The Issue Petitioner Department of Professional Regulation seeks to suspend, revoke, or otherwise discipline respondent's license to practice medicine on charges of professional misconduct violative of Chapter 458 Florida Statutes (1979). The issues for determination are: Whether respondent is guilty of gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, in his treatment of Verdi Hammond Burroughs ("Burroughs") and Charles Kirk ("Kirk") in violation of Section 458.331(1)(t), Florida Statutes (1979); Whether respondent's treatment of Burroughs and Kirk was fraudulent and constituted misrepresentation, and whether the treatment was medically beneficial to the exclusion of other forms of proper medical treatment and was, therefore, harmful to the patient in violation of Section 458.331(1)(1), Florida Statutes (1979); Whether respondent violated Sections 458.331(1)(1), 458.331(1)(h), Florida Statutes (1979) by failing to fully inform Burroughs and Kirk (in his prescribing and administering Amygdalin [Laetrile]) of alternative methods of treatment for their cancer, and the potential of these methods for cure; whether each patient failed to sign a written release releasing respondent from liability; and whether respondent informed each patient, in writing, that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services; Whether respondent's treatment of Burroughs and Kirk, when measured by the prevailing standards of medical practice in the community, would constitute experimentation on a human subject without first obtaining full, informed, and written consent, in violation of Section 458.331(1)(u), Florida Statutes (1979); Whether respondent failed to comply with Sections 458.333 and 458.335, Florida Statutes (1979); Whether metabolic therapy is recognized by a respectable minority of the medical profession as a treatment for cancer. Background By an eight-count administrative complaint dated March 31, 1982, petitioner Department of Professional Regulation, Board of Medical Examiners (Department), charged respondent Daniel J. Clark with multiple violations of Chapter 458, Florida Statutes (1979), the "Medical Practice Act." Respondent disputed the charges and requested a Section 120.57(1) hearing. On April 29, 1982, the Department forwarded this case to the Division of Administrative Hearings for assignment of a hearing officer. Hearing was then set for September 22 and 23, 1982. At hearing, the Department presented the testimony of Evelyn Kuhn, Daniel Clark, Alvin Edward Smith, Tammy Thompson, Brenda Kempton, and Lois Ann White. Petitioner's Exhibit Nos. 1/ 1-5 were received into evidence. The respondent testified in his own behalf and presented the testimony of Rodrigo Rodriquez, Rebecca Scholz, and Allen Bernsten. Respondent's Exhibit Nos. 1-5 were proffered but not received into evidence. The parties filed proposed findings of fact and post- hearing briefs by December 1, 1982. Those proposed findings which are incorporated herein are adopted; otherwise they are rejected as unsupported by the evidence or unnecessary to resolution of the issues. Based on the evidence presented at hearing, the following findings of fact are determined:
Findings Of Fact I. Respondent Since 1976, respondent has been licensed to practice medicine in the State of Florida, holding license number ME0026861. (Tr. 269; Prehearing Stipulation) He received a bachelor of science degree from Georgia Southwestern College and a medical degree from Medical College of Georgia. In 1975, he trained for five months with a gynecological oncologist in Americus, Georgia. In 1978, he completed a three year residency program at University Hospital in Jacksonville, Florida. (Tr. 266-268). Since 1979, he has practiced medicine in Ormond Beach, Florida. Initially, his practice included gynecology, family practice, and general nutrition. He then began to treat cancer patients with metabolic (nutritional) therapy. The purpose of such therapy is to enhance the immunological and biological capacities of a patient--nutritionally, immunologically, and physiologically--in order to improve the patients performance in combating cancer. This cancer treatment includes the administration of Amygadalin (Laetrile), vitamins, herbal teas and detoxifiers, and the application of salves and packs to cause localized hyperthermia. It is not a conventional, orthodox, or widely practiced form of cancer treatment. No other physician in Volusia County uses it. Most accredited medical schools in the United States do not teach it. The American Medical Association (AMA) considers it to be experimental. Eventually, respondent's metabolic treatment of cancer patients began to account for 15 percent to 20 percent of his practice. (Testimony of Clark, Rodriquez; P-3) II. Respondent's Treatment of Verdi Hammond Burroughs In October or November 1979, Nelson Murray, a chiropractor, asked respondent to examine Verdi Hammond Burroughs, a patient who had complained to Dr. Murray about a lump in her right breast. (The offices of Dr. Murray and respondent were close together in the same building. And, in the past, Dr. Murray had referred patients to respondent for medical treatment.) (Testimony of Clark, P-3). Respondent, who considered it an "across-the-hall consult," agreed. He went to Dr. Murray's office, examined Ms. Burroughs' right breast, and noted a small lump. He recommended that she have a biopsy or that she see a surgeon for a second opinion, to make sure that the lump was not malignant. (Subsequently, she failed to follow this recommendation.) Although he did not refer her to a particular surgeon, he looked up the names of several who might be willing to operate on her, as she was a Jehovah's Witness. (Since Jehovah's Witnesses object to blood transfusions, many surgeons refuse to operate on them.) (Testimony of Clark, P-3) During this brief examination, respondent did not perform any diagnostic tests other than to manually examine the breast. Although he kept meticulous patient medical records, he did not open a patient record on Ms. Burroughs or have her complete a patient history form. He took no progress notes during the examination. He did not consider her his patient, did not assume responsibility for her treatment, and did not charge her a fee. (Testimony of Clark; P-1, P-3). Respondent had no contact with Ms. Burroughs until Dr. Murray asked him to reexamine her in February, 1980. The circumstances were similar. Respondent examined her in Dr. Murray's office, noted the breast lump was unchanged, made no medical reports, and charged no fee. He recommended that she undergo a laboratory test, including complete blood chemistry, SMAC 22, CBC, and sedimentation rate. For this purpose, he specifically referred her to Dr. Nelson A. Murray, a medical doctor and pathologist in Jacksonville, Florida. (At that time, she lived in Jacksonville, Florida.) He also recommended, again, that she have a biopsy performed--a recommendation which she, again, failed to follow. (Testimony of Clark; P-3). On September 22, 1980, almost eight months later, chiropractor Murray again asked respondent to come to his office and examine Ms. Burroughs right breast. Respondent's subsequent examination revealed that the entire breast was severely inflamed and the nipple was inverted or sloping downward. The breast had the appearance of an inflamed carcinoma. Respondent strongly suggested that she have laboratory tests (the same tests which he had recommended earlier) done as soon as possible and that she arrange to see him immediately thereafter. He, again, told her that she needed a biopsy and gave a preliminary diagnosis of breast cancer. This time, she followed his recommendation. Two days later, she had the complete lab tests done by Dr. Murray, the Jacksonville pathologist. (Testimony of Clark; P-3). Respondent still did not consider Ms. Burroughs his patient or assume any responsibility for her treatment. During this September 22, 1980, examination, he did not open a patient file, take notes, or charge a fee. There is no evidence that Ms. Burroughs-- at that time--believed that she was his patient--or he, her doctor. Nor is there evidence that either party misunderstood or was confused about their relationship or their respective responsibilities. (Testimony of Clark; P-3). Between the February, ,1980 and September 22, 1980, examinations, respondent did not contact Ms. Burroughs and did not discuss her condition with chiropractor Murray. Between the November, 1979 and the September, 1980, examinations, respondent did not order or perform any further diagnostic tests on Ms. Burroughs and did not attempt to check