondent's notes in the medical records for S.L. and A.L. do not accurately reflect the events that occurred and were an apparent attempt to justify after the fact Seedarnee's actions and treatment. It is also concluded that Respondent never saw A.L. as a patient and that Respondent "recommended" a treatment plan for S.L. which had already been carried out. At the conclusion of her April 4 visit, S.L. wrote a check to the Allergy Clinic for $162 to cover the cost of her visit and the purchase of a product which Seedarnee had recommended and supposedly developed called Allergex. This product was supposed to be put in the laundry and used to wipe down tables, etc. to eliminate household dust. After her visit on April 4, S.L.'s suspicions were aroused. She inquired of authorities about the licensure of the Allergy Clinic (it had none) and of Respondent and Seedarnee (he had no license). Following the April 4 visit to the Allergy Clinic, S.L. went to see a Board certified allergist who questioned the treatment she received at the Institute. The allergist advised S.L. that she was allergic to items other than those Seedarnee had claimed. On May 23, 1989, S.L. wrote to Respondent elaborating on what Seedarnee had done, complaining that she was mislead to believe that Seedarnee was a physician and that Respondent had done nothing but rubber stamp Seedarnee's findings and treatment. Respondent was on notice at least from this time that Seedarnee was practicing medicine without a license. S.L. filed a complaint with the Department of Professional Regulation on June 9, 1989. During the ensuing investigation, Respondent told the Department's investigator on January 23, 1990 that Seedarnee only worked under his supervision and that Seedarnee never made recommendations to patients. These statements were made even though S.L. had told Respondent during her April 4th visit and in her letter of May 23, 1989 about Seedarnee's actions. At the hearing, Respondent disclaimed any knowledge of the "diagnosis" made by Seedarnee and/or the administration of injections to S.L. pursuant to Seedarnee's instructions. He suggests that if any such actions took place, they were contrary to the specific understandings that he had as to the procedures of the Allergy Clinic. Even if Respondent thought that he was supposed to make all diagnoses and develop all treatment plans at the Clinic, it is clear that these procedures were not followed with respect to S.L. and A.L. Moreover, it is clear that Respondent was aware of Seedarnee's activities by at least April 4, 1989. It is the physician's responsibility to formulate a treatment plan and treat a patient. Professional responsibility should be delegated only to individuals who have training and degrees to perform those tasks and non-medical personnel should not be allowed to assume functions that are to be performed by physicians. It is the physician's obligation, if he knows an unlicensed, untrained individual with whom he is working is following practices which constitute the practice of medicine, to stop that activity if possible and report it to the Department of Professional Regulation. Respondent was aware that Seedarnee was not a licensed medical doctor and was not qualified to make a diagnosis or to treat patients. Respondent never reported Seedarnee's unlicensed activity to any authority. Respondent's actions on April 4 with respect to S.L. constitute an acquiescence to Seedarnee's recommendations and treatment. Respondent contends that even if S.L. was administered the two injections discussed above, there is no evidence that those injections were controlled substances. Thus, Respondent argues there is no evidence that Seedarnee engaged in the unauthorized practice of medicine. This contention is rejected. As noted above, neither Seedarnee nor Respondent could explain what the immune booster or "URT" was. They both suggest that anything not prescribed should be considered part of a therapy program not medicine. However, the administration of an injection, particularly if not indicated by medical testing, always runs the risk of causing a reaction in a patient. The Respondent's interpretation of the practice of medicine is unduly narrow and is rejected. As discussed above, it is clear that the Clinic operations led at least one person, S.L., to believe that Seedarnee was a physician and it is clear that, with respect to at least this patient, Seedarnee interpreted test results, developed a diagnosis and directed a treatment plan. Moreover, it is clear that Respondent was made aware of these activities by at least April 4, 1989 and that he took no steps to halt or correct the situation and, indeed, that he acquiesced to it. The Allergy Clinic has been owned by Seedarnee for approximately 12 years. Seedarnee refers to the entity as a "research institute" rather than a laboratory or medical clinic. Seedarnee formulated the internal rules and procedures for the Allergy Clinic. Seedarnee's testimony on these procedures and other issues at the hearing was evasive, ambiguous and inconsistent. Seedarnee recognized that he needed a licensed physician to "approve prescribed substances and supervise techniques." However, it is clear that, at least during the time in question, the Allergy Clinic was operated in a manner that permitted him to diagnose and order vitamins and booster injections. Respondent was Medical Director of the Allergy Clinic from 1988 until at least mid-1990. Other than the matters raised in the Second Administrative Complaint and discussed above, no evidence was presented as to any other situations where Respondent acquiesced in the practice of medicine by Seedarnee. Respondent's testimony regarding his relationship with the Allergy Clinic was vague, conveniently selective and sometimes inconsistent. Respondent admits that he was hired to be Medical Director and was given office space. However, he claims that he had no obligation to Seedarnee, was not salaried (although he admits he was "loaned" money by Seedarnee, only some of which he paid back) and that he had no duties as Medical Director except "to be a good physician and see patients and to build a practice." He says he never had the need to discuss a case from a medical standpoint with Seedarnee or with other physicians there. He also says there were no staff meetings. Seedarnee's version of the relationship was quite different. Seedarnee testified that Respondent was paid a salary for his duties at the Allergy Clinic. At one point, Seedarnee claimed that the Medical Director made decisions for testing of patients on the basis of the patient's medical questionnaire. Because the allegations of the Second Administrative Complaint are limited to the treatment rendered to S.L. and her son, it is not necessary to fully explore and/or resolve the nature of Respondent's affiliation with the Allergy Clinic. That evidence established that, at least with respect to S.L. and her son, Respondent's role differed greatly from his description of the Clinic's operations. Respondent failed to report what was clearly the unauthorized practice of medicine by Seedarnee. Furthermore, by acquiescing in Seedarnee's diagnosis and treatment, Respondent unlawfully delegated professional responsibility to a person he knew to be unlicensed. Finally, Respondent's participation in the treatment of S.L. and her son constitutes the employment of a trick or scheme in the practice of medicine.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a Final Order finding Respondent guilty of violating Sections 458.331(1)(k), (m) and (t), Florida Statutes as alleged in the First Administrative Complaint and finding Respondent guilty of violating Sections 458.331(e), (k) and (w), Florida Statutes as alleged in the Second Administrative Complaint. As punishment therefore, Respondent should be (1) reprimanded, (2) fined $15,000, (3) suspended from the practice of medicine for five years, two years of which should be suspended if Respondent successfully completes Board approved continuing medical education courses, and (4) thereafter, Respondent should be placed on probation for a period of three years, the terms and conditions of which should be set by the Board of Medicine. It is recommended that one condition of probation should be a limitation on Respondent's establishment or participation in a private office practice. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 16th day of September, 1992. J. STEPHEN MENTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 16th day of September, 1992. APPENDIX Case Numbers 89-3723 and 91-3864 Both parties have submitted Proposed Recommended Orders. The following constitutes my rulings on the proposed findings of fact submitted by the parties. The Petitioner's Submittal with Respect to the October 3, 1990 Hearing Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or Reason for Rejection. 1. Adopted in substance in Findings of Fact 1. 2. Adopted in substance in Findings of Fact 6. 3. Adopted in substance in Findings of Fact 4. 4. Adopted and 8. in substance in Findings of Fact 7 5. Adopted in substance in Findings of Fact 9. 6. Adopted 10. in substance in Findings of Fact 7. Adopted 14. in substance in Findings of Fact The first sentence is adopted in substance in Findings of Fact 15. The second sentence is subordinate to Findings of Fact 12. Subordinate to Findings of Fact 20. Adopted in substance in Findings of Fact 11. Adopted in substance in Findings of Fact 11. Adopted in substance in Findings of Fact 13. Adopted in substance in Findings of Fact 16. Adopted in substance in Findings of Fact 21. Adopted in substance in Findings of Fact 22. Adopted in substance in Findings of Fact 23. Rejected as unnecessary. Subordinate to Findings of Fact 26. Adopted in substance in Findings of Fact 26. Adopted in substance in Findings of Fact 29. Adopted in substance in Findings of Fact 30. Adopted in substance in Findings of Fact 24. Adopted in substance in Findings of Fact 24. Adopted in substance in Findings of Fact 24. Adopted in substance in Findings of Fact 25. Adopted in substance in Findings of Fact 31. The Petitioner's Supplemental Proposals regarding the First Administrative Complaint Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or Reason for Rejection. Subordinate to Findings of Fact 27. Adopted in substance in Findings of Fact 19. Adopted in substance in Findings of Fact 19. Adopted in substance in Findings of Fact 21. Subordinate to Findings of Fact 20 and 21. Adopted in substance in Findings of Fact 12. Rejected as unnecessary. Rejected as unnecessary. This subject matter is addressed in Findings of Fact 11. The Petitioner's Proposed Findings regarding the Second Administrative Complaint Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or Reason for Rejection. Rejected as unnecessary. Adopted in substance in Findings of Fact 1. Adopted in substance in Findings of Fact 36 and 38. Adopted in substance in Findings of Fact 37. Adopted in substance in Findings of Fact 38. Adopted in substance in Findings of Fact 39. Adopted in substance in Findings of Fact 40. Adopted in substance in Findings of Fact 41. Adopted in substance in Findings of Fact 42. Adopted in substance in Findings of Fact 43. Adopted in substance in Findings of Fact 44. Adopted in substance in Findings of Fact 45. Adopted in substance in Findings of Fact 46. Adopted in substance in Findings of Fact 47. Adopted in substance in Findings of Fact 48. Adopted in substance in Findings of Fact 49. Adopted in substance in Findings of Fact 50. Adopted in substance in Findings of Fact 52. Adopted in substance in Findings of Fact 53. Adopted in substance in Findings of Fact 53. Adopted in substance in Findings of Fact 53. Adopted in substance in Findings of Fact 56. Adopted in substance in Findings of Fact 54. Adopted in substance in Findings of Fact 55. Adopted in substance in Findings of Fact 57. Adopted in substance in Findings of Fact 58. Adopted in substance in Findings of Fact 58. Adopted in substance in Findings of Fact 58. Adopted in substance in Findings of Fact 59. Adopted in substance in Findings of Fact 59. Adopted in substance in Findings of Fact 59 and 61. Adopted in substance in Findings of Fact 62. Adopted in substance in Findings of Fact 63. Subordinate to Findings of Fact 64. Subordinate to Findings of Fact 66 and 67. Adopted in substance in Findings of Fact 68. Adopted in substance in Findings of Fact 69. Adopted in substance in Findings of Fact 69. Rejected as unnecessary. Adopted in substance in Findings of Fact 49. Adopted in substance in Findings of Fact 49. Adopted in substance in Findings of Fact 47. Adopted in substance in Findings of Fact 57. Adopted in substance in Findings of Fact 76. Subordinate to Findings of Fact 74. Adopted in substance in Findings of Fact 71. Adopted in substance in Findings of Fact 73. Adopted in substance in Findings of Fact 72. Adopted in substance in Findings of Fact 73. Adopted in substance in Findings of Fact 76. Subordinate to Findings of Fact 77. Subordinate to Findings of Fact 76 and 77. Subordinate to Findings of Fact 79 and 80. The Respondent's Proposed Findings of Fact regarding the Second Administrative Complaint Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or Reason for Rejection. Rejected as unnecessary. The first and the third sentences are adopted in substance in Findings of Fact 1. The second sentence is subordinate to Findings of Fact 3. Subordinate to Findings of Fact 33-35, 70, 75 and 79-80. Adopted in pertinent part in Findings of Fact 34. Rejected as unnecessary. This subject matter is addressed in Findings of Fact 38. 6.-10. Subordinate to Findings of Fact 35, 70, 75, 77, 79 and 80. Rejected as unnecessary and subordinate to Findings of Fact 40, 58 and 59. Rejected as unnecessary and subordinate to Findings of Fact 58 and 59. Subordinate to Findings of Fact 59. Adopted in substance in Findings of Fact 36. Adopted in substance in Findings of Fact 37. Adopted in pertinent part in Findings of Fact 37. Adopted in substance in Findings of Fact 39. Adopted in substance in Findings of Fact 40. The first sentence is adopted in substance in Findings of Fact 40. The second sentence is rejected as constituting argument. Adopted in substance in Findings of Fact 41 Adopted in substance in Findings of Fact 44. Adopted in substance in Findings of Fact 44. Adopted in substance in Findings of Fact 45. Adopted in substance in Findings of Fact 42. Adopted in substance in Findings of Fact 48. Adopted in substance in Findings of Fact 49. Adopted in substance in Findings of Fact 46 and 47. 28.-29. Rejected as unnecessary and subordinate to Findings of Fact 70. Adopted in substance in Findings of Fact 50. Rejected as unnecessary. Adopted in substance in Findings of Fact 52 and 53. Adopted in substance in Findings of Fact 54. The first two sentences are adopted in substance in Findings of Fact 55 and 57. The remainder is subordinate to Findings of Fact 70, 79 and 80. Adopted in substance in Findings of Fact 35, 70, 75, 79 and 80. 36.-37. Subordinate to Findings of Fact 70, 75, 77, 79 and 80. Subordinate to Findings of Fact 70. Rejected as unnecessary. Subordinate to Findings of Fact 76, 77 and 78. Subordinate to Findings of Fact 75. Subordinate to Findings of Fact 75, 79 and 80. Rejected as vague, ambiguous and unnecessary. This subject matter is addressed in Findings of Fact 56. Rejected as unnecessary and subordinate to Findings of Fact 64. Subordinate to Findings of Fact 70. Subordinate to Findings of Fact 70. Rejected as unnecessary. This subject matter is addressed in Findings of Fact 34 and 77. Subordinate to Findings of Fact 57 and 70. Rejected as unnecessary. The evidence established that Respondent continued working at the Allergy Clinic for a year or more after S.L. alerted him to Seedarnee's actions. Subordinate to Findings of Fact 76. Subordinate to Findings of Fact 76. The Respondent's Proposed Findings of Fact regarding the First Administrative Complaint Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or Reason for Rejection. Rejected as unnecessary. Adopted in substance in Findings of Fact 1. Addressed in the Preliminary Statement. Addressed in the Preliminary Statement. Addressed in the Preliminary Statement. Adopted in substance in Findings of Fact 5. Adopted in substance in Findings of Fact 5. Adopted in substance in Findings of Fact 4. Subordinate to Findings of Fact 6. Adopted in substance in Findings of Fact 7 and 8. Subordinate to Findings of Fact 9 and 10. Rejected as contrary to the weight of the evidence and subordinate to Findings of Fact 18 and 19. Adopted in substance in Findings of Fact 14. Rejected as contrary to the weight of the evidence and subordinate to Findings of Fact 18 and 19. Subordinate to Findings of Fact 12. Subordinate to Findings of Fact 12. Subordinate to Findings of Fact 12. Rejected as unnecessary and as constituting argument rather than a finding of fact. Subordinate to Findings of Fact 12. Subordinate to Findings of Fact 12. Adopted in substance in Findings of Fact 23. Adopted in substance in Findings of Fact 23. Subordinate to Findings of Fact 27 and 28. Rejected as unnecessary and subordinate to Findings of Fact 27. Subordinate to Findings of Fact 27. Subordinate to Findings of Fact 27. Rejected as constituting argument rather than a finding of fact. Addressed in the Preliminary Statement. Rejected as constituting argument. The issues raised by Respondent go to the weight of the evidence and not to its admissibility. Subordinate to Findings of Fact 12. Rejected as unnecessary. The issues raised by Respondent regarding Dr. Lindbergh's qualifications go to the weight to be given to his testimony rather than its admissibility. Rejected as constituting argument. See #31 above. Rejected as speculative, constituting argument rather than a finding of fact and unnecessary. Subordinate to Findings of Fact 12. Rejected as unnecessary. Rejected as unnecessary. Addressed in Findings of Fact 12. Rejected as unnecessary. Rejected as unnecessary. COPIES FURNISHED: Mary B. Radkins, Senior Attorney Department of Professional Regulation 1940 North Monroe Street Northwood Centre, Suite 60 Tallahassee, Florida 32399-0792 Neil F. Garfield, Esquire Suite 333 3500 North State Road 7 Lauderdale Lakes, Florida 33319 Dorothy Faircloth, Executive Director Department of Professional Regulation/Board of Medicine 1940 North Monroe Street Northwood Centre, Suite 60 Tallahassee, Florida 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Northwood Centre, Suite 60 Tallahassee, Florida 32399-0792
The Issue Through the several administrative complaints to which these cases pertain, Petitioner seeks to take disciplinary action against the medical license held by the Respondent. The alleged misconduct is more fully described in the discussion that follows.
Findings Of Fact Findings of fact set forth in the Recommended Order as modified by the Board's rulings on the Supplemental Exceptions, are approved and adopted and incorporated herein. Specifically, Paragraphs of the Findings of Fact 15, 24, 34, 43, 46, 60, 79, 98, and 108 were modified. There is competent substantial evidence to support the findings of fact of the Board.
