The Issue Whether disciplinary action should be taken against Respondent's license to practice medicine based on the administrative complaint in this case, which charges, in general, that he obtained his license through fraudulent misrepresentations and is unable to practice medicine safely because of illness or use of drugs he prescribed for himself illegally under the names of fictitious patients?
Findings Of Fact The Parties Petitioner, the Board of Medicine, created by Chapter 458, Florida Statutes, (the "Medical Practice Act,") is the regulatory authority charged with regulating the practice of medicine in the State of Florida. The Board is within the Agency for Health Care Administration, Section 20.42, Florida Statutes, which, in turn, is within the Department of Business and Professional Regulation. Id. In particular, as is pertinent to this case, the Board has the power to impose disciplinary penalties on a licensee when it finds guilt of any of the grounds set forth in subsection (1) of Section 458.331, Florida Statutes, the "grounds for disciplinary action" section of the Medical Practice Act. Respondent, John Mark Pennington, M.D., is currently a licensee of the Board of Medicine. He has been continuously licensed as a physician in Florida since March 11, 1994. Currently residing in Terra Ceia, Florida, Respondent has a specialty in anesthesiology. He does not, however, presently practice in his specialty. He practices, instead, as a physician in a walk-in medical clinic where he is closely monitored and his access to drugs and medication is completely restricted. The reason for not presently practicing as an anesthesiologist and being closely monitored at the walk-in clinic is the same: an addiction to narcotics. In recovery from the disease of chemical dependency at the time of hearing, and as long as he remains in recovery, Dr. Pennington is not presently impaired as the result of his addiction. Respondent's Checkered Past History of Drug Use Dr. Pennington's use and abuse of drugs spans many years. His illegal drug use began when he was a teenager in high school. In addition to drinking, he was using marijuana, cocaine and other drugs. He continued in college to use drugs, including amphetamines. In 1981, Dr. Pennington graduated from pharmacy school and began work as a pharmacist licensed by the State of Georgia in the City of Savannah. During his employment, he would take from the pharmacy, without the benefit of a medical prescription and without authorization from the pharmacy, certain drugs for his personal use. These included opiate derivatives, Hydrocordone, for example, which are classified as narcotics, as well as amphetamines and amphetamine-like medications such as Ritalin. Sometime in 1981, shortly after he began using narcotics, Dr. Pennington became addicted to them. Dr. Pennington managed to conceal his narcotic addiction from his closest associates, including his former wife, who was employed as a fellow pharmacist with him at the pharmacy in Savannah. In 1985, following an inventory at the pharmacy that indicated a discrepancy in narcotics, Dr. Pennington admitted his drug usage. He went directly into treatment at Willingway Hospital in Statesboro, Georgia where he remained for six weeks until his release. As the result of the discovery and Dr. Pennington's admission, disciplinary proceedings were brought against Dr. Pennington by the Georgia State Board of Pharmacy. The Georgia Administrative Hearing At the hearing during those proceedings, Dr. Pennington acknowledged his addiction. He testified that he knew that he would have to deal with addiction the rest of his life. But, he further testified, thanks to being in recovery as a result of the program at Willingway and a continuing program of treatment, that he was then drug-free and committed to remaining so. Moreover, he testified, that he felt there was no pressure too great to cause him to return to illicit use of drugs. In his view, no pressure was too great because he was committed to the ongoing drug treatment program in which he was then involved. He found the program to be an effective method for dealing with the addiction, a method he had not even known existed prior to his entry into the Willingway program. With regard to the effect the addiction and his behavior had on his life and others, Dr. Pennington testified: There is no way I can really express the guilt I feel and the remorse I feel for what I have done. I just want to do my best, and whatever the Board wants I will follow any direction they want me to go into. I embarrassed my profession by doing this. I almost lost my life, and my family, and my job and everything else. Regardless of what decision is made, I am going to go in the right direction to get my life back to the way it's supposed to be. Petitioner's Ex. No. 4, pgs. 46 - 47. At this same hearing on the Georgia disciplinary proceeding, Dr. Pennington called as witnesses on his behalf his then current employer, Mr. Rupert Heller, and his then wife, Kim Pennington. Mr. Heller testified that he had allowed Dr. Pennington to return to work at his pharmacy as a pharmacist. But the return was subject to certain conditions. The conditions included weekly random urinalyses, direct supervision by other pharmacists, no access to medications and lie-detector tests when requested. Mr. Heller also testified that Dr. Pennington was a competent, conscientious pharmacist who always performed well the duties of his employment. Kim Pennington testified that she had been unaware that Dr. Pennington had used drugs prior to the revelation of early 1985. She also testified about her involvement in Dr. Pennington's treatment program at Willingway, including spending five days at the facility to integrate her into his care and attendance at family counseling sessions. Persuaded by the testimony of Dr. Pennington, his employer and his wife, Kim, and recommendations by the Attorney for the Board, the hearing officer wrote the following in his Initial Decision: The State produced evidence through testimony and the Respondent produced evidence through testimony of witnesses that the Respondent made a mistake in his life and is coping with that mistake in an attempt to overcome his use of drugs and drug abuse. The Respondent moved on his own volition with the help of others to search out and take advantage of programs that would rehabilitate him with respect to overcoming ... drug abuse ... . The Hearing Officer was persuaded to consider any recommendations which were made by the Attorney for the Board in these matters due to the goodwill effort on behalf of the Respondent as well as the assistance and guidance that has been given to the Respondent b[y] said Respondent's present employer.... Exhibit No. 6 attached to Petitioner's Ex. No. 2. Georgia Discipline Following the hearing in Georgia and the initial decision of the hearing officer, the Georgia Board imposed a suspension of Dr. Pennington's license to practice pharmacy for six months, just as the hearing officer had initially decided. But further, again following the lead of the hearing officer's initial decision, the Board suspended enforcement of the suspension for two years during which Dr. Pennington was to be on probation with conditions. Among other conditions of the probation, Dr. Pennington was required to submit to random urinalyses and to attend professional aftercare treatment and counseling. The probationary period was set from December 1985 until December 1987. Medical School After being on probation for a period of eight months, Dr. Pennington, in August of 1986, entered a medical school in the Caribbean on the island nation of Grenada. Dr. Pennington requested the Board of Pharmacy that the conditions of probation be lifted while he was in medical school because of the difficulty in complying with them in Grenada. The request was granted. After his second year of medical school in Grenada, Dr. Pennington transferred to the Medical College of Georgia in Augusta, Georgia. While in medical school in Georgia, Dr. Pennington began working part-time as a pharmacist again. Dr. Pennington did not resume compliance with the conditions of probation imposed by the order of the Georgia Board of Pharmacy. As to its role in overseeing Dr. Pennington, the Georgia Board apparently simply lost track of his case. In any event, the Georgia Board did not follow up to ensure that Dr. Pennington had completed his probation successfully. Resumption of Drug Use During his third year of medical school, while working as a pharmacist again, Dr. Pennington began drinking. Before long, he was taking drugs from the pharmacy at which he was working for his own personal use, again without authorization from the pharmacy or a prescription. Following graduation from medical school, Dr. Pennington undertook his residency at the Ochsner Clinic in New Orleans. His drug use continued. But instead of taking drugs from a pharmacy inventory, Dr. Pennington opted for a method not subject to pharmacy inventories. He wrote prescriptions for them in the names of other persons. Access to More Powerful Narcotics as an Anesthesiologist Respondent began his residency in internal medicine but switched to anesthesiology. The switch was not helpful to Dr. Pennington in terms of controlling his addiction. Now, different drugs, often more powerful, were readily available to him. Among them was Sufenta. To narcotic addicts subject to monitoring who want to resume narcotic use, Sufenta is a drug of choice because it is difficult to detect in bodily fluids. Listed as a controlled substance under Schedule II, Section 893.03(2), Florida Statutes, Sufenta is used primarily for analgesia in surgery. In addition to eliminating physical pain, it produces feelings of well-being and stops emotional pain. It has an effect similar to hydrocodone but it is shorter-acting and much more potent. In fact, Sufenta is the most potent opiate used in medicine today. Dr. Pennington began using Sufenta while a resident in anesthesiology either by injecting it or by inhaling it nasally. His use of this extremely powerful narcotic continued throughout the first half of this decade. Application for Florida Licensure as an M.D. In July of 1993, Dr. Pennington's fiance, Rachel, (now his wife,) assisted him in filling out his application for licensure by the Board of Medicine. Just as Dr. Pennington's previous spouse and other family members had been unaware of his narcotic addiction while a pharmacist prior to entering medical school, Rachel Pennington, too, was unaware that Dr. Pennington was using narcotics. Moreover, she did not know of his past history of drug use or his discipline in Georgia. Rachel Pennington typed the application for Dr. Pennington. Questions 4, 9 and 10 on the application were these: Have you ever been notified to appear before any licensing agency for a hearing on a complaint of any nature, including, but not limited to, a charge or violation of the medical practice act, unprofessional or unethical conduct? Are you now or have you ever been addicted to or excessively used alcohol, narcotics, barbiturates, or any other medication? Have you ever voluntarily or otherwise been a patient in a hospital, institution, clinic or medical facility for the treatment of mental/ emotional illness, drug, addiction/abuse, or excessive use of alcohol? Although the correct answer to each of the three questions in Dr. Pennington's case is "yes," the answers he gave on the application to each were "no." Dr. Pennington reviewed and signed the application. At this moment of opportunity to reveal the truth to his fiancee, Dr. Pennington chose to continue to conceal his addiction and past history of both drug use and discipline. The falsified application was submitted to the Board of Medicine in November of 1993. During the hearing in this case, Dr. Pennington was asked on cross examination about his awareness that the application contained misrepresentations: Q You were aware at the time you filled out your licensure application that the answers to those three questions were incorrect, weren't you? A ... I don't think it is adequate to answer the question saying that because of my denial of the disease that I didn't know the question was wrong. I definitely, at some level, knew the question was wrong. Q ... You knew that you had been disciplined before?. A Yes. Q And you knew that you had been in a treatment facility before. A Yes. Q ... Did you consider that you were in a treatment facility because you were excessively using drugs? * * * A Well, I guess to answer that ... I have to say yes, at some level I definitely did. I was not willing to admit that but to answer your