Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: At all times pertinent to this proceeding, respondent Robb E. Ross was a licensed physician engaged in the practice of family medicine as a sole practitioner. He was licensed to practice medicine in the State of Florida in 1966 and holds license number 12433. He was board certified in family practice in 1970. Respondent also holds a license as a pharmacist. Respondent treated patient N.B. from September of 1970 through October of 1986. She initially presented as a new patient moving into the area, aged 61, for maintenance of her general physical medical care, primarily relating to her mild depression that she had for years following a mastectomy. While believing that patient N.B. had previously been under the care of a psychiatrist or psychologist, respondent never requested her prior medical records. Patient N.B. informed the respondent that she had been taking Biphetamine, a steroid amphetamine that is no longer produced, for the past ten years. Respondent continued patient N.B. in that treatment modality for over ten years, as well as treating her for other complaints. At some point, he did attempt to titrate her from Biphetamine, but she did not function as well with a substitute drug. When the drug Biphetamine was phased out of the market in either 1980 or 1982, respondent prescribed Dexedrine to patient N.B. and continued to do so approximately every six months. Respondent maintained her on Dexedrine due to her mild depression and the fact that she had been on amphetamines for many, many years. He was reluctant to take her off Dexedrine for fear that she could become overtly depressed. Since she did well with Dexedrine, respondent maintained her on that regiment due to the adverse side effects of other compounds utilized to control depression. The respondent's medical records for patient N.B. contain virtually no patient history or background information. For each patient visit, there is a brief notation which includes N.B.'s temperature, blood pressure and weight and also a reason for the visit. The reason noted on the records are either "check- up" or a brief statement of the patient's complaint on that particular day. The medication prescribed is noted, though very difficult to read. While the symptom or patient complaint is often noted, the patient records contain no statements of medical diagnosis, assessment or treatment plan. It is not possible to determine from N.B.'s medical records the reason that Dexedrine was prescribed for this patient. While N.B. complained of tiredness, she did not suffer from narcolepsy. Patient G.B. was under respondent's care from August of 1979 through May of 1985. He initially presented, at age 56, with problems relating to emphysema, lung collapse, exhaustion, impotency and aches and pains. Respondent prescribed various medications for him, including Nitroglycerin for chest pains. Respondent felt that due to his age and his complaints, patient G.B. had some type of arteriosclerosis. Patient G.B. frequently complained of being weak, exhausted and having no endurance or energy. For this reason, respondent prescribed Dexedrine for him on March 30, 1984. Other medications to increase his energy were tried before this and after this time. Nothing appeared to give him any relief. After determining that patient G.B. "liked his medicine too much," respondent terminated his treatment of him. The respondent's medical records for patient G.B. are brief and difficult to decipher. Again, the patient's temperature, blood pressure and weight are recorded for each visit, and there is a brief statement of the patient's complaint. There is no statement indicating a medical diagnosis or a treatment plan. The medications prescribed at each visit are written on the records, but are difficult to read. D.M. was a patient under respondent's care from December of 1976 until his death, at age 84, in March of 1986. He initially presented with stomach problems and subsequently had a host of other medical problems, surgeries and hospitalizations throughout the years. This patient was given so many different medications for his various physical problems that respondent did not always write each of them down on his records after each office visit. It appears from respondent's medical records that he first started patient D.M. on Dexedrine in January of 1984. At that time, D.M.'s chief complaint was "dizziness, falling, no pep." Respondent maintained D.M. on Dexedrine or an amphetamine type of compound from that period until his death, primarily because of his weakness, dizziness, falling down and low blood pressure. Other specialists were consulted regarding D.M.'s fainting and falling episodes, caused by postural hypotension, and were unable to remedy the problem. Respondent was of the opinion that the administration of Dexedrine enabled patient D.M. to function more properly and that it worked better than anything else. Patient D.M. expired in March of 1986. Respondent listed the cause of death as "cardiac arrest." The respondent's medical records on patient D.M. are typical of those previously described for patients N.B. and G.B. The office visit notes list patient complaints or symptoms and no medical diagnosis or comprehensive assessments. There are indications in the record that D.M. complained of chest pains in 1983, 1984 and 1985. The medications prescribed indicate the presence of cardiac disease. Respondent's record-keeping with regard to patients N.B., G.B. and D.M. are below an acceptable standard of care. They fail to include an adequate patient history and initial assessment of the patients. It is impossible to determine from these records what medicines the patients had taken in the past, what reactions they had to such medications, what medical procedures they had in the past or other important information regarding the patient's background. The respondent's only notation of treatment is a listing, and a partial listing in the case of D.M., of medications prescribed. His remaining notations are not acceptable to explain or justify the treatment program undertaken. Dextroamphedimine sulfate, also known as Dexedrine, is a sympathomimetic amine drug and is designated as a Schedule II controlled substance pursuant to Chapter 893, Florida Statutes. Commonly, it is referred to as "speed" or an "upper." It is addictive and highly abusive. While individual patients react differently to Dexedrine, its consumption can cause psychosis, marked elevations of blood pressure and marked rhythmic disturbances. As such, its use is contraindicated in patients with coronary disease. In addition, because Dexedrine is an "upper" and makes a patient "feel good," it can mask a true physical condition and prevent the patient from being treated for the physical ailment he is experiencing. A patient should not be relieved of pain without first knowing what is causing the pain. In Florida, Dexedrine may only be prescribed, administered or dispensed to treat specifically enumerated diseases, conditions or symptoms. Section 458.331(1)(cc), Florida Statutes. Neither respondent's medical records nor his testimony indicate that patients N.B., G.B. and/or D.M. suffered from the conditions, symptoms or diseases which warranted the statutorily approved and limited use of Dexedrine. Respondent was not aware that there were statutory limitations for the use of Dexedrine. He is aware of the possible dangers of amphetamines and he prescribes Dexedrine as a treatment of last resort when he believes it will help the patient. Respondent further testified that his medical record-keeping is adequate to enable him, as a sole practitioner, to treat his patients, though he admits that his medical records could be improved.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that respondent be found guilty of violating Section 458.331(I), subparagraphs (cc),(q),(t) and (n), Florida Statutes, and that the following penalties be imposed: an administrative fine in the total amount of $2,000.00, and probation for a period of twelve (12) months, with the following conditions: (a) that respondent complete continuing medical education courses or seminars in the areas of medical record-keeping and the dangers and authorized use of compounds designated as Schedule II controlled substances, and (b) that respondent submit to the Board on a monthly basis the medical records of those patients for whom a Schedule II controlled substance is prescribed or administered during the probationary period. Respectfully submitted and entered this 2nd day of September, 1987, in Tallahassee, Florida. DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of September, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-3483 The proposed findings of fact submitted by counsel for the parties have been carefully considered. To the extent that the proposed factual findings are not included in this Recommended Order, they are rejected for the following reasons: Petitioner: The 48 proposed findings of fact submitted by the petitioner consist of summaries or recitations of the testimony of the witnesses presented by the petitioner in this proceeding. While the summaries and/or recitations constitute an accurate representation of the testimony received by those witnesses at the hearing, and are thus accepted, they do not constitute proper factual findings by themselves. Instead, they (along with the testimony presented by the respondent) form the basis for the findings of fact in this Recommended Order. Respondent: Page 4, Paragraph 1 The reference to 30 years is rejected as contrary to the evidence. COPIES FURNISHED: David E Bryant, Esquire Alpert, Josey, Grilli, Paris and Bryant 100 South Ashley Drive Suite 2000 Tampa, Florida 33602 David J. Wollinka, Esquire P. O. Box 3649 Holiday, Florida 33590 Van Poole, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Joseph A. Sole, General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32399-0750 =================================================================
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Respondent on the basis of charges set forth in a three-count Administrative Complaint. The Administrative Complaint charges the Respondent with violations of paragraphs (m), (q), and (t) of Section 458.331(1) Florida Statutes.1
Findings Of Fact At all times material to this case, the Respondent, Donald A. Tobkin, M.D., has been licensed, and continues to be licensed, to practice medicine in the State of Florida. His license number is 30942.5 Sometime during the month of December 2004, the Police Department of Hollywood, Florida, (HPD) received information from a confidential informant that the Respondent was soliciting drug-prescribing business and was writing inappropriate and excessive prescriptions for controlled substances. On the basis of that information, the HPD initiated an undercover operation to investigate the information received from the confidential informant. As part of the undercover investigation, on the evening of January 20, 2005, at approximately 9:56pm, an HPD female detective named Nicole Coffin made a telephone call to the Respondent's telephone. The Respondent answered the telephone and identified himself by name. Detective Coffin pretended to be a person named Melissa Beech. She pretended to be a person who was seeking to obtain OxyContin, which is a Schedule II controlled substance. During the entire undercover investigation, Detective Coffin pretended to be a drug-seeker while interacting with the Respondent. On the telephone she told the Respondent that she wanted a prescription for OxyContin and also told the Respondent that a girl somewhere on Federal Highway had given her the Respondent's card and had told her she could call the Respondent if she needed a prescription. Detective Coffin, in her role as Melissa Beech, did not initially describe any medical complaint to the Respondent; she just said she wanted a prescription for OxyContin. In response to the request for a prescription for OxyContin, the Respondent told the make-believe drug-seeker that he could provide the requested prescription, but that they would have to have a "medical reason" for such a prescription. The Respondent then asked the make-believe drug-seeker if she had ever been in an automobile accident. The make-believe drug-seeker answered "yes," because that is the answer she thought would provide a basis for a "medical reason." The Respondent then proceeded to ask the make-believe drug-seeker a long series of leading questions which, if answered "yes," could provide the appearance of a "medical reason" for the requested prescription for OxyContin. This series of questions was for the purpose of establishing a contrived "medical reason" for the prescription sought by the make-believe drug-seeker. There never was, and there never appeared to be, any real "medical reason" for the prescription sought by the make-believe drug-seeker. The sole purpose for the many questions asked by the Respondent, and for the Respondent's written notations related to those questions, was to create the illusion, or the false impression, that there was a "medical reason' for the prescription when, in fact, there was no such reason. The detective who was pretending to be a drug-seeker answered "yes" to all of the leading questions asked by the Respondent. She answered "yes," even when that was not a truthful answer, because she was trying to give the answers she thought the Respondent wanted to hear.6 The Respondent's leading questions included questions asking about such things as whether the make-believe drug-seeker had ever had an automobile accident, whether she had suffered a herniated disk as a result of that accident, whether she had had an MRI, whether she had had any subsequent accidents, whether she had tried any other drugs to relieve pain, whether she had used Oxycontin in the past, and whether in the past the Oxycontin had relieved her pain. During the course of the first telephone conversation between Detective Coffin and the Respondent a number of significant matters were not discussed. The Respondent did not discuss the possibility of surgical treatments to treat the back pain described in response to the Respondent's questions. The Respondent did not discuss the necessity of reviewing the MRI or X-rays that supposedly would confirm the "herniated disc" he had inquired about. The Respondent did not discuss the necessity of obtaining future MRIs, X-rays, or other diagnostic tests to evaluate the "severe back pain" supposedly described by Detective Coffin in her role as Melissa Beech. The Respondent did not mention that she would need to have any follow-up visits with the Respondent. During the course of the first conversation between Detective Coffin and the Respondent, she told the Respondent that she had previously been obtaining Oxycontin "off the street" and that she was seeking a prescription from the