The Issue The issue in the case is whether the allegations in the Administrative Complaints are correct and, if so, what penalty should be imposed.
Findings Of Fact At all times material to this case, the Respondent was a licensed physician in the State of Florida, holding license number ME0039986. DOAH Case Number 01-3795PL Between May 22 and June 5, 1998, the Respondent ordered a series of diagnostic lab tests for Patient C. H., a 63-year- old female. As to the care provided to Patient C. H., the Petitioner presented the testimony of Hamilton Fish, M.D., whose testimony was persuasive and is credited. According to Dr. Fish, many of the tests performed on Patient C. H. were not medically indicated according to a review of the information set forth in the patient's medical records, and the medical treatment care provided by the Respondent to the patient was inappropriate and failed to meet the applicable standard of care. According to the hemoglobin test performed on Patient C. H., the patient was diabetic and the diabetes was uncontrolled. The Respondent did not provide proper treatment to the patient for the diabetes. According to one of the lab tests, Patient C. H. was deficient in calcium. The Respondent did not provide appropriate treatment for the calcium deficiency. Although there was no medical indication that Patient C. H. had a thyroid problem, the Respondent prescribed a thyroid hormone medication. The thyroid medication was inappropriate and could have exacerbated the diabetic condition. DOAH Case Number 01-3796PL The Petitioner introduced into evidence an advertisement that appears to have been published in the June 25, 1999, edition of the "Sun-Sentinel Community News." There is no evidence that the Respondent created, read, placed, or paid for the advertisement in the newspaper. The ad offered a complementary consultation with the Respondent, who was identified in the ad as a diplomate of the "American Board of Anti-Aging." Florida law requires that a disclaimer appear in such advertisements advising a patient of the right to essentially decline non-free services that are recommended on the basis of the free consultation. The cited advertisement did not include the disclaimer. The Petitioner's administrative rules prohibit advertisement of affiliation with groups not "recognized" by the Petitioner. The Petitioner has not approved of the "American Board of Anti-Aging." DOAH Case Number 01-3797PL Patient D. E. On or about July 21, 1998, the Respondent ordered a series of diagnostic lab tests for Patient D. E., a 53-year-old male. According to the records, Patient D. E. had complained of impotency and loss of sexual desire. As to the care provided to Patient D. E., the Petitioner presented the testimony of Timothy Shapiro, M.D., whose testimony was persuasive and is credited. According to Dr. Shapiro, many of the tests performed on Patient D. E. were not medically indicated according to a review of the information set forth in the patient's medical records. At least one of the tests performed on several of the patients referenced herein (the "Barnes Basil Temperature Test") is not recognized in the medical community as providing valid information for the conventional diagnosis or treatment of any disorder. On or about August 18, 1998, the Respondent diagnosed Patient D. E. with hypothyroidism, panhypothyroidism, food allergies, and impotence of organic origin. He prescribed Cytomel, Armour Thyroid, and testosterone gel for the patient. According to the testimony of Dr. Shapiro, the prescribed medications were inappropriate because the medical record fails to indicate any deficiencies being addressed by the medication. The course of treatment provided for the patient is not documented by the medical records and is below the standard of care. Patient J. N. On or about August 27, 1998, the Respondent ordered a series of diagnostic lab tests for Patient J. N., a 50-year-old female. According to the records, Patient J. N.'s symptoms included fatigue, numbness, tingling and burning in the extremities, muscle and head aches, insomnia, swelling, depression and easy bruising. As to the care provided to Patient J. N., the Petitioner presented the testimony of Hamilton Fish, M.D., whose testimony was persuasive and is credited. According to Dr. Fish, many of the tests performed on Patient J. N. were not medically indicated according to a review of the information set forth in the patient's medical records. On or about September 10, 1998, the Respondent diagnosed Patient J. N. with chronic fatigue, probable hypothyroidism, and unspecified liver disorder. An existing diagnosis of ischemic heart disease was confirmed; he prescribed various medications for the patient. According to the testimony of Dr. Fish, the prescribed drugs (Cytomel, Hydrocortisone, Rezulin, and a female hormonal transdermal gel) were inappropriate and below the standard of care, and the medical records do not justify the course of treatment provided by the Respondent. Patient T. B. On or about October 8, 1998, the Respondent ordered a series of diagnostic lab tests for Patient T. B. (also identified as T. P.) a 49-year-old female. According to the records, Patient T. B.'s symptoms included muscle ache, migraines, insomnia, vaginal discharge, and neck, back and stomach pain. As to the care provided to Patient T. B., the Petitioner presented the testimony of Hamilton Fish, M.D., whose testimony was persuasive and is credited. According to Dr. Fish, many of the tests performed on Patient T. B. were not medically indicated according to a review of the information set forth in the patient's medical records, and the medical treatment care provided by the Respondent to the patient was inappropriate and failed to meet the applicable standard of care. On or about October 21, 1998, the Respondent diagnosed Patient T. B. with hyperthyroidism, migraine headaches, chronic fatigue, yeast infection, and unspecified disorder of the intestines, stomach, and duodenum. He prescribed various medications for the patient. According to the testimony of Dr. Fish, the prescribed drugs (Cytomel and Armour Thyroid) were inappropriate and below the standard of care, and the medical records do not justify the course of treatment provided by the Respondent. The Respondent failed to perform a pelvic examination or to refer the patient to a gynecologist despite the diagnosis that she was suffering a yeast infection, and therefore failed to meet the applicable standard of care. The diagnosis of unspecified disorder of the stomach, duodenum, and intestines was apparently based on described pain. There is nothing in the medical record indicating that appropriate testing to determine causality was ordered or performed. Patient A. M. On or about August 26, 1998, the Respondent ordered a series of diagnostic lab tests for Patient A. M. According to the records, Patient A. M.'s symptoms included muscle and head ache, constipation, cramps and menstrual irregularity, decreased libido, sore throat and sinus problems. As to the care provided to Patient A. M., the Petitioner presented the testimony of Hamilton Fish, M.D., whose testimony was persuasive and is credited. According to Dr. Fish, many of the tests performed on Patient A. M. were not medically indicated according to a review of the information set forth in the patient's medical records, and the medical treatment care provided by the Respondent to the patient was inappropriate and failed to meet the applicable standard of care. On or about September 9, 1998, the Respondent diagnosed Patient T. B. with hypothyroidism, chronic fatigue, hyperinsulinemia, and unspecified ovarian dysfunction. The lab test results do not support the diagnosis. On December 2, 1998, the Respondent prescribed various medications for the patient. According to the testimony of Dr. Fish, the prescribed drugs (Cytomel, Rezulin, Glucophage, glycine, and fish oil) were inappropriate for the patient and below the standard of care, and the medical records do not justify the course of treatment provided by the Respondent.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Agency for Health Care Administration, Board of Medicine, enter a final order suspending the medical license of Robert M. Knight, M.D., for a period of one year followed by five-year period of probation, and imposing an administrative fine of $5,000. DONE AND ENTERED this 19th day of April, 2002, in Tallahassee, Leon County, Florida. ___________________________________ WILLIAM F. QUATTLEBAUM 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 19th day of April, 2002. COPIES FURNISHED: Kathryn E. Price, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Robert M. Knight, M.D. 5650 Camino del Sol, Number 101 Boca Raton, Florida 33433 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Mr. R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact The Respondent, Solomon D. Klotz, M.D., at all times pertinent hereto, has held a current, valid medical license number ME 0002269, issued by the Board of Medical Examiners, Department of Professional Regulation, which is the agency charged with enforcing Chapter 458, the "Medical Practice Act," as it relates to qualification for licensure and standards for regulating medical practice of physicians licensed in the State of Florida. The Respondent is also board- certified by the American Board of Internal Medicine in internal medicine and is board- certified in the field of allergy and immunology by the American Board of Allergy and Immunology. The Respondent obtained his M.D. Degree from New York Medical College in 1937, obtaining a Masters from that institution in 1942. He was licensed in New York in 1938 and was made a diplomate of the National Board of Medical Examiners in 1938. He was issued his Florida license in 1941. He served in the Medical Corps of the United States Army in World War II and during the years 1945 and 1946 was a clinical instructor at New York Medical College, and a research fellow at Metropolitan Hospital Research Unit in New York. The Respondent has practiced in his specialty field of internal medicine as well as allergy and immunology in Florida for many years. He is presently a clinical professor at the College of Health of the University of Central Florida, and an adjunct professor at the Department of Biological Sciences at the University of Central Florida. Respondent is presently on the medical staffs at Winter Park Memorial Hospital, Florida Hospital, Orlando Regional Medical Center and Humana Hospital/Lucerne, with a senior consultant rating at each of the above hospitals. The Respondent is a member of 21 professional societies and was a founding member of the Salk Institute for Biological Studies and, the board of the Joint Council of Allergy and Immunology. He has served as president of the American College of Allergists, the Florida Allergy Society, Southeastern Allergy Society, and is president of the medical staff of Florida Hospital in Orlando. The Respondent has published or presented more than 50 research papers, seven of which have been published within the past three years in such journals as the Annals of Allergy, the Journal of the Florida Medical Association, the Journal of the American Academy of Allergy and Immunology and the American Heart Journal. Concerning the disease or condition most pertinent to the charges in the administrative complaint, the Respondent published a paper jointly with Dr. Von Hilsheimer in 1970 concerning minimal brain dysfunction, attention disorders and the diagnosis of functional narcolepsy. Dr. George Von Hilsheimer was accepted as Respondent's expert witness concerning the diagnosis of narcolepsy and the various forms or manifestations of narcolepsy and the treatment thereof. He is a licensed psychologist in the State of Florida, having been educated at the University of Miami with postgraduate work at the University of Chicago. He interned in psychology at the Corsack Clinic and the Seabrook Institute in San Francisco. He completed his Ph.D. in psychology with a multiple major in neuropsychology, psychoimmunology and psychotherapy. He is an associate fellow in the Society for Clinical Ecology, a consultant to the Science Advisory Committee of the Environmental Protection Agency as a neuropsychologist and behavioral toxochologist. He is eligible for board certification by the Academy for Psychosomatic Medicine and the American Academy of Behavioral Medicine. He has published numerous reference papers and a number of books, one of which books focused on the diagnosis of minimal brain dysfunction and the issue of psychosomatic versus somatic causes for behavior. He has presented two papers in conjunction with the Respondent on the issue of minimal brain dysfunction, tension disorders and the diagnosis of functional narcolepsy. Since 1980, Dr. Von Hilsheimer's practice has been split between psychotherapy and psychoimmunology. In the past ten years he has presented numerous continuing education workshops for physicians, which courses were certified by the American Medical Association. Dr. Dale K. Lindberg, M.D., was accepted as an expert witness for the Petitioner regarding the pharmacological effects, uses and indications of the drugs related to the charges in the administrative complaint. Dr. Lindberg has been a licensed physician in the State of Florida since 1959. He is board certified in nuclear medicine. He took a residency in nuclear medicine at Mt. Sinai Hospital in Miami Beach between the years 1974 and 1977. Since 1973, his practice has been limited to primarily that of supervising methadone maintenance programs and clinics. Prior to 1973 his practice was in the area of family practice, as well as nuclear medicine. He is a member of the Broward County