STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF PROFESSIONAL REGULATION, ) BOARD OF MEDICAL EXAMINERS, )
)
Petitioner, )
)
vs. ) CASE NO. 83-2370
)
SOLOMON D. KLOTZ, M. D., )
)
Respondent. )
)
RECOMMENDED ORDER
Pursuant to notice this cause came on for administrative hearing before P. Michael Ruff, duly designated Hearing Officer of the Division of Administrative Hearings on November 30 and December 1, 1983 in Orlando, Florida. The appearances were as follows:
APPEARANCES
For Petitioner: Joseph W. Lawrence, II, Esquire Chief Attorney
Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32301
For Respondent: Sam C. Meiner, Esquire
26 Wall Street Orlando, Florida 32801
Helen C. Ellis, Esquire 1804 Old Fort Drive Tallahassee, Florida 32301
In an Administrative Complaint filed June 9, 1983, the Petitioner has charged Solomon D. Klotz, M.D. with violations of Chapter 458, Florida Statutes. Specifically, it was alleged that the Respondent, during specific time periods, prescribed controlled substances in excessive or inappropriate quantities and for reasons not medically justifiable. It was further alleged that the prescription of these controlled substances was other than in the course of his professional practice, in violation of Section 458.331(1)(q), Florida Statutes. It was alleged also that this conduct was violative of Section 893.05(1), Florida Statutes, and, as such was therefore violative of Section 458.331(1)(h), Florida Statutes, in that it consisted of the prescription of controlled substances in bad faith and without the course of his professional practice, and a failure to perform a statutory or legal obligation as a licensed physician.
It was alleged with regard to each of the counts in the complaint that Section 458.331(1)(1), Florida Statutes, was violated by the making of deceptive, untrue or fraudulent representations in the practice of medicine, or employing a trick or scheme in the practice of medicine. It was additionally alleged that Section
458.331(1)(cc), Florida Statutes (1981), was violated by the prescription of an amphetamine drug for purposes other than specifically stated in Section 458.331(1)(cc) 1, 2, 3. It was further charged that the Respondent violated Section 458.331(1)(i), Florida Statutes by failing to file a report or record required by state or federal law; by failing to maintain proper records justifying purchase and disposal of Schedule II controlled substances as allegedly required by 21 USC 1306.04 (b).
Finally, based on the foregoing allegations, it was alleged, as to all counts, that the Respondent violated Section 458.331(1)(t) Florida Statutes (1981) by engaging in gross or repeated malpractice, or failure to practice medicine with that level of care, skill and treatment recognized by reasonably prudent, similar physicians as being acceptable under similar conditions and circumstances.
At the outset of the hearing, Petitioner voluntarily dismissed Counts Six, Eight, Nine, Ten, Fifteen, Twenty and Twenty-Two. Additionally, no evidence whatever was presented with regard to Count Seven, involving patient Doris Calloway. Accordingly, that count should be dismissed with prejudice as well.
The Petitioner presented the testimony of its investigator: the Respondent's office manager, Grace Lindblom, and Dr. Dale K. Lindberg, M.D., who was accepted as an expert witness regarding the effects, usages and medical indications of various drugs referred to in the complaint. Seven exhibits offered by Petitioner were admitted into evidence. Petitioner's Exhibit 3 was not admitted, inasmuch as it was not properly authenticated, being merely a typed transcript, typed by a person or persons unknown, of a pre-trial statement of the Respondent transcribed from a tape recording of an interview of the Respondent by Petitioner's investigator. That tape was not offered into evidence and there is no basis for comparison with the transcript to ascertain the transcript's accuracy, nor the accuracy of the person unknown who transcribed the information and material allegedly on the tape.
The Respondent testified on his own behalf and presented the testimony of ten of the patients named in the complaint as his own witnesses. He additionally presented an expert witness, Dr. George Von Hilsheimer, Ph.D., who was accepted as an expert witness in the field of narcolepsy and drug therapy as it relates to narcolepsy, as well as neuro-psychology. See Jenkins v. State, 307 Fed.2d, 637.