Recommendation Upon the consideration of the facts found and the conclusions of law reached, it is, RECOMMENDED: That a Final Order be entered which revokes Respondent's license to practice medicine in Florida. DONE and ENTERED this 30th day of December, 1992, in Tallahassee, Florida. CHARLES C. ADAMS Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of December, 1992. APPENDIX The following discussion is given concerning the proposed facts of the parties: Petitioner's Facts: Facts on Expert Witnesses: Paragraphs 1 through 31 are not necessary to the resolution of the dispute. Paragraphs 32 through 38 constitute legal argument. Patient Kelly John: Paragraphs 1 through 4 are subordinate to facts found. Paragraphs 5 and 6 are not relevant in that the D&C was not performed. Paragraphs 7 through 19 are subordinate to facts found. Paragraph 20 is not necessary to the resolution of the dispute. Paragraphs 21 through 28 are subordinate to facts found. Patient Dottie Akers: Paragraphs 1 and 2 are subordinate to facts found. Concerning Paragraph 3, the surgery by Dr. Becker and its findings standing alone do not form the basis for determining the appropriateness of Respondent's efforts to reestablish fertility. Paragraphs 4 through 18 are subordinate to facts found. Paragraphs 19 through 22 constitute legal argument. Paragraphs 23 through 54 are subordinate to facts found. Paragraphs 55 and 56 are not necessary to the resolution of the dispute. Paragraphs 57 and 58 are subordinate to facts found. Patient Lillian Andrews: Paragraphs 1 through 18 are subordinate to facts found. Patient Emily Rivera: Paragraphs 1 through 23 are subordinate to facts found. Paragraph 24 is contrary to facts found in that the patient had taken birth control pills for thirteen years not ten years. Paragraphs 25 through 27 are subordinate to facts found. Paragraph 28 is not accepted. Paragraph 29 is subordinate to facts found. Patient Balenda Fulton: Paragraphs 1 through 6 are subordinate to facts found. Paragraphs 7 is not necessary to the resolution of the dispute. Paragraph 8 is subordinate to facts found. Paragraphs 9 and 10 are not necessary to the resolution of the dispute nor is paragraph 11. Facts were found found concerning the patient's two children. Paragraphs 12 through 15 are subordinate to facts found. Paragraph 16 is not accepted. Paragraphs 17 and 18 are subordinate to facts found. Paragraph 19 is not necessary to the resolution of the dispute. Paragraphs 20 through 34 are subordinate to facts found. Respondent's Facts Paragraph 1 is subordinate to facts found. Paragraphs 2 through 4 are not necessary to the resolution of the dispute. Paragraphs 5 through 7 are subordinate to facts found. Paragraphs 7 through 9 are not necessary to the resolution of the dispute. It is noted that notwithstanding Dr. Rudolph's reservations concerning his objectivity, on balance his testimony was deemed an appropriate subject for consideration together with the observations of the other experts. Paragraph 10 is spoken to in the preliminary matters to the Recommended Order. Paragraph 11 is subordinate to facts found. Paragraphs 12 and 13 are not necessary to the resolution of the dispute. Paragraph 14 is subordinate to facts found. Paragraph 15 is subordinate to facts found with the exception of the reported advice to the patient to have a tubal reanastomosis that is not accepted. Paragraph 16 through 25 are subordinate to facts found. Paragraph 26 is is not necessary to the resolution of the dispute. Paragraphs 27 through 30 are subordinate to facts found. Paragraph 31 is rejected in that it suggests that there were existing fimbriated ends of the fallopian tubes. Paragraphs 32 through 39 are subordinate to facts found. Paragraphs 40 through 42 constitute legal argument. Paragraph 43 is subordinate to facts found. Paragraphs 44 through 47 are contrary to facts found. Paragraphs 48 and 49 are subordinate to facts found. Paragraph 50 is contrary to facts found. Paragraph 51 is subordinate to facts found. Paragraph 52 is contrary to facts found. Concerning Paragraph 53 while it is not necessary to record instructions about the use of Danazol, Respondent did not perform the needed task of oral instruction. Paragraph 54 is subordinate to facts found with the exception of references to pain two to three days prior to menses. That suggested fact finding is rejected as is Paragraph 55 to the extent that it is dependent upon that fact. Paragraph 56 is rejected in its suggestion that extensive endometriosis was present. The same response is made to the fact finding suggested in Paragraph 57. Paragraphs 58 through 63 are subordinate to facts found. Paragraph 64 is not necessary to the resolution of the dispute. Paragraph 65 is not accepted as to the extent that the proposed finding suggests performing a laparoscopic examination on that limited information. Reference in Paragraph 66 to the civil suit is not necessary to the resolution of the dispute. The balance of Paragraphs 66 through 71 are subordinate to facts found. Paragraphs 72 through 77 constitutes legal argument. Paragraph 78 is contrary to facts found in its suggestion that there was any pelvic exam performed. Paragraph 79 is rejected in its indication that there were any reports of pelvic pain prior to menses. Paragraph 80 is subordinate to facts found. Paragraph 81 is contrary to facts found in its suggestion that an adequate basis was being present to justify the laparoscopy. Paragraph 82 is subordinate to facts found. Paragraphs 83 is rejected as to purported findings on laparoscopy and laparotomy. Paragraph 84 is subordinate to facts found. Paragraph 85 is contrary to facts found. Paragraph 86 is not necessary to the resolution of the dispute. Paragraphs 87 through 94 constitute legal argument. Paragraph 95 is subordinate to facts found. Paragraph 96 is not accepted in its depiction of a complaint of menometrorrhagia, same for paragraph 97. Paragraphs 98 through 101 are contrary to facts found in their suggestion that the D&C and hysterocopy were performed. Paragraphs 102 and 103 are subordinate to facts found. As to Paragraphs 104 and 105 and their suggestion that Respondent instructed the patient concerning ectopic pregnancy those Paragraphs are contrary to facts found as are Paragraphs 106 through 108. Paragraphs 109 and 110 are subordinate to facts found. Paragraphs 111 through 117 constitute legal argument found. Paragraphs 118 through 121 are accepted but are not necessary to be reflected in the fact finding. COPIES FURNISHED: Susan E. Lindgard, Esquire Michael Blazicek, Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Julie Gallagher, Esquire Sandra Stockwell, Esquire Post Office Box 11059 Tallahassee, FL 32302 Dorothy Faircloth, Executive Director Department of Professional Regulation Board of Medicine 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792
Findings Of Fact The Respondent, Joya L. Schoen, graduated from medical school in 1966. Dr. Schoen is board eligible in psychiatry. T. 195-96. She had three years residency in general psychiatry and a two year fellowship in child psychiatry. From 1967 to about 1979, she practiced in psychiatry. Dr. Schoen has been licensed by the State of Florida since 1973. The Respondent's father was a physician, and in 1979, she began to take over his practice in general medicine. The Respondent took about three years to discontinue her psychiatric practice and assume her father's general practice. T. 196. On June 14, 1985, a patient, who will identified by her initials, K. H., was referred to Dr. Schoen by another physician, Dr. Mengel. T. 197. Her symptoms were an inability to concentrate, "spaciness," pervasive fatigue, P.M.S. (premenstrual syndrome), and irregular-periods. Her symptoms were aggravated by certain foods, fumes, and perfumes. T. 217. K. H. had discovered that dairy foods and foods containing high- carbohydrates aggravated her condition, and she was then avoiding them in her diet. T. 218. K. H. had already been seen by a Dr. Mengel, and he had recommended that she receive allergy testing. T. 198. Dr. Schoen had K. H. take the RAST I.G.E. test. T. 217. The RAST I.G.E. test is a screening test to determine, in a general sense, whether a patient has allergies. T. 216; (Supplemental Transcript, ST) ST-14. The degree of allergy is related to the score. A score over a hundred is considered a positive indication of the presence of allergies. T. 217. K. H.'s score on the RAST I.G.E. test was 1,993, T. 85, which was an extraordinarily high level, T. 88-89, indicating a probability of a high degree of allergy. T. 217, ST-14. The RAST test, like the cytotoxic test, is performed on blood samples, and thus is not traumatic to the patient. T. 222. All witnesses viewed this test as an acceptable test. Dr. Schoen also did a general screening for allergies, and determined that environmental allergies were not very high. T. 218. That left food allergies to be investigated. Id. Cytotoxic testing tests for food allergies, or more precisely, for adverse reaction of white blood cells to foods. T. 218, 233. The cytotoxic test confronts samples of the patient's blood with certain foods. The reaction of the leukocytes in the patient's blood is observed. ST-12; T. 47. Foods which cause reactions are then selectively removed from the patient's diet, and the increase or decrease of the allergy is observed. In this way, by trial and error, it is hoped that the particularly food to which the patient is allergic will be identified. Cytotoxic testing was available in 1985, and had been available since at least 1979. Approximately ten thousand cytotoxic tests were conducted from 1979 to 1986 by the laboratory that performed the cytotoxic test for Dr. Schoen for K. H. T. 158. Hundreds of physicians ordered cytotoxic testing from this laboratory; some physicians ordered it repetitively. T. 171. See also T. 101. The users of the cytotoxic test were primarily medical doctors, but were also doctors of osteopathy, chiropractors, and dentists. T. 172-73. The laboratory ceased performing the test in 1986 due to increasing questions concerning the efficacy and reliability of the test and the advent of better tests. T. 165-67. A large number of physicians have used the cytotoxic test at one time or another. ST-12; T. 172-73. Dr. Schoen traveled to Washington, D. C., to learn more about cytotoxic testing. T. 234. She also discussed the utility of the test with another physician. T. 233. Dr. Schoen has used the cytotoxic test about forty or fifty times; in some cases the test has led to marked improvement in the patient's condition, and in other cases, the test has not been helpful. T. 219. She was not aware of any patient having been harmed by use of the test. T. 221. Cytotoxic testing for food allergies ordinarily was less expensive than skin testing. T. 190-92. In August, 1983, the Health Care Financing Administration, United States Department of Health and Human Services, issued in the Federal Register a notice that cytotoxic testing would not be reimbursed by that agency under Medicare coverage. P. Ex. 3. The notice in the Federal Register noted that "there was a wide range of conflicting views regarding the efficacy of cytotoxic food testing ..." P. Ex. 3, p. 37717. The article discusses a number of evaluations of the test, some favorable to the test, and many unfavorable. Cytotoxic testing is a subjective test, T. 47, and is considered by some physicians to be experimental and useful only in research. T. 50. Nonetheless, as discussed above, a large number of physicians disagreed, and used the test in their practice from 1979 through 1985. Since 1985, other tests have come along that are more reliable than the cytotoxic test, and the cytotoxic test is no longer given. T. 220-21. Currently, Dr. Schoen does not use the cytotoxic test, but uses tests like the RAST test in part because it is covered by insurance, and cytotoxic testing is not. (The other reason is that the laboratory that performed cytotoxic testing for Dr. Schoen has discontinued the test.) T. 222. When she arrived at Dr. Schoen's office, K. H. had read The Yeast Connection by William G. Crook, M.D. (R. Ex. 1), and asked Dr. Schoen to give her a cytotoxic test. T. 197-98. K. H. had concluded that she preferred the cytotoxic test because she thought it would be less stressful than other allergy tests. T. 198. She also wanted to be given treatment with the drug Nystatin in hopes that she could avoid shots, desensitization, and a long and expensive process of allergy treatments. T. 199. It is inferred that K. H. was fully aware that the diagnosis of systemic candidiasis and treatment by Nystatin as described by Dr. Crook was a new theory. This inference is based upon the fact that she had been to several physicians, none of whom turned to Dr. Crook's theory, and that she was familiar with Dr. Crook's book. T. 198-99. It is evident from Dr. Crook's book, which is entitled in part "A Medical Breakthrough," and in the first few pages communicates an awareness that the theory is quite new and still not' accepted by mainstream medicine. R. Ex. 1. This finding of fact is further corroborated by the affidavit of K. H. R. Ex. 8. Dr. Schoen gave K. H. reading material about cytotoxic testing and discussed with K. H. the nature of the cytotoxic test and the alternative procedures that were available, that is, to be referred to a physician who specialized in allergies, and to undergo allergy testing by skin testing using needles and shots. See T. 25, 199. This finding is corroborated by the affidavit of K. H., wherein K. H. states that Dr. Schoen explained to K. H. that cytotoxic testing was accepted by only a minority of physicians. R. Ex. 8. K. H. said that she was terrified of needles, and was so allergic to so many things that such testing might make her worse. K. H. wanted to try cytotoxic testing and treatment with Nystatin before trying testing by an allergist. T. 202, 236. K. H. understood that the cytotoxic test was an out-of-the-mainstream test and was perhaps not proven. T. 199; R. Ex. 8. Dr. Schoen's written records of treatment of K. H. do not show consent of K. H. to take the cytotoxic test, or advice to K. H. by Dr. Schoen that the test was experimental and that other alternatives existed. T. 54. Dr. Schoen did not make a written record of her advice to K. H. concerning the cytotoxic test, or of K. H.'s understanding of the nature of the test. The affidavit of K. H., R. Ex. 8, constitutes after-the-fact written evidence of such explanation by Dr. Schoen and consent and understanding by K. H. Failure to obtain written consent from K. H. prior to cytotoxic testing had no adverse effect or potential adverse effect to the health of K. H. T. 68. Dr. Schoen directed that K. H. be given a cytotoxic test. T. 218. Dr. Schoen diagnosed K. H.'s condition as allergies and systemic candidiasis. T. 218. Dr. Schoen prescribed treatment with Nystatin and a diet that avoided yeasty foods, such as dairy foods and foods containing high carbohydrates. T. 218. K. H. took Nystatin as prescribed by Dr. Schoen from June, 1985, to November, 1985. This is the course of treatment recommended by William. G. Crook, M.D., for systemic candidiasis. Id. Dr. Schoen told K. H. that Nystatin is usually given to treat candidiasis, and that the drug is virtually nontoxic and safe. She also told K. H. that Nystatin was not something a regular physician would prescribe for her condition, but that it was widely used among physicians that she knew with safe results. T. 201. This finding is corroborated by the affidavit of K. H. R. Ex. 8. Nystatin is one of the safest drugs available to physicians today, having no serious side effects. ST-9. It is well-tolerated by patients. T. 45. Nystatin is an antifungal medicine that is frequently used to treat localized candidiasis. The alternative course of testing and treatment by an allergist would perhaps take one to three years, and would ultimately be quite a bit more expensive than the testing and treatment selected by Dr. Schoen, due to the need in such alternative treatment for numerous physician visits and shots. T. 203- 04. This finding of fact is corroborated by the medical report of Elmer M. Cranton, M.D. R. Ex. 7, p. 2. Some maladies are difficult to diagnose, but may be diagnosed through trial therapy. Trial therapy is a course of nontoxic therapy without a specific diagnosis. If health improves during such therapy, it is