Medical Association, Florida Medical Association, American Medical Association, Broward County Family Practice Association, as well as the Society of Nuclear Medicine. Dr. Lindberg has never treated a patient with narcolepsy nor has he seen patients exhibiting the various kinds of narcoleptic behavior. METHAQUALONE PRESCRIPTIONS; COUNTS I, II AND III The first three counts in the administrative complaint concern prescriptions written June 24, 1982, for allegedly excessive and unjustified amounts of a controlled substance, methaqualone, prescribed to patients Harri Klotz (Count I) , Sam Meiner (Count II) and Charles Meiner (Count III). Those prescriptions consisted of 121 sopor (150 mgs) for Harri Klotz; 189 parest for Sam Meiner; and 34 quaaludes for Charles Meiner, all of which are methaqualone medications. The Respondent received a telephone call on or shortly before June 24, 1982, the date the prescriptions were written, from a pharmacist whom he regularly dealt with, who informed him that, inasmuch as, effective July 1, 1982, he would be unable to fill methaqualone prescriptions due to a change in the law by which it became a Schedule I drug, that he would make available the small quantity of methaqualone remaining in stock to the Respondent for his patients who required the drug. The Respondent acknowledged having a few such patients and accordingly wrote prescriptions for the above odd numbers of capsules to patients whom had been regularly receiving methaqualone medication for a period of time previously. Patient Harri Klotz is the Respondent's wife. She has been a patient of Respondent since approximately 1940. She suffers from generalized osteo- arthritis involving mainly the hips, which was first diagnosed in 1967. Due to progressive severity of the disease she received surgery in October, 1970, in Germany, for replacement of both hip joints with artificial prosthesis. Since that time the right hip prosthesis joint cracked, causing her severe, chronic pain which caused her great difficulty in sleeping. After taking numerous combinations of medicine, Mrs. Klotz was found to respond most effectively to methaqualone, which induced sleep in spite of the pain, without undesirable side effects the next morning. She ultimately had the right hip prosthesis repaired. Her medical records indicate that this medication had also been prescribed for her by her treating physicians when the prosthetic devices were implanted. In 1981 she again began experiencing the same type of agonizing, chronic pain in her left hip and consulted an orthopedic surgeon at regular intervals concerning it. It was not until November, 1952, however, that the diagnosis was made that her left prosthesis had also broken. During the various attempts to diagnose the cause of this problem with her left hip, she was experiencing severe, chronic pain. Finally, after a third stint of surgery the left hip prosthesis was replaced and her symptoms ultimately improved. In the meantime however, on October 14, 1981, Respondent purchased 1,000 quaaludes for his wife. He did not dispense the entire lot to her, rather she was given 30 capsules at a time for use in inducing sleep during the period when she suffered from her painful condition at intervals of one and one-half to two months. The Respondent carefully monitored her dosage and kept the balance under lock and key at his office, duly recording on a dispensing record the capsules actually given to his wife on each occasion. On June 24, 1982, before methaqualone became a Schedule I Controlled Substance, he last prescribed that substance for his wife when he wrote the prescription for 121 sopor. He has not since prescribed a methaqualone substance to his wife. On June 24, 1982, the Respondent prescribed methaqualone to Sam Meiner. Mr. Meiner (Respondent's counsel) has been a patient of the Respondent since approximately 1968. Be suffers from a severe, chronic painful condition called regional enteritis, a condition characterized by severe, chronic pain and acute bowel spasms associated with acute exacerbations of the enteritis condition. As a result of this condition he has had two bowel resection surgeries, during the course of which surgeons removed approximately six feet of his small intestine. He has suffered from this disease chronically for approximately 18 years, having his first surgery in 1967 and the second in 1977. "hen the enteritis condition became acutely inflamed after his second surgery, he once again sought Respondent's medical advice. He has been a continuous patient of the Respondent ever since that time, seeing him almost on a weekly basis. Included in the total medical care Respondent has given this patient is a prescription of methaqualone for its beneficial soporific and antispasmodic effects designed to curtail the severity and duration of the bowel spasm incidents. Other physicians, as well as Respondent, in treating this patient have attempted many other combinations of medications before the Respondent and patient determined that methaqualone was the most effective modality. Since being under the Respondent's care with attendant methaqualone medication, the patient has required no hospitalization and has been able to lead a substantially normal existence, even though this disease or condition if unsuccessfully treated can ultimately prove fatal, especially if additional such surgical procedures are resorted to. Witness Meiner was shown to have no abnormal adverse effects nor physical or psychological dependence on the drug. It is now no longer legally obtainable, the patient being afforded his last prescription therefor on June 24, 1982, some six days before the prescription of the drug became illegal. On June 24, 1982, the Respondent prescribed 34 methaqualone capsules to Charles Meiner. Charles Meiner (also counsel for Respondent) suffers from a chronic, severe back injury involving a ruptured or degenerative disc. He periodically suffers excruciating, chronic back pain, resulting in his inability to sleep. He has been a patient of the Respondent since 1969. In 1973 he required hospitalization due to the severity of the back pain. lie has seen the Respondent for this problem at regular intervals ever since. He had been prescribed methaqualone on a number of occasions prior to June, 1982, as the medication helps his insomnia resulting from the chronic back pain, without imposing any adverse effect the following morning or inhibiting his ability to function in the legal profession. Be has never taken more than one tablet per day and some days only a half tablet during the course of his back pain flare- ups. In May of 1982, his back condition became particularly severe, with persistent pain. Because of this exacerbation of his back condition, he was given a prescription for 34 quaalude tablets on June 24, 1982, to relieve his pain and enable him to sleep. During the time Respondent prescribed methaqualone to these three above-named patients, methaqualone was an acceptable medication for relief of the symptoms these patients exhibited. Petitioner's witness Dr. Lindberg acknowledged that the prescribing of methaqualone by the Respondent to these patients on or before July 1, 1982, was for a medically justifiable purpose, and that the dosages involved were within recommended daily dosages for the treatment of the symptoms exhibited by these patients, as depicted in the Physician's Desk Reference (PDR) a work relied on by both parties throughout this proceeding. AMPHETAMINE PRESCIPTIONS: COUNTS IV, V, VII, XI, XII, XIII, XIV, XVI, XVII, XVIII and XIX. The prescription of amphetamines became restricted as to use by the enactment of Section 458.331(1)(cc) , Florida Statutes, effective August 30, 1980. This restricted the prescription of any drug which is an amphetamine or a sympathomimetic amine drug (a Schedule II drug) except, as pertinent here, for the condition of narcolepsy. Prior to the restriction of the drug, the Respondent had prescribed such drugs for short-term use for patients who were attempting to embark on a successful weight-control program. The Petitioner's expert witness, Dr. Lindberg, acknowledged that this was a medically appropriate use of this type of medication at the time and that he himself had made similar prescriptions for similar purposes. The Respondent conceded that as of July 3, 1980, that he was not aware of the change in the legal status of amphetamine type drugs by the enactment of the above statute, and did not become aware of such restrictions until the pharmacist with whom he regularly dealt informed him that he could not prescribe Biphetamine, Dexedrine or other sympathomimetics unless the patient had a narcoleptic condition. Upon becoming aware of this restriction after August 30,1980, the Respondent discontinued use of those drugs except for the treatment of narcoleptic symptoms in patients. Dr. Lindberg opined that the only type of narcolepsy he would recognize was "ideopathic narcolepsy." By this he meant that he would only diagnose narcolepsy when all four recognized symptoms are present: excessive daytime sleepiness, cataplexy (a condition when muscles become limp) , hypnogogic hallucinations (dreams shortly before going to sleep or upon awakening) and sleep paralysis whereby the patient is unable to move, although the limbs are not rigid. Dr. Lindberg has never treated a patient with narcolepsy nor has he ever observed a patient exhibit narcoleptic behavior in his practice. Both the Respondent and Dr. Von Hilsheimer, the Respondent's expert witness on the subject, have studied and treated this condition and published recognized research papers on the subject of narcolepsy. Further, the Respondent in connection with his speciality in the field of allergies, has performed testing regarding patients with certain food sensitivities and has observed that some of them will exhibit narcoleptic symptoms as a reaction to certain foods. Dr. Von Hilsheimer, as delineated above, has extensive experience in the diagnosis and treatment of narcolepsy in its various forms and in teaching recognition of the condition to doctors through continuing education courses. Idiopathic narcolepsy, the extreme or classic view of the disease, may involve exhibition of all four of the above symptoms in a patient, however, only 10 percent of patients legitimately diagnosed as narcoleptic present all four symptoms, and therefore most of the scientific and medical community uses the term "narcolepsy" In a broader, more general sense to mean essentially excessive, inappropriate daytime sleepiness, especially at inappropriate times. In addition to narcolepsy being a primary affliction, it can also be a subsyndrome, or secondary disorder related to a different medical problem. It can be permanent or can be a transient condition and can be a by-product of unusual psychological or physical stress. The Respondent prescribed a small dosage of an amphetamine for Nina Balabon between January 11, 1980, and September 17, 1982, at various times. (Count IV) Ms. Balabon is a 92 year old woman who has been taking a very small dosage of Dexedrine for many years. The dosage is substantially below that allowable for such a patient as conceded by the Petitioner and delineated in the Physician's Desk Reference. Ms. Balabon lives alone in Woodstock, New York, and is the foster mother of the Respondent's wife. She had been under the care of another physician who prescribed this course of treatment and drug for her so that she could remain alert enough to independently function and take care of herself in her own home. She is home-bound and after her doctor's death, she was unable to secure another doctor who would make house calls. She called upon the Respondent who is, in effect, a family member, and financially supports her, and asked him to prescribe the medication for her, in conjunction with which she retained the services of a visiting nurse. In her old age she has become afflicted with lassitude, inappropriate and excessive daytime sleepiness, depression and a diminished "will to live." The Respondent visits her in Woodstock, New York, periodically and he or his wife, telephone her at least once a week. A visiting nurse checks on her condition weekly and reports to the Respondent on her physical condition. The Petitioner's expert witness, Dr. Lindberg, has never seen this patient, but surmised upon her recorded weight that she is slightly malnourished. Accordingly, he opines that it is inappropriate to give a person with such a condition (slight malnourishment) amphetamines to curb her appetite and provide her "pep." The Respondent, however, did not prescribe amphetamine for this purpose. Be found, in the exercise of his medical judgment that she exhibits definite symptoms of narcolepsy. The dosage is extremely small and the patient is not shown to suffer any adverse effects therefrom. It was not shown that the dosage curbed her appetite, and indeed, Respondent established that the patient is not malnourished. She is a very small, slightly built woman and her mere recorded weight is not an indication in itself of malnourishment such that the prescription involved would be contraindicated. Petitioner's expert witness, further was unaware that the patient exhibited symptoms of narcoleptic behavior, and admitted that otherwise the dosages were quite small and not excessive for such a patient. Dr. Lindberg merely opposed the prescription of the medication because he believed that the law changed regarding the use of this drug, such that after August 30, 1980, it is only permissible for narcoleptic symptoms. In any event, the Respondent's diagnosis of the patient was uncontradicted and the 92 year old patient was shown to benefit from this treatment of her condition because it permitted