At the conclusion of the hearing the parties requested a transcript of the proceedings and, to avail themselves of the right to file proposed findings of fact and conclusions of law. Subsequent to the hearing, by ore tenus motion, which was agreed to by Petitioner's counsel, Respondent was granted additional time to file a proposed recommended order such that all the proposed findings of fact and conclusions of law or proposed recommended orders were timely filed on or before February 11, 1984.
The issue to be resolved in this proceeding concerns whether Respondent engaged in the conduct alleged in the factual portions of the administrative complaint and, if so, whether that conduct constitutes violations of the statutory authority alleged in the complaint and if that be the case, what, if any, penalty is warranted?
All proposed findings of fact and conclusions of law and supporting arguments have been considered. To the extent that the proposed findings and conclusions submitted are in accordance with the findings, conclusions and views
stated herein, they have been accepted. To the extent that such proposed findings, conclusions and arguments asserted are inconsistent herewith, they have been rejected. Certain of those proposed findings and conclusions have been omitted as not relevant or as not necessary to a proper determination of the material issues presented. To the extent that the testimony of various witnesses is not in accord with the findings herein, it is not credited. See Sonny's Italian Restaurant vs. Department of Business Regulation, 414 So.2d 1156, 1157 (Fla. 3rd DCA 1982); Sierra Club vs. Orlando Utilities Commission, 436 So.2d 383 (Fla. 5th DCA 1983).
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.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction of the subject matter of and the parties to this proceeding. Section 120.57(1), Florida Statutes (1981)
The Respondent has been charged with violation of various subsections and paragraphs of Chapter 458, F.S. (1979) cited below and plead in the remaining Counts I, II, III, IV, V, VII, XI, XII, XIII, XIV, XVI, XVII, XVIII, XIX, XXI and XXIII of the Administrative Complaint. These provisions provide in pertinent part as follows:
458.331(1979) Grounds for disciplinary action; action by the board.--
The following acts shall constitute grounds for which the disciplinary actions specified in subsection (2) may be taken:
(cc) Prescribing, ordering, dispensing, administering, supplying, selling, or giving any drug which is an amphetamine or sympatho mimetic amine drug or a compound designated
as a Schedule II controlled substance, pur suant to chapter 893, to or for any person except for:
The treatment of narcolepsy; hyper kinesis; behavioral syndrome in children characterized by the developmentally inappro priate symptoms of moderate to severe dis tractability, short attention span, hyper activity, emotional lability, and impulsivity; or drug-induced brain dysfunction; or
The differential diagnostic psychia
tric evaluation of depression or the treatment of depression shown to be refractory to other therapeutic modalities; or
The clinical investigation of the effects of such drugs or compounds when an investigative protocol therefor is submitted to, reviewed, and approved by the board before such investigation is begun.
(i) Making or filing a report which the licensee knows to be false, intentionally or negligently failing to file a report or record required by state or federal law, willfully impeding or obstructing such filing or inducing another person to do so....
Failing to perform any statutory or legal obligation placed upon a licensed physician.
* * *
Making deceptive, untrue, or fraudulent representations in the practice of medicine or employing a trick or scheme in the practice of medicine when such trick or scheme fails to conform to the generally prevailing standards of treatment in the medical community.
* * *
(q) Prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's profes sional practice. For the purposes of this paragraph, it shall be legally presumed that
prescribing, dispensing, administering, mixing, or otherwise preparing legend drugs, including all controlled substances, inappropriately or in excessive or inappropriate quantities is
not in the best interest of the patient and is not in the course of they physician's profes sional practice, without regard to his intent.
Additionally, Section 893.05(1), Florida Statutes, regulating the administration of controlled substances by practitioners is made applicable to proceedings and prosecutions such as the instant one by virtue of Section 458.331(1)(h) concerning the requirement that a physician follow all statutory or legal obligations placed upon him. That provision provides as follows:
Practitioners and persons adminis- tering controlled substances in their absence.
A practitioner, in good faith and in the course of his professional practice only, may prescribe, administer, dispense, mix, or otherwise prepare a controlled substance, or he may cause the same to be administered by a licensed nurse or an intern practitioner under his direction and supervision only....
