The Issue The Administrative Complaint in DOAH Case No. 99-4377, charged Respondent with violating Section 458.331(1)(t), Florida Statutes (failure to practice medicine with care, skill and treatment); Section 458.331(1)(m), Florida Statutes (failure to keep written records justifying treatment); Section 452.331(1)(x), Florida Statutes (violation of a rule of the Board or Department) by violating Rule 64B8-9.003(2), Florida Administrative Code, relating to legibility of medical records, in connection with Respondent's emergency room treatment of Patient B.W. on July 21, 1995. The Administrative Complaint in DOAH Case No. 99-4378, charges Respondent with violation of Section 458.331(1)(s), Florida Statutes (being unable to practice medicine with reasonable skill and safety to patients by reason of illness, use of any material, or as the result of any mental or physical condition).
Findings Of Fact At all times material to the incidents alleged in the Administrative Complaints, Respondent was a licensed medical physician in the State of Florida, having been issued License No. ME 0016828. Respondent specialized in internal medicine and emergency medicine but has never been board certified in any specialty. Respondent's license has been delinquent since January 31, 2000, but because delinquent licenses may be subject to renewal, the Petitioner has persisted in prosecuting these cases. DOAH Case No. 99-4377 On July 21, 1995, B.W., a 56-year-old female, presented to Respondent in the emergency room of Florida Hospital Waterman, with complaints of chest, epigastric, and left shoulder pain. B.W. had a history of dermatomyositis, for which she had been taking 100 mg of Prednisone for a month, along with other medications. Prednisone in such large doses can cause gastrointestinal irritation, ulceration, and bleeding. The day before, B.W. had been prescribed Imuran by her rheumatologist for immunologic problems. Dermatomyositis is a degenerative disease of skeletal muscle that can lead to a multitude of complications, including rheumatologic problems evidenced by abnormal laboratory results. The standard of care in the examination and treatment of a patient with chest pain requires an emergency physician to obtain a history including a complete medical history, family history, and social history. Additionally, in order to meet the standard of care, the emergency physician must perform a complete physical examination, including a review of systems. The emergency room records for Respondent's treatment of B.W. show the information contained above in Finding of Fact No. 4. The emergency room records do not show that Respondent obtained or documented a complete medical history, family history, or social history of B.W. Respondent violated the standard of care in that he failed to obtain or document a complete medical history, family history, or social history of B.W. Respondent also violated the standard of care in that he failed to perform or document a complete physical examination, including a review of systems. Respondent ordered an electrocardiogram (EKG), a chest X-ray, a complete blood count (CBC), complete cardiac enzymes testing (CPK and CKMB), and a metabolic profile or chemistry panel (MPC). He also did a rectal exam which was negative for blood. He did all appropriate tests. He did not fail to order any appropriate tests. The EKG and the chest X-ray yielded normal results, but B.W.'s blood count revealed several abnormal values, including a decreased platelet of 21,000 and a markedly elevated white count of 24,000. A platelet count of 21,000 is extremely low and grounds for major concern, as is the elevated 24,000 white count. Together, in the presence of the other symptoms and abnormal blood values present, which included low RBC, anemic hemoglobin, and low hemocrit, the standard of care requires that an emergency physician obtain a consultation with a specialist, such as a rheumatologist or a hematologist. In light of all the foregoing results and normal corpuscular volume, which B.W. also had, the emergency physician should have recognized that B.W. did not have simple iron deficiency anemia. Under some circumstances, the emergency room physician's consultation with B.W.'s primary care physician, who in this case was also a rheumatologist, would have been sufficient. Respondent maintained that he had obtained a history from B.W. as set forth in Finding of Fact No. 4, and an oral report from the hospital lab technician to the effect that a blood test ordered by B.W.'s treating rheumatologist the preceding day, July 20, 1995, had shown a platelet count of 18,000, and that because Respondent presumed B.W.'s platelets were increasing with the use of Imuran plus other factors, Respondent did not admit B.W. to the hospital, but, instead, discharged her without even consultation. Despite Respondent's foregoing explanation, it is clear that Respondent did not record or document on B.W.'s chart his oral conversation with the lab technician, if, in fact, such a conversation occurred. This was below the acceptable standard of medical care and record-keeping for an emergency room physician. Respondent stated that he felt that because the treating rheumatologist had not admitted B.W. to the hospital or transfused B.W. the previous day, she should not be admitted or transfused on July 21, 1995. He stated that he also relied on a medical text (Merck's Manual) which allegedly states that platelet transfusions should not be given until the count falls to 10,000. Respondent stated that he ruled out a myocardial infarction on the basis that both the CKMB on B.W. and the CKMB Index were not elevated and B.W.'s EKG was normal. However, Dr. Tober, who is certified in emergency medicine, testified more credibly that he had never seen a CPK test so high; that interpretation of CPK and CKMB in such a patient as B.W. would be confounded by the co-existence of the dermatomyositis, grossly throwing off these tests in an acute cardiac setting, sometimes causing several EKGs to come back normal in the course of a myocardial infarction; that B.W.'s extremely low platelet count should cause great concern about the hemologic system and clotting response if B.W. started to hemorrhage; and that the suspiciously low lymphocytes and all blood parameters should have caused Respondent not to discharge B.W. prior to a consultation with a specialist. Respondent failed to meet the standard of care by the treatment he rendered to B.W., in that he did not obtain a consultation from either the primary care physician, another rheumatologist, or a hematologist, before discharging her. That standard of care requires an emergency physician to determine an appropriate diagnosis and treatment as related to the patient's complaint and results of examinations. Respondent violated the standard of care in that he merely wrote into B.W.'s chart a portion of her medical history, "dermatomyositis," instead of a current diagnosis which addressed her current abnormalities when she presented in the emergency room. Thus, Respondent did not discern an appropriate diagnosis while appropriately treating B.W.6 Respondent's chart on B.W. is illegible to the extent that Dr. Tober was unable to read most of 23 lines of it. Because proper care of patients requires that medical records be sufficiently legible for successive professionals to discern what the writer has done and analyzed, I find that Respondent is guilty of keeping written medical records that are illegible and difficult to decipher. I do not consider Hospital Waterman's failure to provide dictation or transcription equipment and/or personnel to excuse this flaw. DOAH Case No. 99-4378 On or about July 14, 1995, Respondent was convicted of driving under the influence and placed on probation for 12 months, and his driver's license was revoked for 12 months. About two years later, on July 12, 1997, Respondent's vehicle collided with another vehicle. Respondent and the driver of the other car were injured. Blood was drawn from Respondent at the hospital. Laboratory studies performed by the Florida Department of Law Enforcement revealed that Respondent's blood alcohol level was 0.10 grams of ethyl alcohol per 100 ml. Under Florida law, a driver is legally intoxicated when his blood alcohol level is 0.08 grams of ethyl alcohol per 100 ml or higher. On August 12, 1997, Respondent was arrested and charged with one count of serious bodily injury while driving under the influence, and two counts of property damage while driving under the influence. On July 2, 1998, Respondent entered a plea of guilty7 to one count of serious bodily injury while driving under the influence and was sentenced to imprisonment for a period of seven years, one month, and eight days. On or about January 13, 1998, Walter J. Muller, M.D., a board-certified psychiatrist, performed a psychiatric evaluation of Respondent. Dr. Muller diagnosed Respondent with major depression, dysthymic disorder, and alcohol abuse, pursuant to The Diagnostic and Statistical Manual-IV. At that time, these conditions were active and not in remission. The diagnosis of major depression correlates with impaired social and occupational functioning. A diagnosis of dysthymic disorder is an indication of impairment and the inability to practice medicine with skill and safety to patients. A diagnosis of alcohol abuse can be an indication of inability to practice medicine with skill and safety to patients, but would depend upon when the abuse is occurring and how long it has been since the abuse occurred. In the expert opinion of Dr. Raymond Pomm, who is board certified in adult psychiatry and general psychiatry, with added qualifications in addiction psychiatry, and who relied on Dr. Muller's evaluation, the combined three diagnoses of major depression, dysthymic disorder, and alcohol abuse revealed that, to a degree of reasonable medical certainty, Respondent was unable to practice medicine with skill and safety to patients on the date of Dr. Muller's report. Respondent was evaluated at Menninger Clinic in Kansas, on or about May 26, 1998, and diagnosed with alcohol dependence. After six weeks of treatment at the Menninger Clinic, Respondent was released as being "in early remission." The treating physician made a number of recommendations for rehabilitation of Respondent, including treating his alcohol dependence by entering into a monitoring contract with the Physician's Resource Network in Florida and requiring a further evaluation by a neurologist of Respondent's apparently diminished cognitive skills. Dr. Pomm did not have the opportunity to read the entire evaluation by the Menninger Clinic, and did not rely upon it in forming his opinion of Respondent's inability to practice medicine with skill and safety to patients. However, according to Dr. Pomm, there is no cure for alcohol dependence. It is a life-long illness, which is incurable, and which at best, can only be "in remission." In Dr. Pomm's opinion, one who is alcohol-dependent cannot practice with skill and safety to patients without undergoing a monitoring program. While I accept Respondent's testimony that he has remained sober since approximately May 27, 1998, because he has been in prison, I also note that Respondent has not entered into a monitoring contract or been monitored in a recovery program because he has been in prison. Accordingly, there is no evidence that Respondent's circumstances have changed sufficiently since January 13, 1998, so as to demonstrate that he is able to practice medicine with skill and safety to patients in the real world.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of all violations charged, and as a penalty therefore, suspending Respondent's license to practice medicine in Florida until such time as Respondent presents to the Board and proves that he can practice with skill and safety. DONE AND ENTERED this 15th day of June, 2000, in Tallahassee, Leon County, Florida. ELLA JANE P. DAVIS 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 15th day of June, 2000.
The Issue Whether Respondent raced an animal with a drug in violation of section 550.2415(1)(a), Florida Statutes (2012),1/ as alleged in the Administrative Complaints, and, if so, what sanction is appropriate.