with her to see if she had followed his recommendations. Neither did he expressly inform her that he was not her doctor. The Department contends that his failure to take these actions violates a generally accepted standard of medical care. (Testimony of Clark; P- 3) This contention, however, is unsubstantiated. The evidence does not demonstrate that the generally accepted standard of medical care required respondent to take such actions. Conversely, it has not been specifically shown how, and in what ways, respondent's treatment of Ms. Burroughs between November, 1979 and September, 1980, fell below an acceptable standard of medical care. 2/ Ms. Burroughs became respondent's patient on October 7, 1980, when she came to his office for medical treatment. He performed a complete work up, physical examination, and medical history, and reviewed the results of the lab blood tests. He concluded that her condition was essentially normal except for her right breast, which was severely inflamed and the nipple retracted. In addition, the lymph nodes under her right armpit' were palpable and enlarged. His initial impression was that she had inflammatory carcinoma (cancer) of the right breast with lymph gland involvement. He then scheduled her for a biopsy, which was necessary before he could determine the type of cancer involved. (Testimony of Clark; P-3) The biopsy was performed on October 9, 1980 by Dr. Kluger, a St. Augustine physician. It indicated an inflamatory intraductal adenocarcinoma of the breast, primary. Dr. Kluger, who felt that surgery was inadvisable because of the lymph node involvement, subsequently recommended to respondent that Ms. Burroughs undergo radiation and chemotherapy. (Testimony of Clark; P-1, P-3). During the October 7, 1980, office visit, respondent explained to Ms. Burroughs the alternative methods of cancer treatment, including their potential for cure. The methods discussed included surgery, radiation, chemotherapy, and metabolic therapy. She refused to undergo radiation or surgical treatment, explaining that her husband died of lung cancer after receiving surgery, radiation, and chemotherapy. She agreed however, to consider chemotherapy in conjunction with metabolic therapy. He explained to her that metabolic therapy was not a treatment against the cancer, per se, but that it would help "build up her body to where her own immune system would help her fight the cancer." (P-1). She agreed to accept this treatment--chemotherapy with metabolic therapy--then signed four separate affidavits on forms provided by respondent. The affidavits acknowledged her consent to the ordering and administration of Laetrile. Respondent, however, did not inform Ms. Burroughs in writing (by these affidavits or any other documents), that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services. She also did not sign a written release, releasing him from any liability from the administration of Laetrile. (Testimony of Clark; P-1, P-3) During the October 7, 1980, visitation--after the affidavits were signed--respondent began treating her with metabolic therapy, consisting of Laetrile I.V., Vitamin C, B Vitamins, B-15, B-12, and crude liver injections. Metabolic therapy was commenced without obtaining her prior written consent. (Testimony of Clark; P-1). Several days later, on October 13, 1980, respondent began treating her with small doses of chemotherapy in conjunction with the metabolic therapy. The chemotherapy treatment plan was based on a phone call to Dr. Donald Cole, a New York oncologist. Respondent described the type and extent of Ms. Burroughs cancer and Dr. Cole recommended small 100 milligram doses of 5-FU twice weekly, two to five milligrams of Laetrile twice weekly, and 50 milligrams of Cytoxin PO orally. Respondent administered this regimen until he discontinued chemotherapy at the end of November, 1980. (Testimony of Clark; P-3). These doses and intervals of chemotherapy did not conform to the manufacturers' recommended doses contained in the Physicians Desk Reference, a standard reference used by practicing physicians. The doses administered by respondent were lower than those normally used in chemotherapy and are considered to be in the research or experimental stage. (Testimony of Clark, Smith). Chemotherapy and metabolic therapy are incompatible-- they work at cross-purposes. Chemotherapy drugs are strong immunosuppressants. They are toxic and intended to poison cancer cells; 3/ their effect is to suppress the body's immunological system. In contrast, the purpose of metabolic therapy is to enhance that same immunological system. (Tr. 215-216). For this reason, the use of chemotherapy is not included within the protocols for metabolic therapy found in International Protocols in Cancer Management. 4/ Respondent concedes that this publication is authoritative and contains the standard protocols for metabolic therapy. (Testimony of Rodriquez, Clark). Ms. Burroughs chemotherapy stopped at the end of November, 1980, but her metabolic therapy continued. By March, 1981, her right arm was beginning to swell because of enlarging lymph nodes. On the March 2, 1981, office visit, respondent told her that Laetrile was not stopping the cancer, and discussed restarting chemotherapy. He increased her Vitamin C, and began administering herbal cleaners and botanical medicines containing red clover, chapparral, myrr, goldenseal, yellow dot, juniper berries, yuva, ursaberries, conch grass, and dandelion. Respondent categorizes these medicines as blood purifiers, lymph purifiers, liver cleaners, and kidney cleaners. (P-3). By June, 1981, respondent believed the cancer had metastasized to Ms. Burroughs' right lung. During office visits in early June, he rubbed herbal ointment or liniment, Vitamins E and F, into her rib cage area. He also prescribed herbal packs and poultices to cause localized hyperthermia (heat increase). He prescribed dark and yellow herbal salves and instructed her to apply them to her right breast and underarm area, explaining that they would draw out and break down the cancer tumor. (Testimony of Clark, Kuhn; P-3). These salves--strong and painful--caused pieces of gray tissue to fall off her breast and underarm area. Respondent reacted by encouraging her, telling her that the salves were breaking down the cancerous tumor. (He now admits, however, that the herbal ointments and salves would have been ineffective in treating the cancer which had metastasized to her lungs.) He also prescribed a tea which tasted like black pepper. She forced herself to swallow it because he had told her that it would break up the cancer in her body. This representation was also untrue. (Testimony of Clark, Kuhn, Smith.) In administering metabolic therapy to Ms. Burroughs, respondent also prescribed whole-body hyperthermia for the purpose of stimulating her immune system. This required her to totally submerge herself in bath water which was as hot as she could tolerate. According to the standardized protocols for metabolic therapy, as stated in International Protocols in Cancer Management, such "whole-body hyperthermia, while successful in some cases, is dangerous and considered experimental." (Tr. 320, Testimony of Clark). Respondent's metabolic and chemotherapeutic treatment of Ms. Burroughs failed to conform to the standard of care recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. It fell below the prevailing and generally accepted standard of care recognized by his peers in the medical community: a.) After the diagnosis, respondent made an improper and incomplete staging 5/ of the disease by failing to take a liver scan, which would have revealed the existence (or nonexistence) of liver lesion. Cancer of the liver is deadly and must be dealt with immediately. (Tr. 89-92). b.) After he diagnosed Ms. Burroughs breast cancer, he failed to prescribe surgery or a combination of surgery and radiation therapy, treatment methods which likely would have been beneficial and controlled the disease. (Surgery, such as a radical mastectomy, does not cause a significant loss of blood, so blood transfusions--something Ms. Burroughs opposed--could have been avoided.) If necessary, chemotherapy--using conventional doses--could also have been administered. The chemotherapy and metabolic therapy which respondent provided Ms. Burroughs was probably worthless. The herbal salves and teas which he prescribed were incapable of drawing out or breaking up the cancerous tumor. c.) When Ms. Burroughs' cancer was diagnosed, it was in an advanced and complicated stage. Under such circumstances, a general practitioner (such as respondent) should have