The Issue The issues presented herein are whether or not Respondent's incense to practice medicine should be suspended, revoked or the licensee otherwise disciplined for alleged violation of Chapters 458 and 893, Florida Statutes, as set forth in the Administrative Complaint filed herein signed May 31, 1983.
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, documentary evidence received, stipulations of the parties and the entire record compiled herein, I hereby make the following relevant factual findings. Respondent is a medical doctor and has been issued license number ME 0017825. Respondent's last known address is 2361 N.W. 24 Terrace, Miami, Florida 33172. (Stipulation of the parties) Respondent has been licensed as a medical doctor in Florida since 1971. Respondent studied at Havana University School of Medicine and graduated in 1957. He practiced in Cuba from 1957 through 1966. During that period, he was engaged in a general practice and was also a psychiatrist at Clinica Dependiente. While at Clinica Dependiente, Respondent served as a medical director for the rehabilitation of minors and as medical director for Santa Clinica Psiquiatria. Respondent relocated from Cuba and came to Miami on or about February 15, 1967. Respondent sat for the Federation of State and Medical Boards of the United States during September of 1968, the standardized test for graduates of foreign medical schools. During 1968 and 1969, Respondent was engaged as a psychiatrist at Halifax District Hospital in Daytona Beach, Florida. During 1969, he served a rotating internship at Mount Sinai Hospital for one year. Thereafter, he served rotating internships at Doctors, Victoria, Parkway and one other hospital in the Dade County area until approximately 1974. During his tenure at Halifax Hospital, Respondent treated some parties who were drug addicts. Respondent admits to having treated the patients referred to in the Administrative Complaint filed herein. Additionally, pursuant to Petitioner's Request for Admissions filed herein, Respondent has admitted the allegations set forth in paragraphs 3, 10, 17, 24, 31, 38, 45, 52 and 59 of the Administrative Complaint, to wit: Between the dates of approximately January 5, 1981 and December 15, 1981, Respondent prescribed 360 Dilaudid 2/ (Hydromorphone), a controlled substance, pursuant to Chapter 893, Florida Statutes, for Patrick Golden. Between the dates of approximately March 26, 1981 and January 15, 1982, Respondent prescribed 1425 Dilaudid (Hydromorphone) for Ellen Henderson. Between the dates of approximately March 2, 1981 and November 11, 1982, Respondent prescribed 855 Dilaudid (Hydromorphone) for Ronald Chica. Between the dates of approximately May 12, 1981 and January 9, 1982, Respondent prescribed 132 Dilaudid (Hydromorphone) for James Brannigan. Between the dates of approximately February 19, 1981 and February 2, 1982, Respondent prescribed 965 Dilaudid (Hydromorphone) for Gilbert Fernandez. Between the dates of approximately November 21, 1981 and December 12, 1981, Respondent prescribed 180 Dilaudid (Hydromorphone) for Patsy Gamlin. Between the dates of approximately January 7, 1981 and January 14, 1982, Respondent prescribed 820 Dilaudid (Hydromorphone) for Rudolph Ferguson. Between the dates of approximately February 24, 1981 and February 15, 1982, Respondent prescribed 2220 Dilaudid (Hydromorphone) for Michael Salle. Between the dates of approximately February 24, 1981 and February 15, 1982, Respondent prescribed 2190 Dilaudid (Hydromorphone) for Ronald Weatherington. Dale K. Lindberg, M.D., was tendered and received as an expert in these proceedings in the area of Family Practice, Methadone and Drug Addiction. Dr. Lindberg has been instrumental in establishing a methadone detoxification program at Memorial Hospital in Hollywood, Florida. Methadone is the only legally recognized Schedule II controlled substance used in this country for the treatment of drug addiction. Private practitioners, pursuant to specific federal law, cannot legally administer methadone or any other Schedule II controlled substance for the treatment of drug addition. In order to qualify or be certified to treat drug addicts, application must be made simultaneously with the Federal Food and Drug Administration (to their Methadone Monitor Division), to the Federal Drug Enforcement Agency and to the Federal Department of Mental Health and Drug Abuse. Upon certification with these governmental departments, only then can a physician prescribe methadone to a drug addict to be ingested in oral form, once a day. (21 C.F.R. 291.505) Dr. Lindberg received and reviewed the nine (9) patients' records listed in the Administrative Complaint as well as the prescriptions written for those patients by Respondent. (Petitioner's Exhibit 2-19). Dr. Lindberg, after review, concluded that Respondent inappropriately and excessively prescribed Dilaudid to said patients. Dr. Lindberg opined that Respondent prescribed Dilaudid for those patients for "very little indication" and continued over long periods of time prescribing Dilaudid to those patients. He considered that Respondent was maintaining the patients on Dilaudid in violation of the law. (TR 148, 239). Dr. John Handwerker, M.D., testified as an expert herein on behalf of Petitioner. He has served as the first Chairman of the Department of Family Practice at the University of Florida Family and Community Medicine Programs. He is Chairman of the Family Practice Department of Mercy Hospital in Miami and is Assistant Professor of Pharmacology at the University of Miami. Dr. Handwerker is knowledgeable regarding generally prevailing and accepted standards of family practice in Dade County and was accepted, without challenge, as an expert in the field of Family Practice. Dr. Handwerker reviewed the nine (9) patients' records listed in the Administrative Complaint as well as the prescriptions written for each patient. Based upon Dr. Handwerker's review of those records and prescriptions, Respondent committed gross and repeated malpractice. This opinion stems from Respondent's "inappropriately and excessively prescribing Dilaudid to patient for chronic" while the Physicians Desk Reference clearly stated that Dilaudid should not be prescribed for patients with chronic pain. (Testimony of Dr. Handwerker) SPECIFIC PATIENTS A. Patrick Golden first visited Respondent's office on October 7, 1981. Golden complained of chronic pain arising from trauma suffered while he was involved in an industrial accident. His diagnosis was a compression of the fourth and fifth lumbar disk. He was treated for radiculitis. Respondent prescribed Dilaudid to relieve the pain that patient Golden was suffering from and based on the fact that Golden reportedly had been receiving Dilaudid from a former physician. Respondent conducted an examination of patient Golden and prescribed exercises for him. Respondent did not take x-rays although he states that he observed x-rays which had been taken by Golden's former physician. Respondent prescribed Dilaudid for Golden because it was the only drug which "killed the pain, unlike motrin and metrobromate." Nearing the end of Respondent's treatment of patient Golden, his wife began stealing Mr. Golden's drugs. Respondent referred her to a methadone program and obtained a notarized statement from Mrs. Golden to substantiate the fact that she was diverting drugs intended for her husband. Respondent observed that patient Golden was becoming addicted to Dilaudid nearing the end of his treatment although throughout the major portion of his treatment of patient Golden, he felt that while he was dependent on Dilaudid, he was not felt that while he was dependent on Dilaudid, he was not "addicted." Respondent tried to reduce the amount of Dilaudid that he was prescribing to patient Golden without success. Respondent believed that Dilaudid was medically necessary to treat patient Golden due to the suffering he was undergoing from the chronic pain. (Respondent's testimony and Petitioner's Exhibit 20). B. Ellen Henderson was treated by Respondent during the dates of approximately March, 1981 through January, 1982. Henderson suffered with her lumbar spine. Patient Henderson took motrin tablets since her preteen years. Patient Henderson has been treated at several methadone centers and is believed to have been taking approximately 25-40 Dilaudid four-milligram tablets per day. Upon Respondent's first treatment of patient Henderson, he advised her that she was "killing herself and that she needed to reduce that terrible dosage of Dilaudid." Patient Henderson was "treated for pain in the back and to reduce the amount of Dilaudid." In this regard, Respondent tried to reduce her intake of Dilaudid to approximately 8 Dilaudid four-milligram tablets per day. When Respondent stopped treating patient Henderson, he had reduced the amount of Dilaudid that he was prescribing for her to approximately 8 four- milligram tablets of Dilaudid per day. C. Respondent treated Ronald Chica from approximately March, 1981 through November, 1982. Chica was treated for spondylolysis--a degeneration of the vertebrae. Respondent prescribed Dilaudid for patient Chica because it relieved the pain. Respondent knew that patient Chica was addicted to the drug Dilaudid. D. James Brannigan was treated by Respondent from approximately May of 1981 through January of 1982. Respondent knew that Mr. Brannigan was dependent upon Dilaudid. Despite