her, with the assistance of the visiting nurse, to continue living independently rather than suffering commission to a nursing home or other institutional facility. Count VII concerns alleged prescriptions of amphetamines to one Doris Calloway between February 16, 1982 and October 13, 1982. Petitioner failed to introduce any evidence or testimony concerning this count. With regard to Count XI, Respondent prescribed on only one occasion, 50 Biphetamine capsules for Lori Carroccia on September 29, 1980. At the time this prescription was written and issued, the Respondent was unaware of the recent restrictions imposed by the legislature on the purposes for which amphetamine-type drugs could be prescribed by the passage of Section 458.331(1)(cc), Florida Statutes, effective July 1, 1980. The Respondent had known this patient for approximately six years and she was his nurse, employed at his clinic at the time the prescription was written. The single prescription was written when she complained to him of difficulty in starting a weight loss program and asked for his assistance. Prior to writing the prescription, he checked Ms. Carroccia's physical health, checked her weight and blood pressure, and indeed was already aware of her medical history because of his close association with her. During the entire two months she received this medication Respondent saw her on a daily basis and monitored her progress. The medication proved to be an effective means for her to develop a successful weight loss program. She suffered no adverse effects from receiving this drug. The Respondent only prescribed this medication once, in a small dosage to Initiate her weight loss program and not for the purposes of maintaining weight loss or a particular weight level through long-term prescriptions. Petitioner's sole expert witness conceded that the dosages were not excessive and were medically indicated in the PDR for the initiation of such a weight loss program. Petitioner's expert witness admitted that his opinion regarding inappropriateness of the prescription was solely predicated on the change in the legal status of the drug. The Respondent prescribed an amphetamine medication to patient Evelyn Lilly between April 14, 1981 and December 19, 1981 (Count XII). Ms. Lilly had been his patient since 1979 for allergy evaluation and treatment to alleviate chronic symptoms of runny nose, throat infections and irritations and sinus headaches. Respondent gave her an allergic evaluation in response to these symptoms. In completing her patient history he noted that Ms. Lilly suffers from rheumatism and arthritis. During the course of her allergy treatments Ms. Lilly's weight began increasing dramatically, with a worsening of her arthritic condition. Respondent noted she was markedly fatigued and became concerned about her general physical condition. In response to her fatigue or lassitude complaints, he initially performed a thyroid test in an effort to determine the cause of her lassitude and rapid weight gain. That test was inconclusive. lie then decided that between the complications of arthritis and her allergies he must reduce her weight before he could successfully treat either of those conditions. He initially prescribed Tenuate Dosepan which proved ineffective and then Ritalin, which also proved ineffective. She was then prescribed a course of Biphetamine. She responded dramatically to this medication with relief of her lassitude and the loss of 30 to 40 pounds. After noting that the initial sympathomimetic type drugs prescribed were ineffective and that the change to the Biphetamine produced markedly successful results, Respondent came to the conclusion that the patient was narcoleptic. Narcolepsy sometimes is not alleviated with the prescribing of one type of sympathomimetic drug when the switch to treatment with another type will suddenly prove to be successful in alleviating the narcoleptic symptoms. The doctor's chart for this patient did not definitely indicate the purpose of the prescription of the amphetamine medication, although Dr. Klotz candidly responded in his testimony that it may have been in part for weight control because a reduction in weight would help alleviate her arthritic joint problems. However, inasmuch as narcolepsy can be indicated when one type of sympathomimetic drug will not relieve its symptoms and another type will and since is. Lilly in her reaction to the medications displayed this phenomenon, Respondent, in the reasonable exercise of his medical judgment concluded that she displayed symptoms of narcolepsy. This view is corroborated by Dr. Von Hilsheimer. He has had more than 1,000 patients referred to him over the years by the Respondent. Approximately one-third of these patients were obese and yet he was only aware of four such patients who were treated with biphetamines by the Respondent. Be thus concludes that the Respondent used some differential reason other than mere weight control for prescribing biphetamine which led to the diagnosis of symptomatic narcolepsy with Ms. Lilly. The Petitioner's expert witness once again felt that the Biphetamine and Ritalin prescriptions for Ms. Lilly were inappropriate and excessive, but acknowledged that his criticism of these prescriptions was predicated solely on the fact that the medication had become illegal for prescription for weight control purposes before Ms. Lilly's prescriptions were made. Dr. Lindberg ultimately agreed however, after consulting the PDR that the amounts and types of medication were within appropriate indications, dosage limits and amounts and thus the amounts prescribed were within the reasonable exercise of the Respondent's judgment as a physician for the symptoms displayed, and alleviated them. Concerning this patient, as with all the others involved herein, Petitioner's expert witness bases his testimony merely on the doctor's patient chart which does not specifically refer to narcoleptic symptoms. Respondent admits his records are not detailed in all cases, since the patients were not referrals, but were his patients for many years such that he was intimately familiar with their histories and conditions. Based on the lack of reference to narcoleptic symptoms in the records themselves, Dr. Lindberg opined that the prescription was medically inappropriate, however, the mere absence of reference to that condition in the medical records alone does not establish the medical inappropriateness of the prescription, especially in view of the Respondent's showing (corroborated by Dr. Von Hilsheimer) that indeed Ms. Lilly was narcoleptic. Mr. Emmett Peter was prescribed biphetamines between October 16, 1979 and September 14, 1982 by the Respondent (Count XVI). Mr. peter has been Respondent's patient since 1969 and `gas definitely diagnosed as a narcoleptic individual by a physician who treated him prior to that time and related that fact in his initial medical history provided Respondent. At the time he and his wife became patients of the Respondent, Mr. Peter was receiving a medication called Obedrin, which is a dexedrine-type drug. During the entire time he received medication from the Respondent, he periodically visited the Respondent on his own behalf, as well as accompanying his wife to the Respondent's clinic for treatment, at which times the Respondent also observed Mr. Peter. Although the Respondent was unaware of the change in the law regarding restriction of the use of amphetamines to the treatment of narcolepsy at the time he prescribed Mr. Peter's medications at issue in this case, he continued to prescribe the medication for Mr. Peter after he became aware of the law, because he definitely diagnosed Mr. Peter to be a narcoleptic. The Respondent's expert witness, Dr. Von Hilsheimer, has seen both Mr. and Mrs. Peter on a professional basis as a researcher. He had numerous occasions to observe Mr. Peter, approximately twice a week from March, 1980 through May, 1982. Be became quickly aware of the fact that Mr. Peter was narcoleptic due to the fact that Mr. Peter, when waiting for his wife at Dr. Von Hilsheimer's office, often fell asleep in a very dramatic way, sometimes even when Dr. Von Hilsheimer was engaged in conversation with him. It was thus established that Mr. Peter, based upon his medical history and the personal observation of both Dr. Klotz and Dr. Von Hilsheimer, suffers from a minimal brain dysfunction manifested as excessive, inappropriate sleepiness. Dr. Von Hilsheimer further noted that Mr. Peter's condition is also characterized by moderate cataplexy, another symptom of narcolepsy. There is no question that Mr. Peter suffers from narcolepsy, therefore the prescription of amphetamine medications to Mr. Peter was clearly medically appropriate and the Petitioner admitted that the amounts of the medication were not excessive. On February 24, 1981, Charne D. Porter, the Respondent's daughter was given a prescription for 30 10-mg Ritalin tablets (Count XVII). The Respondent has been her treating physician most of her life. At the time the prescription was written she was editing and producing a motion picture. She was working very long hours and complained to Respondent that she was having difficulty staying awake during all times of the day and in completing her film-editing work. Prior to this period of time however, her typical work schedule involved such long hours with no apparent ill effects. This was not an unusual work schedule for her. Dr. Von Hilsheimer has known Ms. Porter since 1979 and she has consulted him professionally in the past. He was quite familiar with the patient history and had occasion to see her during the time the medication involved was prescribed. During this period of time he found that when she was attempting to do film-editing work which is normally a stimulating, arousing type of endeavor, she did not have her normal responsiveness and while talking to him would doze off in the middle of a conversation in his office. The work she was trying to do at the time was quite arousing under unusual conditions of lighting and interest and yet she would still doze off at inappropriate times during the day while working. The doctor did not find that her long work schedule or hours were responsible for such a condition. Ms. Porter had a debilitating illness consisting of the lingering aftereffects of a form of hepatitis and this, coupled with the stress related to her film-editing job (for which she was obtaining treatment through self-hypnosis training by Dr. Von Hilsheimer) caused her to lose her normal "arousal ability." Because of this she did have an attack or episode of transient narcolepsy as diagnosed by Respondent and Dr. Von Hilsheimer. During visits in his office he observed her display three of the four commonly recognized symptoms of narcolepsy during approximately the same period of time in which she received the Ritalin prescription. These inappropriate sleep episodes were a transient condition and Ms. Porter recovered from that condition and is functioning well personally and professionally. The small original Ritalin prescription needed no renewal. The use of the Ritalin prescription was a reasonable exercise of Respondent's medical judgment and approach to alleviating the transitory narcolepsy symptoms exhibited by Ms. Porter and caused her no harm whatever. Patient Sandy Lee Bradford was prescribed Biphetamine between December 14, 1980 and December 15, 1981. She is the daughter of the Respondent's secretary and has been the Respondent's patient for many years. On December 15, 1980, due to her complaint of fatigue, daytime sleepiness episodes, along with inability to lose weight and excessive weight gain, the Respondent first prescribed biphetamines to her. Over a one year period she subsequently received four other prescriptions of biphetamines. Each time she received a new prescription, she personally saw and consulted with Dr. Klotz. At the time the prescriptions were administered she had recently been divorced and was suffering unusual stress and emotional anxiety related to that divorce, which Respondent believed had a direct effect on her sudden weight gain and inability to lose weight. At the time the Respondent made these prescriptions, he was as yet unaware of the change in the legal status of amphetamine-type drugs such that it was no longer legally permissible to prescribe them for weight loss purposes. The Respondent candidly admitted that he primarily prescribed the drugs for assisting her in embarking on a successful weight loss program, not for chronic use. Other anorectic medications had been tried on this patient and had proved ineffective, however, with the judicious prescription and use of the biphetamine medication the patient made substantial progress in losing weight and in alleviating symptoms of fatigue. When Respondent became aware of the change in the legal status of biphetamines, he discontinued that medication promptly and substituted Tenuate Dosepan, which proved ineffective. He then substituted Ionamine which also proved ineffective, in an attempt to avoid prescribing biphetamines for the patient. The biphetamines prescribed were in appropriate, non-excessive quantities for the condition and symptoms exhibited by the patient and successfully alleviated her complaints with no harm to the patient. He discontinued biphetamines because he felt he could not with reasonable medical certainty, diagnose her as a narcoleptic patient. Dr. Lindberg conceded that the prescriptions were medically appropriate, but for the change in the law regarding their permissible use, and that change was the sole basis for his opinion that the prescription was inappropriate. Patient Trudy Heintz was prescribed Dexedrine between January 3, 1980 and October 29, 1982. She