referred her to or obtained a consult from an oncologist, a specialist in the treatment of cancer. Respondent did neither. (Testimony of Smith). Metabolic therapy is not approved or recognized as acceptable for cancer treatment by a respectable minority of the medical profession. This finding is based on the opinion of Alvin Edward Smith, MD., board certified in oncology and internal medicine, and a Fellow of the American College of Physicians. He has treated cancer patients since 1978. His opinion on this issue is considered more credible than the contrary opinion of Rodrigo Rodriquez, M.D., who practices medicine in Tijuana, Mexico, who is not licensed to practice medicine in the United States, and who--other than acting as a guest resident at Kings County Hospital in Brooklyn, New York--has never practiced medicine in the United States. (Testimony of Smith, Rodriquez). III. Respondent's Treatment of Charles Kirk Charles Kirk became respondent's patient on August 13, 1980, and died shortly thereafter on September 9, 1980. Mr. Kirk, a 77-year-old male, was having great difficulty swallowing food and had a history of recurring choriocarcinoma of the larynx or throat. Surgery had been performed on him several times, and his larynx (voice-box) had been removed. Respondent explained to him the alternative methods of treatment, including surgery, chemotherapy, radiation, and metabolic therapy. Mr. Kirk opposed further surgery and objected to chemotherapy and radiation. He requested Laetrile. After he signed an affidavit provided by respondent (the same form which had been provided Ms. Burroughs), respondent ordered Laetrile. (Testimony of Clark; P-2). Respondent then referred him to a general surgeon for the placing of a gastrostomy feeding tube, a device which would enable him to swallow food and liquids. The tube was successfully placed surgically, after which respondent began administering Laetrile to him as part of metabolic therapy. The treatment was brief, only nine or ten days. On September 26, 1980, Mr. Kirk died. (Testimony of Clark; P-2). Mr. Kirk's condition, when he first became respondent's patient, was essentially irreversible; he was in the final stages of a fatal cancer. (Testimony of Clark, Smith; P-2). Respondent administered Laetrile to Mr. Kirk without first obtaining from him a release of liability and without informing him, in writing, that Laetrile has not been approved as a treatment or cure by the Food and Drug Administration of the United States Department of Health and Human Services. (Testimony of Clark.)
Recommendation Based on the foregoing, it is RECOMMENDED: That respondent's license to practice medicine be suspended for one year, for violating Section 458.331(1)(h), (1), (t), (u), Florida Statutes (1979). DONE AND RECOMMENDED this 9th day of March, 1983, in Tallahassee, Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of March, 1983.
Findings Of Fact Dr. Gans is a chiropractor licensed in Florida on the basis of examination. Dr. Gans prepared and filed an application for examination and licensure with the Florida State Board of Chiropractic Examiners. Dr. Gans answered the question on the application, "Do you have a chiropractic license in any state?" by stating: "Ohio - Mechanotherapy." The Ohio authorities recognized several professions whose functions would be included under the practice of chiropractic in Florida. Mechanotherapy generally would be limited to the practice of manipulation only. Dr. Gans was licensed in Ohio as a mechanotherapist. Dr. Gans answered the question on the application, "Have you ever been refused licensure in any state?" by stating, "No." Dr. Gans had applied for, taken, and failed the Ohio chiropractic examination whereupon he was not issued a license as a chiropractor by the State of Ohio. Dr. Gans was eligible to reapply to take the Ohio examination. At the time of his application to Florida, Dr. Gans had appealed the determination by the Ohio authorities that he had failed the Ohio examination.
Recommendation Based upon the foregoing findings of fact and conclusions of law, the Hearing Officer recommends that the Florida State Board of Chiropractic Examiners revoke the license of Ray E. Gans. DONE AND ORDERED this 2nd day of October, 1978 in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: John R. Sutton, Esquire 250 Bird Road, Suite 310 Coral Gables, Florida 33146 Paul Lambert, Esquire 1311 Executive Center Drive Tallahassee, Florida 32301 C. A. Hartley, Director Florida State Board of Chiropractic Examiners Suite 202, Building B 6501 Arlington Expressway Jacksonville, Florida 32211
Findings Of Fact Upon consideration of the oral and documentary evidence presented at the hearing, the following relevant facts are found: At all times pertinent to the matters considered here, the Respondent was a medical doctor licensed by the State of Florida under license number ME1472. He has been engaged in the practice of medicine for 50 years. While in practice in Orlando, Florida, during the period March 14, 1980, through August 8, 1980, Respondent had as a patient, and acted as treating physician for, Mary Walsh, who was at the time suffering from cancer of the lung. Respondent's treatment of Mary Walsh during the entire period she was his patient included the administering to her of laetrile, dimethylsulfoxide (DMSO) intravenously, enzymes, and megavitamins. Dr. James M. Johnstone (D.O.) had been a physician to Mrs. Walsh over a period of several years for a variety of complaints. (Her lung cancer was detected in December, 1979, however, when she went into his office on a routine visit.) Over the period of time he had treated her, she had suffered from such things as seizures, thyroid problems, and the like, but on this particular December 1979 visit, she complained of a sore throat. Dr. Johnstone referred her for consultation with a Dr. Porth, who ultimately opined she might have cancer of the epiglottis. As a result, in January, 1980, she was admitted to the hospital, where she was diagnosed as having cancer of the left lung. Exploratory surgery conducted during a second period of hospitalization in February, 1980, revealed that the cancer was inoperable and terminal, and the procedure was terminated without any surgical excision. Dr. Johnstone and several other physicians advised Mrs. Walsh and her daughter, Vicki L. Chapman, that conventional-treatments such as radiation therapy were available for, if not a cure, at least palliative treatment to reduce pain and perhaps extend life somewhat, but Mrs. Walsh was afraid of radiation therapy and refused it repeatedly. During this period of diagnoses and tests, Mrs. Walsh and her daughter, Vicki, were told by an acquaintance named Elmer Boener, of the Fairfield Medical Center in Jamaica, which offered the organic approach to cancer control, including the use of diet and vitamins. While Mrs. Walsh and her daughter were deciding whether to go to Jamaica, Mr. Boener informed them that a Dr. Wedel would be working at Respondent's clinic offering the same treatment as available in Jamaica, and they would not have to have the stress of going out of the country. They decided to go to Jamaica, however, because of the stress in this course of treatment on diet and, in March, 1980, went to the Fairfield Clinic for ten days, returning during the first week in April, 1980, at which time Mrs. Walsh took up treatment of her condition with Dr. Wedel and Respondent at the latter's clinic in Orlando. Mrs. Chapman went with her mother on almost every visit to Respondent's office and was present when Mrs. Walsh talked with either doctor or got her treatment. On one occasion, after looking at some X rays taken of Mrs. Walsh's lungs, in the presence of Mrs. Chapman, Dr. Lynn allegedly told Mrs. Walsh that her cancer was shrinking and getting better. This was not true. Dr. Lynn denies telling her this, saying he told her the amount of fluid in the lungs had reduced, but not the size of the cancer. Considering all the evidence and weighing all the factors, I find that Dr. Lynn did make the statement alleged. However, Mrs. Walsh still had pain, and Respondent would not prescribe medication for her. Because of that, she had to go to another doctor for a prescription for whatever she needed to relieve pain. During the time that Respondent treated Mrs. Walsh, he was assisted by a "Dr." Wedel, who held himself out to be a nutritionist. However, search of the records of the various licensing agencies for the medical disciplines within this state reveals that he is not licensed as a medical doctor, osteopath, naturopath, physical