Respondent because her street source had "dried up." She also told him that she had previously taken Valium and Percocet. During the course of the first telephone conversation Detective Coffin, pretending to be a drug-seeker, told the Respondent that she suffered from back pain as a result of the make-believe automobile accidents. She did not say that she was currently experiencing pain at the time of that telephone conversation. During the first telephone conversation the Respondent did not ask the make-believe drug-seeker any questions about her menstrual cycle, about whether she was pregnant, or about whether she had had any prior pregnancies or had ever had any children. However, in his written notes the Respondent included notations that purport to be answers to those unasked questions. Similarly, the Respondent did not ask the make-believe drug-seeker any questions about her consumption of alcohol, but included in his notes notations that purport to memorialize the answer to that unasked question. The Respondent's "history" notes also report that he warned the make-believe drug-seeker that OxyContin tablets should not be crushed or broken, even though he did not include any such warning in his telephone conversation with the make-believe drug-seeker. During the first telephone conversation, Detective Coffin was never asked about, and never provided any information about, whether other physicians had either prescribed OxyContin for her or had refused to prescribe OxyContin for her. The only prior sources of OxyContin she mentioned to the Respondent were non-prescription illegal sources on the street. The Respondent never discussed with Detective Coffin the possibility or necessity of a more structured medical treatment plan for addiction. The Respondent never discussed with Detective Coffin the possibility or necessity of a more structured medical treatment plan to treat a complaint of "severe pain." During the course of the first telephone conversation, the Respondent agreed to provide a prescription to the make- believe drug-seeker for a total of sixty-two 80-milligram OxyContin tablets. It was agreed that the make-believe drug- seeker would pay $100.00 for the first prescription and that the Respondent would provide similar prescriptions in the future for $50.00 per prescription. Towards the end of the first telephone conversation the Respondent told the make-believe drug-seeker that he had another matter to attend to and that she should call him later to arrange the time and place for the two of them to meet later that same evening. During the course of the first telephone conversation, which lasted for approximately 14 minutes, the Respondent made written notes of the answers given by the make-believe drug-seeker. Those notes were prepared in such a manner as to resemble the types of notes customarily made by physicians who are making a medical record of information elicited from a patient. A number of the details recorded in the Respondent's notes of the first telephone conversation were inconsistent with the information provided by the make-believe drug-seeker. Specifically, those notes contained a significant amount of information that was never uttered by the make-believe drug- seeker. The fictitious and false history details memorialized in the Respondent's notes are intentional falsehoods. Later that evening, at approximately 12:20am on January 21, 2005, Detective Coffin, still pretending to be the drug-seeking person named Melissa Beech, placed a second telephone call to the Respondent. She spoke with the Respondent for about three minutes on this occasion. Most of the second conversation consisted of providing the Respondent with information about the location where Detective Coffin would be waiting for him and information about where the Respondent should park when he arrived. Law enforcement officers of the HPD attempted to record both of the telephone conversations between the Respondent and Detective Coffin. Both of those attempts were unsuccessful. There is no recording of either of the telephone conversations. Sometime later that evening, during the early morning hours of January 21, 2005, the Respondent met the make-believe drug-seeker at the motel or efficiency apartment. He entered the room where the make-believe drug-seeker was pretending to be staying. Prior to his arrival, two cameras had been concealed in the room by the HPD police officers. During the entire time the Respondent was in the room the two cameras were attempting to record everything he said and everything he did, as well as everything said or done by the detective pretending to be the drug-seeking person named Melissa Beech. After entering the room, the Respondent spoke with the make-believe drug-seeker and asked her additional questions related to her request for a prescription for OxyContin. He made some written notes that purported to be summaries of her answers. During the course of the meeting with the make-believe drug-seeker the Respondent provided her with a document titled "Patient's Acknowledgement," which she signed, but did not read. That document contained information about the patient-physician relationship, about what was expected of the patient, and also memorialized the patient's informed consent to the treatment she was requesting from the Respondent. The Respondent also conducted a brief physical examination of the make-believe patient and made written notes that purported to be a memorialization of what he had observed during the course of his examination. The Respondent's examination of the make-believe drug-seeker included the following: check of pulse and blood pressure, check of reflex responses at several joints, and check of chest sounds with stethoscope. The Respondent performed a deep tendon reflex test on Detective Coffin by striking her wrists, elbows, and knees with a medical hammer. Detective Coffin's feet remained on the floor during this test. A deep tendon reflex test cannot be performed properly with the subject's feet touching the floor. Such a test performed in such a manner will not produce reliable results. The Respondent indicated in his written notes that he had examined Detective Coffin's head, eyes, ears, nose, and throat. However, the Respondent did not perform any examination at all of Detective Coffin's head, ears, nose, or throat. The Respondent perhaps performed a partial examination of Detective Coffin's eyes, but did not perform an adequate examination of her eyes. The Respondent indicated in his written notes that Detective Coffin's pupils were equal, round, and reactive to light and accommodation. However, the Respondent did not conduct any examination of Detective Coffin's eyes that was sufficient to support a conclusion that they were equal, round, and reactive to light and accommodation. The Respondent included in his written notes that Detective Coffin's chest and lungs were clear to auscultation and percussion. The Respondent did not examine Detective Coffin in a manner that could determine whether her chest and lungs were clear to auscultation and percussion. Therefore, the Respondent did not have any basis for writing that the detective's chest and lungs were clear to auscultation and percussion. The Respondent included in his written notes an observation that Detective Coffin's abdomen was soft. The Respondent never touched or otherwise examined Detective Coffin's abdomen. The Respondent had no factual basis for writing that Detective Coffin's abdomen was soft. In his written notes the Respondent indicated that Detective Coffin experienced pain upon lifting her leg thirty degrees. Detective Coffin never raised either leg in the Respondent's presence and never complained of pain in his presence. There was no factual basis for the subject notation. The Respondent never conducted a Rhomberg examination on Detective Coffin, but he included in his written notes an observation that a Rhomberg test was negative. There was no factual basis for such a notation. The Respondent included in his written notes an observation that he had examined Detective Coffin's gait. However, the Respondent never performed an adequate and sufficient examination of Detective Coffin's gait. The Respondent did not conduct a range of motion test of Detective Coffin. The Respondent never asked Detective Coffin to lift her leg towards her chest. Nor did he ask her to touch her toes. The Respondent never asked her to manipulate her body in any way. At no time during the encounter between Detective Coffin and the Respondent did Detective Coffin state that she was experiencing pain. At no time during that encounter did she behave or move in any manner that would suggest she was experiencing pain. To the contrary, Detective Coffin crossed and uncrossed her legs, alternatively slouched and sat up straight in her chair, and made other movements that would indicate to a reasonable prudent physician that she was not experiencing any pain at all. The Respondent never discussed with Detective Coffin the necessity of obtaining further MRIs, X-rays, or other forms of diagnostic testing. He never discussed any need to obtain and review any prior medical records. The Respondent never asked Detective Coffin to sign a medical records release document that would have authorized the Respondent to obtain prior medical records. The Respondent's written notations regarding his examination of the make-believe drug-seeker contain false information because, among other things, the notations contain the results of tests and examinations the Respondent did not perform. Such false notations are intentional falsehoods. The Respondent never discussed with Detective Coffin the need for a follow-up appointment. The Respondent never asked Detective Coffin for any form of identification. Under the circumstances presented in this case, a reasonable prudent physician would have performed a range of motion test and a leg-raising test, neither of which were performed by the Respondent. Under the circumstances presented in this case, a reasonably prudent physician would have established a treatment plan that would have included a schedule for follow-up visits, a review of prior medical records, and plans for future diagnostic tests. The Respondent did not establish any type of treatment plan. The prescription provided to Detective Coffin was inappropriate, unjustified, and excessive because the physical examination was inadequate, the medical record was falsified, and the patient never exhibited any sign of being in pain. Under the circumstances presented in this case, the Respondent's act of providing a prescription to a total stranger with no medical justification for doing so was an action taken other than in the course of the Respondent's professional practice. Ultimately, the Respondent wrote and delivered a prescription to the make-believe patient. The prescription was for sixty-two 80-milligram tablets of OxyContin. This was a 31- day supply if the OxyContin was taken as directed; one tablet every 12 hours. The Respondent wrote several warnings at the bottom of the prescription document. The warnings included such things as the fact that OxyContin impairs driving ability and may cause drowsiness, loss of balance, and/or loss of coordination. The Respondent also wrote on the prescription: "Must swallow whole and do not crush or break." Other law enforcement officers of the HPD were listening to and observing the events inside the room. Shortly after the Respondent handed the prescription to the make-believe patient and received the one hundred dollars from her, other law enforcement officers rushed into the room, arrested the Respondent, and seized various items of the Respondent's personal property, including the medical record he had been preparing regarding his care and treatment of the make-believe patient. With regard to obtaining information about the characteristics of, and the proper use of, specific drugs, medical doctors customarily rely on the information contained in the Physician Desk Reference (PDR) and on the information contained in the manufacturer's package insert that often accompanies a drug. The package insert for OxyContin includes the following information: (Following an initial caption reading WARNING) OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the- clock analgesic is needed for an extended period of time. * * * (Following caption reading CLINICAL PHARMACOLOGY) Oxycodone is a pure agonist opioid whose principal therapeutic action is analgesia. *** With pure opioid agonist analgesics, there is no defined maximum dose; the ceiling to analgesic effectiveness is imposed only by side effects, the more serious of which may include somnolence and respiratory depression. * * * As with all opioids, the minimum effective plasma concentration for analgesia will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids. As a result, patients must be treated with individualized titration of dosage to the desired effect. The minimum effective analgesic concentration of oxycodone for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome and/or the development of analgesic tolerance. * * * OxyContin Tablets are associated with typical opioid-related adverse experiences. There is a general relationship between increasing oxycodone plasma concentration and increasing frequency of dose-related opioid adverse experiences such as nausea, vomiting, CNS effects, and respiratory depression. In opioid-tolerant patients, the situation is altered by the development of tolerance to opioid-related side effects, and the relationship is not clinically relevant. As with all opioids, the dose must be individualized . . . because the effective analgesic dose for some patients will be too high to be tolerated by other patients. (Following caption reading WARNINGS) OxyContin 80 mg and 160 mg Tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. These tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids. * * * Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. The development of addiction to opioid analgesics in properly managed patients with pain has been reported to be rare. However, data are not available to establish the true incidence of addiction in chronic pain patients.
Recommendation On the basis of the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be issued in this case to the following effect: Dismissing Counts One and Two of the Administrative Complaint; Concluding that the Respondent is guilty of having violated Section 458.331(1)(q), Florida Statutes, as charged in Count Three of the Administrative Complaint; and Imposing a penalty consisting of an administrative fine in the amount of ten thousand dollars ($10,000.00) and the revocation of the Respondent's license to practice medicine. DONE AND ENTERED this 26th day of June, 2006, in Tallahassee, Leon County, Florida. S MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of June, 2006.