Initially, it should be pointed out that the Respondent has been charged with regard to Counts I, II, III, IV, V, XI, XII, XIII, XIV, XVI, XVII, XVIII, XIX, XXI with the generalized allegation that the Respondent violated Section 458.331(1)(1) and Section 893.05 (1), Florida Statutes by allegedly making a deceptive, untrue or fraudulent representation in the practice of medicine or employing a trick or scheme in the practice of medicine, and by prescribing prescriptions in bad faith. There is absolutely no evidence of record supportive of the charges made under these provisions. A thorough review of all testimony and evidence of record reveals that Dr. Klotz, in the case of all patients, made the prescriptions involved in a genuine good faith effort to treat and alleviate the presenting symptoms of the patients involved. Even in the case of patients Carroccia and Bradford, which patients he candidly admitted did not truly exhibit narcoleptic symptoms and for whom he prescribed amphetamine medications inadvertently after the date upon which such medications became illegal for prescriptions for other than narcoleptic symptoms, the doctor followed the appropriate medical indication in the PDR for treating these patients with these drugs in an attempt to initiate a successful weight control program. He duly considered their medical histories and monitored their physical conditions throughout the course of this therapy. Respondent simply was not aware at the time he prescribed amphetamines for these two patients that it was technically no longer lawful to use them for purposes of weight control. With regard to all the other patients in the Administrative Complaint, as will be seen below, not only, were his prescriptions designed to alleviate their symptoms and complaints, they in all cases genuinely did alleviate the complaints and were prescribed, in consideration of the Respondent's Hippocratic Oath, based upon Dr. Klotz's reasonable medical opinion that the prescriptions would indeed relieve the suffering and complaints of the patients.
Dr. Lindberg felt that the prescription of amphetamines was inappropriate because he felt the doctor's records did not show on their face the occurence of narcolepsy in the patients who were prescribed biphetamine. He felt that it was inappropriate to prescribe methaqualone shortly before it became illegal to do so. Nowhere in Petitioner's testimony and evidence however, was it established that the prescriptions were made for reasons other than the Respondent's genuine good faith efforts to provide the most efficacious treatment for the symptoms and medical problems exhibited by his patients.
Thus, thorough consideration of all the evidence propounded by Petitioner clearly shows a lack of proof that Respondent made any deceptive, untrue or fraudulent representations in the practice of medicine, nor that he made any of the prescriptions in bad faith, and thus, as to all counts, there have been no
violations of Section 458.331(1)(1) and Section 893.05(1), Florida Statutes, proven.
Turning to Counts I, II and III involving the prescriptions of methaqualone to patients Harri Klotz, Sam Meiner and Charles Meiner for allegedly medically inappropriate purposes and in excessive quantities, the Petitioner relied upon its expert witness, Dr. Lindberg. Dr. Lindberg himself established that, despite his criticism of some of the Respondent's patient records in which, in his opinion, the Respondent should have noted in more detail the precise bases for the prescriptions, he acknowledged that the prescriptions in the amounts prescribed and for the conditions prescribed (excessive pain, inability to sleep and Sam Meiner's otherwise uncontrollable gastrointestinal spasms); that the prescriptions were appropriate from the standpoint of good medical practice. It was uncontradicted throughout the proceeding that the Respondent was following a proven course of treatment to which each of the three patients responded favorably.
Though Dr. Lindberg repeatedly admonished Respondent for prescribing methaqualone, which could be used by the patients beyond July 1, 1982, he also repeatedly conceded that the prescriptions were within the course of appropriate medical practice but for his opinion concerning the statutory change precluding their prescription after July 1, 1982. See Section 893.03(1)(d), Florida Statutes (Supp. 1982). There is, however, absolutely no evidence of record that the Respondent prescribed methaqualone after July 1, 1982, rather he last prescribed it on June 24, 1982, when it was entirely legal to do so. Dr. Lindberg's opinion is thus clearly not supportive of a violation of Section 458.331(1)(q) or (h) nor of the other charges discussed above. It is axiomatic that penal statutes cannot be applied retroactively in penal proceedings, which is the sole basis for the doctor's opinion that the prescriptions were medically inappropriate under the statutory authority cited in these three counts. Nechtman vs. Saker, 271 So.2d 26 (Fla. 3rd DCA 1972).