concluded that the patient had the disease treatable by such therapy. T. 200, 205. It is not uncommon in medicine for a physician to prescribe a course of treatment that in fact works to either cure the malady or relieve the symptoms, but no one understands scientifically why it works. T. 205-06. This finding of fact is corroborated by R. Ex. 6, attachment: "`Think Yeast'--The Expanding Spectrum of Candidiasis," reprinted by "The Journal of the South Carolina Medical Association," and by R. Ex. 1, "A Special Message for the Physician," p. 2. The diagnosis of systemic candidiasis cannot be tested by conventional scientific tests. This finding of fact is corroborated by R. Ex. 4, p. 10. It may take many months, or a year or two years, for a patient to respond to Nystatin treatment. Dr. Schoen saw no significant improvement in K. H. from June, 1985, to November, 1985, when she was her patient. T. 236. K. H. had psychological problems when she visited Dr. Schoen. Dr. Schoen was aware that K. H. had psychological problems, but determined that she deserved a chance to receive the treatment Dr. Schoen selected because it was not harmful, and might be of help to her in her case. T. 201. Dr. Schoen assessed K. H.'s circumstances and determined that medical treatment should be attempted first, and that psychological treatment was then not appropriate. Her conclusion was based upon her observation that due to K. H.'s symptoms (irregular memory, spaciness, and fatigue), K. H. would not be capable of participating in psychological therapy. She also noted the dysfunctional condition of her parents as an additional reason that psychological treatment was not appropriate at that time. T. 202-04. Finally, K. H. was a newly converted fundamentalist Christian, and had turned to religion for emotional help. She had psychological counseling suggested to her, but apparently did not follow up on the suggestion. Under these circumstances, Dr. Schoen concluded that psychological counseling was not possible at that-time. T. 238. Dr. Schoen did not discuss these conclusions with K. H. There is no evidence that she should have discussed these conclusions with K. H. Dr. Robert M. Stroud graduated from medical school in 1956, and is licensed to practice in Florida, Alabama, and North Carolina, and is board certified in internal medicine, allergy, immunology, and rheumatology. His board certification in immunology was in 1974. Dr. Stroud practices in Ormond Beach, Florida, and specializes in allergy and rheumatology, ST-4,6. Allergy is a subspecialty of internal medicine. ST-15. He was a professor of medicine at the University of Alabama for 14 years, teaching medicine, microbiology, and immunology. ST-3. He has been a clinical professor at the University of Florida since 1982. ST-4, 6. Dr. Stroud was accepted as an expert in medicine, allergy, and immunology. ST-7. Dr. Stroud uses the diagnosis "yeast allergy" or candida allergy" in his practice, and by that diagnosis, means the same thing as systemic candidiasis. ST-7. He views the condition as an allergic reaction to yeast on the surface of membranes. Id. When Dr. Stroud makes the diagnosis of yeast allergy, or if he strongly suspects that diagnosis, the treatment he prescribes is a yeast elimination diet and Nystatin administered orally. ST-9. Dr. Schoen discussed K. H.'s case with Dr. Crook, and Dr. Crook told Dr. Schoen that he agreed with her diagnosis and course of treatment. T. 206- 11; R. Ex. 6. Dr. Schoen also discussed K. H.'s case with Elmer Cranton, M.D., and Dr. Cranton told Dr. Schoen that he agreed with her diagnosis and course of treatment. T. 211-15; R. Ex. 7. (Both of these findings of fact find that Dr. Schoen was in fact told this by both physicians. To the extent that the opinions of these two physicians are offered for the truth of the opinions, the evidence is hearsay, but is corroborative of the finding of fact which follows.) The diagnosis of systemic candidiasis, or yeast allergy, as used by Dr. Stroud, is used by a thousand or more physicians in this country who practice internal medicine, osteopathy, and allergy medicine, and the number has been growing rather than diminishing. ST-10, 16-17. Serious research continues in this field, and a large number of physicians in the country have seriously investigated the possible link between candida and the immune system. ST-11. A substantial minority of physicians in Florida and in other states agree with the theories of diagnosis and treatment of Dr. Crook in The Yeast Connection, and believe that systemic candidiasis is a medically proper diagnosis. T. 225, 228- 30, and the testimony of Dr. Stroud. This finding of fact is corroborated by R. Exs. 2, 6 (attachments), and 7, and T. 206-15. The American Academy of Allergy has issued position papers disapproving the diagnosis of systemic candidiasis and cytotoxic testing, and calling them experimental. P. Ex. 2. 45. Dr. James E. Quinn is a medical doctor and has practiced family medicine in Sanford, Florida, for 11 years. He has been board certified in family practice for the last 8 years. T. 10. On about November 26, 1985, K. H. came to Dr. Quinn for treatment. Her sister and brother-in-law were concerned about the treatment she was receiving from Dr. Schoen, and told Dr. Quinn that the family felt that K. H. actually had an emotional problem. T. 10. K. H. complained that she was being poisoned by the environment around her, by chemicals, by perfumes, and by foods. T. 11. She could not tolerate certain foods, would become confused when near perfume, and her period was irregular. T. 12. She was chronically fatigued. T. 12. K. H. was examined by Dr. Quinn. Dr. Quinn diagnosed the existence of a severe emotional problem, but found no evidence of a typical amount of allergic disease. T. 11. In Dr. Quinn's opinion, systemic candidiasis occurs only in association with severe illnesses in a general hospital setting, such as certain carcinoma, leukemia, AIDS, after chemotherapy, or after sustained use of antibiotics. T. 12-13, 22. This form of candidiasis occurs in identifiable areas, such as the esophagus, the bladder, or other systems. T. 22. Dr. Quinn was of the opinion that it would be proper to treat this form of systemic candidiasis with an infectious disease medication and with an antifungal agent such as Nystatin. T. 23-24. Dr. Quinn had no familiarity with the concept of systemic candidiasis as set forth by Dr. Crook. T. 26. Dr. Quinn had no personal experience with cytotoxic testing. T. 25. Dr. Quinn saw K. H. only once, T. 19, and did not review Dr. Schoen's records for K. H. T. 26. Dr. Quinn referred K. H. to a psychiatrist, Dr. Moises, for mental health evaluation, and referred K. H. to an allergist, Dr. Alidena, for an allergy evaluation. T. 13-14. Dr. Alidena felt that K. H. possibly had mild food allergies. T. 18. She recommended a food elimination diet and wait for the psychiatric report. Id. Dr. Eugene F. Schwartz is a medical doctor who has been in private practice specializing in adult and pediatric allergy and immunology since August, 1983, in Altamonte Springs, Florida. T. 28, 30. He is board certified in pediatrics and allergy and immunology. T. 29. He is a member of the American Academy of Allergy and Immunology, an organization composed of the largest number of board certified allergists and immunologists in the country. T. 41, 104. Dr. Schwartz agreed with Dr. Quinn that systemic candidiasis occurred in certain severely debilitated patients, such as those with cancer, or having immune suppression problems. T. 37. Dr. Schwartz was of the opinion that systemic candidiasis as described by Dr. Crook was not an appropriate diagnosis, and thus that prescription of Nystatin for such a diagnosis was inappropriate because the diagnosis "did not exist." T. 39-40. Dr. Schwartz had two methods of diagnosing patients who thought that they had systemic candidiasis after reading Dr. Crook's book: to either find another cause of the problems or to advise the patient that he (Dr. Schwartz) did not know what the cause of the problem was. T. 40, 44. If a patient came in complaining of adverse reactions after eating certain foods, Dr. Schwartz would have prescribed a skin test for food allergies. T. 48. Dr. Schwartz was of the opinion that the cytotoxic test was spurious and "quite experimental," and should be limited to research projects. T. 50. Dr. Schwartz was of the opinion that Dr. Schoen's practice with respect to diagnosis of K. H. as having systemic candidiasis was "outside the mainstream of medicine, that other prudent, physicians would not have done so." T. 65. He was also of the opinion that prescription of Nystatin was not proper, that use of cytotoxic testing was not proper, and that lack of written informed consent to the cytotoxic test was not proper. T. 66-67. Dr. Schwartz believed that a minority of physicians thought that the diagnosis of systemic candidiasis is a proper diagnosis. T. 109. Dr. Schwartz stated that Dr. Crook is one of the leading authorities with respect to the diagnosis of systemic candidiasis and treatment by use of Nystatin, T. 70, and agreed that there have been other articles supportive of Dr. Crook's Views. Id. Dr. Schwartz testified that the symptoms that K. H. presented to Dr. Schoen met the criteria for Dr. Crook's diagnosis of systemic candidiasis. T. Dr. Schwartz also agreed that if the diagnosis of systemic candidiasis was proper, Dr. Schoen did prescribe the proper treatment as recommended by Dr. Crook, and that her prescription of Nystatin was proper as recommended by Dr. Crook. T. 42, 81. Dr. Schwartz also conceded that a minority of physicians used cytotoxic testing to determine the presence of allergies to various given substances. T. 110. Dr. Joseph Akerman has been in the general practice of medicine since 1952 in Apopka, Florida. He is board eligible in family practice medicine. T. 120. He was accepted as an expert witness in the practice of medicine, including the standard of care for general medical practitioners and family practitioners in the Orlando area. T. 122. Dr. Akerman had never seen a case of systemic candidiasis. T. 124. Dr. Akerman would not use that diagnosis in his own practice, nor would he use the course of treatment prescribed by Dr. Crook. T. 124, 130. He was not familiar with any physicians who subscribed to Dr. Crook's theories. T. 131. Dr. Akerman personally disagreed with Dr. Crook's theories. T. 130. If Dr. Crook's theory of systemic candidiasis were correct, Dr. Schoen's diagnosis of systemic candidiasis in the case of K. H. was correct, in Dr. Akerman's opinion. T. 130. On December 31, 1987, the Respondent filed a motion to dismiss the administrative complaint. The motion raised two issues: whether the probable cause panel considered some evidence that the violations alleged occurred, and whether the probable cause panel was composed of three members as required by law. Attached to the motion was a transcript from that portion of the meeting of the probable cause panel that considered the charges against the Respondent. That transcript was admitted into evidence as R. Ex. 4. The probable cause panel met in Palm Beach, Florida, on August 21, 1987. Two members were present. The members present had been furnished the investigative report and a recommendation. R. Ex. 4, p. 3-5. The transcript shows who attended the meeting, but does not show the composition of the panel. The two members agreed with the administrative complaint. R. Ex. 4, p. 10-11, with one exception which apparently was deleted from the complaint. Id. at p. 10. The Petitioner submitted an affidavit concerning the composition of the probable cause panel. P. Ex. 7. The affidavit is hearsay, and cannot be relied upon to make a finding of fact as to the composition of the probable cause panel. There is no competent evidence in the record from which a finding of fact can be made that the probable cause panel in this case was composed of less than three members.
Recommendation For these reasons, it is recommended that the Department of Professional Regulation, Board of Medicine, enter its final order dismissing the administrative complaint against the Respondent. DONE and ENTERED this 26th day of September, 1988, in Tallahassee, Florida. WILLIAM C. SHERRILL, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 26th day of September, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-4351 The following are rulings upon proposed findings of fact which have either been rejected or which have been adopted by reference. The numbers used are the numbers used by the parties. Numbers have been sequentially attributed to the unnumbered paragraphs filed by the Respondent. Statements of fact contained in this appendix or adopted herein by reference are intended to be additional findings of fact. Findings of fact proposed by the Petitioner: 5. A categorical finding that the cytotoxic test was considered to be purely experimental by allergists and immunologists cannot be made in view of the fact that many physicians used the test in the years in question. The record cited does not contain evidence that Nystatin is a legend drug. Findings have been made that K. H. received this drug through prescription by Dr. Schoen. The first sentence is not supported by the record cited. The second sentence is thus not relevant. Since a substantial minority of physicians accept the diagnosis of systemic candidiasis as described by Dr. Crook, the word "only" in the first sentence is rejected. The second sentence is a true statement of the opinion of the majority of such physicians, but a substantial minority of physicians disagree. All physicians who testified agreed that K. H.'s symptoms were consistent with the diagnosis of systemic candidiasis as described by Dr. Crook. It is true that K. H. did not suffer from a severe illness of the type with which systemic candidiasis is also a potential associated diagnosis. Since systemic candidiasis as described by Dr. Crook cannot be detected by testing, the lack of the tests set forth in this proposed finding of fact is irrelevant. Diagnosis by trial therapy is a medically accepted way to proceed where testing is ineffective for diagnosis. Rejected for the reasons stated in findings of fact 11-14. Rejected for the reasons stated in findings of fact 18-25. Rejected for the reasons stated in findings of fact 30-36, 39-43, 62- 64, and 69. Findings of fact proposed by the Respondent: 1. The first sentence of this proposed finding of fact is subordinate to findings of fact that have been adopted. It is true, however, and is adopted by reference. 3. Mr. Zavik was accepted only a- an expert in cytotoxic testing procedures. T. 164, 166, 169-70. He did not have expertise to express an opinion as to the jurisdiction of the Food and Drug Administration. The second sentence is cumulative and unnecessary. 9. The fourth sentence is cumulative and unnecessary. The sixth sentence is subordinate to findings of fact that have been adopted. It is true, however, and is adopted by reference. 14. These proposed findings of fact are not supported by the record cited. The summary of what Dr. Godorov said is confused and ambiguous. 17. The sixth sentence is cumulative and unnecessary. The second sentence is irrelevant. The second is subordinate to findings of fact that have been adopted. It is true, however, and is adopted by reference. 25 and 28. These proposed findings of fact are subordinate to findings of fact that have been adopted. They are true, however, and are adopted by reference. 29. The second is subordinate to findings of fact that have been adopted. It is true, however, and is adopted by reference. 31. These proposed findings of fact are irrelevant since the summary of what Dr. Godorov said is too confused and ambiguous to be a basis for a finding of fact. COPIES FURNISHED: Robert D. Newell, Esquire Newell & Stahl, P.A. 817 North Gadsden Street Tallahassee, Florida 32303-6313 Salvatore A. Carpino, Esquire One Urban Centre, Suite 750 4830 West Kennedy Boulevard Tampa, Florida 33609 Bruce D. Lamb, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Ms. Dorothy Faircloth Executive Director Board of Medicine Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 =================================================================
The Issue Should discipline be imposed against Respondent's license to practice medicine for violation of Section 458.331(1)(t), Florida Statutes (2003)?