Findings Of Fact The Division is the state agency charged with regulating pari-mutuel wagering in the state of Florida, pursuant to chapter 550, Florida Statutes (2015). At all times material, Mr. Ziadie held a pari-mutuel wagering occupational license, number 701515-0121, issued by the Division. At all times material, Mr. Ziadie was subject to chapter 550 and the implementing rules in Florida Administrative Code Chapter 61D-6.2/ Under section 550.2415(1)(a), an animal may not be raced with any drug. It is a violation for any person to administer a drug to an animal which results in a positive test in samples taken from the animal after the race. Under section 550.2415(1)(c), "[t]he finding of a prohibited substance in a race-day specimen constitutes prima facie evidence that the substance was administered and was carried in the body of the animal while participating in the race." Under rule 61D-6.002(1), "[t]he trainer of record shall be responsible for and be the absolute insurer of the condition of the . . . horses he/she enters to race." As reflected in Division records kept in accordance with the 2010 Equine Detention Barn Procedures Manual ("the Manual"), which was in effect at all relevant times, Mr. Ziadie was the trainer of record of the thoroughbred horses from which samples were obtained in Ziadie I and Ziadie II. Mr. Ziadie is substantially affected by the Division's intended action. The equine detention barn is the site at each licensed racetrack in Florida where employees of the Division collect urine and blood samples from racehorses. It includes a fenced- in and secured area that generally has at least six stalls, as well as an area for walking the horses after a race. After a horse has been selected for sample collection (usually the top two or three finishers and sometimes a "special" that has been added at the request of the stewards), a Division employee tags the horse and accompanies it back to the detention barn. Along the way, a Division veterinary assistant assigned to the horse assumes custody and escorts the horse. At the barn, the horse is positively identified by means of a tattoo on the underside of its lip. The horse is walked to cool it down and sometimes bathed, and then taken into a stall for sample collection. Following their respective races, Mr. Ziadie's horses were immediately taken in this fashion to the detention barn for the taking of urine and blood samples. The Division publishes the Manual under the direction of Ms. Blackman as the chief of operations. The Manual is used at all horse racing facilities in the state of Florida and was last updated on June 25, 2010. The Manual provides that veterinary assistants, chief veterinary assistants, detention barn security guards, and detention barn supervisors "study, become completely familiar with, and put into practice" the procedures outlined in the Manual. It describes seven steps in chain-of-custody procedures, three of which are "collecting the specimen, sealing the specimen, and completing the required forms," and describes detailed procedures in this "strict sequence of events that must be followed." As the Manual makes clear, Division employees at the detention barns in the state of Florida are all required to follow the procedures outlined in the Manual "each and every time" they work with samples. They do not have discretion not to follow its requirements. Mr. Stirling credibly testified that in his capacity as executive director of the Florida Horseman's Benevolent and Protective Association, a position he has held for 20 years, he was an advocate for the horsemen. He attended all of the workshops for rules relating to medication overages as one of his primary duties. The centrifuging process, extraction of the serum, and sealing of the serum specimen as described in detail in the Manual were never discussed at a rulemaking hearing. These procedures are not a part of rule 61D-6.005, adopted in 2001. As he testified, Mr. Stirling was not even aware of these procedures until a month or two before the final hearing in these cases. The Manual has not been adopted under the procedures of section 120.54. At the time of these races, rule 61D-6.005, effective November 19, 2001,3/ governed the procedures for the taking of urine and blood samples from the horses. Subsection (3) provided in part: The specimen shall be sealed in its container, assigned an official sample number which is affixed to the specimen container, and the correspondingly numbered information portion of the sample tag shall be detached and signed by the owner, trainer, groom, or the authorized person as a witness to the taking and sealing of the specimen. Subsection 4.5 of the Manual describes the sample tag in greater detail: RL 172-03 is a self-adhesive sequentially numbered bar-coded, three part form (blood label, urine label and card) provided by the University of Florida Racing Laboratory that is used to catalog specimens by assigning them "Specimen Numbers." As specimens are collected, information regarding the animal from which the sample was collected is written on the bottom of this form. The top two portions of the form (Blood, Urine) are completed with the Track Number and Collection Date. The applicable top portions of the form are then separated and applied to the urine specimen cup and/or evergreen blood tube. The bottom portion, or Specimen Card, is completed and appropriately signed and is sent to the Tallahassee Office of Operations to be filed. The sample tag thus consists of three portions: the numbered portion designated for the blood specimen ("blood label"), the numbered portion designated for the urine specimen ("urine label"), and the numbered portion containing additional information about the animal and trainer that is to be signed by the witness ("card"). In the sampling procedures followed in these cases, the blood label was not affixed to the collection tube. The blood label, from which the card portion was "detached," was affixed to the evergreen blood tube. This was consistent with the governing rule, as well as the Manual. The evergreen tube is the specimen container for the serum. The sampling procedures followed with respect to the serum and urine samples taken in Ziadie I and Ziadie II were in compliance with the procedures set forth in the Manual. As stated in subsection 4.4 of the Manual, "[s]ealing the sample ensures the specimen does not spill during shipment to the laboratory and assures all parties that the sample has not been tampered with." The same purposes are served by sealing the serum specimen. After the blood samples were taken by the veterinarian, they were not "sealed" in the collection tubes. The fact that the collection tubes are air tight prior to and after the taking of the blood and initially contain a partial vacuum to facilitate collection, does not constitute "sealing" of the specimen in its container for purposes of the rule. As Dr. Watson testified: Q: Okay. Are these 15 milliliter tubes sealed? A: Well, they're sealed in that there's a vacuum in there and in order to draw the blood efficiently, that vacuum has to be there. If that seal is broken then it would not work. But, as far as sealing for legal purposes, they're not sealed at that time. There's a process that it has to go through in order to extract the serum. The three collection tubes are not the specimen container, but the last three digits of the number from the blood label affixed to the specimen container were written on each blood collection tube with a black "Sharpie" type marking pen to ensure control of the sample. The Manual prescribes detailed procedures for spinning the blood collected from the race horses in a centrifuge to extract the serum. After the blood was centrifuged, and the serum was poured into the evergreen tube, the serum was sealed with evidence tape, as described in the Manual, and the chief veterinary assistant put his initials over the seal. This constituted "sealing" of the specimen in its container. Subsection 4.6 of the Manual provides: Serum is poured into applicable (numbered) "evergreen" tubes. Each "evergreen" tube is immediately properly sealed with evidence tape. Rule 61D-6.005 does not make any reference to spinning the blood in the centrifuge to extract serum, the pouring of serum into an evergreen tube, the sealing of the evergreen tube with evidence tape, or the freezing of the specimen. The Manual establishes additional policies and procedures not contained in the rule. The serum must be separated from the blood because whole blood cannot be frozen without damage that would affect its usefulness in laboratory testing. Centrifuging facilitates the separation of the serum from the whole blood. The transfer of the separated serum from the glass collection tubes to the plastic evergreen tube is then done for two reasons. First, the plug that helps separate the serum can allow the blood cells to seep around and return to the serum, where they can release hemoglobin and iron, which can distort laboratory analysis. Second, using the plastic evergreen tube saves shipping weight and reduces the incidence of breakage during shipping. The centrifuged collection tubes are stored in a locked refrigerator. The opening of the centrifuged collection tubes and the pouring of the serum into correspondingly numbered evergreen specimen containers is carefully performed by Division employees with the intent to avoid contamination. The sealed evergreen specimen containers then remain in a locked freezer until they are shipped to the laboratory. The evidence was clear and convincing that the serum specimens in these consolidated cases were derived from the blood sample tubes bearing the same last three numbers as the tag which was prepared when the blood was taken. The serum specimens came from Mr. Ziadie's horses. Dr. Barker testified that the "free pour" of the serum was the point at which the specimen was most vulnerable, and that contamination or tampering was possible. He stated he would have preferred more supervision, witnessing, and documentation as to who was doing what, at what time. Dr. Cole concurred that there is always a possibility of contamination when a sample is transferred from one container to another. However, the free pour method used to transfer the serum from the collection tubes into the evergreen specimen container is one of the better approaches, as opposed to using a pipette or other method that would put something into the sample. Contamination from the free pour of the serum is unlikely. There was no evidence introduced to suggest that misidentification, tampering, or contamination of the specimens was likely or probable. The state veterinarian who took the blood sample from each horse signed PMW Form 504, a Daily Record of Sample Collection, indicating that this had been done. After centrifuging the whole blood in the collection tubes, at the end of the day the state veterinarian usually leaves the collection tubes with the chief veterinary assistant, who pours the separated serum from each collection tube into the correspondingly numbered evergreen container and seals it. Sometimes, the state veterinarian stays to observe the transfer of the serum to the evergreen specimen container. No document is signed to note the time that the state veterinarian leaves the samples at the detention barn or the time that the chief veterinary assistant opens the collection tubes and transfers the serum. Custody of the samples remains with Division personnel throughout this process. No transfer of custody takes place until the specimen containers are shipped to the laboratory. In each instance of sampling in these cases, the owner's witness signed the card portion of the sample tag (Form RL 172-03) after the taking of the urine and blood samples. In each instance of sampling in these cases, the owner's witness signed the card portion of the sample tag after the sealing of the urine specimen in its container, but before the sealing of the serum specimen in its container, the evergreen tube. In each instance of sampling in these cases, the owner's witness did not observe the extraction of the serum or the sealing of the serum specimen in its container with the evidence tape. The witnesses could have remained to watch those procedures had they requested to do so. Subsection 4.6 of the Manual states, "the owner, trainer of record or designated authorized witness may leave with the released animal or may elect to witness the conclusion of the collected blood specimen processing and sealing cycle." According to Division policy, two signs are posted in the detention barns to advise owners' witnesses that they may remain to witness the centrifuge process and sealing of the sample. Specific testimony that a sign was in place at the exact times sample collection took place in each of these races, or the exact location that it was posted, was lacking. However, there was more general testimony from Dr. Watson that signs have been posted ever since he has been employed. Dr. Watson credibly testified that, during the five years he has been working at the tracks, no owner's representative has ever stayed to watch the centrifuging of the samples or the sealing of the serum specimen container. The pouring of the collection tubes into the specimen container takes place at the end of the racing day, after all of the horses have departed from the detention barn. It would be very inconvenient for an owner's witness to remain until the serum specimens were sealed. The procedures that were followed--set forth in the Manual--which allowed the owner's witness to sign the sample tag after witnessing the taking of the blood but before the sealing of the specimen, were not in compliance with rule 61D-6.005(3), quoted above, which required the owner's representative to sign as a witness to both the taking and sealing of the specimen. Even had it been clearly shown that signs advising the owners' representatives that they were allowed to stay and witness the sealing of the specimen container were prominently displayed on every occasion on which the samples were taken, this would not bring the procedure being followed into compliance with rule 61D-6.005(3). The requirement that the authorized representative must witness not only the taking, but also the sealing of specimens, is a provision directly related to maintaining integrity in the sample collection process. Such deliberate disregard of the plain language of the rule directly affects the fairness of the entire blood sampling procedure. The urine and serum samples in these cases were properly delivered to the University of Florida racing laboratory and the integrity of the samples was intact. The laboratory conducts an initial screening of each urine sample in a process of elimination to weed out negative samples that do not contain any suspected drugs. This screening looks at a large number of samples and screens them broadly. The suspicious samples are then subjected to confirmation testing, in either serum or urine, testing a fewer number of samples and targeting for detection of specific drugs. The Association of Racing Commissioners International create Uniform Classification Guidelines for Foreign Substances. Classes range from class I drugs, which have no therapeutic value and are most likely to affect the outcome of a race, to class V drugs, which have the most therapeutic value and the least potential to affect the outcome of a race. Class III, IV, and V drugs all have some therapeutic value. Clenbuterol is a bronchodilator, a drug which may be prescribed for horses for therapeutic purposes. If a horse had blood or sand in his lungs after a race, he might be placed on clenbuterol for five to eight days, twice a day, and the medication would clean the lungs out completely. Clenbuterol also has the capacity to be a repartitioning (conversion of fat into muscle) agent. It is not as effective as an anabolic steroid, but it does have the capacity for building muscle. Rule 61D-6.008 does not permit any clenbuterol in the body of a racing animal on race day. Clenbuterol is a Class III drug under the Uniform Classification Guidelines for Foreign Substances. Phenylbutazone is a nonsteroidal anti-inflammatory drug effective in treating fever, pain, and inflammation. It was credibly described as having effects similar to aspirin. Rule 61D-6.008(2)(a)2. provided in part that, "[p]henylbutzone may be administered to a horse providing . . . the post-race serum sample of such horse contains a concentration less than 2 micrograms (mcg) of Phenylbutazone or its metabolites per milliliter (ml) of serum." Phenylbutazone is a class IV drug under the Uniform Classification Guidelines for Foreign Substances. The laboratory routinely receives only the information on the urine and blood labels with the specimens and does not know the identity of the horse or trainer. Samples tested in the laboratory are assigned an "LIMS" number internal to the laboratory and do not contain any information that would identify the horse or trainer. The technicians who actually conduct the tests are not informed of the name of the horse or trainer involved. Once the Division is advised by a laboratory report that a sample has "tested positive" for a particular substance, the Division matches the laboratory report to the sample tag, which has been kept under lock and key, to determine the identity of the horse and trainer. The stewards and trainer are then notified. After the trainer is notified of positive results, he has the opportunity to request a split sample. In this procedure, a portion of the specimen is shipped from the University of Florida laboratory to an outside laboratory for independent analysis. There is a minimum amount of a drug that can be detected scientifically with a reliable concentration range. As the scientific capability to detect a drug improves, this testing level can be lowered by a laboratory. The instrumentation can almost always detect the presence of the drug below the reliable concentration range that establishes the testing level. As Ms. Wilding testified, a "withdrawal time" is the time interval prior to sample collection at which the last administration of a drug can take place to allow the drug to be cleared from the horse's system so that no "positive" would be reported in that sample based upon the test detection level or reporting point for that particular drug. Mr. Stirling testified that based upon informal conversations with Dr. Tebbet, Dr. Cole, and Dr. Sams, former directors of the laboratory, he had disseminated information to horsemen for years that a five-day withdrawal time would be appropriate for clenbuterol. From July 1, 2010, until June 30, 2011, there were four clenbuterol positives from horse race tracks in Florida. From July 1, 2011, until June 30, 2012, there were 13 clenbuterol positives from horse race tracks in Florida. During this same fiscal year, the laboratory also found the presence of clenbuterol in 193 additional samples, but did not deem them "positives." In these samples, the laboratory detected clenbuterol in a concentration of less than 25 picograms per