therapist, podiatrist, chiropractor, pharmacist, registered nurse, or licensed practical nurse. His service to Mrs. Walsh consisted of nutritional counselling as to diet, vitamins, etc., and writing prescriptions for vitamins that were subsequently signed by Respondent. Respondent's supervision of Wedel was not regular, but periodic. Wedel was recommended to Respondent by a friend in Oregon and intended to apply for a Florida license as a medical doctor. Dr. Lynn states that before offering Wedel employment, he cleared taking him on with the Orange County Medical Association, which agency interposed no objection. When Mrs. Walsh returned to Respondent's care from Jamaica, she requested that he continue the course of treatment she had been undergoing there, which included diet control and the use of vitamins, enzymes, laetrile, and DMSO. Though Dr. Lynn's medical notes were not introduced at the hearing, he indicated that they fail to reveal he counseled Mrs. Walsh on other, conventional forms of treatment for her condition, such as X-ray therapy or chemotherapy. He is satisfied, however, that she was aware of them. Respondent, due to Mrs. Walsh's request to him that he continue the use of laetrile and DMSO, had her oral consent to do so. However, he did not have, nor did he insure that, his staff secure for him her informed, written consent to treat her with either drug. Further, he did not, prior to utilizing either drug, inform her in writing that neither was approved for use in the treatment of cancer by the Federal Food and Drug Administration of the United States Department of Health and Human Services (FDA). Laetrile, DMSO, enzymes, and megavitamins, either singly or taken together, are unconventional treatments for cancer, as accepted by the medical community, and are generally recognized by that community as being experimental.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Respondent's license to practice medicine in the State of Florida be suspended for a period of one year. RECOMMENDED this 11th day of April, 1983, in Tallahassee, Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 11th day of April, 10983. COPIES FURNISHED: Charlie L. Adams, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 William Trickel, Jr., Esquire 35 West Pine Street Orlando, Florida 32801 Ms. Dorothy Faircloth Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact The Respondent is a state agency which initiated a proceeding with the filing of an Administrative Complaint against Marc Richman, D.O. The said complaint was assigned to the Division of Administrative Hearings pursuant to a request for Administrative Hearing pursuant to Chapter 120 and was assigned Division of Administrative Hearing Case Number 88-5258. On June 24, 1989, the Department of Professional Regulations issued a notice of voluntary dismissal in the above captioned proceeding and dismissed all charges against Marc Richman, D.O., in that case. Marc Richman, D.O. is a prevailing small business party within the meaning of Section 57.111(3)(c) and (d). The amount of attorney's fees and cost sought by the Petitioner in the Petition for Attorney's Fees is reasonable for the Representation of Marc Richman, D.O., in the defense of the Administrative Complaint through the date of issuance of the Notice of Dismissal. The Department of Professional Regulation maintains that the proceeds (sic) above-captioned were substantially justified at the time the Administrative Complaint was initiated by the state agency in that it maintains that there existed a reasonable basis in law and fact at the time of the filing of the Administrative Complaint. This position is disputed by the Petitioner, Marc Richman, D.O. The request for attorney's fees in the amount of $8,572.00 and costs of $563.96 for a total of $9,225.96 is reasonable for the representation of Petitioner throughout the instant proceeding. These proceedings were initiated by the filing of a complaint on September 16, 1986 with the Department of Professional Regulation (DPR), Petitioner in Case 88-5258, by the parents of G.H. who died October 18, 1984. G.H. was a long time patient of Dr. Jaffee, D.O. who called in Dr. Richman, an orthopedic surgeon to consult and perform an arthodesis on the left ankle of G.H. to relieve constant pain. G.H. was a 34 year old male accountant who had suffered from juvenile rheumatoid arthritis since the age of 4. Although badly crippled he was able to lead a relatively independent life. As a result of his malady G.H. had for years taken steroid and corticosteroid medications. These medications depress the body's immune system and the ability to fight off infections. Accordingly, G.H. was at more than normal risk anytime he was exposed to infectious diseases. After Petitioner explained the procedure and the risks to G.H., the latter elected to have Petitioner perform the arthodesis. This operation consists of grafting bone into the ankle to stabilize that joint. The donor site chosen for the bone to graft to the ankle was the crest of the left ilium of the patient. This operation was successfully performed on August 2, 1984 at Metropolitan General Hospital, Pinellas Park, Florida. In the hospital on August 9, 1984, while G.H. was being adjusted in his bed, he felt a pop in his left hip and a large hematoma developed over the wound at the donor site. It is not unusual for hematomas to develop over surgical wounds but it is important that such conditions be closely watched because hematomas are a fertile field for an infection. The hematoma on G.H.'s hip showed no evidence of infection and G.H. was discharged from the hospital August 12, 1984 and sent home. Arrangements were made by Petitioner for Robert's Home Health Services, Inc. of Pinellas Park to send a nurse 3 times per week to check on G.H., take his vital signs, dress his wounds and attend to any other medical needs he may have. Verbal reports were made by the nurse to Richman reporting the condition of G.H. While being helped from his wheel chair into bed by his parents on or about August 15, 1984, G.H. apparently fell and caused additional bleeding of the wound on the left hip. On August 16, 1984 the nurse reported to Richman the additional bleeding and she was directed to have G.H. taken to the hospital to be seen by Richman. On August 16, 1984, Petitioner examined the wound, noted the reports that the hematoma was neither inflamed nor more tender, and that G.H.'s temperature had remained normal since the hematoma developed. He sent G.H. back home without further tests. The classic signs and symptoms of infection are redness, swelling, heat and pain. Redness of the skin due to intense hyperemia, is seen only in infections of the skin itself. Swelling accompanies infection unless the infection is confined to the bone which cannot swell. Heat results from hyperemia and may be detected even in the absence of redness. Pain is the most universal sign of infection. Along with pain goes tenderness, or pain to the touch, which is greatest over the area of maximal involvement. (Exhibit 12, Principals of Surgery, Fourth Edition). The hematoma on G.H.'s left hip between its inception and September 13, 1984 never exhibited any sign of infection. On September 6, 1984, G.H. reported to the visiting nurse that he had a pain in his stomach and didn't feel well. The nurse described this as having flu-like symptoms. This was reported to Petitioner and the nurse received no additional orders. On the nurse's next visit on September 10, 1984, G.H. reported his abdomen was still hurting and he didn't feel good. At this time his temperature was elevated at 101. The nurse called Dr. Jaffee's office and was told to have the patient admitted to Metropolitan Hospital. Upon admission to the hospital on September 10, 1984, G.H. was nauseous, vomiting, and had a high fever (103). He had no complaints regarding his ankle or iliac crest and the hematoma had decreased greatly. On September 13, 1984, while G.H. continued showing signs of infection (high fever) Petitioner operated on G.H. to remove the hematoma. At this time aerobic and anaerobic cultures were obtained. Forty-eight and seventy-two hours later these cultures had grown no infectious substance. Further studies and tests revealed that G.H. had bleeding ulcers and surgery was required to patch the ulcers. At this time the spleen was also removed. Following this surgery G.H. was more debilitated and with the precarious condition of his immune system he continued to go down hill until he expired on September 18, 1984. Cause of death was cardiac pulmonary arrest caused by candida septicemia. During the initial stage of the