question I have to say yes. (Tr. 201). Practice in Florida and Continued Drug Use Dr. Pennington was licensed by the Board of Medicine on March 11, 1994. He continues to hold that license, license number ME 0065888. In June of 1994, Dr. Pennington completed his residency. Shortly thereafter, he moved to Florida to begin practice as an anesthesiologist. He continued to use narcotics. In order to stave off withdrawal symptoms, the onset of which can occur within several hours of using a powerful opiate like Sufenta, Dr. Pennington was forced to use narcotics throughout the day, including while at work. Moreover, he was unable from time-to-time to avoid the side effects of withdrawal, which included chills and diarrhea. To control those symptoms, he used drugs such as Lomotil. Lomotil, like Sufenta and the other opiates Dr. Pennington has used, requires a prescription. Self-prescribing and Fictitious Patients In order to obtain some of these drugs, Dr. Pennington wrote out prescriptions for Bob Pennington (his father), Rachel Pennington (his wife), and Kim Patrick (his ex-spouse), none of whom were patients of his. For example, between November, 1994, and February, 1995, he wrote or called in at least fourteen prescriptions for Hycodan, Lomotil and Tussionex, in the names of the three fictitious patients. In reality, the prescriptions were for himself. The Self-prescribed Medications Hycodan contains hydrocodone bitartrate, and is a Schedule III controlled substance under Section 893.03(3), Florida Statutes. It is used for cough-relief. The maximum recommended daily dose is 30 milliliters, or six tablets, which consists of thirty milligrams of hydrocodone. Tussionex contains hydrocodone polistirex, and is a Schedule III controlled substance under Section 893.03(3), Florida Statutes. It is used for cough relief and upper respiratory symptoms associated with allergies or colds. The maximum recommended daily dose is ten milliliters consisting of twenty milligrams of hydrocodone. Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. It is a narcotic with potential, of course, for abuse. It has the potential for abuse because it is an opiate derivative, one that, attached to the morphine or opiate receptor in the brain, produces effects of somnolence and euphoria, as well as suppressing other nerve impulses. Hydrocodone causes one to feel good about oneself, blurs time relationships, and changes a person's perceptions. It can cause lack of attention or cause one to be easily distracted, traits that pose extreme danger to patients under the care of an anesthesiologist. Once a certain level of tolerance is reached with hydrocodone, it causes twitching, nervousness, diarrhea, flushing, chills, goosepimples, and other classic symptoms of narcotics withdrawal. Lomotil contains diphenoxylate hydrochloride, and is a Schedule V controlled substance under Section 893.03(5), Florida Statutes. It is used in the management of diarrhea, a common symptom of narcotics withdrawal. It is also used to control other symptoms of withdrawal such as pain and twitching. The maximum recommended daily dose of Lomotil is eight tablets a day or twenty milligrams. At high doses, it is addictive, causing codeine-like effects. Between November, 1994, and March, 1995, Dr. Pennington was taking approximately 15-20 hydrocodone tablets, that is, 75- 100 milligrams, per day, and 30 to 50 Lomotil tablets or 75 to 125 milligrams per day. These levels of consumption are three to five times the recommended maximum daily dosage. Dr. Pennington was self-administering these substances for several purposes: satisfying his addiction, fending of withdrawal symptoms and controlling withdrawal symptoms he could not avoid. Caught Again On March 24, 1995, Dr. Pennington was questioned by an official of the Drug Enforcement Agency (DEA) and a Pinellas County Sheriff's Office detective regarding the fourteen prescriptions for fictitious patients written in late 1994 and early 1995. The interview took place immediately after Dr. Pennington had completed administering anesthesia during an operative procedure on a patient. Dr. Pennington admitted writing the fraudulent prescriptions. Furthermore, he provided the officers with a syringe containing approximately one cubic centimeter of Sufenta. Dr. Pennington admitted that he had used Sufenta about two hours earlier before administering anesthesia to the patient. Talbott-Marsh On March 25, 1995, the day after the DEA discovered Dr. Pennington was illegally using narcotics, he was admitted to the Talbott-Marsh Recovery System in Georgia, having been referred because of his chemical dependency by the Physicians Recovery Network. An inpatient chemical dependency treatment facility, Talbott-Marsh is specifically designed to meet the treatment needs of chemically addicted health care professionals, especially physicians. Five months after admission, on August 25, 1995, Dr. Pennington was discharged from Talbott-Marsh. He had completed the program successfully. Once again, just as upon successful completion of the program at Willingway, Dr. Pennington was in recovery from the disease of chemical dependency. Addiction: the Disease of Chemical Dependency The Disease and its Stages Chemical dependency or addiction is a chronic illness. An identifiable disease recognized by the medical profession, it is not the result of voluntary behavior. Rather, it is the result of a biogenetic defect, one with which the addicted person is born. Together with introduction into the person's system of a sufficient amount of a mood altering substance, this defect produces addiction. Initially, the disease manifests itself in abuse of the drug. In this early stage, addiction has not yet occurred. As use recurs, however, at some point the person crosses the threshold of addiction. After addiction, the individual becomes more and more preoccupied with obtaining the drug, primarily to avoid withdrawal symptoms when the addiction is not satisfied. The more preoccupied the individual becomes with obtaining the drug, the more avoidance there is of external responsibilities: those related to family, work and self. The disease is characterized by the continued use of the drug in the face of ongoing adversity as the result of the avoidance of external responsibilities. Left untreated, the disease leads to serious consequences: institutionalization due to a number of factors which may include brain damage or uncontrollability, disability, and, in extreme cases, death. Crossing the Wall As the disease progresses, eventually it takes control of not only the individual's use of the drugs but all of the individual's thinking as well. This point is referred by practitioners of addictionology as "crossing the wall." When the addict crosses the wall, the disease is in control. It is not uncommon for an addict who crosses the wall to conceal the drug use from everyone including spouse, other family members, friends, and employers. It is common for an addict who has crossed the wall to lie about drug use and minimize the extent of its effects on the addict's life. The acts of denying, concealing, and lying about drug use are common manifestations of the disease of chemical dependency. They fall into a continuum of symptoms of the disease ranging from denial, which relates to the negative consequences the use is having on the addict, to lying. Physicians as Addicts It is common for physicians addicted to drugs to steal them, divert them, write prescriptions for their own use or engage in other deceptive means of obtaining drugs. The manner used by physicians to obtain drugs is often dependent upon the physician's specialty. Nonetheless, self- prescribing medications is found in almost all of the cases of addicted physicians. Consuming massive quantities of drugs is not unusual for the addicted physician, often, in part, because of ready access to drugs. It is, moreover, a sign of tolerance of the drugs. Even in cases of great consumption, and despite the characteristics of narcotics and opiates, when physicians develop tolerance, they remain able to function well while under the influence of the substance. It is common, therefore, for drug usage to go undetected for long periods of time. Furthermore, with regard to opiates and narcotics, it is often difficult to determine whether a person is using them. There tends to be much less muscular coordination, slurred speech and recent memory deficits as would be observed of persons under the influence of other drugs. An individual addicted to and under the influence of opiates, even a physician practicing in a specialty as demanding as anesthesiology, can appear to be functioning as well as a person not under the influence of drugs. This is the case, in part, because a person addicted to opiates can develop tolerance rapidly. The more powerful the opiate, the sooner tolerance may be developed, as in the case of Sufenta. A physician under the influence of Sufenta can take a massive dose and appear to be basically normal to the untrained eye. Dr. Pennington's Stage of Addiction at the Time of Application Prior to the fall of 1993, that is, the time when Dr. Pennington made out and submitted his application to the Board of Medicine, he exhibited all the symptoms of a person who has crossed the wall. He had concealed his drug use, which at that time had become quite advanced, from his fiancee, his family, friends, and colleagues. He was taking massive quantities of narcotic opiates, yet, to the untrained eye, he was not exhibiting symptoms of a person under the influence. At the time of application, Dr. Pennington was well- thought of by his colleagues in the residency program in Louisiana. He was highly recommended for licensure to the Board of Medicine by the instructors of his residency training program. Treatment, Care and Aftercare Treatment is an important phase of the recovery process. Those suffering chemical dependency generally do well in treatment because of the controlled and structured nature of the treatment environment. The environment is safe. The patient is surrounded by others with similar problems. There is a lot of support both from those suffering the disease as well as from professionals. A successful treatment program must insist that the patient be rigorously honest in order to attain full recovery. Rigorous Honesty Because lying is an integral part of the disease of chemical dependency, a program of recovery demands rigorous honesty. In an effective recovery program, such as the one Dr. Pennington participated in at Talbott-Marsh, the physician is required to face the consequences of addiction and participate in psychotherapy when needed. During the treatment phase, the physician is required to go through identification with the family, have a fourth and fifth step of identifying the history of past defects and telling them to another human being. The Physician Recovery Network The Physician Recovery Network is the program used by the Board of Medicine to monitor physicians impaired by addiction in the State of Florida under Section 455.261, Florida Statutes. The Physician Recovery Network ("PRN,") assists the physician in developing and maintaining a manner of living which demands rigorous honesty. PRN does this by requiring the physician to enter into an Advocacy Contract, a five year contract that can be extended if necessary. The Advocacy Contract is designed to serve as a deterrent, promote honesty, to verify through face-to-face conferences and monthly and weekly meetings and periodic urine screens, that a physician is progressing or improving and is not endangering the public or him or herself. Physicians are required to identify the consequences of their drug use and admit their powerlessness over their ability to stop using drugs. Rigorous honesty is demanded by PRN from its participants because it is absolutely required in order to break denial and to prevent rationalization and denial from returning to the behavioral patterns of the addicted physician. PRN educates physicians about the negative behavioral patterns of their disease and monitors the physicians for the return of erratic behavior or evidence of returning denial or evidence of lying. PRN educates physicians about their own indicators for relapse so that they avoid positions likely to produce relapse and so that they will not be unconsciously driven to resume drug use to relieve personal discomfort. PRN monitors its physician participants through local group facilitators. Monitors are assigned because of geographic proximity that will allow immediate access in order to provide counseling. Initially, the PRN monitor undertakes a direct physical evaluation of the physician and becomes