milliliter. Dr. Barker credibly testified that the fact that 193 findings of clenbuterol at less than 25 picograms per milliliter were not called "positives" indicated that either the laboratory or the Division had some form of confirmation level established. As Ms. Wilding testified, changes to the protocol as to the amount of a drug that must be present in a sample before that sample will be called "positive" are made through revisions to the laboratory's standard operating procedures (SOPs). Ms. Blackman testified that she had conversations with Ms. Wilding at the laboratory "sometime in, maybe, the summer of 2012" about the ability of the laboratory to calibrate their instruments to detect clenbuterol at the lowest level, based upon Ms. Blackman's understanding that clenbuterol was being abused, in that it was being prescribed not just for its bronchodilator effect, but also for its anabolic effects. SOP DCN: R1.07.04.05.04-07, entitled "Extraction of Clenbuterol from Horse Serum or Plasma and Identification by Liquid Chromatography-Tandem Mass Spectrometry," effective April 27, 2012, established the low end of the calibration curve at 10 picograms per milliliter. The amount of the lower positive control was 25 picograms per milliliter. The SOP provided: "If the mean concentration of clenbuterol in the test sample is less than the lower end of the calibration curve, it will not be reported." From July 1 until December 31, 2012, there were nine clenbuterol positives from horse race tracks in Florida. The first Florida positive called by the laboratory for a thoroughbred race horse whose post-race serum sample contained a level of clenbuterol less than 25 picograms per milliliter of serum was for the first race in Ziadie I, on July 4, 2012, which was reported as a positive with a level of 18 picograms per milliliter. Testing also confirmed in serum the presence of phenylbutazone in that first sample, in the amount of 2.3 micrograms per milliliter, an amount in excess of the 2 micrograms per milliliter which is permitted. The laboratory results were sent to the Division by letter dated August 6, 2012. The initial confirmation of the phenylbutazone overage and clenbuterol positive from the race of July 4, 2012, was originally sent to the stewards to resolve but was later taken from the stewards and turned into an administrative complaint. On August 9, 2012, a long article appeared in the Miami New Times entitled "Cheaters Prosper at Calder Park." The article described a racing industry tainted by drug violations and criticized the Division for lax regulations and poor enforcement. The article identified Mr. Ziadie by name, giving a short biography and saying there were signs of "systematic rulebreaking" over his long racing career. Ms. Blackman saw the article. She also forwarded an e-mail attaching the article to Ms. Wilding at the laboratory. Clenbuterol was confirmed in serum taken after the other four races of the Ziadie I complaint, held on August 17, August 30, September 14, and September 27, 2012. The concentration of clenbuterol in those samples ranged from 10 to 21 picograms per milliliter. The results from the laboratory were provided to the Division on September 25, October 1 (two races), and October 16, 2012. At Mr. Ziadie's request, the samples were split, and an independent laboratory confirmed the presence of clenbuterol in each sample. In late December 2012, the Division gave the laboratory authority to begin conducting confirmation testing for clenbuterol in urine rather than in serum. In the beginning of 2013, the laboratory changed to a 140 picogram per milliliter confirmation level for clenbuterol in urine. The Division did not give notification to the horsemen or veterinarians of these changes. From January 1, 2013, until June 30, 2013, there were 154 clenbuterol positives from the horse race tracks in Florida. Dr. Barker testified: So you would be able to see clenbuterol in urine for a much longer period of time. And, of course, that's also why ARCI now has a urine threshold instead of a plasma threshold because the idea was to push it out as far as they could and still be able to call it. They couldn't do that sufficiently in blood, they felt, so they converted it to a urine threshold. So if you go from a plasma threshold to a urine threshold, particularly the-–if it's a threshold that ARCI has recommended, you know, ARCI threshold is 140 picograms per ml in urine, and that's based on using the lowest dose and a 14-day withdrawal. Well, if you had been using the lowest dose and had been following a five-day withdrawal, you would come up positive. If you had been using the lowest dose and had been following a ten-day withdrawal, you're going to come up positive. And so if people, trainers and veterinarians, were not being informed of a change in how the laboratory was testing and interpreting data, and basically was working from a position that required a longer withdrawal time and the horsemen didn't know that, well, you're going to-–you should get all kinds of positives. Dr. Barker's explanation of the consequences of changing from a serum confirmation to a urine confirmation for clenbuterol is credited. His testimony also at least partially explains why there is not a clear correlation between the concentrations of clenbuterol detected in serum with the concentrations detected in urine from samples taken at the same time. The amounts of clenbuterol and the times it was administered to the horse remain unknown variables, and clenbuterol is detectable for a longer period of time in urine. Differences might also be explained by the amount of water the horse drank, or other factors. On or about February 8, 2013, following the great increase in the number of positive calls for clenbuterol, Mr. Stirling posted a notice regarding withdrawal times at the tracks and published it in the "overnights" that went to trainers. The notice stated: According to the Department [sic] of Pari Mutuel Wagering the withdrawal time for clenbuterol is the same as it was previously (5 days) at the proper dosage. If you had a recent positive for clenbuterol and used the old/new withdrawal time there should be no administrative action taken against you. At either the end of February or the beginning of March of 2013, the Division requested the laboratory to return to clenbuterol confirmation screening in serum, rather than urine. SOP DCN: R1.07.04.05.04-09, entitled "Extraction of Clenbuterol from Horse Serum or Plasma and Identification by Liquid Chromatography-Tandem Mass Spectrometry," effective March 7, 2013, established the low end of the calibration curve at 5 picograms per milliliter. The low end of the calibration curve reflects the lower limit of detection at which the SOP can detect a drug with a reliable concentration range. The amount of the lower positive control was set at 15 picograms per milliliter. The SOP provided: "If the mean concentration of clenbuterol in the test sample is less than the lower end of the calibration curve, it will not be reported." Clenbuterol was confirmed in serum in confirmation testing of 13 of the Ziadie II samples, taken after races from March 13, 2013, through October 27, 2013, ranging in concentration from 5 to 14 picograms per milliliter. These samples were also split, and an independent laboratory confirmed the presence of clenbuterol in each sample. Testing also confirmed in serum the presence of phenylbutazone in the sample taken from the race on January 19, 2014, in Ziadie II, in the amount of 2.3 micrograms per milliliter, plus or minus .3 micrograms. The Division did not give notification to the horsemen of any changes in the testing level at which the laboratory would report that a sample had tested positive for clenbuterol. Ms. Blackman testified that clenbuterol is not permitted at any level on race day, and it is the trainers' responsibility, in conjunction with their veterinarians, to decide whether to administer a particular medication at all. She testified that she did not think it was in the best interest of the horses or the Division to make announcements every time they are able to detect a new drug or an existing drug at a lower level. In contrast, she noted, when the amount of phenylbutazone permitted in a horse on race day was lowered from mg to 2 mg, this was announced to the horsemen through the public rulemaking process. An advance notice of about six months allowed trainers to work out adjustments with veterinarians so there would not be a huge number of phenylbutazone positives when the new rule became effective. Since phenylbutazone is a "threshold" drug permitted on race day at no greater than prescribed amounts, Ms. Blackman testified that it was reasonable to give horsemen notice of this change. Dr. Cole testified that she had a different view about changes to testing levels of drugs such as clenbuterol that were completely prohibited on race day when she was the director of the lab, saying she believed it was "prudent and fair" to notify the horsemen of changes in advance: Often when we're changing levels or sensitivity for medication type—drugs that have legitimate use in a horse, we would try to have a conversation with the horsemen to let them know that change was coming so that they could comply. Generally it's going to be an increase in the withdrawal time that they're going to be needed. On March 20, 2013, Mr. Stirling sent an e-mail to Ms. Blackman stating that he was beginning to get low-level positives for clenbuterol again, giving an example of picograms per milliliter. He stated he thought the testing medium had been changed back to blood to return to a five-day withdrawal time and asked how the Division planned to handle the low-level clenbuterols from December. In e-mail correspondence continuing through April and May of 2013, Mr. Stirling continued to question the Division about the withdrawal time and to urge a 25 picogram per milliliter testing level. Ms. Blackman advised that the laboratory was re-confirming in serum the clenbuterol positives that had been confirmed in urine. She noted that a 10 picogram per milliliter reporting point for testing in serum had been established prior to the change in the medium for confirmation and noted there was no "threshold" for clenbuterol in Florida. On May 24, 2013, Ms. Blackman advised Mr. Stirling that clenbuterol positives confirmed in serum at 5 picograms per milliliter or a greater concentration would be prosecuted. On or about May 29, 2013, Mr. Stirling issued a memorandum to Florida horsemen advising that the Division was continuing to call clenbuterol positives at levels detected below 25 picograms per milliliter and suggesting that they should no longer rely on a five-day withdrawal time. The memorandum suggested that a 14-day withdrawal time "should be more than safe" for avoiding a clenbuterol positive. Mr. Ziadie admitted he did not change his practice of utilizing a five-day withdrawal time in response: I was still stuck on the five days, your honor. I was stubborn. I know I did wrong. I know that there was a rumor and I know there was a brochure going around 14 days. but I was trying to do the best for my horses. I thought that it was the medication that they needed at the time when we were racing and I take blame for being stubborn and making a mistake, but I did keep it at 5 days. SOP DCN: R1.07.04.05.11-06, entitled "Extraction of Clenbuterol from Horse or Dog Urine and Identification by Liquid Chromatography-Tandem Mass Spectrometry," effective October 9, 2014, established the low end of the calibration curve at 50 picograms per milliliter and the high end of the calibration curve at 2000 picograms per milliliter. The amount set for both positive controls was 140 picograms per milliliter. The SOP provided: Report the calculated concentration of clenbuterol in the suspect sample as the average of its duplicates if its calculated value lies within the range of the calibration curve. If the calculated concentration of clenbuterol in the test sample is outside the range of the calibration curve, it will be reported as either greater than, or less than the limits of the calibration curve. Based on the serum test results, the Second Amended Complaint in Ziadie I was served on Mr. Ziadie on or about September 8, 2014. The First Amended Complaint in Ziadie II was served on Mr. Ziadie on or about March 16, 2015. Other trainers whose horses tested positive for clenbuterol did not have administrative complaints filed against them. The Division, instead, settled their cases with fines. Almost all of these trainers had few prior violations, however. There was credible testimony that the Division had offered to settle charges against one other trainer who had numerous prior violations with the imposition of fines and a short suspension, but there was no evidence that a settlement had been reached. It was also noted at hearing that this trainer's recent violations were in close proximity, which suggested that he might not have been informed of the violations in one case before the samples were taken in the next. The Division noted that this could be a mitigating factor, because a trainer would not reasonably have had an opportunity to adjust his medication levels in response to the earlier violations. Ms. Wilding testified that, in early 2015, she was asked by the Division to re-confirm the 2012 positive serum confirmations from Ziadie I using the urine samples taken immediately after those races. The urine samples had been used for initial screening in 2012, but had not been used for confirmation at that time. The urine samples had been stored in a minus 30-degree freezer since the initial screening in 2012 had determined them suspicious for clenbuterol. On March 18, 2015, Ms. Wilding sent an e-mail to her immediate subordinates, the supervisors of the laboratory's four main divisions, advising that "PMW Legal is asking us to analyze the five urine samples in the first Ziadie case for clenbuterol." Her e-mail listed the sample numbers for the five urine samples and directed that they be rescreened for clenbuterol and then tested for confirmation. The 2012 urine samples were rescreened for clenbuterol in 2015, and, as Ms. Wilding testified, the results were in "good agreement" with the screening results from 2012. This indicated that the presence of clenbuterol remained relatively stable over that period of time. Although the laboratory supervisors knew the trainer associated with the samples, as Ms. Wilding and Mr. Russell testified, samples tested in the laboratory do not contain identification of the horse or trainer and are only marked with a "LIMS" number internal to the lab. The technicians who actually performed these tests were not informed of the name of the horse or trainer involved. Clenbuterol was confirmed in the urine in the 2015 tests in each of the five samples from Ziadie I, ranging in concentration from 1.8 nanograms per milliliter to 1.3 nanograms per milliliter. The samples were also split, and an independent laboratory confirmed the presence of clenbuterol in each urine sample. There was no significant degradation of the urine samples over the three-year period. The results were scientifically sound. In early May 2015, again at the Division's request, the laboratory began confirmation testing for clenbuterol in urine samples from the Ziadie II races. These urine samples were not rescreened because, as Ms. Wilding had earlier determined from the Ziadie I urine samples, the stability of clenbuterol in urine stored in a minus 30-degree freezer for several years was "excellent." The senior staff members were again likely told about the identity of the trainer. Again, samples tested in the laboratory do not contain identification of the horse or trainer and are only marked with a "LIMS" number internal to the lab. The technicians who actually performed the confirmation testing were not informed of the name of the horse or trainer involved. The samples confirmed positive for clenbuterol at concentrations, in picograms per milliliter, of 973, 551, 390, 212, 718, 450, 236, 740, 698, 225, 435, 197, and 435, all amounts with a measurement of uncertainty at plus or minus 30 picograms. Again, these results were scientifically sound. The serum specimens were routinely collected without the owners' representatives witnessing the sealing of the specimens and were not collected pursuant to the requirements of chapter 61D-6. The systematic and regular violation of this important requirement constituted a significant procedural error that affected the fairness of the blood sampling procedure. Subsection 4.6 of the Manual is an unadopted rule. The only evidence of the presence of phenylbutazone in any of Mr. Ziadie's horses was from serum obtained pursuant to the unadopted procedures of subsection 4.6 of the Manual and in a manner contrary to the Division's own rule. The Division failed to prove that Mr. Ziadie's horses carried a prohibited level of phenylbutazone in their bodies on race day. The urine test results proved that Mr. Ziadie's horses in these consolidated cases had clenbuterol in their bodies on race day. Mr. Lawson testified that as a licensed horse owner in the United States, South Africa, and Jamaica, he has had an opportunity to observe the different ways that trainers care for their thoroughbred horses. He testified that Mr. Ziadie's stalls were always clean, the handling of the feed was always done in a very systemized and structured way, and the best feed available was used, even though it had to be imported and was much more expensive. He testified that Mr. Ziadie's horses were always well groomed, they always looked very healthy, their coats were very shiny, their feet were carefully inspected, and they were happy horses. He testified that Mr. Ziadie looked after the specific needs of each horse, rather than treating them all the same, and spent a lot of time personally inspecting them. He noted that Mr. Ziadie didn't race his horses as often as other trainers. Mr. Lawson's testimony was bolstered by the stipulated testimony of Dr. Al Smollen, a veterinarian for the tracks, and the testimony about the excellent condition of Mr. Ziadie's horses, the cleanliness of their surroundings, the quality of the feed, and the care given to the horses is credited. The Division presented clear evidence that Mr. Ziadie has had 14 prior violations of section 550.2415, Florida Statutes. The Division case number, date of offense, name of restricted drug, classification, and disposition are as follows: CASE NUMBER DATE DRUGS CLASS
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Department of Business and Professional Regulation, Division of Pari-Mutuel Wagering, enter a final order finding Mr. Kirk M. Ziadie guilty of 18 counts of violating section 550.2415(1)(a), Florida Statutes, and Florida Administrative Code Rule 61D-6.002(1); imposing an administrative fine of $18,000; and suspending his license for six years. DONE AND ENTERED this 15th day of December, 2015, in Tallahassee, Leon County, Florida. S F. SCOTT BOYD 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 December, 2015.
