The Issue This is a proceeding under Section 408.7056, Florida Statutes (2002), in which the issue is whether the denial by Health Options, Inc. (the Petitioner), of a request that it cover additional lymphedema outpatient therapy after a mastectomy to treat C.B. (the Subscriber),1 is consistent or inconsistent with the rules and laws that regulate managed care entities.2
Findings Of Fact The following facts were stipulated to at hearing by the Petitioner and AHCA: Effective April 1, 2002, the Subscriber in question was enrolled as a participant in a group HMO plan issued by the Petitioner to the Subscriber’s employer for the benefit of its employees and their eligible dependents. This plan constitutes an “employee welfare benefit plan” pursuant to the Employee Retirement Income Security Act of 1974 (ERISA). As a result of breast cancer, the Subscriber had a partial mastectomy of her left breast. Subsequent to her surgery, she required decongestic therapy due to lymphedema. The Petitioner authorized and provided coverage for decongestic physical therapy benefits for the Subscriber for services rendered from a participating provider for the authorized period of August 9, 2001, through October 18, 2001. The Petitioner denied coverage for additional decongestic physical therapy beyond the authorized period of August 9, 2001, through October 18, 2001, on the grounds that the Subscriber’s benefit had been exhausted under the terms of the Member Handbook. The Member Handbook for the Subscriber's HMO, signed by Robert I. Lufrano, M.D., the president of the Petitioner’s company, establishes the description of the rights and obligations of the Subscriber and the Petitioner with respect to the coverage and/or benefits to be provided by the Petitioner. Pages 20-23 of the Member Handbook requires the preparation and review every 30 days of a treatment plan as recommended by the Subscriber’s primary care physician or authorized provider. Further, provisions of the Member Handbook document the Petitioner's obligation to comply with state and federal laws and regulations and states that the terms of the agreement shall be interpreted to comply with those laws. Joel Mattison, M.D., is board-certified in plastic and reconstructive surgery. He holds a license in Florida and in North Carolina to practice medicine and surgery. Dr. Mattison has a specialty in plastic surgery and tropical diseases. Dr. Mattison's testimony establishes that the most common treatment form for lymphedema is a method of massage known as decongestic therapy. Lymphedema is the type of problem that will reoccur and no current treatment permanently eliminates the problem. If treatment is not received, the patient will suffer swelling of the body part located near the problem area causing trauma and infection with fungi and bacteria. The decongestic therapy is outpatient post-surgical follow-up care in keeping with the prevailing medical standard. As established by Dr. Mattison's testimony, the massage, which is the prevailing medical standard of care for lymphedemas, could be needed in excess of 62 days. Included in the therapy is the education of the patient to perform self-massage. The instruction in self-massage, however, is only part of the therapy and the other massage should not be discontinued. The evidence does not establish that the Subscriber received any instruction in self-massage or her ability to perform this function. In addition, Dr. Mattison testified that lymphedemas as a result of reconstruction and as a result of mastectomy, are indistinguishable without other indication, such as scars or patient history. Dr. Mattison testified that lymphedema pumps are available to assist in treatment. While it is hoped that the patient will learn how to use the pump, patients cannot always be depended on to learn to use them. The evidence fails to establish that the patient was offered a lymphedema pump or that using the lymphedema pump constitutes the prevailing medical standard.
The Issue Should Respondent be disciplined for practicing beyond the scope of his license or by accepting and performing professional responsibilities which he knows or has reason to know that he is not competent to perform? See Section 460.413(1)(t), Florida Statutes, formerly Section 460.413(1)(u), Florida Statutes.
Findings Of Fact Petitioner is charged with regulating the practice of chiropractic pursuant to Sections 20.165, 20.42, Florida Statutes and Chapters 455 and 460, Florida Statutes. Respondent is a Florida licensed chiropratic physician. His license number is No. CH-0001538. He was issued that license on September 21, 1968. Respondent practices chiropratic at the McCall Chiropractic Clinic located at 811 Grace Avenue in Panama City, Florida. Respondent is not licensed as an osteopathic or allopathic physician as recognized by the Florida Board of Osteopathic Physicians or the Board of Medicine respectively. In 1992 Respondent sent Micheal Smith, D.C., a chiropractic physician practicing in Panama City, Florida, information described as an invitation for Dr. Smith to join Respondent in clinical research "designed to test the effectiveness of Scalar E.M. Technology upon AIDS-CANCER opportunistic organisms falling within the meaning of chapter 460.403(3)(a)(b)(c)(e), and Rule 21D-1702, Florida Statutes." The correspondence went on to describe some details about the research. In particular, Respondent stated that "preliminary field data suggest that Scalar E.M. TENS Technology is effective in 47 pathological conditions including AIDS-Cancer disease." The correspondence also set forth information concerning patients who wished to contribute to the research by making financial contributions to the "Allaganey Occupational Development Foundation, 22 Floor Pacific First Center, 1425th Avenue, Seattle, Washington 98101-2333". Respondent provided Dr. Smith a sheet on the McCall Chiropractic Clinic letterhead related to purported medical research at Stanford University in 1988 studying "the Biological Interactions with the Scalar Energy Cellular Mechanisms of Action" in response to weak ELF ectromagnetic (EM) radiation and the claimed results. That sheet describes how the McCall Chiropractic Clinic would be "conducting private research into the effectiveness of Scalar E.M. Technology upon the following conditions, for a two-year period of time." Arthritis Arm Pains Angina Pectoras Arethemia Asthma Allergies Bacterial Infection of the Lung Carple Tunnel Syndrome Cancer of the: Bone, Brain, Bladder, Bowell, Lungs, Liver, AIDS Colon Polyps Cholitis Candidia Albicans Deafness Diabetes Neuropathy Emphysemia Eckcemia Ear Infection Epstine Barr Infection Exothalmic Goider Feavers Fungus of the skin Fibrosis of the Lung Gout High Blood Pressure Herniated disc Herpes B infection Hemrroids Hardening of the arteries Herpes of the Genitals Hypertrophy of the Prostate Inflimation of the joints Nectniuria Kendidia Albicans Leg Pains Multipleschlerosis Musculardistrohy Neuropathy Nose bleads Premenstral Syndrome Paracititis of digestive track Phlebitis Sinus Infection Tumors of the Eye Varicose Veines Warts Leupus Erethematosis Parkinsons Disease Dr. Smith was also provided with a copy of an advertisement which stated: ATTENTION: Aids - Cancer Patients Dr. Curtis J. McCall, Jr. Chiropractor Research program utilizing scalar tens antineoplastic technology is available through the provisions of Chapter 460.403(3)(a)(b)(c)(e) Rule 21D-1702 Florida Statutes. Patients suffering with Aids - Cancer disease who would like to participate in the research program should call 769-1708 for an appointment or come by the office: 811 Grace Ave., P.C., Fla. 32401 In the 1993 yellow pages for the Panama City, Florida, telephone book, Respondent placed an advertisement to this effect: MCCALL CHIROPRACTIC CLINIC PEOPLE HAVE TRUSTED THE HANDS OF DR. McCALL SINCE 1968 -- TENS AIDS -- CANCER THERAPY -- 811 Grace Av Panama Cy 769-1708 In the July 8, 1993 advertising service in the "Thrifty Nickel" circulated in Panama City, Florida, Respondent placed the following advertisement: NOTICE: The McCall Chiropractic Clinic has on display a 1953 classified federal document that discloses successful treatment for cancer. Patient response indicates this technology is effective in the treatment of 47 conditions. This technology is available through the provisions or Chapter 460- 1403(3), (a), (b), (c), (e). Rule 210-1702 Florida Statutes. Phone 769-1708 for appointment, 811 Grace Avenue, Panama City, Florida 32401. F24 On July 19, 1993, Respondent, on stationary from McCall Chiropractic