familiarized with the physician's specific problems to allow early identification of developing problems that would endanger the public or the physician. In addition, the monitor maintains close contact with PRN. Reports to PRN are made at least weekly providing information about general progress, insight, attentiveness, responsiveness to urine screens, participation in group sessions, openness of the physician, assessment of honesty, and assessment of coping skills. The contact between the monitor and PRN is so comprehensive that it can be characterized as an ongoing dialogue about all aspects of the physician related to management of the addiction and the medical-legal implications for the physician's practice and protection of the public. The monitor is also charged with providing the participating physician with support. If a physician fails to comply with PRN instructions or relapses, the monitor immediately reports it to PRN so that the physician can be submitted to treatment. If necessary to protect the public in such a case, PRN does not hesitate to report the matter to the Agency for Health Care Administration for entry of an emergency order suspending the license. While some number below 20 percent of physicians who enter PRN require more than one treatment to become firmly committed to recovery, 97 percent of the physicians who enter PRN practice without difficulty after five years. The ninety-seven percent success rate PRN has experienced with addicted physicians is significantly higher than the success after treatment of the general population of sufferers of chemical dependency in returning to lives committed to recovery and free of the problems of addiction. Aftercare Aftercare, the stage of recovery which follows treatment and the diseased physician's entry into recovery, is an essential phase of the recovery process, every bit as important, if not more so, than the initial program of treatment. It must consist of close monitoring with repetitive follow-up. This is provided by PRN. As an aftercare program more highly developed than the aftercare received by Dr. Pennington from Willingway in the previous decade, in part, due to advances in the study of addictionology, PRN provides the type of aftercare that supports recovery as fully as possible in light of the status of addictionology today. For example, the syndrome of "protracted withdrawal from opiates," was not even known to exist at the time Dr. Pennington participated in the Willingway program. The syndrome is the result of the body shutting off its own, natural, manufacture of endorphins and other "internal opiates," necessary to a sense of well-being while taking narcotic opiates and introducing into the body exogenous opiates. As a result, it takes the body several years, a period longer than the initial treatment phase, to begin producing its own internal opiates. In the meantime, the opiate addict will continue to suffer withdrawal symptoms, hence the term "protracted" withdrawal. Unlike the care after the Willingway program, the PRN aftercare program provides treatment for protracted withdrawal. Dr. Pennington's Experience with PRN and Adherence to the Advocacy Contract At least through the time of hearing, Dr. Pennington has maintained a strict adherence to his PRN contract. He has fully complied with monitoring by PRN. He has shown a significant commitment to his program of recovery since entering into the advocacy contract. Since late summer, 1995, PRN has considered Dr. Pennington to be safe to practice under the terms of his advocacy contract with continued monitoring. In making that determination, PRN has considered all of the Respondent's past addictive behavior including the length of his addiction, his ability to function normally while under the influence of opiates and other drugs, lying about drug use, concealing it from family, friends, work colleagues, even the Board, stealing drugs, and self-prescribing. Moreover, PRN has considered his prior discipline by the Georgia Board of Pharmacy, the treatment at Willingway and the failed aftercare in his first effort at recovery. Most importantly, PRN has considered the potential danger Dr. Pennington poses to patients and the public. Because of restrictions imposed upon him by both Talbott-Marsh and PRN, Dr. Pennington is not practicing as an anesthesiologist. He cannot resume that practice until his treatment professionals and PRN agree that it is safe for him to do so. Dr. Pennington is not permitted access to controlled substances. He must utilize triplicate prescriptions, one for the patient, one in the chart, and the other for monitoring. Since leaving Talbott-Marsh, Dr. Pennington has successfully met these requirements imposed for his aftercare from the moment he left Talbott-Marsh: Monitor and addictionologist: Dr. Roger Goetz and a local monitor, Jim Noyes, Ph. D. Primary physician of Marte Kautzler, D.O. Not to return to anesthesiology for at least one year following treatment. Return to Talbott-Marsh for reassessment. Work 40 hours per week maximum. Utilize triplicate prescription pads in his practice. Reside with wife, Rachel, and attend couples therapy as directed by Dr. Noyes. Attend Caduceus and AA, 90 meetings in 90 days, followed by attending at a frequency of four to seven times per week. See Joint Exhibit 1. Board Action Had it Been Aware of the Truth at the Time the Application Was Filed Had the Board been aware at the time Dr. Pennington filed his application that the answers to questions 4, 9 and 10 were inaccurate, Dr. Pennington would have had to appear before the Board's Credential Committee. The Committee would have required a personal appearance of Dr. Pennington and a PRN evaluation. Based on the evaluation and Dr. Pennington's explanation for the inaccuracies in the application, the Committee would have recommended either denial of licensure or issuance of the license. Dr. Pennington is in full compliance with his PRN contract and has demonstrated a strong commitment to his program of recovery and the requirements of PRN. It is likely, based on an analysis of similar cases, that if Dr. Pennington were to apply for a license today, with full disclosure, and under the current circumstances of his good standing in the PRN program, that the Board would grant him a license with conditions. Dr. Pennington's Practice Today Today, Dr. Pennington is employed as a practicing physician at a private walk-in clinic. In addition to the practice of requiring his prescriptions in triplicate, his access to controlled substances is completely restricted and the restriction is closely monitored. The nurses at the clinic maintain the keys which allow access to the drugs. An inventory is conducted in the morning when the facility opens and is matched every day with an inventory done in the evening when the facility closes. A urinalysis to check for recent drug use was performed when Dr. Pennington was hired and random urinalyses are done of all employees, including the owner, from time to time without warning. Dr. Pennington, at the time of hearing, had been subject to two urinalyses. Dr. Pennington is observed at the facility for behaviors that would indicate relapse. At the time of hearing, he had not exhibited any such behaviors. His knowledge of medicine was described by his employer as good. Moreover, Dr. Pennington has shown good clinical judgment in the cases he has encountered as well as excellent skills in dealing with his patients. The Impact of Discipline on Dr. Pennington It would be counter-therapeutic to Dr. Pennington to remove him from the practice of medicine while he is in recovery. In fact, one of the main reasons for the extremely high success rate of PRN's work with physicians suffering from the disease of chemical dependency when compared to the general population of those with the disease, is that the physician is working and his or her license is always at stake. Protection of the Public The department, in an attempt to protect the public, is seeking discipline of Dr. Pennington. Yet, the Board, by not taking emergency action against his license, has conceded that he is not impaired at the moment and so long as he is in recovery. Moreover, by allowing his practice pending this proceeding and not taking emergency action against his license, the Board has determined Dr. Pennington's practice as a physician in a walk-in clinic does not pose an imminent danger to public health safety and welfare.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That Dr. Pennington's license to practice medicine be suspended for five years; That the suspension be stayed and that he be placed on probation immediately for at least five years with probation to be extended, if necessary at the end of the five years; That appropriate conditions of the suspension be imposed by the Board to include, at a minimum: No practice of anesthesiology during the period of probation; No access to controlled substances, drugs or medicines requiring a prescription during the period of probation; and, Participation in the Physician's Recovery Network for the entire period of probation. DONE AND ENTERED this 22nd day of November, 1996, in Tallahassee, Leon County, Florida. DAVID M. MALONEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of November, 1996. COPIES FURNISHED: Monica Felder, Esquire Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399 Grover C. Freeman, Esquire Jon M. Pellett, Esquire Freeman, Hunter & Malloy 201 East Kennedy Blvd., Suite 1950 Tampa, Florida 33602 Dr. Marm Harris Executive Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against a medical doctor on the basis of alleged violations of paragraphs (m), (q), and (t) of Section 458.331(1), Florida Statutes. The violations charged relate to allegations that the Respondent improperly prescribed legend drugs, including controlled substances, and that he failed to keep certain records.
Findings Of Fact The Respondent is, and has been at all times material to this proceeding, a licensed physician, having been issued license number ME 0026758 by the State of Florida. During 1988 and 1990 the Respondent wrote five prescriptions for a person named V. L. R. The prescriptions were dated 7/9/88, 8/23/88, 9/27/88 11/18/88, and 2/12/90. As of October 22, 1990, the Respondent did not have any medical records in his possession regarding V. L. R. The Respondent has never had any medical records regarding V. L. R. The prescriptions the Respondent gave to V. R. L. included a prescription for 100 tablets of Eskalith CR, 450 milligrams each. Eskalith is a brand name for Lithium. The prescriptions the Respondent gave to V. L. R. also included a prescription for 500 tablets of Lithobid, 300 milligrams each, which is another brand name for Lithium. Before prescribing Lithium, a physician should establish the existence of a mood disorder as a diagnostic basis for the prescription. The diagnosis should be reflected in medical records. When prescribing Lithium, a physician should also monitor the concentration of the drug in the system of the person to whom the drug is prescribed, because the therapeutic level of Lithium is very close to the toxic level of Lithium. If the concentration is too low, the drug is not effective. If the concentration is too high, there can be toxic effects including vomiting, diarrhea, unsteady gait, and the possibility of falling. The prescriptions the Respondent gave to V. R. L. included a prescription for 30 tablets of Ativan, 100 milligrams each. Ativan is a controlled substance which is habit forming. It is a tranquilizer. A physician should not prescribe Ativan without a diagnosis of a sleeping problem or anxiety. The diagnosis should be documented in the medical records of the person to whom the prescription is given. The name of the drug, the dosage, and the times the drug should be taken should all be included in the medical records. The prescriptions the Respondent gave to V. R. L. included a prescription for 100 tablets of Tegretol, 100 milligrams each. Tegretol is an anti-seizure medication that is also used as a mood stabilizer in people who have a major mood disorder. When prescribing Tegretol, a physician should also monitor the concentration of the drug in the system of the person to whom the drug is prescribed, because the drug has the potential for adverse side effects, including inhibition of blood cell production and the production of platelets leading to the risk of infection or bleeding. A physician should not prescribe Tegretol unless a diagnosis of a mood disorder has been made. The diagnosis should be reflected in medical records. A physician should not prescribe Tegretol and Lithobid to the same person unless there