Findings Of Fact At all times pertinent to the issues herein, the Board of Medicine was the state agency responsible for the licensing of physicians and the regulation of the practice of medicine in this state. Respondent was licensed as a physician in Florida and holds license number ME 0017915. He practices medicine, specializing in psychiatry, in Clearwater, Florida. He is board certified in that specialty. On September 7, 1987, Patient #1, a 55 year old married female, whose husband had recently separated from many years in the armed service of the United States, came to see Respondent at his office, complaining of severe headaches, loneliness, depression, and a lowering of self esteem. She had been referred to him by physicians at the U.S. Coast Guard Station Dispensary. Respondent examined Patient #1 and found her to be of limited intelligence, considerably overweight, anxious, depressed and confused. She was ashamed of her new status in life as a result of her husband's inability to find work and was experiencing difficulties with him and her children. She was suffering from severe insomnia. Respondent's examination of Patient #1 was limited. He was satisfied with the medical work-up which had been conducted by his colleagues at the Dispensary. Because he was consulting psychiatrist for that facility, he knew all the physicians there and was familiar with the caliber of their work. Based on the medical information furnished him from the Dispensary and his own examination, he diagnosed Patient #1 as suffering a major depression and a psychogenic pain disorder manifested by headaches and insomnia. He developed a treatment plan for the patient which included a wide variety of psychotherapy interventions, the first of which was to effect relief of the symptoms. This included clarification of relationships, interpretation of dreams and fantasies, and allowed for catharsis. When Respondent found out that empathy and intervention alone would not work on this patient, and he had established a relationship with her, he started psychotropic medications including Elavil, the drug of choice for this type of condition in 1988. Elavil is a "superb" antidepressant. While the antidepressant factor is "cranking in", the medication also works as a sedative. For this reason, it is normally prescribed for administration at bedtime. Patient #1 responded to this course of treatment and she and the Respondent established a good and friendly working relationship, which he noted in his April 4, 1988 letter and treatment report to the Coast Guard and to CHAMPUS. In that treatment report, however, Respondent noted Patient #1 had a suicidal ideation. The term "suicidal ideation" does not import that the patient was, at that time, seriously considering suicide. Her mentioning suicide was but an overcompensation - more an alerting statement of depression and sadness with emptiness and angst. She never indicated to Respondent any thought of or plan to commit suicide. Patient #1 thrived for many months in Respondent's therapy. She complained often of her impoverished condition, however, and as a result, he wrote prescriptions for her in such a way that they could be filled at the Coast Guard dispensary without charge. This required writing prescriptions for more tablets of a drug at a lower strength which was stocked by the Dispensary. It was a surprise to him to learn, later on, that she was filling her prescriptions at Eckerds. Throughout the period he treated her, Dr. Fireman prescribed psychotropic drugs for Patient #1, which consisted primarily of amitriptyline, (Elavil), and butalbital, (Fiorinal), in varying strengths, and, at times, in compounds with other substances. As was noted previously, Elavil is an antidepressant with sedative effects. The recommended daily dose for a patient in an outpatient setting is indicated as 150 mg by the Physicians' Desk Reference, (PDR), which also recommends suicidal patients not be allowed unrestricted access to it because of the danger of intentional overdose. Other qualified psychiatrists who testified, including Dr. Spreyhe and Dr. El Yousef, indicate up to 300 or even 350 mg/day may be appropriate. As Dr. Spreyhe noted, it is not so much the daily dose on any given day which is pertinent but the aliquot over an extended period. In that regard, he notes, Dr. Fireman's prescriptions for both Elavil and Fiorinal were within recommended maximums and, therefore, within the appropriate standard of care. Fiorinal is a barbiturate anti-anxiety agent and muscle relaxant with habit forming potential. Fiorinal #3 contains codeine, a legend drug and narcotic. Generally, according to Dr. El Yousef, it should be dispensed for use at a rate of between 8 to 12 tablets per day over the short term, but over a 9 month period he would prescribe between 4 and 9 tablets per day. Pharmacy records indicate that over the period he treated patient #1, Respondent gave her numerous prescriptions for both Elavil and Fiorinal which, at first glance, appear to be excessive. For example, the records reflect that on December 29, 1987, Respondent wrote prescription number 390073 for 100 Elavil 25 mg tablets. Though the prescription clearly indicates no refills were authorized, and the back of the prescription form, where refills are noted by the pharmacist, fails to reflect any refills were authorized by the physician, the pharmacy records indicate two additional dispensings by the pharmacy for 100 tablets each on January 11 and April 20, 1988. There is no evidence to indicate how these additional fillings came about; who arranged for them, or who received them. On February 22, 1988, Respondent wrote prescription number 394289 to the patient for 12 Fiorinal #3 tablets. Again the prescription form authorizes no refills and the back of the prescription form indicates but one coordinated refill but the pharmacy records show the prescription was filled twice - once on April 6, 1988 and once on April 23, 1998. Only the latter is annotated. On March 3, 1988, Respondent wrote prescription number 397144 to the patient for 60 Fiorinal tablets. While the doctor's refill note reflects none were allowed, the computer printout sticker for the bottle reflects 2 refills were authorized. The back of the prescription form shows no refills annotated thereon as required, but the pharmacy's computer listing of all prescriptions indicates the prescription was refilled on May 28 and again on June 3, 1988. No further explanation is given. Prescription number 396378, written to the patient by Respondent on March 14, 1988 for 50 Fiorinal tablets, reflects no refills authorized by the physician nor does the reverse of the form bear any refill annotations. Nonetheless, the pharmacy records as shown on the computer printout indicates a refill on March 27 and April 6, 1988 with no explanation therefore. Before the last refill, however, Respondent wrote prescription number 397091 to the patient on March 29, 1988, for 21 Fiorinal #2, later approved for #3's. He also, on April 4, 1988, wrote prescription number 398853 for 35 Fiorinal tablets. Respondent claims he would not authorize a refill of a prior prescription for the same medication for which he is writing a new prescription, and, since neither of the refills of the earlier prescription properly reflect any physician authorization, it is so found. On May 2, 1988, Respondent wrote prescription 399717 for 50 Fiorinal tablets, and prescription 399718 for 100 Elavil 25 mg tablets. Both reflect Respondent's instruction that no refill be given, and neither form bears an annotation for authorized phone refills. Yet, the pharmacy's computer printout indicates that the prescription for Elavil was written on May 31, 1988 even though the bottle sticker shows it was filled on May 3, 1988. On August 1, 1988, Respondent wrote prescription 405572 for 100 Fiorinal and 475573 for 100 Elavil 100 mg tablets. Both were filled the next day but neither form bears any annotation of authorized refill, consistent with the physician's instructions. On August 16, 1988, Respondent prescribed another 100 Fiorinal by Prescription 406536. It was not refilled. On August 29, 1988, Respondent wrote prescription 407201 for 150 Elavil 50 mg tablets to patient #1, and number 407202 for 100 Fiorinal tablets. Both prescription forms clearly reflected no refills, but the back of the forms reflect refills were authorized. The Elavil prescription was refilled on September 10, 1988 by pharmacist Ivan Funkhouser who contends he refilled on the basis either of a call to or from the doctor's office. He cannot recall which. He also, at the same time, refilled the Fiorinal prescription under the same conditions. The Elavil prescription was filled again, this time for 225 tablets, on September 30, 1988, by pharmacist Robert Wivagg who also indicated phone refills made only on the basis of a call to or from the physician's office. In this case, however, he believes that because of the amounts involved, he would have spoken to the physician himself before filling the prescription. He cannot be sure of this, however, and Respondent denies having ever prescribed 225 Elavil tablets, regardless of strength, at one time. Mr. Lewis, the pharmacy expert, indicates that proper pharmacy practice would have allowed the pharmacist to issue fewer tablets than on the prescription but not more without express approval of the physician. The Fiorinal prescription, refilled on September 30, 1988, this time for 150 tablets, is not reflected on the prescription form though it is on the computer printout. Respondent denies that he ever called in prescriptions for Patient #1 because he never had to. She came to his office frequently enough that he was able to provide her with a new prescription for whatever medication she needed. Indeed, his medical office billing records reflect that in June, 1988 he saw her on June 6, 13, 20, and 27; in July, 1988 on July 5, 12, 19, and 26; and in August, 1988, on August 2, 9, 16, and 30. It would appear, therefore, that the refills of prescriptions reflected on the pharmacy computer printout either are in error or were arranged for under some unexplained process not involving Respondent. There appears to be no reason for him having had to authorize refills since he saw the patient so frequently, notwithstanding his comments to Ms. Sutton, during the investigation, that 90 percent of the refill calls are authorized by him personally, and only 10 percent through his secretary. There was no showing that the authorization comment Ms. Sutton recalls was related to this particular patient. Further, according to Ms. Maguire, Respondent's secretary, Respondent frequently refuses to grant refills, and, to her knowledge, he never gives refills to psychiatric patients. Since most, if not all Respondent's patients are psychiatric patients, this does not make sense. Respondent does not deny writing the two prescriptions on August 29, 1988. At that particular time patient #1 was planning a trip to New York to make peace with her dying mother. As a result, and since her headaches had gotten worse, as had her depression, he decided to increase her dosage of Elavil. This was a medical decision which is not in issue here. He admits that Elavil is a drug which is often used to commit suicide and that prescribed at even its lowest strength, a full prescription can be lethal. This became, therefore, an assessment problem wherein Respondent, the physician, had to evaluate the risk of the patient's depression against the benefits to be gained by the use of the drug. Respondent gave patient #1 enough Elavil to hold her through her visit up north. He had previously given her sixty 50 mg tablets to be taken 6 per day for a 300 mg dose at bedtime. He now told her not to use the 50 mg tablets any more and to destroy them. He believed she did. He then gave her a new prescription for one hundred and twenty 25 mg tablets for her trip. He unequivocally states that he never prescribes more than 300 mg/day of Elavil. He admits, however, that while she was on that dosage, he neither hospitalized her nor had blood work done on her. Respondent feels his original treatment plan and diagnosis were sufficient and his records pertaining to those factors were adequate. He uses checkoff forms because he believes they are the most open way of showing how he sees his patient and what he is doing for her. This same conclusion was reached by Dr. Spreyhe, another Board certified psychiatrist who is Clinical Professor of psychiatry at the University of South Florida Medical School, who has served as an expert witness for the Department in the past, and who continues to serve as a contract consultant for it and as a member of the Medical Advisory Committee of the Department. Examination of Respondent's medical records pertaining to Patient #1 indicates that the medical history and treatment plan are in the form of check sheets on which the physician makes no more than minimally worded entries. The Department's witness, Dr. Greener, an expert in the completeness of medical records, is of the opinion that Respondent's records should have reflected an initial detailed assessment of the patient's condition, including the reasons for her referral to him, a complete medical history, and a subsequent detailed mental status examination. This should be followed by a formulation of her problems and a treatment program. After the initial evaluation, according to Dr. Greener, the physician should make regular progress notes as to treatments, communications with others, phone calls received, prescriptions issued, and matters of that nature. This is done to memorialize the particulars for the patient and to keep a tally of which and how much of any drug is given to the patient. This would show over or under use as a possible flag as to how well the patient follows instructions or if the patient develops a use addiction problem. Based on Dr. Greener's review of Respondent's records for patient #1 and the prescription records relevant to her, he concluded those records were "totally inadequate." This conclusion is based on his opinion that the initial evaluation is cursory and without detail and there are few progress notes in the records. Those which are there are inadequate in detail and full of conclusions without the required supporting information such as drug side-effects, the patient's ability to follow instructions, follow-up, changes in dosages, and the like. He complains that Respondent's records do not really outline a plan of treatment designed specifically for that patient. For example, the forms used by Respondent are merely check-off forms even though, during the period, the patient was receiving continuing analgesic medications. From Respondent's records, it was impossible to determine how the patient was doing on the medications prescribed or whether additional medical evaluation was required. It is important to put this information in patient records to memorialize what is done and not just to keep the information in the treating physician's memory. Respondent denies that his initial evaluation and treatment plan, prepared by the use of form check sheets, is below standard. Dr. Spreyhe concluded the use of such check sheets is not inappropriate for the initial work-up of a patient and he opined that Respondent's forms, and the information thereon provide sufficient information for an independent understanding of the patient's situation and are within an appropriate standard of care. It is so found. However, the medical progress notes which make up the bulk of the remaining medical records are not so complete and, in Dr. Spreyhe's opinion are insufficient. Respondent concurs and admits this. It is so found. As to Respondent's prescribing practices, Dr. Greener is far more conservative than Respondent in prescribing Elavil. He starts with a low dose and gradually works up to a therapeutic level dosage depending upon the patient. He would start an average patient out at 25 mg/day and work up to a maintenance dose of 150 mg/day. Elavil is a dangerous drug and the doctor must closely monitor the patient for possible side effects and the direct effect it is having on the patient. It should never be ordered "prn", (as needed) when that designation relates to the amount to be taken. Based on Respondent's records for this patient, it would appear to Dr. Greener that the medication was being used improperly. There appears to have been no monitoring of the amount of the drug the patient was getting and it would appear that the patient was given the prerogative as to dose, which is not a good thing to do. In his opinion, a dose at 300 mg/day of Elavil is very and unnaturally high and he would not use so high a dose. He would do other tests first to see why the medication was not working at the lower dosage. As was seen before, however, other physicians of equal expertise disagree. Fiorinal is habit forming and, according to Dr. Greener, should be used only over the short term. If needed for a longer period, the patient should be reviewed to see why. The doctor must keep in mind the addictive properties of the drug. Here, Dr. Greener is of the opinion that Respondent prescribed excessive amounts of Fiorinal for patient #1. From January 27, 1988 through March 2, 1988, a period of 34 or 35 days, Respondent prescribed 302 tablets and Dr. Greener would be concerned that the patient was addicted. On March 21, 1988 Respondent prescribed another 50 tablets, and on March 27,1988, he prescribed 50 more followed by another 60 somewhat later and more after that. All of these were being prescribed for a patient whose records reflect she was doing "OK", and was "nicely stabilized". To Dr. Greener, this is just too much, especially for a patient who is obviously addicted and who appears to be taking the medication only to prevent withdrawal symptoms. By his prescription regimen, a patient would get no more than 10 tablets a day for no more than 4 to 5 days, and he would prescribe this drug for 9 months, as here, only with support for it in the patient records, including the opinions of other specialists to whom the patient would have been referred. While it is obvious Dr. Greener is more conservative in his approach to medication than is Respondent, the evidence does not clearly show Respondent's approach fell below standards. Dr. Spreyhe is of the opinion that the levels of Elavil and Fiorinal prescribed by Respondent for this patient were appropriate in both dosage and amounts. He has patients of his own who take such doses and he is not swayed by the PDR recommendations for dosage which, he believes, is too conservative. As for the Fiorinal, he would prescribe no more than 8 per day because there is some information that a patient may develop a tolerance for the substance. In any case, the drug is appropriate for the treatment of psychogenic headaches as were suffered by Respondent's patient here. Both W.L.P. and M.J.S. have been patients of Respondent. Both found him to be concerned and available. When patient #1 died, Ms. Sherman was in a therapy group with her. She did not appear to be suicidal and was looking forward to her proposed trip to New York. Patient #1 died on October 8, 1988. The report of the Hillsborough County Medical Examiner reflected her death as suicide from the combined effects of amitriptyline, (Elavil), butalbital, (Fiorinal), and salicylate.