this knowledge, Respondent continued to prescribe Dilaudid for Mr. Brannigan in an effort to treat Brannigan's addiction with Dilaudid. Respondent was attempting to ease the withdrawal symptoms that patient Brannigan would suffer if he were immediately cut off from his supply of Dilaudid. E. Respondent treated patient Gilbert Fernandez during the dates of approximately February of 1981 through approximately February of 1982. During that period, Mr. Fernandez suffered from compression features of the ribs and the lumbar region. Mr. Fernandez had a physical and psychological dependence on the drug Dilaudid. Respondent treated patient Fernandez by prescribing Dilaudid tablets for him. Patient Fernandez had been treated at methadone centers in the past and presently was receiving methadone treatment while Respondent was treating him. Respondent prescribed Dilaudid to relieve the pain as well as to ease the withdrawal symptoms that patient Fernandez would undergo if he was immediately taken from the administration of Dilaudid. F. Between the dates of approximately February of 1981 through February of 1982, Respondent prescribed approximately 2,190 four-milligram Dilaudid tablets for patient Ronald Wetherington. Patient Wetherington was given approximately 60 tablets every 7 days. Patient Wetherington was addicted to the drug Dilaudid and Respondent ultimately referred him to a methadone center to deal with his withdrawal problems. G. During the period of February, 1981 through February, 1982, Respondent prescribed approximately 2,220 four-milligram Dilaudid tablets for patient Michael Sallee. Patient Sallee suffered from and was treated by Respondent for a compression fracture of the fifth lumbar. Mr. Sallee was a cabinetmaker and did considerable lifting in the performance of his work. Respondent knew that Mr. Sallee was dependent upon Dilaudid and continued to prescribe the narcotic during the term of his treatment. Respondent attempted to treat Mr. Sallee's addiction with Dilaudid. H. During the period of January of 1981 through January of 1982, Respondent treated patient Rudolph Ferguson and, during that period, prescribed approximately 820 four-milligram Dilaudid tablets for him. Patient Ferguson suffered from and was treated for back and rib problems from an auto accident. Respondent knew that patient Ferguson was dependent upon the drug Dilaudid and knew he was addicted to Dilaudid. Despite this knowledge, Respondent continued prescribing the drug Dilaudid to patient Ferguson to reduce the withdrawal symptoms and "to continue to treat the disease." Respondent referred patient Ferguson to a methadone clinic and, in fact, drove him to a nearby clinic for treatment. I. Respondent treated patient Patsy Gamlin during the period of November 21, 1981 through December 12, 1981. During that period, he prescribed 180 tablets or approximately 60 tablets every 10-14. Respondent administered a drug screen during December of 1981 and did not treat patient Gamlin after December. Dilaudid is a narcotic analgesic; its principal therapeutic effect is relief of pain. There is no intrinsic limit to the analgesic effect of Dilaudid; like morphine, adequate doses will relieve even the most severe pain. Clinically however, dosage limitations are imposed by the adverse effect, primarily respiratory, depression, nausea and vomiting which can result from high dosages. (Physicians Desk Reference, page 1038 [1984 Edition]) The Physicians Desk Reference has this to say about drug abuse and dependence: Dilaudid is a schedule II narcotic. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore dilaudid should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when dilaudid is used for a short time for treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, usually assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Prior to prescribing a drug such as Dilaudid, a physician should take a full history from a patient and perform a thorough physical examination. The history should include, inter alia, the patient's chief complaint, with questions from the physician to the patient involving areas of past problems with the nervous system, ears, eyes, lungs, chest, respiratory system, GI tract and urinary tract. The physical examination should involve all body systems, including blood pressure, examination of the head, neck, chest and back regions. If patient complains of low back pain, there should be a physical examination specifically involving the low back area before prescribing the scheduled controlled substance here at issue. The past history is important to determine the duration of the problem, any previous medical treatment, examinations or tests by other physicians regarding the lumbosacral or low back area. A physical examination should be performed designed to elicit indications of neurological evolvement, including straight-leg raise tests, impairment of sensation in the extremities tests and other neurological inquiries. Such a full history and a physical examination is prior to initiating a course of treatment involving treatment of chronic pain due to the existence of a wide assortment of other treatment modalities which might treat the root of the problem, rather than merely being pain symptoms. An examination of the Respondent's records and the prescribing patterns of Dilaudid for the patients involved indicates that Respondent simply made insufficient findings upon which to base the decision to prescribe the drug Dilaudid. By prescribing Dilaudid, without an adequate physical examination, or the gathering of detailed patient medical history, would constitute a failure to conform to the level of care, skill and treatment recognized by reasonably prudent similar physicians under these conditions and circumstances. By continuing to prescribe these drugs, without any involved discussion or consideration of the effect the previous course of treatment had had on the patient, other than simple inquiry by Respondent concerning, as example, how the patient was feeling, 3/ also constitutes inappropriate prescribing of scheduled controlled substances, and demonstrates a failure to conform to the generally accepted an prevailing standards of medical practice in the Dade County community. (Testimony of Dr. Handwerker) Respondent has never been subjected to disciplinary proceedings in the past. His past professional record reveals that he has a sincere concern for his patients. Throughout these investigative proceedings and the final hearing herein, the Respondent was candid, forthright and truthful. His prescribing of the controlled substance Dilaudid was based on his mistaken opinion that it was medically necessary to prescribe Dilaudid for his patients. Throughout these proceedings, it became clear that Respondent had not kept abreast of the proper course of treatment, detection and proper prescribing patterns for scheduled drugs for the patients be treated. To Respondent's credit, he has been studying the proper prescribing of controlled substances since the initiation of the investigation and the administrative proceedings involved herein. Respondent has never "faked" exams and every prescription that he wrote was based on an office visit and an exam, though a very cursory exam. Respondent did not receive any illegal profits from the sale of drugs nor did he divert, or attempt to divert, any drugs for illegal profit. His office fees, which range from $15 to $25 were not based on the amount of the drugs prescribed but, rather, on the patient's ability to pay. Respondent operates a small general practice with his wife serving as his receptionist. He personally completes all prescription forms with his wife/receptionist. Patients receiving treatment from Respondent are free to get their prescriptions filled at any pharmacy of their choice. Respondent was unaware and the evidence does not show that any of his patients had prior criminal records.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, and the entire evidence of record, it is therefore recommended that a Final Order be entered imposing a written reprimand and one year's probation upon the Respondent Carlos de la Fe, and requiring that during the probationary, he enroll and complete, to the satisfaction of the Board of Medical Examiners, a continuing medical education course concerned with the appropriate indications for and prescription of scheduled controlled substances. 4/ RECOMMENDED this 24th day of October, 1984 in Tallahassee, Florida. JAMES E. BRADWELL 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 25th day of October, 1984.
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 The issues are whether Respondent obtained Oxycontin by using a forged prescription, in violation of Section 464.018(1)(h), Florida Statutes, and Rule 64B9-8.005, Florida Administrative Code, which prohibit unprofessional conduct, and in violation of Section 464.018(1)(i), Florida Statutes, which prohibit the unauthorized possession, sale, or distribution of controlled substances; and whether Respondent's use of Oxycontin affects her ability to practice nursing with reasonable skill and safety, in violation of Section 464.018(1)(j), Florida Statutes, which prohibits the inability to practice nursing with reasonable skill and safety by reason of illness or use of alcohol, drugs, narcotics, or chemicals or as a result of any mental or physical condition. If so, an additional issue is what penalty should be imposed.