have been some difficulties in the treatment of the person and a need for simultaneous prescription of both drugs has been established by the physician. The name of the drug, the dosage, and the times the drug should be taken should all be included in the medical records. The prescriptions the Respondent gave to V. R. L. included a prescription for 100 tablets of Anafranil, 25 milligrams each. Anafranil is a drug prescribed to treat obsessive/compulsive disorder with or without depression. A physician should not prescribe Anafranil without a diagnosis of an obsessive/compulsive disorder. The diagnosis should be documented in the medical records of the person to whom the prescription is given. Any symptoms of depression should also be noted in the medical records. The name of the drug, the dosage, and the times the drug should be taken should all be included in the medical records. When prescribing Anafranil, the physician should monitor the effect of the drug by observation of the person to whom the prescription is given. Such observations should be noted in the medical records. The prescriptions the Respondent gave to V. R. L. included a prescription for 10 tablets of Endep, 25 milligrams each. Endep is a commercial name for amitriptyline, which is an antidepressant. It is used to treat depression. A physician should not prescribe Endep unless a diagnosis of depression has been made. The diagnosis should be included in the medical records. The name of the drug, the dosage, and the times the drug should be taken should all be included in the medical records. The prescriptions the Respondent gave to V. R. L. included a prescription for 15 tablets of Halcion, 25 milligrams each. Halcion is a controlled substance that is used to treat sleeping disorders. A physician should not prescribe Halcion unless a diagnosis of a sleeping disorder has been made and the need for the drug is established. When prescribing Halcion, the physician should monitor the effect of the drug by means of observations of and discussions with the person to whom the prescription was given. The diagnosis of sleeping disorder and the observations and discussions should all be noted in the medical records. The name of the drug, the dosage, and the times the drug should be taken should also all be included in the medical records. The Respondent prescribed quantities of medication that represented a potential danger to V. L. R. The Respondent prescribed excessive or inappropriate quantities of drugs to V. L. R. The Respondent, by providing the prescriptions described above to V. L. R., prescribed legend drugs, including controlled substances, outside the scope of his professional practice.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that the Board of Medicine issue a Final Order in this case to the following effect: Dismissing the charges alleged in Counts One and Two of the Amended Administrative Complaint; Finding the Respondent guilty of a violation of Section 458.331(1)(q), Florida Statutes, as alleged in Count Three of the Amended Administrative Complaint; and Imposing an administrative penalty comprised of (i) an administrative fine in the amount of one thousand dollars ($1,000.00), (ii) a requirement that the Respondent attend one or more continuing education courses on the subject of legal and ethical issues associated with the prescription of controlled substances, and (iii) a public reprimand of the Respondent for the violation described above. DONE AND ENTERED this 28th day of June, 1994, at Tallahassee, Leon County, Florida. MICHAEL M. PARRISH, 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 Adminsitrative Hearings this 28thday of June, 1994. APPENDIX The following are the specific rulings on all proposed findings of fact submitted by all parties. Findings submitted by Petitioner: Paragraphs 1 and 2: Accepted. Paragraph 3: Rejected as subordinate and unnecessary details. Paragraph 4: Accepted in substance. Paragraph 5: Rejected as not supported by clear and convincing evidence. (It is clear that the Respondent did not make any records of any such examinations or tests, but it is not clearly established that he did not perform the examinations or tests.) Paragraph 6: Rejected as subordinate and unnecessary details. Paragraph 7: Accepted in part and rejected in part. It is clear that the Respondent failed to keep medical records regarding V. L. R.; it is not clear that he "treated" her or that she was a patient. Paragraphs 8 through 36: Accepted. Paragraphs 37 and 38: Rejected for several reasons, including the following: These two paragraphs are to some extent arguments, rather than proposed findings of fact. The opinions described in these two paragraphs are both based on an assumption that was not proved; the assumption that V. L. R. was a patient who was being treated. There is no clear and convincing evidence that V. L. R. was the Respondent's patient. Paragraph 39: Rejected as an invalid and incorrect opinion. The issuance of a prescription does not always constitute treatment of the person for whom the prescription is written. (A classic example of when prescription writing does not constitute treatment is when a prescription is written for a drug to be used for recreational purposes, rather than for a legitimate medical purpose.) Paragraph 40: Rejected as not supported by clear and convincing evidence. (It is clear that the Respondent did not make any records of any history, psychiatric evaluation, or diagnosis of V. L. R., but it is not clearly established that he did not do those things.) Paragraph 41: Accepted. Paragraph 42: Rejected for several reasons. First, the facts proposed in this paragraph were not established by clear and convincing evidence. (McKenzie's testimony about who wrote the notes was hearsay that would not meet one of the recognized hearsay exceptions; Norwich's testimony about who wrote the notes was limited to an unquantifiable "probably.") Paragraph 43: Rejected for several reasons. First the evidence is insufficient to establish what kind of relationship the Respondent had with V. L. R. Second, there is no clear and convincing evidence of a sexual relationship between the Respondent and V. L. R. Third, there is no clear and convincing evidence that V. L. was a patient of the Respondent. Fourth, any findings about a sexual relationship would be irrelevant because there is no allegation in the Amended Administrative Complaint regarding any sexual relationship. Paragraph 44: Rejected because this opinion is based on at least one fact that was not proved at the formal hearing. Paragraph 45: Accepted. Paragraph 46: First three lines and first word of fourth line are accepted. The reference to the sexual relationship is rejected as not charged and as not proved by clear and convincing evidence. Paragraph 47: Rejected because this opinion is based on at least one fact that was not proved at the formal hearing. Findings submitted by Respondent: Paragraph 1: Accepted. Paragraphs 2 and 3: Rejected as subordinate and unnecessary procedural details. Paragraphs 4 and 5: Rejected as not supported by persuasive competent substantial evidence. Paragraph 6: Accepted in substance. Paragraph 7: Rejected as subordinate and unnecessary details. Paragraphs 8 through 10: Accepted in substance, with some subordinate and unnecessary details omitted. Paragraph 11: Rejected as incorrect dates; the correct dates are 1988 to 1990. Paragraph 12: Accepted in substance. Paragraph 13: Rejected as irrelevant. COPIES FURNISHED: Francesca Plendl, Esquire Senior Attorney Department of Business and Professional Regulation 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Harold M. Braxton, Esquire, and Tania Therese Wong, Esquire Suite 400, One Datran Center 9100 South Dadeland Boulevard Miami, Florida 33156 Jack McRay, General Counsel General Counsel Department of Business and Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Dr. Marm Harris Executive Director Board of Medicine Department of Business and Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792
Findings Of Fact At all times pertinent to the issues herein, the Criminal Justice Standards and Training Commission was the state agency responsible for the training and certification or law enforcement and corrections officers in Florida. Respondent was certified as a Corrections Officer under certificate No. 48891 on August 8, 1991. On June 29, 1994, Respondent was employed as a Corrections Officer I at the Hillsborough Corrections Institute in Tampa and had been so employed for approximately three and a half years. On that day, officer Ricardo Sementilli, a policeman with the Tampa Police Department's narcotics bureau, with approximately six and a half years experience in law enforcement, was targeting a house in Carver City, a Tampa housing area, for suspected unlawful narcotics activity. In the course of his investigation, Officer Sementilli was using the services of a confidential informant, Penny DuFour. Ms. DuFour, herself a former drug user, had been working as an informant for the police in general and for Officer Sementilli in particular for almost two years. On this evening, he proposed to have Ms. DuFour make a controlled purchase of illegal drugs at this particular residence. As preparation for the controlled buy, Ms. DuFour was searched by Officer Keene, also of the Tampa Police Department, to insure that she did not have any narcotics or other contraband in her possession. None was found during this search which is a normal procedure of the Tampa Police Department as a part of a controlled purchase by a confidential informant. Officer Keene was assigned to the Police Department's Tactical Division in narcotics enforcement and had worked in that division for approximately five years. She was working with Sementilli on this operation because he was well known and she was unknown in the geographic area in which the buy was to be made. Pursuant to the officers' plan, Officer Sementilli drove Ms. DuFour and Officer Keene to the intersection of Laurel and Manhattan Streets in Carver City. At this point, Keene, who had binoculars with her, hid out of sight behind a wall at Jefferson High School in a position where she could see Ms. DuFour. When Keene was in place, DuFour was sent out from the police vehicle to approach the residence in question. Keene was able to keep DuFour in sight the entire time using the binoculars. As DuFour approached the residence in question, a red compact car, occupied by Mr. Sampson and the Respondent, drove up. Both DuFour and Keene indicated Mr. Sampson was in the passenger seat and Respondent, who was dressed in a law enforcement uniform, was driving. DuFour went up to the vehicle and leaned in the passenger window. She asked Mr. Sampson if he was "straight." By this she meant to ask if he had any narcotics on his possession. In response, Sampson said he did, reached under the passenger seat of the car, and pulled out a plastic baggie in which were several pieces of what appeared to be cocaine. He placed the baggie in his lap and from it extracted a small piece of the substance which he gave to DuFour in exchange for $20.00 in U.S. currency which DuFour had been given by Officer Sementilli. All during this time, the baggie was in plain view on Sampson's lap and Respondent could see what was happening. She was either looking at Sampson or looking out the window, and Ms. DuFour was of the opinion that Respondent was fully aware of what was going on though she did not say anything. It is so found. After she received the substance from Sampson and paid him for it, DuFour left the vehicle and returned to where Officer Keene was located without either stopping or speaking with anyone on the way. When she got to Keene, she handed over the substance she had received from Sampson and was searched to insure she had not hidden any additional contraband on her person. She had not. Sementilli performed a field test of the substance at the scene. The test indicated the substance DuFour had received from Sampson in the presence of the Respondent was cocaine. This tentative identification was subsequently confirmed by a laboratory analysis conducted by the Florida Department of Law Enforcement. No issue was raised as to chain of custody of the sample in question or as to its identification as cocaine. At the time the sale took place from Sampson to DuFour, the officers obtained the license tag number on the vehicle being driven by Respondent and from which Sampson made the sale. A subsequent check with the Department of Motor Vehicles revealed that the vehicle was owned by Louis Sales, Respondent's father. Approximately one month after the sale described above, the car was discovered at