It is also noted that the Petitioner failed to raise in its complaint any alleged violation of Section 893.03(1)(d) concerning the illegal prescribing of methaqualone after July 1, 1982 when it became a "Schedule I" controlled substance. Indeed, these three counts concerning methaqualone allege that it had "Schedule II" legal status (and, in effect, could be legally prescribed) at the times pertinent to these three counts. Thus the evidence of record does not reveal that Respondent was apprised of this statutory change as an additional basis for the instant prosecution until Dr. Lindberg raised it in the course of the hearing and principles of "notice pleading," permitting the Respondent a fair opportunity to defend against this element of the charges, have not been complied with. Lester v. Dept. of Professional and Occupational Regulation, State Board of Medical Examiners, 348 So.2d 923 (Fla. 1st DCA 1977): Johnson v. Johnson, 346 So.2d 591 (Fla. 1st DCA 1977) and Dept. of Natural Resources v. Sheffield, 420 So.2d 842 at 843 (Fla. 1st DCA 1982). Thus, for these reasons, Counts I, II and III have not been proven.
Counts IV, V, XI, XII, XIII, XIV, XVI, XVII, XVIII and XIX concern the prescription of amphetamine-type medications to the patients named in those counts and it is alleged variously under the authority cited above that this was for medically unjustifiable purposes, inappropriate prescribing, and prescribing in excessive quantities. Count IV, concerning patient Balabon, Count XII, concerning patient Lilly, Count XVI, concerning patient Peter and Counts XVIII and XIX involving patients Sandy Bradford and Trudy Heintz, contain the allegation, in effect, that the prescription of these amphetamine drugs may only be prescribed, as pertinent here, for narcolepsy. Counts V, XI (patient
Carroccia), XIII, XIV, and XVII (patient Porter ), do not specifically allege that Section 458.331(1)(cc) has been violated by the prescription of amphetamines for other than the treatment of narcolepsy, however, they do charge generally that the substances were prescribed other than in the course of professional practice and in a manner constituting a failure to perform a statutory obligation placed upon the Respondent as a licensed physician (in effect, by prescribing them for weight control) Count VII asserts similar charges, however no evidence whatever was adduced in support of Count VII and it should be dismissed.
In the case of patients Balabon (Counts IV and V) , patient Peter (Count XVI), patient Porter (Count XVII), and patient Heintz (Count XIX), the Petitioner contends that the amphetamine was prescribed for purposes of weight control or instilling "pep" in these patients, which is not permissible under Section 458.331(1)(cc). Its expert witness, Dr. Lindberg, relied for this opinion on the Respondent's patient record files which as Respondent admits, do not in every case contain complete information as to the bases for a diagnosis and other facts concerning these patients, because the Respondent was so personally familiar with their histories, having treated them for long periods of time. Be that as it may, Dr. Lindberg opined that amphetamine was not indicated for these patients because he saw no evidence of narcoleptic symptoms nor such a diagnosis in the patient records themselves. He acknowledged however, that the dosages were not themselves excessive and were not inappropriate from the standpoint of the exercise of good medical judgment for the presenting complaints, but rather only because the law changed on August 30, 1980, restricting amphetamines to treatment of narcolepsy. The Respondent however, presented his own testimony and that of the expert witness, Dr. Von Hilsheimer in establishing that the patients in fact, exhibited substantial symptoms of narcolepsy so as to justify the Respondent, in the reasonable exercise of sound medical judgment to diagnose and treat them for narcolepsy.
In this regard the testimony of Dr. Lindberg must be discounted when compared with that of the Respondent and Dr. Von Hilsheimer, since Dr. Lindberg examined only the "cold" documents from the Respondent's files and was not familiar with the Respondent's precise reasons for prescribing as he did under the circumstances. He did not personally examine, interview or otherwise inquire into the particular problems and histories of the patients involved. Dr.