Findings Of Fact Stipulated Facts Petitioner is the state department charged with the regulation of the practice of medicine pursuant to Chapter 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. Respondent is Michael D. Fox, M.D. Respondent is board certified in obstetrics and gynecology. Respondent is a licensed medical doctor in the State of Florida having been issued license ME 66312. Respondent's address is 3627 University Boulevard, South, Suite 200, Jacksonville, Florida 32216-4211. At all times material to this complaint, Respondent provided professional services as an employee of North Florida Gynecologic Specialists in Jacksonville, Florida. On or about September 26, 2003, Patient T.D. presented to Respondent with a history of worsening pelvic pain and abnormal menstrual bleeding. On or about October 6, 2003, Respondent and Patient T.D. agreed that Patient T.D. would undergo a hysterectomy. On or about October 22, 2003, during a pre-operative examination, Respondent ordered pre-operative lab studies, including a urine pregnancy test, for Patient T.D. On or about October 27, 2003, Respondent performed a total abdominal hysterectomy on Patient T.D. During Patient T.D.'s hysterectomy, Respondent took a specimen from Patient T.D., which was sent to pathology for evaluation. On or about October 29, 2003, a microscopic examination of the surgical specimen was performed that revealed Patient T.D. was pregnant at the time Respondent performed the hysterectomy on Patient T.D. Respondent did not ascertain the correct results of Patient T.D.'s pre-operative pregnancy test prior to performing the October 27, 2003, hysterectomy on Patient T.D. Respondent's Care of Patient T.D. Respondent attended medical school at the University of Alabama, Birmingham, Alabama. He did a four-year residency in obstetrics and gynecology (ob/gyn) in Jackson, Mississippi, and a two-year sub-specialty fellowship in reproductive endochrinology in Lexington, Kentucky. He is board-certified in reproductive endochrinology and ob/gyn. At present his specialty is reproductive endochrinology. Respondent has experience in performing hysterectomies and the pre-operative evaluations associated with those surgeries. Respondent does 30 to 40 hysterectomies a year. That number represented his experience in 2003. The principal reason for performing hysterectomies in his practice, is associated with sub-specialty interests, surgery for endometriosis and adenomyosis, a co-disease with endometriosis. Respondent has privileges to practice in hospitals in the Jacksonville, Florida area. In particular, he has privileges at St. Vincent's, St. Luke's, Baptist, Baptist Beaches, Memorial and Shands hospitals. He performs surgeries in all those hospitals. The hospitals where Respondent practices have computer systems that allow access to laboratory records and other forms of information associated with patient care. Although he has access to the computer systems in the facilities, his routine is to obtain laboratory information in the hospital setting from other persons involved in the patient care. He asks those persons to find out the information for him and report the finding(s). Respondent would have access to the patient hospital record, as well as a source for obtaining laboratory information. Respondent routinely looks at the patient hospital record in preparing for surgery. Concerning Patient T.D., the subject of this proceeding, when seen by Respondent she was described as a young female, of child-bearing age who presented with chronic pain. She had pain with periods which Respondent found to be characteristic of adenomyosis. She had pre-cycle pain approximately a week prior to her menses, another characteristic of adenomyosis. The patient had irregular bleeding that is an indication of adenomyosis. The patient was found to have an enlarged uterus, the primary source of her pain on the examination. This visit with Respondent, that formed the basis for his impression, took place on September 26, 2003. On the initial visit Respondent also obtained a history consistent with endochrine disorder causing irregular cycles. In the patient's case, the cycles extended as much as 60 days in relation to her periods. Based upon his initial impression, Respondent did not find evidence that Patient T.D. was pregnant. The patient told Respondent that she had no desire for fertility. At that time, she did not report having a partner, nor did she indicate that she was sexually active. To further evaluate the Patient T.D.'s condition and complaints, Respondent ordered an ultrasound test. That study was performed on October 2, 2003, and a gynecological ultrasound report rendered. Based upon the report, Respondent held to the view that the report showed evidence of adenomyosis. There was a mild and moderate enlargement of the uterus, which Respondent found to be consistent with adenomyosis. The patient had had a prior pregnancy and delivery and Respondent found the depiction on the ultrasound of a mild enlargement of the uterus consistent with the prior pregnancy and delivery. On their next visit, Respondent discussed the choice of a hysterectomy or some other form of surgery that did not involve a hysterectomy, to treat the endometriosis and relieve her symptoms. That visit took place on October 6, 2003. On October 22, 2003, Respondent met the patient again. He reviewed the details of what he believed was the underlying disease and potential treatments in discussion with the patient. The patient indicated that she wanted to proceed with the hysterectomy. That choice having been made, the surgery was discussed between the patient and Respondent and the necessary paperwork was started to arrange for the surgery in the hospital. When preparing for surgery Respondent ordered a pregnancy test to verify whether the patient was pregnant or not. The nature of the test was a urine pregnancy test under Respondent's preoperative orders given October 22, 2003. The specimen was collected on October 22, 2003, and received by Memorial Hospital (Memorial), Jacksonville, Florida, where the hysterectomy was to be performed. The test result was positive for pregnancy. The point in time that the result was revealed to Respondent will be discussed beyond this reference to the result. On October 27, 2003, Respondent began his surgery cases at Memorial at 7:30 a.m. On that date there was no indication in the patient record or chart maintained in his office practice that reflected information concerning the pregnancy test result, nor was that information found in the hospital chart related to Patient T.D. Absent the information, Respondent testified that he asked the circulating nurse at Memorial about the result of the pregnancy test. That was Tracy Lloyd, R.N. According to Respondent, the nurse went away to check the result and as Respondent describes "subsequently told me it was negative." No further effort was made by Respondent to confirm the oral report that Respondent says was made by the nurse. Respondent did not document the results of Patient T.D.'s pre-operative pregnancy test in the medical record. It was not his habit to write that type of a pre-operative note. Respondent testified that Ms. Lloyd told him about the pregnancy test results while in the holding area in the presence of the patient. Respondent commented that his question to the nurse would have been "What are the results of the pregnancy test?"1/ Aside from the results of the pregnancy test, nothing in the patient's condition, known to Respondent, led him to believe that the patient was pregnant. When the laparoscopic surgery commenced, Respondent did not perform an examination of the patient under anesthesia, given his recent examination of the patient in his office and the results of the ultrasound. Moreover, Respondent does not believe that such an examination under anesthesia would reveal anything other than the adenomyosis and the endometriosis which conformed to his preoperative diagnosis. On that subject, the later examination of the specimen on October 29, 2003, revealed that Patient T.D. had an early pregnancy, estimated as 4 to 5 weeks. In Respondent's opinion, in a 4-to 5-week pregnancy, the uterus would not normally achieve the size of a uterus that was reported on the ultrasound as mildly enlarged, not pregnant. Mildly enlarged refers to a 6 to 8 weeks' pregnancy. Respondent expected to see an enlarged uterus because of the adenomyosis which could be anticipated to cause an inflammatory response in the wall of the uterus, softening the uterus and giving it an appearance that would be similar to an early pregnancy. The rounded globular description of the findings during surgery were consistent with the expectations in addressing cases involving adenomyosis, according to Respondent. Returning to the surgical specimen obtained in Patient T.D.'s case, it was examined through surgical pathology conducted by Robert E. Barnes, M.D. A report was rendered. The report explains that in the examination of the specimen, the endometrium, "gestational endometrium with products of conception" were present. This was the finding related to Patient T.D.'s pregnancy. Dr. Barnes, is a board-certified pathologist in anatomic and clinical pathology. He describes his findings pertaining to Patient T.D., the gestational endometrium with products of conception, as referring to an early embryo, the endometrium showing changes associated with pregnancy. In his opinion the pregnancy was between 10 and 16 days following conception. When Dr. Barnes contacted Respondent on October 29, 2003, to advise of his findings in the pathology. It was a brief conversation and he does not recall the details. After the revelation concerning the pathology, Respondent's office staff found the information concerning the results of the urine pregnancy test in the hospital chart retained in the computer at Memorial. This finding was made around November 4, 2003. In a section within the report on the pregnancy test it refers to the "Result" and underneath that, the word "POSITIVE" is entered referring to pregnancy. When it was discovered that the hysterectomy had been performed while the Patient T.D. was pregnant, at her post- surgery scheduled office visit, a discussion was held with the patient concerning the "checks and balances" in place to avoid the problem. That refers to the surgery at a time the patient was pregnant. Respondent talked to the patient about counseling, or something similar, given the outcome in the case. As a result of the error, steps were taken within Memorial to address this circumstance. The Respondent and the Memorial Department of OB/GYN made changes, by requiring a pre- operative pregnancy test as protocol, that established a urine pregnancy test within 72 hours of surgery. That test would be performed by the nurses in the holding area. Respondent now orders a blood pregnancy test which is a more sensitive test to determine pregnancy. Expert Opinion Jose Cortes, M.D., is board-certified in ob/gyn, licensed to practice in Florida. He was recognized as a expert in ob/gyn for purposes of expressing his opinion about the care Respondent provided Patient T.D. Dr. Cortes has done hysterectomies in his practice, as recent as June 2006. He was called upon to render an opinion concerning the care Respondent provided Patient T.D. involving her hysterectomy. He had access to material concerning her care involved with this case. Dr. Cortes' impression of Respondent's medical treatment of the patient in the beginning, was that it was adequate and correct, with the proper evaluation performed and an appropriate decision made for surgery. Dr. Cortes expressed the opinion that in performing a hysterectomy on a woman who is of child-bearing age, which Patient T.D. was, a physician should order a pre-operative pregnancy test. In reviewing Patient T.D.'s records Dr. Cortes did not find a record documenting that the pregnancy test was ascertained by Respondent, referring to the test results. In his experience the results of the preoperative tests would be reflected in the patient's medical records as a matter of custom. Respondent, according to Dr. Cortes, could have obtained the results of the pre-operative pregnancy test for Patient T.D. by a fax to his office, a copy obtained through a computer, laboratory printouts sent to Respondent's office, and a copy of the pre-operative laboratory results obtained by the hospital placed in its medical record. Dr. Cortes stated the position that an experienced ob/gyn, and Respondent fits that category, could reasonably be expected to rely upon an oral report from a nurse as to the results of the pregnancy test, before entering the operating room, in the area of the pre-operative alcove as the patient is being interviewed by the physician. Dr. Cortes goes on to explain that if the conversation with the nurse in the presence of the patient was in the operating room holding area, then the pregnancy test results would have to have been documented in the patient chart to find the oral report acceptable. Those test results as reported would have had to be entered by the physician in the patient chart to meet the standard of care upon the oral report.2/ Later on, Dr. Cortes in his testimony seems to subscribe to the view that an oral report by the nurse as to the pregnancy test results would meet the standard of care, assuming that the Respondent in this case was provided an oral report. In the testimony at hearing, Dr. Cortes also said that obtaining an oral report or verbal report on test results, in an emergency situation, would meet the standard of care. By contrast, in elective surgery, such as that being performed on Patient T.D., it would be such that there was ample time to review a chart and laboratory studies before the patient was brought into the surgical suite. Generally stated, Dr. Cortes accepts that physicians frequently rely upon oral information imparted by nurses in performing surgeries, be they elective or emergent, but without an oral report this concession is not important. Regardless of the pre-conditions for Respondent to receive and rely on an oral report of the results of the pregnancy test, without an oral report, there being no other basis for Respondent's knowledge of the pregnancy test results, it was below standards to proceed with the hysterectomy. This view is taken from Dr. Cortes' testimony. Dr. Cortes expressed the opinion that it was below the standard of care to not ascertain the results of the patient's pre-operative pregnancy test prior to performing a non-emergent hysterectomy, that is an elective hysterectomy. Dr. Cortes expressed the opinion that it was below the standard of care for Respondent to perform a hysterectomy on Patient T.D. while she was pregnant in an elective setting. In addition to the results of the pregnancy test, Dr. Cortes believes that Respondent had other opportunities to detect the pregnancy, including an examination of the patient while she was under anesthesia during the surgery, and would have allowed a comparison of the results at the time of surgery against previous examinations that Respondent had performed on the patient. In referring to the previous examinations compared to an examination under anesthesia, this included the results of the ultrasound performed on October 2, 2003. Dr. Cortes does agree that the underlying condition visualized under anesthesia could be associated with prior pregnancy or the pre-operative diagnosis of adenomyosis. Dr. Cortes believes that Respondent's medical records, in the context of what could have been found upon an examination under anesthesia during the surgery, could be consistent with a possible pregnancy. A change seen in the pelvic examination at surgery would create an opportunity to evaluate and raise in the Respondent's mind any doubt concerning pregnancy. A slight increase in the size of the uterus between September 26, 2003, and October 27, 2003, is what is being referred to, promoting clinical judgment about possible pregnancy. Bryan Cowen, M.D. specializes in ob/gyn and reproductive endochrinology. He practices at the University of Mississippi in Jackson, Mississippi. He is a professor and chair in the Department of OB/GYN and has been for five years. He has been affiliated with the University of Mississippi for 24 years. He did his undergraduate work at the University of Colorado in Boulder, Colorado, and attended medical school in Denver, Colorado. Dr. Cowen is licensed to practice medicine in Mississippi and is board-certified. Dr. Cowen has performed a number of hysterectomies during his career. Dr. Cowen is familiar with the standard of care applicable for physicians such as Respondent, in the evaluation of patients suspected of endometriosis and adenomyosis and the considerations for treatment by hysterectomy. He is also familiar with the standard of care in relation to pre-operative testing and the associated duties of physicians when ordering such tests. In preparing to testify in this case, Dr. Cowen examined the Memorial medical records, Respondent's office records, and the depositions of Respondent, Dr. Freeman, Dr. Widrich, Dr. Barnes, and Dr. Cortes. With this information in mind, Dr. Cowen was able to provide an opinion concerning the standard of care in relation to the treatment provided by Respondent to Patient T.D. That opinion was that Respondent did not breach the standard of care in that he met due diligence in the process by the pre-operative laboratory-ordered, and pre- operative evaluation and assessment. Speaking to the September 26, 2003, office visit, Dr. Cowen saw nothing on the physical examination to indicate to him that Patient T.D. was pregnant. Concerning the ultrasound that was conducted on October 2, 2003, Dr. Cowen's opinion is that Respondent's assessment that Patient T.D. had adenomyosis based upon presentation, was confirmed by the ultrasound, the overall impression being that the Patient T.D. was not pregnant at that time. The further visit by the patient prior to the hysterectomy did not reveal anything in the history or physical examination that would suggest that Patient T.D. was pregnant, according to Dr. Cowen. On October 22, 2003, the pregnancy test was ordered by Respondent. The arrangement of ordering the test, sending the patient for pre-operative evaluation and laboratory tests is a common practice in Dr. Cowen's experience. In the instance where Respondent did not get a call from the pre-admission testing as to any abnormal results in the pregnancy test, and no report reflecting in the patient chart that the results were normal, Dr. Cowen commented on the need to check the laboratory results before taking the patient into the operating room. Based on Dr. Cowen's experience, there was no necessity to personally lay eyes on the test results to ascertain those results. He recognizes that his hospital may be different from Memorial in its expectations but he believes that Respondent followed Memorial's policy in accepting the report of a nurse as to the results of the pregnancy test. Dr. Cowen's opinion relies upon the factual predicate that Respondent was told by a nurse that the pregnancy test was negative, to the extent that is not true, and it has not been found as a fact, his opinion is without foundation. Further, Dr. Cowen believes that in the setting where surgery is being performed in other than an emergency, it is a sufficient practice to rely upon an oral report of a nurse concerning laboratory results, such as the outcome in the pregnancy test for Patient T.D. In his experience he has relied upon nurses to report both in an emergent and non-emergent settings. He goes on to describe how those reports come back to the medical records and the physician signs off, which did not occur in this case. Dr. Cowen was asked to express his opinion about the value of an examination under anesthesia as an assist to understanding the underlying condition of the Patient T.D. Dr. Cowen does not believe that this would provide additional information. In his experience most physicians have abandoned examinations under anesthesia. If a better insight is needed an ultrasound is the best choice. To Dr. Cowen, an examination under anesthesia does not relate to standard of care, it is in relation to an individual practitioner's protocol. An ultrasound used in this case, a transvaginal ultrasound, may have shown the gestational sack at the time of the hysterectomy but proceeding on the basis that a negative pregnancy test had been established and other findings during the course of the operation, as well as the preoperative record, would not indicate the necessity for an ultrasound in this case, at that time, the place in time where the hysterectomy was being performed. Dr. Cowen did not find anything in the intra-operative findings that would suggest to Respondent that the Patient T.D. was pregnant. Overall Dr. Cowen believes that Respondent met the standard of care in addressing the case of Patient T.D., who probably had polycystic ovarian disease, irregular cycles, was without a sexual partner by history, used condoms for contraception, had an ultrasound that confirmed a slightly enlarged uterus and had symptoms compatible with adenomyosis or endometriosis. Respondent discussed the treatment options, made an appropriate pre-operative evaluation, learned that the lab results for pregnancy were negative (an erroneous assumption), and therefore, he met the standard of care, according to Dr. Cowen. Ultimately, Dr. Cowen believes that it is essential to determine whether a patient is pregnant prior to performing a non-emergent/elective hysterectomy, which was not done here. Wyatt McNeill, M.D., testified. He is an ob/gyn practicing in Jacksonville, Florida, who in the past has had privileges at Memorial. He has performed hysterectomies at that facility. Dr. McNeill graduated from Florida State University. He graduated from the University of Miami Medical School. He is licensed in the state of Florida and is board-certified in ob/gyn. Dr. McNeill is familiar with the standard of care in relation to preoperative laboratory work done before a hysterectomy. Dr. McNeill is familiar with the standard of care applicable to Respondent in the evaluation of Patient T.D. for hysterectomy, knowing after the fact that the patient was found to be pregnant. To familiarize himself with the facts of this case, Dr. McNeill examined the hospital records of Memorial, Respondent's office records, various depositions, to include that of Dr. Cortes and the anesthesiologist and pathologist, before providing testimony. He also examined the testimony of the nurses involved in the care before offering his opinions. Concerning the patient history, objective and subjective evidence available, Dr. McNeill did not believe that there was anything to suggest that Patient T.D. was pregnant. In particular, Dr. McNeill comments on the history and physical done by Respondent, counseling, laboratory evaluation, and the decision beyond that to proceed with the surgery. Dr. McNeill found the ultrasound results consistent with a patient, who by history had a previous child and had the complaints expressed in the report concerning the September 26, 2003, visit with Respondent. Nothing in the ultrasound results compared to the findings in the operative report indicated to Dr. McNeill that the patient needed to be examined under anesthesia. The use of the examination under anesthesia is a training regimne for residents and students, in his experience. It has no utility beyond that application, in Dr. McNeill's opinion. Dr. McNeill believes that an oral report of the results of the pregnancy test meets the standard of care. As with others, Dr. McNeill assumes that Respondent was told the test results, which is not found. There was no further duty by Respondent to investigate those results having been told. In Dr. McNeill's opinion, the test results are either positive or negative, they are highly accurate. A negative test result means that the patient is not pregnant. No further duty is established beyond that realization, according to Dr. McNeill. In summary, there is no disagreement among the experts that Respondent is expected to ascertain the results of the preoperative pregnancy test before performing the hysterectomy and it would be inappropriate to perform the hysterectomy without those results. Respondent does not disagree with that perception. Conceptually, having considered the testimony of Respondent and the experts, it would be acceptable to proceed on an oral report, if one had been made, a report that the pregnancy test was negative.3/ Otherwise, the physical examination of the patient prior to surgery, the results of the ultrasound, and the observations intra-operatively made by Respondent did not indicate that the patient was pregnant. There was no necessity to make an examination under anesthesia. Even if made, it would not necessarily lead to the conclusion that the patient was pregnant, taking into account other information known by Respondent. Mitigation/Aggravation The outcome here was that the patient underwent a hysterectomy when she was pregnant, an adverse result. There is no indication that Respondent has ever been disciplined in Florida or other jurisdictions while practicing medicine.
Recommendation Based upon the findings of facts found and the conclusions, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes (2003), and imposing an administrative fine of $10,000.00, requiring Respondent to take a course on Risk Management for physicians, and issuing a letter of reprimand. DONE AND ENTERED this 22nd day of June, 2007, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS 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 22nd day of June, 2007.