Clinic, wrote to TCRS, Inc., in Tallahassee, Florida, asking that company to place McCall Chiropractic Clinic on its list of AIDS/Cancer Therapeutic Center listings for national referrals. That correspondence gave a brief description of the service that Respondent intended to provide. It indicated that the therapy to be provided would cost the patient $18.00 per 20 minutes. Through Respondent's activities that have been described, Respondent directly held himself out to the public as having the ability to treat persons with AIDS. In furtherance of his intentions, Respondent developed a treatment protocol consisting of approximately 55 weeks of treatment to be monitored initially by Respondent at his chiropractic facility. That protocol required the patient to receive TENS therapy for two hours each day. The TENS device is designed to deliver transcutaneous electrical nerve stimulation. Its principal chiropractic use is for pain control. However, Respondent, in his intended care, contemplated that the device would stimulate "T-Cells" in combatting AIDS. In the protocol, Respondent also required monthly blood tests to monitor the patient's "T-Cell" counts. The protocol required the patient to be free from all other drugs, in particular, the AIDS treatment medication "AZT". Under the protocol, the patient was required to receive a weekly injection of a compound identified as "chondriana", in amounts determined by Respondent. Finally, the patient was to ingest a compound identified by Respondent as "life crystals". On or about February 4, 1994, Respondent began to care for the patient C.L. That care ended on September 29, 1994. In this arrangement Respondent and C.L. had a chiropractic physician-patient relationship. Patient C.L. died on August 18, 1995. Respondent made a diagnosis, proposed a course of treatment and directly treated C.L. for AIDS. In this treatment Respondent maintained a patient record for C.L. In an effort to secure reimbursement for the services provided to C.L., Respondent prepared insurance claim forms, affixing a diagnosis of AIDS to the claim forms and had C.L. assign benefits to the Respondent from the insurance policy. In this connection Respondent had C.L. execute a sworn statement describing the services received from Respondent. It was Respondent's expectation that the claim forms would be honored by the insurance carrier and that Respondent would be paid for the services rendered to C.L. With one exception, Respondent's billings to the insurance carrier for C.L.'s visits to Respondent's office were all for the treatment of AIDS. An investigation was instituted by the State of Florida, Department of Business and Professional Regulation/ Agency for Health Care Administration to ascertain whether Respondent was offering patient treatment for AIDS. James Cooksey, an investigator with the regulator, performed that investigation in conjunction with Tom Willoughby, investigator for the Bay County, Florida, Sheriff's Office. James Cooksey is an insurance fraud/medical malpractice investigator. To conduct the investigation Mr. Cooksey assumed the fictitious name James Stark. The reason for assuming the name was to present James Stark as a patient suffering from AIDS. In furtherance of the investigation Mr. Cooksey went to the Tallahassee Memorial Regional Medical Center and obtained a fictitious positive AIDS test in the name James Stark. On May 16, 1994, Mr. Cooksey initiated contact with Respondent. The investigator traveled from Tallahassee to Panama City. When he reached Panama City he called Respondent and told Respondent that he needed to come and talk to him. Respondent invited Mr. Cooksey to come by that afternoon. On May 16, 1994, Mr. Cooksey met with Respondent at Respondent's office. At that meeting Mr. Cooksey told Respondent that the investigator understood that Respondent could possibly cure AIDS. Mr. Cooksey further stated that he had seen something in a newspaper article that Respondent was treating AIDS patients and explained to Respondent that Mr. Cooksey had contracted AIDS and was interested in being cured. Mr. Cooksey provided Respondent with the results of the fictitious blood test. When Mr. Cooksey presented to Respondent he did not complain of any condition other than AIDS. Respondent did not physically examine Mr. Cooksey. Respondent explained to Mr. Cooksey about the nature of Respondent's treatment in which the TENS unit, also known as a Rife machine, chondriana and life crystals would be used. To demonstrate the treatment Respondent took Mr. Cooksey into a room in the back of his office, a treatment room, and had Mr. Cooksey take his shoes and socks off and place his feet on a metal pad associated with the TENS unit. When the unit as turned on Mr. Cooksey could feel tingling inside his feet. On this occasion Respondent told Mr. Cooksey that, he, Mr. Cooksey could get injections of chondriana and then the machine would be turned on and Cooksey would receive stimulation to fight the infection associated with AIDS. Respondent told Mr. Cooksey that the initial treatments for AIDS would have to be done at his office where Respondent would monitor the investigator. Respondent indicated that a nurse would come to the office and give the injections of chondriana and that Mr. Cooksey would be monitored concerning those injections until Mr. Cooksey's "system built up a little". Mr. Cooksey understood that he was to receive those injections and use the TENS unit and was not to take other forms of medication during the treatment. Respondent gave Mr. Cooksey a card with the name of a blood test that would need to be obtained and the results reported to Respondent. Mr. Cooksey was responsible for paying for the blood test. Respondent told Mr. Cooksey that the life crystals were to be taken in orally as a drink and they were described as being part of the AIDS treatment. On this date Respondent gave the investigator an estimate of the costs of this treatment, constituted of $2,000 for the TENS unit and $2,925 for chondriana and life crystals. Subsequent to that date Respondent called Mr. Cooksey and left a message on Cooksey's telephone. Respondent also wrote the investigator on May 23, 1994, providing the investigator more information concerning Respondent's treatment for AIDS. The investigator then went to the state attorney's office in Panama City and informed the state attorney of the nature of the administrative investigation and the belief that the activities by Respondent might constitute a criminal law violation. The state attorney represented to the investigator that he concurred. The state attorney then had Mr. Cooksey contact the Bay County Sheriff's office. Following that contact Mr. Cooksey took up a joint investigation between Mr. Cooksey and Bay County Sheriff's investigator Tom Willoughby. On October 18, 1994, Mr. Cooksey placed a call to Respondent and told the Respondent that he was in Panama City and would like to come by and meet with the Respondent and that he would be accompanied by a friend who might be able to "come up" with the money that was required to purchase the chondriana and life crystals and TENS unit. The part of the friend was to be played by Officer Willoughby. Mr. Cooksey and Officer Willoughby then went to Respondent's office where Respondent again explained the nature of the AIDS treatment. Officer Willoughby asked the Respondent questions concerning the nature of the treatment and how much the treatment would cost. Respondent explained that the treatment involved injections of the chondriana, drinking the life crystals and using the TENS machine for two hours a day to treat James Stark for AIDS. At the October 18, 1994 meeting between the investigators and Respondent, Respondent stated that a nurse practitioner with whom he was friends would administer the chondriana and that activity would be monitored by Respondent in Respondent's office. Officer Willoughby asked Respondent if there would be side affects to the injections. Respondent indicated that there would be sweating and that Respondent would monitor Mr. Cooksey for whatever period of time would be necessary for the side affects to subside. The investigators watched a video tape explaining the treatment for AIDS which Respondent intended to employ. The injections of chondriana would be given monthly. Respondent indicated to the investigators that he would instruct Mr. Cooksey on how many of the life crystals to take. Respondent told the investigators that the cost of the TENS unit was $2,000.00 and that the unit would be used to spread the impulses through