has been a patient of the Respondent since the early 1950's. She has displayed, over many years, symptoms of excessive, inappropriate daytime sleepiness and a simple inability to perform her employment duties as a result. The Respondent was treating her for phlebitis and arthritis, and thus she is an internal medicine patient. As such the Respondent monitored her physical condition quite closely, making physical examinations including monitoring of blood pressure when necessary. He observed no adverse effects caused by the administration of Dexedrine to this patient, which alleviated her narcoleptic symptoms and enabled her to remain productive and fully functional in her employment and daily pursuits. The Respondent thus diagnosed her as suffering from narcolepsy and established that as an appropriate basis for the prescription of Dexedrine. He continued to prescribe Dexedrine for the patient, even after he became aware of the restriction of its use because he genuinely believes that she is a true narcoleptic. Dr. Lindberg opined that the Dexedrine was inappropriate medication and was prescribed in excessive amounts. He did not believe that Ms. Heintz exhibited narcoleptic behavior, but he had never observed the patient and based his opinion merely upon less than detailed references to narcoleptic behavior in the patient's records. The Respondent, however, established that this patient had been a patient for many years and he was intimately familiar with the physical condition, complaints and medical history, and makes notes only for his own use. Because of his familiarity with her medical history and problems, it was unnecessary for him to make his own notes in sufficient detail so that Dr. Lindberg would be able to thoroughly review the patient's status and treatment indications by looking at her chart alone. Dr. Lindberg, in opining that the dosage was excessive at 30 mg. per day failed to take into account that the PDR provides that the accepted prescription of Dexedrine for narcolepsy is from 5 mg to 60 mg per day with no time limitation as to its use. His opinion as to excessiveness was based on the medical indications in the PDR for obesity only, not for narcolepsy. Such a dosage for this patient was not excessive in view of her proven diagnosis of narcolepsy. Count XXI concerns the purchase on October 14, 1981, of 1,000 quaalude tablets with regard to which it is alleged that the Respondent failed to maintain proper records justifying purchase and disposal of them as allegedly required by Section 21 USC 1306.04(b). Section 21 USC 1306.04(b) has not been placed in evidence in this proceeding, nor has it been made the subject of judicial notice, pursuant to Section 120.61, Florida Statutes. In any event, the 1,000 quaalude tablets were purchased by the Respondent for use by his wife, Harri Klotz. The Drug Enforcement Administration (DEA) Form 222, required to be maintained by the purchaser of such drugs was maintained by the Respondent and his office manager, and a dispensing record also maintained by them shows that the medication was dispensed upon receipt to Respondent's wife. In fact the drugs were established to be retained in the Respondent's office under lock and key and not physically dispensed to the Respondent's wife at one time, rather they were dedicated to her use, but maintained securely on the Respondent's office premises. Mrs. Klotz was then dispensed 30 tablets at a time in approximately one and one-half to two month intervals, and an additional journal card was established by Ms. Lindblom, the office manager, showing the dates when Mrs. Klotz drew down upon that medication in 30 tablet increments which withdrawals were recorded ads "pills dispensed." Additionally, the 130 methaqualone tablets prescribed for Mrs. Klotz on June 24, 1982, were for the purpose of providing her an additional supply to be used in a light, periodic, controlled manner because the drugs were about to become illegal. Later in August or September, 1982, Ms. Lindblom, when she became aware that the additional prescribing of methaqualone might be illegal, upon advice of Mr. Meiner, the Respondent's counsel, elected to dispose of the remaining quaalude tablets at which time 790 of the original 1,130 tablets dedicated to the use of Mrs. Klotz remained at the Respondent's office and were disposed of. Thus the receipt of 1,000 quaalude tablets was duly recorded in Respondent's record and the 30 tablet dispensations of the medication periodically from October 14, 1981 through June 28, 1982, were recorded in a dispensing record in evidence, which record also reflects the disposal of the 790 unused tablets.
Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence of record and the candor and demeanor of the witnesses and the pleadings and arguments of counsel, it is, therefore RECOMMENDED: That the Administrative Complaint against the Respondent, Solomon D. Klotz, be DISMISSED except as to the minor violations of Section 458.331(1)(h) and (cc) Florida Statutes, proven with regards to Counts XI and XVIII for which, under the circumstances of this case, no disciplinary action should be taken. DONE and ENTERED this 4th day of May, 1984, in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of May, 1984. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Chief Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Sam C. Meiner, Esquire 26 Wall Street Orlando, Florida 32801 Helen C. Ellis, Esquire 1804 Old Fort Drive Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact At all times material hereto, Respondents have been physicians licensed in the State of Florida, with Dr. Arias having been issued license number ME 0018151 and Dr. Belle having been issued license number ME 0002207. Robert Furman was a college-educated executive who was born November 16, 1905. He died November 8, 1988, of pancreatic cancer. About 1940, Furman complained to his personal physician Jules Gordon, M.D., of a lack of energy. Dr. Gordon diagnosed Furman as having "a low thyroid" and prescribed a thyroid medication which improved Furman's low energy level to a degree. Furman continued to complain of lack of energy, and Dr. Gordon prescribed Dexedrine for Furman in 1943. The amount of Dexedrine first prescribed was too much, and Furman did not take it. However, in 1945 Furman started a regimen of a daily 5 milligram Dexedrine pill, which helped his lack of energy allowing him to perform his daily employment responsibilities. Dr. Gordon also prescribed Seconal to Furman in 1945 which he began taking each night. Dr. Gordon also started Furman on a regimen of Testosterone/vitamin B-1/vitamin B-12 injections for the purpose of developing more energy. While Furman was the president of an international real estate company in New York from 1950 until 1970, he spent quite a bit of time in the company's West Palm Beach office from 1965 until 1970. In 1970 he retired from the company and began permanently residing in South Florida. In 1970, at 65 years of age, Furman started another career as marketing director for the Keyes Company in Miami and remained in that position through September, 1988. Furman began seeing Drs. Belle and Arias, partners in a medical practice, in 1970 upon referral. At that time, Furman was taking two 5 mg. Dexedrine pills per day. Dr. Arias began treating Furman as his primary physician from 1970 until 1983. Dr. Belle treated Furman as his primary physician after 1983. Furman had the problem of lack of energy throughout his adult life. Furman had no complaints regarding the treatment he received from Drs. Belle and Arias. He had great confidence in them. As of September, 1988, Furman was taking nine 5 mg. Dexedrine pills per day and one 100 mg. and one 50 mg. Seconal pills per day. Furman unsuccessfully tried to cut back on Dexedrine in 1986, but could not function without it; he was foggy, mentally slow and unable to perform his job. He also cut back on Seconal from two pills to one half pill per day. Furman was unwilling to stop taking Dexedrine, especially after taking it for so long. Furman had been told by Respondents on a number of occasions that it would be better if he did not take Dexedrine and Seconal. Since he had been taking them since 1945 without any problems, he was unwilling to stop taking them because he knew he could not function without them. He continued to take them until his death at age 83, a total of 43 years. Since he never suffered any ill effects from them, he saw no reason to be concerned. Furman jogged five times per week until he was 80 years old. At that time Respondents told him to stop jogging due to a back injury. He then switched to exercising twenty-five minutes per day on a stationary bicycle. Furman was never contacted by anyone from the Department of Professional Regulation about his case, was unaware that the Department had subpoenaed his medical records and made them public, was never requested to give his permission for the release of his medical records, would not have given his authority to release his medical records if he had been asked, and was very distressed by the Department's subpoena and use of his records. This prosecution of Drs. Belle and Arias had a tremendous effect of Furman's personal and professional life. It cost him a lot of time and money; it required him to travel to New York to continue his prescription for Dexedrine from Dr. Jules Gordon; it required him to consult with Dr. Cohn; and it affected his concentration in his day-to-day life. An autopsy was performed on Robert Furman at the request of his family. The autopsy was performed by Board- certified pathologist Miguel Gonzalez, M.D. The autopsy was confined to the pancreas, but had Dr. Gonzalez seen anything else abnormal, he would have noted it in the report. No such notations were made. Dr. Gonzalez reviewed the microscopic section slides which would reveal the presence of chronic hypertensive state and Furman's general vascular condition. The review of the microscopic section slides did not reveal any evidence of sustained hypertensive state or hypertensive disease; it revealed that Furman's vascular condition was normal for a man of 83 years of age. One of the side effects of Dexedrine is hypertension; in small vessels, one might see changes that are suggestive or at least indicative that a patient had a sustained hypertensive state. The only thing seen in the microscopic slides of Furman's arteries was normal hardening of the arteries in the large blood vessels. This case came about, not as a result of a patient complaint, but as a result of analyses of data from the Epson Survey, a computer review of prescriptions filled by Florida pharmacies. The computer is programmed to identify prescriptions which do not match its profile for appropriate quantities or combinations. The Epson survey identified four prescriptions for Dexedrine filled on 6/13/85, 6/14/85, 8/19/85, and 8/30/85 and three prescriptions for Seconal filled on 6/12/85, 6/14/85, and 6/14/85, written by Dr. Belle. The Epson survey identified one prescription each for Dexedrine and Seconal filled on 8/2/85, written by Dr. Arias. The DPR investigative report states that the data appears to indicate large amounts of Dexedrine and Seconal being prescribed by Doctors ARIAS and BELLE to a patient named Robert Furman. Investigation reveals both doctors (same practice) treating patient FURMAN for diagnosed severe depression. Patient is an 80 year old male who has been treated "for this condition for over 36 years. Patient is in good physical health and holds down a full time job. The Department subpoenaed the medical records of patient Furman without his consent or knowledge and submitted them to one of the Department's consultants, John V. Handwerker, M.D.. Dr. Handwerker gave the Department a written letter opining that a review of the records revealed no violations of the Medical Practice Act. Unsatisfied with Dr. Handwerker's opinion, the Department requested a supplemental investigation consisting of sending the patient records of Furman to a second consultant, Laurence Neufeld, M.D., who practices medicine in Tampa. Dr. Neufeld issued a conflicting written opinion stating both that the medical records of Furman supported the long-term prescribing of Seconal to him and that the prescription of Seconal to him was inappropriate. Contrary to representations made to the Board of Medicine's probable cause panel by Department attorney, Leslie Brookmeyer, neither Dr. Arias nor Dr. Belle knew Dr. Handwerker, except on a casual basis; they would say "hello" while passing in the halls of Mercy Hospital where all three had hospital privileges, they did not socialize with each other, and they did not refer patients to one another. The investigative reports, with the opinions of Drs. Handwerker and Neufeld, were considered by the probable cause panel of the Board of Medicine on April 27, 1987. One panel member physician commented that he had never before seen such well-documented records. Dr. Arias has been certified by the American Board of Internal Medicine since 1972. He graduated first in his medical school class in 1948, studied under a British Council Scholarship in London (1950-51), studied on scholarship at Massachusetts General Hospital in the Department of Cardiology, and taught electrocardiography and phonocardiography during a fellowship at Massachusetts General Hospital, after which he practiced medicine in Cuba. He completed a residency at the Miami Heart Institute (Chief Resident) in 1961, and practiced at the V.A. Hospital in Nashville, after which he began a private practice in Miami in 1968. Dr. Arias served as Associate Professor (1967) and Clinical Professor (1968) of Medicine at the University of Miami Medical School. He is a member