Findings Of Fact Respondent Anila Poonai began her medical education in her native land, India, and, in 1960, she received a medical degree from Bombay University. After an internship in Bombay, she spent three months in training in the United Kingdom, before travelling to Georgetown, Guyana, to become a resident medical officer at the public hospital there. After two years in Guyana, she returned to England where, in 1964, she passed a post-graduate examination. As a result of a residency in obstetrics and gynecology and a satisfactory showing on the requisite examinations, she became a member, in 1969, of the Royal College of Obstetrics and Gynecology. All told, respondent has spent six years as a resident in obstetrics and gynecology. From England, she travelled to the University of the West Indies in Kingston, Jamaica. At the University of the West Indies, she was senior registrar in obstetrics and gynecology and, for six months, acting lecturer in obstetrics and gynecology. In 1973, she and her husband, who is a general surgeon, moved to Cleveland, Ohio. Respondent has not sought certification by the American College of Obstetrics and Gynecology. She testified that the American College of Obstetrics and Gynecology recognized her membership in the Royal College of Obstetrics and Gynecology as an equivalent certification. Until moving to Port St. Joe, she worked as a house physician in St. Alexis and Hillcrest hospitals in Cleveland. Respondent and her husband moved to Florida at the invitation of the Board of Trustees of the Municipal Hospital of Port St. Joe. The Board wanted to upgrade the Hospital. Almost from the time of their arrival, respondent and her husband found themselves at the center of controversy. Respondent's husband testified that, when he and respondent began work at the Municipal Hospital of Port St. Joe, in August of 1976, norms of practice at the Hospital were "miles below standard" and that the medicine practiced by other physicians in the community was "about 25 years" out of date. Whether true or false, this view, and its blunt articulation, may account for the friction respondent and her husband experienced in their relationships with some of the nurses and physicians with whom they came into contact. Being the only such specialist on the staff, respondent was named chief of obstetrics and gynecology at the Municipal Hospital of Port St. Joe. In this capacity, she ordered drugs and other obstetric and gynecologic supplies for the Hospital. Chief of staff at the Hospital, from 1961, until the spring of 1977, was John Wayne Hendrix, who has practiced medicine in Port St. Joe for some three decades. During Dr. Hendrix' tenure as chief of staff, Dr. Orr of Wewahitchka, a general practitioner, was granted "courtesy privileges" at the Municipal Hospital of Port St. Joe. At all pertinent times, Hospital bylaws forbade a physician to whom only courtesy privileges had been granted, to attend a delivery, except under the supervision of the chief of obstetrics and gynecology. On March 27, 1977, in violation of the Hospital's bylaws, Dr. Orr attempted, for the first and only time, to deliver a baby in the Municipal Hospital of Port St. Joe. When Gloria Pippin, R.N., arrived to begin the 3 to 11 shift, Dr. Orr's patient was already in labor. At 9:30 that night, the patient's cervix was fully dilated; at 9:45 she was taken to the delivery room. At 11:00 Dr. Orr "did a saddle block," i.e., he administered a spinal anesthetic. Five minutes later he had finished an episiotomy. At quarter past eleven, he used Tucker-McClain forceps in an effort to extract the baby. That failing, he tried long Simpson forcens at 11:25 and Kielland forceps at ten minutes before midnight, March 27, 1977. The baby's head was too big for the mother's pelvis. Five minutes later, Ms. Pippin telephoned respondent, at Dr. Orr's request. Respondent expressed dismay that Dr. Orr had been permitted to begin, and asked Ms. Pippin to notify Dr. Hendrix of the situation. She herself telephoned Gerald Sullivan, the chairman of the Hospital's Board of Trustees. Afterwards, she and her husband, Dr. Parmanand Vijay Poonai, went to the Hospital. They arrived at approximately 12:40. Dr. Hendrix, who had considerable experience in performing Ceasarean sections, preceded them to the Hospital. By the time the Drs. Poonai reached the hospital, arrangements had been made for Dr. Orr's patient to be transferred to Panama City's Bay Memorial Hospital. At quarter past midnight, when Dr. Hendrix arrived at the hospital, the mother's blood pressure was 134/78. Ten minutes before she left in the ambulance, her blood pressure was 137/98 and her pulse was 112. At that time, the fetal pulse was 156. At 1:20 a.m., an ambulance left the Municipal Hospital of Port St. Joe for Panama City. When they reached Bay Memorial Hospital, the mother's vital signs and the infant's heart beat were within normal limits. Dr. Stephen Smith, the obstetrician who performed a Caesarean section upon the patient's arrival in Panama City, was the man of the hour. Mother and baby did well. For many years, it has been common to send women in labor to Panama City from Port St. Joe, and hundreds have made the trip. It takes a half hour to an hour to drive from the Port St. Joe hospital to the Panama City hospital. The longer a woman in the condition Dr. Orr's patient was in continues in labor, the greater are the chances of injury or death to the fetus and even to the mother. At no time did Dr. Hendrix telephone respondent on the night of the 27th or morning of the 28th. Neither Dr. Hendrix nor Dr. Orr ever asked respondent for assistance with Dr. Orr's patient. When respondent and her husband arrived at the Hospital early on the morning of March 28, 1977, neither Dr. Hendrix nor Dr. Orr spoke to either of them. Dr. Hendrix refused to speak to them, even though respondent addressed him and asked him specifically about Dr. Orr's patient. Both respondent and her husband remained at the Hospital until after the ambulance left for Panama City. It is unethical for one physician to intervene in the care of a patient whose treatment is being actively managed by another physician, unless requested. It may also be dangerous. On January 16, 1978, Dr. P. V. Poonai saw Beverly R. Bass in his office. Ms. Bass, who was born on December 15, 1951, told Dr. P. V. Poonai that a Dr. Vasquez of Port St. Joe (of whose wife Ms. Bass was a cousin) and other physicians had recommended a hysterectomy; that she had been passing blood clots for the preceding four months; that she had epigastric pain; that her most recent menstrual period was December 19, 1977; that she had two daughters and a son by three different men; that she wanted no more children; and that she wanted a hysterectomy both to prevent conception and to stop her bleeding. After examining her and finding an ovarian cyst and a slightly bulky uterus, Dr. P. V. Poonai prescribed hospitalization for a series of gastrointestinal X-rays to investigate the possibility of an ulcer, and for an obstetric and gynecologic consultation with respondent. On January 18, 1978, Ms. Bass entered the Municipal Hospital of Port St. Joe. An electrocardiogram was done. Dr. J. B. Harbison prepared a report of the X-rays taken as prescribed by Dr. P. V. Poonai. Respondent met Ms. Bass for the first time, in the Hospital, on January 19, 1978. She took Ms. Bass' history and examined her under general anesthesia, finding a left ovarian cyst, a normal cervix and a bulky anteverted uterus. Respondent recommended a dilatation and curettage (d & c) for diagnostic and therapeutic purposes, and, on the same day, Ms. Bass signed a form consent to diagnostic and treatment procedures authorizing respondent to perform a d & c. The following day, January 20, 1978, respondent did perform a routine d & c. Afterwards, the curettings resulting from the procedure were transmitted to a pathologist. After examining this material, the pathologist prepared a tissue report, and stated, as the pathological diagnosis: SECRETORY PHASE, DYSFUNCTIONAL BLEEDING. NO EVIDENCE OF POLYPS, PREGNANCY OR MALIGNANCY OBSERVED IN THE SPECIMEN SUBMITTED. FRAGMENT OF ENDOCERVIX WITH SQUAMOUS METAPLASIA, ACUTE AND CHRONIC INFLAMATION. Petitioner's exhibit No. 2. On January 21, 1978, Ms. Bass left the hospital, with a final diagnosis of dysfunctional bleeding. Before discharging Ms. Bass, respondent instructed her to refrain from sexual intercourse and from douches for four to six weeks. Eight to ten days after her discharge, Ms. Bass resumed sexual intercourse. On February 2, 1978, respondent saw Ms. Bass at her office and discussed the pathologist's tissue report with her. She related to Ms. Bass her clinical impression of uterine fibroids and prescribed Orthonovum, a birth control pill, as an additional means of forestalling dysfunctional bleeding. On February 2, Ms. Bass reported no bleeding subsequent to the d & c. Respondent did not ask and Ms. Bass did not volunteer that she had failed to follow instructions to abstain from sexual intercourse. Although the birth control pills respondent prescribed were to be taken daily, Ms. Bass did not take one every day. Respondent next saw Ms. Bass on February 13, 1978, when her only complaint was of an upper respiratory tract infection. On March 4, 1978, Ms. Bass returned to respondent's office complaining of heavy breakthrough bleeding, and reported that she was passing blood clots. Respondent examined her and suggested a hysterectomy. Ms. Bass asked if she could enter the hospital on March 12, 1978, saying she could make arrangements for her children by then. Respondent administered no pregnancy test to Ms. Bass on March 4, 1978, or at any time thereafter. She thought none was necessary because she believed that Ms. Bass had followed her instructions. Respondent does not knowingly perform abortions, even for therapeutic purposes, on account of religious scruples. A d & c elicits inflamatory responses hostile to fertilization. Even when a pregnancy has begun, no pregnancy test will be positive before 41 days have elapsed since the last menstrual period. Some hospitals, like Jackson Memorial in Miami, require pregnancy tests before surgery as a matter of routine, but the Municipal Hospital of Port St. Joe had no such policy. On March 12, 1978, Ms. Bass was admitted to the Municipal Hospital of Port St. Joe. The following day respondent performed a hysterectomy and an incidental appendectomy. An appendectomy ordinarily accompanies this procedure. Respondent's pre-operative diagnosis was "menorrhagia and fibroid uterus," and her postoperative diagnosis, on March 13, 1978, was unchanged. This was the same condition specified on the form consent to diagnostic and treatment procedures which Ms. Bass signed on March 12, 1978, authorizing respondent to perform a hysterectomy. Ordinarily, a surgeon performing a hysterectomy removes the uterus intact, as respondent did in the case of Beverly Bass. After its removal but while still intact, Ms. Bass' uterus yielded no additional information pertinent to the diagnosis of her condition. The uterus was sent to a pathologist. After examining the uterus, the pathologist prepared a tissue report and stated, as the pathological diagnosis: APPENDIX WITH FIBROUS OBLITERATION (DISTAL) AND FOCAL FIBROUS ADHESIONS. LUTEAL CYST OF LEFT OVARY, BENIGN. PARATUBAL CYST, BENIGN, RIGHT. ENLARGED UTERUS (205 GMS) WITH: ENDOMETRIUM: CHANGES RELATED TO PREGNANCY (HYPERSECRETORY GLANDS AND DECIDUAL REACTION). ACUTE ENDOMETRITIS. ANGULAR IMPLANT OF PLACENTA ASSOCIATED WITH UNDERLYING NECROSIS AND ACUTE INFLAMMATION OF DECIDUA, ACCOMPANIED BY HEMATOMAS. CHORION-AMNIONITIS, ACUTE, NECROTISING ASSOCIATED WITH NECROSIS OF GROUPS OF CHORION VILLI. EMBRYO, APPROXIMATELY 4-6 WEEKS OLD. FLUID BLOOD PRESENT IN UTERINE CAVITY. MYOMETRIUM: HYPERTROPHY (FUNCTIONAL). CERVIX: ACUTE AND CHRONIC CERVICITIS ASSOCIATED WITH SQUAMOUS METAPLASIA OF THE ENDOCERVICAL LINING, FOCAL. SQUAMOUS CELL HYPERPLASIA OF ECTOCERVIX, BENIGN. MUCUS CYSTS. When the pathologist opened the uterus, he found an enlarged cavity partly occupied by a ruptured ovisac. Extruded through the perforation, hanging outside of the ovisac from the umbilical cord, was an embryo 1.8 centimeters long. The placenta, which was acutely inflamed, adhered to the fundus at a right angle. Uterine rupture is inevitable if an angular pregnancy continues, but it is possible for an angular pregnancy to go to term, just as it is possible for a fetus to live after the ovisac has burst. In Ms. Bass' case, however, the embryo was probably non-viable at the time of the hysterectomy. The pathologist's report arrived while Ms. Bass was still in the hospital. Because respondent was upset on reading it, she asked Dr. P. V. Poonai to tell Ms. Bass what the pathologist had learned. Dr. P. V. Poonai did tell Ms. Bass, at which time she confirmed that she had engaged in sexual intercourse shortly after the d & c. Confusing an incipient pregnancy with a fibroid uterus is an occasional mistake any physician could make. An isolated mistake of this kind does not constitute a deviation from acceptable medical practice. The most conservative approach is to wait for two months after the patient has stopped taking birth control pills, before performing a "semi-elective" procedure, and to administer a pregnancy test beforehand. Several physicians testified, however, that they would not have ordered a pregnancy test before performing a hysterectomy in the circumstances of Ms. Bass' case. Respondent did not prepare the summary sheet at the end of Ms. Bass' stay after her March 12, 1978, admission, Chart No. 23622. Petitioner's exhibit No. 2A. The summary sheet that was prepared is not signed by anybody. When respondent asked for the chart in order to prepare a summary sheet, the Hospital's records custodian advised her that it was not with the other charts. When Beverly D. Stover was about three and a half months pregnant, she began seeing respondent. She saw her every month until November, when she began seeing her every two weeks. On her first visit, she told respondent she wanted to be sterilized after the birth of the child she was carrying, her second. At respondent's request, Mrs. Stover brought her husband to respondent's office, about six weeks before the baby was born. The three of them discussed Mrs. Stover's planned sterilization. On November 22, 1977, both Mr. and Mrs. Stover signed a form request for sterilization witnessed by two persons who were not called to testify at the hearing. On November 30, 1977, Mrs. Stover was admitted to the Municipal Hospital of Port St. Joe. On the day of her admission, she signed a form consent to diagnostic and treatment procedures authorizing respondent to perform a bilateral tubal transection and ligation, and both she and her husband signed another form request for sterilization. At the time of the signing of the last two documents, Mrs. Stover told Sarah Maddux, the nurse who gave her the forms to sign, that she did not want to be sterilized unless her baby was normal. Ms. Maddux never relayed this oral reservation to respondent. It is impossible to tell, at the time of birth, whether an infant has a sense of smell, whether it is intellectually impaired, or whether it can see or hear. At 1:50 on the afternoon of November 30, 1977, Mrs. Stover was delivered of a daughter, Katrina. Respondent examined the eight pound two ounce infant for two minutes. She put her fingers in the infant's mouth, cleared a passage for air, and checked for a cleft palate. The child started crying. Respondent observed good muscle tone. Respondent clamped, then cut the umbilical cord. She inspected the baby all over, noticed puffiness on the child's back, which she attributed to the trauma of birth, and noticed that the baby's anal opening was smaller than normal, but was not alarmed. She thought she had seen even smaller such openings which had not affected function. Respondent placed Katrina on her mother's stomach, and asked Mrs. Stover whether she was ready for surgery. When Mrs. Stover answered affirmatively, at 1:55, anesthesia was administered, at respondent's direction. A nurse took the baby from respondent for cleaning. In contemporaneous notes, the nurse described the baby as apparently normal. In fact, Katrina had an imperforate anus or anoperitoneal fistula, and a lipoma on the sacral area of her back. These conditions were discovered a few hours later by a nurse in the Hospital nursery. The nurse brought both problems to the attention of Dr. Shirley R. Simpson, a physician who had been on the staff of the Municipal Hospital of Port St. Joe for approximately ten years and who happened to be in the Hospital at the time. Respondent had left Port St. Joe to meet her husband at the airport in Panama City. Examining Katrina at the nurse's request, Dr. Simpson mistook the lipoma for a meningomyocele. Dr. Simpson took no further action in the case, other than leaving word with the nurse for respondent to call her, until she furnished the Board of Medical Examiners Katrina's hospital chart. By that time, somebody had forged an entry in the nurse's notes for 1:50 P.M. on November 30, 1977, viz., "Appears to have NO rectal orifice-Dr. A. Poonai notified." Petitioner's exhibit No. 4. After her return from Panama City, on December 1, 1977, respondent correctly diagnosed the lipoma. At respondent's request, Dr. P. V. Poonai examined Katrina. After obtaining consent, Dr. P. V. Poonai, used surgical implements, when the baby was 16 hours old, to remove the obstruction which had prevented the expulsion of all but the merest drop of meconium during the first 16 hours of the baby's life. Although this emergency procedure solved the immediate problem and allowed the baby to defecate, further surgery has been necessary to move the anal opening to its norman site posterior of the dimple where Dr. P. V. Poonai made his incision. An imperforate anus occurs once in 5,000 births. The imperforation may or may not be visible, depending on its location. In the past five years, three infants with this problem have been born in Panama City. In each instance, the examining pediatrician did not discover the imperforation, which came to light some hours after birth, on account of the baby's failure to expel its first stool. In Katrina's case, however, the abnormality could be seen and its existence could be confirmed by an attempt to probe. The lipoma on Katrina's back measured less than four by five centimeters in area. It was a soft, skin-colored mass of benign, fatty tissue, which a pediatric surgeon has since removed. The trauma of birth sometimes causes edemas that resemble lipomas. No harm befell Katrina as a result of respondent's failure to diagnose either her lipoma or her anal abnormality at birth. Beverly Stover continued as a patient of respondent for some time after Katrina's birth. Respondent first saw a certain patient on September 19, 1977. This patient, who was born on June 1, 1907, suffered from diabetes mellitus and congestive heart failure, among other things. Two months