out the body. Respondent indicated to the investigators that the nature of the treatment would form new T-cells to replace T-cells containing the AIDS virus or which were cancerous. Respondent had stated in Officer Willoughby's presence that the TENS unit cost $500.00 to produce. Respondent and the two investigators then went to a local health food store, known as the Olive Leaf, to ascertain the amount of money needed to pay for chondriana which the health food store would provide. There, the attendant at the store indicated that he could arrange to provide the chondriana and life crystals for a price approximating $2,800.00. After leaving the health food store the investigators told the Respondent that they would come back with the necessary money on October 21, 1994. The investigators returned to Respondent's office on October 21, 1994, after obtaining warrants to search the office and arrest the Respondent. Before Respondent was arrested and the search made, the investigators asked Respondent to again explain the nature of the treatment that would be provided to Mr. Cooksey and paid Respondent $1,700.00 for the TENS unit from funds belonging to the Bay County Sheriff's Office. Respondent gave the investigators a receipt for the $1,700.00 payment. Respondent was then arrested for practicing medicine without a license. On one occasion Respondent explained to the investigators that the procedures that were used to treat Mr. Cooksey for AIDS were not condoned by the FDA, but that it was working in other places where it had been tried and that three patients treated in another location had gained remission from the AIDS. Based on the proof, it is found that Respondent diagnosed Mr. Cooksey as having AIDS and developed a course of treatment for that condition. Paul Doering, M.S., is a registered pharmacist in the State of Florida. He is also licensed as a consultant pharmacist in the State of Florida. He is a Distinguished Service Professor of Pharmacy Practice at the University of Florida. He is accepted as an expert pharmacist. Mr. Doering established that the drug AZT is an antiviral drug designed to address the HIV virus associated with AIDS. Mr. Doering established that AIDS is an acronym for acquired immuno- deficiency syndrome, "a disease that affects the immune system caused by a virus or different types of viruses which attack the immune system in the body rendering the body unable to effectively mount an immune response when it comes into contact with certain types of infectious organisms." Mr. Doering established that drugs are divided into two basic groups, one group which is sold without prescription and the other group requiring a doctor's prescription. The latter category of drugs are known as Federal Legend Drugs. Mr. Doering established that there is no reference to a medication known as "chondriana" in any directory of medications which he was familiar with. As he established, chondriana does not constitute a food because foods are not generally injected into the human body. Mr. Doering established that chondriana has not been approved to be used as a drug in the United States, nor is it an experimental drug, based upon his research of sources that list drugs or experimental drugs. Marianne Gengenbach, D.C., is licensed to practice chiropractic in Florida and is an expert in chiropractic practice. She established that chiropractors are limited to using proprietary drugs, and then only where the chiropractor has passed a specific exam and obtains a proprietary drug license. Proprietary drugs are "over the counter drugs" not prescription drugs. Absent such as a license to prescribe proprietary drugs chiropractors may only make recommendations, educate patients and prescribe nutritional supplements. Dr. Gengenbach established that Respondent had diagnosed C.L. for AIDS and had treated C.L. for that condition. The treatment was directly related to the condition AIDS, and Dr. Gengenbach established that the treatment was outside the accepted standard of care for chiropractic and exceeded the scope of authorized practice from the view point of a practitioner. As Dr. Gengenbach established, Respondent also exceeded the proper scope of practice in caring for C.L. by recommending that C.L. discontinue the AZT therapy. Those same perceptions were held for treatment of Mr. Cooksey and are accepted. Dr. Gengenbach established that Respondent proposed a course of treatment for Mr. Cooksey related to the condition AIDS, without reference to any other complaints by the patient. As a consequence the course of treatment which Respondent planned for Mr. Cooksey was directed solely to the HIV infection as established by Dr. Gengenbach. Dr. Gengenbach established that the use of the chondriana and life crystals was intended to treat Mr. Cooksey for AIDS. Dr. Gengenbach established that even should the substances chondriana and life crystals be considered food or nutritional supplements, there proposed use for Mr. Cooksey would not meet the prevailing standard of care for chiropractic, in that they would be employed for the treatment of AIDS. Respondent intended that the chondriana and life crystals be used in the cure, treatment, therapy and prevention of AIDS in C.L. and Mr. Cooksey. Respondent intended that those substances affect the structure and function of the bodies of those patients. In proposing and carrying out the treatment that has been described directed to AIDS, Respondent did so mindful that chiropractic physicians in Florida are prohibited from directly treating the AIDS condition. Respondent's treatment of C.L. and proposed treatment of Mr. Cooksey violated the standards of practice acceptable to a reasonably prudent chiropractic physician under similar conditions and circumstances and exceeded the scope of his chiropractic license. In the past Respondent has been disciplined by the Board of Chiropractic on three separate occasions. Two of those cases involve the receipt of a reprimand and in the third case Respondent's license was suspended and he was required to pay an administrative fine. Respondent was also required to cease and desist the activities described in these facts based upon action taken by the Board of Medicine, which was persuaded that Respondent was engaging in the treatment of AIDS without benefit of a medical license.
Recommendation Based upon the facts found and the conclusions of law reached, given the severity of the offense and the danger posed to the public, it is, RECOMMENDED: That a final order be entered which revokes Respondent's license to practice chiropractic medicine in Florida. DONE and ENTERED this 21st day of November, 1995, 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 21st day of November, 1995. APPENDIX CASE NO. 95-2881 The following discussion is given concerning the proposed findings of fact of the parties: Petitioner's Facts: Paragraphs 1 through 4 are subordinate to facts found. Paragraphs 5 and 6 constitute conclusions of law. Paragraphs 7 through 13 are subordinate to facts found. Paragraph 14 is not necessary to the resolution of the dispute. Paragraphs 15 through 35 are subordinate to facts found. Paragraphs 36 through 40 are conclusions of law. Paragraph 41 is subordinate to facts found. Paragraphs 42 and 43 are conclusions of law. Paragraphs 44 through 51 are subordinate to facts found. Respondent's Facts: Paragraphs 1 through 5 constitute legal argument as reported at pages 2 through 5. The proposed facts 1-3 found at pages 15 and 16, Paragraph 1 is contrary to facts found. Paragraph 2 is rejected as a discussion of activities of the Probable Cause Panel, not a proper subject for consideration. Paragraph 3 constitutes a conclusion of law. COPIES FURNISHED: Jon M. Pellett, Esquire Medical Quality Assurance-Allied Health Agency For Health Care Administration 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 Curtis J. McCall, D.C. 514 North Bonita Avenue Panama City, FL 32401 Diane Orcutt, Executive Director Agency For Health Care Administration Board of Chiropractors 1940 North Monroe Street Tallahassee, FL 32399-0792 Jerome W. Hoffman, General Counsel Agency For Health Care Administration 2727 Mahan Drive Tallahassee, FL 32308
The Issue Whether respondent's license to practice medicine should be disciplined on grounds that: (1) he engaged in gross or repeated malpractice or failed to practice medicine with the required level of care, skill, and treatment, and (2) he is unable to practice medicine with the requisite skill and safety by reason of illness or as a result of a mental or physical condition.