investigation, which was initiated some two years after the death of G.H., the investigator interviewed the parents of G.H., who had filed the complaint, and assembled the medical records including those kept by the home health agency. The parents contended that when the hematoma was removed by Dr. Richman he told the parents that he had found infection at that site. Dr. Richman denies making any such statement to the parents of G.H. and the medical records support the conclusion that there was no infection in the hematoma on September 13, when the hematoma was excised. The parents complained of the treatment that G.H. received from Drs. Jaffee and Richman as well as Roberts Home Health Services. Accordingly the investigation started with both Jaffee and Richman charged with malpractice by the parents of G.H. The investigator selected an orthopedic surgeon, Dr. Richard M. Couch, D.O., from DPR's consulting list and forwarded to him on January 7, 1987, the patient records of G.H. and requested he review those records and give his opinion on whether Drs. Jaffee and Richman diagnoses and treatment of G.H. was appropriate. In this letter (Exhibit 1) the investigator advised Dr. Couch that following surgery a hematoma developed, that after G.H.'s discharge from the hospital the hematoma ruptured and that G.H. was taken back to the emergency room where Dr. Richman saw the patient but found nothing significant about the hematoma. He also told Dr. Couch that when Richman cleaned out the hematoma he advised the family (of G.H.) that infection was found, and that, after this G.H. started internal bleeding which ultimately resulted in the patient's death. Dr. Couch responded to this request with two letters, the first of February 16, 1987 and a second on March 6, 1987. In his first letter Dr. Couch concluded that the iliac wound began draining on or about August 14, 1984 and cultures of this wound were not secured until after G.H.'s hospitalization on September 10, 1984. Since the hematoma was a post-operative complication he opined that Richman failed to adhere to certain tenets regarding wound care in this situation. However, Dr. Couch suggested the records be referred to an internist who reviewed the treatment provided by Dr. Jaffee. In his second letter Dr. Couch opined that Richman was at fault for not incising, debriding and draining the hematoma when it developed and for not taking cultures when Richman saw G.H. in the emergency room on later dates. He also found Richman at fault for not referring G.H. to a consultant in infectious diseases. A letter similar to the letter sent to Dr. Couch was sent by the investigator to Neal B. Tytler, Jr., D.O., an internist. Although the investigator contends he submitted the records maintained by Roberts Home Health Services in this case to Dr. Tytler it is obvious that before he submitted his report on June 5, 1987, Dr. Tytler had not read those records and was concerned regarding the absence of medical records during the period between G.H.'s discharge from the hospital on August 12, 1984, and his readmission on September 10, 1984. In his report Dr. Tytler carefully noted G.H.'s long term medication for juvenile rheumatoid arthritis and the serious side effects, viz depression of the immune system, which results from long-term steroid therapy. Recognizing the risk to G.H. from any surgery Dr. Tytler questioned the wisdom of the arthodesis but recognized that this was more of an orthopedic problem than an internal medicine problem. From the records received, Dr. Tytler concluded that G.H. developed a hematoma after his departure from the hospital and before September 6, 1984. Significantly, Dr. Tytler reported "Of concern to me is the apparent lack of records to document the events which transpired between August 12, 1984 and September 10, 1984. In this one month period an abscess formed at the surgical site and led to disastrous consequences. Unfortunately it can only be inferred that the first recognition of any problem occurred on September 6, 1984, when the patient developed `flu-like symptoms'. He was not examined and no one perceived that his problems were serious." When the probable cause panel met on June 25, 1988 to consider the charges against Drs. Jaffee and Richman, no probable cause was found as to Jaffee. One of the two members of the probable cause panel disclosed at the opening of the panel meeting that he knew Dr. Richman socially and that Richman had been his treating physician for a finger injury. He was excused from further participation and the hearing was tabled regarding Dr. Richman. At a subsequent panel meeting by telephone conference call, after a substitute lay panel member was selected and had been furnished the medical records, a vote was taken to find probable cause. The excerpt from those proceedings (Exhibit 8) shows that the DPR attorney opened the conference call by stating that Richman was charged with medical conduct falling below acceptable minimal standards and "at the last probable cause panel meeting you voted to find probable cause, and asked that administrative complaint be issued. At this time the Department recommends that you do find probable cause to believe that this violation exists." Following receipt of this erroneous information regarding the previous probable cause panel meeting, the Chairman, Mr. Wheeler, stated that after reviewing the entire file he believes probable cause exists to file an Administrative Complaint. Dr. Barker concurred. The case against Dr. Richman began to unravel when the deposition of Dr. Tytler was taken on February 24, 1989. Prior to taking this deposition Dr. Tytler had been provided records from Metropolitan General Hospital, records from Roberts Home Health Services and a copy of the Administrative Complaint. In response to questions regarding the treatment of G.H. as afforded by Dr. Richman, Dr. Tytler stated that a review of all medical records clearly demonstrated that after the hematoma developed at the donor site for the transplant no indication of infection ever appeared; that considering the medical history of G.H. and his high susceptibility to infection it would be more dangerous to the patient to evacuate the hematoma and risk additional infection than it would to continue to observe the hematoma and let it cure itself; that the cultures taken on September 13, 1984, when the hematoma was evacuated clearly and unequivocally demonstrated that the hip wound was not the source of the infection that ultimately led to the demise of G.H.; and that the treatment rendered by Petitioner was in all respects in conformance with required medical standards and procedures. Dr. Tytler further opined that treating an immune compromised patient with antibiotics without a specific infection in mind "could lead to the very scenario that caused his (G.H.) death", namely secondary infection. Further, with respect to the contention of Dr. Couch regarding the failure of Petitioner to take cultures at the hematoma site before September 10, 1984, Dr. Tytler opined that indiscriminate taking of cultures when no evidence of infection is present could result in a positive culture unrelated to the wound but which the doctor would be called upon to treat. This could invite a major change in therapy and an inappropriate prescribing of an antibiotic. Following the deposition of Dr. Tytler, DPR referred the medical records to another orthopedic physician and this doctor concurred with the opinion of Dr. Tytler that Dr. Richman's treatment of G.H. was not below minimally acceptable standards, that no malpractice was involved and that the treatment was in accordance with acceptable medical standards. The Department then dismissed the Administrative Complaint. In his deposition the physician member of the probable cause panel, James H. Barker, D.O., emphasized that his conclusion that probable cause existed to go forward with the Administrative Complaint was significantly influenced by the fact that no culture was done at the hematoma site. From his subsequent testimony it is clear that Dr. Barker was unaware, when he voted to find probable cause, that the culture taken from the hematoma site on September 13, 1984 was negative. The record clearly shows this to be a fact. As stated by Dr. Tytler in his testimony "hematoma yes; infection no." Dr. Barker was also concerned, and perhaps rightly so, that any time that someone goes in for an elective procedure and he dies "that alone makes you think there may be probable cause here." However, there must be factual evidence to support a finding of probable cause and here there was no such evidence.