Findings Of Fact Respondent is a licensed registered nurse, holding license number RN 521142. She has been so licensed for 31 years. Respondent's long career in nursing has featured dedication, hard work, commitment, and competence. The record does not reveal any past discipline. For most of Respondent's professional career, starting in 1971, she has worked at Indian River Memorial Hospital in Vero Beach. Respondent has worked in various capacities at the hospital, including the emergency room and operating room. Respondent later helped develop a neurological unit at the hospital. Starting in 1980, she worked for a couple of years at Vero Orthopedics. Since 1997, Respondent has worked on a contract basis at the Indian River Memorial Hospital, although her present physical infirmities, partly described below, prevent her from working at present. In May 2000, Respondent injured her back while moving a heavy patient in the hospital. A couple of months later, Respondent underwent a laminectomy to relieve the pain from two herniated disks. Six weeks after the surgery, Respondent reinjured her back and had to undergo additional surgery. Six weeks after the second surgery, Respondent, who was not doing well, left her job at the orthopedic clinic and took a less strenuous job. One month after doing so, Respondent was still experiencing pain when she got into and out of cars. In June 2001, Respondent underwent a third operation, in which the surgeon fused two injured vertebrae. The surgery obtained access to the vertebrae by a posterior incision running from the breast to the pubis. The surgery also required a hip bone graft, thus necessitating an incision to the hip. The recovery from this excruciatingly painful surgery was difficult, and Respondent has not yet returned to work, although she is nearing the point at which she can perform some nursing-related work, such as teaching. At present, she still has difficulty walking or standing. When discharging Respondent from the hospital in late June 2001, Dr. Gomez prescribed her Oxycontin for pain. Dr. Gomez was covering for Respondent's neurosurgeon, Dr. Magana. Later, Dr. Cunningham, a pain management specialist and Respondent's family physician, resumed the care of Respondent. Dr. Cunningham continues to monitor Respondent and treat her pain. On direct examination, Respondent testified that she has not taken Oxycontin since December 2001. (However, on August 9, 2002, Respondent told her certified addictions professional that she had not taken any Oxycontin since March 2001.) Respondent testified that, after Oxycontin, she took no pain medication besides nonsteroidal anti-inflammatory medications and steroids. However, on cross-examination, Respondent admitted that she takes Methadose as needed, pursuant to a prescription from Dr. Cunningham. Respondent testified that he switched her from Oxycontin in July 2002. Respondent filled the Methadose prescription at a different drug store than the one that she has used for her other prescriptions. On October 5, 2001, Respondent presented a forged prescription to a different drug store than the one she has used for her other prescriptions. The prescription was for fifty 20- mg. Oxycontin tablets, which Respondent picked up two days later. Respondent fraudulently obtained the Oxycontin for her own use. Oxycontin is an analgesic opioid and a schedule II controlled substance. It is highly addictive and presently among the most commonly abused controlled substances. Oxycontin can produce a feeling of short-lived euphoria, as well as impaired cognitive functioning and impaired judgment. Methadose, a form of methadone, is a synthetic analgesic. It is also used in the detoxification process undergone by heroin addicts. Petitioner has proved by clear and convincing evidence that Respondent engaged in unprofessional conduct in her acquisition of the Oxycontin by using a forged prescription and that Respondent unlawfully possessed a controlled substance. Petitioner has not proved by clear and convincing evidence that Respondent's use of Oxycontin affects her ability to practice nursing with reasonable skill and safety. First, Petitioner did not prove by clear and convincing evidence that Respondent still uses Oxycontin. It appears likely that she may have substituted Methadose for Oxycontin to manage her pain. It is unclear from the present record whether Respondent's use of Methadose is also to assist her in overcoming an addiction to Oxycontin. But even if Petitioner had pleaded Methadose rather than Oxycontin, the record does not reveal the extent to which Respondent presently uses Methadose. For the reasons stated in the preceding paragraph, the relevance of the Methadose is not to prove the third count of the Administrative Complaint, but to underscore the risk that Respondent may pose if she practices nursing at present. Respondent was not candid at the hearing. She was not candid about the October 2001 incident. She was not candid about the recent use of Methadose and was evasive about the drug's properties. The two-hour evaluation that Respondent underwent by a certified addictions professional was cursory and curiously deferential to Respondent. This remarkable evaluation is entitled to absolutely no weight whatsoever. The opinion of the certified addictions professional that Respondent does not suffer from a drug abuse or dependency may or may not be true, but, if true, the result is a chance occurrence, rather than a professional conclusion following the comprehensive collection of relevant, reliable data and the careful, informed analysis of such data. The safeguards provided by the pretrial intervention program, into which Respondent entered after her arrest for the fraudulent acquisition of the Oxycontin, are inadequate. The random drug tests always occur on Tuesdays, just not every Tuesday. The assurances that ensue from Respondent's apparent compliance with the conditions of her probation, which include negative urinalyses, are meaningful, but not sufficiently rigorous to provide the necessary protection to a nurse's patients. On December 26, 2001, Petitioner entered an emergency suspension order in this case. The record amply demonstrates that Respondent will suffer considerable financial distress if denied the opportunity to practice her profession. However, Respondent's lack of candor precludes a detailed analysis of the safeguards in her current monitoring program and a detailed prescription of what, if any, additional safeguards would be required to permit any discipline short of a suspension. In its proposed recommended order, Petitioner seeks a suspension until lifted pursuant to, and subject to the conditions set by, an evaluation coordinated by the Intervention Project for Nurses (IPN); treatment as recommended by the IPN; probation for three years if no treatment is recommended by the IPN; an administrative fine of $750; a reprimand; and the assessment of costs of the investigation and prosecution.
Recommendation It is RECOMMENDED that the Board of Nursing enter a final order finding Respondent guilty of violating Section 464.018(1)(i), Florida Statutes, and imposing a penalty of a $250 administrative fine, a suspension until lifted pursuant to, and subject to the conditions set by, an evaluation coordinated by the IPN; treatment as recommended by the Intervention Project for Nurses; probation for three years if no treatment is recommended by the Intervention Project for Nurses; and the assessment of costs of the investigation and prosecution, upon remand, if necessary. DONE AND ENTERED this 20th day of December, 2002, 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 20th day of December, 2002. COPIES FURNISHED: Dan Coble, RN PhD CNAA C, BC Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way, Bin C02 Tallahassee, Florida 32399-3252 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Amy M. Pietrodangelo Assistant General Counsel Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Suzanne H. Suarez Suzanne Hope Suarez, P.A. The Legal Building 447 3rd Avenue North, Suite 404 St. Petersburg, Florida 33701-3255
The Issue Whether Dr. Henson inappropriately administered repeated injections of vitamin B-12 to his patient, Gertrude Ashton, without documenting their necessity in the patient's medical records? Whether Dr. Henson inappropriately administered repeated injections of steroids to his patient, Gertrude Ashton, without documenting their necessity in the patient's medical records? Whether Dr. Henson inappropriately administered repeated injections of Mandol to his patient, Gertrude Ashton, which were not considered to be therapeutically effective?