Lindberg, although accepted as Petitioner's expert witness regarding the effects and usage of amphetamines, is not truly a "similar healthcare provider" as that term is defined in Section 768.45, Florida Statutes for purposes of Section 458.33(1)(t) above. Dr. Lindberg has had no experience dealing with narcoleptic patients and indeed has never seen a patient with narcolepsy. He has not been engaged in family practice since 1973 and his board certification is in nuclear medicine, which is not a comparable field to the Respondent's board certifications in internal medicine, allergy and immunology. Such training and experience do not provide the Petitioner's witness with qualifications needed to substantiate the allegations in the Administrative Complaint in the face of the testimony of the Respondent and Dr. Von Hilsheimer, who have both had experience with the research and treatment of narcolepsy and are considerably more qualified to diagnose, treat and render opinions concerning the symptoms of narcolepsy.
In this regard the Petitioner's expert witness accepted only one definition of narcolepsy, idiopathic narcolepsy, characterized by all four of the above-named symptoms. The Respondent and Dr. Von Hilsheimer established however, that narcolepsy is a broad-based, generalized diagnostic term as generally employed in the medical profession, with the chief determinative being excessive, daytime sleepiness at inappropriate times as a functional, behavioral
manifestation, or it may be symptomatic, as a sub-syndrome or related to another disease or condition. It can be of a permanent or a transient nature. With this dichotomy in mind, a physician reading Section 458.331(1)(cc), Florida Statutes would not be certain of the guidelines he should employ in making a diagnosis of narcolepsy that would justify his legal use of amphetamines for its treatment. The ambiguity in the medical profession concerning the precise meaning of the term "narcolepsy" is not explained by the bare use of that "all- encompassing term" in that statutory section. In Lester, supra, the Third District Court of Appeal concluded that if ambiguities exist in the statute they must be construed in favor of the licensee. Thus, although Dr. Lindberg felt that only idiopathic narcolepsy, in which a patient exhibits all four of the symptoms described above, is justification for the prescription of amphetamines, the Respondent and Dr. Von Hilsheimer established that it can take one of several forms delineated above and thus, the doctor was within the realm of sound medical judgment in diagnosing narcolepsy and prescribing amphetamines for these patients. Further, as Dr. Lindberg acknowledged, concerning the issue of inappropriate or excessive prescribing, the Respondent actually followed an accepted course of treatment for narcolepsy as set out in the PDR which Dr.
Lindberg himself relied upon. This course of treatment resulted in favorable responses in his patients and they suffered no ill effects. Thus, considering the entire body of evidence and the above Findings of Fact, the Respondent was acting in a lawful manner in diagnosing these patients as narcoleptic and in prescribing amphetamines to relieve that condition.
In view of the presence of narcoleptic symptoms in these patients, clear and convincing evidence otherwise not having been demonstrated by the Petitioner, it follows that Section 458.331(1)(cc), Florida Statutes has not been violated as to these patients nor has paragraph (h) in that a statutory or legal obligation of the physician involved has not been violated. Concomitantly it has not been proven that paragraph (q) has been violated as to these patients since the prescriptions were shown to have been appropriate and in appropriate quantities. It already having been concluded that Sections 893.05(1) and 458.331(1)(1), Florida Statutes have not been violated as to any of the conduct charged in the various counts of the Administrative Complaint since no bad faith, trick, scheme or device, etc. has been demonstrated, it follows then that Counts IV, V, XVI, XVII and XIX have not been proven.