The Issue The issue is whether Respondent is guilty of departing from the applicable standard of care, failing to keep adequate medical records, or making deceptive, untrue, or fraudulent representations in the practice of medicine and, if so, what penalty should be imposed.
Findings Of Fact Respondent has been a licensed physician in Florida continuously since August 30, 1983. His license number is ME 0042770. Respondent has never been disciplined and has, since the events described below, attended a course on the preparation of medical records. Respondent has been Board Certified in Family Practice since 1995. He specializes in the area of family practice and maintains his office in the Naples Medical Center in Naples. T. M., who was born on June 13, 1951, presented to Respondent for the first time on April 3, 1991. She had seen other physicians at the Naples Medical Center, but not Respondent. She had last visited the Naples Medical Center on February 25, 1988. T. M. had several purposes in her first visit with Respondent. First, she wanted to establish herself as a patient of Respondent following the retirement of her previous physician. Second, she wanted a prescription for Premarin following an earlier hysterectomy. Third, she wanted to determine if she had any need for a PAP smear. T. M. completed a patient questionnaire during the April 3 office visit. In her answers, T. M. affirmed that she had had "hemorrhoids or rectal bleeding," but she underlined only "hemorrhoids." She denied any colitis or other bowel disease, constipation or diarrhea, or recent change in bowel action or stools. T. M.'s testimony that she was experiencing a feeling of pressure in her bowels and felt the need to have a bowel movement when she did not need to have one is not credited. It is inconsistent with the history, as discussed below, that T. M. related to Respondent's office on her second office visit and later to Dr. Cooper. In the medical records for the April 3 office visit, Respondent noted that he reviewed T. M.'s chart and discussed her physical, "etc." The notes state that Respondent found no need for a PAP smear due to prior hysterectomy and bilateral salpingo- oophorectomy. The notes add that T. M. daily uses Premarin, which replaces estrogen, that she is not cycling, and that she will return to the office as needed. The notes report that T. M. will return to the office as needed. The notes record that T. M. will need a mammogram this year and that Respondent is refilling her Premarin prescription. These are Respondent's original medical records for T. M. As noted below, following Respondent's discovery that another physician had detected colo-rectal cancer in T. M. in January 1992, Respondent made additions to his notes. He did not date the additions to show that they were added months after the original notes. At the top of the notes, Respondent added: "Needs prescription--refill Premarin." After "etc.," Respondent added: "Family history of cancer + preventative care." Immediately preceding "RTO PRN" (which means return to office as needed), Respondent added: "Wants to." Immediately after this shorthand notation, Respondent added: "+ will call to reschedule." Adding the number 1 to the mammogram note and the number 3 to the refill Premarin note, Respondent also inserted a number 2, which states: "labs + physical this year." Within a few weeks of this initial office visit, T. M. began to experience problems with her bowels in the form of rectal bleeding and the feeling of pressure, as though she had to have a bowel movement or urinate when she did not. In June 1991, T. M. set up an appointment for June 28. By this time, T. M. was finding red blood in her stool and when she wiped her rectum with toilet paper. She told the nurse that she had been experiencing this problem for two months. The nurse recorded T. M.'s report of blood in her stool and the feeling of needing to move her bowels when she did not really need to do so. Respondent noted in the medical records: "Tenesmus." "Tenesmus" is the sensation of an urge to have a bowel movement. Under "tenesmus," Respondent wrote: "Bleeding + urgency urination." At this point, Respondent correctly commenced the process of diagnosis, rather than screening which is the performance of a test on an asymptomatic population. T. M. presented with specific complaints and symptoms that required diagnosis; by the second visit, she had self-screened. T. M.'s relevant history was that family members had had cancer, but not colon cancer. She had had hemorrhoids, but only during her two pregnancies. Respondent performed a focused examination to determine the source of T. M.'s complaints. Respondent conducted a urinalysis to rule out a urinary tract infection. The urinalysis was negative. Respondent next performed an anoscopy. An anoscope is a funnel-like instrument 4-6 inches long that is inserted into the anus. A separate light source allows the physician to observe the anus and rectum, just past the anal verge, for a total distance of about 6 centimeters. Respondent placed his finger into T. M.'s anus, but not for the purpose of conducting a digital rectal examination. A physician conducting an anoscopic examination first inserts a finger into the anus in order to relax the sphincter and confirm the absence of any blockages that would prevent the insertion of the anoscope. Consistent even with Respondent's augmented records, Respondent performed no separate digital examination of T. M.'s rectum. The purpose of the digital rectal examination is to feel the contour of the rectal wall for bumps, irregularities, or areas of unusual consistency. Although the location of T. M.'s cancerous lesion would have been within reach of a digital examination, the record does not establish that that anything would have been discoverable at the time of the June 28 office visit. Testimony to this effect from Petitioner's expert witness, Dr. Thomas Hicks, did not establish clear and convincing proof because, despite Dr. Hicks' evident competence, of his expertise in family medicine, rather than oncology, and the difficulty of determining, in hindsight, the likely size of cancerous lesions based on their condition months later after surgical intervention. The parties discuss in their proposed recommended orders Respondent's failure to document a digital rectal examination, but their shared assumption--that one took place--is unwarranted. The failure to perform a digital rectal examination raises a question as to Respondent's conformance with the applicable standard of care, but the real standard-of-care issue is Respondent's handling of the preparation of a treatment plan. As Dr. Hicks' testified, the timely preparation of a treatment plan would have satisfied all standard-of-care issues, despite the failure to perform a digital rectal examination. The situation is similar as to the performance of a hemocult blood test. Respondent's testimony that he performed one is rejected as a fabrication. The records reflect no such test. The failure of the medical records to document the hemocult blood test is thus explained by the failure of Respondent to conduct this test. The anoscopy was negative. Respondent recorded in his medical records: "Anoscope + Hemorrhoids. No clots." Following the anoscopy, Respondent tentatively diagnosed T. M. as suffering from hemorrhoids. However, Respondent set up an appointment for T. M. to return to the office for a sigmoidoscopy, which would allow examination of the lower intestine above the area examined by the anoscope. Respondent made undated additions to the medical records for the June 28 office visit. Below the recorded findings from the anoscopy, Respondent later added: "Wall color looks OK." In the original record, Respondent concluded the entries with documentation that he prescribed Anusol and