The Issue The issue is whether Dr. Orasan violated Section 458.331(1)(n), Florida Statutes (1985), by failing to keep medical records that justify the course of treatment for two (2) patients, and whether he violated Section 458.331(1)(t), Florida Statutes (1985), by failing 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 by failing to order any laboratory testing to determine the efficacy of the course of treatment he prescribed for a patient.
Findings Of Fact Dr. Orasan is a licensed physician in the State of Florida holding license number ME 0022079. He has been licensed in Florida since 1974. There is no evidence of any prior charges against Dr. Orasan in Florida or anywhere else he has practiced. Dr. Orasan treated an undercover agent of the Broward County Sheriff's Office, Jodie Raft, during the period July 3, 1985, to October 10, 1985. Officer Raft used the name of Jodie Rafferty when she sought treatment from Dr. Orasan on three different occasions, and on a fourth where she accompanied another undercover deputy seeking treatment from Dr. Orasan, Joseph Damiano. For purposes of this order officer Raft will be referred to as Jodie Rafferty. When she first came to Orasan's office on July 3, 1985, Rafferty filled out a patient history form. Upon seeing Dr. Orasan, her chief complaint was her inability to relax with her boyfriend. Rafferty said she had previously been given Valium by a doctor in New York and it had helped her in interaction with a boyfriend there. By her appearance, her complaints, and clinical examination revealing a positive Chvosteck's sign and spots on her fingernails, Dr. Orasan determined that she had a calcium deficiency (which he referred to as spasmofilia), anxiety and reactive neurosis. He prescribed calcium and gave her a prescription for a small quantity of Valium for anxiety (60 2mg. tablets). After making his diagnosis on the facts set out above, Dr. Orasan did not order diagnostic blood testing to validate the diagnosis of a calcium deficiency. Dr. Orasan examined Rafferty on two more occasions, September 19, 1985 and October 10, 1985. His clinical examination continued to reveal a positive Chvosteck's sign and an indication from the fingernails that there was an underlying calcium deficiency. He continued to prescribe small quantities of Valium and a calcium supplement. An expert for the Board of Medicine opined that routine blood work should have been done to obtain a serum calcium level, and that the failure to have blood tests done on Rafferty (or at least to recommend them and note this in her records if Rafferty had indicated resistance to the cost of the test), constituted a failure to practice medicine with that level of care, skill, and treatment which is recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances. Dr. Orasan contends that his clinical findings justified the diagnosis of low calcium, and that testing to confirm this would be redundant and wasteful of the patient's money. Regarding the records kept on Rafferty, the entries made in Dr. Orasan's own medical records form with regard to the history, physical examination, diagnostic impressions and plan of treatment are exceedingly brief and inadequate. On October 17, 1985, Joseph Damiano, using the name Joseph Delano, came with Rafferty for a consultation with Dr. Orasan. Delano filled out a medical form for the receptionist. When he saw Dr. Orasan, Delano explained he wanted Valium to increase sexual longevity. Orasan checked Delano's blood pressure, reflexes and found a positive Chvosteck's sign. He determined that Delano also had a calcium deficiency and prescribed a small quantity of Valium for anxiety and premature ejaculation (60 10mg tablets). Dr. Orasan emphasized to Delano, as he had to Rafferty, the addictive quality of Valium, and emphasized that it should not be used for a long period or in large doses. The expert witness for the Board of Medicine found that the actual interviews which Orasan had with the patients (which had been taped and the transcriptions of which were entered into evidence), justified the prescriptions for the small quantities of Valium, and that Dr. Orasan "exercised good to excellent judgment and control over how [he] wrote the prescriptions and the advice he gave to the patients. Particularly, in the advice [he] gave to the patients, I must comment that I believe that that is above community standard" (Tr. 89). With regard to his records, Dr. Orasan, himself, admitted to some deficiency in the charts and conceded that "they were perhaps two of the worst charts in my life". (Tr. 108.) The office charts kept on both patients were inadequate. Dr. Orasan prefers not to record a diagnosis of sexual dysfunctions such as anxiety or premature ejaculation. He believes these conditions may be transient, but health insurers or others who may later have access to the records may view such diagnoses as indication of psychosis and cause patients difficulties such as denial of insurance. This belief fails to justify the brevity of the records. The problem with the records is not just with the diagnosis, but also with the inadequate record of history and clinical findings. With respect to the charge of malpractice by not obtaining serum calcium levels on patient Rafferty, there is not clear and convincing evidence that Dr. Orasan's performance failed to meet prevailing standards of practice in the Broward County medical community. Dr. Orasan's difference in approach from the Department's expert is one of relative emphasis on the usefulness of the information to be derived from testing, when balanced against the cost of testing. These two doctors disagree. The evidence taken as a whole is not persuasive that Dr. Orasan's judgment that further testing was unnecessary constituted malpractice.
The Issue The issues in this case are whether the allegations of the Administrative Complaint are correct, and, if so, what penalty should be imposed.
Findings Of Fact The Respondent is a licensed medical doctor, holding license number 44726. At all times material to this case, the Respondent was a physician holding board certifications in internal medicine, hematology, and oncology. Patient 1 was a patient of another hematologist, Dr. Thomas Katta. On March 17, 2003, Dr. Katta had Patient 1 admitted via the patient's internist (Dr. Frank Leiva) to Sand Lake Hospital in Orlando. The patient was anemic and thrombocytopenic and had been previously diagnosed with autoimmune hemolytic anemia, the treatment for which was transfusion. Failure to transfuse a person suffering from autoimmune hemolytic anemia can lead to death, and such a transfusion had been ordered for the patient. Dr. Katta apparently had personal obligations for the evening of March 17, 2003, and for the following day, and, in the late afternoon of March 17, 2003, he asked the Respondent to "cover" his hospitalized patients. The Respondent agreed to do so. Dr. Katta's office transmitted a list of the patients by fax to the Respondent's office. The list contained the full names and locations of Dr. Katta's other hospitalized patients, but identified Patient 1 only by last name and diagnosis ("AIHA"). The fax did not indicate the patient's first name or gender and did not specifically identify the patient's location. The Respondent made no attempt to obtain additional information from Dr. Katta or his staff. The lab work performed upon admission to the hospital indicated that the patient was severely anemic and had a critically low platelet count. At approximately 6:30 p.m. on March 17, 2003, the Respondent received a telephone call through her answering service from a hospital nurse who reported that the patient was severely anemic and that there were problems obtaining a proper blood match for the transfusion. The Respondent advised the nurse to call the blood bank and tell them to find the least incompatible blood and get the transfusion done. The Respondent did not inquire as to the patient's name or location. At about 10:19 p.m. on March 17, 2003, the Respondent was again contacted by a hospital nurse, who advised that the patient was short of breath and had tachycardia at 133 beats per minute. The nurse also advised that the blood bank had been unable to find an appropriate match for the previously ordered transfusion and that the transfusion remained uncompleted. The Respondent directed the nurse to contact the patient's primary care physician or the cardiologist on call, but did not ask the identity of either practitioner. The nursing notes indicate that the Respondent stated that she did not provide treatment for tachycardia and did not believe that Dr. Katta did either. The Respondent also advised the nurse to call the blood bank and direct them to find the least incompatible blood and perform the transfusion. The Respondent did not inquire as to the patient's name or location and provided no other direction to the reporting nurse. On the next day, March 18, 2003, at about 6:15 a.m., the Respondent was contacted by a hospital nurse, who advised that the transfusion had still not taken place. The Respondent took no action and provided no direction to the reporting nurse. The Respondent did not inquire as to the patient's name or location. Later during the morning of March 18, 2003, the Respondent attempted to locate the patient while making her rounds but was unsuccessful. In attempting to locate the patient, the Respondent talked with various hospital personnel, but had no information other than the patient's last name and diagnosis. Based on her inability to obtain any additional information, the Respondent assumed that the patient had been transfused and discharged. The patient had not been discharged, but had been transferred to an intensive care unit in the hospital. The transfusion had not yet occurred. Patient 1 died on March 20, 2003. The Respondent was unaware of the patient's death until she saw Dr. Katta at the hospital, at which time he questioned her about the patient and informed her that the patient was dead. The Petitioner presented the testimony of Dr. Howard Abel, M.D., regarding whether the Respondent met the standard of care in her treatment of the patient. Dr. Abel's testimony regarding the standard of care issues is credited and is accepted. As to the issue of the uncompleted transfusion, the evidence establishes that the transfusion did not occur while the Respondent provided hematological care for Patient 1. The Respondent should have personally contacted the blood bank to identify the cause of the inability to provide blood for the transfusion and determine whether another option was available. The Respondent should have responded to the 10:19 p.m. call on March 17 by personally examining the patient and reviewing the history and lab test results. While the Respondent's directive to contact a cardiologist was not inappropriate, breathing difficulties and tachycardia are symptomatic of severe anemia for which hematological care was required. If the Respondent determined that the symptoms were cardiac-related, the Respondent should have personally made the cardiology referral and provided the information to the cardiologist. The Respondent did not do so and was unaware of the cardiologist's identity. A review of additional lab test results including observation and evaluation of blood smears would have provided useful information as to whether the patient's condition was deteriorating and to whether the patient was developing thrombotic thrombocytopenic purpura ("TTP"), a serious condition which, left untreated, is fatal in not less than 90 percent of cases. The blood smears had been performed by the time of the phone call, but the Respondent reviewed no lab test results and made no inquiries related to the results. The failure to review lab test results may have delayed a diagnosis of TTP. While there was some disagreement between testifying witnesses as to whether or not the patient had TTP, Dr. Katta ordered that the patient be treated for TTP immediately upon his return on March 19, 2003, and there is no evidence that Dr. Katta treated the patient for TTP without reasonable cause to do so. The evidence clearly establishes that the Respondent failed to review the patient's test results that could have provided timely and useful information regarding the patient's condition. As to the Respondent's failure to locate the patient on March 18, 2003, the Respondent testified that the patient's last name was common, but the Respondent had not called Dr. Katta at the time she received the faxed list of his hospitalized patients to obtain additional identifying information. The Respondent did not request the information from the nursing staff during any of the telephone calls and made no effort to obtain the information prior to arriving at the hospital to make her rounds. The Respondent would have become aware of the patient's location had she attended to the patient's breathing difficulties and tachycardia on the night of March 17. She would have also likely reviewed the medical records and would have become aware of the admitting physician as well as other information regarding the patient's condition. The Respondent consulted with hospital personnel on March 18, 2003, in attempting to identify those patients admitted by Dr. Katta. There were approximately ten to 12 other hospitalized patients with the same last name, none of which had been admitted by Dr. Katta. The Respondent was unaware that the patient had been admitted under Dr. Leiva's name. The Respondent did not visit the ten to 12 patients with the same last name to locate the one for which she was responsible. The Respondent did not contact the blood bank, which had been having difficulty providing transfusion blood to the patient. It is reasonable to assume that the blood bank, charged with the responsibility to provide the appropriate blood supplies to the patient, would have been aware of the patient's location, and could have provided it to the Respondent. The Respondent made no effort to identify patients located in the hospital's intensive care units, despite the critical nature of the patient's condition at last report. Had she done so, she would have located the patient. The Respondent presented testimony that it was not uncommon for a physician, unable to locate a hospitalized patient, to routinely assume that the patient has been appropriately treated and has been discharged, or is deceased. However, the Respondent testified that it was unusual for her not to be able to identify and locate a patient. Even assuming that such practice is routine, it is unlikely that such an assumption could reasonably be made in the case at issue here, where the Respondent did not know the patient's name, had never seen the patient, had personally reviewed no medical records, was unable to find anyone in the hospital who could provide her with any information, and at last communication with the nursing staff had been told that a critically-needed transfusion had not occurred. The testimony is not credited and is rejected.