of the Florida Medical Association, the Dade County Medical Association and the American College of Physicians. He has written and published a number of articles. Dr. Arias has practiced in partnership with Dr. Belle since about 1970. Dr. Belle has been certified by the American Board of Internal Medicine since 1948 and Board-certified in cardiovascular diseases since 1954. He received his medical degree from Emory University Medical School in 1939, completed his internship and residency at Grady Hospital in Atlanta, served in the Army Medical Corps, and served as Associate Clinical Professor of Medicine at the University of Miami School of Medicine (1962-present). He is a member of the Heart Association of Greater Miami (President 1962), the Florida Society of Internal Medicine, the American Society of Internal Medicine, the Dade County Medical Association, the American College of Physicians, the American Diabetes Association, and the American College of Chest Physicians. Dr. Arias originally prescribed Dexedrine to Robert Furman in 1970 based upon, and after performing, a complete physical examination and based upon his past history of poor energy state, lassitude, fatigue, and sleepiness. He continued Furman on the regimen of Dexedrine which Furman had been on for the prior 25 years, because it allowed Furman to function normally in society, which he could not do without the Dexedrine. The doses prescribed to Furman were within the recommended doses set forth in the Physicians' Desk Reference (hereinafter "PDR"). Dr. Arias never formally diagnosed Furman as having narcolepsy, but treated him for lassitude, loss of energy, weakness, and mild depression, which are symptoms of narcolepsy. When Furman first came for treatment in 1970, the diagnosis of narcolepsy was not used by family practitioners, and Dexedrine was the medication used to treat the symptoms of lassitude, loss of energy, weakness, and mild depression. Physicians did not generally know, in the 1970s and early 1980s that the symptoms presented by Furman were narcoleptic symptoms. The narcolepsy explains why Furman could not function without Dexedrine and why he was always tired and could not function with the other medications Respondents prescribed when they attempted to switch him away from the Dexedrine. Furman was the only patient out of 5,000 patients in the office of Dr. Arias and Dr. Belle whom they treated with Dexedrine. Dr. Arias tried to wean Furman from Dexedrine in the first few years of treatment with Ritalin and Ascendin, but Furman complained that the alternative methods did not work, and he returned to taking Dexedrine. Dr. Belle continued to prescribe Dexedrine to Furman in 1983 for the continuing symptoms of fatigue, sleepiness, and poor energy state. Furman was even hospitalized in 1984 to try to find the reason for the poor energy state. Though Dr. Belle felt that Furman could be classified as narcoleptic, narcolepsy was not a common term for family practitioners in the 1970s. Dr. Belle did not write the diagnosis of narcolepsy in Furman's medical records, but did write the symptoms of narcolepsy, i.e., poor energy state, lassitude. Dr. Belle did not learn about sleep tests before about 1985. Furman had been doing well on Dexedrine for the prior 40 years before Dr. Belle continued prescribing it to him. A dosage of Dexedrine within the PDR recommended limits for an indicated usage is in keeping with appropriate medical usage. A physician may even decide to use a dose higher than the PDR recommended dose. Not every person reacts in the same way to Dexedrine, and the best judge of how Dexedrine is affecting a patient is the patient's physician. A person who has taken Dexedrine on a daily basis for forty-three years, who lives a vigorous and productive personal and professional life until 83 years of age, and who suffers no adverse effect from the Dexedrine is not taking dangerous doses. Further, the only other effective drug for narcolepsy generally available during 1983 and 1984 was Ritalin, which did not work for Furman. Comparison of the doses of Dexedrine taken by Furman with the doses recommended in the PDR reveals that the doses he was taking were always below the maximum PDR recommended limits. Martin A. Cohn, M.D., an expert in sleep disorders, served as Chief, Sleep Disorders Center, at Mt. Sinai Medical Center in Miami Beach. Dr. Cohn examined Furman in 1987 at the request of Dr. Belle. Based upon that examination, Dr. Cohn wrote a report in which he stated: It is my medical opinion that the diagnosis of narcolepsy is probable but cannot be proven at this time in the face of continued treatment. It is also my opinion that it is in the best interest of the patient and society that he be continued on treatment for narcolepsy with Dexedrine especially in view of his continued functioning ability to work and relatively low dosage of medication required. Dr. Cohn concluded that the dosage of Dexedrine prescribed by Respondents to Furman was not excessive. Moreover, Dr. Cohn saw no evidence at the time he examined Furman of physical damage from taking Dexedrine or any evidence that Furman needed a referral to a psychiatrist. Dr. Cohn describes narcolepsy as an uncommon but not rare disease, characterized by recurrent and excessive drowsiness or sleepiness from which subjects are readily awakened. It is frequently accompanied by cataplexy, a phenomenon of acute, brief, generalized muscular weakness, precipitated by feelings of emotion. If no cataplexy occurs, the disease is diagnosed as pure narcolepsy. The symptoms range from mild drowsiness to severe sleepiness in which subjects spend the day drifting in and out of sleep. The attacks may occur one or several times a day and may last minutes to hours. The sleep is similar to normal sleep but is apt to occur at inappropriate times. The usual onset of the disease is in adolescence or young adulthood, though some cases do not occur until later years. Once diagnosed, the symptoms generally remain forever, although in some cases they go into remission. Ideopathic narcolepsy is diagnosed when four symptoms are present: excessive daytime sleepiness, cataplexy, hypnogogic hallucinations, and sleep paralysis whereby the patient is unable to move although the limbs are not rigid. Only 10% of patients legitimately diagnosed as narcoleptic present all four of the above mentioned symptoms, and, therefore, most of the medical community uses the term "narcolepsy" in a broader, more general sense to mean essentially excessive, inappropriate daytime sleepiness, especially at inappropriate times. Narcolepsy can be a permanent or a transient condition and can be a by-product, of unusual psychological or physical stress. The best test to diagnose narcolepsy is the physician's clinical evaluation of the patient, and the mere response to medication alone cannot be the sole basis for diagnosing the disease. A combination of fatigue, lassitude, poor energy state and depression is consistent with a diagnosis of narcolepsy. The most generally accepted treatment for narcolepsy is the dispensing of amphetamines. Once a person is under treatment with amphetamines, confirming a diagnosis of narcolepsy is not possible because the amphetamines affect the objective testing procedures. The best way to diagnose narcolepsy is by sleep tests which did not become available in the Miami area until about 1978; even then, the medical community did not begin generally using them until about 1984. It would not have been appropriate to withdraw Dexedrine and Seconal from Furman just to administer a sleep test to confirm a diagnosis of narcolepsy. However, the treatment administered by Drs. Belle and Arias was appropriate and would probably have been confirmed, if a sleep test could have been administered and the diagnosis of narcolepsy confirmed. The treatment received by Furman from Drs. Belle and Arias is consistent with treatment for narcolepsy. Since the medical records of Drs. Belle and Arias contained symptoms of fatigue, lassitude, poor energy state and depression, that is equivalent to having written narcolepsy. Prescribing Dexedrine to Furman without referring him to a sleep disorder center was within community standards, especially in view of the length of time over which Furman took the Dexedrine. Dexedrine was a very common way years ago to treat patients with the symptoms presented by Furman. Such a diagnosis by a name other narcolepsy is consistent with the standard of medical practice in the 1970s and early 1980s. Furman would have had a deleterious effect had he been withdrawn from Dexedrine in 1970, at age 65, after taking Dexedrine for 25 years, or in 1980, at age 75, after taking it for 35 years. It would have been unethical for Respondents to discontinue treatment of Furman with Dexedrine under the circumstances of this case. Furman did not develop hypertension in October, 1977, or at any time while he was treated by Respondents. There was no evidence of hypertension revealed in the 1988 autopsy of Furman. Furman's blood pressure was no cause for alarm. Furman had brief episodes of slight labile hypertension on a few visits, which was effectively reduced to normal with diuretics. A review of his blood pressure readings reveals overall normal readings for a man of Furman's age and condition. If a person has taken Dexedrine in the quantities taken by Furman and does not experience an elevation in blood pressure until after 30 years, then that would indicate that the Dexedrine is not the cause of the elevation. Dr. Arias did not refer Furman to a psychiatrist or for an electroencephalogram, because he did not feel Furman needed it. Dr. Belle did not refer Furman to a psychiatrist or for an EEG, because, even though Furman was mildly depressed, he saw no need to take him off his prescriptions merely to confirm or justify the prescriptions with which he was doing well; at Furman's age, he did not feel that the expense and anxiety of a psychiatric referral was justified and Dr. Belle felt that he could treat Furman's mild depression well, which was born out by Furman continuing to function successfully in society. Dr. Arias originally prescribed Seconal to Furman in 1970 based on, and after performing, a complete physical examination on Furman and based upon his past history. Furman had been taking Seconal in small doses for 25 years before coming to Dr. Arias, and Arias kept him on it as the medicine of choice at that time for his symptoms of difficulty in sleeping. He continued Furman on the regimen of Seconal on which he had been for the past 25 years, because it allowed Furman to function normally in society, and because it could not safely be withdrawn. Dr. Belle continued to prescribe Seconal to Furman in 1983, because of his symptoms and because Furman had been taking it for 38 years. It was unusual to see patients who had taken Seconal over a long period of time who were healthy and had not been harmed by it. There was no other drug to effectively substitute for Seconal that was not equally addictive. The dosage prescribed was a small therapeutic dose. The Seconal was prescribed to Furman within the standard of the community, without referring him to a sleep disorder center, especially in view of the length of time over which Furman took the Seconal. Seconal was a very common way to treat patients years ago with the symptoms presented by Furman. It was appropriate to prescribe the Seconal, particularly in the low dosages prescribed. Furman would have suffered a deleterious effect had he been withdrawn from Seconal in 1970 at age 65, after taking Seconal for 25 years, or in 1980, at age 75, after taking it for 35 years. Dr. Cohn, the expert in sleep disorders who examined Furman in 1987, saw no adverse effects on Furman from taking the Dexedrine or the Seconal. It was common to combine the prescription of Seconal with the prescription of Dexedrine at the time Furman saw Respondents and continuing for some time. All patients do not respond the same way to Seconal. The best judge of how Seconal is affecting a patient is the patient's physician. It would have been unethical for Respondents to discontinue treatment of Furman with Seconal under the circumstances of this case. Withdrawing Furman from Seconal in 1970, at age 65, when he first came to Dr. Arias, after taking it for 25 years, could have been lethal. The risks of withdrawal would increase every year thereafter. Dr. Arias did not treat Furman with systemic steroids between May, 1983, and September, 1983. Dr. Belle treated Furman with the systemic steroid cortisone during that period of time. Further, Dr. Arias was weaning Furman off the cortisone in September, 1983, not treating him with it. Dr. Belle had sound medical reason stated in the records for that treatment. The prescription of the cortisone met the appropriate standard of care and was within the limits of good practice. There is no evidence that Furman needed a referral to a psychiatrist for the mild depression from which he suffered but from which he experienced no disabling effects. Dr. Neufeld testified on behalf of Petitioner that Dr. Arias and Dr. Belle fell below minimum standards by not referring Furman to a psychiatrist. Dr. Lindberg, the other expert witness on behalf of Petitioner, disagreed with Dr. Neufeld on that point; Dr. Lindberg testified that Furman should not have been referred to a psychiatrist. Dr. Neufeld himself does not refer his patients to a psychiatrist for slight depression and Dr. Neufeld recognizes that Furman did not have severe depression.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondents not guilty of the allegations contained in the Administrative Complaints filed against them and dismissing those Administrative Complaints, with prejudice. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 13th day of December, 1989. LINDA M. RIGOT 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 13th day of December, 1989. APPENDIX TO RECOMMENDED ORDER DOAH CASE NOS. 87-2389 AND 87-2484 Petitioner's proposed findings of fact numbered 1-6, 8, 9, 11, 12, 14, 16, 17, 19, 20, 22, 24, 25, 29-34, and 64 have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed findings of fact numbered 13, 15, 21, 23, 26, 48, and 60 have been rejected as not being supported by the competent, substantial evidence in this cause. Petitioner's proposed findings of fact numbered 18, 35, 36, 38-47, 49, 51-59, 63, and 65-96 have been rejected as not constituting findings of fact but rather as constituting recitations of the testimony, conclusions of law, or argument of counsel. Petitioner's proposed findings of fact numbered 10, 27, 37, and 50 have been rejected as being subordinate to the issues under consideration in this cause. Petitioner's proposed findings of fact numbered 7, 28, 61, and 62 have been rejected as being irrelevant to the issues under consideration herein. Respondents' proposed findings of fact numbered 1-17, 19, 20, 22, 23, 25, 26, 29 the first 32, 34, the first 35, the second 40, 41, 45-47, 51, 53, and 54 have been adopted either verbatim or in substance in this Recommended Order. Respondents' proposed findings of fact numbered 18, 24, 28, the second 35-the first 40, 43, 44, 48, and 49 have been rejected as being unnecessary for determination of the issues under consideration in this cause. Respondents' proposed findings of fact numbered 21, 27, the second 32, 33, 50, and 52 have been rejected as not constituting findings of fact but rather as constituting conclusions of law, recitation of the testimony, or argument of counsel. COPIES FURNISHED: Paul Watson Lambert, Esquire 1355 Mahan Drive Tallahassee, Florida 32308 Peter S. Fleitman, Esquire Department of Professional Regulation 401 Northwest Second Avenue Suite N621 Miami, Florida 33128 Kenneth D. Easley, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Dorothy Faircloth, Executive Director Department of Professional Regulation Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 =================================================================
Findings Of Fact At all times pertinent to the allegations involved in this hearing, Respondent, Robert A. Lieberman, was licensed to practice medicine in the State of Florida. John P. Spanogle, an investigator with the Department of Professional Regulation since 1980 and with the Board of Medical Examiners prior to that back to 1975, in November, 1979, was requested by representatives of the Orlando Florida Police Department to work with their detectives in several ongoing drug investigations. Respondent was not the subject of any of those particular Orlando Police Department investigations. However, during the course of these investigations, Mr. Spanogle secured certain prescriptions for Class II controlled substances that were written by the Respondent. As a result of these prescriptions, Mr. Spanogle interviewed the Respondent on July 7, 1982, at Respondent's office. At the outset of the interview, Mr. Spanogle advised Respondent of the nature of the allegations and of his rights regarding being questioned. He found Respondent to be extremely cooperative and received full answers to the questions asked, as well as patient release forms and patient records as to the patients listed in the various counts of the Administrative Complaint. During the course of the interview, Mr. Spanogle and Dr. Lieberman discussed several of the doctor's patients and the prescriptions he had written for them over the period in question. Dr. Lieberman seemed surprised he had prescribed so many Percodan and other drugs and could not readily explain why he had written so many prescriptions. Only one of the doctor's former patients testified for the Petitioner at the hearing. This was Linda Gorsuch Creed, a/k/a Linda Clary Morgan, the individual described in Count I of the Administrative Complaint. Ms. Creed is a former drug abuser who started abusing drugs when she was 18 years of age. She is now 26. During the course of her drug abuse, she used such substances as heroin, Dilaudid, Demerol, and others, injecting them into her arms and hands. She first saw Respondent in early 1979 for the purpose of securing drugs. Dr. Lieberman did not know this, however, because her stated complaint was of not being able to have sex without pain. This, however, was false. During the first visit, she was examined by the Respondent and was nude except for the examination gown. She cannot state whether she had drug injection track marks on her arms, but imagines she did since she was using drugs at the time. She does not know whether Respondent saw them, if in fact she had them. Respondent denies noticing any track marks on the witness; and on the basis of the evidence as presented, it can be concluded, reasonably, that Dr. Lieberman was not aware that this patient was in fact a drug abuser. During the first visit, she asked for Dilaudid and Valium and was given a prescription for both. Several months later, she again visited Dr. Lieberman for the purpose of securing drugs. On this visit, she complained of cramps, which again was not true, but at the conclusion of the visit was issued a prescription for Dilaudid. Approximately four years later, she again visited Respondent for the purpose of procuring drugs. At this time, she was mainlining and presumes that she had tracks which she feels may have been seen by the doctor. However, she asked for and received drugs based upon her represented "illness" and the Respondent's examination of her. Just about this time, she was arrested for drug abuse. At the time of her arrest, she had a prescription bottle for Dilaudid and one with Valium in it, both of which she had received from the Respondent. While she was out on bond, she again went to see the Respondent and asked for drugs. He refused, however, to give her any at this time because he had finally become aware that she was abusing drugs. She saw him several times thereafter and, on each occasion, he gave her only legitimate prescriptions; and she has not taken any illegal drug since 1980. The testimony of Dr. Lieberman on this same patient is consistent with that of the patient herself, though from a different perspective. The doctor's records reflect that the first visit from this patient on January 10, 1979, concerned her claim that she had had no period for three months and was in great pain. Examination revealed that her stomach was distended. He did a pelvic examination and found that her vagina was inflamed and she had a vaginal discharge. He gave her antibiotics for the infection and suggested that she have a laparoscopy examination in which a light device is passed through the navel into the fallopian tubes. The conditions described by the patient, if true, are in fact painful. The lack of period can be extremely painful because as a result the organs are swollen with fluid. The vaginal discharge and the history associated therewith indicated a possibility of pelvic disease and an inflammation of the fallopian tubes. It was for this reason that the laparoscopy was suggested. Because it was obvious that the patient was suffering great discomfort and because of her representation that Dilaudid was all that helped her (she was allergic to codeine and aspirin), he prescribed that drug for her. It is significant to note here that her allergy to codeine and aspirin limited the painkillers she could take and, as a result, which he could prescribe. He states that at the time of the examination, he saw no drug tracks on her body and did not know that she was an addict. He cautioned her on Dilaudid's addictive propensity and wanted her to have the laparoscopy so as to get her off Dilaudid as soon as possible. Dr. Lieberman was again visited by Ms. Creed in March 1979, approximately two months after the first visit. During this second visit, in which she stated she again had no period in the intervening two months since the first visit, the examination reflected that her stomach was tender, as were her organs, as well. The doctor gave her a hormone to start and regulate her periods and Dilaudid for the pain. On each prescription, Dr. Lieberman prescribed 20 capsules of Dilaudid. This drug is for severe pain, and he prescribed it only because, in his professional judgment, he felt she was in pain severe enough to justify it. Wilda Sue Boudreaux, another of Respondent's former patients, went to see him in May 1979, for the treatment of female problems. Dr. Lieberman recommended she have a hysterectomy, to which she agreed. She went into the hospital on May 23, 1979, for that operation and a bladder tac with removal of preexisting adhesions. Both operations were successful, and she was released after seven days' hospitalization. Dr. Lieberman saw her several times during her postoperative course of treatment. The surgery was done during the second or third day she was in the hospital. After the surgery, she was having severe pain and complications with a nerve in her leg that had been nicked during the hysterectomy surgery. After she was released from the hospital, because of these conditions, she was in constant, severe pain to the point she could not walk. Pain radiated through her leg and her lower body. She communicated these complaints to the doctor and received from him a prescription for Percodan. The Administrative Complaint alleges she received prescriptions on June 4, 5 and 19 and September 4 and 12. Ms. Boudreaux admits having received all prescriptions except the one on June 5 and denies emphatically that she received prescriptions for Percodan two days in a row. At the time the doctor prescribed Percodan for her, he told her it was a strong drug and should be taken carefully. She requested it, however, because it was the only drug that helped her. A couple of months after this surgery, she developed a urinary infection which resulted in severe pain during urination. She also continued to have severe pain in her left side where the leg nerve damage was and repeated pain from the prior surgery. She went back to the Respondent for a follow-up visit, and he hospitalized her for further tests. As a result of the tests, it was determined that the pain was due to severe nerve damage and that the pain would continue for some extended time until the nerve damage healed. Ms. Boudreaux considers Dr. Lieberman to be a good doctor who was concerned about her as a patient and who, at the time he gave her a prescription, explained to her why she was having the problems, what drugs he was giving her and what the drugs were for. It is her opinion that, throughout the entire period of time she was in contact with him, he appeared to be concerned about her as a person, not only as a patient. Respondent's testimony regarding his treatment of this patient was consistent with hers. He first saw her in March 1979, when she had a complaint regarding constant vaginal bleeding, painful periods and, as a result, he determined that she needed a complete hysterectomy, including complete removal of the tubes and ovaries, and surgery for preexisting bladder problems. During that operation, she sustained damage to a nerve which resulted in constant pain in her leg and abdomen. Nerve damage is one of the slowest types of damage to heal. As a result, this patient experienced constant pain over a long period after the surgery. On top of that, she developed a urinary tract infection as a result of the bladder surgery. As a result, she was maintained on Percodan until the infection cleared up and the nerve damage repaired itself. In the doctor's opinion, all the prescriptions for Percodan were appropriate. It is important to note here and with regard to the other allegations not the date of the prescriptions, but when and how they were to be used. Ms. Boudreaux is a school bus driver and a very responsible person; and Dr. Lieberman felt it was appropriate to prescribe Percodan as he did for her to stockpile them so that she would not have to come back into his office so often. In fact, she did not come back after June 19 until September 4, almost three months later. At that point, she still had the nerve damage and the bladder infection was first discovered. Petitioner made much of the fact that there may have been a less addictive drug that could have been used, both for this patient and for Linda Creed. Respondent claimed, however, that, based on his knowledge of the case of the individuals, he had no reason to disbelieve them; and in the case of Linda Creed, when she said Dilaudid had worked previously, he prescribed that in good faith. There is no evidence to show he did other than that in any case. Regarding the allegations pertaining to patient Patricia Rousseau, the patient information reflects that when first seen by Dr. Lieberman, Ms. Rousseau was a 30-year-old waitress with one child. She appeared well kept and was the sole support of herself and her child and needed to continue to work. At the first visit on July 9, 1979, Ms. Rousseau came in for an abortion, which was accomplished. At the time of her release, Dr. Lieberman prescribed 20 Percodan tablets to be taken one every six hours because, in this case, he thought it was medically indicated. Ms. Rousseau indicated she was in severe pain; and, based on the doctor's experience, he was convinced that, as a result of the procedure followed surgically, the pain could last for at least five days, which was the time it would take to use 20 tablets, taking one every six hours. Dr. Lieberman saw Ms. Rousseau again in January 1980. By this time, she had gotten