Findings Of Fact The parties stipulated to the following findings of fact: The Respondent, D. Ross Henson, D.O., is currently, and at all times relevant to this proceeding was, licensed as an osteopathic physician in the State of Florida; Dr. Henson's license number is OS 0001793; Between December 1979, and September 1983, Dr. Henson treated a patient by the name of Gertrude Ashton. Ms. Ashton's husband died in 1981. Ms. Ashton witnessed Mr. Ashton's death in the back yard of their residence. Mr. Ashton's death caused Ms. Ashton anxiety and depression. Ms. Ashton's business had some financial problems during the period at issue in this case. During the approximately forty-six months at issue in this proceeding, Dr. Henson treated Ms. Ashton on sixty occasions. During this period of time Dr. Henson prescribed 2,000 micrograms of vitamin B-12, to be administered intramuscularly, for Ms. Ashton. Ms. Ashton received injections of vitamin B-12 on sixteen separate occasions from Dr. Henson. When Dr. Henson prescribed vitamin B-12 injections for Ms. Ashton, he documented the various problems which she was having at the time in her medical records. Dr. Henson indicated that the reasons for the injections were that Ms. Ashton was under stress, she had long-standing, ongoing disease processes which produced further stress, she was on antibiotics and she was receiving diuretic therapy. Additionally, on occasion, Ms. Ashton requested vitamin B-12 injections. Generally, vitamin B-12 should be administered intramuscularly only if a patient is suffering from vitamin B-12 deficiency. A vitamin B-12 deficiency may be caused by pernicious anemia or malabsorption of vitamin B-12. If a physician suspects that a patient is suffering from vitamin B-12 deficiency, a simple blood test should be administered to determine if the patient's vitamin B-12 level is low. If it is, the physician should then attempt to determine the cause of the deficiency. Dr. Henson did not determine whether Ms. Ashton was suffering from a vitamin B-12 deficiency. Occasionally vitamin B-12 may be administered to a patient who believes that the vitamin will help him or her feel better. Although vitamin B-12 is included as part of nutritional supplements, it is not taken intramuscularly as a nutritional supplement. If a patient is in need of vitamin B-12, 1,000 micrograms is a sufficient dosage. An injection of 2,000 micrograms of vitamin B-12 is excessive. It would be difficult to harm a patient by injecting the patient with vitamin B-12. The reasons for administering vitamin B-12 injections to Ms. Ashton advanced by Dr. Henson and Dr. Henson's medical records fail to justify all of the vitamin B-12 shots administered to Ms. Ashton. Nowhere in Dr. Henson's records concerning Ms. Ashton is it indicated that Ms. Ashton suffered from a vitamin B-12 deficiency. Nor is any other adequate reason for administering the shots she received indicated. It is true that a few of the vitamin B-12 shots prescribed by Dr. Henson for Ms. Ashton may have been requested by Ms. Ashton because she believed they would help her. Not all of the sixteen shots were requested by Ms. Ashton, however. Nor would all sixteen shots be justified by such a request had it been made. Prescribing 2,000 micrograms of vitamin B-12 for Ms. Ashton was also not justified. The repeated injections of 2,000 micrograms of vitamin B-12 administered to Ms. Ashton were a deviation from the accepted standard of care. Dr. Henson also prescribed 34 intramuscular injections of steroids for Ms. Ashton over the 46 months at issue in this proceeding. Dr. Henson injected Ms. Ashton with methylprednisolone acetate, a form of injectable steroid. The brand name of the methylprednisolone acetate used by Dr. Henson was Depo-Medrol. The 34 injections of methylprednisolone acetate were given in doses of fifty milligrams. Methylprednisolone acetate should be given in doses of twenty to eighty milligrams per injection. Prednisolone tebutate, another form of injectable steroid, should be given in doses of four to forty milligrams. Dr. Henson did not, however, give Ms. Ashton prednisolone tebutate. Dr. Henson noted in his medical records concerning Ms. Ashton that he had given her an injection of "Pred." Identifying the injections as "Pred" was insufficient to inform others of how Ms. Ashton was treated with steroids. Dr. Henson indicated that he gave Ms. Ashton steroid injections for the following problems: Acute synovitis and osteoarthritis of the lumbar and cervical spine, acute contact dermatitis, acute allergic rhinitis and acute polyposis. Steroids can be used to treat bursitis and tendinitis. Usually, an injection of steroids for this type of treatment is administered locally. Ms. Ashton's acute contact dermatitis was attributable to her repeated contact with poison ivy and the use of undiluted bleach which Ms. Ashton bathed in as a treatment of her poison ivy. Ms. Ashton also inhaled the fumes from the bleach. Occasional injections of steroids for the treatment of poison ivy, especially when the area affected has been bathed in undiluted bleach, is appropriate. The weight of the evidence concerning Dr. Henson's treatment of Ms. Ashton with steroids proved that generally, most physicians would have administered the injections locally or orally. The evidence did not prove that Dr. Henson's treatment of Ms. Ashton with steroids was not within acceptable standards of care. Dr. Henson also prescribed three injections of Mandol for Ms. Ashton over the 46 months at issue in this proceeding. Injections of Mandol were administered on March 13, 1980 and November 13 and 16, 1981. The injections of Mandol administered to Ms. Ashton were in doses of 250 milligrams. The recommended dose of Mandol is from 500 milligrams to one gram. A dose of 250 milligrams is sub-therapeutic. Mandol is a cephalosporin, which is a form of antibiotic. The March 13, 1980, injection of Mandol was given for acute bronchitis, acute pyelonephritis and acute cystitis. Ms. Ashton was also taking Ceclor, another cephalosporin, orally at the time the injection of Mandol was given. The November 13 and 16, 1981, injections of Mandol were given for acute bronchitis and acute generalized dermatitis due to poison ivy and exposure to bleach. Ms. Ashton was taking another cephalosporin orally at the time the injections of Mandol were given. If a lower dose of Mandol would be effective, it would be listed by the drug manufacturer as a recommended dose. Although there are possible side effects from treatments with Mandol, Dr. Henson did not establish that those side effects were present in Ms. Ashton's case. Dr. Henson's treatment of Ms. Ashton with Mandol during the period of time at issue in this proceeding deviated from the standard of medical care reasonably acceptable under similar conditions and circumstances. Ms. Ashton subsequently filed a complaint concerning Dr. Henson with the Department. The Department investigated the complaint and found probable cause to formally charge Dr. Henson.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Dr. Henson be found guilty of failing to keep written medical records justifying his treatment of Ms. Ashton with injections of vitamin B-12, steroids and Mandol between December 1979, and September 1983. A fine of $500.00 should be imposed on Dr. Henson for his treatment of Ms. Ashton with excessive doses of vitamin B-12; a fine of $500.00 should be imposed on Dr. Henson for his failure to adequately document the type of steroid administered to Ms. Ashton; and a fine of $500.00 should be imposed on Dr. Henson for his treatment of Ms. Ashton with sub-therapeutic doses of Mandol. Dr. Henson should also receive a reprimand for these three violations of Section 459.015(1)(p), Florida Statutes (1987) It is further RECOMMENDED that Dr. Henson be found guilty of failing to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances with regard to his treatment of Ms. Ashton with injections of vitamin B-12 and Mandol between December 1979, and September 1983. Dr. Henson should be fined $1,000.00 for his violations of Section 459.015(1)(y), Florida Statutes (1987), placed on probation for ninety (90) days and required to successfully complete ten (10) hours of Category I continuing medical education in prescribing controlled substances during the twelve months following the issuance of a final order in this case. It is further RECOMMENDED that the charge that Dr. Henson's treatment of Ms. Ashton with steroids between December 1979, and September 1983, constitutes a violation of Section 459.015(1)(y), Florida Statutes (1987), be dismissed. It is further RECOMMENDED that the charge that Dr. Henson's treatment of Ms. Ashton with vitamin B-12, steroids and Mandol between December, 1979, and September, 1983, constitutes a violation of Section 459.015(1)(u), Florida Statutes (1987), be dismissed. DONE and ENTERED this 24th day of June, 1988, in Tallahassee, Florida. LARRY J. SARTIN Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this day of June, 1988. APPENDIX Case Number 86-3336 The parties have submitted proposed findings of fact. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they have been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted. The Department's Proposed Findings of Fact Proposed Finding Paragraph Number in Recommended Order of Fact Number of Acceptance or Reason for Rejection 1-2 1. 3-6 Hereby accepted. 7 4. 8 15-16. 9 19. 10 25-26. 11-13 Not relevant to the charges contained in the Administrative Complaint against Dr. Henson in this case. 14 2. 15-25 & 27 Not relevant to the charges contained in the Administrative Complaint against Dr. Henson in this case. 26 33. Dr. Henson's Proposed Findings of Fact Proposed Finding Paragraph Number Recommended Order of Fact Number of Acceptance or Reason for Rejection 1-2 1. 3 Not relevant to this case. 4 2-3. 5 Not relevant to this case or not supported by the weight of the evidence. 6 4-5. 7 5. 8 4-5. 9 Summary of testimony and events which took place during the formal hearing. The facts this testimony supports were not supported by the weight of the evidence. 10 15-19. 11 20. 12-13 22. Not relevant to this case. Summary of testimony. The facts this testimony supports were not supported by the weight of the evidence. 16 25 and 28. 17 26 and 28. The last three sentences are not supported by the weight of the evidence. 18 29. 19 Summary of testimony. The facts this testimony supports were not supported by the weight of the evidence. COPIES FURNISHED: Theodore Doran, Esquire James J. Kearn, Esquire DOPAN & DANIELS, P.A. P. O. Drawer 1231 Daytona Beach, Florida 32015 James W. Smith, Esquire Kim D. Bouck, Esquire SMITH, SCHODER & ROUSE, P.A. 605 S. Ridgewood Avenue Daytona, Florida 32014 Rod Presnell Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Lee Sims Staff Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 =================================================================