stool softener and would perform a "Sigmoid to [check mark] higher up." The relevant changes were to write "Plan" beside these notes, number the three steps, and add "for malignancy" after "higher up." On July 2, 1991, T. M. visited Respondent's office so that he could conduct a sigmoidoscopy. This examination involves the insertion of a flexible tube, with its own light source, through the anus and rectum and into the sigmoid colon up to 60 centimeters for observation of the rectum and sigmoid colon. Respondent was able to insert the sigmoidscope 45 centimeters, which was adequate. He detected a spastic colon, hemorrhoids, and diverticuli, but no lesions or strictures. The absence of lesions or strictures is an indicator of the absence of precancerous or cancerous conditions. The findings of the sigmoidoscopy were thus consistent with Respondent's working diagnosis of hemorrhoids. Respondent again made undated additions to T. M.'s medical records, but the additions are unremarkable augmentations to the original notes, which adequately described the findings of the sigmoidoscopy. Following the June and July office visits, T. M.'s symptoms worsened. She began bleeding between bowel movements and was losing more blood. She felt tired all the time. She continued to feel pressure in the area of her rectum. Respondent discussed with T. M. her symptoms. He learned that she experienced some constipation, but no spasms, no feeling of a foreign body in her anus, and no abdominal or urinary tract pain. Respondent noted these findings in T. M.'s medical records. For the September 24 office visit, the medical records reflect the above-described discussion together with Respondent's recommendation that T. M. take a stool softener. Respondent later added notes showing that he reviewed the findings of the sigmoidoscopy. In the space between two lines in the original records, Respondent added: "She may need colonoscopy + referred to GI." Other additions immaterially expanded on the original notes. At the bottom of the note for this office visit, Respondent added: "To GI soon if not resolved. She will call." Respondent produced a "super bill" for the September 24 office visit. The bottom of the bill contains a block for the next appointment. The lower left-hand corner of the block states "wait." The remainder of the block states: "Appt. Dr. K. Hussey. Reason: rectal bleeding. Needs colonoscopy." Beneath this block at the very bottom of the page is the following statement: "(She will call us)." T. M. did not have her copy of this super bill. Nothing in the record suggests that, when requested to provide T. M.'s medical records to the New York physician, Respondent's office sent a copy of the super bill, which Respondent unsuccessfully contends is part of T. M.'s medical records. While notations on super bills that do not functionally assist in the process of ensuring continuity of care do not qualify as medical records, the other question concerning the super bill is whether it serves as contemporaneous documentation of Respondent's recommendation that T. M. consult a gastroenterologist. Respondent's readiness to add undated entries to T. M.'s medical records inspires no confidence in the self- serving note contained at the bottom of the super bill. To the contrary, given the succinctness of Respondent's unaltered medical records, it is unlikely that Respondent would take the time, on a bill, to write in the reason for the appointment with Dr. Hussey and the need for a colonoscopy. The parenthetical comment that T. M. will call Respondent's office renders these entries even more suspicious. A preponderance of the evidence, but not clear and convincing evidence, suggests that these entries on the super bill are also undated additions following Respondent's discovery that T. M. had rectal cancer. T. M. did not return to Respondent. Instead, while visiting her brother-in-law, who is a physician, in New York over Christmas, she scheduled an appointment on December 27, 1991, with a gastroenterologist who practiced with the brother-in-law. The physician performed a digital rectal examination and found a firm irregular area on the anterior wall of the rectum. A sigmoidoscopy revealed a large ulcerated lesion approximately 2 to 3 centimeters above the anal verge. After additional diagnostic work, a surgeon removed the lesion and performed a permanent colostomy in early January 1992. Petitioner contends in its Proposed Recommended Order that Respondent deviated from the applicable standard of care when he did not order a complete blood count during the September 24 office visit. However, Dr. Hicks accurately defined the issue when he testified that the complete blood count, as was the case with the omission of a digital rectal examination on the June 28 office visit, would not have represented a departure from the applicable standard of care if Respondent had timely prepared a treatment plan. The issue of the timeliness of the preparation of a treatment plan arises as of the September 24 office visit. Dr. Hicks' testimony precludes a finding that the failure to develop a treatment plan to pursue an alternative to the working diagnosis of hemorrhoids was a departure from the applicable standard of care any earlier than the September 24 office visit. As of the September 24 office visit, though, Respondent had three alternatives. He could either perform sufficient diagnostic tests to explore T. M.'s ongoing symptoms, he could refer her to a gastroenterologist, or he could briefly continue treatment of hemorrhoids. There is no dispute that Respondent attempted further diagnostic tests after the September 24 office visit; he did not do so. Respondent contends that he continued treatment of the hemorrhoids. There is a brief note on December 2, 1991, that T. M. received a prescription to control bowel spasms. However, Respondent's nurse evidently prescribed this medication on her own, and the spasms were not shown to be linked to hemorrhoids. To the contrary, Respondent testified that he felt that her problem at the September 24 office visit was likely constipation, which could aggravate the hemorrhoids. There is no evidence that Respondent elected, at the end of the September 24 office visit, to briefly continue treating hemorrhoids; if nothing else, Respondent's contentions about a gastroenterological referral tend to undermine further treatment by him of hemorrhoids. There is no dispute that Respondent could have met the applicable standard of care by referring T. M. to a gastroenterologist at the end of the September 24 office visit. However, the evidence is clear and convincing, despite Respondent's testimony and other evidence to the contrary, that he did not do so. This finding is based partly on the testimony of T. M., whose recall of her visits with Respondent and her visit with Dr. Cooper is obviously imprecise and sometimes inaccurate. This finding is also based on a close assessment of the evidence offered by Respondent to support his contention that he made a referral. Assessment of Respondent's contention of a referral begins with close examination of the already-noted entry, "She may need colonoscopy + referral to GI." This entry does not evidence a recommendation of a consultation, but rather mentions the possibility that a consultation might take place in the future. On January 10, 1992, T. M.'s mother called Respondent and informed him of T. M.'s rectal cancer surgery. At this time, Respondent, who was unaware that his office had already supplied a copy of T. M.'s original medical records to her New York physician, made all of the above-described changes in the medical records, plus another, properly dated entry, which states: "I recommended GI at last visit for a check-up or a colonoscopy but she did not schedule." However, despite the fact that Respondent