the home belonging to Mr. Sampson's mother. As the officers were attempting to impound the vehicle, Respondent approached them. Keene at that time identified Respondent as the driver of the vehicle at the time of the sale in issue here and placed her under arrest. However, criminal charges were not preferred against her. At hearing, Respondent indicated that on the day of the alleged sale, she had been driven to work in her father's car by her boyfriend, Mr. Sampson, who was without his own vehicle at the time. While at work, she was interrogated by facility investigators relative to an allegation that she was introducing contraband into the corrections facility. Because this upset her, she asked for and was give permission to leave work early, approximately 5:30 PM. She then contacted Mr. Sampson who picked her up in her vehicle at approximately 7:00 PM that evening. When Sampson and Respondent left the corrections facility, they drove to Carver City because Sampson said he had to run an errand in the area. At that time Carver City, located some 45 minutes from Plant City, where Respondent lived, was known as an area of high drug activity. It was not uncommon for many drug dealers to be operating on the streets of the community. Respondent knew that Mr. Sampson was a drug dealer. He would sometime sell drugs openly in front of her. She had been present on several other occasions when DuFour had purchased cocaine from Mr. Sampson. At the time she met Mr. Sampson, in December, 1993, notwithstanding she denied it, Respondent knew he had just recently been released from prison because he told her so. He had been convicted of escape and grand theft. Nonetheless, they developed a relationship during the course of which she admittedly began to suspect he was dealing drugs. She did not ask him if this was so, however, even though she knew that her knowing association with a drug dealer could place her certification in jeopardy. When she became convinced that Sampson was dealing drugs, Respondent still did not terminate the relationship, however, claiming she was afraid to do so. When she was arrested as a result of the instant sale, however, she finally broke off the relationship. As a result of the controlled buy in issue, Mr. Sampson was convicted of sale of cocaine.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Respondent, Sydell T. Sales, be found guilty of demonstrating less than good moral character, and that her certification as a corrections officer be placed on probation for a period of one year. RECOMMENDED this 29th day of December, 1995, in Tallahassee, Florida. ARNOLD H. POLLOCK, 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 29th day of December, 1995. COPIES FURNISHED: Richard D. Courtemanche, Jr., Esquire Florida Department of Law Enforcement P.O. Box 1489 Tallahassee, Florida 32302 Miriam L. Sumpter, Esquire 2700 North MacDill Avenue Suite 208 Tampa, Florida 33607 A. Leon Lowry, II Director Division of Criminal Justice Standards and Training Post Office Box 1489 Tallahassee, Florida 32302 Michael Ramage General Counsel Department of Law Enforcement Post Office Box 1489 Tallahassee, Florida 32302 James T. Moore Commissioner Department of Law Enforcement Post Office Box 1489 Tallahassee, Florida 32302
The Issue The issues posed for decision herein are whether or not the Respondent, Michael Hornstein, registered pharmacist, individually and as owner/operator of Rolette Drugs, Inc., d/b/a Curtiss Pharmacy, has engaged in conduct which will be set forth hereinafter in detail which warrants disciplinary action by the Board of Pharmacy. 1/
Findings Of Fact Based upon my observation of the witness and his demeanor while testifying, the arguments of counsel and the entire record compiled herein, the following relevant facts are found. Michael Hornstein is a registered pharmacist and is the owner/operator (licensee) of Rolette Drugs, Inc., d/b/a Curtiss Pharmacy. Pursuant to a Complaint and Notice to Show Cause filed December 20, 1979, 2/ against Respondent, individually and as owner/operator of Curtiss Pharmacy, the subject administrative hearing was convened to consider allegations that the Respondent, as alleged in the Complaint and Notice to Show Cause, permitted the keeping of improper records, in that he failed to maintain current and accurate records of scheduled controlled substances during the period January 1 through November 30. Pursuant to information furnished by the Drug Enforcement Administration (DEA) in Miami, Florida, a drug accountability audit was performed at Curtiss Pharmacy covering the period January 1 through November 30. The subject audit covered the controlled drugs, Quaalude, Dilaudid, Biphetamine, Tuinal and Desoxyn. Vernon K. Bell, the investigative supervisor for Region V investigative services (Miami, Florida), conducted the drug accountability audit of Curtiss Pharmacy by conducting an on-site review and reconciliation of Respondent's scheduled drug purchases and prescription files respecting the subject drugs. Investigator Bell started the audit period with a beginning inventory for the subject drugs of zero, making no allowances for drugs the Respondent had on hand on January 1. Investigator Bell also allowed Respondent a credit for those scheduled drugs claimed to have been lost due to thefts and robberies. Respondent introduced records which revealed that as a result of robberies of the pharmacy on February 5 and September 26, approximately two hundred (200) Biphetamine capsules and three hundred (300) Quaalude tablets were taken. Examination of the drug accountability report reveals that during the audit period, from total purchases of approximately ten thousand six hundred (10,600) Quaalude 300 mg tablets, Respondent was short approximately eight thousand six hundred nine (8,609) tablets when the drug report was completed for the audit period on December 7 by Investigator Bell. For the scheduled drug, Dilaudid four mg tablets, of total purchases of one thousand four hundred (1,400) tablets, Respondent was short one thousand two hundred eighty (1,280) tablets as of the audit period ending November 30. Biphetamine 20 mg capsules were short approximately one thousand six hundred fourteen (1,614) tablets from total purchases of two thousand three hundred (2,300) tablets during the audit period. Allowing for adjustments, there is still an outstanding shortage of approximately one thousand three hundred fourteen (1,314) Biphetamine capsules. Of total purchases of two thousand (2,000) Tuinal three gram capsules, Respondent's records revealed a shortage of approximately one thousand eight hundred sixty-four (1,864) capsules. Finally, of seven hundred (700) Desoxyn 15 mg tablets, Respondent's records reflect a shortage of six hundred forty (640) tablets. (Petitioner's Exhibit 1 and testimony of Vernon K. Bell.) 3/ RESPONDENT'S DEFENSE Respondent introduced exhibits which substantiated that Respondent's pharmacy was robbed on at least two occasions and police incident reports were completed, as well as DEA controlled drug loss forms to substantiate Respondent's claimed loss for the subject drugs, Biphetamine and Quaalude. Allowances were made herein for the claimed losses. (Respondent's Composite Exhibits 1 through 5.) Thereafter, Respondent invoked the Fifth Amendment privilege based on the claimed pendency of other criminal litigation. Respondent also allowed that the instant administrative proceedings herein should have been abated based on the pending or imminent criminal proceedings involving the subject drug losses by DEA. Respondent requested leave to supplement the record at such time as immunity is granted or jeopardy is removed when the related criminal proceedings have been terminated. This request was considered and denied based on the undersigned's conclusion that the Petitioner is authorized and is in fact duty bound to proceed as the regulating agency charged with protecting the public. See Schwartz v. Florida Board of Pharmacy, 302 So.2d 423 (1DCA 1974), cert. denied, 314 So.2d 151 (,Fla. 1975). Finally, Respondent questioned the accuracy of the audit based on the adjustments made when the police incident and DEA 106 forms were presented. Respondent also claimed that there was a possibility that there should be an additional downward adjustment of approximately nine hundred (900) Quaalude tablets. 4/
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Respondent's license to practice pharmacy and permit to operate a pharmacy in this State be SUSPENDED FOR A PERIOD OF TWO (2) YEARS. RECOMMENDED this 16th day of July, 1980, in Tallahassee, Florida. JAMES E. BRADWELL, Hearing Officer Division of Administrative Hearings 101 Collins Building Tallahassee, Florida 32301 (904) 488-9675
The Issue The issue is whether the Petitioner, Harvey Donley, is liable for the jeopardy assessment as set forth in the Revised Notice of Assessment and Jeopardy Findings dated August 6, 1990.
Findings Of Fact On June 9, 1989, Petitioner sold a quantity of cocaine to a confidential informant at Albertson's Food Store on Apalachee Parkway, Tallahassee, Florida. On June 9, 1989, Petitioner drove to Albertson's Food Store, parked his car, and got into the confidential informant's vehicle. Shortly after Petitioner had entered the confidential informant's vehicle and conducted a transaction of cocaine, he was arrested. At the time of Petitioner's arrest, one plastic bag containing cocaine was recovered from the seat next to where Petitioner had been seated. A second bag of cocaine was recovered from Petitioner's shirt. After Petitioner's arrest, Petitioner told Sgt. McKissack that he got the cocaine from one Paul Dorlag. Petitioner further told Sgt. McKissack that the bag of cocaine in his shirt pocket was his "cut" of the cocaine. After Petitioner's arrest, police officers executed a search warrant at Petitioner's residence. During the search, under the search warrant, a small quantity of paraphernalia and drug residue were seized in Petitioner's home. This paraphernalia consisted of a plastic cocaine straw. Other evidence seized during the search of Petitioner's residence consisted of a cedar box containing cannabis residue and one bottle of Insitol. After his arrest, Petitioner was charged with trafficking in cocaine. Twenty-five and one-half (25.5) grams of cocaine were recovered from Petitioner's person when he was arrested. The estimated retail price of the cocaine seized from Petitioner was $100 per gram. The estimated retail value of the total amount of cocaine seized from Petitioner amounted to $2,550. The Revised Notice of Assessment and Jeopardy Findings dated August 6, 1990, is legally valid and mathematically correct. The 50% tax according to the revised assessment is $1,275. The 25% surcharge according to the revised assessment is $637.50. The penalty of 5% per month according to the revised assessment is $95.63. Interest accrued through August 2, 1990, amounts to $238.14. The total amount of the legal assessment against Petitioner is $2,246.27. The additional interest for the period from August 2, 1990, to the date of the hearing, January 31, 1991, amounts to $114.66. Interest continues to accrue until the assessment is paid. The total assessment due through January 31, 1991, is $2,360.93.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Department of Revenue enter a Final Order upholding the revised assessment in the amount of $2,360.93, plus additional interest as shall become due after the date of the hearing. RECOMMENDED this 13th day of March, 1991, in Tallahassee, Florida. DIANE K. KIESLING Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 13th day of March, 1991. APPENDIX TO RECOMMENDED ORDER, CASE NO. 90-2734 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on the proposed findings of fact submitted in this case. Specific Rulings on Proposed Findings of Fact Submitted by Respondent, Department of Revenue 1. Each of the following proposed findings of fact is adopted in substance as modified in the Recommended Order. The number in parentheses is the Finding of Fact which so adopts the proposed finding of fact: 1-20(1-20) and 21(16). COPIES FURNISHED: Lee R. Rohe Assistant Attorney General Tax Section, Capitol Building Tallahassee, Florida 32399-1050 Harvey Donley 4918-B Crawfordville Road Tallahassee, Florida 32304 J. Thomas Herndon Executive Director Department of Revenue 104 Carlton Building Tallahassee, FL 32399-0100 Vicki Weber General Counsel Department of Revenue 204 Carlton Building Tallahassee, FL 32399-0100
The Issue Whether Petitioner has been substantially affected by agency statements made by Respondent, and, if so, whether the statements violate section 120.54(1)(a), Florida Statutes?