earlier she had had a second pacemaker inserted. On her first visit to respondent, the patient complained of pain in her chest and of dysuria. She said she had difficulty retaining urine, but that she was unable to empty her bladder completely. In examining her, respondent discovered a moderate cystocele, which is a herniation of the bladder into the vagina. Respondent admitted her into the Municipal Hospital of Port St. Joe for treatment of her congestive heart failure, the cause of the chest pain. Congestive heart failure is not a disease of which people are cured, but it is a condition that may grow better or worse. When this patient's condition improved, respondent sent her home. Respondent saw her again in her office on October 3, 1977, when she complained of paroxysmal dyspnea and swollen feet. Respondent diagnosed superimposed congestive cardiac failure and prescribed a diuretic. On November 18, 1977, respondent admitted her to the hospital because symptoms like those she had complained of during the office visit persisted. On November 22, 1977, she was discharged. A similar episode resulted in rehospitalization from January 10, 1978, through January 19, 1978. The patient entered the hospital again, on February 12, 1978, with congestive cardiac failure. She complained about nocturnal incontinence and asked respondent to correct her bladder problem. At this time, respondent described the cystocele as large. After medical care which petitioner's own witness described as excellent, the patient's condition stabilized. Respondent testified that, in her judgment, the patient's general condition just before surgery was as good as it was likely ever to be. Nine days after she admitted the patient, respondent effected a repair of the cystocele by performing an anterior colporrhapy under local anesthetic. This procedure requires unusual surgical skill, and most surgeons do not attempt it. The repair of a cystocele is a therapeutic measure. In the absence of treatment, urine is likely to stagnate in the herniated portion of the bladder, and become a source of possibly serious infections. All surgical techniques for repairing cystoceles, other than the one employed by respondent, require general anesthesia. The risk from anesthesia to which respondent's patient was subjected was very moderate compared to the risk from general anesthesia. It was the same risk a person faces whose mouth is numbed by local anesthesia before a tooth is filled. Respondent had performed this operation 20 or 30 times before, and had performed it on her own mother, who was 75 years old and suffered from myocardial ischemia at the time. Sometimes, although decreasingly in recent years, a physician may employ a pessary as treatment for a cystocele. A pessary is a rubber or plastic solid that can be inserted in the vagina as a support for the intruding bladder. This is only a temporary measure, however, and involves a high risk of infection, which is the principal danger the cystocele itself poses. Respondent testified that her prescription for temporary relief was bed rest, since lying flat relieves the pressure that forces part of the bladder into the vagina. Respondent first saw another patient, the 29 year old mother of three children, on December 23, 1976. This patient was in the Municipal Hospital of Port St. Joe at the time, for a hemorrhoidectomy, and respondent was called in because the patient had complained of profuse, irregular and painful vaginal bleeding over a period of several years, and particularly during the preceding nine months to a year. The patient was anemic, according to tests run two days earlier. In July of 1976, the patient had been hospitalized on account of pelvic sepsis and bleeding. At that time, Dr. Simpson told her she would need a hysterectomy in the near future. She had been hospitalized for the same reasons in 1975. Respondent ordered a pap smear and an X-ray to locate a coil that had been inserted into the patient's uterus, as a contraceptive measure. When she recovered from the hemorrhoidectomy, the patient was discharged. After three weeks of severe menorrhagia, including two final days of heavy clotting, the patient was readmitted, on January 24, 1977, to the Municipal Hospital of Port St. Joe. Respondent had earlier prescribed iron pills. Perhaps as a result, the patient was no longer anemic. Respondent observed the patient's uterus "enlarged to about 10 weeks size with [what she thought was] fibroids. Petitioner's exhibit No. 6. Respondent ordered no pregnancy test. When an intrauterine device is in place, excessive vaginal bleeding is inconsistent with a viable pregnancy. An intrauterine device not only irritates the wall of the uterus, making conception unlikely, but also operates to abort incipient pregnancies, in the event of conception. With the intrauterine device still in place, on January 26, 1977, respondent performed a total abdominal hysterectomy and an incidental appendectomy, with conservation of both ovaries. Afterwards, the appendix, part of the cervix, and the uterus were sent to a pathologist. The pathologist examined these materials, and, on January 31, 1977, prepared a tissue report, in which he stated as the pathological diagnosis: APPENDIX WITH SEROSAL FIBROSIS, FOCAL (INCIDENTAL). ENDOMETRIUM: DECIDUA WITH EXTENSIVE NECROSIS ASSOCIATED WITH CHORIONIC VILLI (PREGNANCY) WHICH ARE LARGELY NON-VIABLE. SECRETORY ENDOMETRIUM WITH ACUTE AND CHRONIC ENDOMETRITIS. MYOMETRIUM: HYPERTROPHY, POSTERIOR. CERVIX: CHRONIC ENDOCERVICITIS AND MUCUS CYSTS. SLIGHTLY HYPERTROPHIC UTERUS (95 GRAMS). The pathologist found no evidence of fibroids. This demonstrates that respordent's clinical diagnosis of fibroids was inaccurate. One of the pathologists who routinely examined tissue removed by surgeons in the Municipal Hospital of Port St. Joe, Dr. Garcia-Rios, also routinely examined tissue removed by surgeons in other hospitals. Whenever a tissue report indicated disagreement between a clinical diagnosis and the pathological diagnosis, Dr. Garcia-Rios designated the tissue report "Code 3." The frequency of Code 3 tissue reports did not differ as between specimens removed by respondent and specimens Dr. Garcia-Rios examined which had been removed by other surgeons, taken as a group. From the presence of morphologically viable chorionic villi, the pathologist concluded that the patient had been pregnant. From pathological findings alone, he was unable to determine whether the pregnancy had terminated weeks or months earlier; or whether an ongoing microscopic pregnancy was interrupted by the hysterectomy. (Clinical evidence-excessive bleeding-ruled out the possibility of a viable pregnancy.) The pathologist's findings were consistent with, but did not conclusively establish the existence of, a placental polyp. Placental polyps may cause prolonged bleeding. Before surgery, respondent discussed three options with this patient: removal of the intrauterine device, removal of the intrauterine device followed by a d & c, and hysterectomy. The patient said that the presence or absence of an intrauterine device had made no difference in her bleeding problem in the past. She also told respondent that she wanted no more children, and that she wanted prompt, definitive treatment for her bleeding. After listening to explanations from respondent about the available options, the patient chose a hysterectomy. Respondent did not tell her that a hysterectomy was the only way to correct her problem. The patient testified that she has had no problems since her surgery; and that, knowing what the pathologist's tissue report subsequently revealed, she would make the same choice again, at least if it would not involve her as a witness in legal proceedings. Respondent initialled a summary sheet in the patient's chart, which stated the patient's final diagnosis as, inter alia, "FIBROID UTERUS [and] MENORRHAGIA." This final diagnosis fails to take the pathologist's tissue report into account, even though the tissue report routinely becomes part of the chart and presumably was available to respondent at the time she initialled the summary sheet. Respondent testified that she initialled this summary sheet as one of a group of documents, and that she did not read it beforehand. Any discrepancy between the tissue report and the final diagnosis would have been apparent to a knowledgeable reader. Without the tissue report, respondent would not necessarily have known that the pathologist's findings had demonstrated the error of her diagnosis of fibroid uterus. After controversy about this case arose, respondent caused an addendum to be prepared and incorporated into the chart, on August 16, 1978, and amended the discharge diagnosis to state, inter alia: "Menorrhagia, Chronic endometritis [and] Hypertrophy of the myometrium." This diagnosis is consistent both with respondent's clinical findings and with the pathologist's tissue report. In stating her amended discharge diagnosis, respondent took the tissue report, which had been incorporated into the chart, into account. This amended discharge diagnosis was not shown to be erroneous. On August 11, 1976, respondent saw Linda Whitfield for the first time. She came as a patient to respondent's office and related that her last menstrual period had taken place on June 26, 1976. Respondent examined her, observed a uterus of six weeks' size, and diagnosed early pregnancy. Respondent next saw Mrs. Whitfield in the emergency room of the Municipal Hospital of Port St. Joe on August 27, 1976, when her uterus looked to be of eight weeks' size. There Mrs. Whitfield told respondent that, while driving a tractor earlier in the day, she had experienced abdominal cramps and fairly heavy bleeding. Mrs. Whitfield did not report and respondent did not observe the passage of a fetus. Respondent diagnosed a threatened abortion (miscarriage) admitted Mrs. Whitfield to the Hospital, ordered bed rest, ordered that Mrs. Whitfield's urine be tested for the presence of chorionic gonadotropin, and prescribed an intramuscular injection of two cubic centimeters (cc.) of Depo-Provera (Upjohn's registered trademark for sterile medroxyprogesterone acetate suspension, U.S.P.). Although respondent did not specify the strength, she had ordered the Hospital's entire supply of Depo-Provera, and knew that the only strength on hand was 100 milligrams per milliliter. Depo-Provera is a synthetic progestational agent in an oily base. It has been commercially available for approximately 15 years. The 1971 Physicians' Desk Reference (PDR) reported that daily doses were indicated in the event of a threatened miscarriage. The 1972 PDR reported pregnancy as a contraindication for the use of Depo-Provera. (In 1972, respondent lived in Jamacia.) The 1976 PDR and the 1977 PDR, however, contain neither indications nor contraindications for Depo-Provera, in the event of pregnancy. The 1979 PDR reports pregnancy as a contraindication for the use of Depo-Provera. The phrase "missed abortion" describes the situation where a non- viable fetus remains in its mother's uterus. "Missed abortion" was named as a contraindication for Depo-Provera in the literature that accompanied each vial of Depo-Provera, at the time respondent prescribed it for Mrs. Whitfield. The contraindication of Depo-Provera for missed abortion reflected the view, generally shared in the medical community for many years but now rejected, that Depo-Provera acts to prevent uterine contractions and so make fetal expulsion less likely. The only indication stated in the literature that accompanied each vial of Depo-Provera, at the time respondent prescribed it for Mrs. Whitfield, was "[a]djunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial carcinoma." Petitioner's exhibit No. 12B. Also on petitioner's exhibit No. 12B, under the heading "ADVERSE REACTIONS," is the statement: There is inferential evidence supporting the existence of an association between the administration of progestins early in pregnancy and the occurence of congenital malformations (see also WARNINGS). The referenced warning stated that "[u]sage in pregnancy is not recommended because of data indicating a possible association between administration of progestins early in pregnancy and congenital heart defects in the offspring." Petitioner's exhibit No. 12B. Mrs. Whitfield bled, off and on, during her first stay in the Hospital under respondent's care, until two or three days before her discharge. Because Mrs. Whitfield was bleeding on August 28, 1976, respondent prescribed an intra- muscular injection of one cc. of Depo-Provera. Altogether, respondent prescribed 1100 milligrams of Depo-Provera for Mrs. Whitfield over a 16 day period. She ordered administrations of two cc. doses of Depo-Provera on September 2, 1976, on September 4, 1976, on September 7, 1976, and on September 11, 1976, the day Mrs. Whitfield was discharged. At that time, respondent was hopeful that the pregnancy had been saved. At the time respondent prescribed Depo-Provera for Mrs. Whitfield, she believed she was aware of the inferential evidence referred to in the adverse reaction portion of petitioner's exhibit No. 12B. The evidence of which respondent was aware was the result of a retrospective study involving 10,000 mothers who took various hormonal substances during pregnancy and 10,000 mothers who did not. The number of deformed children born to mothers who had taken the hormonal substances exceeded by two percent the number of deformed children born to the mothers who had not. At the time she prescribed Depo-Provera for Mrs. Whitfield, respondent was one of a considerable number of physicians who believed that this drug could supply a hormonal deficiency that a woman faced with a threatened abortion (miscarriage) might lack, and which might be causing premature uterine contractions. Respondent weighed Depo-Provera's possibly teratogenic effect against its possibly ameliorative effect and made a conscientious professional judgment to prescribe Depo-Provera for Mrs. Whitfield. The 1971 PDR specifies a dosage of 50 milligrams day for threatened abortion, as long as symptoms persist. No dosages for threatened abortion are specified in the 1976 PDR, the 1977 PDR or on petitioner's exhibit No. 12B, the literature that accompanied each vial of Depo-Provera. When used to treat "inoperable, recurrent and metastatic endometrial carcinoma," Depo-Provera is prescribed in doses of 100 to 1000 milligrams at intervals of one week to one month. No evidence adduced at the hearing suggested that Depo-Provera has any known or suspected toxic effect on the mother, regardless of the dosage. Nor was it shown to have been scientifically established that Depo-Provera has had an adverse effect on any fetus, when administered to the mother, regardless of the dosage. It is no longer used in the case of threatened miscarriages because recent evidence suggests that it is inefficacious for this purpose. Outside of the United States, Depo-Provera is used as a contraceptive. While Mrs. Whitfield was in the Hospital, on August 29, 1976, respondent ordered a blood serum test to determine the level of chorionic gonadotropin. The results of this test, which respondent saw for the first time on September 16, 1976, were 6,554 milliunits of chorionic gonadotropine per milligram of test fluid. On September 16, 1976, Mrs. Whitfield came to respondent's office and complained of additional bleeding. At that time, a two minute slide test for pregnancy was performed, with negative results. Respondent examined Mrs. Whitfield and concluded that her pregnancy had miscarried despite the efforts to preserve it. She was admitted to the Municipal Hospital of Port St. Joe on September 17, 1976, with the diagnosis of "incomplete abortion," which was changed to "missed abortion," as the pre-operative diagnosis. On the day of her admission, additional pregnancy tests were ordered. A two minute test was negative, but a two hour test was positive. Every pregnancy test is fallible to some extent. These test results did not alter respondent's clinical judgment that the pregnancy had miscarried. A pregnancy test of a urine specimen can yield positive results from four days to two weeks after a pregnancy ends, and sometimes even later. It was undisputed that a result on a blood serum test for chorionic gonadotropin of 6,554 milliunits per milliliter virtually rules out a viable pregnancy of two or three months' duration, although the level may fall that low after the fifth month of a normal pregnancy. At eight to ten weeks, normal levels range from 46,000 to 60,000 milliunits per milliliter. Respondent performed a routine d & c on September 18, 1976. Fifteen grams of the resultant curettings were transmitted to a pathologist who reported "products of conception," but no embryo. Port St. Joe is not a prosperous town. At the time of the hearing, respondent and her husband were the only physicians in Port St. Joe who accepted patients on medicaid. Respondent has admitted patients approximately 500 times to the Municipal Hospital of Port St. Joe. During her time in Port St. Joe, respondent has treated numerous medicaid patients, and has delivered 249 babies. In one instance there was a neonatal fatality. This record compares favorably with a national average on the order of 12 neonatal fatalities per 1,000 births. Respondent has three articles in respectable technical journals to her credit, including two in "Obstetrics and Gynecology." On one she collaborated with her husband. They received 168 requests for reprints from interested persons in some 15 countries. The other article in "Obstetrics and Gynecology" she co-authored describes the first documented full-term pregnancy of a woman with diabetes mellitus, Addison's disease, and hyperthyroidism. The patient described in the article was under respondent's care for the duration of her pregnancy, which eventuated in a normal delivery.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner dismiss counts one, two, four, five and six of the administrative complaint. That petitioner reprimand respondent for her failure to diagnose the imperforation at the time of birth, in violation of Section 458.1201(1)(m), Florida Statutes (1978 Supp.), as alleged in count three of the administrative complaint. That, in all other respects, petitioner dismiss count three of the administrative complaint. DONE and ENTERED this 15th day of November, 1979, in Tallahassee, Florida. ROBERT T. BENTON, II Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 904/488-9675 COPIES FURNISHED: Clifford L. Davis, Esquire 197 South Bronough Street Tallahassee, Florida 32301 J. Ben Watkins, Esquire Post Office Drawer 1814 Tallahassee, Florida 32302 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE STATE OF FLORIDA DEPARTMENT OF PROFESSIONAL REGULATION BOARD OF MEDICAL EXAMINERS IN RE: The License to Practice Medicine as a Physician of: CASE NO. 79-1144 ANILA POONAI, M.D. License No. 27070 /
The Issue Whether Respondent's license as a physician should be disciplined for the alleged violations set forth in the Administrative Complaint.