Findings Of Fact Based upon the evidence presented at hearing, the following facts are determined: Respondent is an 80-year-old physician licensed to practice medicine in Florida. He has been a general practitioner in the Miami area for over 40 years; during that time, he has earned the respect and esteem of the medical community. During the 1940s, he helped establish the first cancer clinic in Dade County; he is recognized as one of the community's early medical pioneers. He has never before been the subject of a disciplinary action for professional misconduct. (Testimony of Bishop, Boughton; R-2.) I. The Claresta Halloran Abortion On July 3, 1980, Ms. Claresta Halloran, age 35, visited respondent's office for a therapeutic abortion. She told respondent that her last menstrual period was "sometime in April." (P-3.) Respondent palpated her, examined her by use of a sounding instrument, and dilated her uterus. After determining that she was approximately 12 weeks pregnant, respondent attempted to abort the fetus by suction and curettage. Fearing that he had perforated Ms. Halloran's uterus, respondent had her transported to North Miami General Hospital for an exploratory laparotomy. Results of the exploratory surgery were negative; there was no evidence of perforation of the uterus or injury to the bowel. (Testimony of Boughton; P-3.) William Wickman, M.D., performed the exploratory surgery on Ms. Halloran at the hospital. His bimanual examination revealed an enlarged uterus, "the size of approximately [a] 12 week pregnancy." (Testimony of Boughton; P-3.) Two days after the surgery, Ms. Halloran passed a macerated fetus which, after pathological examination, was estimated to be of 17 weeks' gestation. Her convalescence from surgery was otherwise uneventful and she was discharged from the hospital the next day, July 6, 1980. (Testimony of Boughton; P-3.) Absent specialized training, abortions "from below," that is, by dilating the cervix and removing the contents of the uterus, should not be performed on pregnancies which have progressed beyond 12-weeks. This is because, after 12 weeks, the fetus's bones have developed calcium and sharp, razor-like edges which can perforate the uterus and endanger the health and safety of the patient. (Testimony of Rudolph.) Respondent has not received specialized training which would enable him to safely use the "from below" method on pregnancies beyond 12 weeks. However, his examination of Ms. Halloran led him to believe she had been pregnant for 12 weeks. In reaching that conclusion, he did not rely solely on the date of the patient's last menstrual period. His palpation and examination of the patient's uterus confirmed that the pregnancy was approximately 12 weeks. Dr. Wickman's subsequent examination of the patient at the hospital confirmed that the patient's uterus indicated an approximate 12-week pregnancy. (Testimony of Rudolph, Boughton; P-3.) There are other more advanced methods, such as sonography, which enable one to more accurately determine the gestational age of a fetus. However, the evidence does not support a finding that respondent's failure to use such methods constitutes malpractice or a failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. (Testimony of Rudolph.) Respondent admits that he erred in his diagnosis of the stage of Ms. Halloran's pregnancy. However, his diagnosis was not shown to have been unjustified or unreasonable in light of the facts known to him at the time. Both the date of the patient's last menstrual period and manual examination of the uterus supported a determination that the pregnancy was approximately 12 weeks. The "from below" abortion procedure which respondent utilized is only unacceptable for use on pregnancies in excess of 12 weeks. In short, respondent's treatment of the patient was consistent with his diagnosis. While the diagnosis was in error -- the fetus was of 17 weeks' gestation, not 12 weeks -- other physicians, under similar circumstances, would likely have made the same error. (Testimony of Boughton; P-3.) II. The Wilhemina Evans Abortion On August 5, 1980, Ms. Wilhemina Evans, age 18, visited respondent's office for a therapeutic abortion. She told respondent that her last menstrual period was at the end of April. He palpated her, placed a sounding instrument, and dilated her uterus. After concluding that she was at least 13 weeks pregnant; 2/ he attempted to abort the fetus "from below" by use of placental forceps and a curette. He thought the abortion had been successful and permitted the patient to, return home. (Testimony of Rudolph, Boughton; P-4.) The next day, the patient went to Jackson Memorial Hospital complaining of abdominal pain. Several minutes after arriving at the emergency room, she passed a 750-gram male still-born fetus. Subsequent pathological examination indicated that the fetus was of 24 weeks' gestation. (P-4.) Respondent failed, in several respects, to provide Ms. Evans with treatment which is recognized by a reasonably prudent similar physician as acceptable under similar circumstances. Without special training, the "from below" method of aborting the fetus should not have been used on a woman beyond 12 weeks pregnant. 3/ Moreover, if respondent was uncertain of the gestational age of the fetus, he should not have attempted to abort the fetus "from below" in an office setting. Despite the patient's obesity, respondent should have been able to determine the advanced gestational stage of the fetus. Finally, a reasonably prudent similar physician would have realized that the attempted abortion had been unsuccessful and would not have permitted the patient to immediately return home. Thus, it is concluded that respondent's treatment of Ms. Evans was inconsistent with acceptable medical practice. 4/ (Testimony of Rudolph.) III. Treatment of Skin Lesions of Bernice Riordan Since 1951, Bernice Riordan, age 68, has been a patient of respondent's. Over the years, he treated her for various ailments, including basal cell carcinomas and squamous cell carcinomas on her face and neck. He used different techniques to treat the carcinomas; electrocoagulation in 1955; electrodesiccation and silver nitrate in 1961, 1962, 1972, and 1976; bichloracetic acid in 1976; and 5-Fluorouracil in 1978. In April, 1961, respondent referred Ms. Riordan to a dermatologist for specialized treatment. In 1969, he referred her to Jackson Memorial Hospital for radiation therapy because of multiple lesions on her face. She was a difficult and eccentric patient; she continually resisted his efforts to refer her to specialists for treatment of her increasingly serious carcinomas. Finally, in 1980, he referred her to two specialists -- a plastic surgeon and another dermatologist. By 1980, the cancer of the skin on her face had destroyed the entire nose and perioral skin. (Testimony of Boughton; P-2.) The Department presented, by deposition, the testimony of Dr. Richard C. Childers, a dermatologist who had reviewed the patient records of Ms. Riordan. He graduated from medical school in 1969 and was licensed to practice medicine in Florida in 1971. Since 1974, he has engaged in the private practice of dermatology in Gainesville, Florida, with a clinical appointment at Shands Teaching Hospital. It was Dr. Childers' opinion that respondent should have referred Ms. Riordan, no later than 1959, to a specialist for treatment of recurring skin lesions. Dr. Childers also opined that respondent, on numerous occasions over the years, had used ineffective or inappropriate treatment techniques on Ms. Riordan's lesions. (P-2.) Dr. Childers' testimony is rejected as inadequate to establish that respondent failed to provide treatment to Ms. Riordan which is recognized by a reasonably prudent similar physician as being acceptable under similar circumstances. Dr. Childers is a specialist in dermatology, not a general practitioner. He practices in Gainesville, not Miami. When respondent applied many of the complained of treatment techniques to Ms. Riordan, Dr. Childers had not yet begun medical school. It would be patently unfair to measure treatment for carcinomas furnished by a general practitioner in 1961 by a specialist's with the standard of care applicable to general practitioners in the Miami area during the period in question. to establish an appropriate standard of care applicable to respondent's treatment of Ms. Riordan. (Testimony of Boughton; P-2.) IV. Respondent's Ability to Practice Medicine with Reasonable Safety to His Patients On April 27 and 30, 1981, a mental status examination was given psychiatrist's opinion, respondent's appearance, behavior, and overall thinking was intact; there was no evidence of psychosis. However, respondent's response was somewhat impaired. Dr. Bishop concluded that respondent suffers from of Bishop.) Respondent recognizes that his advanced age affects his ability to However, he believes that he is able to operate an office practice with reasonable skill and safety and without endangering his patients. He is willing his work. The practice of medicine is his avocation as well as his profession; it is the habit and pleasure of his life. (Testimony of Boughton.) interfere with his ability to practice medicine with reasonable skill and safety to his patients. The ability to remember facts is essential to a physician's patient's illness. (Testimony of Bishop.) However, the evidence is insufficient to demonstrate that respondent's his livelihood. The evidence on the extent which his impairment will affect his ability to practice is problematic. He is willing to submit to the supervision supervision of another physician, it is likely that he will be able to practice medicine with reasonable skill and safety to his patients. (Testimony of
Recommendation Based on the foregoing, it is That respondent's license to practice medicine be suspended until respondent submits to the Board an acceptable proposal which ensures that his the Board approves the proposal, respondent should be placed on a probationary status and his practice restricted to exclude the performance of surgery and DONE AND RECOMMENDED this 20th day of November, 1981, 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 20th day of November, 1981.