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 Vasundhara Iyengar, M.D., in violation of Subsection 458.331(1)(t), Florida Statutes (2002), and imposing a penalty as follows: a three-year period of probation; a fine of $10,000; and such additional community service and continuing education requirements as the Department of Health determines necessary. DONE AND ENTERED this 31st day of January, 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 31st day of January, 2008. COPIES FURNISHED: Jennifer Forshey, Esquire Dorys H. Penton, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 H. Gregory McNeill, Esquire Lowndes, Drosdick, Doster Kantor & Reed, P.A. Post Office Box 2809 Orlando, Florida 32802-2809 H. Roger Lutz, Esquire Lutz, Bobo & Telfair, P.A. 2 North Tamiami Trail, Suite 500 Sarasota, Florida 34236 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
The Issue This case concerns an administrative complaint brought by the State of Florida, Department of Professional Regulation, against Respondent, charging violations of provisions of Chapter 458, Florida Statutes. In particular, it relates to the treatment of the patient Sandra Gilhousen in the placement of an IUD and in the performance of an abortion. Respondent is also charged with misprescription of a controlled substance, Ionamin, for that patient. Respondent is also charged with misprescription of Ionamin, Demerol and Quaalude for the patient Betty Boling. Finally, Respondent is accused of misprescription of Demerol for the patient Margo Stewart. These allegations are more completely described in the conclusions of law.
Findings Of Fact William J. Lee, M.D., is a physician licensed to practice medicine in the State of Florida according to licensure by the State of Florida, Department of professional Regulation, Board of Medical Examiners, License No. ME012345. At all times relevant to this cause, he has held that license and has practiced general medicine and general surgery at Jacksonville Beach, Florida. Dr. Lee is a graduate of Emory University in 1958 and received an M.D. degree from Emory in 1964. His internship was done at the University of Florida, followed by residency and general surgery at the University of Florida from 1965-1968, which was completed at the Duval Medical Center in Jacksonville, Florida, in 1969. After appropriate service of the subject administrative complaint, Respondent made a timely request for formal hearing pursuant to Subsection 120.57(1), Florida Statutes. SANDRA GILHOUSEN On January 5, 1983, Sandra Gilhousen went to the office of Respondent in Jacksonville Beach, Florida, for purposes of the placement or insertion of an IUD. She filled out a patient history information form to the extent as reflected in a copy of that form found in Petitioner's composite Exhibit No. 5, admitted into evidence. That information included home address, employment status, occupation, phone number and age. No information was given or requested on the subject of her past medical history, other than Dr. Lee asking if she suffered any allergies. During the examination process and the subsequent placement of the IUD, the patient indicated that her menstrual cycle had concluded two or three days before, when in fact, she had missed a normal cycle and had suspicion of being pregnant. When the Respondent placed the IUD, there was some seepage of blood indicating to him that the menstrual cycle had just concluded as the patient had indicated. On the other hand, the uterus was enlarged which was consistent with pregnancy. The uterus was found to be mildly boggy upon the placement of the Intrauterine Device. It was the expectation of the patient that the placement of the IUD would cause her to abort the fetus. No pregnancy test was performed prior to the placement of the IUD and no laboratory work was done. These procedures were not performed, according to Lee, because he believed her when she said she had just concluded menses and she had a healthy appearance. Prior to the placement of the Intrauterine Device, Dr. Lee checked the patient's blood pressure, lungs, masses in the abdominal cavity and for pelvic irregularities. None of the results of these observations were recorded in her records with Dr. Lee. The notations in her record related to the visit simply indicates insertion of IUD and the cost of that service plus the cost of the device. At the conclusion of the procedure, Dr. Lee gave the patient a pamphlet related to the IUD and asked for her to make a return visit to make certain there were no complications. The patient Gilhousen and an acquaintance, Betty Boling, returned to Dr. Lee's office on January 7, 1983. The purpose of the visit was not the return visit contemplated by Dr. Lee related to the IUD. On this occasion, Gilhousen was provided a prescription for Ionamin, a medication which is a controlled substance used for weight control. Prior to being provided this prescription from Dr. Lee for 30 units in 30 milligram amounts, the blood pressure of the patient was taken. A copy of the prescription may be found as Petitioner's Exhibit No. 1, admitted into evidence. At that time, the patient weighed less than on the date of the final hearing in this cause. On the final hearing date, the patient was 5'5" tall and weighed 120 pounds. The patient Gilhousen had been weighed before the prescription was given but the weight is not recorded in her records held by Dr. Lee. No indication whatsoever is made of the prescription of the Ionamin or of any examination given prior to prescribing that substance. Dr. Lee did not do a full-scale examination, more than blood pressure and weight, when he prescribed the Ionamin, because in his mind he had observed the patient through an examination two days before when he placed the IUD. A pregnancy test was performed after January 5, 1983, not by Dr. Lee, and Gilhousen had her pregnancy confirmed. She then requested Dr. Lee to perform an abortion, with the understanding that the procedure would have to be done at the convenience of Dr. Lee, in that she did not wish to pay for that service immediately. Dr. Lee was made aware of the results of the pregnancy test prior to subsequently performing the requested abortion. He expected that he would be able to gain the assistance of Betty Boling when he performed that procedure. After a telephone conversation on the evening of January 14, 1983, Gilhousen went to Dr. Lee's office around 8:30 p.m. for the purpose of having the abortion done. As with the case with the IUD, no written consent was given to have the abortion done. Nonetheless, it was discussed with Dr. Lee and it was the desire of the patient Gilhousen to have the abortion. When Gilhousen arrived, the Respondent was smoking marijuana and asked her if she would be interested in marijuana, hashish or cocaine, which she declined. Dr. Lee was unattended by other staff at this time and throughout the abortion procedure. The patient was taken to a patient examining room and placed on an examining table where the abortion was done by D&C. The room had an operating light, necessary instruments to conclude the procedure, an electrocardiogram, suction devices, epinephrines, IV fluids and emergency drugs. No monitoring equipment was used during the procedure other than checking her blood pressure. Blood pressure had been checked prior to the procedure and Dr. Lee had listened to the patient's heart and lungs and a pelvic examination had been made. The procedure took approximately 40 minutes and the observation was made by Dr. Lee that the pregnancy was in the range of four to five weeks. No pregnancy test or laboratory work was done prior to the termination. Laboratory tests were not done because, according to Dr. Lee, this was Betty Boling's friend who didn't have any money. A pregnancy test was not done because Dr. Lee felt that this was an additional expense not necessary in that he believed the patient when she said that she had been informed of a positive pregnancy test. Missing information through laboratory work included Rh typing and a hemoglobin test. Related to the hemoglobin test, Dr. Lee observed that the patient's outward appearance was acceptable and that the mucous membranes had good color. Dr. Lee recognized the possibility of Rh factor problems in the sense of the mother being negative and the father positive as it might affect the next pregnancy of the patient pertaining to Rh incompatibilities. Again, the Rh testing was not done for financial reasons. Moreover, per Lee, the patient wanted the procedure done on that evening and the patient, as he understood it, did not wish to become pregnant in the future. Being unable to locate Betty Boling to assist, Dr. Lee decided to go forward with the procedure without an attendant being present. The patient was given Valium to calm her nerves and Dr. Lee utilized Stadol and Phenergan for sedation and as analgesic. Through this combination, the patient was placed in a sort of "twilight condition" on a plane which made her unconscious, but not a deep unconscious state. While giving her this medication, he asked her if she felt "sexually aroused." In Petitioner's Exhibit No. 5, the amounts and types of medication are recorded in the patient's chart and it is noted that the D&C was done and tolerated well. It is also noted that the patient was picked up by a friend and the charge of the procedure is given. Ergotamine was given to retract the uterus and minimize bleeding. No other information is recorded in the patient's chart. The patient's recovery from the medications in terms of regaining consciousness took longer than might be expected given the amount of medication. Notwithstanding the patient's slow recovery, Dr. Lee left the patient unattended later in the evening for reason that he felt that she was "ready to go home." After leaving the patient unattended, Respondent tried to gain the assistance of Betty Boling to take her home. Boling did not agree. When Dr. Lee returned to his office, which is also his place of residence, visitors came by and he consumed alcohol with those people. He then left a second time to make purchases at a store and when he returned, a Mr. Hobbs, who was a friend of Gilhousen, had arrived to pick the patient up. Hobbs observed Lee staggering and with slurred speech, indications of intoxication. Hobbs and Dr. Lee took Gilhousen to a car and she left with Hobbs. Gilhousen came back to Dr. Lee's office on January 15, 1983, to pick up her car and asked Dr. Lee if she needed to be prescribed any antibiotics for her post procedural circumstance. He told her that this would not be necessary at present and advised her to monitor her temperature. As reflected in Petitioner's composite Exhibit No. 5, Gilhousen was later seen at Memorial Hospital of Jacksonville related to her post abortion condition and was found to be acceptably recovering. It was noted on the basis of a pelvic sonogram that the abortion had been a success. Dr. Doris Newell Carson, M.D., a board-certified gynecologist and obstetrician, who practices in Jacksonville, Florida, was qualified as an expert and gave her medical opinion on the quality of the Respondent's performance in treating Ms. Gilhousen. Her testimony was premised upon an examination of the medical records of Dr. Lee pertaining to Sandra Gilhousen. Dr. Carson felt that in the insertion of an IUD, that Dr. Lee should have obtained the history of the patient's medical condition with particular emphasis on menstrual period and allergies because of the possibility of allergic reaction being brought about with the placement of the IUD. Physical examination was necessary to include heart, lungs, and abdomen and examination of the position of the uterus. In addition, it was necessary to take the blood pressure of the patient and to have laboratory work done related to hemoglobin, a gonorrhea culture and pap smear. Dr. Carson also felt that it was necessary to determine pregnancy by test, prior to the placement. All of these matters should be recorded in the patient records, per Dr. Carson. In addition, written permission should have been received prior to the placement of that IUD. Any physician who failed to do these things and document them, would have demonstrated less prudence than a reasonably prudent, similar physician. As established in prior facts found, Dr. Lee failed to record any of these matters and failed to obtain necessary medical history and to have necessary testing and laboratory work up envisioned by Dr. Carson. Her opinion as to what is needed for the placement of the IUD in the patient Gilhousen in order to achieve community standards in the place where Dr. Lee practiced is accepted. Based upon her opinion, Dr. Lee is found to have practiced medicine in the placement of that IUD with less care and skill than a reasonably prudent similar physician in his community would have been expected to give. Dr. Carson did not feel that Gilhousen, according to the patient's height and weight, needed Ionamin to control the patient's weight. Ionamin, a controlled substance, is a stimulatory drug which has addictive qualities, from Dr. Carson's understanding. The prescribing of the Ionamin on the information available to Lee was not the act of a prudent, similar physician who might be confronted with the same conditions and circumstances as Dr. Lee was when he prescribed Ionamin for Gilhousen, per Carson. Carson did not feel there was a medically justifiable reason for issuing the prescription of Ionamin. Moreover, Dr. Lee was deficient in the mind of Dr. Carson by not recording the issuance of the prescription in the patient's medical records. Dr. Carson's observations about Ionamin and the quality of Dr. Lee's performance in prescribing Ionamin to Gilhousen on January 7, 1983, are accepted. Dr. Carson was questioned on the matter of the abortion procedure which was performed on January 14, 1983. In giving her opinion, she was made aware of certain hypothetical facts related to the setting, time of day, nonavailability of a medical attendant, Dr. Lee's leaving the patient unattended, Respondent smoking marijuana and the offering of marijuana and other drugs to the patient, in addition to the matters set forth in the patient's record. In Dr. Carson's mind, a complete physical, including blood pressure, would be necessary prior to the termination; laboratory work, to include hemoglobin, to measure the amount of iron in the blood would be necessary; a CG culture and RH typing; and discussion with the patient as to allergies to medications would be necessary. In addition, a pregnancy test prior to termination would be indicated. The physician would also need a medical assistant in attendance and written permission would be necessary prior to the termination of the pregnancy. Dr. Carson would have used a D&E as opposed to D&C for termination of this early pregnancy and would not have used the form of anesthesia chosen by Dr. Lee. Her choice would have been a local block. Her testimony as to the choice of procedures and type of anesthesia does not lead to the conclusion that his choice of technique and anesthesia is below the level of care acceptable for a reasonably prudent, similar physician in the Jacksonville community. In Dr. Carson's opinion, it was inappropriate for Dr. Lee to smoke marijuana on the night of the abortion before conducting that procedure and to offer marijuana, hashish and cocaine to the patient. Dr. Carson felt that it was necessary to monitor blood pressure, and other vital signs related to pulse and respiration, the amount of flow from the site of the abortion and to give medication for pain as needed. Dr. Carson finds the act of leaving the patient unattended an unacceptable performance by Dr. Lee. Dr. Carson also believed that the patient's medical history, laboratory information and observations related to the physical examination should be recorded in the patient records and they were not. Per Dr. Carson, the failure to do those things she described