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that a Final Order be issued herein, finding Respondent not guilty of all allegations except those relating to his failure to keep adequate medical records regarding Patient #1 as alleged in Count One, of which he is shown to be guilty, and imposing an administrative reprimand and a requirement for continuing medical education in the area of proper record keeping. RECOMMENDED this 31st day of August, 1994, 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 31st day of August, 1994. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 93-5048 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. & 2. Accepted and incorporated herein. 3. - 6. Accepted and incorporated herein. 7. Accepted as a restatement of witness testimony but not as a Finding of Fact. 8. Accepted as a restatement of witness testimony but not as a Finding of Fact. 9. & 10. Accepted that the medications were dispensed based on prescriptions written under the patient's name. 11. & 12. Accepted and incorporated herein. 13. & 14. Accepted as a restatement of witness testimony. - 18. Accepted and incorporated herein. Rejected as not a necessary conclusion to be drawn. Accepted. - 23. Accepted as restatements of witness testimony. Accepted and incorporated herein. - 26. Accepted and incorporated herein as pertaining to the dosage level of Elavil used and the balance accepted as a restatement of witness testimony. Accepted and incorporated herein. Accepted as a restatement of witness testimony. Accepted and incorporated herein. Accepted. & 32. Rejected as Findings of Fact, and found to be Conclusions of Law. FOR THE RESPONDENT: Accepted and incorporated herein. - 4. Accepted and incorporated herein. - 7. Accepted and incorporated herein. Accepted and incorporated herein. - 12. Accepted and incorporated herein. 13. & 14. Accepted. 15. & 16. Accepted and incorporated herein. 17. & 18. Accepted. 19. & 20. Accepted and incorporated herein. 21. Accepted. 22. This Proposed Finding of Fact is, in reality, a restatement of the evidence presented, in several subparagraphs, some of which are identified by letter and some of which are not. It is, however, accepted as an accurate restatement of the evidence admitted at hearing on this point, except where it becomes argument. 23. & 24. Accepted and incorporated herein. 25. First four sentences accepted and incorporated herein. Balance considered only as argument in support of the position taken. 26. Accepted and incorporated herein. 27. Accepted. 28. Rejected as a Conclusion of Law and not a Finding of Fact. 29. - 31. Accepted as basic findings. This does not go to their adequacy, however. 32. & 33. Rejected as contra to the weight of the evidence. & 35. Accepted as the substance of the witness' testimony. Accepted and incorporated herein. Accepted. Accepted. Rejected as a Conclusion of Law. COPIES FURNISHED: Steven Rothenberg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard Suite 210 Tampa, Florida 33619 Bruce D. Lamb, Esquire Christopher J. Schulte, Esquire Shear, Newman, Hahn & Rosenkranz, P.A. Post Office Box 2378 Tampa, Florida 33601 Harold D. Lewis, Esquire Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Dr. Marm Harris Executive Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
Findings Of Fact At all times material hereto, Respondent has been licensed as an osteopathic physician in the State of Florida, having been issued license number OS-0001053 in 1954. According to Respondent's office records for a patient named Barry Belikoff, Respondent saw Belikoff in his office on twenty-five (25) occasions between September 5, 1980, and July 24, 1981, and during this time wrote twenty-four (24) prescriptions for a total of 344 Quaaludes (Methaqualone) with a dosage of 300 mg. each. According to his patient records, Respondent also saw Belikoff on thirteen (13) occasions between October 31, 1981 and June 18, 1982 and wrote four (4) prescriptions for controlled substances, including Talwin, Restoril, and Percodan. Respondent was treating Belikoff for back pains and insomnia. According to expert testimony, the records kept by Respondent of this patient's office visits were inadequate and do not provide the required documentation which would support and explain the controlled substances prescribed in this case. In addition, a proper course of patient care would not include the on-going prescription of Quaaludes over almost a one year period at a rate of over one a day without a record of additional tests, x-rays, or neurological exams during this period. Belikoff's patient records do not show any such additional tests, x- rays or exams. Without such documentation in the patient's records, the prescriptions for controlled substances written by Respondent for Belikoff were without medical justification, excessive and inappropriate, according to expert testimony. Respondent was treating a patient named Lyndon Ellis during 1981 and 1982. Ellis was hospitalized on four occasions while under Respondent's care, and according to expert testimony the level of care and medical records for this patient, while hospitalized, were excellent. As a result of office visits by Ellis, Respondent wrote thirty-eight (38) prescriptions for controlled substances between April 20, 1981 and September 29, 1982 which included Percocet 5, Demerol, and Fiorinal. Ellis was being treated by Respondent for chronic headaches and pain from accident injuries, and also for a problem with his toe. However, according to expert testimony, the records kept by Respondent on Ellis' office visits were inadequate and do not provide documentation which would support and explain the controlled substances prescribed in this case. The absence of a thorough patient medical history, exam, evaluation, x- rays and lab tests in this patient's office records is explained by Respondent by the fact that this information was available in hospital records for this patient. Nevertheless, Respondent's office records for Ellis are totally inadequate. These office records do reflect that Respondent was aware of Ellis' overuse of controlled substances and the need to detoxify this patient on October 29, 1982. Yet he prescribed Percocet, a controlled substance, on five additional occasions after October 29, 1982. Without adequate documentation in the patient's records, the prescriptions for controlled substances written by Respondent for Ellis were without medical justification, excessive and inappropriate, according to expert testimony. Between July 14, 1980 and April 23, 1982, Respondent treated a patient named Alan Fogler. During this time Respondent wrote twelve (12) prescriptions for a total of 464 Percodan, a controlled substance. Respondent was treating Fogler for headaches, whiplash and a concussion reported by the patient, as well as allergies, but patient records reveal no x- rays, brain scans, lab work or neurological exams. According to expert testimony, patient records in this case are inadequate and do not justify the treatment rendered which consisted primarily of prescriptions for Percodan. Without adequate patient medical records, the prescriptions for controlled substances were without- medical justification, excessive and inappropriate, accordingly to expert testimony. While treating patients Belikoff, Ellis and Fogler, Respondent repeatedly reissued prescriptions for controlled substances without a substantiation of medical reasons in the patients' office medical records. According to expert testimony concerning the standards expected of osteopathic physicians in keeping office medical records on patients, Respondent did not perform with reasonable skill, nor meet the standards expected of physicians in this aspect of their practice. Vicki Cutcliffe, a deputy sheriff with the Broward County Sheriff's Office, saw Respondent in his office on March 30, April 11 and April 25, 1984 using the alias "Vicki Tarra". After taking a brief medical history which revealed that "Tarra" used alcohol daily, Respondent began treating her for situational anxiety by prescribing controlled substances, including Librium and Tranxene. On April 25 "Tarra" told Respondent she wanted some extra pills for her friend named Jo Ann and asked him to write her friend a prescription. Respondent said he could not do that, but did give "Tarra" a prescription for Tranxene and two refills, after initially giving her a prescription which allowed for only one refill. He told her that she could give some of the pills to her friend and then she could refill the prescription twice. Respondent knew that "Tarra" wanted the extra pills for a friend and that she would give them to her friend who was not a patient of Respondent. According to expert testimony, the treatment given to "Tarra" by Respondent, which consisted simply of prescriptions for controlled substances without adequate documentation of the reasons for this course of treatment in the patient's medical records, was totally inappropriate. Increasing a prescription when a patient says they want some extra pills for a friend is never justified and constitutes malpractice, according to expert testimony.
Recommendation Based upon the foregoing it is recommended that a Final Order be issued suspending Respondent's license for a period of two ( 2) years. DONE and ENTERED this 30th day of September, 1985, at Tallahassee, Florida. DONALD D. CONN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 3 2301 (904) 488- 9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of September, 1985. COPIES FURNISHED: Stephanie A. Daniel, Esq. Department of Professional Regulation 130 North Monroe Street Tallahassee, FL 32301 John W. Gaul, D.O. 11360 Tara Drive Plantation, FL 33325 Dorothy Faircloth Executive Director Board of Osteopathic Medical Examiners 130 North Monroe Street Tallahassee, FL 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, FL 32301 Salvatore A. Carpino, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, FL 32301 ================================================================ =
The Issue The issues in this case are whether the allegations of the Amended Administrative Complaint are correct, and, if so, what penalty should be imposed.
Findings Of Fact The Respondent is a licensed physician in the State of Florida, holding license number ME 81249. At all times material to this case, the Respondent was board-certified in family medicine. The Respondent held no board certification at the time of the administrative hearing, and, according to his response to the Petitioner's First Request for Admissions, the family medicine certification expired in July 2007. On February 8, 2006, the Respondent prescribed hydrocodone (10/325, generic Norco, 10mg.) to Patient M.R. through an internet service called ERMeds.com. On June 26, 2006, the Respondent prescribed hydrocodone (Hydro/APAP 10/325, generic Norco, 10/325) to Patient M.R. through the internet service called ERMeds.com. Hydrocodone is a Schedule II controlled substance listed in Chapter 893, Florida Statutes. Hydrocodone/APAP is hydrocodone combined with acetaminophen, and the combined drug is a Schedule III controlled substance listed in Chapter 893, Florida Statutes. Both hydrocodone and hydrocodone/APAP have high potential for abuse and addiction. The prescriptions issued to Patient M.R. contained the Respondent's identification including address and DEA number on the prescription form, as well as the Respondent's electronic facsimile signature. The Respondent had no contact with Patient M.R. either before or after the prescription was issued to Patient M.R. The Respondent conducted no health evaluation of Patient M.R. The Respondent did not obtain or review any medical information related to Patient M.R. The Respondent testified during deposition that a physician's assistant for whom the Respondent was the supervising physician was responsible for gathering and reviewing medical information from the patient. According to the Respondent's response to the Petitioner's First Request for Admissions, the physician's assistant obtained patient history, including current medications and complaints, and the "information was available to Respondent at the time the prescriptions were authorized." According to the Respondent's response to the Petitioner's First Request for Admissions, a completed medical questionnaire was available for the Respondent's review. There is no evidence that the Respondent reviewed any information or questionnaire regarding the patient's medical history or complaint either before or at the time the prescriptions were authorized. The Respondent did not know and never met the physician's assistant and was unable to recall the last name of the physician's assistant. There is no evidence that the Respondent had any discussion with any physician's assistant related to Patient M.R. either before or at the time the prescriptions were authorized. At the hearing, the Petitioner presented the testimony of Bernd Wollschlaeger, M.D., a Florida-licensed physician holding board certification in family practice. Dr. Wollschlaeger testified that a physician must evaluate a patient, take a patient's medical history, review any available medical records, and document the findings and diagnosis in a contemporaneous record prior to issuing a prescription for hydrocodone to a patient. Based upon the Respondent's deposition testimony and the responses to the Petitioner's First Request for Admissions, it is clear that the Respondent failed to evaluate Patient M.R. in any respect prior to issuing the prescriptions for hydrocodone to the patient. The Respondent reviewed no medical history or records related to Patient M.R. The Respondent failed to diagnose any medical condition that would support prescribing hydrocodone to Patient M.R. The Respondent failed to document any medical information related to Patient M.R. in any written record.