made these two notes on the same date, they reveal a significant discrepancy. Unlike the added note for September 24, which refers to a future referral, the note for January 10 refers to an actual referral. In a deposition taken four years after the surgery, Respondent gave a more elaborate version of whether he made a referral during the September 24 office visit and reveals the same variation between an actual referral and a possible referral in the future. Taken for a pending medical malpractice action that T. M. had brought against Respondent, the deposition testimony states: Q. You would agree with me, sir, if you failed to get her to see a doctor other than yourself to get this problem checked out that that would have been a breach in the standard of care? A. If I failed to what? Q. If you failed to send her to a doctor--if you said, T[.], you need to get somebody to check this out, I want you to go get this checked out, then you would have breached the standard of care, wouldn't you, sir? A. If I told her to go somewhere? Q. If you failed to tell her. A. I would agree. * * * Q. All right. Did you suspect in your differential diagnosis on 9-24-91 when she came in that could be rectal cancer? Was that in your differential diagnosis? A. Yes, it could have been. Q. Okay. When you told her that you--I assume that you told her then--it's your contention you told her at that time you could have rectal cancer; correct? A. No. Q. You didn't tell her that? A. No. Q. Why not? A. Because--I mean, I told her that she needed to have this evaluated. That doesn't mean she has rectal cancer, to get it evaluated. Q. Well, what did you tell her if you suspected that she could have that and that was properly in your differential diagnosis to impress upon her the need to follow through, if anything? A. You mean to scare her into getting--into making an appointment? Q. Well, not to scare her. You didn't need to scare her to do it, did you? A. No. Q. Well, what did you say to her to get her to make the appointment? A. That she should--if this doesn't resolve, she should get an opinion from a gastroenterologist. Q. If this doesn't resolve; is that right? A. If this continues. Q. Okay. So if I understand what you're saying now, you didn't tell her you definitely need today to go get this. You told her, well, if it doesn't resolve, then you should see somebody--see a gastroenterologist? A. That why the-- Q. Am I correct? A. Well, I sort of let it--well, I didn't leave it at that, but it was--it was problem enough to get some other opinion. Q. Why was it problem enough to get some other opinion? A. Because it's been so persistent. * * * Q. What do you mean, because it's been so persistent? A. Well, the complaint has been going on for months. Q. Okay. And what about that persistency that this complaint's been going on for months made it difficult to have her go see somebody else? A. Well, it wasn't that. It was--I think it was her hesitance to make an appointment, whether to have something done or not or to have an operation or to have, you know, the hemorrhoids looked at. It wasn't that type of thing that she was looking forward to, so we sort of put a wait on it. We didn't go through with making the appointment. Q. Okay. When you say we put a wait on it, then this was something you discussed? A. Right. Q. And she—what did she say that gave you the impression that she wanted to wait? A. Well, she was--you know, she was upset about the whole thing. Q. Okay, because it had been going on so long? A. Right. Q. And you said-- A. Then--then about the other--then going to another physician, of having a specialist-- specialist look at her to do a procedure, you know, the same type of procedure except it would be more thorough, more--you know, a colonoscopy and possibly some procedure like a surgical procedure. Q. Well, was it your belief on 9-24-91 that it could, in fact, be just simply hemorrhoids? A. It was possible, but that--that wasn't--I mean, there was hemorrhoids, but that might not have been the reason for all her problems. Q. Did you ever say to her, T[.], the persistence of this problem leads me to believe that it might be something other than hemorrhoids? Did you ever say anything like that to her? A. Yes. But I did not mention malignancy or anything like that. Q. Were you trying to convince her to go get another opinion or another examination? A. No. I mean, I didn't. Q. Why not? A. Right now I don't recall why not, but-- Q. Okay. (Petitioner Exhibit 5, pages 117-22.) Each of Respondent's recountings of his discussion with T. M. on September 24 varies with regard to whether he recommended a referral or merely discussed the possibility of a referral in the future. The thrust of the deposition testimony is essentially is that Respondent was concerned about the possibility of rectal cancer and wanted T. M. to see a gastroenterologist, that T. M. resisted this recommendation, and that, in the face of this resistance, Respondent did not voice his concern about the need to rule out rectal cancer. This testimony is simply not credible. If he were making a firm recommendation of a referral, he would have voiced his explicit concerns, even if only as to the necessity at this time to rule out these more serious possibilities. If Respondent discussed a referral with T. M. at all, he mentioned nothing more than the possibility of a referral at some point in the future; interestingly, this is consistent with the additions to the September 24 medical records. Thus, the evidence is clear and convincing that Respondent did not refer T. M. to a gastroenterologist at the end of the September 24 office visit. The evidence is clear and convincing that Respondent did not prepare any other form of treatment plan, besides a referral, that would meet the applicable standard of care. As for the fraudulent alteration of medical records, the first question is whether Respondent discussed even a future referral with T. M. during her September 24 office visit. It is a close question, but the evidence is less than clear and convincing that Respondent did not discuss even the possibility of a future referral, just as the evidence is less than clear and convincing that Respondent fabricated the note on the super bill. However, the evidence is clear and convincing that the January 10 note fraudulently claims that Respondent recommended a gastroenterological consultation for a check-up and colonoscopy, but T. M. did not schedule an appointment. As for whether the medical records justify the scope and course of treatment, this issue is subsumed in the standard- of-care and fraudulent-records issues. To the extent that the records (i.e., September 24 entry) fail to reflect a clear referral to a gastroenterologist or alternative treatment plan, they do not justify the scope and course of treatment, but this issue is covered by the standard-of-care issue. To the extent that the records (i.e., January 10 entry) are fraudulent, this issue is covered by the fraudulent-record issue.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of one violation of Section 458.331(1)(t) and 458.331(1)(k), but not Section 458.331(1)(m), and imposing the following penalties for these two violations: 30 days' suspension followed by two years' probation, ten hours of continuing medical education in ethics, and a $10,000 fine. DONE AND ENTERED this 2nd day of April, 1999, in Tallahassee, Leon County, Florida. ROBERT E. MEALE 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 2nd day of April, 1999. COPIES FURNISHED: Kristina L. Sutter John Terrel Senior Attorneys Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Grover C. Freeman Jon M. Pellett Freeman, Hunter & Malloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Pete Peterson, General Counsel Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750