The Issue The issue in this case is whether the Board of Medicine should discipline the Respondent, Carlos C. Soriano, M.D., on allegations contained in an Administrative Complaint filed against the Respondent in DPR Case No. 89-05941: namely, allegations that the Respondent practiced medicine below the acceptable level of care, skill and treatment, in violation of Section 458.331(1)(t), Fla. Stat. (1993), by failing to offer one of his patients the option of radiation therapy or chemotherapy for cancer of the rectum and by inappropriately delaying treatment for the condition.
Findings Of Fact The Respondent, Carlos C. Soriano, M.D., is a physician licensed in the State of Florida, holding license number ME 0024149. In late 1988 and early 1989, the Respondent, Carlos C. Soriano, M.D., was the medical director of a health maintenance organization called Gold Plus. On or about October 24, 1988, a physician at Gold Plus examined the patient in question, a 90 year-old female in apparent good health for her age, and made a preliminary diagnosis of suspected cancer of the rectum. She referred the patient to the Respondent, a surgeon, for further evaluation and treatment. The Respondent examined the patient on October 31, 1988. He confirmed his associate's preliminary diagnosis of cancer of the rectum but pointed out that a flexible sigmoidoscopy with biopsy would be necessary to make a final diagnosis and to determine the kind of cancer involved. The diagnostic procedure was scheduled for November 17, 1988. The Respondent also discussed with the patient that, due to her age and the size and extent of the tumor, surgical removal of the tumor may not be appropriate. The Respondent suggested that the best course might be to perform a palliative colostomy, if necessary, and "let nature take its course." The patient was not pleased with the Respondent's attitude and consulted a nephew, who was a physician, for advice. The nephew referred the patient to another physician, who was a gastroenterologist, for a second opinion. The gastroenterologist examined the patient on or about November 8, 1988, prepared a report for the referring physician, with copies also sent to the patient and to the Respondent. The gastroenterologist's report recommended: a colonoscopy and biopsies like those already scheduled by the Respondent; a complete work-up preliminary to surgical removal of the tumor (including CEA levels, a liver/spleen scan, chest X-ray, and CT scan of the pelvis) to determine whether the cancer had metastasized; and (3) radiation therapy if there was no evidence of metastasis, or palliative radiation prior to snare polypectomy or laser fulguration, to avoid the necessity of a colostomy in the future if there was evidence of metastasis. The Respondent performed the flexible sigmoidoscopy and three biopsies as scheduled on November 17, 1988. He told the patient he would discussed the results with her as soon as they were received from the pathology laboratory. The Respondent received the pathology report and scheduled an appointment to discuss the results with the patient and her family (another nephew, and his wife) on November 30, 1988. The pathology report on the biopsies confirmed that the tumor was malignant. The report stated that the cancer was coacogenic. At the time, and to this day, radiation therapy and chemotherapy is not considered effective curative treatment for coacogenic carcinomas. Assuming the accuracy of the report, the only course of possible effective curative treatment for the patient was surgical removal. Whether or not the cancer had spread, the Respondent did not think surgical removal was appropriate for the patient, due to her age and the size and extent of the tumor. He did not think she would tolerate the kind of surgery that would be required. The decision whether to perform a particular surgery on a particular patient requires the exercise of the physician's professional medical judgment. Such a judgment cannot be made without a knowledge of the patient, through history and physical examination. It is found that, based on all of the evidence, including the Respondent's knowledge of the patient, through history and physical examination, the Respondent's medical judgment not to recommend surgical removal of the patient's tumor was not below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. During the meeting with the patient and her family on November 30, 1988, the Respondent explained the results of biopsies and what he considered to be the treatment alternatives. He told them that he would not recommend surgical removal, due to the patient's age and the size and extent of the tumor. He mentioned but did not elaborate on the possibility of radiation therapy because he did not know much about it. He suggested that the patient consider a colostomy to bypass the tumor and to "let nature take its course." He informed the patient and her family that he would be out of the country on vacation for the next four weeks but that she should make an appointment to see him after the holidays. Meanwhile, he would have someone research for him whether radiation or other alternative treatment modes were appropriate. It is found that the Respondent's failure to recommend radiation therapy or chemotherapy was not below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Radiation therapy and chemotherapy is not considered effective curative treatment for coacogenic carcinoma. Assuming the accuracy of the pathology report on the biopsy, the only course of possible effective curative treatment for the patient was surgical removal. Subsequent events revealed that the patient's cancer was not coacogenic but rather squamous cell carcinoma. (It is not uncommon for biopsy reports to make such an error due to the relatively small size of the biopsy sample.) But even if the biopsy report had shown that the patient suffered from squamous cell carcinoma, it could not be found that the Respondent's failure to recommend radiation therapy or chemotherapy was below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. In 1988 and 1989, the medical community did not recognize radiation therapy or chemotherapy as an acceptable curative treatment for squamous cell carcinoma of the anus. Once again, the patient became anxious that the Respondent was not offering any curative treatment plan. She asked whether the Respondent should not at least have a liver/spleen scan done to see if the cancer had metastasized. Since the Respondent was not recommending surgery (the only possible curative treatment), he did not think a liver/spleen scan would serve any useful purpose. But to satisfy the patient, and because it was one of the gastroenterologist's recommendations, he agreed to schedule one for the patient before he left for vacation. The patient scheduled a follow-up appointment for January 9, 1989. Meanwhile, the Respondent left for vacation, and the liver/spleen scan was performed on December 8, 1988. In the Respondent's absence, Gold Plus delayed giving the patient the results of the scan. She became more and more anxious as time went by. When the patient called for the results, she initially was told that Gold Plus could not give her the results until the Respondent returned. It took an angry telephone call from the wife of the patient's nephew on the day before Gold Plus closed for the Christmas holiday for Gold Plus to agree to allow another of its physicians discuss the results of the scan. The patient was promised that the physician would call the next day. Still, no call came, and the wife of the patient's nephew called again just hours before the office closed for Christmas. The patient and her family were told that the results of the scan were negative. This distasteful experience further soured the patient's relationship with Gold Plus and, by extension, with the Respondent, and they lost faith in the Respondent and his medical practice. Instead of seeing the Respondent on January 9, 1989, as scheduled, the patient cancelled the appointment and made another appointment to see the gastroenterologist again. By this time, the tumor had grown to some extent and, along with it, the patient's discomfort. It was difficult to even examine the patient's rectum either digitally or by flexible sigmoidoscopy. The gastroenterologist agreed to refer the patient to another surgeon for possible surgical removal of the tumor. The patient initiated disenrollment from Gold Plus so that her Medicare could be reinstated to cover the anticipated surgery. The gastroenterologist asked the Respondent for the patient's medical records. The Respondent's care of the patient and responsibility for the care of the patient effectively ended when the patient cancelled her appointment on January 9, 1989. Another appointment with the gastroenterologist was scheduled for February 1, 1989, in anticipation of imminent surgery. Surgery was scheduled for February 14 but, after the patient's admission, was postponed to February 17, 1989. Initially, the patient's recovery from surgery was slow, and she remained hospitalized until March 14, 1989. Subsequent events raise questions whether the surgery was effective or worth the trauma. It is debatable how well the patient tolerated the surgery. It appears that she did not ever recover the level