pregnant again and wanted another abortion. She advised him that she had been to a clinic for that procedure and had developed an ovarian cyst. When Dr. Lieberman examined her, he felt that she could have a cyst, which, in his opinion, is a painful condition, and gave her medication for it. Here, he feels Percodan was indicated because of the fact that the condition arose from a second abortion and the additional pain that went along with it. Along with this condition, she also had dismenhorreah, a condition manifesting itself in painful periods, which, according to the Respondent, can be extremely painful and, in some women, totally disabling. Considering the fact that the patient needed to continue to work, as she was the sole support of herself and her child and could not be bedridden because of her period for three to five days each month, he felt Percodan was indicated, which he prescribed 15 or 20 at a time once a month for use during her period. The quantities prescribed were not, in his opinion, excessive. An additional patient who visited Respondent and whose course of treatment was considered to be improper by Petitioner was Martha Star Curtis, whose first visit to Respondent was on July 27, 1978. She was complaining of lower abdominal pain which, upon examination, turned out to result from a pregnancy. On August 2, 1978, this pregnancy was aborted. Her medical history, taken by Dr. Lieberman, revealed a prior ectopic pregnancy in the right tube and a lost tube and ovary. The following year, she had a cyst removed from her left ovary. At her first postoperative checkup, three weeks after surgery, Dr. Lieberman noticed a small ovarian cyst. When she came back a month later, the cyst was larger and was very painful. This pain related to the cyst was magnified because of chronic pelvic inflammatory disease, and Dr. Lieberman proposed to do a laparoscopy. Ms. Curtis had previously agreed that if this procedure had shown anything irregular, the doctor could go in, check it out and take care of whatever problem existed on the condition that her reproductive capability not be removed. As it turned out, upon accomplishment of the procedure, the doctor discovered that Ms. Curtis had substantial internal scar tissue in her pelvic area which had attached itself to her bladder, tubes, ovaries, intestines, interior of the "belly" and other internal and pelvic areas. This creates almost debilitating, constant pain as scar tissue develops, which increases as the scarring advances. Movement makes it worse--even the simple movements of walking, turning, etc. Even when the scar tissue is removed, it comes back unless there is a hysterectomy. Contra to this theory is the testimony of the Petitioner's expert, Dr. Lewis, who opined that movement not of the individual, but of the organ, would create pain. This difference in opinion is not particularly significant, however, as it is hard to conceive how movement by an individual, unless undertaken with an extremely delicate step, would not result in movement of the organs. In any case, since Dr. Lewis did not examine the patient, was not familiar with her nature, her makeup, or her disposition, it is more logical to assume that the physician who treated her over an extended period of time would be more acquainted with her condition and with the results of her activities than would one who sits in his office examining merely records. In this case, therefore, the observations and opinions of Respondent, who treated the patient, who performed the surgery and who was familiar with the individual, prevail. It is also pertinent to note here that Ms. Curtis, at the time this situation was going on, had met a man she intended to marry and bear children for. As a result, she did not agree to have the needed hysterectomy that was the only procedure that would cure the problem and remove the pain, at least until such time as she conceived and bore this man a child. Therefore, under those circumstances, in the opinion of the Respondent, Percodan was appropriate. Even though they are frequent and repeated, in his opinion, in light of her circumstances, her mental, physical, emotional and situational needs, this regimen was called for. While the Physician's Desk Reference indicates the standard dosage of Percodan as one every six hours, it also provides that this dosage can legitimately and should be exceeded when the situation calls for it. It is pertinent, also, to note here that Ms. Curtis at this time was traveling with her intended husband, a truck driver, in his truck, a situation which created more pain than would normally be experienced, and because of that could not come into the doctor's office as often as necessary. Therefore, in light of the fact that she would not agree to the only procedure that would alleviate her pain, the hysterectomy, and insisted on traveling with her putative husband, it was imperative that she receive relief from the pain, and Percodan was the only thing that would do it. Dr. Lieberman also treated a Julie Londy, first on August 18, 1980, when she came to see him, complaining of chronic pelvic pain, chronic bleeding from the vagina and painful periods. This lady was married, wanted no children and desired a hysterectomy. She entered the hospital for that procedure on April 22, 1980, and had a total abdominal hysterectomy plus an appendectomy on April 24, 1980. She was discharged on May 3, 1980. The conjunction of two major surgical procedures may have increased her pain, and her pain may have carried over from the previous condition she was experiencing, thereby reducing her tolerance for pain. Dr. Lieberman prescribed Tylox on three separate days within a six-day period, May 3, 7 and 9, 1980. Tylox is a Class II drug which is indicated for the reduction of pain. The generally accepted dosage is one every six hours, except in extreme discomfort, when the dosage can be increased. In this case, Ms. Londy was experiencing great pain because, coincident with her recuperation from the hysterectomy and appendectomy, she was experiencing a bladder infection; and, since she is allergic to codeine, Demerol, Dilaudid and aspirin and had told Respondent that Tylox was the only medication that would relieve her pain to which she was not allergic, he prescribed that substance. The first prescription was given on May 3, 1980, the day of her discharge from the hospital, and consisted of 40 pills. That should have lasted for ten days at the normal rate. The second prescription, for 30 pills, was given four days later because she was experiencing great discomfort. The third prescription, for 40 more, was administered on May 9, 1980, at her regular follow-up visit, after which the doctor was not to see her again for at least a month. It was his intention, by prescribing so many pills at one time, to give her a restful postoperative recovery; and the large number of pills was an advance. As a matter of fact, after May 9, the doctor did not see her again until late June 1980, some six weeks after the date of the last prescription. At that time, she was experiencing no pain, and neither asked for nor received additional narcotics. Respondent first saw Marilyn Quantrill on February 1, 1977. At that time, the patient, a 21-year-old female, was in early stages of pregnancy and wanted an abortion. This procedure was accomplished on February 7, 1977. Shortly thereafter, she got pregnant again and, despite the fact that she was being beaten by her husband, she decided to have the baby and did. Her husband continued to beat and emotionally abuse her (threats to take the child) to the point that she was a "nervous wreck." When she came to see Dr. Lieberman for the Seconal on July 17, 1978, her condition was such that she could not sleep because of her relationship with her husband, and Respondent gave her the Seconal to help her sleep. She was experiencing difficulty in coping with stress, and this condition is made worse by lack of sleep. She needed to sleep, and he gave her the pills in question to help her sleep. He thought his prescription for one pill per day at night for sleep was appropriate. The total number of Quaaludes prescribed over the five-month period was 210 pills. The period in question accounted for approximately 163 days. This is slightly over one pill per day, not notably excessive. It is also noted that Dr. Lieberman initially prescribed Seconal, thereafter switching to Quaaludes. He discontinued the Seconal because it was not strong enough to provide the necessary effect in light of her situation. It is also noted that Ms. Quantrill's husband was reported to be a drug dealer. When Dr. Lieberman found out this was the case, he not only stopped providing drugs for Ms. Quantrill, he declined to take her as a patient any longer. In the case of patient Stormy Druga (Smith) who received a drug called Eskatrol on three different occasions for weight loss, the allegation is not that the doctor prescribed improper amounts of the drug, but that the drug was prescribed for a purpose not permitted under Florida Statutes. Dr. Lieberman admits prescribing the drug on the date set out and the amount. He had used this drug for this patient before because she was overweight. She had just had a hysterectomy, was getting a divorce and desperately wanted to lose weight to improve her appearance. The prior use was successful in that she lost 30 pounds. Though Dr. Lieberman subscribed to numerous publications, he did not know that Florida had changed the law, prohibiting the use of Eskatrol for diet purposes. During the period in question, from August through November 1980, Ms. Druga came in every month for a weight control regimen, and he prescribed 30 pills each visit for a total of three visits. Unknown to him, the Florida Legislature had recently changed the law, prohibiting the use of any amphetamines or sympathomimetic amine drug or a compound designated as a Schedule II controlled substance, except for certain conditions of which weight control is not one. The first notice that Dr. Lieberman had that the law was changed was a bulletin issued by the Department of Professional Regulation in February 1981, three months after he stopped the prescription. In that regard, Dr. Lewis, the Petitioner's witness, stated that according to his experience, a doctor becomes aware of a change in one of several ways: (1) drug company flier, (2) a pharmacist's comment, and (3) national subscription-type letters. However, the State does not normally send out any bulletins regarding changes at the time the change is considered or initially made. Under these circumstances, it is quite likely that Respondent was not aware of the fact that the law had changed, prohibiting the use of Eskatrol for weight control purposes, during the time he prescribed it for Ms. Druga, as alleged. Each allegation against Respondent was evaluated by an expert in the field of obstetrics/gynecology for both Petitioner and Respondent. Petitioner's expert, Dr. Lewis, concluded, with regard to Ms. Rousseau, at least, that Respondent's charting is weak; he did not indicate on the record if the patient was seen on any of the visits which resulted in the issuance of a prescription and that Percodan, in this case, was prescribed without any clinical entry of observations on the records. On the other hand, Respondent's expert, Dr. Harry J. Stone, concluded that Percodan was appropriate in both the substance and the amount prescribed for Ms. Rousseau, a total of approximately 320 capsules over a two-plus-year period. If, as was claimed by Dr. Lewis, none of the prescriptions are charted, even that does not constitute malpractice because, according to Dr. Stone, in the practice of obstetrics end gynecology, quite often medications are not charted when the doctor is called out on an emergency situation before he can put it on the chart. As to Ms. Druga, Dr. Lewis indicated that Eskatrol was withdrawn from market use for weight control in 1980 because so much got into the Black Market and because of the undesirable side effects of amphetamines. The records examined by the doctor, which cover a period of time not alleged in the Administrative Complaint, show that over a period consisting of one year, five months and 21 days, Ms. Druga received 480 capsules and diuretics with a total weight loss of 10 pounds. While this is not successful weight loss maintenance, it is nonetheless not unusual depending upon the individual. Dr. Stone, himself, did not know of the change in the law regarding Eskatrol when it went into effect on July 1, 1980, and in his opinion, knowledge of this change within the medical community was poor. Both experts are in agreement that the State does not notify doctors of the changes, as the federal government does. The notices generally go to the pharmacists and, as a courtesy, the pharmacist should have called the Respondent, especially since the prescription here clearly stated it was for diet control. There is no question that prescriptions were issued for Eskatrol by Dr. Lieberman at a time when the law had been changed to prohibit the use of that drug for weight control purposes. It is equally clear, however, that Dr. Lieberman was unaware of the change and that insufficient effort was made by the State at the time to provide knowledge of the change to the various physicians. Turning to Ms. Quantrill, Dr. Lewis feels that because the patient came in and requested Valium and thereafter, as indicated in her letter to the Respondent, took 30 milligrams at one time, which is an excessive dose, Respondent should have suspected that she was likely to abuse drugs. She received prescriptions for 210 Quaalude capsules within a 163-day period. Dr. Stone, on the other hand, opined that the amounts in question