Findings Of Fact The Respondent, Clayton E. Linkous, Jr., M.D., at all times pertinent to this proceeding, has held a current and valid medical license issued by the Board of Medical Examiners of the Department of Professional Regulation. The Petitioner is an agency of the State of Florida charged with enforcing the requirements of Chapter 458, Florida Statutes, and appurtenant rules involving the licensing of physicians, the regulation of their licensure status and the enforcement of standards of professional practice of physicians it licenses to practice in the State of Florida. The Respondent received his medical degree from the University of West Virginia Medical School. Be entered the Navy and served a "rotating internship" at Bethesda Naval Hospital. He was on the staff at Bethesda Naval Hospital for approximately one year. The Respondent then came to Pensacola for Naval Flight Surgeon training and was ultimately assigned to Camp Pendleton, California. The Respondent later was assigned to Vietnam with the Marine Corps as a Flight Surgeon and General Surgeon. Upon concluding his tour of duty in Vietnam, the Respondent returned to the Naval Air Station in Pensacola where he was placed in charge of the Division of Physical Evaluation of Aviation Medicine, serving in that post for some two and a half years. The Respondent resigned from the service and opened a practice of emergency medicine at Sacred Heart Hospital in Pensacola, serving in that capacity for approximately four years. The Respondent then entered private practice in the areas of acute medicine and family practice, which practice he was engaged in at the time of the hearing. The Respondent is a member of the County Medical Society in Escambia County, the American Medical Association, Southern Medical Association, Association of Military Surgeons and a Charter Member of the American College of Emergency Physicians. The Respondent is current on continuing medical education requirements through September, 1983. In January of 1978, Mrs. Julie Hebert visited the Respondent with complaints of a recent weight gain of 7 pounds and sleeping long hours. Mrs. Hebert weighed approximately 101 pounds at that time. The Respondent treated Mrs. Hebert for sleeping long hours and for depression, for which he prescribed antidepressants as well as anorexiants, which are appetite suppressors. During his course of treatment of Mrs. Hebert on this and later occasions, the Respondent failed to record her height, which has a direct relationship to a determination of her ideal weight, although he was treating her to alleviate a supposed excessive weight gain. The Respondent also failed to take a psychosocial or neurological examination of Mrs. Hebert and thus, of course, failed to make a written record of any such examination or history. The Respondent made a diagnosis of obesity. The patient complained of a 7 pound weight gain and her weight was 101 pounds, but if a diagnosis of obesity is made, the usual and reasonable course of treatment for a physician engaged in family practice is to try and predict an ideal body weight or weight loss goal, interview the patient extensively with regard to diet habits, exercise habits and then try to make recommendations to modify those in order to alleviate the diagnosed condition of obesity. This should always be done before an anorexiant drug is prescribed and the appropriate standard of care for a patient with a diagnosis of obesity does not consist of merely prescribing anorexiants to suppress appetite. Anorexiants suppress the appetite control center of the brain. Their use can be helpful to suppress appetite during the first few weeks of treatment for obesity, but they must be prescribed as a part of a total program of weight control consisting of diet modification and exercise on a long-term basis. Anorexiants provide a diminishing return in their benefits in treating obesity because, as their use continues, their effectiveness diminishes and an increasing dose is required as a few weeks elapse. The need to increase the dosage to achieve the same effect of suppressing appetite, and therefore weight control increases geometrically. Thus, if their dosages continued at or near the originally prescribed amount, the anorexiant soon no longer has the effect of suppressing the patient's appetite and the patient has nothing helping him to lose weight unless an appropriate diet and exercise program was thoroughly discussed and prescribed. On the other hand, if anorexiant dosages are increased as their beneficial effect diminishes, then the serious side effects of anorexiant drugs come into play. Anorexiants cause an elevated pulse rate and an increased body temperature similar to that of an adrenaline response or "high active state." Anorexiants are amphetamines or "amphetamine-analogue" drugs, which, because of their stimulative effects, often cause cardiac arrhythmias and increasing dosages can often prove seriously harmful or fatal to a patient. Because of these potentially dangerous effects of anorexiant medications and because their use necessitates geometrically increasing dosages in order to remain effective in weight control, the use of such "amphetamine- family" anorexiants is inappropriate in a patient like Julie Hebert, particularly because of her age of 17 years, because of the potential for causing serious heart rhythm abnormalities and possible death, as well as the addictive potential of such increasing dosages. The use of anorexiants were especially contraindicated in the case of patient Hebert because no long-term diet and exercise modification program was discussed with the patient nor prescribed and the diagnosis of obesity, when the patient reported a recent weight gain of only 7 pounds and only weighed approximately 101 pounds on the first examination, was established to be incorrect. (Cohen deposition; Petitioner's Exhibit 2) The Respondent also diagnosed Julie Hebert, as suffering from depression. The appropriate standard of care in treating depression is a thorough consultation with the patient about depression, its causes and means for alleviating it. A family practitioner practicing an appropriate standard of care in dealing with depression should recommend counseling for the patient herself, as well as involving her family and should take an extensive psychosocial history of the patient's personal and family background in order to assist him in determining the causes of her depression. The Respondent failed to do this in this case. Instead he immediately prescribed two antidepressant medications, which, without the accompanying consultation and counseling and eliciting of a detailed history, can be a potentially dangerous deviation from the standard practice when dealing with such a 17-year-old patient. Antidepressant medication, when appropriately prescribed, requires approximately four weeks to exert its full, antidepressant effect. Its benefit is not immediate, but rather is a cumulative effect. This patient's antidepressant medications, however, were changed frequently. Two medicines were prescribed the first visit and two different antidepressant medications were prescribed on the next visit and still a third medication prescribed on the her third visit, all in the space of less than two months. In fact, on her third visit a major phenothiazine tranquilizer was prescribed when, according to the Respondent's notes, the patient seemed anxious and agitated. That type of medication is used to treat schizophrenia or a major psychosis. There is no psychosocial history in the case of Julie Hebert to indicate that she had or ever had a psychosis which would justify prescribing that drug, especially in view of the fact that it represented a third change from the previous course of antidepressant medications prescribed. The changing of antidepressant medications three times in less than two months is not a course of treatment followed by reasonable, prudent general practitioners or family practitioners in treating such a patient because an insufficient opportunity was provided for the initial medications prescribed to render their full beneficial effects before their use ceased. Further, the doctor prescribed three different amphetamine-family medications in less than three weeks and failed to keep any record of the amounts of any of those medications. The use of such amphetamine-family drugs or anorexiants has no therapeutic place in diet therapy, especially with a 17-year-old girl who only weighs approximately 101 to 105 pounds. On April 18, 1978, patient Gloria Brock visited Respondent at his office complaining of a weight problem. At that visit the Respondent failed to record the patient's height and failed to record an ideal body weight or any weight loss goals. No record was made of the patient's diet habits or exercise habits, nor the type of therapy he prescribed for her. The doctor did prescribe a substantial number of medications. He prescribed diuretics, thyroid medication and amphetamine-family anorexiants. The doctor prescribed Tofranil, an antidepressant; Valium, a minor tranquilizer; Oretic, a diuretic; Thyrolar, a thyroid hormone; Ionamin and Bacarate, both amphetamine analogue medications; and well as Midrin, a headache medication. The sole diagnosis underlying these prescriptions was the patient's weight problem. The doctor next saw this patient on May 9, 1978, at which time he refilled the prescriptions for the previous medications and added a prescription for Phenaphen #2, a narcotic analgesic and Didrex, a different diuretic medication. On that visit she had an additional complaint of mild muscle tenderness in her neck. On June 15, 1978, she came in complaining of additional problems involving miofasciculitis and vascular cephalgia (sore muscles and headaches). He refilled the previous medications, except the Oretic and Tofranil, and added a prescription for Elavil, which is a different anti-depressant from that previously prescribed. He also increased the dose of thyroid hormone. On July 17, 1978, she again visited the Respondent's office and he administered an injectable medication called Vernate, a decongestant and antihistamine combination. Vernate has no therapeutic