Findings Of Fact Petitioner, Harmony Environmental (Harmony), is duly- licensed as a Universal Waste Transporter Facility (UWTF) with the Florida Department of Environmental Protection (FDEP), holding EPA ID No. FLR000202424. Additionally, Harmony is registered as a Hazardous Waste Transporter by FDEP as well as the U.S. Department of Transportation (USDOT); a Used Oil Handler by FDEP; a Biomedical Waste Transporter by the Florida Department of Health; and as a Waste Transporter by Broward and Miami-Dade counties. Respondent is the state department charged with regulating drugs, devices, and cosmetics pursuant to section 20.165 and chapter 499, Florida Statutes. Respondent does not have jurisdiction over the permitting of universal waste transporters or over Florida Administrative Code Chapter 62-730. Respondent has not issued any permits or licenses to Petitioner. On May 20, 2014, Respondent’s Inspector Dr. Tram Vu inspected Petitioner. The Entry Notice and On-Site Inspection Report was included as an exhibit to the Petition filed in this matter. It makes reference to the “inspection” by Dr. Vu as one, “conducted under Ch. 499.051, F.S., and Rule 61N-1.019, F.A.C., to assess firm’s activities and compliance.” Respondent admitted the May 20th inspection was conducted under the authority cited in the report. On July 16 and 17, 2014, Dr. Vu again inspected Petitioner. A number of photographs were taken during the inspection. The photographs depict two large white containers referred to in the Petition and at the hearing as “yard super sacks.” Inspector Vu testified that the yard super sacks were sealed and that none of the “prescription drugs” photographed were found outside of the sealed Universal Pharmaceutical Waste (UPW) containers. Dr. Vu subsequently requested Petitioner to “voluntarily” quarantine the super sacks and a black tote, and a voluntary quarantine form was prepared and executed. The voluntary quarantine form states that it is “an alternative to the Florida Department of Business and Professional Regulation (‘DBPR’) removing some or all of the products for examination and sampling pursuant to Section 499.065(2), Florida Statutes.” Respondent issued a Notice of Intent to Deny (NOID) to Petitioner on August 18, 2014, regarding its application for a restricted drug distributor/destruction permit. The NOID concluded that Petitioner acted as a restricted drug distributor/destruction establishment without a license. The NOID cited rule 61N-1.023(4), which provides that such a permit is required for a person to take possession in Florida of a prescription drug for the purpose of arranging for its destruction. When asked by Petitioner in an interrogatory, “Are there any facts or circumstances that would cause the DDC to consider that a prescription drug has become UPW and no longer subject to its authority? If so, state or identify each and every such fact or circumstance.” Respondent answered, “No. The term ‘UPW’ is a term that is within the jurisdiction of another Florida state agency, the Department of Environmental Protection (DEP). A prescription drug is no longer a prescription drug when the nature of the prescription drug is altered or changed in a way that the active ingredient which causes the prescription drug to be a prescription drug is no longer active.” Reginald Dixon, the Director of the Division of Drugs, Devices, and Cosmetics (DDC), acknowledged that in his two years as Director, Respondent’s chapter 61N-1 has not contained any definition that addresses the difference between viable drugs and non-viable drugs and that it contains no reference to UPW. Mr. Dixon further acknowledged that chapter 61N-1 does not contain the statement that “[a] prescription drug is no longer a prescription drug when the nature of the prescription drug is altered or changed in a way that the active ingredient which causes the prescription drug to be a prescription drug is no longer active.” He further acknowledged that he is not aware of any federal or Florida law, rule, or regulation that provides the same or similar statement; and that chapter 61N-1 does not contain any definition or explanation as to how the change or alteration that may render the active ingredient inactive takes place. Respondent’s policy that a drug continues to be a prescription drug until its nature is altered or changed so that the active ingredient that makes it a prescription drug is no longer active applies not only to Petitioner. Such policy would apply to other entities engaged in a similar business, as well as to pharmacies, drug wholesalers, and hospitals when considering how to legally dispose of prescription drugs. Respondent takes the position that the UPW rule “is not a rule that belongs to DBPR” (Hr’g Tr. 62); that Respondent “does not have any jurisdiction over the DEP rules” (Hr’g Tr. 75); and that Respondent does “not look at the DEP rules to determine or use their determination of whether or not a drug is viable . . . or nonviable” (Hr’g Tr. 75). “To the extent that [the UPW] rule talks about viable and nonviable pharmaceuticals, that’s not something within our jurisdiction and we don’t deal with it” (Hr’g Tr. 78). Respondent admitted that it is important for regulated entities to know when the agency considered that a drug is no longer under its jurisdiction. Respondent also admitted that if other regulations exist that do not call prescription drugs “prescription drugs” anymore, but instead call them “solid waste, universal pharmaceutical waste or hazardous waste,” those statutes and regulations may “possibly” have a bearing on chapter 499 and chapter 61N-1. In response to Petitioner’s Request for Admissions, Respondent claimed to be “without knowledge” of whether the hazardous waste program under the Federal Resource Conservation Recovery Act (RCRA) established a “cradle to grave” system for controlling hazardous waste; and whether pursuant to 40 C.F.R. § 272.501, the Federal EPA approved the hazardous waste management program administered by the FDEP pursuant to chapter 403, Florida Statutes. Moreover, Respondent was “without knowledge” of whether the U.S. Food and Drug Administration (FDA) does not regulate drugs that have been discarded as hazardous or pharmaceutical waste; and that the FDA does not regulate generators or handlers of hazardous or pharmaceutical waste. Respondent also claimed to be “without knowledge” that some UPW is generated by hospitals during surgical procedures when a vial containing a standard dose of medication is not fully used because of the patient’s size or condition, with the unused dose “wasted” by placing it in a sealed, properly labeled UPW container; that hospitals that dispose of non-controlled and non-viable drugs in a properly labeled UPW container pursuant to rule 62-730.186, do not routinely create a list or inventory of the drugs being wasted or placed in the container that includes the name of the manufacturer, the name of the drug, the quantity, lot number, expiration date, or any combination of these elements; and that hospitals wasting non-viable controlled substances maintain a log that identifies the name and quantity of the controlled substance wasted, but not the manufacturer, the lot number, or the expiration date; and that such controlled substance log complies with DEA regulations as well as chapter 893, Florida Statutes. Mr. Dixon testified that the act of disposing of the unused portion of a prescription drug in a UPW container at a hospital that also contains sharps, broken glass, tissue, and bloody gauzes could constitute the adulteration of that prescription drug. Further, Mr. Dixon testified that when hospitals dispose of drugs in UPW containers they are “possibly” adulterating drugs, and when Petitioner picks up the UPW container, Petitioner may likewise “possibly” be holding adulterated drugs. Petitioner’s witness, Michelle Chambers, was accepted as an expert witness on UPW and related regulations, both state and federal. Although unpaid for her work due to being the spouse of Petitioner’s owner, she is the compliance coordinator, bookkeeper, and registered agent for Petitioner. Mrs. Chambers trains drug wholesalers how to manage their UPW by directing them to “utilize a return if they can get credit for the drug, but that once a drug becomes waste it falls under the guidelines of UPW and those drug wholesalers need to create a separate area that can handle UPW containers.” When discussing the process of sending UPW to a reverse distributor regulated by Respondent, Mrs. Chambers referred to the FDEP’s pharmaceutical waste guidelines, which state: Only pharmaceuticals with a reasonable expectation of credit can be sent to a reverse distributor. Drop pills, non- credible items, formulated mixtures, items with patient’s names, and raw chemicals cannot be sent to a reverse distributor for credit; thereafter, a waste determination is required and the decision must be made to manage this waste as hazardous waste or UPW waste. Mrs. Chambers stated she had knowledge of unexpired drugs, still in the original packaging that were declared waste by the wholesaler. She asserted that drug wholesalers abandoned or discarded the unexpired drugs in their original packaging because “they couldn’t send it back to a reverse distributor to get credit. There was just no value to it, whatsoever, so they decided to make that waste determination that this is waste, UPW.” Mrs. Chambers stated that UPW labels are attached to UPW containers in Petitioner’s facility, according to the FDEP rule regarding UPW. These labels represent the characteristics of the hazardous waste and other waste inside those containers. Some of the notations on the label refer to a substance, material, or a chemical product that is a prescription drug. She also testified that several documents may be created in the UPW process, such as a hazardous-waste manifest and a bill of lading. In records that a UPW handler is expected to maintain under FDEP rules, a UPW handler is not required to have those records contain the name of the drugs that are in the UPW containers, the manufacturer’s information, or the expiration date of the drugs in the UPW container. She asserted that Petitioner could not reasonably create inventories of all the drugs inside a UPW container because “some of the labels have been poured on by other elements within the container; some are unidentifiable; some are broken . . . it would be very difficult to create an inventory.” Based upon her audits of more than 200 hospitals, Mrs. Chambers stated that if a hospital has a procedure to put non-viable drugs in a UPW container, it is because they are trained to do so. She testified that no hospital she has ever audited has ever kept records that include drug names, manufacturers, or expiration dates for anything they have placed in the UPW containers. Petitioner picks up these containers and brings them to its facility. A UPW handler can add waste to the container, as well as consolidate those containers. Mrs. Chambers also discussed consumer packaging under rule 62-730.186(4)(a), which states: “Consumer packaging” means the packaging that surrounds and encloses a container, in a form intended or suitable for a healthcare or retail venue, or rejected during the manufacture process as long as it is enclosed in its bottle, jar, tube, ampoule, or package for final distribution to a healthcare or retail venue. Further, UPW handlers can conduct activities, including disassembling packages containing several pharmaceuticals into individual pharmaceuticals from consumer packaging. In her experience in the auditing of hospitals for UPW, as well as with Petitioner, Mrs. Chambers stated that controlled substances are put into UPW containers from time to time, yet Petitioner has never been cited or received a notice of violation from the DEA regarding the possession of a controlled substance. To her knowledge, the DEA has never notified any UPW handler in Florida of any violations for possessing controlled substances. Dr. Vu conducts inspections and investigations pursuant to chapter 499, specifically investigating unlicensed activities as well as inspecting facilities that are attempting to obtain a DDC permit. Dr. Vu was tendered and accepted as an expert in pharmacy and conducting inspections for Respondent pursuant to chapter 499. She testified that during her inspection of Petitioner on July 14, 2014, she pulled drugs from UPW containers to inspect them. She admitted there were no prescription drugs outside the UPW containers on Petitioner’s premises. She stated that Petitioner’s agents or employees volunteered to open the UPW containers for her inspection. The scant evidence Dr. Vu relied upon that Petitioner had any controlled substances on the premises was based upon documents she obtained from a third party as well as from Petitioner. She admitted there was no evidence of controlled substances on Petitioner’s premises. While Dr. Vu stated she is able to recognize prescription drugs when she sees them, she is not able to recognize UPW since she is “not trained in universal pharmaceutical waste.” She also stated she is not able to recognize a non-viable drug when she sees it. Dr. Vu has received no training from Respondent on the opening of UPW containers, and even though she has not been trained in UPW rules and definitions, she strongly asserted that Petitioner “[c]learly was in possession of prescription drugs,” and that Petitioner had no permit or authorization to possess prescription drugs. When asked about her understanding of when a prescription drug ceases to be a prescription drug, she replied that “a prescription drug is always a prescription drug unless it’s inactivated or loses its drug ability –- characteristics.” Dr. Vu noted that this understanding is not stated in chapter 61N-1 or chapter 499. David Laven, another drug inspector for Respondent, was tendered and accepted as an expert in pharmacy and issues related to the inspection for Respondent under chapter 499. He testified that Petitioner is not allowed to possess prescription drugs without a DDC permit. On cross-examination, however, he admitted he had not read the rule on UPW, has no knowledge of EPA rules and requirements, and that he is not trained to recognize a non-viable drug. He testified that he considers a prescription drug that is discarded in a UPW container still to be a prescription drug because “there’s still a possibility, depending on how that drug has been disposed of, the container may be partially full –- it can be a full container sometimes. Drugs are thrown in a container for a number of reasons, doesn’t necessarily mean that the drug is no longer viable or can be used in any way.” Regarding the definition of prescription drugs, Mr. Laven stated that “[a] drug is no longer viable or useable if it’s out of date, it’s been damaged in some way, compromised, mis-branded, [or] adulterated.” On October 6, 2014, Petitioner sent a Notice of Unadopted Rules letter to Respondent, stating that the conduct and statements set forth above constitute unpromulgated rules and that, according to section 120.595(4)(b), Florida Statutes, they have 30 days to begin proposed rulemaking in order to rectify the actions and statements made. Respondent did not begin proposed rulemaking in that 30-day period. Respondent presented no evidence or testimony to establish that rulemaking was not feasible or practicable.
Findings Of Fact The Petitioner, A. Lincoln Schaub, was committed to the custody of the Department of Health and Rehabilitative Services by order of the juvenile court in Palm Beach County, Florida, on May 24, 1982, and placed in a drug program called "Here's Help" in Miami after his arrest on burglary charges. After two weeks at home prior to entering the program, Petitioner entered "Here's Help" on June 8, 1982. On June 21, 1982, Petitioner left the "Here's Help" program without consent or knowledge. On June 25, 1982, Petitioner's mother reported that Petitioner had returned home. Petitioner's parents subsequently transported him to detention. On July 17, 1982, he was arrested for burglaries allegedly committed while he was absent from the "Here's Help" program. The Department had a transfer hearing on July 29, 1982, and found that Petitioner had left "Here's Help" without consent. Based on that hearing, Petitioner was transferred to the Florida State School for Boys at Okeechobee. Petitioner left "Here's Help" because he had received demerits for a dirty locker and because he was not permitted to work. While absent from "Here's Help", Petitioner used narcotic drugs and was arrested for several burglaries. Petitioner evidenced a lack of self-discipline and an inability at this time to remain in a program voluntarily. Petitioner has a drug addiction problem.