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order finding Gerard Romain, M.D., in violation of Subsections 458.331(1)(m), 458.331(1)(q), and 458.331(1)(t), Florida Statutes (2005), and imposing a penalty as follows: a reprimand; a three-year period of probation, the first year of which shall include a prohibition on issuing prescriptions for Schedule II and III controlled substances; an administrative fine of $20,000.00; and such additional continuing education and community service requirements as the Department of Health determines appropriate. DONE AND ENTERED this 23rd day of September, 2008, in Tallahassee, Leon County, Florida. S WILLIAM F. QUATTLEBAUM Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 23rd day of September, 2008. COPIES FURNISHED: Elana J. Jones, Esquire Ephraim D. Livingston, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Dale R. Sisco, Esquire Stacy Estes, Esquire Sisco-Law Post Office Box 3382 Tampa, Florida 33601-3382 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.30 and Chapters 455 and 458, Florida Statutes. Respondent is a licensed physician in the State of Florida and holds license number ME 0043566. Respondent has never been the subject of a previous complaint from the Department of Professional Regulation (now the Department of Business and Professional Regulation). No patient involved in this proceeding incurred injury as a result of any procedure performed by Respondent or as a result of any medical record kept by Respondent, nor did any patient claim injury or make a complaint against Respondent. Respondent derived no financial gain from any act or omission alleged in the administrative complaint. All events pertaining to this proceeding occurred in 1987 or 1988. Prior to February 8, 1988, the effective date of Chapter 88-1, Laws of Florida, Section 458.331(1), Florida Statutes provided, in pertinent part, as follows: The following acts shall constitute grounds for which the disciplinary action specified in subsection (2) may be taken. * * * (m) Failing to keep written medical records justifying the course of treatment of the patient, including, but not limited to, patient histories, examination results, and test results. * * * (t) Gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is acceptable under similar conditions and circumstances. The board shall give great weight to the provisions of s. 768.45 when enforcing this paragraph. As used in this paragraph, "repeated malpractice" includes, but is not limited to, three or more claims for medical malpractice within the previous 5-year period resulting in judgment or settlement and which incidents involved negligent conduct by the physician. As used in this paragraph, "gross malpractice" or "the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances", shall not be construed to require more than one instance, event, or act. Section 25 of Chapter 88-1, Florida Statutes, became effective February 8, 1988, and amended the pertinent provisions of Section 458.311(1), Florida Statutes, to read as follows: The following acts shall constitute grounds for which the disciplinary action specified in subsection (2) may be taken. * * * (m) Failing to keep written medical records justifying the course of treatment of the patient, including, but not limited to, patient histories, examination results, test results, records of drugs prescribed, dispensed, or administered, and reports of consultations and hospitalizations. * * * (t) Gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is acceptable under similar conditions and circumstances. The board shall give great weight to the provisions of s. 768.45 when enforcing this paragraph. As used in this paragraph, "repeated malpractice" includes, but is not limited to, three or more claims for medical malpractice within the previous 5-year period resulting in judgment or settlement and which incidents involved negligent conduct by the physician. As used in this paragraph, "gross malpractice" or "the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances", shall not be construed to require more than one instance, event, or act. Nothing in this paragraph shall be construed to require that a physician be incompetent to practice medicine in order to be disciplined pursuant to this paragraph. At the times pertinent to this proceeding, Petitioner had adopted no rules pertaining to the keeping of records by a licensed physician. Imperial Point Medical Center (Imperial Point) is a hospital located in Broward County, Florida. Unless otherwise indicated, all hospital records referred to in this matter are from Imperial Point. PATIENT #1 (C.S.) On August 8, 1988, Respondent performed an upper endoscopy on Patient #1, a male, who was 44 years old at the time of the procedure. This procedure was performed at Imperial Point on an outpatient basis. An upper endoscopy is the viewing of the mouth, the pharynx, the esophagus, the stomach and portions of the duodenum with a fiber optic instrument that allows direct visualization of the lining of these structures and allows therapeutic maneuvers. The records kept of this procedure performed on Patient #1 on August 8, 1988, include an outpatient hospital record entitled "Operative Report". The description of the procedure portion of this report includes the following: ". . . The gastric portion was infiltrated with 1:1,000 adrenaline . . ." Adrenaline, also known as epinephrine, is a vasoconstrictor that can be used to control minor bleeding and oozing. It is used regularly in gastroenterology to treat actively bleeding lesions or ulcers with evidence of recent bleeding prior to performing a more permanent type of hemostasis. Dr. Goldberg testified that epinephrine was usually injected into these areas by a needle. Dr. Goldberg was of the opinion that epinephrine should not be used in cases of trivial bleeding or oozing or after routine biopsies unless there is an imminent danger of a significant arterial bleed. The testimony of Dr. Cerda and Dr. Singh established that spraying epinephrine over an area that is subject to bleeding is a precautionary technique some gastroenterologists follow. Dr. Singh and Dr. Cerda have both either used this technique, or have observed its use by other physicians. The expert witnesses agreed that the injection by needle of epinephrine into the gastric wall would be a procedure that falls below an established standard of care. There was a dispute among the expert witnesses as to how the term "infiltrated" should be interpreted. Petitioner contends that the term "infiltrated" is synonymous with the term "injected", and that the medical records should be construed to mean that Respondent injected the gastric wall with a needle, and therefore practiced below the standard of care. This contention is consistent with the testimony of Dr. Goldberg. Respondent asserts that the medical record should be construed to mean that Respondent sprayed the gastric wall as a precautionary measure. This contention is consistent with the testimony of the expert witnesses who testified on behalf of the Respondent. This dispute is resolved by finding that the term "infiltrated" does not have the same meaning as the term "injected" and does not prove that Respondent injected Patient #1's gastric wall with a needle. This conclusion is based, in part, on the definition of the term "infiltrate" and on the context in which epinephrine is sometimes administered by gastroenterologists during this type procedure. According to The American Heritage Dictionary of the English Language, the term "infiltrate" means to pass a liquid or a gas into something through its interstices or to permeate with a liquid or gas passed through interstices. Dorland's Illustrated Medical Dictionary, Twenty Sixth Edition (Dorland) has a similar definition of the term "infiltrate". According to Dorland, an "interstice" is small interval, space, or gap in a tissue or structure. According to Dorland, the term permeate means to penetrate or pass through, as through a filter. Also according to Dorland, the term inject means the act of forcing a liquid into a part, as into the subcutaneous, the vascular tree, or an organ. Based on these definitions, it is found that the use of the term "infiltrate" is more consistent with the practice of spraying epinephrine onto the gastric wall, and that the use of the term "infiltrate" does not prove that Respondent injected the epinephrine into the gastric wall with a needle. It is found that Petitioner failed to prove that the use of epinephrine was improper or that the manner in which Respondent used the epinephrine during the subject procedure was improper. Since Petitioner failed to prove that Respondent injected Patient #1 with epinephrine, its charge that Respondent failed to document his reasons for doing so must also fail. A pathology report dated August 8, 1988 contained in the medical file provided a pathological diagnosis as follows: "esophageal brushings: no evidence of malignancy." Brushings are the result of passing a small brush through the biopsy channel of an endoscope, rubbing it over an area of concern that might have either a malignancy or a fungal infection, taking the brush out of the scope, wiping it on a microscopic slide, and sending the slide to the pathologist for cytological examination. The reference to the "esophageal brushings" in the pathology report was error. The brushings taken from Patient #1 during the procedure on August 8, 1988, came from the stomach, a fact obvious to all of the expert witnesses in light of the operative report and operative drawing made by Respondent. Because Petitioner failed to prove that Respondent took esophageal brushings from Patient #1, its charge that he failed to properly document his reasons for doing so must also fail. 1/ Petitioner proved that Respondent's medical records, including his office notes as to Patient #1 failed to contain an adequate medical history for Patient #1 and failed to reflect the findings of any physical examination of Patient #1 by Respondent. Petitioner further proved that such failures fall below an established standard of care as alleged in Count Two of the Amended Administrative Complaint. PATIENT #2 (R.B.) Patient #2 was a 70 year old male seen by Respondent for a consultation because of the patient's history of hematemesis, which is the vomiting of blood. Respondent prepared a formal consultation note dated September 25, 1988. The consultation note contains a description of the patient's condition, references a rectal exam, which was positive for blood, and indicates that a physical examination of the patient was made. Respondent again saw the patient on September 27, 1988 and performed an upper endoscopy. Dr. Goldberg was critical of the medical records kept by Respondent as to this procedure and was of the opinion that the medical records were inadequate. Other, equally credible expert witnesses were of the opinion that the medical records provided sufficient information to document the procedure. While it may be concluded that Respondent's medical records could be improved, it is found that Petitioner failed to prove that the medical records pertaining to this patient were inadequate. It is further found that Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. The records kept of this procedure reflect that Respondent "infiltrated" Patient #2 with epinephrine. This is the identical dispute over the meaning of the term "infiltrated" that pertained to Patient #1 as discussed above. For the reasons given in resolving the dispute as it pertains to Patient #1, it is found that the term "infiltrated" does not have the same meaning as the term "injected" and that the use of the term does not prove that Respondent administered the epinephrine by injecting Patient #2 with a needle. It is found that Petitioner failed to prove that the use of epinephrine was improper or that the manner in which Respondent used the epinephrine during the subject procedure was improper. Since Petitioner failed to prove that Respondent injected Patient #2 with epinephrine, its charge that Respondent failed to document his reasons for doing so must also fail. PATIENT #3 (B.B.) Patient #3, a 65 year old female was admitted to Imperial Point with chest pains by her physician, a Dr. Fanfan. Patient #3 had a history of cancer which included the prior surgical removal of a tumor. On October 3, 1988, Respondent performed a colonoscopy of Patient #3. A colonoscopy is an examination of the colon from the anus to the ileocecal valve using a fiber optic instrument. A colonoscopy is indicated to evaluate abnormal X-rays, changes in bowel habits, evidence of bleeding, suspicions of inflammation, tumors, or polyps. Respondent adequately performed the procedure on Patient #3. The colonoscopy detected that Patient #3 had polyps. Subsequent laboratory results established that these were hyperplastic polyps that required no follow-up. Had the polyp been an adenomatous polyp, which is a true neoplasm with malignant potential, a follow-up for recolonoscopy would have been appropriate in one year. Prior to receiving the pathology reports, on the polyp, Respondent recommended a six month follow-up for the patient. This follow-up recommendation was appropriate at the time it was made. Petitioner failed to prove that the recommendation that a follow-up be performed was below an established standard of care. Petitioner failed to prove that the recommendation that the follow-up for this patient with a history of cancer be in six months as opposed to one year fell below an established standard of care. The barium enema for this patient was originally scheduled by the attending physician, Dr. Fanfan. Dr. Fanfan clearly wrote a note on the same day following Respondent's report of the colonoscopy that the barium enema was pending, yet the attending physician did not cancel the barium enema. There is no disagreement among the experts that the barium enema was unnecessary in light of the findings of the colonoscopy. It is medically unnecessary and inappropriate for both tests to be performed on the same day. Dr. Goldberg was of the opinion that Respondent was responsible for the patient once he began his consultation and that Respondent should have canceled the barium enema. Dr. Cerda, Dr. Eberly and Dr. Singh were of the opinion that the attending physician was responsible for scheduling the barium enema and that the attending physician or the radiologist should have canceled the barium enema. Dr. Eberly testified that as the primary care physician, the admitting physician is the "captain of the ship" and has the responsibility to make final determinations with respect to tests of this nature. Because of the conflicting testimony from equally credible expert witnesses, it is found that Petitioner failed to prove that Respondent violated an established standard of care by not cancelling Patient #3's enema. Dr. Goldberg was of the opinion that Respondent's medical records pertaining to Patient #3 were inadequate. He had several criticisms of the records. Dr. Goldberg opined that there should have been a formal consultation note on Patient #3's chart that included past history, present illness, review of systems, allergies, pertinent laboratories, a thorough organ specific or system examination, an impression, an adequate discussion of the consultant's impression and the consultant's plans. He opined that the indications for Patient #3's procedure were inadequately dictated on the procedure notes and that Respondent's history pertaining to Patient #3 was inadequate because there was no pertinent review of systems or past history, no mention of the previous tumor, no mention of allergies, and an extremely scant examination. Other, equally credible expert witnesses were of the opinion that the medical records were adequate. It is found that Petitioner failed to prove the standard by which the adequacy of this patient's medical records are to be judged, other than the pertinent statutory standards set forth above. While it may be concluded that Respondent's medical records could be improved, it is found that Petitioner failed to prove that the medical records fell below an established standard of acceptability. PATIENT #4 (E.K.) On October 4, 1988, Patient #4, a 92 year-old female, was admitted to the hospital with an acute onset of vomiting, dehydration, and abdominal pain. Respondent was asked by Patient #4's attending physician to evaluate Patient #4 for a potential small bowel obstruction following an X-ray that was consistent with a small bowel obstruction. Respondent performed an upper endoscopy on Patient #4 on October 7, 1988. An obstruction of the intestines is a blockage in the large or small intestine. The bowel behind the blockage may become inflated with fluid or air and may be seen on X-ray. The obstruction may result from a variety of abnormalities. Dr. Goldberg was of the opinion that the upper endoscopy was contra- indicated and potentially dangerous to the patient because of the X-ray indicating a complete bowel obstruction. Dr. Goldberg was also of the opinion that an upper endoscopy should be used only under compelling circumstances if there is a partial bowel obstruction. Dr. Goldberg was of the opinion that Respondent did the right tests on Patient #4, but in the wrong order since he did not first rule out an obstruction. Prior to performing the upper endoscopy Respondent monitored the patient for several days. During that time period, examinations