purpose with a patient in Mrs. Brock's medical situation. The patient also received an injection of Keflex, as well as Comhistla and Ionamin injections. Keflex is an antibiotic. The Respondent had made a note on that date that he thought her ear canal was inflamed or infected. The Keflex was used, however, in conjunction with Terramycin, which is a brand of Tetracycline, the use of which in combination with Keflex is wholly inappropriate. The use of the antibiotic Keflex with the antibiotic Tetracycline is incompatible and the Tetracycline actually will impair the effect of the Keflex prescription. Comhistla is an antihistamine decongestant and Ionamin is a amphetamine-family anorexiant. On September 6, 1978, the Respondent prescribed to her Parafon Forte, a muscle relaxant; Triaprin DC, which is an analgesic containing synthetic Codeine; Histalet, an antihistamine and Minocin, an antibiotic. No record was made by the Respondent of any of these prescriptions. The next office visit was October 23, 1978. No complaints by the patient were recorded for that date, but some physical findings were noted such as her weight (121 3/4 pounds) and that her nasal mucus membranes were swollen. The patient received three injectable medications that date; Iatric, a multi- vitamin combination that is combined with Testosterone and Estrone. That medication is designed for geriatric use and has no therapeutic value in treating Mrs. Brock, a 38-year-old patient with no symptoms indicating its use. She was also injected with vitamin B-12. The only therapeutic indication for a B-12 injection is for pernicious anemia, which Mrs. Brock did not have. Vernate was again injected on that date. The Respondent also prescribed Brexin, another amphetamine-family anorexiant; another antibiotic (Erythromycin); Sinequan, an anti-depressant; and refilled Thyrolar, a thyroid medication. On November 15, 1978, Mrs. Brock came to his office complaining of a muscle spasm. At that time she was injected with Aristocort and Vernate. Prescriptions were also given on that date for Soma Compound, an analgesic- muscle relaxant combination. The next visit was January 18, 1979, when the previous medications were re-prescribed. The Respondent made no notes on that visit regarding the patient's complaints and no physical findings were recorded in his notes. The Respondent last saw this patient on January 30, 1979, and injected her with Lincocin, an antibiotic; Aristocort, a cortisone synthetic preparation; and Cofene, another decongestant-antihistamine combination. On that visit she complained of intermittent auxiliary or underarm swollen glands as well as swollen glands in the groin area (lymphnodes), nausea and weakness. Prescriptions for Vectrin, Elavil and Cofene were given on that date. Those are, respectively, antidepressants and an antihistamine decongestant. . . None of these medications were medically indicated for these complaints. The Respondent's records and notes made during this visit and his course of treatment of Mrs. Brock do not reflect an appropriate history, physical findings or amounts of drugs prescribed. Some of the later physical complaints by the patient during her course of treatment, such as nausea and weakness, are actually signs of misuse or overuse of the medications prescribed and yet the Respondent's later prescription practice and treatment of the patient does not reflect consideration of any adverse drug reactions or side effects. Patient, Vassie Johnson, came to the Respondent on November 7, 1977, complaining of a weight problem. The Respondent recorded her weight as 190 pounds and her age as 60 years and made no recordation of her height at that time as it related to her then present weight or her ideal weight. The Respondent prescribed Ionamin and Bacarate, two amphetamine anorexiants. He also prescribed Hygroton, a diuretic; Thyrolar, which is a thyroid hormone; Quibron Plus, a bronchial dilator; Triavil, an antidepressant. The Respondent diagnosed her problems as being chronic, obstructive pulmonary disease; peripheral vascular insufficiency; obesity; and Mitral Valve Prolapse, a disease or condition of the heart. When she came to the Respondent on this first visit, this patient was already taking the following medications: Triavil, an antidepressant; Donnatal, a gastro-intestinal anti-spasmodic; Dyazide, a diuretic; Inderal, an anti-hypertensive drug; Premarin, a female hormone replacement; Nicotinic Acid; and Librax, a gastro-intestinal anti-spasmodic. The patient had indicated on the personal history she supplied the Respondent that she had emphysema, that she had high blood pressure (hypertension), and that she had Mitral Valve disease of the heart. The prescription of amphetamine-family anorexiants are particularly dangerous for someone known to have heart disease and are contraindicated with a patient who has hypertension, as this patient did. This is because the stimulant effects of such drugs speed the heart rate, stress the heart muscle and elevate the blood pressure in someone who already has a problem with elevated blood pressure. Such a course of treatment with a patient such as Mrs. Johnson could have serious adverse health consequences for her, possibly even fatal ones. The standard treatment for obesity with a patient such as Mrs. Johnson is to do a standard medical history, including her diet and exercise history. The practitioner should then establish a program of diet and exercise habit modification appropriate to the patient. The doctor's records do not reflect that this was done with Mrs. Johnson. Catecholamine is a substance produced by cells in the nervous system which acts as a stimulant. Exogenous catecholamines are drugs that have that same effect. They are prescribed for persons with asthma or lung disease, but should not be used with amphetamine-family anorexiants. The Respondent however prescribed two amphetamine-family anorexiants on the same occasion that he prescribed Quibron Plus, a bronchodilator (catecholamines) which is clearly contraindicated in the manufacturer's recommendations. As noted above, amphetamine-family anorexiants can cause heart rhythm problems. On the very next visit, November 28, 1977, Mrs. Johnson complained of chest pain and Dr. Linkous' notation for that visit notes that it is relieved by nitroglycerin. He also notes, in addition to chest pain, that the patient had an occasional extra heart beat or altered heart rhythm. This is a known adverse side effect from the prescription of amphetamine anorexiants. Thus the Respondent, already having a history of the patient's heart problems before prescribing the anorexiants the first time, was supplied additional unequivocal evidence of the patient's heart condition by her complaints of chest pains and altered heart rhythm. In spite of this, on the next visit, on December 5, 1977, the doctor merely prescribed additional medications. Those medications were Hygrotin, a diuretic, P 200 (nature unidentified) ; Bacarate and Ionamin, the same amphetamine-family anorexiants once again. The heart symptoms she experienced at that time are consistent with the known side effects of the prescription of such amphetamine-family medications. Two days after the patient had complained of chest pains and occasional irregular heart beat, November 30, 1977, the Respondent admitted her to Sacred Heart Hospital of Pensacola. His diagnosis at that time consisted of ruling out ischemic myocardial disease, peptic ulcer disease, chronic obstructive pulmonary disease, hyperthyroidism. In his admission summary, the doctor made no record whatever of the medication already prescribed to the patient and which she was at that time taking. He merely indicated in his admission summary the medications the patient was already taking when she first came to him for her first visit. The subsequent office notes during the Respondent's entire course of treatment of this patient do not reflect the course of treatment in the hospital nor that she was ever hospitalized, which is a significant error of omission, as is the failure to record in the hospital admissions summary the medications the patient had been taking and was taking. On December 23, 1977, Mrs. Johnson returned to the Respondent complaining of dysphagia, meaning difficulty in swallowing. The doctor's records don't reflect that any prescriptions were given on that date. She again returned to the Respondent on February 13, 1978, and the doctor's notes indicate that the same medications were continued. In summary, there is no question that the care he provided these three patients was indeed quite dangerous and could or may have been substantially harmful to them. The Respondent has never been charged with a violation of statutory professional practice standards and has never been disciplined with regard to his licensure status.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence in the record and the candor and demeanor of the witnesses, it is, therefore RECOMMENDED: That the Respondent, Dr. Clayton D. Linkous, Jr., be found guilty of violating Subsections 458.1201(1)(m) and (k), Florida Statutes (1977), as substantially reenacted by Subsections 458.331(1)(t) and (h), Florida Statutes, and that his license be suspended for one (1) year, but with that suspension to be stayed and held in abeyance after 45 days of that suspension has been served, and that it be permanently abated after the Respondent demonstrates to the Board that he has successfully completed a continuing medical education course designed to enhance his skills regarding the appropriate use of drugs in medical practice and therapy, appropriate prescription practices and appropriate patient record-keeping and monitoring. DONE and ENTERED this 4th day of June, 1983, in Tallahassee, Florida. P. MICHAEL RUFF, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of June, 1983. COPIES FURNISHED: Harold E. Regan, Esquire The Whitehouse - Suite 3 203 North Gadsden Street Tallahassee, Florida 32301 Paul W. Lambert, Esquire 1114 East Park Avenue Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Nonroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE BOARD OF MEDICAL EXAMINERS DEPARTMENT OF PROFESSIONAL REGULATION, Petitioner, vs. CASE NO. 81-1631 CLAYTON E. LINKOUS, JR., M.D., License No. 15233 Respondent. /
The Issue The issue to be resolved in this proceeding concerns whether the Respondent is guilty of certain alleged violations of Section 458.331(1)(m), (q), and (t), Florida Statutes, concerning his treatment of one patient during 1984 and 1985 and, if so, what penalty is warranted.