related to the pregnancy termination would constitute substandard care to the patient, as would his use of marijuana and offering of illegal drugs to the patient. With the exception of Dr. Carson's opinions about the abortion technique, D&C, and type of anesthesia, her perception about appropriate care is accepted. By her description, this substandard care is tantamount to failure to provide care that a reasonably prudent, similar physician in a similar circumstance would have provided and Dr. Lee has not been sufficiently prudent in his treatment of Gilhousen on the date of the abortion, as shown in contrasting his performance as reported and Dr. Carson's idea of acceptable performance. BETTY BOLING Betty Boling requested assistance from Dr. Lee to control her weight. This request was made on January 7, 1983. Her blood pressure was checked and her weight taken. No other information was sought from the patient related to her history and no further examination was made of the patient as to her physical condition. Neither of these observations related to blood pressure and weight were recorded in her patient records, a copy of which may be found as Petitioner's composite No. 2, admitted into evidence. Boling was then prescribed 30 units, 30-milligram Ionamin by Dr. Lee. The record in this proceeding is left in the posture that the only basis of knowing the true circumstance of the patient Boling related to the need of weight reduction is her comment that she was overweight when she requested the provision of diet medication. This does not sufficiently justify the prescription of Ionamin and promotes the conclusion, based upon Dr. Carson's perception of the Gilhousen situation where Ionamin was prescribed, that there was no medical justification for prescribing Ionamin to Boling and that to do so was substandard care and not the care expected of a reasonably prudent, similar physician in dealing with the Boling case. (The prescription may be found in Petitioner's Exhibit No. 3.) On July 14, 1981, Dr. Lee prescribed for Betty Boling 30, 50-milligram Demerol units. On August 23, 1981, an additional 20, 50-milligram Demerol units were prescribed for Boling by Lee. On November 1, 1981, an additional 20, 50- milligram Demerol units were prescribed by Dr. Lee for Boling. On December 7 or 8, 1981, an additional 30, 50-milligram Demerol units were prescribed by Dr. Lee for the benefit of Boling. On December 7, 100, 300-milligram Quaaludes were prescribed for Boling by Dr. Lee. Finally, on February 19, 1982, 100 300- milligram units of Quaaludes were prescribed by Dr. Lee. The prescriptions of Demerol and Quaaludes may be found in Petitioner's composite Exhibit No. 3. Prescriptions indicate the basis for prescribing the Demerol was related to pain and the Quaaludes related to sleep. None of these prescriptions or the reason for the prescriptions are indicated in the patient records of Betty Boling, found as part of Petitioner's composite Exhibit No. 2, as a copy. Although Dr. Lee claimed to have conducted a physical examination on the patient before prescribing the Demerol and Quaaludes, that testimony is not believed. Moreover, Dr. Lee has no specific recollection of why he prescribed the Demarol for the patient as to the exact details. Dr. Lee had on occasion prescribed Demerol for migraine headaches for Boling. Dr. Lee indicated that other analgesic medication given for the migraine headaches had not been successful and that was why Demerol was used for the patient Boling. Dr. Lee's indication that he might not have entered the details of the prescription of Demerol and Quaaludes for Boling in her records on the occasions in question because of her concern that other persons who had access to her patient records not see those entries, is not tenable and is not accepted as fact. Especially in view of the fact that Boling does not have any recollection of such a request. Notwithstanding the risk to health in prescribing Quaaludes continually as recognized by Dr. Lee in his testimony at hearing, he prescribed Quaaludes in 100 units and in a further 100 units 70 days thereafter in the strongest dosage available. The methaqualone or Quaaludes were for purposes of assisting Boling in sleeping and the explanation given by Dr. Lee about the possibility of using more than one tablet per day within the 70 days in which the original 100 tablets had been prescribed is not accepted. Dr. Carson, after examining the Boling records, did not find any justification in the records for prescribing Demerol and Quaaludes, in the sense of a medical reason for such prescription. As Dr. Carson identified, Demerol is a narcotic analgesic, equivalent to morphine, with 60 milligrams of Demerol being comparable to 10 milligrams of morphine sulfate. Per Carson, Demerol is a drug highly susceptible to abuse, leading to addiction. For that reason, it is not appropriate for migraine headaches in that migraine headaches are repetitive in nature, thereby promoting greater chance of addiction. Demerol is a very potent respiratory depressant and can have allergic manifestations. Demerol and Quaaludes are Schedule II controlled substances. Quaaludes are a sedative which are used for inducing sleep and might be used for people suffering insomnia. Quaaludes have high potential for addiction and the substance became a street drug and has, since the time of this case, become illegal in the State of Florida. To use Demerol and Quaaludes together, according to Dr. Carson, would potentiate depression, thereby compounding effects of the drugs taken singularly. Dr. Lee's prescription of the Demerol and Quaaludes as described in the Boling circumstance, related herein, in the mind of Carson represented a failure of Lee to practice medicine with a level of care, skill and treatment recognized by reasonably prudent, similar physicians as being acceptable under similar conditions and circumstances and represented malpractice. It also was a prescription of controlled substance in bad faith not within the course of professional practice. These opinions by Dr. Carson, related to the Demerol and Quaaludes, and the practices of Dr. Lee in prescribing the substances for the patient Boling are accepted. MARGO STEWART No testimony was given related to the allegations found in Count Six pertaining to Margo Stewart and that count was abandoned by the prosecution.
The Issue The central issue in this case is whether the Respondent committed the violations alleged in the administrative complaint; and, if so, what penalty should be imposed.
Findings Of Fact The Department is the state agency charged with the responsibility of regulating the practice of medicine in the State of Florida. Respondent holds an active license to practice medicine, license number ME 0030238 (Physician). Respondent's practice is limited to what he has described as "cosmetic" surgery, but which is considered plastic or reconstructive surgery. Typically, Respondent performs elective surgery for cosmetic purposes to breasts, abdomen, buttocks, face (eyes, lips, cheeks), or hips. In August, 1990, the patient, V.A., presented to the Respondent for a pre-operative consultation and examination. At the time, V.A. was interested in having liposuction, breast enlargement, and an abdominoplasty. Due to her medical history, V.A. was an extremely poor candidate for an abdominoplasty. The pre-operative history and physical examination performed by Respondent as reflected in the records maintained by Respondent for the patient, V.A., were inadequate. No records supporting a complete physical examination and history have been provided. The pre-operative medical records maintained for the patient, V.A., do not support the course of treatment proposed for the procedures to be performed. Respondent did not order a pre-operative lab work-up for the patient, V.A. Such lab order would normally consist of a complete blood count, a urinalysis, electrolytes, blood sugar, blood nitrogen test, and a mammogram or breast examination since the breasts were to be augmented. Respondent relied on lab test results for V.A. which were approximately three months old. Respondent believes that the reliance on tests up to six months old would be acceptable since he only performs surgery on healthy patients. Respondent performed no independent examination of V.A. to verify she was "healthy," prior to surgery. Failing to obtain current lab tests of the types described above before performing elective surgery of the nature sought by V.A. constitutes the practice of medicine below the standard of care, skill, and treatment which a reasonably prudent physician would find acceptable under similar circumstances and conditions. On or about August 30, 1990, Respondent performed the following procedures on V.A.: liposuction; breast enlargement; and an abdominoplasty. In order to perform the procedures noted, Respondent used general anesthesia so that V.A. was under anesthesia for six hours. During that time, Respondent opened V.A.'s abdomen, removed tissue, removed adipose tissue from various parts of the patient's body, injected fat tissue into the patient's breasts, cheeks and hands, and closed the abdominal wound with stitches. The surgical or operative notes maintained by Respondent for the patient, V.A., are inadequate to fully describe the procedures performed. The Respondent was released to go home approximately two hours after the surgery. The postoperative notes maintained by Respondent for the patient, V.A., are inadequate to fully describe how the patient was able to be discharged in so short a time after surgery. V.A. returned to Respondent's office numerous times following the surgery. V.A. sustained an infection and complications from the wound to her abdomen that took months to heal. Respondent treated the infection by scraping the wound and attempting to re-stitch it on at least two occasions. V.A. sustained necrosis which is the death of tissue and which complicated the healing of the abdomen wound. The loss of skin from necrosis is much more likely to occur when the patient has scarring. Given V.A.'s medical history (scarring throughout the areas), the necrosis was almost inevitable. Two procedures are available under the circumstances applicable to V.A.: allowing the wound to heal without stitches or to use a skin graft. The procedure used by Respondent (stitching the infected area) fell below the standard of care, skill, and treatment which a reasonably prudent physician would find acceptable under similar circumstances and conditions. Injecting fat tissue for breast augmentation is inappropriate. Since it is common for the fat tissue to die after injection, the injected tissue then appears on a mammograph as a mass of suspicious origin. That is, it is difficult to differentiate from a breast mass that is a medical problem from that of the dead fat tissue. As a result, biopsies may be required to verify the mass content. In fact, V.A. has already had to have such a procedure following the augmentation performed by Respondent. Respondent also conducted a pre-operative interview with a patient, P.T. P.T. was a radio talk show host at the time and suggested that the station, she and Respondent could all benefit from a campaign wherein she would have liposuction, the Respondent would receive her endorsement through advertising, and the station would have advertising paid for by the Respondent's clinic. In an attempt to negotiate the terms of the advertising campaign, P.T., an advertising executive with the radio station, Respondent's office manager, and Respondent met together to discuss the project. Respondent wanted a multifaceted campaign requiring P.T. to undergo more than just the liposuction she sought. Respondent's scope for the campaign included many of the surgeries his clinic offered. While discussions continued for the advertising campaign terms, P.T. underwent pre-operative testing which included a blood test, medical history forms, and photographs. During an office consultation in anticipation of surgery, Respondent requested that P.T. allow him to examine her. Unlike a previous examination which had occurred without incident with someone in the room, Respondent closed and locked his office door and requested that P.T., who was alone with Respondent, stand near his desk. When she complied, he leaned forward and raised her dress over her breasts. Next he unhooked her bra and pulled it over her breasts. Respondent proceeded to poke and prod P.T. across her breasts and abdomen during which time P.T. presumed it was for medical purposes. P.T. became uncomfortable when the prodding which continued became more like a caress. She attempted to presume Respondent was merely checking the texture of her skin but became increasingly uncomfortable with his touch. P.T.'s discomfort accelerated when she realized Respondent had placed his face in her vaginal area and was licking her. She immediately attempted to pull away. Respondent grabbed her on the breast and, as P.T. put it, "in the crotch." P.T. struggled with Respondent who made several sexually inappropriate comments to her. As P.T. attempted to regain her composure and close her clothes, the Respondent's office manager knocked on the door. On hearing the office manager, Respondent released P.T. and went to unlock the door. At the time of the foregoing incident, P.T. was the Respondent's patient. Respondent did not maintain appropriate medical records for the course of treatment proposed for the patient, P.T. Respondent's course of conduct with the patient, P.T., fell below the standard of care a reasonably prudent physician would pursue for treatment of this patient. Respondent attempted to engage a patient in a sexual activity. P.T. did not consent to the activity described above.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That Agency for Health Care Administration, Board of Medicine enter a final order finding the Respondent guilty of violating Sections 458.331(1)(j), (m), and (t), Florida Statutes, and imposing the following penalties in accordance with the guidelines set forth by rule: revocation of the license together with an administrative fine in the amount of $15,000.00. DONE AND ORDERED this 16th day of August, 1995, in Tallahassee, Leon County, Florida. JOYOUS D. PARRISH Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 16th day of August, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-3609 Rulings on the proposed findings of fact submitted by the Petitioner: 1. Paragraphs 1 through 56 are accepted as accurate as to the facts but not necessarily the form for findings of fact. Typically, findings of fact should not recite testimony. Rulings on the proposed findings of fact submitted by the Respondent: 1. None submitted. COPIES FURNISHED: Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Jerome W. Hoffman General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Kenneth J. Metzger Senior Attorney Agency for Health Care Administration/Board of Medicine 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Leon Doyan, M.D. 2817 E. Oakland Park Boulevard Fort Lauderdale, Florida 33306
The Issue Whether Respondent's license shall be disciplined for violations of Section 458.331(1)(n), Florida Statutes [failure to keep written medical records justifying the course of treatment of patients as set out in Counts 1-4, 6-9, 11, and 13-14 of the administrative complaint]. Whether Respondent's license shall be disciplined for violations of Section 458.331(1)(cc) 1, 2, and 3, Florida Statutes [prescription of an amphetamine drug for purposes other than specifically stated in those subsections as set out in Counts 5 (Preludin), 10 (Preludin), and 12 (Ritalin) of the administrative complaint]. Whether Respondent's license shall be disciplined for violations of Section 453.331(1)(t), Florida Statutes [by engaging in gross or repeated 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 as set out in Counts 1-15 inclusive, of the administrative complaint].