indicated that the patient was having bowel movements. Both the attending physician's notes, Respondent's notes, and the nurse's notes indicate positive bowel signs on October 5 and 6, indicating that there was not a complete bowel obstruction. Respondent ordered a Golytely preparation administered to the patient, which usually consists of one or two liters of non-absorbable solution that basically washes the bowel out. That preparation would have been improper with a complete bowel obstruction. Dr. Goldberg was of the opinion that the use of a Golytely prep in this patient was a gross judgment error. Dr. Singh was of the opinion that there was no contra-indication for using the preparation in this situation. Petitioner failed to prove that Patient #4 had a complete bowel obstruction or that the procedure, including the use of the Golytely preparation, violated an established standard of care. It is found that Respondent was acting within the scope of his discretion as the consulting physician to order the administration of the Golytely preparation and to perform the upper endoscopy. On October 11, 1988, Respondent performed a colonoscopy on Patient #4. Respondent stated on the operative report that the colonoscopy was indicated because of diverticulitis. Diverticulitis was not mentioned in any of Respondent's notes concerning Patient #4, and there was no notation as to the reasons Respondent thought the patient had diverticulitis. Although Respondent failed to document why he felt that diverticulitis was an appropriate indication for the colonoscope, there is no dispute that a colonoscope was, in fact, indicated. Further, the colonoscope established that the pretest diagnosis of possible diverticulitis was not incorrect. The colonoscopy revealed areas of colitis, and the pathology report noted an ulcer with acute and chronic inflammation. Respondent's experts testified that they were of the opinion that Respondent violated no established standard by listing diverticulitis as an indication for the colonoscopy. It is found that Petitioner failed to prove that Respondent practiced below an established level in listing diverticulitis as an indication for the colonoscope. During the colonoscopy, Respondent found several mildly bleeding areas and infiltrated Patient #4 with epinephrine. For the reasons discussed pertaining to Patient #4, it is found that Petitioner failed to prove that Respondent violated an established standard of care in administering epinephrine to Patient #4. Dr. Goldberg was of the opinion that Respondent's handwritten consultation report was inadequate. Dr. Goldberg bases his conclusion on the following observations. The report was difficult to read and failed to include any significant historical events concerning Patient #4. In his consultation report, the Respondent failed to note anything about having done a rectal examination on this patient, whether or not the abdomen was distended, and whether there were active or inactive bowel sounds. Dr. Goldberg was of the opinion that these findings would help to distinguish between an obstruction and an ileus or paralysis of the bowel. Dr. Goldberg was also of the opinion that the patient's records of the upper endoscopy performed October 7, 1998, fail to reveal any significant findings. Other, equally credible expert witnesses were of the opinion that the medical records were adequate. It is found that Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. While it may be concluded that Respondent's medical records could be improved, Petitioner failed to prove that the medical records fell below an established standard of acceptability. PATIENT #5 (J.T.) Patient #5, an 89 year-old male, was admitted to Imperial Point with a history of peptic ulcer disease and arthritis. This patient was seen by Respondent on a consulting basis. The patient was vomiting blood and Respondent was asked to see the patient to determine the source of the bleeding. Respondent performed an upper endoscopy on October 13, 1988, and found a significant outlet obstruction. On October 17, 1988, a G.I. series was performed and a repeat upper endoscopy and pyloric dilatation was performed. The procedures performed by Respondent were properly indicated and had a beneficial result to the patient. Back-to-back pyloric dilatations were appropriate and clinical judgment was properly exercised. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records pertaining to the upper endoscopy of October 13, 1988, in that Respondent's operative report failed to document Respondent's findings in detail. Dr. Goldberg testified that an essential endoscopy report that physicians are trained to do should include the following: indications for the procedure, medication used to sedate the patient, identification of instrument used, description of the anatomical landmarks and their condition as visualized by the physician passing the endoscope, the removal of the scope, the physician's impressions and what the physician plans to do about those impressions, how the patient tolerated the procedure and what the patient's condition was after the procedure, and that the patient was sent to the recovery area. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records pertaining to the procedures performed on this patient on October 17, 1988, in that Respondent's operative report did not document Respondent's findings in detail and did not indicate if the scope was passed through Patient #5's dilated pylorus into the duodenum. In Respondent's impressions on the second endoscopy, he noted pyloric stenosis and duodenal ulcer. In his procedure note Respondent does not mention whether he passed the scope into the duodenum or how he knew there was a duodenal ulcer. Dr. Goldberg was of the opinion that Respondent did not properly document what he did. On October 18, 1988, Respondent performed a repeat pyloric dilation on Patient #5. Dr. Goldberg was of the opinion that Respondent failed to record the reasons for the second procedure and to document his findings. Dr. Goldberg was of the opinion that the third endoscopy note did not adequately detail the examinations of the esophagus and stomach. Dr. Goldberg was of the opinion that every procedure note stands alone, and that if a physician does an endoscopy on day one and repeats it on day two, the physician still must make that report complete because it is not always going to be part of a document. Dr. Goldberg was of the opinion that Respondent's records did not stand alone. Dr. Goldberg was of the opinion that Respondent's handwritten consultation note was sketchy and should have contained a history of allergies because of the need to give the patient medications for sedation. Dr. Goldberg's criticisms of Respondent's medical records do not prove that the medical records kept by Respondent were inadequate as measured by an established standard. Other, equally credible expert witnesses were of the opinion that the medical records provided sufficient information to document the procedures and that the records were adequate. While it may be concluded that Respondent's medical records could be improved, it is found that Petitioner failed to prove that the medical records were inadequate. It is further found that Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. PATIENT #6 (D.Y.) From October 19, 1988, until October 22, 1988, Respondent was consulting physician to Patient #6, a 72 year-old male, who was admitted to Imperial Point with rectal bleeding. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records pertaining to Patient #6 because a formal consultation note was lacking. The medical records which were reviewed by Dr. Goldberg were incomplete when reviewed by him. A specific reference is made to a consultation note that is not contained in the hospital records. Respondent established that other medical records were missing from the hospital records. In light of the specific reference to the consultation note, it is found that the absence of this consultation note from the hospital records is insufficient to prove that there existed no consultation note. On October 20, 1988, Respondent performed an colonoscopy on this patient and a biopsy was taken in the segmental descending colon area. The colonoscopy could not be completed because the colonoscopy could not pass to the patient's cecum. The following recommendation was made by Respondent (the original is in all capital letters): IN VIEW OF NOT REACHING TO THE CECUM, THE PATIENT WOULD NEED BE (this is an abbreviation for barium enema) AND ALSO IF EVERYTHING IS NEGATIVE, RECOLONOSCOPY IN ONE YEAR AND IF THERE ARE ANY CHANGES IN THE BIOPSY OF THE POLYP, THEN ACCORDINGLY WILL PLAN. On October 21, 1988, the follow-up barium enema was performed by Dr. Nicholas M. Arfaras, a radiologist. The radiology report reflected the following finding: "Also in the sigmoid there is an approximately 1 cm. rounded filling defect identified near the junction with the descending colon. This is felt to be secondary to a polyp." The possible polyp detected by the barium enema should have been followed up. However, it was not established that Respondent was consulted by the attending physician about the results of the barium enema. Dr. Lipton, as the attending physician, would have had the responsibility for following up the recommendations made by Respondent and for bringing Respondent or another gastroenterologist in for further consultations following the barium enema if Dr. Lipton had believed it necessary to do so. This patient was discharged from Imperial Point by Dr. Lipton on October 22, 1988. The final page of the discharge summary for this patient reflected the following notation: "Condition was improved. The patient is to have a follow up in one week in the office with Dr. Lipton and with Dr. Gupta in two weeks." The evidence presented in this proceeding, including Respondent's office notes, does not reflect that Respondent had any involvement with this patient after October 21, 1988, until 1990, when he performed on the patient at North Broward Medical Center a procedure described as a "multiple colonoscopy with multiple biopsies and cauterization." This procedure in 1990 revealed multiple polyps. The polyp removed on colonoscopy in 1988 was an adenomatous polyp, a polyp with significant malignant potential. This patient needed a follow-up colonoscopy in one year. Respondent was the consulting physician and recommended reevaluation of the patient in one year. Follow-up care was not the responsibility of Respondent, but of the treating physician. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records in that Respondent failed to adequately document the indications for the colonoscopy performed on Patient #6 and why the colonoscope could not be passed to Patient #6's cecum. Dr. Goldberg opined that a physician doing a colonoscopy needs to tell why he did not get to the cecum so that the next physician colonoscoping this patient can take appropriate precautions. Other, equally credible expert witnesses were of the opinion that the medical records were adequate and provided sufficient information to document the procedures that were performed. Petitioner failed to prove that the medical records were inadequate. Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. PATIENT #7 (C.R.) Respondent was a consulting physician to Patient #7, a 64 year old male who was hospitalized with rectal bleeding. Respondent saw this patient because of a possible colonic fistula, which is a connection with any piece of the intestine and some other structure. Respondent recommended a barium small bowel X-ray and a barium enema, both appropriate clinical recommendations. On November 11, 1987, Respondent performed a colonoscopy on Patient #7. Petitioner contends that Respondent failed to keep adequate written medical records pertaining to the aforementioned procedure in that Respondent failed to document an adequate history as an indication of Patient #7's colonoscopy. This contention is rejected based on the testimony of Dr. Singh. The medical records provide adequate justification for the procedure. Dr. Goldberg was critical of Respondent's records pertaining to this patient and considered the records inadequate. He was of the opinion that the records should have better detailed his findings and should have recorded any follow-up plans for a repeat colonoscopy on the patient. Other, equally credible expert witnesses were of the opinion that the medical records were adequate and provided sufficient information to document the procedures that were performed. Petitioner failed to prove that the medical records were inadequate. Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Petitioner enter a final order which finds that Respondent violated the provisions of Section 458.331(1)(m), Florida Statutes, by failing to provide a history or physical examination for Patient #1 as alleged in Count Two, which reprimands Respondent for that violation, and which imposes an administrative fine in the amount of $250.00 against the Respondent for that violation. It is further recommended that all other charges against Respondent contained in the Amended Administrative Complaint be dismissed. DONE AND ENTERED this 12th day of October, 1993, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON 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 12th day of October, 1993.
The Issue The issues to be determined are whether Respondent overprescribed controlled substances and failed to maintain legible medical records as alleged in the Administrative Complaint and, if so, the appropriate penalty.
Findings Of Fact The Department of Health, through its Board of Osteopathic Medicine, is the state agency charged with regulating the practice of osteopathic medicine in the state of Florida, pursuant to section 20.43, and chapters 456 and 459, Florida Statutes. At all times material to this proceeding, Richard D. Vitalis was a licensed osteopathic physician in the state of Florida, holding license number OS 4823. Respondent’s current address of record is 3774 China Grove Mews Lane, Fairfax, Virginia 22025. At all times material to the Administrative Complaint, Respondent was practicing as an osteopathic physician at All Family Medical in North Lauderdale, Florida, a licensed pain management clinic. On or about January 27, 2011, L.N., a 29-year-old female, and a resident of Biloxi, Mississippi, presented to Respondent at his Fort Lauderdale office with complaints of back pain. Between January 27, 2011, and August 3, 2011, L.N. presented to Respondent on seven occasions. L.N. indicated that she had previously been prescribed oxycodone 15 mg, oxycodone 30 mg, and Xanax 2 mg. She also indicated that she was dependent on her prescriptions, that she needed them every few hours, that she expected to need them the rest of her life, and that they were not helping resolve her medical problems. L.N. underwent a magnetic resonance imaging (MRI) study on January 27, 2011. The MRI diagnostic images showed that L.N.’s spine had no evidence of pathological disease. There was a normal alignment of the vertebral bodies without evidence of compression or spondylolisthesis. There was normal signal throughout the vertebral bodies and within the visualized spinal cord. There was no significant disc disease, evidence of spinal stenosis, or exiting nerve root impingement at L1-2, L2-3, L3-4, or L5-S1. Although the MRI depicted some annular disc bulging at L4-5, there was no spinal stenosis or neural foraminal stenosis. There was no pathology shown on the MRI, and it was, in general, “a normal MRI.” As such, the MRI would not provide support for a conclusion that L.N. would have been in pain. There were no diagnostic images in L.N.’s file to contravene the medical conditions shown in the MRI. The only evidence of anything requiring treatment was L.N.’s complaint of low back pain. Such a complaint would call for muscle relaxers, physical therapy, hot/cold packs, or ultrasound, rather than narcotic pain medications. There was no evidence in the medical records that L.N. exhibited signs of nerve root impingement with pain radiating down the leg. The records did not demonstrate that Respondent performed a comprehensive medical examination of L.N., or that Respondent performed any type of objective testing of L.N., including straight leg raises, checking for deep tendon reflexes, or palpation of the area of concern for spasms. The records did not contain an adequate medical history of L.N., including height, weight, temperature, pulse, respiration, blood pressure, age, date of birth, and medication lists, nor did they contain an assessment of L.N.’s chief complaint or plan of treatment. The intake from L.N.’s first visit to Respondent indicated that she was taking opioids and benzodiazepines, though there was no evidence of prescriptions or prescribing physicians for those substances. The records