Findings Of Fact Petitioner, Department of Health, Board of Medicine (Petitioner), is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes. Respondent, Santo S. Bifulco, M.D. (Respondent), is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued License Number ME 0056868 on February 13, 1990. He has been continuously licensed since February 1990 and has never been disciplined by the Board of Medicine. Respondent, a physiatrist, specializes in physical medicine and rehabilitation. He entered private practice immediately after completing a four-year residency program in physical medicine and rehabilitation. During his residency, Respondent learned and performed electrodiagnostic and neurodiagnostic tests. He was trained in the use of videofluoroscopy, electroencephalogram, needle and surface electromyography, nerve conduction studies, and other electrodiagnostic tests. Respondent performed far above the minimum 200 required for successful completion of the residency program. As a part of his residency, Respondent also had the opportunity to observe and work with chiropractic physicians from the local chiropractic medical school, thereby allowing him to understand the role of chiropractic care and allopathic medicine in the treatment of a patient. Respondent first saw E. C. on December 9, 1991. At the time, he had been practicing physical medicine and rehabilitation for a little more than a year since completion of his residency program. Prior to coming under the care of Respondent, E. C. had been involved in a motor vehicle accident on August 9, 1991. The patient had been treated by both her family physician, Dr. George Harris, and her chiropractic physician, Dr. Richard Thomas, D.C., for the injuries which resulted from the accident. Dr. Harris prescribed medications for E. C. and Dr. Thomas provided and was continuing to provide several modalities for E. C.'s injuries resulting from her motor vehicle accident. Despite ongoing treatment by Dr. Thomas, E. C. was not significantly improving. Because E. C. was not improving under his care, Dr. Thomas referred her to Respondent. The purpose of the referral was for consultation and a second opinion. Respondent was also asked to determine what, if any, medications should be given to the patient and to provide them to the patient if it were appropriate. Respondent was not asked to nor did he assume direct primary care for the patient. Rather, Respondent's role was to provide Dr. Thomas with guidance as to the diagnosis and treatment direction for E. C. In his written report dated November 25, 1991, Dr. Thomas indicated that he was referring the patient to Respondent for further evaluation and for medication that might assist in the improvement of her symptoms. He noted that he would continue to provide palliative care to E. C. until such time as Respondent evaluated her and he had received Respondent's report and recommendation. When E. C. first came under Respondent's care, it was four months after the accident. However, her overall condition had not significantly improved. She had constant headaches, which were extreme and associated with dizziness, a history of high blood pressure, constant cervical pain radiating into her arms, thoracic pain or pain between the shoulder blades, numbness and tingling, and was limited in her physical activities. The pain was interfering with all aspects of her life, including her ability to work and sleep. Respondent performed a physical examination of E. C. on December 9, 1991. On physical examination, Respondent found that E. C.'s neck range of motion was markedly limited and associated with pain; that her lower back range of motion was markedly limited and associated with pain; and that she had positive findings on orthopedic examination, as well as, on neurologic examination. From Respondent’s examination, it appeared that E. C. had suffered injuries from the motor vehicle accident. Moreover, Respondent determined that E. C. was in need of continuing care and because she had not improved, was also in need of further diagnostic studies to evaluate the extent and nature of her injuries and her complaints. E. C. presented as a complicated case due to the length of time that had passed since the motor vehicle accident and the lingering and persistent complaints experienced by E. C. associated with that accident. Respondent’s impression was that E. C. had post- traumatic headaches and injuries to the soft tissues of the neck with radiating pain. Respondent believed that E. C. was involved in what is commonly known as a medical/legal case. Consistent with this belief, Respondent reasonably concluded that his role was to thoroughly evaluate E. C.'s condition by addressing and objectively documenting answers to the questions relative to the cause, extent, and nature of her injuries. Respondent obtained Dr. Thomas’ records to evaluate the care E. C. had been receiving and reviewed E. C.'s X-rays with her on her first visit. Based on his review of the records and his examination of E. C., Respondent believed that the care provided by Dr. Thomas was appropriate for E. C.'s condition and that she would benefit from continued conservative care. However, Respondent felt that for E. C. to reach her maximum potential, additional diagnostic tests could reasonably assist him in arriving at a diagnosis and recommendation for treatment of the patient’s condition. Respondent initially recommended that E. C. undergo diagnostic testing or studies including: nerve conduction studies; a Dermatomal Somatosensory Evoked Potential (DSEP); an electroencephalogram (EEG); a cervical Magnetic Resonance Imaging (MRI); and cinefluoroscopy or videofluoroscopy studies of the cervical spine. These tests were ordered and/or recommended because Respondent reasonably believed that they could assist him in determining the nature and extent of E. C.'s injuries and complaints and arriving at a recommendation for treatment. E. C. subsequently underwent the recommended testing. To assess the discs and other cervical soft tissues, Respondent recommended that E. C. receive imaging studies. Respondent recommended an MRI study of the cervical spine. This study was conducted on December 19, 1991, at the Access Imaging Center. The purpose of the MRI was to evaluate whether E. C. was suffering from a condition that could be treated by surgery. An MRI is a static exam and is the "gold standard" in looking for a herniated disc. E. C.'s MRI was normal, thus, ruling out the possibility of the need for surgical treatment of her condition. To assess ligamentous structures and capsular stability, Respondent also recommended that E. C. receive a videofluoroscopy of the cervical spine or dynamic motion studies. The videofluoroscopy was obtained on December 11, 1991, and was performed at the Tampa Bay Dynamic Imaging Center. The videofluoroscopy was the only test available to observe the movement of the cervical spine through a full range of motion versus the limited views obtained in extension and flexion X-rays, where the patient's neck is seen in a fully extended position, neutral position, and fully flexed position. In E. C.'s case, videofluoroscopy served to confirm the presence of a soft tissue injury. The videofluoroscopy exam revealed hypomobility of the cervical spine at the level of C5-6 and C6-7. This result was consistent with the extension and flexion X-rays of E. C. that had been taken while she was under Dr. Thomas' care. However, Respondent felt the videofluoroscopy was an appropriate diagnostic tool to determine if E. C. had deteriorated since her last exam or had greater instability than was thought to be present from review of the static flexion/extension films. The videofluoroscopy and the MRI allowed Respondent to determine the extent and nature of the patient’s injuries and make recommendations for continuing treatment to her primary physician, Dr. Thomas. Both imaging tests provided useful information in the diagnosis and treatment of the patient’s condition. E. C., who worked as a florist, was experiencing problems working, lifting, and performing many routine activities in her daily life. Because E. C. was not progressing in treatment, Respondent wanted an objective assessment of her strength and ability to lift. Respondent believed that this information would help guide E. C. and Dr. Thomas in advising the patient concerning what she should or should not be lifting. To accomplish this objective, Respondent ordered a N.I.O.S.H. lift test and a Range of Motion test. These tests were performed on December 19, 1991, in Respondent's office. The N.I.O.S.H. lift and Range of Motion tests are components of a battery of tests that make up what is commonly known as a functional capacity evaluation. A functional capacity evaluation is an extensive series of tests to determine a patient’s ability to return to work. By itself, a N.I.O.S.H. lift test is not a functional capacity evaluation and was never intended to be used in that manner by Respondent. Though E. C. had not significantly improved under Dr. Thomas' care, it appeared to Respondent that she had reached a plateau in that her condition was not improving. The N.I.O.S.H. test is appropriate when a patient like E. C. has reached a plateau in her care and is not progressing. It gives the physician information from which to base recommendations on the scope and nature of the activities in which the patient may participate. Furthermore, it helps the physician in designing a strengthening program appropriate to the patient’s physical limitations. It can also provide a baseline for future tests and serial evaluations of the patient’s progress. Respondent was unable to make use of the results from the N.I.O.S.H. test or obtain comparison tests because E. C. failed to return to his office after February 1992. To assess the presence or absence and the extent of any neurologic dysfunction in the upper extremities, Respondent recommended that the patient undergo nerve conduction studies. E. C. underwent those studies on December 30, 1991, in Respondent's office. The purpose of nerve conduction studies is to objectively evaluate peripheral nerve function. It is an average measure of the time it takes an electrical nerve impulse to travel down a segment of the nerve from the spinal column to a particular muscle group. It also includes a measure of the time it takes an electrical nerve impulse to travel from the point of stimulation up to the brain and back. Respondent’s use of nerve conduction studies to objectively look for pathology of the spine or peripheral nerves was warranted given her continued complaints and failure to improve after four months of conservative care. The nerve conduction studies were interpreted by Respondent as abnormal. However, many physicians would have interpreted the studies as normal because, in part, the latency was less than 30 and the difference was less than three milliseconds when compared to both sides. Nonetheless, it is also recognized that these interpretations are judgment calls by physicians based on several factors. To differentiate between problems with the peripheral nerves from those in the central nervous system, Respondent also recommended a DSEP of the upper extremities. This study was conducted on December 30, 1991, in Respondent's office. The DSEP was a companion exam to the nerve conduction studies and supplemented information learned from those studies. The combined exams assisted Respondent with localization of the source of the patient’s complaints and it was appropriate for the Respondent to have obtained both studies. In 1991, the use of the DSEP was relatively new, but it was a test that held out promise to physicians in helping them objectively quantify the functioning of nerves in all of their segments. Over time, it has been found that the DSEP does not provide any greater information than that gained by use of electromyography combined with imaging studies. However, in 1991, the thinking was different. In addition to the nerve conduction studies and the DSEP, Respondent recommended that E. C. undergo a standard awake or EEG. This test was performed on December 30, 1991, in Respondent's office. The purpose of the EEG was to evaluate the source of the patient’s continued complaints of headaches and of difficulty with sleeping. According to E. C., these problems had persisted for four months. The EEG was an inexpensive tool to evaluate whether E. C. was suffering from an intracranial bleed or from some other pathologic condition unrelated to her soft tissue injuries. Given the intensity and persistence of the headaches, Respondent felt that there was the possibility of trauma having gone undetected; he believed that such trauma could not be ruled out even though the patient had not related a history of having hit her head during the motor vehicle accident. The EEG came back as a normal study, thus, allowing Respondent to rule out more serious causes for the E. C.’s headaches. The results of the diagnostic tests allowed the Respondent to report to her primary treating physician his conclusions concerning the extent of the care to be provided, prescribe medications for E. C., identify the distribution of ligamentous instability, the etiology of her complaints, and her safe lifting capacities. It allowed him to rule out the possibilities of serious intracranial lesion and serious neurologic abnormalities. The data was suggestive of a problem in the thoracic outlet. In February 1992, E. C. returned to Respondent for re- evaluation and discussion concerning her medications. She was still experiencing headaches and was reporting that Dr. Thomas’ care was helping but she was unsure if her overall condition was improving. E. C. also reported a new problem with a burning sensation in the right foot at night, which Respondent had not assessed to be problematic. During this visit, Respondent altered her medications and scheduled her for surface electromyography exam (EMG) of the face and neck. The EMG was performed on February 28, 1992, in Respondent's office. The purpose of the surface EMG was to objectively evaluate whether E. C. had muscle spasms, and if so, the degree, interest and location of the spasms. The surface EMG also confirmed the clinical finding of muscle spasms. From the information gained from the study, Respondent could also objectively assess E. C.’s response to existing treatment and her need for further treatment including potential adjustments to be made to her medications in type and quantity. In 1991 and 1992, the results obtained from the surface EMG were thought to be important in providing care to patients or evaluating the treatment being provided. However, over time, it has been learned that muscle spasm can vary on a daily basis and, thus, the data obtained from the surface EMG may not be the best indicator as to how the patient is progressing in treatment. As physicians have learned more about the usefulness of surface EMG, they have come to rely upon it in biofeedback training. The exam provides the patient with an objective visual representation of muscle spasm, which then allows the clinician to teach the patient to relax the affected area. In E. C.’s case, the surface electromyography allowed Respondent to identify areas of muscle spasm for the purpose of planning her continued care. His use of the test in this manner, given the time period in which it was administered, was not inappropriate. E. C. left Respondent’s care after February 28, 1992, and subsequently came under the care of a neurologist, Dr. Alan Spiegel. Dr. Spiegel, who assisted in the treatment of the patient after she left Respondent’s care, did not have any criticisms of the care she had received from her prior treating physicians. As he formulated his treatment plan, Dr. Spiegel had the benefit of the records from E. C.'s prior physicians, including Respondent’s records. While receiving treatment from Dr. Spiegel, E. C. was still under the care of Dr. Thomas. Dr. Thomas’ role was to provide physical therapy while Dr. Spiegel provided medications to reduce inflammation and spasm. In fact, because she had received prior diagnostic exams, there was no need for Dr. Spiegel to perform any additional tests. Dr. Spiegel placed E. C. at maximum medical improvement on April 20, 1992, and found that there was a significant impairment of her physical condition. She experienced an exacerbation of her condition, received additional treatment, and was again placed at maximum medical improvement on October 9, 1992. At the time of the formal hearing, E. C. was still suffering from the injuries sustained in the motor vehicle accident of August 9, 1991. She continues to experience flare- ups of her condition and continues to receive treatment for her condition. Respondent's use of the diagnostic tests was not exploitative and was medically indicated at the time they were ordered. Respondent’s use of diagnostic tests was reasonably calculated to assist him in reaching a diagnosis and in making recommendations for continued treatment to her primary physician, Dr. Thomas. The tests were also used by her subsequent treating physicians in rendering care to the patient. This avoided the necessity of having the patient undergo further testing. As with many new practitioners, Respondent ordered more diagnostic tests than a more experienced practitioner might have thought necessary under the same circumstances. Moreover, since Respondent was fairly new in the practice, it was not unreasonable for him to have ordered more diagnostic exams than a more experienced practitioner might have ordered under similar conditions and circumstances. However, the fact that Respondent ordered more tests than a more experienced practitioner does not mean that the tests he obtained were not reasonably calculated to assist him in arriving at a diagnosis and recommendation for treatment of E. C.'s condition. Nor do more tests mean that they were not medically indicated. Several practitioners testified at the hearing and in their depositions that the tests were appropriate, particularly in 1991. Reasonable practitioners will differ as to the number and type of tests they will order to arrive at a diagnosis and treatment of a patient’s condition. At the formal hearing and in the written reports submitted into evidence, the opinions of seven physiatrists (Respondent, Dr. Gerber, Dr. Goodgold, Dr. Kelley, Dr. Krimshtein, Dr. Lichtblau, and Dr. Narula), a neurologist (Dr. Spiegel), a psychiatrist (Dr. Sprehe), and a neurosurgeon (Dr. Meriwether) were offered by the parties. Each of the physicians had a different belief as to the tests that he would order to evaluate E. C.'s condition. The Department provides appropriate and comprehensive training to members of the Board of Medicine as required by Section 458.307(4), Florida Statutes. At all times relevant to this proceeding, such training was provided to Board members when they were initially appointed as well as periodically throughout their tenure on the Board. Various methods utilized to implement and accomplish the required training included the following: viewing of appropriate videotapes; attendance at seminars and retreats; regular presentations at Board meetings; and dissemination of newsletters.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order in this case dismissing all charges against Respondent. DONE AND ENTERED this 7th day of July, 1999, in Tallahassee, Leon County, Florida. CAROLYN S. HOLIFIELD 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 7th day of July, 1999. COPIES FURNISHED: John E. Terrel, Senior Attorney Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308 Grover Freeman, Esquire Jon M. Pellett, Esquire 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308