were justified based on the emotional strain the patient was undergoing, as well as the pain from her condition. As to Ms. Creed, Dr. Lewis feels that when a patient asks for a particular Class II drug, that is characteristic of an addict, and he does not believe that Dilaudid was called for when Respondent administered it. On the other hand, Dr. Stone, based on the medical records he reviewed, including patient's case history, feels that under the circumstances of the first visit, the prescription of Dilaudid was appropriate in both substance and amount because of the acute pain associated with chronic pelvic disease. The antibiotics that were prescribed by Dr. Lieberman to cure this condition take a long time to work, and the patient needs help to stand the pain. If Dilaudid had worked in the past, it was not inappropriate to use it again. As to the second visit when Ms. Creed got Dilaudid, Dr. Stone feels that again the drug and the amounts prescribed were appropriate for much the same reasons. As to Ms. Boudreaux, Dr. Lewis feels that Respondent's records do not show any complications, and he feels that the drugs prescribed were too much in quantity for an uncomplicated postoperative course. It should be noted here, as elsewhere, that Dr. Lewis, in examining Dr. Lieberman's records, is at times very critical of them as being not complete enough, but at other times relies on them to support his viewpoint. For example, the witness uses the number of pills listed in the record to support the conclusion of over prescription without knowing the patient or having seen her, but when asked if the records say that Respondent stopped prescribing the drugs, this same witness states, "But we don't know what transpired because it's not in the record of what he saw the patient about, whether a medical problem or a drug problem." Dr. Stone, on the other hand, is of the opinion that the prescription of Percodan for Ms. Boudreaux was appropriate because of the combination of the two operations., the insertion of a painful catheter for a long period (six days) , the infection (which was painful) and the nerve injury (very painful). Because of the second hospitalization for the infection in September, Dr. Stone feels that the Percodan prescribed in September and October was appropriate. There does not appear to be an opinion from Dr. Lewis on the treatment given to Ms. Curtis. Dr. Stone, however, opines that the Percodan prescribed by Respondent for this patient from March to July 1979, was justified because of the repeated surgery. A second operation in the same area as former surgery is very painful. This drug can be given and was given at a prescribed rate of one every four hours as necessary for pain. In the opinion of Dr. Stone, this is reasonable, even though the Physician's Desk Reference calls for administration of one every six hours. In addition, continued use, which admittedly this patient had done, develops a tolerance which can result in raised usage. Therefore, even though Dr. Lieberman prescribed 830 pills over 121 days, a rate of almost seven a day, while higher than normal, this is not so aberrant a prescription rate under these circumstances as to be considered necessarily inappropriate or constitute substandard practice. Dr. Lewis also did not give an opinion as to Ms. Londy, for whom Tylox was prescribed. Dr. Stone, on the other hand, felt that the use of Tylox in the amounts prescribed was justified. Here, the patient had undergone major surgery, including an appendectomy, had had implanted a drain and had developed a fever, which indicates infection, with swelling and pain. All of these conditions justify the use of the drug in the amounts. Though the total quantity may seem high, it should be noted, however, this was only for a short period, and the pain of all the surgery and the patient's condition under these circumstances rendered this prescription in this amount not necessarily inappropriate. Based on his overall evaluation of the various patient records and his knowledge of Dr. Lieberman gained from observing him on staff at Florida Hospital and Respondent's excellent reputation as a gynecological and obstetrical surgeon in his community, he is satisfied there has been no gross or repeated malpractice in what Dr. Lieberman has done. Further, his review of the records reveals no indication of fraud, trickery, or any of the other alleged deceptive representations or any indication of bad faith on the part of the Respondent. Petitioner offered no evidence of these latter characteristics. Turning to the issue of medical stockpiling, however, Dr. Stone is quick to admit and recognize that the stockpiling of medicines as was done here in some cases by this Respondent is not a good idea. However, in the world as it exists, it may in some cases, and he is of the opinion that it was in the cases here, be acceptable practice, and not malpractice. Respondent, who has treated approximately 10,000 patients since he entered medical practice in 1976, routinely prescribes controlled substances in his practice. When he does so, he uses a high degree of care because of the addictive nature of Class II drugs. Before prescribing, he considers the individual and their medical problem needs. Modern OB/GYN practice allows physicians in these specialties to serve as "full" physicians to women, and they can treat their patients for illnesses other than those related to the OB/GYN practice. Under this situation, the doctor is required to also consider the emotional, physical, psychological and socioeconomic needs of his patients. It is wrong to merely consider records. A doctor treats people.
Recommendation On the basis of the above, it is, therefore, RECOMMENDED: That the Administrative Complaint against Respondent, Robert A. Lieberman, M.D., be dismissed and no disciplinary action be taken against him on the basis of the activity alleged in this Administrative Complaint. RECOMMENDED this 31st day of January 1984, in Tallahassee, Florida. ARNOLD H . POLLOCK 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 31st day of January 1984. COPIES FURNISHED: Barbara K. Hobbs, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Herbert M. Hill, Esquire Thomas Michael Burke, Esquire Post Office Box 1873 Orlando, Florida 32802 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Ms. Dorothy Faircloth Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issue is whether respondent should be fined $3,350 for allegedly violating various agency rules.
Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: Respondent, Barbara Knight Manors, Inc., d/b/a Four Palms (Four Palms or respondent), operates a licensed adult congregate living facility (ACLF) at 302 11th Avenue Northeast, St. Petersburg, Florida. The facility is subject to the regulatory jurisdiction of petitioner, Department of Health and Rehabilitative Services (HRS). As such, Four Palms is required to adhere to various HRS rules codified in Chapter 10A-5, Florida Administrative Code (1987). On December 3, 1987, an HRS program analyst, Diane Cruz, conducted a change of ownership survey of respondent's facility. The survey was prompted by the fact that the facility had just been purchased by its present owner, Barbara Knight. During the course of the survey, Cruz noted the following deficiencies which constituted a violation of applicable portions of Chapter 10A-5, Florida Administrative Code (1987): the patient daily medication records were incomplete in that some medications administered to patients had not been documented by the staff (10A-5.024(1)(a)3., FAC); (2) two employees did not have medical certificates reflecting they were free from communicable diseases (10A-5.019(5)(g), FAC); there were no standardized recipes (10A- 5.20(1)(g), FAC) the facility did not have a one week supply of non-perishable food (fruit and vegetables)(10A-5.20(1)(k), FAC) two showers did not have grab bars (10A- 5.023(9), FAC); and there were no screens on the windows (10A-5.023(13), FAC) The deficiencies were noted in a survey report received in evidence as petitioner's exhibit 4. A copy of the survey report was given to the facility's administrator on January 14, 1988. The report advised the licensee that monetary fines could be imposed if the violations were not timely corrected. At the completion of the December 3 survey, Cruz held an exit interview with Knight and explained the reason why each deficiency was cited and the steps required to correct the same. Also, Cruz advised Knight that all deficiencies had to be corrected no later than February 3, 1988 and that she would return for an unannounced follow-up visit to verify whether such deficiencies had been corrected. An "exit letter" confirming this process was furnished to Knight, and Knight signed and acknowledged receiving the letter. On March 2, 1988, Cruz returned to the facility for an unannounced follow-up visit. The purpose of the visit was to ascertain whether the deficiencies noted on December 3 had been corrected. During the visit, Cruz observed the following deficiencies that had not been corrected: The daily medicine records were still not accurately documented (initialed); one staff member had no medical certi- ficate attesting she was free from communicable diseases; there were no standardized recipes; the facility did not have a one week supply of non-perishable food (fruit and vegetables) on hand; two showers did not have grab bars; and two bedrooms did not have screens on the windows. As the result of an unidentified complaint, an HRS analyst, Sharon McCrary, visited respondent's facility on March 28, 1988. McCrary discovered that one resident's records had not been properly documented (initialed) to reflect that the staff had observed the patient receiving medication that morning. This violation was the same type that had been previously noted during the December 3, 1987 survey. On June 24, 1988, Cruz and a registered dietician, Mary Cook, returned to Four Palms to conduct a routine, annual survey. During the course of their survey, the two noted the following deficiencies that constituted violations of chapter 10A-5: there were three employees who had no medical certificate showing they were free from communicable diseases (10A-5.019(5)(g), FAC); three residents required supervision when given medications, but there was no licensed nurse on the staff to supervise this activity (10A-5.0182(3)(c), FAC) the facility had no activities calendar (10A-5.0182(7)(a), FAC) live roaches were observed in the kitchen area (10A-5.020(1)(n)1., FAC); the facility did not have a one week supply of powdered milk on hand (10A- 5.020(1)(k), FAC) there were no meal patterns or modified menus at the facility (10A-5.020(1)(e), FAC), and a county sanitation report citing various health deficiencies contained no evidence that such deficiencies had been corrected (10A-5.024(1)(d)2.a., FAC). An exit interview was conducted after the survey, and respondent was advised that it had until July 24, 1988 in which to correct the deficiencies. Also, a copy of the survey report was furnished to respondent. On September 13, 1988, an unannounced follow-up survey was conducted by Cruz and Cook to determine if the previously noted deficiencies had been corrected. They observed the following deficiencies that were not corrected: One staff member had no medical certificate reflecting he was free from communicable diseases; the facility's records indicated one resident required supervision when given medications but the facility did not employ a licensed nurse; although an activities calendar had been prepared, it was incomplete; there were no modified menus in the kitchen; live roaches were observed in the kitchen area; and the deficiencies noted on the county health inspection report had not been corrected. Respondent did not deny that many of the violations occurred. However, its owner and administrator argued that HRS was unfair in filing an administrative complaint more that a year after the first violations were noted. The facility maintained that HRS should have assisted it in remedying the violations since the owner had just purchased the business a few months earlier and was going through a "learning curve." The owner contended that many of the chapter 10A-5 requirements were impractical for a small ACLF and that HRS was simply "nit-picking." Knight also claimed she did not understand what she had to do in order to meet HRS rule requirements. Respondent offered a number of excuses as to why the violations occurred. For example, she contended that (a) the screens were off the windows because the windows were being painted, (b) her employees either would not bring their medical certificates to work or would not see a doctor to obtain one, (c) the quantity of non-perishable foods required to be kept on hand was a judgment call and was not susceptible to precise measurement, (d) roaches can never be totally eradicated in Florida, (e) one of the bathrooms without a grab bar was not being used by the residents, (f) the patient medication records were inaccurate or incomplete due to a misunderstanding by the physician who had prepared some of those records, and it is impossible to prepare a detailed, accurate activities calendar for ACLF residents. While these matters may serve to mitigate the severity of any penalty to be imposed, they do not excuse or justify the rule violations.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that respondent be found guilty as charged in the administrative complaint and that it pay an administrative fine of $1600, or $100 per violation DONE and ORDERED this 3rd day of October, 1989, in Tallahassee, Florida. DONALD R. ALEXANDER 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 3rd day of October, 1989.