Findings Of Fact Respondent, Tariq Husam Abdullah, is a licensed medical physician, practicing under license number ME 0021526. He is also known as Henry Nichols. The two are one and the same and there is no dispute over identity. Respondent appears to have been a hard worker, rising from a "bed pan hustler" at the old Fort Walton Hospital to his current level of education, licensure, and community position. Previous to Florida licensure, Respondent received his medical degree from Meharry Medical College in Nashville, Tennessee, where he also did his internship in straight medicine. Thereafter, Respondent performed three years of anatomical and experimental pathology at Washington University School of Medicine in St. Louis, Missouri, and two years in clinical pathology at the National Institute of Health and the United States Public Health Service in Bethesda, Maryland. Respondent is not board-certified, but is currently board-eligible in both pathology and laboratory medicine. At all times material hereto, Respondent engaged in medical practice in Bay County, Florida. During much of the time in question, Respondent had no assisting staff. His usual fee for each office visit of each of the patients referred to in the fifteen count administrative complaint was approximately $15- 20 maximum. They are a small portion of the approximately 1,000 patients he treated between 1978 and 1982, and in most cases his fees for office visits were $10.00 apiece. Sometimes his fees were paid and sometimes they were not paid. Medicaid and Medicare reimbursed all or a portion of many fees. In the course of his practice Respondent treated the following patients: D.B.; T.B.; Tommy B.; J.C.; L.C.; T.G. a/k/a L.C.; David G.; Dan G.; C.R.; B.W.; and J.M. Petitioner's expert-witness medical doctors were Jabe Armistead Breland and Michael W. Cohen. Dr. Breland was present at the formal hearing and had the advantage of reviewing Respondent's exhibits as well as Petitioner's exhibits in the forming of his opinions. Dr. Breland has been a licensed medical doctor in the State of Florida since September 1950. Most of that time he has practiced in the panhandle of north Florida which includes Panama City, Bay County. His office is in Marianna, Florida. He is board- certified in family medicine, licensed by the federal government to prescribe controlled substances, and was stipulated as an expert in the field of medicine. Dr. Michael W. Cohen testified by means of a deposition taken prior to formal hearing and did not have the advantage of review of Respondent's exhibits admitted in evidence at the formal hearing. He is a family physician with an M.D. from the University of Miami School of Medicine (1975), a graduate of Tallahassee Memorial Hospital Regional Medical Center Family Practice Program, and has been a board-certified family physician for six and one-half years. His practice is limited to Tallahassee and he has testified on contract for Petitioner six times previous to this case. He is accepted by the undersigned as an expert medical witness, but because of the unavailability to Dr. Cohen of Respondent's exhibits which were admitted in evidence at the formal hearing held subsequent to his deposition and because some of the materials upon which Dr. Cohen's opinions were predicated were excluded from evidence at the formal hearing, the weight and credibility of his prior deposition testimony is significantly impaired through no fault of Dr. Cohen and without any unfavorable reflection upon him. Dr. Wilson, Respondent's expert medical doctor who testified by after-filed deposition knew nothing of Respondent's records and was unaware of the precise charges against him. In the absence of appropriate predicate as to medical opinion, his testimony has been accepted only as to facts of which he had personal knowledge and as to character. It is his opinion that Respondent is the kind of person who deserves not to have his license suspended or revoked. Dr. Wilson partly financed Respondent's education. The parties by Request for Admission have established that Preludin is an amphetamine; more accurately Preludin is phenmetrazine. Ritalin is methylphenidate. Dioxan is a methylamphetamine. At all times pertinent these were Schedule II controlled substances pursuant to Chapter 893, Florida Statutes. Percodan is also a Schedule II controlled substance. Valium is a Schedule IV controlled substance. Darvon Compound and Tylenol 4 are Schedule III controlled substances. Respondent frequently talked to police, Sheriff's deputies and pharmacists in an effort to avoid his patients becoming addicted to drugs. He never was made aware from any source of any drug addiction or any arrests of any patients concerned in this action. He testified that he performed a physical examination in every case and verified all prior medications in every case, but he also conceded not verifying prior medications with previous doctors or hospitals. It is specifically found that in many instances none of these precautions appear in his records as set out infra. D. B. (Counts I; XV) It is admitted (Requests for Admission) and found that between February 19, 1979, and April 23, 1983, Respondent prescribed at least the following quantities of controlled substances to his patient, D. B.: DATE DRUG STRENGTH QUANTITY 02/19/79 Percodan Approximate 04/30/79 Darvon Compound 03/23/82 Valium 05/13/82 Tylenol #4 06/03/82 Percodan Demi 40 06/16/82 " " 18 07/10/82 " " 07/17/82 " " 36 08/14/82 " " 18 08/28/82 Percodan 08/28/82 Valium 01/15/83 Percodan 03/26/83 " 03/26/83 Valium 04/23/83 Percodan Respondent's treatment of his patient, D.B. with controlled substances was predicated upon his diagnosis of "traumatic arthritis." His records reflect, "hurting ankle, leg, and back" as the chief complaint. In no instance of prescribing scheduled drugs for this patient did Respondent maintain a record of the strength (dosage) and on only a few occasions did he record the quantity prescribed. This particular inadequacy of record-keeping seems also to have applied to additional non- scheduled drugs prescribed by Respondent for this patient. Although Dr. Breland acknowledged that many doctors only record the word "refill," good medical practice dictates that Respondent should have recorded at least the quantity and dosage at the time of the initial prescription. Normal protocol would be to also record the method of taking the medication. On this analysis, in Dr. Breland's professional medical opinion, Respondent's medical records for his patient, D.B. (Composite P-1) were inadequate and did not justify the course of treatment upon the recorded chief complaint. Dr. Cohen concurs. Further record inadequacies as noted by Dr. Breland include failure of the records to indicate which bone was fractured in relating the patient's medical history, recording only blood pressure as a vital sign, and failure to state what condition was being treated on subsequent visits. Dr. Cohen recited the same inadequacies in forming his professional medical opinion that Respondent's records do not justify the treatment received. Dr. Cohen further opined that if the patient had traumatic arthritis, the treatment prescribed was wholly inadequate due to the absence of any recorded plans for therapy. Dr. Breland, on the other hand, felt that a Percodan prescription is consistent with good medical practice for a patient who complains of traumatic arthritis and that Valium, a benzodiazepine drug which is a calmative or tranquilizer, may also be properly used for traumatic arthritis but that Valium would be contraindicated if there were associated patient nervousness and anxiety. Dr. Breland's opinion is that it would not be medical malpractice to prescribe Valium upon the basis of Respondent's records nor would it be medical malpractice based upon the continued prescribing of Percodan unless the patient became addicted. Dr. Breland's experience is that 1-3 months on Percodan would cause individuals to run the risk of addiction but knows of doctors in the Panama City locale who have prescribed Percodan in excess of three months with addiction resulting in some patients and not in others. Respondent conceded that his records for this patient should show greater detail but according to his recollection independent of the medical records, he recalled that on the first visit, he had accepted D.B.'s representation that D.B. had had prior surgery on the left ankle because the pins could be seen through that swollen ankle. Respondent's independent recollection was that D.B. did not ask for Percodan. Respondent testified that he prescribed the Percodan because "after codeine I can't think of another drug with potential for comfort." His failure to record further detail he explained as his belief that writing down prescriptions was a sufficient reference back to the original first visit diagnosis. Respondent admittedly did not record, but expressed independent recollection of also accepting D.B.'s representation of previous unsuccessful medication with codeine from a Dr. Smith and of recommending acupuncture as an alternative pain therapy but admitted he also did not record this latter instruction. The medical records themselves confirm Respondent's testimony in the course of the hearing that Respondent prescribed the scheduled drugs in addition to a number of other medications such as Roboxin and anti-inflammatories which he did record and which Dr. Breland confirmed were appropriate as treatment for traumatic arthritis. A portion of Petitioner's Composite Exhibit 15, court certified records, show one "Donald Richard Bozeman" was charged in two counts of illegally selling Valium in Bay County on September 2 and September 11, 1982. This person was subsequently tried and found guilty of one count and entered a plea of guilty to the other. A Circuit Court Judgment was entered. The date of the commission of this person's offenses are close to the date of a prescription by Respondent to his patient "D.B." but there is absolutely nothing in the court documents to connect them to the D.B. treated by Respondent except a partial similarity of name. Nor does the similarity of name of a co-defendant, Tereza Ann Bozeman (see infra.) prove an inescapable link of "Donald Richard Bozeman" to Respondent's patient, "D.B." who was married to someone of partially similar name. Accordingly, the court documents are probative of nothing in connection with Respondent's records or his patients, including but not limited to Petitioner's assertions that Respondent prescribed to his patient, "D.B." for a non-medical or criminal purpose or that the patient was drug-addicted. Upon all the foregoing information taken together it is clear Respondent failed to keep written medical records justifying the course of treatment of his patient, D.B. This finding is made despite both of Petitioner's experts' testimony that there is no affirmative professional requirement that dosage and number of tablets be recorded anywhere except on a prescription. That concern is only a portion of the inadequacies of these records. However, in light of Dr. Breland's greater familiarity with all of Respondent's records and the standard of medical practice in the community, and the greater detail provided by his testimony and the explanations provided by Respondent at formal hearing, Dr. Breland's opinion that the course of treatment for this patient, isolated from all others, does not represent malpractice is accepted over Dr. Cohen's opinion that it does. T. B. (Counts II, XV) It is admitted (Requests for Admission) and found that between approximately May 1, 1982, and April 9, 1983, Respondent prescribed at least the following quantities of schedule- controlled substances to his patient, T.B.: DATE DRUG STRENGTH QUANTITY 05/01/82 Valium 05/01/82 Percodan Demi 07/10/82 " " " 30 08/14/82 " " " 08/14/82 " " " 18 08/14/82 Valium 09/11/82 Percodan 09/11/82 Valium 12/12/83 Percocet #5 Although in some respects, Drs. Breland and Cohen emphasized different faults or inadequacies of Respondent's records which they reviewed concerning T.B. (Composite P-2), both experts concur that the records do not justify the course of treatment of this patient. Dr. Cohen bases his opinion on his analysis that the history Respondent recorded for this patient was not sufficiently detailed. Specifically, the initial office visit record is flawed by only writing down patient's vital signs and recording no physical findings. Dr. Cohen stated it is unjustifiable to prescribe a narcotic analgesic on the first office visit and to continue to refill the prescription on subsequent visits without recording how the patient had done on those medications and further without recording physical examination, assessment of how the patient is responding to the medication, a plan outline for prophylactic care, and patient education. Further, both Drs. Breland and Cohen assert that although there is no affirmative professional requirement to record dosage and tablet numbers except on prescriptions, it is the custom of reasonably prudent similar physicians to record amount, dosage quantity of drugs prescribed, and method of taking drugs, and Respondent's records do not do so. Respondent's records for this patient also offend custom and usage of the profession in that they indicate several office visits for which there are no recorded findings or treatments whatsoever. Dr. Breland's opinion that the records do not justify the treatment and that they fall below the customary standard of care are based on his analysis thereof emphasizing that the records of the first office visit do not evidence a physical examination other than taking a blood pressure reading and weighing the patient. There is a brief history of migraine headaches for three months recorded and also recorded is a past diagnosis and treatment with codeine and talwin; the records note no previous surgery, no previous fracture, and no physical findings. Then, Cafergot PB #2, Valium #3 and Percodan-demi were prescribed by Respondent. The records should have specified whether or not previous treatment was successful and if it was successful, Respondent could have subsequently prescribed less addictive drugs. In Dr. Breland's opinion, it is "hard to justify" a Class II drug without trying some other modalities available. Respondent first saw this patient on May 1, 1982, for migraine headaches and prescribed Cafergot PB and Percodan-demi. He selected Percodan- demi because Percodan is habit-forming. In the course of the formal hearing, he testified, "I just didn't know another medication to go to after you pass codeine that would be effective with patients, other than giving them Demerol and the harder narcotic medications" and that when he first began seeing this patient he was less aware of the similar use of the less addictive drug, Inderal, than he is now. On the physical examination portion of his clinical notes, Respondent indicated that the patient had been using Codeine, Talwin, and "Dx" and "Rx". He then and thereafter (8/14/82 and 9/11/82) prescribed analgesics and vasoconstrictors (Cafergot PB and Ergotamine) together with the Valium because Valium, in his opinion, is often ineffective without more because of the significant emotional components of migraine headaches. Respondent also expressed his independent recollection of discussing with this patient the alternative treatment of acupuncture but admitted he did not record this instruction. Respondent's explanation is not sufficient justification