Concerning Counts XII and XIII regarding the appropriateness of the prescriptions of ritalin and biphetamines to Evelyn Lilly, it was clearly established by the Respondent and Dr. Von Hilsheimer that she was justifiably believed by the doctor to be exhibiting symptoms of narcolepsy, primarily excessive daytime sleepiness and fatigue-like symptoms. The doctor, not being aware of the legal change effective August 30, 1980, genuinely believed the patient to exhibit narcoleptic behavior and accordingly, felt that within his sound medical judgment the medication involved in the charges in Counts XII and XIII, was medically justified. In Ms. Lilly's case she suffered from stress, excessive weight, as well as the markedly excessive fatigue and daytime sleepiness. While the prescription for amphetamines for this patient was an aid in controlling her weight, it was also designed and intended to treat the symptoms of narcolepsy she exhibited. This patient, having been established to exhibit such symptoms, it was the Respondent's right as her treating physician, in the due course of his exercise of sound medical judgment, to prescribe amphetamines for such narcoleptic symptoms, even if they were not the primary affliction of which the patient complained, since the statute is silent on whether the treatment of narcolepsy as a secondary affliction or sub-syndrome related to the patient's stress and overweight is proscribed. Such an ambiguity in the statutes should be construed in favor of the licensee. Lester v. State
Department of Professional and Occupational Regulation, supra. Thus, Counts XII and XIII have not been proven. Concomitantly those portions of Count XIV related to Counts XII and XIII (as well as to Counts I through V) similarly have not been proven and that count should be dismissed. Parenthetically it should be noted that the charge of a violation of Section 458.331(1)(h) in Count XIV is duplicitous of the same statutory violation charged in Count XI which will be dealt with below, thus Count XIV should be dismissed in its entirety.
Count XI involves the prescription of 50 12.5 mg biphetamine tablets to Lori Carroccia on September 29, 1980. She was employed by the Respondent, and the Respondent was intimately familiar with her medical history. Indeed, the Petitioner's expert witness acknowledged that the prescription of the short course of light-dosage biphetamines for this patient was appropriate to get her started on a weight control program, which the Respondent candidly admitted was the purpose of this one-time prescription. At the time, the Respondent was unaware that the legal status of biphetamine had changed such that it could only be prescribed for narcoleptic conditions. In this connection it is important to remember that the prescriptions involved were given on September 29, 1980. Section 458.331(1)(cc) making such prescriptions illegal in the case of this patient, was enacted into law in the regular session of the 1980 legislature and became effective, under the terms of Article 3, Section 9, Florida Constitution,
60 days after the adjournment sine die of that session. The legislature adjourned that year on June 30, 1980, and the provision became effective August 30, 1980, thus to the Respondent's credit, the prescription given Ms. Carroccia had only been technically illegal for approximately one month, of which fact Respondent was unaware.
In any event he only gave Ms. Carroccia one such prescription and never intended to give her another because she thereafter embarked on a successful weight control program and no more biphetamine was required for her treatment. The Respondent later, in 1981, learned of the illegality of biphetamine for such purposes but learned of the change only through information supplied him by his pharmacist and was never informed by the medical board or other government agency of this legal contraindication for biphetamines. In any event, such a small dosage for this patient only a month after the prescription became technically illegal should not, given the anguish and turmoil already occasioned the Respondent by this prosecution, be the basis for any penalty for such a de minimus violation of Section 458.331 (1)(h). That was the only statutory violation proven inasmuch as Dr. Lindberg himself found the prescription otherwise appropriate, in the course of professional practice and not in an excessive amount.
Concerning Count XVIII, the Respondent prescribed biphetamine to Sandra Lee Bradford during 1980 and 1981 before he became aware that biphetamine could no longer be prescribed for conditions other than narcolepsy. The prescription for weight control had been a medically justifiable purpose and an appropriate prescription, so long as it was not in excessive quantities, prior to the effective date of Section 458.331(1)(cc). Dr. Lindberg agreed that the prescriptions to Sandy Lee Bradford, as in the case of all other patients involved in this proceeding, were medically appropriate and not in excessive quantities once he reviewed, upon cross examination, the PDR, to ascertain the appropriate dosage level. He only found fault in terms of the medical justification for this prescription because it was made after the effective date of this statutory section and, as Respondent candidly admitted, this patient did not truly exhibit symptoms of narcolepsy. There is no question however, that the doctor prescribed biphetamine for Ms. Bradford in good faith and in the reasonable exercise of his medical judgment in the genuine belief that this
would assist her in a weight control program, which it did. Thus, the Petitioner could establish no fault with the quantities prescribed, which were well within accepted limits. As soon as the doctor became aware that the prescription was illegal, he immediately ceased prescribing them, well before this prosecution commenced. Thus, as to Count XVIII, the Respondent has committed a technical violation of the above-cited section, as well as Section 458.331(1)(h), Florida Statutes, by failing to conform to the legal obligation imposed by paragraph (cc). Since the patient benefited and, but for the change in the drug's legal status, the Respondent did not depart from the appropriate course of his professional practice, such an inadvertent mistake is not deserving of any penalty.