of physical vigor and energy she had before surgery. During the summer of 1989, the cancer reappeared on her coccyx and had to be treated by radiation. By the fall of 1989, another abdominal perineal resection was necessitated by the reappearance of the cancer in her rectum. Based on the best expert testimony available at the hearing, it cannot be found that the time that went by during the Respondent's treatment of the patient was "substantial," i.e., that it contributed to the spread of the patient's cancer. Notwithstanding the results of the liver/spleen scan, which was not definitive or even very useful in evaluating the patient's cancer for metastasis, it is probable that the patient's cancer already had metastasized by the time the Respondent first saw the patient. The Respondent clearly did not inordinately delay the flexible sigmoidoscopy with biopsy or his discussion of the results and treatment alternatives with the patient. The only questionable delay was the four-week delay caused by the Respondent being out of the country on vacation; by the time he was scheduled to see the patient on his return, she had terminated his care and treatment. There was no evidence on which it could be found that this delay was below the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order dismissing the Administrative Complaint against the Respondent. RECOMMENDED this 21st day of March, 1994, in Tallahassee, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of March, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-5068 To comply with the requirements of Section 120.59(2), Fla. Stat. (1991), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1.-4. Accepted and incorporated to the extent not subordinate or unnecessary. 5.-6. The date of the procedure was November 17, not November 11. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 7.-10. Accepted and incorporated to the extent not subordinate or unnecessary. "[A]pproximately four (4) weeks after the Christmas holidays" rejected as not proven and as contrary to the greater weight of the evidence. (He said "in four weeks, i.e., after the Christmas holidays.") Accepted and incorporated. Rejected as not proven and as contrary to the greater weight of the evidence that it was just "for a second opinion." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 14.-15. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven and as contrary to the greater weight of the evidence that the gastroenterologist made such a determination; rather, the subsequent surgeon did. Also, rejected as not proven and as contrary to the greater weight of the evidence that the surgery was "successful." In some senses it was, in other senses it was not. Rejected as not proven and as contrary to facts found. 18.-19. Accepted but subordinate to facts contrary to those found, and unnecessary. 20. Both as to the growth of the tumor and as to the evidence of metastasis, rejected as not proven and as contrary to the greater weight of the evidence. (The liver/spleen scan was negative, but the best expert testimony presented as the hearing indicated that subsequent events showed prior metastasis.) 21.-22. Rejected as not proven and as contrary to facts found. (The evidence was that those treatments were not alternative curative treatments. The Respondent was not given an opportunity to use them palliatively.) 23. Rejected as not proven and as contrary to facts found. Respondent's Proposed Findings of Fact. For purposes of these rulings, the Respondent's unnumbered paragraphs of proposed findings of fact are assigned consecutive numbers. 1.-3. Accepted but subordinate and unnecessary. 4.-6. Accepted and incorporated to the extent not subordinate or unnecessary. 7. As to the second sentence, a "transverse colostomy" was discussed, not a "transverse colonoscopy." Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. 8.-9. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to facts found and to the greater weight of the evidence that there was no delay. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. Subordinate and unnecessary. COPIES FURNISHED: Barbara Makant, Esquire Steven A. Rothenburg Senior Attorney Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792 Hugh Smith, Esquire P. O. Box 3288 Tampa, Florida 33601 Dr. Marm Harris Executive Director Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, Esquire Acting General Counsel Department of Business and Professional Regulation 1940 N. Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint dated March 27, 2009, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made:1 At the times material to this proceeding, the Department was the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 456.072, Fla. Stat. (2004-2005). At the times material to this proceeding, the Board of Medicine ("Board") was the entity responsible for regulating the practice of medicine and for imposing penalties on physicians found to have violated the provisions of Section 458.331(1), Florida Statutes (2004-2005). See § 458.331(2), Fla. Stat. (2004-2005). At the times material to this proceeding, Dr. Genao was a physician licensed to practice medicine in Florida, having been issued license number ME 58604. Dr. Genao practiced in the field of pediatric medicine, and he was board-certified in pediatrics. His practice was located at 13059 Southwest 112th Street, Miami, Florida. In or about 2005, Dr. Genao became aware that so-called "infusion centers" were opening in Miami-Dade and Broward Counties, Florida, to treat patients who had been diagnosed with HIV/AIDS and who required injections and infusion treatments for HIV/AIDS-related conditions. Dr. Genao visited one such center and observed a physician, a Dr. Fauler, as he provided infusion treatments to HIV/AIDS patients. Dr. Genao believed that Dr. Fauler's treatment of the HIV/AIDS patients was appropriate. Dr. Genao had training in intravenous treatments, and, after observing Dr. Fauler and working for a time under Dr. Fauler's supervision, Dr. Genao considered himself ready to begin treating HIV/AIDS patients in an "infusion center" that he intended to operate out of the office housing his pediatric practice. By his own admission, Dr. Genao had no formal training or experience treating patients with HIV/AIDS. Dr. Genao's first patient was G.M., whom Dr. Genao treated for HIV/AIDS-related conditions between May 25, 2005, and June 20, 2005. At the end of July, Dr. Genao was approached by two men who offered to bring him HIV/AIDS patients for injections and infusion treatment for HIV/AIDS-related conditions. Dr. Genao felt he was competent to treat HIV/AIDS patients with infusion therapy, and he signed a contract with the two men in which he agreed to see HIV/AIDS patients in exchange for a salary. Dr. Genao assumed that the patients he would see also had primary care physicians who were treating the patients for HIV/AIDS. In mid-August, 2005, Dr. Genao began to see HIV/AIDS patients regularly at his office in the mornings, before his pediatric patients arrived. Between August 15, 2005, and October 14, 2005, Dr. Genao treated 11 HIV/AIDS patients. Dr. Genao diagnosed these patients as suffering from conditions associated with HIV/AIDS, such as neuropathy; neutropenia; thrombocytopenia; and diarrhea. Dr. Genao ordered various treatments for these patients, including intramuscular injections of drugs such as Sandostatin and infusion of such drugs as Rituxan, Neupogen, and Neumega. Shortly after he began treating these HIV/AIDS patients, Dr. Genao began to question the appropriateness of the modes of treatment he had observed at Dr. Fauler's infusion center and to feel uncomfortable about treating the HIV/AIDS patients. He sought training at Jackson Memorial Hospital in Miami, Florida, and attended training sessions during which he observed a physician who specialized in the treatment of HIV/AIDS patients and who ran the HIV/AIDS clinic at Jackson Memorial Hospital. Dr. Genao attended these training sessions three days per week for two weeks. Dr. Genao realized that the treatment given by the physician at Jackson Memorial Hospital was completely different from the treatment he was providing the HIV/AIDS patients in his office. Dr. Genao also realized that the patients he was treating for HIV/AIDS-related conditions were not being treated for the underlying HIV/AIDS by primary care doctors. Dr. Genao decided to stop treating the HIV/AIDS patients that he was seeing pursuant to the contract with the two men, who were not physicians. When he told the men that he wanted to renege on the agreement, they told Dr. Genao that he had to continue treating the HIV/AIDS patients until they could find another physician to provide them treatment. Dr. Genao felt threatened by the men, and he continued to treat the patients until on or about October 14, 2005. During the time that Dr. Genao treated the HIV/AIDS patients brought to him by the two men, the men prepared all of the bills to be submitted to Medicare and/or Medicaid. Dr. Genao signed each bill in the large stacks of bills presented to him without reviewing any of them. The Department's expert testified at length about the treatment that Dr. Genao provided to the 12 HIV/AIDS patients he had treated, and the expert enumerated the ways in which Dr. Genao