Findings Of Fact The Respondent, Samir Najjar, M.D., is a licensed physician in the State of Florida, having been issued License No. ME0041782. He has been licensed as such at all times pertinent hereto. He received his medical degree from the University of Mexico in 1978. He performed an internship and residency in internal medicine at the Greater Baltimore Medical Center, completing that in 1981. He then completed a fellowship in pulmonary medicine at Wayne State University in Detroit, Michigan, in 1983. He is board certified in internal medicine and holds a Ph.D. in pharmacology and toxicology from Howard University in Washington, D.C. Pharmacology is a specialized field of study in drug pharmacology. It includes the study of chemistry, the effects and uses of drugs, including their toxicology, the origin and nature of drugs, and the pharmacodynamics of drugs. A pharmacologist also studies the effects of drug combinations and their effects on various illnesses and on the body generally. The patient involved in this proceeding is an adult male, who was born on March 4, 1950. He had a long history of reactive, obstructive airway disease, beginning at the age of 17 months to approximately 14 years of age. Between the ages of 14 and 30, the condition alleviated substantially so that he only had very occasional shortness of breath, which could be treated with bronchodilator inhalers. In April of 1980, however, the patient suffered an acute onset of shortness of breath, which condition worsened. He was treated by physicians with a course of Prednisone, an oral steroid medication, for some two to three weeks. This was prior to his being treated by the Respondent. The patient’s condition improved with the Prednisone therapy, but he experienced increasing shortness of breath one to two weeks after terminating that therapy. His shortness of breath become acute, resulting in a respiratory arrest and coma in May of 1980. The patient experienced a hypoxic seizure (lack of oxygen) and was hospitalized at St. Vincent’s Hospital in Jacksonville, Florida, for approximately seven days. Between April of 1980 and July of 1984, he was hospitalized 12 to 15 times for exacerbations of the asthma condition. During this time, he required intubation, or the placing of a breathing tube in the trachea, due to respiratory arrest on three or four occasions, the last one being in December of 1983. The patient has clearly been steroid dependent, with outpatient doses ranging from 5 milligrams four times per day of Prednisone to 35 milligrams twice per day of Medrol through September of 1984. Between July and September of 1984, the patient was receiving 35 milligrams twice per day of Medrol, also an oral steroid. The patient was primarily treated by Edward A. Mizrahi, M.D., between June of 1984 and June of 1985. Dr. Mizrahi is an allergist in Jacksonville, Florida. Prior to that time, he was treated by Irwin Schneider, M.D., a pulmonologist in Jacksonville, Florida. Upon initial presentation to Dr. Mizrahi, the doctor felt that the patient had severe steroid-dependent bronchial asthma with corticosteroid side effects. Patients who have life- threatening asthma are typically treated with anti-inflammatory medications, such as corticosteroids. Severe asthmatics can have life-threatening risks from their condition and will die, on many occasions, without the administration of steroid medications. Thus, such patients must take these medications to survive. Steroids have significant adverse side effects, including “cushinoid features”, development of cataracts and the development of osteoporosis. Despite such adverse side effects, the use of corticosteroids may be necessary in order to simply allow the patient to survive. The subject patient was in such a category. The patient suffered from many of the side effects from long-term steroid use. Dr. Mizrahi noted compression fractures of the spine, cataracts, peptic ulcer disease, and weight gain during his initial evaluation of the patient on June 11, 1984; and on October 10, 1984, noted cushinoid appearance or features. This was before the patient was ever seen or treated by the Respondent. On August 20, 1984, Dr. Mizrahi arranged for the patient to be evaluated at the National Asthma Center (Center) of the National Jewish Hospital and Research Center in Denver, Colorado. This is a specialty facility for the treatment of asthma and is commonly referred to as a “court of last resort”, where pulmonologists refer patients with difficult asthmatic conditions which have not as yet responded satisfactorily to treatment regimens. Between September 12, 1984 and September 16, 1984, the patient was evaluated and treated at the Center. The Center noted the patient’s long history of severe asthma and resultant steroid dependency. Upon initial evaluation, the physicians at the Center felt that the patient would probably require continuing steroid therapy, but they did attempt to reduce the steroid dosage. The attempt to reduce the steroid dosage in the patient was unsuccessful, and the Center ultimately had to increase the steroid dosage. The patient was discharged from the Center on an oral steroid medication, Medrol, 20 milligrams, alternating with 40 milligrams, four times per day. This is considered a high dose of steroid medication and was reluctantly arrived at and prescribed by the physicians at the Center after they made bona fide attempts to wean the patient from steroids to the extent possible. During his hospitalization, the physicians at the Center noted that the patient gave a “convincing history for ischemic heart disease”. They suggested an investigation to determine the presence of this condition. Upon the patient’s return to Jacksonville, Florida, he continued to be treated by Dr. Mizrahi and continued to receive oral steroid medication in high doses. Additionally, he was receiving Halcion, Adivan, Fiorinal, and Fastin. The Respondent first saw the patient on June 13, 1985 upon a referral from Dr. Samara, a urologist in Jacksonville, Florida, who had some contact with the patient. The Respondent took an extensive history from the patient, including a list of the current medications he was receiving from Dr. Mizrahi, which then included Medrol, 24 milligrams, four times per day, with a bolus of Medrol as needed of 60 milligrams four times per day for 48 hours, followed by 30 milligrams four times per day for two weeks. The patient was also receiving Halcion at 0.25 milligrams at bedtime and Adivan at 2 milligrams. The Respondent had the impression that the patient suffered from asthma and possibly from coronary artery disease. Due to the possibility of coronary artery disease, which had been raised during the admission at the Center, the Respondent hospitalized the patient from June 17, 1985 to June 22, 1985 at St. Vincent’s Medical Center in Jacksonville, Florida, to investigate the coronary situation. During this hospitalization, an extensive history and physical were performed, including a neurological examination of the patient. A cardiac workup was performed by consulting cardiologist, Joel Ferree, M.D. This included a cardiac catheterization performed by Dr. Ferree, which indicated that the patient had normal right ventricular function, no significant arteriosclerotic lesions, and no significant artery response to adrenergic agonist agents. The cardiac catheterization reported normal left ventricular function. The cardiac catheterization report ruled out any cardiomyopathy. During this hospitalization, the Respondent also ordered x-rays of the cervical and thoracic spine. The x-rays revealed “mild, old compression deformities of the eighth and ninth thoracic vertebral bodies, with no change since a previous examination on November 30, 1983”. This x-ray report was consistent with the previously- reported compression deformities, or compression fractures, which are the result of osteoporosis. Osteoporosis leaves the bones weak, with loss of trabeculation. The patient’s vertebra were already being crushed as of June of 1985, when the Respondent undertook his care. At the time of discharge from this hospitalization, the Respondent recorded that he would like to wean the patient off steroids over several months. The Respondent continued to treat the patient through April of 1989. During this period of time, the asthma was reasonably controlled with the use of steroid medications and bronchodilaters. Unlike the previous few years, the patient only required hospitalization for treatment of exacerbation of asthma symptoms on one occasion, on November 7, 1985. During this period of treatment, he never had a respiratory arrest and intubation was never required. The Respondent would wean the patient from the use of steroids during this period of treatment when the symptoms allowed. When the symptoms were exacerbated, he would provide prescriptions for corticosteroids so as to address the patient’s condition. The Respondent made numerous attempts to wean