Concerning Count XXI, the Petitioner failed to establish the charge predicated on Section 458.331(1)(i). There is simply no evidence that the Respondent filed or made any report knowing it to be false, or intentionally or negligently failed to file a report required by state or federal law. It was not proven that any report was required to be "filed" at all with regard to the drug related to this count. The Petitioner is also charging a violation of Section 458.331(1)(h), Florida Statutes, because of the Respondent's alleged failure to maintain proper records justifying the purchase and disposal of the 1,000 methaqualone tablets, as reputedly required by 21 USC 1306.04(b) and "Chapter 893." It has not been proven that he violated any record-keeping standard imposed by that un-introduced federal law nor any provision of Chapter 893, Florida Statutes, the relevant provision of which (893.07) was not cited in the complaint. Thus, no derivative violation of Section 458.331(1)(h), Florida Statutes, has been demonstrated. The evidence of record shows that the Respondent purchased the 1,000 quaaludes himself on October 14, 1981, and that he maintained a record of the receipt of the quaalude tablets and of the subsequent regular, orderly dispensing of 30 at a time to his wife over a long period of months, with his records clearly showing that the drug was kept under Respondent's control at his office. At all times material to those prescribing and dispensing episodes the Respondent, as a duly licensed physician, was entitled to purchase, dispense and prescribe such medication. The mere fact that he kept the quaalude at his office for his wife violates no statute. The quaalude involved did not become illegal for such purposes until July 1, 1982. The Respondent having recorded the purchase and then recorded each dispensation of this medication, partly through the record-keeping efforts of his office manager and agent, Mrs. Lindblom, and although Petitioner attempts to find fault with his record-keeping as to form and detail, the fact remains that the Petitioner's own witnesses and evidence establish that the purchases were recorded on a proper "DEA Form 222" and a regular dispensing record was maintained. The Respondent's records depict in sufficient detail the purchase of the medication, its quantity, the dispensing dates and amounts, the recipient, and even the disposal of the lost 790 undispensed tablets. It has simply not been clearly and convincingly demonstrated that the records were so ineptly maintained as to amount to be a violation of the authority cited in Count XXI. See Walker v. Florida State Board of Optometry, 322 So.2d 612 (Fla. 3rd DCA 1975).
Count XXIII contains the allegation that Respondent, with reference to all the alleged aberrant conduct described in the Complaint, engaged in gross or repeated malpractice or failed to practice medicine with that level of care, skill and treatment recognized as acceptable by reasonably prudent similar physicians. Section 458.331(1)(t), Florida Statutes. A careful review of the evidence of record establishes no indication whatever that the Respondent is guilty of gross or repeated malpractice or a deviation from that statutory standard of care. First of all, the testimony of Dr. Lindberg is based solely
upon his examination of "cold" patient records of the Respondent which Dr. Lindberg decries on a number of occasions as being inadequately detailed. Thus, Dr. Lindberg himself, on the one hand criticizes the scant information he feels is provided in the Respondent's patient records and on the other hand uses them as the sole basis for the formulation of his opinion that the Respondent has violated this statutory section. Dr. Lindberg conceded however, that in the case of each of the patients, the course of treatment and medication was medically appropriate for the conditions exhibited by these patients and that the amounts were medically proper. His sole basis for finding a departure from the standard of care delineated above was because of the changed statutory status of the medications involved. Proper diagnosis and treatment decisions cannot be effected on the basis of an examination of medical records alone. A doctor treats the "whole patient." The Respondent's intimate familiarity with each of these patients far outweighs Dr. Lindberg's testimony based merely upon the Respondent's patient records without any knowledge as to why Dr. Klotz particularly prescribed as he did under the circumstances. Thus, in light of this and in view of the fact that no proof was adduced sufficient to establish any of the charges in the Administrative Complaint save those related to the two inadvertent violations of Section 458.331(1)(cc) and (h), it cannot legitimately be concluded that Respondent's treatment of the patients involved herein constitutes malpractice or a departure from that level of care, skill and treatment recognized as acceptable by prudent similar physicians under similar conditions and circumstances.