did not demonstrate that Respondent obtained records of prior treating physicians, nor was there any evidence of an effort to do so. The records do not demonstrate that Respondent consulted with any other physician which, in the case of treatment resulting from an MRI review, would fail to meet the standard of care. The records do not demonstrate that Respondent recommended alternative interventions for L.N.’s pain complaints, including physical therapy, which would have been appropriate, and within the standard of care given the normal MRI results. The only alternatives noted were “heat” and “massage” on January 27, 2011, and “heat” on June 23, 2011. Although it is possible that other alternative interventions were recommended, the illegibility of the intake forms prevents such a finding. The failure to recommend alternative interventions was a failure to meet the standard of care. On L.N.’s first visit to Respondent on January 27, 2011, a urine drug screen was performed. The drug screen tested positive for opioids and benzodiazepines. Subsequent to that first visit, Respondent performed no other drug tests. Such tests can confirm that the patient is taking prescribed medications, and not diverting them, and that the patient is not taking other non-prescribed medications. It is the medical standard of care to perform follow-up drug tests of patients when prescribing high doses of controlled substances, including opioids. The failure to closely monitor L.N. when prescribing high doses of opioids and benzodiazepines was a failure of the standard of care. Respondent did not communicate with L.N.’s pharmacy to ensure that she was not getting prescribed medicines from other doctors. Such information was, in 2010 and 2011, available from pharmacies. It was, during that period, the medical standard of care to communicate with the dispensing pharmacy. Respondent failed to meet that standard of care. There was no evidence to the contrary. Despite the fact that L.N. presented to Respondent with a stated history of opioid use and a positive drug screen, Respondent did not record L.N.’s medication history for the period up to her first visit with Respondent. The failure to take a medication history to substantiate the need and justification for the prescription of high-dose opioids is contrary to the 2010-2011 medical standard of care. Oxycodone was, during the relevant period, a Schedule II controlled substance with a high potential for abuse, and an accepted but severely restricted medical use in treatment in the United States. Abuse of oxycodone may lead to severe psychological or physical dependence. § 893.03(2), Fla. Stat. Roxicodone is a brand name for oxycodone hydrochloride. It is a short-acting opioid that is rapidly absorbed. Short- acting opioids have a greater potential for abuse. Furthermore, prescription of short-acting opioids, such as Roxicodone, would not be within the standard of care for long-term, chronic pain such as that described by L.N. Xanax is the brand name for alprazolam and is prescribed to treat anxiety. Alprazolam was, during the relevant period, a Schedule IV controlled substance, with a low potential for abuse, and an accepted medical use in treatment in the United States. Abuse of alprazolam may lead to limited physical or psychological dependence. § 893.03(4), Fla. Stat. At L.N.’s initial January 27, 2011, visit, Respondent prescribed medications including 210 tablets of Roxicodone Oral 30 mg, 120 tablets of Roxicodone Oral 15 mg, and 90 tablets of Xanax Oral 2 mg. The prescribed doses and amounts were consistent with L.N.’s self-reported medications that she was then taking, presumably prescribed by “Dr. Sanchez” in Biloxi. Respondent’s plan of treatment listed the medications L.N. requested and recommended follow-up in one month. The records contain no individualized treatment plan. Respondent’s examination notes are entirely illegible. Respondent’s records lack copies of prescriptions issued to L.N. on January 27, 2011. A patient agreement and informed consent form was included in L.N.’s patient file, but was not signed by L.N. L.N. next presented to Respondent with complaints of chronic lower back pain on February 22, 2011. The intake form is largely illegible, though “overall feels well” is discernable. At that visit, Respondent prescribed 210 tablets of Roxicodone Oral 30 mg, 120 tablets of Roxicodone Oral 15 mg, and 90 tablets of Xanax Oral 2 mg. Respondent’s plan of treatment was medication refill and follow-up in one month. Again, there was no individualized treatment plan, and the examination notes were largely illegible. L.N. presented to Respondent with further complaints of chronic lower back pain on March 22, 2011. The intake form is largely illegible, though “overall feels well” is discernable. Respondent again prescribed 210 tablets of Roxicodone Oral 30 mg, 120 tablets of Roxicodone Oral 15 mg, and 90 tablets of Xanax Oral 2 mg. Respondent’s plan of treatment was medication refill and follow-up in one month. Again, there was no individualized treatment plan, and the examination notes were illegible. L.N. presented to Respondent on April 21, 2011. The intake form is largely illegible, though “overall feels well” is discernable. Respondent renewed L.N.’s previous prescriptions. L.N. next presented to Respondent with complaints of chronic lower back pain on May 19, 2011. The intake form is entirely illegible. Respondent prescribed 210 tablets of Roxicodone Oral 30 mg, 120 tablets of Roxicodone Oral 15 mg, and 90 tablets of Xanax Oral 2 mg. Respondent’s plan of treatment was medication refill and follow-up in an illegible timeframe. There was no individualized treatment plan. Respondent’s examination notes were illegible and minimal. On June 23, 2011, L.N. presented to Respondent. The intake form, though largely illegible, appears to state that “pt feels good pain solved with meds.” The treatment prescribed by Respondent apparently having the desired effect, Respondent renewed L.N.’s prescription for 210 tablets of Roxicodone Oral 30 mg (though in two separate prescriptions for 180 tablets and 30 tablets, respectively), 120 tablets of Roxicodone Oral 15 mg, and 60 tablets of Xanax Oral 2 mg. The prescription originally called for 150 tablets of Xanax, but Respondent struck 90 of those. Respondent’s plan of treatment was medication refill and follow-up at the next appointment on July 23, 2011. A monthly medication dosage evaluation was completed for the June visit, as was a pain management treatment plan medical record. Those records provided little individualized information regarding L.N.’s plan of care. The pain management treatment plan form indicated that drug testing was completed; however, there were no results. L.N.’s final visit to Respondent occurred on August 3, 2011. She indicated, in what appears to be her handwriting, that she had used a “hot bath,” “heat,” and “some exercise.” Her treatment objective continued to be “complete resolution of pain with medication.” At that visit, Respondent prescribed 150 tablets of Roxicodone Oral 30 mg, 120 tablets of Roxicodone Oral 15 mg, and 60 tablets of Xanax Oral 2 mg. Respondent’s plan of treatment included only a list of medications. The pain management treatment plan form indicated that drug testing was completed; however, there were no results. Based on the evidence of record, including the testimony of Dr. Porcase, and in the absence of any evidence to the contrary, it is found that Respondent failed to practice medicine with that level of care, skill, and treatment recognized in general law as being acceptable under similar conditions and circumstances in his treatment of L.N. Based on the evidence of record, including the testimony of Dr. Porcase, and in the absence of any evidence to the contrary, it is found that Respondent prescribed excessive and unnecessary amounts of Roxicodone and Xanax without a justifiable basis to do so, especially since the January 27, 2011, MRI report did not support a determination that L.N. was experiencing back pain so as to justify Respondent’s course of opioid treatment for L.N. Based on the evidence of record, including the testimony of Dr. Porcase, and in the absence of any evidence to the contrary, it is found that Respondent failed to create and maintain adequate and legible records supporting the course of treatment for L.N., or records documenting performance of a comprehensive physical examination of L.N. proportionate to her diagnoses. Based on the evidence of record, including the testimony of Dr. Porcase, and in the absence of any evidence to the contrary, it is found that Respondent failed to adequately monitor L.N.’s use of opioid therapies. The findings set forth herein are the result of Dr. Porcase’s undisputed expert testimony regarding the standard of care as it existed in 2010-2011, as well as the undersigned’s independent review of the record. Whether Respondent could have produced evidence to support his treatment of L.N. will remain a mystery, since Respondent essentially abandoned this proceeding. Despite challenging the Department’s Administrative Complaint, Respondent minimally and incompletely responded to written discovery, failed to meaningfully participate in Dr. Porcase’s deposition, twice refused to appear for his own deposition, despite personal service of the notice, and failed to make an appearance at the final hearing. In the absence of any testimony or evidence to counter that of the Department, the evidence presented by the Department, including the testimony of Dr. Porcase, was clear and convincing as to the matters set forth herein. Despite Respondent’s failure to actively contest the allegations in the Administrative Complaint, it must be recognized that the allegations concern a single patient over a total period of scarcely more than 6 months. There was no pattern of misconduct. Furthermore, Dr. Porcase acknowledged that the practices regarding the prescription of opioids in 2010-2011 were far different from those that exist today. Rather, “there was no standards that you were -- individualized your treatment to the pathology on imaging studies and patient’s complaints and their ability to function on medicine.” As to a doctor’s actions to rule out a patient’s drug-seeking behavior, he testified that “[i]t would be the individual physician having to make that determination based on his experience and diagnostic testing . . . and physical exam.” While the undersigned believes and gives weight to Dr. Porcase’s opinions regarding the standard of care, his testimony is equally compelling that the standard was not as clear-cut in 2010-2011 as it is in 2018. Though not affecting the ultimate findings regarding violations of law, it does affect the nature of the penalty that is warranted.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Osteopathic Medicine, enter a final order: determining that Respondent violated sections 459.015(1)(x), 459.015(1)(t), and 459.015(1)(o); imposing an administrative fine of $2,000; issuing a letter of reprimand against Respondent’s license to practice osteopathic medicine; and awarding costs incurred in the prosecution of this case to the Department. DONE AND ENTERED this 15th day of May, 2018, in Tallahassee, Leon County, Florida. S E. GARY EARLY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of May, 2018. COPIES FURNISHED: Ann L. Prescott, Esquire Philip Aaron Crawford, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed) Richard D. Vitalis, D.O. 230 Caddie Court DeBary, Florida 32713 Richard D. Vitalis, D.O. 3774 China Grove Mews Lane Fairfax, Virginia 22025 Kama Monroe, Executive Director Board of Osteopathic Medicine Department of Health 4052 Bald Cypress Way, Bin C-06 Tallahassee, Florida 32399-3257 (eServed) Nichole C. Geary, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 (eServed)
The Issue Did Respondent, James Sotrop, M.D. (Dr. Sotrop), violate section 458.331(1)(t), Florida Statutes (2007),1/ by committing medical malpractice by failing to adequately assess patient P.A.'s complaints and symptoms? Did Dr. Sotrop violate section 458.331(1)(t), Florida Statutes, by committing medical malpractice by failing to order diagnostic imaging studies and laboratory tests for P.A.? Did Dr. Sotrop violate section 458.331(1)(t), Florida Statutes, by committing medical malpractice by failing to document a complete patient history and physical examination? Did Dr. Sotrop violate section 458.331(1)(t), Florida Statutes, by committing medical malpractice by failing to immediately refer P.A. to the emergency department of a hospital on January 14, 2007? Did Dr. Sotrop violate section 458.331(1)(t), Florida Statutes by committing medical malpractice by failing to refer P.A. for specialized consultations? Did Dr. Sotrop violate section 458.331(1)(t), Florida Statutes by committing medical malpractice by making an inappropriate diagnosis of P.A.'s condition? Did the Petitioner, Department of Health (Department), fail to properly notify Dr. Sotrop of its investigation and provide an opportunity to respond to the allegations before determining probable cause? If so, do sections 456.073(1) and 458.331(9), Florida Statutes, require dismissal of the complaint?2/
Findings Of Fact The Department is the state agency charged with the licensing and regulation of medical doctors pursuant to section 20.43, and chapters 456 and 458, Florida Statutes. At all times material to the allegations in the Administrative Complaint, Dr. Sotrop was a licensed medical doctor within the State of Florida, having been issued license number ME 41092. Dr. Sotrop's address of record with the Department of Health is Post Office Box 1628, Lutz, Florida, 33548. He has used this address for mailing purposes for 10 to 15 years. The Department mailed a copy of the complaint against Dr. Sotrop and its investigation in this matter to Post Office Box 1628, Lutz, Florida, 33548. Dr. Sotrop says the he "believes" that he did not receive it. This testimony is not sufficiently persuasive to establish that he did not receive the notice. Dr. Sotrop completed medical school at the Medical School of Wisconsin and started working with his father’s family medical practice in Lutz, Florida. Florida licensed Dr. Sotrop to practice medicine in Florida in 1982. Although Dr. Sotrop intended to attend a residency program after practicing medicine with his father for a short time, he never left his father’s practice and thus never attended a residency program. Dr. Sotrop is not board eligible in family medicine because he never attended a residency program. Dr. Sotrop assumed his father’s practice and operated as a solo practitioner until he sold the practice to a large group. After working for the group practice for several years, Dr. Sotrop left the group in 2006 and started to rebuild his solo practice. While he was rebuilding his practice, Dr. Sotrop worked part-time for a colleague at the New Tampa Urgent Care walk-in clinic. He started working at the walk-in clinic in early January of 2007. Dr. Sotrop eventually rebuilt his medical practice and stopped working at the walk-in clinic. He currently maintains a solo medical practice. New Tampa Urgent Care utilized an electronic medical record keeping system known as Amazing Charts. This was Dr. Sotrop’s first exposure to an electronic medical record keeping system. Dr. Sotrop is a “hunt and peck” or “two-finger” typist. He had previously maintained only hand-written medical records. The Amazing Charts system requires physicians to enter some of the information regarding patient visits into the system by manually typing. Because of his lack of familiarity with the Amazing Charts system and his poor typing skills, Dr. Sotrop limited the information he included in patient records using the Amazing Charts. January 13th Patient Visit Patient P.A. first presented to the walk-in clinic on January 13, 2007, with a chief complaint of right-sided facial pain and weakness of the face. Dr. Sotrop saw her. P.A. reported a history of right-sided facial pain for two to three days, and right-sided facial droop that started that morning. Her right eyelid was swollen. P.A.’s vital signs were: temperature of 101 degrees; blood pressure of 114 over 70 (which was normal); pulse rate of 138; and respiratory rate of 18. Dr. Sotrop examined P.A., following his routine physical-examination process. The process, as Dr. Sotrop generally described during his testimony, consists of observing the patient’s gait as they walk to look for any abnormalities. He then examines both ears and both nostrils. He examines the patient’s mouth in the traditional method, checks the neck for movement, and palpates the neck and upper body for swollen lymph glands. He listens to the patient’s heart and lungs and, if appropriate for the presentation, asks the patient to lie down so he can perform an abdominal examination. While performing the physical examination, he talks to the