the patient off high-dose steroid medication, but the patient’s condition would not permit a cessation of it. The fact that the Respondent was unable to wean the patient from steroids is not surprising to physicians who treat such a condition. It is not a deviation from the accepted standard of care. The patient had a very significant case of asthma, which was life threatening, as demonstrated by the records of not only the Respondent, but the prior treating physicians. His asthma was so significant that he had to receive steroid medication, despite the significant side effects caused by such medication, in order to insure survival. During the course of treatment, the Respondent also treated the patient for cervical strain and low-back pain. His compression fractures were a source of great pain, justifying the prescription of narcotic analgesics. The Respondent’s treatment for these conditions included physical therapy, paralumbar trigger point injections, biofeedback, TENS Unit, ice packs, as well as drugs, including muscle relaxants and analgesics. The Respondent also referred the patient for examination by orthopedic physicians and neurologists. These efforts were appropriate and within the standard of care. The prescriptions for Flexeril, Fiorinal, Lortab and Tylox and other medications for the control of back pain and muscle spasms were appropriate and under the circumstances of this severely-distressed patient, were within the standard of care. The Respondent, on occasion, prescribed medications for control of insomnia, including Halcion. These same medications had previously been prescribed for the patient by Dr. Mizrahi for the same condition and were appropriate prescriptions. The corticosteroids and other medications used to control asthma can produce a side effect of insomnia. This manifestation must be treated for the benefit of the patient. The prescriptions for Halcion were appropriate and within the standard of care. An additional side effect of steroid medication is weight gain. The Respondent advised the patient regarding dietary control for his weight to alleviate such a problem. The patient, however, exhibited substantial weight gain. Therefore, the Respondent prescribed a limited amount of Fastin, an appetite suppressant. Physicians must use medications such as Fastin with caution on patients with significant hypertension. The patient’s blood pressure, however, was not significantly elevated; and his blood pressure was being monitored during his use of Fastin. The use of Fastin by this patient did not cause a significant increase in his blood pressure. Fastin is a sympathomimetic amine. It is not a true amphetamine. It is appropriately prescribed for weight control and this patient had exhibited an increase in weight, doubtless due to a side effect of the steroid medications. Increased weight in the patient was medically significant because he already had compression fractures of his vertebrae caused, no doubt, by osteoporosis, also attributable to side effects of steroid medications. Increased weight could exacerbate his skeletal problem and cause additional pain. Increased weight is also dangerous for patients with asthma, in any event, because it severely taxes the respiratory system and can make intubation, if necessary, more difficult. The Respondent’s prescriptions for Fastin were shown to be appropriate and within the standard of care, as demonstrated by the expert testimony of Dr. Miller and the other testimony in evidence offered by the Respondent. During treatment of the patient, the Respondent prescribed Adivan also. Adivan is a muscle relaxing drug, and it was shown to be appropriately within the standard of care for physicians confronted with a patient with the multiple problems exhibited by this one. Although there can be some concern about mood alteration under certain circumstances with the use of Adivan and perhaps to some extent with Halcion, the Respondent did perform mental status examinations and referred the patient for evaluation when indicated. During his treatment of the patient, there was never any symptom of suicidal ideation expressed by the patient. There was no reason demonstrated which would justify the referral of the patient to a psychiatrist at an earlier date in the subject situation. The testimony of Dr. Miller and the other experts adduced by the Respondent shows that under the peculiar circumstances of this patient, the use of Adivan, as well as Halcion, in conjunction with the other medications the patient was taking, was medically justified and within the appropriate standard of care. It has been demonstrated that the medical records maintained by the Respondent justify the course of treatment of the patient, as shown by testimony of record at pages 105 and 106 of the transcript of the proceedings and Respondent’s Exhibit 1 at pages 52-54. The Respondent practiced with that level of care, skill and treatment recognized as appropriate to meet the standard of care for similar physicians. Upon weighing the expert testimony adduced by the parties, it is determined that the expert testimony presented by the Respondent was more persuasive and creditable than that presented by the Petitioner. The Petitioner’s expert, Dr. Kreitzer, relied upon some flawed information in developing his expert opinions, including, but not limited to, his reliance upon compilations of prescription information which was not established as accurate in the course of this proceeding, being merely computer printouts from records of pharmacists. Those records do not, for instance, even show that the Respondent prescribed all of those medications represented thereon. Dr. Kreitzer’s opinion was also flawed because his belief was based, in part, on his understanding that the patient was suffering from cardiomyopathy, when that condition had already been ruled out by cardiac tests performed upon the Respondent’s order during the June of 1985 hospitalization. Dr. Kreitzer’s mistaken belief that Fastin is an amphetamine, which it is not, also detracts from the weight which can be ascribed to his opinion. Further, Dr. Groble, the other expert presented by the Petitioner, cannot be relied upon because in his testimony he admits that he cannot render an opinion that the Respondent departed from appropriate standards of care in his practice with regard to the subject patient in the instances alleged in the Administrative Complaint because he had not seen all of the Respondent’s pertinent medical records. Consequently, he could not render a definitive opinion, one way or the other. The Respondent’s expert witnesses, Dr. Miller and Dr. Sharpe, are accepted as more credible than the Petitioner’s expert testimony. Both Drs. Miller and Sharpe indicated that they had reviewed, in some depth, the medical records which the Respondent maintained concerning the patient and those records and the history pertaining to treatment rendered by other physicians and the Center. Their testimony revealed an in-depth study, reflection and consideration of the concededly large doses of multiple medications, some of which have significant side effects. They regrettably agree, that confronted with a complex, life-threatened patient, such as this, the Respondent could have done little else than follow the course of treatment and medication pattern and practice which he followed. While these experts and the Respondent, in the course of treatment, recognized the risks attendant to the engendering of dependency on the steroids and the use of the other medications, they acknowledged that under the circumstances there was little else that could be done in order to keep the patient stable, accord him some quality of life, and even to save his life. In summary, it has not been established that the Respondent failed to adequately keep written medical records which justify the course of treatment of the patient. It has not been established that the Respondent prescribed legend drugs, including controlled substances, other than in the course of his professional practice, nor has it been established that he prescribed legend drugs in excessive quantities and in excessive combinations or, otherwise, inappropriately in relation to generally-accepted medical practice. It has not been established that the Respondent failed to practice medicine with that level of care, skill and treatment recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered by the Board of Medicine dismissing the Administrative Complaint in its entirety.DONE AND ENTERED this 5th day of February, 1997, in Tallahassee, Florida. P. MICHAEL RUFF Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 5th day of February, 1997. COPIES FURNISHED: Albert Peacock, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Bruce D. Lamb, Esquire SHEAR, NEWMAN, ET AL. Post Office Box 2378 Tampa, Florida 33602 Dr. Marm Harris, Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0770 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403