had violated the standard of care in their diagnosis and treatment. In his responses to the Department's request for admissions, Dr. Genao admitted that he failed to diagnose and treat these patients properly.2 Furthermore, in his testimony at the final hearing, Dr. Genao admitted that his treatment of these patients fell below the standard of care, and he agreed with the Department's expert that he misused some of the drugs he prescribed for the patients, failed to follow through with necessary treatment for these patients, and neglected their care.3 Based on the patients' medical records, on testimony of the Department's expert, and on Dr. Genao's admissions and testimony, the ways in which Dr. Genao failed to meet the applicable standard of care in treating the 12 HIV/AIDS patients may be grouped into categories and summarized as follows: Dr. Genao treated patients S.B. and J.S. for diarrhea with intramuscular injections of Sandostatin; Sandostatin is a medication that is not appropriate for the treatment diarrhea but is used to treat the very rare disease, acromegaly. Dr. Genao treated patients S.B. and G.M. for thrombocytopenia with multiple intravenous infusions of Rituxan, a drug that is not appropriate for the treatment of thrombocytopenia, which is a bleeding disorder caused by an abnormally low level of platelets. Rituxan is used to treat lymphoma and rheumatoid arthritis, and it is a very expensive and dangerous drug that can sometimes cause death. Dr. Genao failed to follow-up with diagnoses and treatment for seriously abnormal values that showed up in the results of blood work ordered by Dr. Genao for patients S.B., S.E., L.G., G.M., J.S., and J.T. Dr. Genao failed to refer patients S.B., S.E., M.E., L.G., J.T., E.T., and J.T. 2 to specialists for evaluation when such evaluation was indicted by the patients' complaints and symptoms. Dr. Genao failed to notify patient M.E., whom Dr. Genao saw only once, of abnormal blood test results that should have been evaluated and treated. Dr. Genao failed to revise his treatment of patients S.E., L.G., J.T., and E.T. when it became clear that there had been no improvement in the conditions of the patients after Dr. Genao had treated them for a month or more. Dr. Genao administered Neupogen to patients E.T. and J.T. 2 when treatment with this drug, which is used primarily to treat patients with a critically low white blood cell count resulting from chemotherapy, was not indicated by the results of blood tests. Dr. Genao failed to diagnose accurately and/or timely conditions that were indicated by the complaints, symptoms, and results of blood tests for patients S.B., S.E., M.E., L.G., G.M. J.S., J.T., E.T. and J.T. 2. By his own admission, Dr. Genao failed to keep appropriate medical records of the treatment of these 12 patients. Dr. Genao's medical records were often illegible4; there were no medical records for patients M.C. and R.M., just billing records; and the medical records were incomplete and generally failed to justify the course of treatment for patients S.B., S.E., M.E., L.G., G.M., J.S., M.S., J.T., E.T., and J.T. 2. Summary and findings of ultimate fact The evidence presented by the Department, together with the admissions and testimony of Dr. Genao, is sufficient to support a finding that Dr. Genao committed medical malpractice because he did not provide to the 12 HIV/AIDS patients he treated the level of treatment, skill, and care that would be found acceptable by a reasonable prudent similar physician under similar circumstances. Even though the evidence presented by the Department, together with the admissions and testimony of Dr. Genao, is sufficient to support a finding that Dr. Genao prescribed and administered Rituxan, Sandostatin, and Neupogen inappropriately and in excessive quantities for some of his HIV/AIDS patients, the evidence is not sufficient to establish that this conduct occurred outside Dr. Genao's professional practice. The evidence presented by the Department, together with the admissions and testimony of Dr. Genao, is sufficient to support a finding that Dr. Genao failed to keep medical records that were legible and complete and that justified the treatment that he provided his HIV/AIDS patients.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Estaban Antonio Genao, M.D., violated Section 458.331(1)(m) and (t), Florida Statutes (2004 and 2005), and revoking the license of Estaban Antonio Genao, M.D., to practice medicine in the State of Florida. DONE AND ENTERED this 30th day of November, 2010, in Tallahassee, Leon County, Florida. S Patricia M. Hart 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 30th day of November, 2010.
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Respondent on the basis of charges set forth in a three-count Administrative Complaint. The Administrative Complaint charges the Respondent with two violations of Section 458.331(1)(t), Florida Statutes, and one violation of Section 458.331(1)(m), Florida Statutes.
Findings Of Fact Background facts At all times material to this case, the Respondent, Rene A. Munecas, M.D., has been licensed to practice medicine in the State of Florida. Dr. Munecas is board-certified in Obstetrics. As of the date of the events from which the charges in this case arise, Dr. Munecas had practiced obstetrics for approximately 45 years. Dr. Munecas has practiced obstetrics in the State of Florida since 1970. Dr. Munecas was born in Cuba, and he attended medical school in that country. He graduated from the Havana University, School of Medicine, in 1950. He then did a two-year internship in obstetrics at the University Hospital, Havana, Cuba, followed by a two-year residency in obstetrics at the same hospital. Dr. Munecas practiced obstetrics in Cuba until 1961, at which time he moved to the United States. In this country he did a one-year rotating internship at the Highland Park General Hospital, Highland Park, Michigan, followed by a two-residency in obstetrics/gynecology (OB/GYN) at Jackson Memorial Hospital in Miami, Florida. He completed his OB/GYN residency training at Orange Memorial Hospital in Orlando, Florida. Upon completion of his residency training in this country, he practiced in Michigan until 1970, when he moved to Florida. During the many years Dr. Munecas has practiced in Florida, there has been only one prior instance of disciplinary action concerning his practice of medicine. 1/ The prior disciplinary proceeding did not arise from any misconduct by Dr. Munecas, but from concerns as to whether he was "unable to practice medicine with reasonable skill and safety to patients by reason of illness . . . or as a result of any mental or physical condition." 2/ By the time of the final hearing in the prior disciplinary proceeding, all of the medical experts were of the view that Dr. Munecas was able to practice with reasonable skill and safety so long as he continued to be monitored by his treating psychiatrist. The final order in that case (dated August 27, 1984) concluded as follows: ORDERED AND ADJUDGED that Respondent be placed on probation for a period of two (2) years during which time Respondent shall appear semi-annually before the Board and shall continue to be monitored by his treating psychiatrist, Dr. DeJesus who shall submit quarterly reports concerning Respondent to the Board during the two year probation period. No appearances by the treating psychiatrist, Dr. DeJesus, before the Board are required. Facts regarding patient A. B. There is very little evidence in the record of this proceeding concerning the quality or sufficiency of the written medical records kept by Dr. Munecas regarding his treatment of Patient A. B. 3/ There is no clear and convincing evidence that Dr. Munecas failed to keep written medical records justifying the course of treatment of patient A. B. Patient A. B., born July 4, 1965, was seen by Dr. Munecas on August 11, 1994, in the outpatient obstetrical clinic of Baptist Hospital of Miami. She was pregnant with twins. The hospital record indicates periodic visits to the clinic from August 11 through November 17, 1994. Her weight at the initial visit of August 11 was 210 pounds. She was 5 feet, 2 inches, tall. An outpatient ultrasound performed on November 3, 1994, indicated that both twins were in breech position. The results of that ultrasound were reported on November 4, 1994, and were known to Dr. Munecas prior to November 18, 1994, when another outpatient ultrasound was performed on patient A. B. At approximately 6:30 a.m. on November 19, 1994, patient A. B.'s membranes ruptured, and she was taken to the hospital. Dr. Munecas ordered an x-ray of the patient's abdomen for the purpose of ascertaining fetal position. An x-ray of A. B.'s abdomen was taken at about 8:15 a.m. For reasons not clear in the evidence in this case, a second x-ray of A. B.'s abdomen was taken about 10 minutes later. The two x-ray films did not provide any useful information about the position of either of the twins. A few minutes later, Dr. Munecas performed a pelvic examination of patient A. B., for the purpose of trying to determine the positions of the twins. On the basis of that examination Dr. Munecas was of the opinion that twin "A" was in a vertex position, and twin "B" was in a breech position. Later in the day, this opinion was shown to be incorrect. 