Recommendation Having found that the Department's initial decision to place Petitioner in the Florida State School for Boys is in the Petitioner's best interest, it is so recommended. DONE and RECOMMENDED this 21st day of October, 1982, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, 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 21st day of October, 1982. COPIES FURNISHED: Thomas Rolle, Esquire Assistant Public Defender 224 Datura Street West Palm Beach, Florida 33401 K. C. Collette, Esquire Department of HRS 111 Georgia Avenue West Palm Beach, Florida 33401 Mr. & Mrs. Melvin Schaub Route 1, Box 642 (Loxahatchee) Pompano Beach, Florida 33060 Ms. Judith Hill, Supervisor Children, Youth and Families Program 111 Georgia Avenue West Palm Beach, Florida 33401 David H. Pingree, Secretary Attn: Susan B. Kirkland, Esquire Department of HRS 1317 Winewood Boulevard Building One, Room 406 Tallahassee, Florida 32301
Findings Of Fact The Respondent Walter Deryk is a pharmacist licensed in the State of Florida, License No. 12139. On or about July 30, 1980, while in his employment as chief pharmacist at St. Joseph's Hospital in Port Charlotte, Florida, the Respondent took or converted to his own use, without prescription or permission of his employer, the legend drugs described in attachment one to the administrative complaint, and incorporated by reference herein, which were the property of St. Joseph's Hospital. On or about that same date the Respondent packaged the drugs and delivered them to the United Parcel Service in a package marked "souvenirs shells" for shipment to Kenneth J. Moffa in Long Island, New York. Kenneth J. Moffa is a pharmacist licensed in the State of New York. On a number of other occasions prior to July 30, 1980, while in his employment as chief pharmacist at St. Joseph's Hospital and without permission of that employer nor proper prescription, the Respondent similarly converted legend drugs belonging to the hospital to his own use and shipped them to New York. During a routine inspection for proper packaging by the United Parcel Service, it was discovered that the box shipped to New York on July 30, 1980, contained legend drugs which had been taken from St. Joseph's Hospital pharmacy. The Respondent was arrested for theft shortly thereafter and admitted taking the drugs from the pharmacy. Criminal charges were instituted against the Respondent and the Respondent made a motion to suppress the physical evidence based upon allegations of improper search and seizure. The motion was denied in Circuit Court and the Respondent entered a plea of nolo contendere, but reserving the right to appeal the court's ruling on the suppression issue. That appeal is still pending. The Respondent was convicted in Circuit Court for the theft and this administrative prosecution resulted.
Recommendation Having considered the foregoing findings of fact, the evidence in the record and the pleadings and arguments of counsel, it is RECOMMENDED that the license of Walter Deryk authorizing him to practice pharmacy in the State of Florida be REVOKED. DONE AND ENTERED this 6th day of October, 1981, in Tallahassee, Leon County, 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 6th day of October, 1981. COPIES FURNISHED: William M. Furlow, Esquire Department of Professional Regulation 130 North Monroe St. Tallahassee, Florida 32301 John D. Hooker, Esquire Suite 100, The Legal Center 725 E. Kennedy Boulevard Tampa, Florida 33602
The Issue The issues are whether Respondent deviated from the applicable standard of care, failed to keep medical records justifying the course of treatment, improperly delegated professional responsibilities, or prescribed, dispensed or administered controlled substances other than in the course of his professional practice; and, if so, what penalty should be imposed.
Findings Of Fact Respondent is a licensed physician in Florida, holding license number 59702. He has been licensed in Florida since 1991. Respondent is Board-certified in obstetrics and gynecology. His last certification was in November 2009. Respondent received his bachelor of science degree from the University of North Carolina at Chapel Hill in 1978. He received his doctor of medicine degree from Meharry Medical College in Nashville in 1982. He performed a surgical internship from 1982-83 with the Madigan Army Medical Center in Tacoma, an obstetrics and gynecology residency from 1987-91 at the Harbor Hospital Center in Baltimore, and a maternal fetal medicine fellowship from 1991-93 at the University of South Florida. During the residency, Respondent completed a six-week rotation in the mental evaluation, diagnosis, and treatment of transgendered patients. The training took place on the campus of Johns Hopkins University, which was one of the first medical schools to offer training in the diagnosis and treatment of transgendered patients. During this rotation, Respondent assumed responsibility for the care of about 30 patients, a little over half transitioning from female to male. From 1991-93, Respondent performed obstetrics and gynecology at several medical facilities in Florida, Maine, and Missouri. From 1993-96, Respondent was the Chief of Perinatology, Healthy Start Program, at the D.C. General Hospital/Howard University in Washington. In 1996, Respondent started the Orlando Women's Center (OWC) in Orlando, which he still owns and operates. He opened a second women's clinic in Orlando the following year. Respondent also participated in the starting of women's clinics in Ocala in 1998, Fort Lauderdale in April 1999, and Tampa in October 1999. In October 1996, about six months after opening, OWC hired M. W. as a medical assistant. She had nearly completed the coursework to become a licensed practical nurse, but at no time material to this case was she ever a licensed health care provider. M. W. was employed by OWC until 1999. M. W. was a diligent employee. Her initial duties were answering the telephone and working in the lab. However, her enthusiasm, intelligence, dedication, and discretion earned M. W. a promotion. In January 1997, Respondent promoted M. W. to a trusted position in which she would care for patients undergoing abortions during the second trimester of pregnancy. Working conditions required M. W. to be on-call nearly all of the time, as certain patients demanded to be admitted during nights or weekends to preserve confidentiality. The work was stressful because some patients bore fetuses with abnormalities, and protestors regularly demonstrated outside the clinic. M. W.'s new duties allowed Respondent himself to observe her work and determine that M. W. had the psychological stability to perform her job well. M. W. demonstrated her trustworthiness by dealing with patients' valuables, opening and closing the clinic, ordering supplies and stocking five surgical rooms, and drawing controlled substances for administration by Respondent. At the end of 1997, Respondent promoted M. W. to ordering and stocking the clinic's medical supplies, which include controlled substances. For Schedule II drugs, which includes narcotics, and Schedule III drugs, which includes steroids, M. W. had to fill out a DEA Form 222, using Respondent's DEA number to place the order. When OWC received Schedule III drugs, M. W. matched the order with the shipment. She then recorded the information in the OWC drug log. M. W. would place the drugs in a locked cabinet, if they were not needed for immediate use in the clinic. After nearly one year of ordering supplies, toward the end of 1998, M. W. approached Respondent to discuss a personal matter. At this point, the material disputes between the parties emerge. Respondent testified that M. W. discussed with him the possibility of undergoing transgender therapy, as well as treatment for an injured shoulder. According to Petitioner, M. W. discussed with Respondent the possibility of using anabolic steroids to improve her bodybuilding and weightlifting. The parties do not dispute that M. W. had participated in bodybuilding and weightlifting for several years prior to her employment with OWC. The Administrative Law Judge credits Petitioner's version of the purpose of treatment. Respondent testified that M. W. told him that she had thought about changing genders for several years. She did not like or want her breasts. She did not like the shape of her hips and thighs. She had decided that she did not want children and did not want to undergo menstruation. Although M. W. may have told Respondent that she did not like her body shape, she did not tell him that she wanted to change into a man. As discussed below, M. W. is not available to confirm or deny Respondent's version of events, and Respondent does not have any medical records documenting his care and treatment of M. W. Assigning a secondary reason for the treatment--healing a long-injured shoulder--is an awkward fit with Respondent's version of events, given the unlikelihood that someone considering a decision as major as changing genders would bother assigning a secondary reason for the decision. This secondary reason for the treatment is a better fit with Petitioner's version of events, although treatment of an injured shoulder was, at most, a very minor factor in the steroid treatment because the reconstructed medical records, discussed below, mention strength and bodybuilding, not recovery from a shoulder injury. The most important reason to credit Petitioner's version of the purpose of the steroid treatment over Respondent's version is that Petitioner's version conforms to Respondent's initial description of the purpose of the treatment. In other words, this is not a case of Respondent's word against contrary inferences drawn by Petitioner; this is a case of Respondent's later word against Respondent's earlier word. The parties do not dispute that, after the initial meeting to discuss the personal matter, Respondent agreed to allow M. W. to order anabolic steroids using his DEA number and at the discounted price charged to OWC. The drugs that Respondent expressly allowed M. W. to order--and which he prescribed for her--were Winstrol and, a short while later, depo-testosterone. Respondent prescribed for M. W. Winstrol orally at the rate of 2 mg per day, increasing to 10 mg per day at the end of six weeks, and depo-testosterone by intramuscular injection, which Respondent administered initially at the rate of 50 mg every two weeks, increasing to 200 mg every two weeks. The parties do not contest that, in early summer 2009, M. W. ordered through OWC sufficient Winstrol and Deca-Durabolin for her weightlifting father and brother, with whom she lived, to complete one six-week bodybuilding cycle each with these two anabolic steroids. For her brother, the evidence establishes that M. W. ordered through OWC additional Winstrol and sufficient depo-testosterone for him to complete a second six- week cycle. The evidence is undisputed that M. W. administered the injections of Deca-Durabolin and depo-testosterone to her brother, Deca-Durabolin to her father, and Deca-Durabolin to herself. M. W. probably took additional Winstrol at home. The evidence is also clear that, in addition to ordering the Winstrol and depo-testosterone in quantities in excess of the amount that she was authorized to order and Deca-Durabolin without any authority whatsoever, M. W. also ordered--without authorization--Xanax, an anti-anxiety drug, and Soma, a muscle relaxant, possibly for her own use. Petitioner contends that Respondent knew or reasonably should have known of these unauthorized orders, but the evidence that Respondent knew is nonexistent, and the evidence that he should have known is insubstantial. There is little, if any, dispute that, unknown to Respondent, M. W. was using cocaine and heroin--by her own admission since early 1998. In late July 1999, Respondent was informed that M. W. had passed out at work. When Respondent spoke with her about this incident, M. W. admitted to the use of cocaine and heroin, most recently a couple of weeks earlier. Respondent immediately withdrew his authorization of M. W. to order supplies and medications for OWC and immediately discontinued further steroid treatment. Acting as M. W.'s employer, not physician, Respondent ordered M. W. to submit to a drug screen for Demerol, which had been missing from OWC,2 Valium, and cocaine. Three weeks later, he received the results, which were positive for cocaine. After giving M. W. an opportunity to discontinue illegal drug use, Respondent ordered M. W. to submit to another drug screen for Demerol, Valium, fentanyl, cocaine, and heroin, and the report, received in late August, was positive for cocaine and Valium. On September 22, 1999, M. W. was found dead in her home by her father. The first law enforcement officers responding to the 911 call reported that they had found a lifeless male dressed in woman's panties; this mistaken observation was based on M. W.'s muscularization and shadowy presence of facial hair. A homicide detective conducting an initial investigation found large quantities of syringes and prescription drugs, mostly steroids, in M. W.'s bedroom. He also found shipping labels and receipts with the names of OWC and Respondent. The parties have stipulated that the death was unrelated to steroid use. M. W.'s death was classified as a natural death. She was 30 years old. In resolving the major factual dispute--i.e., the purpose of the treatment--the Administrative Law Judge has assigned considerable weight to Respondent's earlier responses to law enforcement and regulatory inquiries. In these responses, Respondent never mentioned transgender treatment or gender identity disorder, but instead admitted that the treatment was to enhance athletic performance and to facilitate bodybuilding. In a written reconstruction of the medical