patient and asks questions so he can verify whether the patient’s mental status is normal. Dr. Sotrop observed P.A.'s gait, examined her eyes (including a fluorescein and fundus examination of the eyes), and examined her face and mouth which included her ability to swallow and move her jaw normally. Dr. Sotrop documented his physical examination findings for P.A. during the January 13th visit as follows: Rt lower facial droop not involving forehead. HEENT neg. ex sl grn d/c nares and eryhema rtconj, fluoro neg. no rash (yet) neck supple Dr. Sotrop interpreted this entry in the patient’s record during his testimony as follows: The patient had a right-lower facial droop not involving her forehead. The head, eyes, ears, nose and throat examination were negative except for a slight green discharge from the right nares (or nasal passage) and there was redness of the right conjunctiva (the white part of the eye) . . . I did a fluorescein examination of the eye which involves putting a drop in the eye and using a special light and looked at the eye and it was normal, negative. There was no rash on the face, and I put in parentheses, “yet” because I expected one… And the neck was supple. Dr. Sotrop explained that he documented “no rash (yet)” because he believed the patient most likely had shingles and would soon develop a rash consistent with this diagnosis. Dr. Sotrop's records document that the patient’s neck was supple to document that her neck was not stiff or painful. Dr. Sotrop found the patient’s mental status normal. As he noted, she was well enough to drive herself to the office. Dr. Sotrop determined that the patient was suffering from either Bell’s palsy or Shingles. In the medical record under A/P (or assessment and plan), he documented “Bell’s Palsy (351.0), Herpes Zoster of Eyelid (053.20).” Dr. Sotrop selected these possible alternative diagnoses from a drop-down menu from the Amazing Charts program. “Herpes Zoster” is another name for shingles. He selected Herpes Zoster of the Eyelid because that was the only Herpes Zoster diagnosis he could find in the Amazing Charts drop down menu at the time. Dr. Sotrop discussed his impressions with the patient. He told her that he was not sure whether she had Bell’s palsy or shingles. Dr. Sotrop told the patient to call him back or go to the emergency room if her symptoms got worse. He documented this advice in the records using the drop-down menu of the Amazing Charts system: “re check 2-3 days sooner, if worse, discussed natural and expected course of this diagnosis, and need to alert me if symptoms do not follow expected course, or if any worse. Re-check or go to ER if symptoms get worse.” Dr. Sotrop prescribed Prednisone, a steroid for treatment of suspected Bell’s palsy, Vicodin for pain, and Acyclovir, an antiviral drug to treat the patient for suspected shingles. The Department did not question Dr. Sotrop’s prescription of these medications. Dr. Sotrop’s records do not indicate that, on January 13, he considered the possibility that the patient had meningitis. During the January 13 visit, P.A. did not present the typical complete constellation of symptoms for meningitis. A stiff or painful neck and confused mental status are two common signs of meningitis. Dr. Sotrop's records do not indicate that he advised P.A. on January 13 to go to an emergency room for additional testing, such as a CT scan or spinal tap, to rule out or confirm more serious conditions like a tumor, meningitis, or other infection. Dr. Sotrop's demeanor during his testimony and inconsistencies in testimony make his claim that he advised P.A. to go to an emergency room or obtain further testing not credible. The testimony is not logically consistent with the fact that Dr. Sotrop entered in the records the much less significant information that he advised the patient to return or visit an emergency room if her symptoms did not improve. And it is not consistent with his stated beliefs about the uses and importance of records for patient care, insurance, and legal concerns. January 14th Patient Visit P.A. called the walk-in clinic the following day, Sunday, January 14th, and told the nurse that she was still having headaches and that the pain medication was not helping. Dr. Sotrop told the nurse that he wanted the patient to return to the office for further evaluation. P.A. drove herself to the walk-in clinic for the return visit. During this visit, she complained of nausea and vomiting and headache. The patient’s vital signs had improved. Her temperature was now normal, 97.8, and her blood pressure was 124/84. P.A.'s pulse rate had come down to 126, and her respiratory rate was slightly higher, at 20. Dr. Sotrop repeated the physical examination he conducted on January 13th. P.A.'s neck was still supple. And her mental status was normal. The patient’s facial symptoms had significantly improved from the January 13th visit. Dr. Sotrop documented “facial symptoms much better” and “exam shows near full return of facial movement and full closure of eye.” Dr. Sotrop also documented that P.A. still had no rash. Dr. Sotrop tapered the prescription for Prednisone and asked P.A. to hold Acyclovir for 12 hours because headaches are a known side effect of these medications. He also gave her an injection of Phenergan during the visit for nausea. Dr. Sotrop’s records do not indicate that on January 14th he considered the possibility that the patient had meningitis. They indicated, as on the 13th he told the patient to return or got to an emergency room if her condition worsen. A stiff or painful neck and confused mental status are two common signs of meningitis. During the January 14th visit, P.A. did not present the typical complete constellation of symptoms for meningitis. Dr. Sotrop's records do not indicate that he advised P.A. on January 14th to go to an emergency room for additional testing such as a CT scan or spinal tap to rule out or confirm more serious conditions like a tumor, meningitis, or other infection. Dr. Sotrop's demeanor during his testimony and inconsistencies with his other testimony make his claim that he advised P.A. to go to an emergency room or obtain further testing is not credible. The testimony is not logically consistent with the fact that Dr. Sotrop entered in the records the much less significant information that he advised the patient to return or visit an emergency room if her symptoms did not improve. And it is not consistent with his stated beliefs about the uses and importance of records for patient care, insurance, and legal concerns. January 15th Hospital Admission On January 15th, P.A.'s daughter found her unresponsive. P.A. was taken to the University Community Hospital by ambulance and placed in the Intensive Care Unit. Dr. Sotrop was not consulted on this hospital admission. But he did visit the patient after he learned of her admission. P.A. was unresponsive when she was admitted to the hospital. Her condition did not improve. A lumbar puncture showed possible bacterial meningitis. P.A. died about 48 hours after her admission to University Community Hospital. The patient’s final diagnoses included acute bacterial meningitis and “possibly shingles.”
Recommendation Upon consideration of the facts found and conclusions of laws reached, it is RECOMMENDED that the Florida Board of Medicine deny the Motion to Dismiss and enter a Final Order dismissing the Administrative Complaint in its entirety. DONE AND ENTERED this 2nd day of July, 2012, in Tallahassee, Leon County, Florida. S JOHN D. C. NEWTON, II Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of July, 2012.
Findings Of Fact At all times relevant hereto Thomas P. Elliott was licensed in Florida as an osteopathic physician having been first licensed in Florida in 1977 and issued Certificate No. 0003751. He graduated from an accredited osteopathic school of medicine in Kirksville, Missouri in 1952 and was duly licensed in Missouri where he practiced for some 23 years before entering the U.S. Air Force medical corps for two years. He was assigned to Tyndall AFB in Panama City, Florida. Upon his release from the USAF and licensure in Florida, he moved to Largo, Florida in 1977 where he set up a general practice as an osteopathic physician. Jack Bianco was first seen by Respondent on 12/19/B3 complaining of constant back pain. Examination and x-rays showed the degeneration of lower spine which could result in some pain. Bianco gave a history of an accident while in the military in 1966 which required extensive surgery and use of a brace for several years. Respondent acknowledged that if a patient said he had pain, he was given the benefit of the doubt. Although Bianco had received treatment at VA facilities those records were never asked for nor obtained by Respondent. Bianco stated he was allergic to Codeine and refused prescriptions for anti-inflammatory drugs. On this initial visit he was treated by manipulation, high frequency pulse and given a prescription for Dilaudid. Bianco remained a patient of Respondent until September 1984. At each visit, which occurred at approximately one week intervals, Bianco was treated with manipulation, high frequency pulse therapy and issued a prescription for Dilaudid. During the nine months Bianco was a patient he was given prescriptions for 374 Dilaudid, 4 mg. Dilaudid is the brand name for Hydromorphone Hydrochlorite. It is the strongest form of morphine available for oral ingestion and is a Class II controlled substance because of its highly addictive attributes. Extended use of Dilaudid (beyond two or three weeks) is generally deemed suitable only for terminally ill patients suffering from a painful malady such as cancer. Respondent recognized that Bianco was coming for treatment principally to get Dilaudid but he nevertheless continued to prescribe Dilaudid and never referred Bianco to a drug treatment facility. In March 1984, Respondent reduced the number of Dilaudid prescribed at one time to 8 but in July 1984 increased the number to 10. Respondent testified he attempted to take Bianco off the Dilaudid and Bianco did not return for treatment after receiving his last prescription from Respondent September 6, 1984. However, as noted below, Bianco's records (and others) were seized by the Sheriff's Office September 11, 1984. Records maintained by Respondent on Bianco fail to record results of the treatment given. On nearly every visit the same treatment was given followed by the prescription for Dilaudid. Although Respondent testified + + + + shown on the patient record showed that response to the treatment was first class, there is no record that Bianco's condition was improving, remaining constant or getting worse, or that any effort was made to change the medication to a less addictive drug. Respondent was never registered to participate in a detoxification program. Without such registration it is illegal for a practitioner to prescribe maintenance drugs to an addict. Between 1979 and 1984, Respondent also treated Stanley Berry, Lawrence Brainard, Cheryl Morelli, Michael Morelli; Donald Murray, Nicholas Spano, Linda Valentine, Paul Broussard, Lee Coryell, Arthur Gray, Sherri Gray, Raine Troupe, Bruce Flood, Debora Bolte, Leon Clifford, Gail Outlaw, William Ellmore, Horace Maybee, William Noble, Irene Morelli and Ernest Pingatore, as alleged in the Administrative Complaint. All of these patients complained of pain, generally back pain, on the first visit. Most reported having been involved in an earlier accident and reinjuring the back recently. The examinations given by Respondent consisted of checking the x-rays if the patient presented one to see if there was any skeletal problem that could cause pain. Otherwise he would palpate the patient to find a potential cause of pain. On these initial visits and throughout the period the patient was treated by Respondent, vital signs (blood pressure, temperature and pulse) were rarely, if ever, taken by Respondent or anyone else at his office. Most of these patients were given manipulation, heat or high pulse frequency treatment and prescriptions for Dilaudid on the first visit. Those who presented records showing they had been given Demerol or Percodan were usually given prescriptions for Demerol or Percodan and a muscle relaxant. Both Demerol and Percodan are Class II controlled substances. These patients' charts, like the chart on Bianco, failed to record what, if any, progress was made as the treatment progressed. Petitioner's expert witnesses, who reviewed the patient records and testified in these proceedings, could not decipher some of the notations made by Respondent on these charts as he used abbreviations, pluses, etc. While it would be very important for a doctor to read the patient record of a patient who had been treated by another physician, there is no specific format or specified abbreviations for maintaining patient records. All of these patients were given prescriptions for Class II drugs with inadequate documentation to justify the use of such drugs in the patient records. They were also given these prescriptions for a much longer time than was indicated for the physical symptoms which could easily lead to addiction, assuming the patient was not already addicted. Many of these patients were referred to Respondent by other patients above named. Those patients with the same surnames were from the same family, generally husband and wife. Respondent testified he gave no significance to the fact that he was prescribing large quantities of Class II drugs to two members of the same family. Frequently drug addicts refer other addicts to a doctor from whom the referrer is able to obtain drugs. Some of these patients were recognized as addicts by Respondent. Nevertheless, he would discuss their dependency with them, continue to prescribe controlled substances for them and never referred any of his patients to a detoxification center. Some of Respondent's patients listed above were given prescriptions for sufficient quantities of Schedule II drugs that they disposed of these drugs on the street. Approximately of those patients above noted were arrested by police for drug related offenses. These practices constitute prescribing controlled substances not in the course of Respondent's professional practice. Donald Murray was a patient of Respondent's from July 1979 through July 1984. During this period he received 198 prescriptions for Dilaudid, 240 prescriptions for Percodan, 16 prescriptions for Tuinol, as well as prescriptions for Tylox and Desoxyn (for narcolepsy). No entry in the patient record justified a diagnosis of narcolepsy for this patient. During the 28-day period between May 18, 1982 and June 28, 1982, Murray was given prescriptions for 72 Dilaudid, 4 mg. and 74, Percodan. In April 1983, Murray was given prescriptions by Respondent for 240 Percodan in less than a 30-day period. Respondent testified Murray needed the drugs to maintain his law practice. Nicholas Spano was a patient of Respondent from July 10, 1980 until September 7, 1984. Between July 19, 1982 and September 7, 1984, Spano received prescriptions for more than 2700 Percodan and prescriptions for 424 Tylox, another Class II drug. At the time these prescriptions were given to Spano, Respondent was aware of a psychiatric report by Dr. Joye dated 3/23/81 that Spano was believed to have a narcotic dependence on Percodan, of Joye's recommendation to discontinue Percodan, and of a report by Dr. Adams dated March 31, 1981 that Spano had been a chronic user of Percodan. In 1982, Detective William Logan in the vice and narcotic squad of the Pinellas County Sheriff's Office contacted Respondent regarding a forged prescription to one of his patients. At that meeting they discussed how not to get involved with drugs. Subsequent thereto Logan received complaints from pharmacies in Largo regarding what appeared to the pharmacist as excess prescriptions for narcotics written by Respondent and an investigation was commenced. On March 6, 1984, Respondent telephoned Logan to say he had read that two of his patients had been arrested, viz. Raine Troupe and Bruce Flood. Respondent acknowledged to Logan that he knew these men were addicts and that he was taking them off slowly. Respondent also admitted having other patients who were questionable. By this time Respondent had become a suspect in the criminal investigation and further telephone calls from Respondent were not returned by Logan. Respondent's office was searched on September 11, 1984, pursuant to a subpoena and patient records of the 23 patients above noted were seized. Respondent was subsequently brought to trial in Circuit Court in and for Pinellas County, entered a plea of nole contendere, and on August 25, 1985, adjudication of guilt of unlawful delivery of controlled substance was withheld, Respondent was placed on probation for three years, ordered to pay certain costs, and prohibited from prescribing Schedule II drugs.