Findings Of Fact On or about August 15, 1988, Respondent received a complaint from Walt Disney World questioning the "type[,] frequency and cost" of treatment that Petitioner was providing to a patient. Petitioner is employed as a physician by the Central Florida Health Center and was providing treatment to the patientin response to allergic-type complaints. As the letter acknowledges, Walt Disney World had denied the patient's claim for Workers Compensation benefits. By December 11, 1989, Respondent's investigator had completed an final investigative report on the matter. The cover sheet of the report notes that Petitioner had not responded to the charges as of December 4, 1989. The cover sheet also notes that the Social Security Administration had determined, by decision dated September 9, 1989, that the patient had suffered a "disability" since July 22, 1987. The cover sheet cites from the decision as follows: "the medical evidence establishes that the claimant has respiratory allergies, especially to molds . . ." and "the claimant's allegations of respiratory distress, nausea, anxiousness, rapid heartbeat, confusion, headaches, and loss of coordination and strength are supported by the objective and clinical laboratory findings of record and are credible." Summarizing an interview on October 26, 1989, with the manager of another allergy clinic in the Orlando area, the investigative report states that the manager stated that fee schedule for the Central Florida Health Center listed fees for patient evaluation that were "high" and for interdermal tests that were "excessive." The investigative file accompanying the investigative report contains numerous documents relating to the patient and his diagnoses and treatments. One document appears to be an independent medical examination referenced by WaltDisney World in its letter to Respondent dated August 15, 1988. By letter dated May 16, 1988, Richard F. Lockey, M.D., of the Allergy, Asthma and Immunology Associates of Tampa Bay, reported the results of his examination of the patient on April 5 and 22, 1988. Dr. Lockey found that the patient "does not have nor suffer from any allergic disease." Dr. Lockey found, among other diagnoses, "vasomotor rhinitis with possible allergic rhinitis." Expressly disagreeing with Petitioner's "impression that [the patient] has multiple problems secondary to his environment at Disneyworld," Dr. Lockey recommended that the patient could return to work without hazard to his health and needed psychiatric counselling to reassure him that he is physically healthy. Dr. Lockey's letter accompanies a complete history that he took of the patient. By letter dated December 1, 1989, and also contained in the investigative file, Diane S. Storey, D.O., employed with Petitioner at the Central Florida Health Center, explained why the only appropriate treatment for the patient was immunotherapy for long-term exposure to mold byproducts. The letter refers to the corroborating opinion of Douglas H. Sandberg, M.D. Dr. Sandberg's undated report, which is also contained in the investigative file, includes a comprehensive history. Dr. Sandberg, who is a Professor of Pediatrics and Director of the Division of Gastroenterology and Nutrition at the University of Miami Children's Hospital Center, concludes thatPetitioner has "an excellent grasp of [the patient's] overall problems and should be able to help him significantly and to have him back to work in a few weeks." The letter also states: "Testing and treatment with [Petitioner] has shown that [the patient] does have environmentally triggered illness or complex allergy." By memorandum to the probable cause panel dated February 23, 1990, Respondent noted the allegations that Petitioner violated Section 458.331(1)(t) and (n). The memorandum recommends that the case is "legally sufficient and should be reviewed by an expert to determine whether [Petitioner] operated within the standard of care, if there is a pattern of excessive and unnecessary testing and if he over-charged for his services." The probable cause panel agreed to refer the file to an expert. By letter dated June 18, 1990, Respondent requested Michael P. Pacin, M.D., to offer an expert opinion as to several questions concerning Petitioner's diagnosis and treatment of the patient. Respondent gave Dr. Pacin the entire investigative file to review. By letter dated September 13, 1990, Dr. Pacin, who is a board- certified internist and immunologist, noted the differing opinions of Drs. Lockey and Sandberg. The letter states: there can be more than one opinion regarding treating allergy patients. Dr. Lockey was trained in the same manner as I was, and I agree almost completely with everything thathe has said regarding [the patient's] treatment. On the other hand, Dr. Sandberg's views are quite contrary to mine, although they are along the lines of those which [Petitioner] has followed. [Petitioner] and Dr. Sandberg practice what is known as environmental medicine, a field which is quite controversial and not very well substantiated in the medical literature. I believe [the patient] is a very sick man; however, I do not believe, based upon the information given to me, that much of his problem is due to allergy. Most of the testing and treatment provided to him by [Petitioner] was probably unnecessary, but what surprises me is the fact that [Petitioner] is a psychiatrist who practices allergy and seems possibly to have misdiagnosed a patient with a psychiatric problem as having an allergy problem. The letter describes environmental medicine, which Petitioner practices, as a very unsubstantiated theory. These patients, as in the case of [the patient], have very subjective symptoms, some of which can be explained by other medical problems and some of which cannot be explained medically but are quite real to the patient and do, indeed, contribute to their disability. It is quite hard to define what makes them ill and to know how to treat them. Responding to the specific questions asked, the letter states: I do not feel that the [patient's] condition was adequately assessed. Based upon Dr. Lockey's assessment, I, too, feel that the [patient] is suffering from multiple psychiatric problems and that any allergy problems he has are minimal and not contributing to his overall problem. . . . I believe [Petitioner] did not treat the patient in an appropriate manner--i.e., all of the allergy testing and treatment was probably not necessary, and even if they were, they were far in excess of what would be appropriate for a patient who did haveallergy problems. . . . I do believe [the insurance company was] exploited for financial gain by [Petitioner]. Even though [Petitioner] has continued to provide medical care to the patient at no cost, I think this is only being done to cover up the exploitation that has preceded it. . . . I do not believe that [written medical records kept by Petitioner] justify the course of treatment of the patient. The test results were far from conclusive, especially based on the patient's history, to warrant such an extensive treatment regime for allergies. Dr. Pacin's letter responds to the concluding question posed by Respondent's letter as follows: [Petitioner] did not meet the "standard of care" as I and my colleagues practice allergy. I believe his diagnosis was wrong and the treatment, therefore, also was wrong. I believe the treatment would have been wrong even if the diagnosis had been correct, as it was overdone and the patient was being exploited for financial gain. This patient may have had some minimal allergy problems; however, he needs a complete psychiatric evaluation to better have an idea [sic] of what his true medical problems are. The fact that [Petitioner] is a psychiatrist tells me that this case should also be evaluated by a psychiatrist to see if he meets the "standard of care" in the field of psychiatry. It seems that [Petitioner] has missed the psychiatric diagnosis or possibly is treating the patient for allergies because that diagnosis gave him the opportunity to charge for services which would provide a greater cash flow. The only justification that I could find for [Petitioner's] deviating from the standard of care was the fact that another, rather eminent physician agreed with his diagnosis and treatment. However, as I stated above, this is due to the fact that Dr. Sandberg, as well as [Petitioner], seemed to be practicing in the very controversial field known as clinical ecology [also known as environmental medicine]. By letter dated January 30, 1991, Respondentrequested Dr. Pacin to elaborate upon: those factors which lead you to believe that the patient was suffering from multiple psychiatric problems and that any allergy problems were minimal[;] . . . which tests and treatment performed by [Petitioner] were either unnecessary or "far in excess of what would be appropriate for a patient who did have allergy problems"[;] . . . which medications were inappropriate for this patient and whether the quantities given were also inappropriate[; and] . . . what test results would have justified this treatment and . . . [what] tests not performed by [Petitioner] . . . could have definitely established if the patient was actually suffering from these allergies? By letter dated February 12, 1991, Dr. Pacin responded to these questions. The letter states that he could not say that the patient's symptoms were psychiatric and had thus recommended a psychiatric evaluation. Dr. Pacin explained that he had based his finding of "excess treatment" upon the billings and services that he had reviewed. The letter states that the patient did not suffer from sufficiently severe allergy problems to warrant immunotherapy. As to the last question, Dr. Pacin opined that "missing symptoms," not missing test results, failed to "warrant allergy testing and allergy immunotherapy." The case was considered by the probable cause panel on May 4, 1991, with a recommendation from Respondent that probable cause be found. Respondent's attorney adequately summarized Dr. Pacin's findings. Expressly relying upon Dr. Pacin's report, one panel member moved to find probable cause and file an Administrative Complaint alleging violations of 458.331(1)(t), (m), and (n). The panel approved the motionunanimously. Pursuant to the probable cause finding, Respondent filed an Administrative Complaint on May 16, 1991, in DOAH Case No. 91-4068. Corresponding to the violations cited by the probable cause panel, the Administrative Complaint alleges that Petitioner failed to practice medicine in accordance with a reasonable standard of care due to the misdiagnosis of a patient, failed to keep medical records justifying the course of treatment of a patient, and exploited a patient for financial gain. On November 6, 1991, Respondent filed a Notice of Voluntary Dismissal, and DOAH Case No. 91-4068 was closed by Order Closing File entered November 13, 1991. The opinion of Dr. Pacin adequately addressed the differing schools and training of Petitioner and Dr. Sandberg, on the one hand, and Drs. Lockey and Pacin, on the other hand. After doing so, Dr. Pacin identified clearly and unequivocally what he opined were deficiencies in Petitioner's diagnosis and, in particular, treatment of the patient. There was a reasonable basis for Dr. Pacin's opinions. Other evidence existed concerning the possible unreasonableness of the fee schedule. Although Respondent might anticipate some difficulty overcoming by clear and convincing evidence what may be a legitimate difference of professional opinion concerning diagnosis and treatment, Respondent had a reasonable basis in law and fact for filing the Administrative Complaint.
The Issue The issue for consideration herein is whether Respondent's license as a physician in Florida should be disciplined because of the misconduct alleged in the Administrative Complaint filed herein.
Findings Of Fact At all times pertinent to the allegations contained herein, the Respondent, Rolando C. Jamilla, was licensed as a physician in Florida. The Board of Medicine is the state agency charged with the regulation of the practice of medicine in this state. Respondent's office for the practice of general medicine in located in Ft. Myers, Florida and Respondent is also the medical director at the Lee Convalescent Center, a nursing home for the elderly with between 140 and 160 beds. Patient A. J. entered the emergency room at Lee Memorial Hospital in Ft. Myers on the afternoon of August 13, 1983, complaining of shortness of breath. A 55 year old male, he previously had been diagnosed as having chronic lung disease, and was a heavy smoker. The physician on duty in the emergency room, Dr. Gavin, treated A.J. with intravenous aminophylline, a bronchodilator, and ordered a theophylline level drawn. Theophylline is a medication the level of which can be measured in the patient's serum. It is a drug which falls within the purview of the proscription in Section 458.331(1). The theophylline test ordered by Dr. Gavin indicated that A.J. had a theophylline level of 11.0 mcg/ml. A normal therapeutic range for theophylline is 10 to 20 mcg/ml. Excessive levels of the substance can result in theophylline toxicity manifested by rapid cardiac rhythm disturbances and possible cardiac arrest. It can also cause neurotoxicity and neurologic seizures. Respondent first saw A.J. at about midnight after his admission and confirmed the orders previously given by Dr. Gavin, continuing the aminophylline. When he saw A.J. the following day, Respondent continued the aminophylline regimen for another day at which time A.J.'s breathing was much more regular and easy and the aminophylline treatment was discontinued. Respondent did not order an aminophylline level test at that time because, in his opinion, since the therapy was being discontinued, the test would not have been of value. A.J.'s condition continued to improve after Respondent discontinued the aminophylline therapy on August 15, 1983 and on the morning of August 18, 1983, Respondent indicated his intent to discharge the patient the following day. However, during that evening, prior to discharge, A.J.'s condition worsened and the proposed discharge for the following day was cancelled by Dr. Bercau, the on-call physician. At this time, A.J. was again suffering severe shortness of breath, and aminophylline, along with other broncodilators, was again ordered by Dr. Bercau. Since, on August 19, 1983, A.J. was still experiencing breathing difficulties, Respondent continued the aminophylline therapy and ordered a series of tests be run on the patient which included an electrocardiogram, a chest x-ray, and a CPK (measure of blood enzyme). Respondent also requested that A.J. be seen in consultation by Dr. Charles, a cardiac specialist. On August 20, 1983, Dr. Bercau, believing that the patient was experiencing cardiac problems, had him transferred to the telemetry unit for continued and detailed monitoring of his cardiac situation and ordered a theophylline level test run on him. This showed that the patient's theophylline level was 36.8 mgc/ml, considered to be in the toxic range. Both Respondent and his expert agreed that at this point, A.J. was experiencing theophylline toxicity. As a result of the chemical tests, Dr. Bercau ordered the aminophylline therapy be discontinued as of the evening of August 20, 1983 and directed another theophylline level test be run. The result of this test, done on the morning of August 21, 1983, indicated A.J.'s theophylline level had reduced to 27.6 mcg/ml, still considered to be in the toxic range, and the doctor's notes for this day indicate that though the theophylline level was high, it was much better than it had been. Notwithstanding this entry in the doctor's notes, on August 22, 1983, Respondent again ordered the resumption of aminophylline therapy. The records do not reflect any indication that Respondent attempted to determine his patient's theophylline level before resuming this therapy. On August 24, 1983, A.J. began to have premature ventricular contractions, a cardiac rhythm disturbance. When Dr. Charles saw the patient that same day, he indicated that these arrhythmias were "most likely" due to the effect of the aminophylline administered. Dr. Charles ordered this drug be discontinued at that time. On August 30, 1983, A.J. was examined by Dr. Dosani, a pulmonary specialist, who ordered the administration of steroids in an effort to counteract the patient's bronchospasms. This apparently was successful since the patient's condition improved and he was discharged from the hospital on September 3, 1983. Aminophylline is a drug which can produce cardiac arrythmia and both cardiac and neurological toxicity can be an outgrowth of theophylline toxicity. Respondent admitted at the hearing he was aware that aminophylline can produce cardiac arrythmia. Respondent's expert, Dr. Chadha, a specialist in lung diseases, utilizes aminophylline on a daily basis since it is widely used in his specialty. Dr. Chadha could find no reason for Respondent to order a theophylline level test when there were no indications of problems manifested to Respondent and he had discontinued the administration of the drug. The patient presented no evidence of toxicity and the two other physicians who were treating the patient at the time both prescribed administration of aminophylline as well as other medication at the time Respondent did. Petitioner's expert, Dr. Cohen, opined that the prescribing of aminophylline simultaneously with oral choledyl is inappropriate and excessive and life-threatening to the patient. According to Dr. Chadha, a review of theophylline level test results at Lee Memorial Hospital for June, 1989, revealed that 31% showed a level in excess of the maximum therapeutic level of 20 mgc/ml. In Dr. Chadha's opinion,, levels of this drug within the body are extremely hard to control. Whereas Dr. Cohen was of the opinion that the Respondent's treatment of his patient, A.J., in these particulars, constituted a failure to practice medicine with the appropriate level of care, skill and treatment recognized as reasonably prudent by similar physicians under similar circumstances, Dr. Ratnesar, an internist testifying as an expert for the Respondent, was of the opinion after reading the medical charts involved, that the care and treatment given in this case by Respondent was well within medical standards. This opinion was confirmed by Dr. Charles, the cardiologist mentioned previously. Respondent admitted another patient, J.H., to the hospital on August 27, 1983. The admitting documents indicated the patient was being admitted for the treatment of pulmonary distress when in reality as admitted by Respondent at hearing, the hospital admission was primarily a "social admission" necessary as a prerequisite to the placement of the patient in a nursing home. The patient, J.H., was not in any actual pulmonary distress either at the time of admission nor at any time during his stay, and Respondent admits this. Nonetheless, Respondent prescribed Theo-Dur, a theophylline bronchodilator, and Halcion, a tranquilizer, for the patient. It is well accepted in medical circles that Halcion should be used with caution when a patient is known to have a respiratory condition because the medication effects the central nervous system which, when depressed, can have an adverse effect on the respiratory function. Dr. Cohen is of the opinion that the prescription of Theo-Dur and Halcion, conjunctively, to the patient was inappropriate and the medical records on this patient fail to indicate a medical basis for it. The records make no reference to diagnostic tests ordered by Respondent for the patient and in Cohen's opinion, they are inadequate and do not justify the treatment provided. Respondent rebuts this contention urging that the use of the two drugs together is neither contraindicated nor harmful. This position is supported by information from the manufacturer of Halcion that there is no known contraindication for its use with Theo-Dur. In fact, none of the witnesses, including Dr. Cohen, could provide any firm evidence of contraindication in the use of the two drugs. Further, the four physicians who testified on behalf of Respondent were of the opinion that his records regarding this patient were adequate. Patient C.T. was a 79 year old woman admitted to the hospital on April 13, 1983, suffering from vaginal bleeding. She was admitted from a nursing home where Respondent had been her treating physician. She was a patient in the nursing home as a result of a stroke she sustained in 1976. Several days prior to her admission to the hospital, Respondent had attempted a pelvic and a bimanual examination of the patient at the nursing home to attempt to confirm the area from which the patient was bleeding. The bimanual examination was unsatisfactory due to her obesity and, because she had a protruding hernia in the abdominal wall. Upon admission, Respondent did not perform any additional specified area examination of the patient either with a speculum or bimanually because of her advanced age and the fact that her family preferred no further discomfort be imposed on her. As a result, Respondent made a presumptive diagnosis that the patient was suffering from cancer of the uterus/cervix, but this was not confirmed by actual examination. The patient was treated medically to stop the bleeding and she was returned to the nursing home with no further complications. Though the examination at the nursing home by the Respondent was characterized as satisfactory and though no positive diagnosis could be confirmed of the cause of the bleeding, Respondent failed to request a gynecological consultation for the purpose of further diagnosis. Due to the family's wishes, however and the advanced age of the patient, this may not necessarily constitute a failure to take proper care. When Dr. Cohen gave his opinion that the failure to do a bimanual and pelvic examination was improper, he was apparently unaware that Respondent had done these examinations at the nursing home three days prior to the patient's admission.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Respondent, Rolando C Jamilla, M.D., be placed on probation by the Board of Medicine for a period of two (2) years under such terms and conditions as are specified by the Board, and that as a part thereof, he complete no less than 40 hours of continuing medical education in subjects specified by the Board. RECOMMENDED this 18th day of September, 1989, 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 18th day of September, 1989. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 87-5414 The following constitutes my specific rulings pursuant to Section 120.57(2), Florida statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. For the Petitioner: 1. Accepted and incorporated herein. 2.-4. Accepted and incorporated herein. 5. Accepted and, as it pertains to failure to monitor theophylline levels, incorporated herein. 6.-11. Accepted and incorporated herein. 12. Accepted and incorporated herein. 13.&14. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Accepted and incorporated herein. Accepted except for the finding that the patient's life was endangered. Rejected. 21.&22. Accepted and incorporated herein., Accepted and incorporated herein but not necessarily dispositive. Accepted. Accepted and incorporated herein. Accepted and incorporated herein. Rejected. &29. Accepted and incorporated herein. Accepted and incorporated herein. Accepted. Rejected. Accepted and incorporated herein. For the Respondent: 1.&2. Accepted and incorporated herein. 3.&4. Accepted and incorporated herein. 5. Accepted and incorporated herein. 6.&7. Accepted and incorporated herein. 8.-11. Not a Finding of Fact but a recitation of testimony. 12.-16. Restatements of the evidence. 17.&18. Accepted and incorporated herein. 19A-D. Not a Finding of Fact but a recitation of testimony. COPIES FURNISHED: Robert D. Newell, Jr., Esquire Newell & Stahl, P.A. 817 North Gadsden Street Tallahassee, Florida 32303-6313 James A. Neel, Esquire 3440 Marinatown Lane, N.W. North Fort Myers, Florida 33903 Kenneth A. Easley, Esquire General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Dorothy Faircloth Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 =================================================================