Finally, it must be borne in mind, that in a proceeding as grave as a license revocation proceeding, it must be made to appear clearly that a Respondent breached a duty required of licensees. Here the Petitioner has alleged a number of instances of misconduct which were not proscribed at the time they were committed and, as to all, has relied upon an expert witness who simply reviewed patient records without ever having attempted to interview the patients or otherwise become more familiar with their medical histories and the details of their symptomology and treatment. Such testimony can be accorded little weight when juxtaposed with that of Respondent and Dr. Von Hilsheimer, for reasons already discussed. The Petitioner misplaces its reliance on such uninformed expert testimony, in attempting to establish Respondent's guilt.
Disciplinary proceedings such as this can potentially result in license revocation. Even in the absence of a recommendation for revocation that ultimate penalty may be imposed since it lies within the agency's discretion if allegations of misconduct are proven. Florida Real Estate Commission vs. Webb,
367 So.2d 201 (Fla. 1979). License revocation proceedings have been found to be "penal" in nature. State ex rel Vining vs. Florida Real Estate Commission, 281 So.2d 478, 491 (Fla. 1973); Bach vs. Florida State Board of Dentistry, 378 So.2d
34 (Fla. 1st DCA 1979) (rehearing denied 1980). The Petitioner herein had the burden to demonstrate by clear and convincing evidence that the Respondent committed the acts alleged in the Administrative Complaint. Before the Respondent should be deprived of his opportunity to continue earning his livelihood in the manner for which he has been trained and licensed in excess of
40 years, the evidence of wrongdoing on his part must be substantial. Walker v. State Board of Optometry, supra. As stated by the First District Court of Appeal in Bowling vs. Department of Insurance, 394 So.2d 165 (Fla. 1st DCA 1981):
In a proceeding under a penal statute for suspension or revocation of a valuable business or professional license, the term `substantial
competent evidence' takes on vigorous implications that are not so clearly present on other occasions.
Here, with the sole exceptions of Counts XI and XVIII, which involve minimal legal violations in a course of treatment which actually benefited the patient involved, the Petitioner has clearly failed to establish any of the allegations contained in the Administrative Complaint. Further, the fact that the two minor violations proven were inadvertent and occurred through Respondent's genuine ignorance of the change in the law concerning the medication involved; in view of the Respondent's prompt discontinuance of any use of amphetamines when he became aware of this, even before this prosecution commenced and in view of the fact that a protracted, expensive proceeding such as this has already caused a great deal of anguish, expense and inconvenience to this generally worthy and responsible practitioner; these factors together do not warrant any disciplinary action being carried out here.
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
| Issue Date | Proceedings |
|---|---|
| Jul. 03, 1984 | Final Order filed. |
| May 04, 1984 | Recommended Order sent out. CASE CLOSED. |
| Issue Date | Document | Summary |
|---|---|---|
| Jun. 29, 1984 | Agency Final Order | |
| May 04, 1984 | Recommended Order | No discipline warranted only two minor technical violations proven. No prior discipline record. |
DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs JOHN NKOLO MUBANG, M.D., 83-002370 (1983)
DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs JOHN NKOLO MUBANG, M.D., 83-002370 (1983)
DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs GILBERT SHAPIRO, M.D., 83-002370 (1983)
AGENCY FOR HEALTH CARE ADMINISTRATION vs FLORA ALF, INC., D/B/A FLORA ALF, 83-002370 (1983)