records done prior to the commencement of this case, Respondent stated that he was "unable to locate [M. W.'s] chart so I will reconstruct her chart from memory. Last time chart was seen was June [19]99 which was given to [her]." The reconstructed chart shows three office visits: November 7, 1998, March 20, 1999, and June 26, 1999. None of the reconstructed notes mentions anything about lab work being ordered, the results of any lab work, or anything about an injured shoulder and whether it was healing. The entry for November 7 starts: "[Patient] request being placed on testosterone for body building. States she . . . is considering Pro-Wrestling." The notes indicate blood pressure of 118 over 64, pulse of 72, and nothing remarkable from a basic physical examination. The notes state: "Wants to body build; requests steroids." The notes report that Respondent prescribed Winstrol in 2 mg doses and explained the side effects, and Respondent was going to allow M. W. to order her steroid medication from the clinic's vendors. This entry concludes with a note for a followup visit in three months. The entry for March 20, 1999, states that M. W. had no complaints, reported getting stronger, and was happy with "bench," meaning bench-pressing, a form of weightlifting. This note states that M. W. denied experiencing any side-effects and wanted to add a second steroid: "Request to add Depo- Testosterone." The entry for June 26, 1999, notes that M. W. "feels good about herself and her outlook on life is much improved" and is "continuing to [increase] strength [with] weights." This note contains findings of a physical exam, including blood pressure of 124 over 78 and pulse of 72, and the note concludes that M. W. was doing well and Respondent planned to continue the same steroid regime. The other time that Respondent discussed the purpose of the treatment was when he was interviewed by a law enforcement officer on March 10, 2000, in the presence of Respondent's attorney. Respondent did not say anything about transgender treatment or gender identity disorder, and he was evasive when asked if he were M. W.'s physician. When asked if M. W. were ever a patient or just an employee, Respondent responded by referring to the incident when she passed out at work: "She now when you say she would ah the only time when she and I were upstairs that day. . . . And when she had the overdose." The law enforcement officer asked, "And that's like in August [1999]?" Respondent replied, "Yeah. The question was and I and I still haven't been able to define that because she asked me not to tell anybody about her problem with her drug habits and this type of scenario. So the question is whether or not she was a, whether or not honestly she was a patient of mine at that particular point in time."3 Shortly after this exchange, the law enforcement officer asked Respondent if the steroids that Respondent allowed M. W. to order through the OWC were for competitive purposes, such as weightlifting. Respondent replied, "we had a discussion about her wanting to . . . make it so that her, that she could work out harder because she was having some problems with her shoulders and these type of things "4 These reconstructed records and statements to a law enforcement officer were not casual statements uttered in an informal setting. This was information that Respondent provided to assist in the investigation of the circumstances surrounding the death of this 30-year-old woman. Except for mention of a shoulder injury in the last-cited statement--an effort by Respondent to convert the treatment objective from pure enhancement of athletic performance to a mix of enhancement of athletic performance and therapy for some undiagnosed shoulder injury--the information consistently implies that the treatment objective was to improve M. W.'s efforts in bodybuilding and weightlifting. And the mention of the shoulder injury suggests only that its healing was subordinate to the weightlifting and bodybuilding. The failure of the reconstructed records to contain any diagnostic information or progress reports on the injured shoulder precludes a finding that the treatment objective was to heal a shoulder injury. Respondent testified about the importance of confidentiality for his patients, especially M. W., as she was undergoing "gender transformation." But patient confidentiality is not an end in itself; it is a means to assuring that the patient will trust the physician with all relevant information necessary for diagnosis and treatment. Respondent implied that the requirement of patient confidentiality somehow trumped the duty not to affirmatively frustrate investigations into the death of his employee and patient. This makes no sense. Respondent's strained "explanation" for creating a misleading set of medical records yields to the simpler explanation that Respondent told the truth in these reconstructed records and in the police interview: Respondent was treating M. W. with steroids for bodybuilding and wrestling, not for gender transformation and not for an injured shoulder. These findings are supported by the fact that the first drug that Respondent prescribed M. W. was Winstrol. The anabolic effect of a steroid promotes muscularization, and the androgenic effect of a steroid promotes masculinization. Because Winstrol produces more anabolic than androgenic effect, it was long favored by females who wanted to produce muscle mass, such as for bodybuilding, without masculinization. Initiating treatment with Winstrol and following with depo- testosterone is a conventional example of the cyclical use of steroids for muscularization, not masculinization. One of Respondent's expert witnesses made an interesting observation based on the misidentification of the gender of the body of M. W. by the first responders. He testified that, if Respondent had been ordering the anabolic steroids for weightlifting and bodybuilding, M. W. must have been seriously dissatisfied with the masculinization that she had undergone. However, this observation overlooks the fact that M. W., without Respondent's knowledge, had administered to herself unknown quantities of the prescribed anabolic steroids and Deca-Durabolin. Like Winstrol, Deca-Durabolin is more anabolic, or muscle-making, than androgenic, or masculinizing-- which is consistent with M. W.'s intent to enhance her athletic performance and bodybuilding, not change her gender. Although the first responders observed some facial hair, in addition to muscularization, nothing in the record suggests that M. W. could take all of these anabolic steroids in unknown quantities without experiencing some masculinization, or that she expected no such masculinization side effects. Under these circumstances, M. W. could not legitimately have confronted Respondent over the incidental masculinization that she had experienced, while self-administered steroids whose main effect was muscularization, without running the risk that he would detect her unauthorized ordering of steroids. As noted above, there are no available medical records. Respondent testified that he gave M. W.'s medical chart and drug log "VIP" treatment to preserve confidentiality: Respondent allowed M. W. to keep her medical records and the drug log pertaining to her medications. Each time M. W. presented to Respondent, such as for an injection, she brought with her these files, according to Respondent. Petitioner contends that these records never existed, and, therefore, Respondent failed to document that he monitored the effects of the anabolic steroids that he ordered for M. W. The Administrative Law Judge credits Petitioner's version of the situation regarding medical records. At the hearing, Respondent characterized as a mere "sampling" the medical records that he had initially called a reconstruction. He implied that the reconstructed medical records were illustrative of what the records originally contained. This probably explains how he could reconstruct blood pressure readings of 118 over 64 and 126 over 78 taken six and nearly twelve months prior to the reconstruction of the records. Likely, he recalled that the values were normal and inserted these readings merely to illustrate his recollection. However, as noted above, these reconstructed records are significant for their omission of any similar illustrative reconstructions of an SBC for blood chemistry, SMAC 18 for electrolytes and kidney and liver function, and lipids for cholesterol and triglycerides. This lab work is essential, at the start of a course of treatment with anabolic steroids and periodically during treatment, to ensure the safety of any patient, especially when orally ingested anabolics--here, Winstrol--are administered, due to the possibility of liver damage. Respondent testified at the hearing that the lab results were normal, but, unlike his addition of illustrative, normal values for blood pressure and pulse, Respondent never added illustrative, normal values for this lab work. This is because he never ordered such lab work. These lab tests are common in a variety of circumstances, so they did not require the "VIP treatment" that Respondent claimed was required for the transgender treatment plan. However, Respondent never produced medical records or even lab paperwork, such as test results or invoices, documenting that these tests had been done. Also, if such records had existed and Respondent had allowed M. W. to keep them, one obvious place for them would have been in M. W.'s room at her home, but Respondent never sent anyone there to look for them after her death. As to the Standard of Care allegations, Petitioner has thus proved first, that Respondent prescribed steroids for M. W. both for muscle building (not to treat an injured muscle) and for enhancement of athletic performance; and, second, that Respondent did not order lab work to monitor the effects of the steroids that he prescribed for M. W. The evidence fails to establish that Respondent ever undertook the treatment of M. W.'s drug addiction (despite his statement to the contrary, which has been discredited). The evidence fails to establish the circumstances out of which a duty to treat could have arisen, especially within the brief time frame between Respondent's discovery of her drug problems and her death. Any evidence relevant to the remaining allegations within Count One involves the employer-employee relationship, not the physician-patient relationship, between Respondent and M. W. As to the medical records violation, Petitioner has proved that Respondent's medical records failed to adequately document the monitoring of the effects of anabolic steroids that Respondent prescribed for M. W. The evidence establishes the necessity of lab work, at the start and during steroid treatment, to ensure the safety of the patient. Without this lab work, documented in the medical records, the course of steroid treatment is not justified. The evidence fails to establish that Respondent delegated responsibilities to a person whom Respondent knew or reasonably should have known was not qualified by training, experience, or licensure to administered controlled substances to patients. Drug addiction is not a deficit in training, experience, or licensure. Even if drug addiction fell within one of these statutory categories, the evidence fails to establish any improprieties in M. W.'s administration of controlled substances to patients, and, even if the evidence proved such improprieties, the evidence fails to establish that Respondent knew of M. W.'s drug addiction at a point to have timely relieved her of her duties, or that Respondent reasonably should have known of M. W.'s drug addiction in time to do anything about it. To the contrary, Respondent's termination of these responsibilities of M. W. appears to have been timely. Petitioner has proved that Respondent prescribed and administered controlled substances--i.e., anabolic steroids--for muscle building, not the treatment of an injured muscle, and for enhanced athletic performance. Respondent has previously been disciplined. By Final Order entered on December 18, 2007, in DOAH Case No. 06-4288PL, the Board of Medicine imposed one year's suspension, a $10,000 fine, and three years' probation for failing to perform a third- trimester abortion in a hospital and failing to obtain the written certifications of two physicians of the necessity for the procedure; committing an associated medical-records violation; and committing a Standard of Care violation for failing to perform a third-trimester abortion in a hospital. Respondent's acts and omissions occurred in 2005. The Fifth District Court of Appeal affirmed the Final Order in Pendergraft v. Department of Health, Board of Medicine, 19 So. 3d 392 (Fla. 5th DCA 2009). By Final Order entered on January 28, 2010, in DOAH Case No. 08-4197PL, the Board of Medicine imposed two years' suspension, a $20,000 fine, and three years' probation for committing a Standard of Care violation for failing to a advise subsequent treating physicians that he had removed a portion of a patient's fetus and an associated medical-records violation. Respondent's acts and omissions occurred in 2006. Although Respondent has been disciplined prior to this recommended order, the acts and omissions in this case took place several years prior to the acts and omissions in the two cases described immediately above.
Recommendation It is RECOMMENDED that the Board of Medicine enter a Final Order finding Respondent guilty of violations of Section 458.331(1)(m), (t), and (q), Florida Statutes (1998), and suspending his license for one year followed by three years' probation, imposing a fine of $10,000, and assessing costs as provided by law. DONE AND ENTERED this 8th day of June, 2010, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 8th day of June, 2010.