4/ Dr. Munecas decided it was appropriate to deliver the twins vaginally, and began to take steps to implement that plan of treatment. Among other things, Dr. Munecas attempted to induce labor by administration of Pitocin, which induces labor by increasing uterine contractions. At approximately 5:00 p.m. on November 19, 1994, Dr. Munecas ordered a portable ultrasound examination of patient A. B.'s abdomen. 5/ The ultrasound examination was promptly performed, and by approximately 6:00 p.m. Dr. Munecas received the examination report. The report revealed that both twins were in a breech position. At some point after receiving the report of the ultrasound examination, Dr. Munecas changed his plan of treatment and decided that patient A. B. should be delivered by cesarean section. For reasons not clear from the record in this case, the cesarean section was not done until approximately 10:00 p.m. Twin "A" was delivered at 10:16 p.m., and twin "B" was delivered at 10:19 p.m. Both twins were healthy. Facts regarding current practice of obstetrics Ultrasound imaging is the procedure of choice for obtaining images to show fetal status. Ultrasound is superior to x-ray for such purposes for a number of reasons. Ultrasound produces fetal images that show more details than can be obtained by x-ray. The use of ultrasound also avoids certain potential fetal health risks that are associated with x-rays. Accordingly, except in the most unusual of circumstances, x-rays should not be used to obtain images of fetal status. Under the circumstances presented by patient A. B. on November 19, 1994, a reasonably prudent similar physician would have ordered an ultrasound. If for some reason an ultrasound was not available on the morning of November 19, 1994, a reasonably prudent similar physician would have relied on the results of the ultrasound that was performed on November 3, 1994. Pitocin is a drug that is commonly used by obstetricians to induce and enforce labor. The effect of Pitocin is to increase uterine contractions. Pitocin should only be used when it is desirable to induce labor. The obvious corollary is that Pitocin should never be administered to a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient A. B. because of risks to fetal safety inherent in a situation when twins are both in a breech position. Those risks can be avoided by cesarean section delivery. In circumstances like those presented by patient A. B., with both twins in a breech position, a reasonably prudent similar physician would find it unacceptable to attempt a vaginal delivery. The only acceptable course of treatment under such circumstances would be a cesarean section. 6/ Therefore, it was a departure from standards of care, skill, and treatment acceptable to a reasonably prudent similar physician for Dr. Munecas to attempt to induce labor by patient A. B. Facts regarding patient M. E. Patient M. E., born November 28, 1963, was seen by Dr. Munecas on May 2, 1995, in the outpatient obstetrical clinic of Baptist Hospital of Miami. The hospital record indicates periodic visits to the clinic from May 2 through June 21, 1995. The record also indicates that lab tests had been performed prior to May 2. Dr. Munecas' note for the visit of June 2 indicates his belief that the fetus may have had intrauterine growth retardation. The visits of June 14 and June 21 indicate increases in patient M. E.'s systolic and diastolic blood pressure, and increased protein in her urinalysis. Pre-eclampsia is a term used to describe a form of pregnancy-induced hypertension. Symptoms of pre-eclampsia include elevated blood pressure, presence of protein in the urine and/or the presence of swelling or edema of the hands and feet. A patient exhibiting symptoms of severe pre-eclampsia is at risk for three circumstances of extreme urgency. One is the possibility of a brain hemorrhage, which can be fatal. Second is the possibility of heart failure and pulmonary edema. Third is the possibility of liver hemorrhage, which can cause the liver to swell and burst. This third possibility manifests itself by right upper quadrant abdominal pain. In the early morning hours of June 22, 1995, patient M. E. awoke with severe right upper quadrant abdominal pain. When the pain continued, she called Dr. Munecas at home and described her pain to him. Dr. Munecas instructed her to go to the hospital. At approximately 4:50 a.m. on June 22, 1995, patient M. E. arrived at the hospital. Her blood pressure was taken in the supine position and read 196/111. Patient M. E. complained of continuous severe right upper quadrant abdominal pain. Dr. Munecas was called at home and advised of the patient's status. At that time, Dr. Munecas gave no orders, but indicated his desire for a perinatal consultation. At about 5:00 a.m., the hospital nursing staff called Dr. Lai. Dr. Lai gave no orders, but said that Dr. Munecas should call him at home. Hospital nursing staff called Dr. Munecas a second time at approximately 5:15 a.m. They requested his presence at the hospital to evaluate the patient. At about 6:00 a.m. on June 22, 1995, the hospital nursing staff again called Dr. Munecas and again requested his presence at the hospital. At this time the nursing staff also requested that Dr. Munecas prescribe medication to lower the patient's blood pressure. Dr. Munecas did not prescribe any medications for the patient. Instead, he ordered that an abdominal ultrasound be performed on the patient immediately to see if the patient had gallbladder problems. The ultrasound was promptly performed. It did not reveal any gallbladder problems. At approximately 6:05 a.m., a nurse manager called Dr. Munecas at home, and again requested his presence at the hospital. Dr. Munecas thereupon embarked for the hospital. He arrived at approximately 7:00 a.m. He promptly examined the patient and found her cervix to be dilated up to 2 centimeters. Dr. Munecas' impressions following the examination included "severe pre-eclampsia." Following the examination of patient M. E., Dr. Munecas performed an amniotomy on the patient. Amniotomy is a technique for the induction of labor. It is accomplished by manual rupture of the patient's membranes. An amniotomy should only be performed when it is desirable to induce labor. The obvious corollary is that an amniotomy should never be performed on a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient M. E. for two main reasons. First, following examination of patient M. E., it should have been obvious to any obstetrician that the patient was suffering from severe pre-eclampsia and that prompt action was necessary to minimize the risk of severe harm to the patient's health. Under the circumstances presented by patient M. E., on June 22, 1995, urgent delivery of the baby was the only acceptable course of patient treatment. Under the circumstances presented that day by patient M. E., there was no prospect for her to have an urgent vaginal delivery. A cesarean section was the only prospect for an urgent delivery of patient M. E. The second reason for which vaginal delivery was contraindicated for patient M. E., was the fact that the fetus appeared to have intrauterine growth retardation. Such a fetus is less able than a normal fetus to withstand the rigors of labor. Therefore, such a fetus is at greater risk for possible brain damage or death during vaginal delivery. Such risks are avoided by a cesarean section delivery. By inducing labor in patient M. E., Dr. Munecas exposed both patient M. E. and her fetus to unreasonable dangers which could be avoided by cesarean section delivery. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, would have gone to the hospital as quickly as possible following the first call from the hospital nursing staff describing the patient's status. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, in view of the obvious need for urgent relief of the severe pre- eclampsia, would have promptly made arrangements for a cesarean section delivery at the earliest possible time. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. Dr. Munecas appears to have voluntarily limited the scope of his medical practice since the incidents which gave rise to this proceeding. He limits his medical practice to gynecology and obstetrics in the office. He no longer performs major surgery or vaginal deliveries.
Recommendation On the basis of the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be issued in this case to the following effect: Dismissing Count Two of the Administrative Complaint; Concluding that the Respondent is guilty of having violated Section 458.331(1)(t), Florida Statutes, as charged in Count One of the Administrative Complaint and as charged in two of the three paragraphs of Count Three of the Administrative Complaint; and Imposing a penalty consisting of a permanent restriction on the scope of the Respondent's medical practice to the following extent: the Respondent is restricted from all hospital-based obstetrical practice and is barred from performing or assisting in the labor or delivery of any hospital obstetrical patient. DONE AND ENTERED this 10th day of February, 2000, in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH 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 10th day of February, 2000.