for the repeated prescriptions of controlled substances in light of Dr. Breland's more knowledgeable and thorough explanation of the standards of record-keeping necessary to justify continued prescription of the particular controlled substances here at issue. Dr. Breland faults another of Respondent's prescriptions dated 12/4/82 of Cafergot PB#2 (a combination of drugs primarily containing an Ergotamine derivative and caffeine), Percocet, and Valium because Respondent's records do not show how many pills were prescribed nor do they give directions for taking them. For prescriptions on 1/8/83, 8/14/82, 9/11/82, and 2/12/83, Dr. Breland expressed as his chief concern that there was an absence of recorded physical findings, history, and blood pressure plus no recorded amount of dosage listed for most prescription drugs, but Dr. Breland also determined that prescribing Cafergot is consistent with Respondent's diagnosis of vascular headaches and his prescriptions for these dates is an appropriate lesser treatment to be tried before prescribing a Schedule II drug, and, further, that Respondent's records justify prescribing Cafergot. However, the opinion expressed in the prior sentence is not compelling in face of the records having no notations to show the effect, if any, of Cafergot or other drugs or to show why Respondent prescribed stronger medication. Dr. Breland also felt Respondent should have prescribed other less addictive drugs before going to the Schedule II-controlled substances as he did, and that if Respondent's findings were negative, he should have recorded them as negative rather than leaving the record blank, because without such records it cannot be determined if a physical examination was ever made and because in absence of recorded physical findings, no Schedule II drugs should have been prescribed. A portion of Petitioner's Composite 15, court-certified records show one "Tereza Ann Bozeman" was charged in two counts of illegally selling Valium in Bay County on September 2 and September 11, 1982. This person entered a plea of guilty to a lesser-included misdemeanor. The Circuit Court withheld adjudication and placed her on probation. The date of one of the offenses coincides with one of the dates of a prescription by Respondent to his patient, "T.B." but there is absolutely nothing in the Court documents to connect them to the "T.B." treated by Respondent, except a partial similarity of name. The court documents also charge "Donald Richard Bozeman" who has a similar name to that of another of Respondent's patients (see supra.) but the court documents do not indicate the charged individuals are married or provide any other link to Respondent's patient(s). Accordingly, the court documents are probative of nothing in connection with Respondent's records or his patients, including but not limited to Petitioner's assertions that Respondent prescribed to his patient, T.B., for a non-medical or criminal purpose or that the patient was drug-addicted. Tommy B. (Counts III, XV) It is admitted (Request for Admissions) and found that between approximately August 16, 1981, and February 19, 1983, Respondent prescribed at least the following quantities of schedule controlled substances to Tommy B.: DATE DRUG STRENGTH QUANTITY 08/15/81 Valium 08/15/81 Percodan 08/15/81 Dalmane 10/30/81 Tylox 12/05/81 " 12/05/81 Valium 12/06/82 Darvon compound 02/17/82 Percodan 30 04/01/82 " Demi 04/01/82 Percodan 30 05/29/82 Percodan Demi 06/21/82 Tylox 24 07/12/82 Percocet #5 30 02/19/83 Percocet 02/19/83 Valium In the course of the hearing, Respondent independently recalled that this patient presented on 8/15/81 and that Respondent himself personally recorded the notes for that date including a history, diagnosis of L-S syndrome, and treatment. On that date he observed scars on the patient's back from back surgeries which the patient related had been done at Southern Baptist Hospital in New Orleans. Respondent conceded that he failed to record the physical findings of scars and failed to record full details of the related surgeries so that at first glance it might appear to others, in this case Dr. Breland, that Respondent was only filling in a history of surgeries without making his own diagnosis. Respondent stated that he had relied on the Physician's Desk Reference, which he characterized as a "bible of the medical profession", and which recommends Percodan as a pain-killer. The treatise itself was not offered in evidence. Respondent also stated that the Percodan-based drugs he prescribed effectively relieved this patient's pain. There is no contrary evidence on this point of effectiveness but it still was not contemporaneously recorded by Respondent in the patient's record. Both Drs. Cohen and Breland opined that Respondent's records for Tommy B. did not justify the prescribing of these controlled substances, most specifically Percodan. These opinions have not been accepted for the following reasons. In the absence of any supporting evidence, Dr. Cohen's considerable testimony concerning his belief that this must have been a scam or scheme of Respondent to indirectly charge for a controlled substance prescription by requiring frequent office visits is rejected as conscientious but pure conjecture. Dr. Breland expressed concern that Percodan-demi was among the drugs prescribed by Respondent in the presence of a record notation within the physical findings which relates that "patient says he can't take Percodan". Respondent denied he made this notation, and related it is in someone else's handwriting and not true. Respondent's testimony on this score is corroborated by clear observation of the records. Most of Dr. Breland's other complaints concerning Respondent's record of this patient devolve to Dr. Breland's inability to read Respondent's handwriting and his original erroneous belief that the history and exam was chronologically incorrect and taken by someone other than Respondent. Dr. Breland's opinion that the records are deficient because the fracture of the back was not specifically recorded by Respondent's indicating whether there was an old fracture or current pain and by Respondent's not indicating whether there was thoracic or lumbar distress, and because there is no recitation of whether the fracture is pelvical or in any body of the vertebrae, and his objection to failure of Respondent to either record "no x- rays" if none or to record x-rays if there were some instead of leaving a blank space constitute technique over professional custom requirement of record- keeping. Dr. Breland also described the two month fluctuation down to Percodan- demi and then up to the stronger drug of Percocet from 4/1/82 to 2/19/83 as unjustified because no less addictive medicines had been tried and no degree of relief from less addictive drugs was attempted by Respondent, but Dr. Breland described the Percodan- based drugs and the Valium as medically acceptable where based on the degree of relief the patient had received. In such a situation Dr. Breland would use these drugs for pain treatment and consider them medically justified. Like Dr. Cohen, Dr. Breland also found unacceptable the failure of Respondent to record amounts and dosages in his office medical records, but on many occasions throughout their testimony, both of Petitioner's experts observed the requirement of listing amount and dosages is for prescriptions only and not for a doctor's office records. Upon the failure of adequate predicate for Dr. Cohen's conclusion of unjustified prescriptions, the absence of any admissible evidence of any addiction in this patient, and the only positive evidence of the effect of these prescriptions being Respondent's opinion that it was effective, the opinions of both Drs. Cohen and Breland that the medical records do not justify the course of treatment of Tommy B. are rejected. J. C. (COUNTS IV; XV) It is admitted (Requests for Admissions) and found that between January 4, 1982, and February 26, 1983, Respondent prescribed at least the following schedule-controlled substances to J.C.: DATE DRUG STRENGTH QUANTITY 01/04/82 Percodan 24 03/23/82 Tylox 30 04/17/82 Percodan 04/17/82 " " 05/01/82 Tylenol #4 30 05/01/82 Valium 30 05/04/82 Tylox 30 06/12/82 Valium 06/16/82 Tylox 36 07/17/82 " 30 08/14/82 " 30 10/03/82 " 30 10/30/82 Tylenol #4 11/13/82 Percodan 30 01/15/83 Percocet 01/15/83 Valium 28. J.C.'s chief complaint was migraine headaches, "nerves", and back trouble. Respondent prescribed Percodan for pain, Valium for "nerves", and Cafergot-pb for migraines. He diagnosed hypertensive heart disease, anxiety neurosis, migraine headaches, and lumbosacral syndrome. He only used Percodan four times over a year's period due to the severity of the symptoms brought on by the tug and strain on this 200-pound woman's back. Dr. Cohen ranks the relatively minimal fault of writing progress notes in two corners and across the top and side of a page in the same category as overprescribing. Dr. Cohen's concern over the absence of recorded physical findings for this patient was not confirmed by Dr. Breland (see infra.) and his concern because the number and dosage of Cafergot-pb (non-scheduled), Valium (scheduled) and Percodan (scheduled) were frequently not recorded by Respondent is less significant in light of Dr. Breland's testimony that the best custom and practice of the medical profession is to record these matters but such recordation is not required for office records but only for prescriptions. Dr. Cohen also faulted Respondent for prescribing symptomatically with no effort to educate the patient to prevent or "prophylax" against migraines or to prescribe common anti- inflammatory medications usually prescribed for migraines. Dr. Breland noted that Tylenol #4 is a controlled substance but made no specific objection to Respondent's prescription of it for this patient. Cafergot-pb is not a controlled substance and its prescription by Respondent was not faulted by Dr. Breland. All of Dr. Breland's testimony on this patient is couched in vague terms of "it is hard to justify" Respondent's prescription of Percodan and Percocet on just this work-up and Dr. Breland felt Respondent's prescription of Percodan on the first visit was not justified without obtaining a further medical history, but he would have approved eventual (not first visit) use of Percodan for this patient's migraine headaches if it were not for the presence of hypertensive heart disease or her neurosis. Although the records fail to state why Percodan-based drugs were used, Dr. Breland felt these drugs would have been appropriately prescribed for the lumbosacral syndrome. By comparison, J.C's recorded medical history is more extensive than that of most of the patient records involved in this action. The history taken by Respondent lists previous surgery of a hysterectomy, of a previous fracture to the left hip, and of a tonsillectomy. Also given is an elevated blood pressure of 160 over 100, height and weight, state of parity, and diagnoses. The date of her last period and of her hysterectomy are not given. Petitioner's two expert witnesses each would have made separate and different judgment calls on all prescriptions here related, except that each concurs that Respondent's initial prescription of Percodan on this patient's first visit was unjustified without a further recorded history; therefore, Dr. Breland's summation that the records justify overall treatment of this patient is accepted. L. C. (COUNTS V; VI; XV) It is admitted (Requests for Admission) and found that between approximately March 27, 1978, and April 23, 1983, Respondent prescribed at least the following quantities of schedule-controlled substances to L.C.: DATE DRUG STRENGTH QUANTITY 03/27/78 Darvon Compound 07/21/78 Darvon 07/21/78 Darvon Compound 07/21/78 Valium 10/23/79 Percodan 10/31/79 Preludin 11/17/80 Preludin 11/28/81 Darvon Compound 12/28/81 Percodan 24 01/14/82 " " 30 04/02/82 " " 36 06/08/82 " " 36 07/17/82 " " 36 08/28/82 " " 36 09/25/82 " " 24 09/25/82 Darvon Compound 12/03/82 Percodan 30 01/15/83 " " Dr. Cohen's opinion that there had been prescription of an amphetamine drug for an unjustified purpose and that the patient's records did not justify the Respondent's prescribed course of treatment is rejected as partially predicated upon inadmissible and unadmitted exhibits. The opinion of Dr. Breland is accepted that most of these prescriptions as only part of the course of treatment as a whole were acceptable. More particularly, Dr. Breland indicated there are other doctors similarly geographically situated who use Percodan similarly; there was a very adequate history taken, although the date appears out of order on the page; Respondent's early prescribing of Roboxin and Darvon (one of the less addictive controlled substances) would be a good treatment for osteoarthritis which was part of Respondent's diagnosis of this patient; there was not enough Percodan prescription here for Dr. Breland to say it was not justified in this patient's case. Dr. Breland was unsure when Preludin became a scheduled substance and so would not comment on that aspect of the case. This is an issue of law and is discussed under "Conclusions of Law." T. G. (COUNTS VII; XV) Between approximately July 23, 1978, and April 26, 1983, Respondent treated a patient by the name of T.G. During that period, the stipulated records reveal at least the following prescriptions, among others: DATE APPROXIMATE QUANTITY CONTROLLED SUBSTANCE 7/23/78 30 Percodan 7/23/78 Darvon Compound 9/21/78 Percodan 10/14/78 Percodan 10/14/78 Darvon Compound 11/21/78 24 Percodan 11/21/78 Darvon 12/6/78 30 Percodan 12/6/78 Darvon Compound 12/28/78 Percodan 12/28/78 Darvon 1/23/79 Qualudes 1/29/79 24 Percocet 1/19/82 24 Percocet 3/4/82 Valium 3/4/82 Percodan 4/29/82 Percocet 8/19/82 Percodan 8/19/82 Valium 10 mg 9/25/82 Valium 9/25/82 Percocet 10/14/82 40 Percocet 10/14/82 40 Valium 10 mg 10/14/82 40 Percocet 10/14/82 40 Valium 10/14/82 40 Percocet 10/14/82 40 Valium 10 mg 10/14/82 40 Valium 10/14/82 40 Percocet #5 10/14/82 40 Percocet 10/14/82 40 Valium Additionally, the Respondent occasionally prescribed Tetracycline and Actifed Syrup for colds, and the parties have stipulated these are not controlled substances. Although Dr. Breland tagged Respondent's use of Roboxin 750, Percodan 30, Darvon compound and Prednisone (a Cortisone- like anti-inflammatory) on the first visit as "borderline acceptable," it was his and Dr. Cohen's mutual opinions that in the absence of recorded physical findings, the Respondent's prescribing of controlled substances in these quantities and with this frequency to this patient was not justified by the records Respondent kept. Dr. Breland, in particular, found unacceptable the Respondent's diagnosis of lumbosacral syndrome without detailed physical findings or any x-ray diagnosis, and both experts took exception to the continued and repeated prescriptions of the addictive drugs, Valium and Percodan, in a case where Respondent's records repeatedly indicate a good response. Both further opined against Respondent's delayed attempt to diminish the use of these addictive drugs. The doctors' opinion that the records do not justify the prescriptions are accepted. DAVID G. (Counts VIII; XV) The stipulated records reveal at least the following controlled substances were prescribed by Respondent to his patient, David G., between December 17, 1981, and February 12, 1983. DATE APPROXIMATE CONTROLLED QUANTITY SUBSTANCE 12/17/81 Ativan 12/30/81 Ativan 2/12/82 Valium 3/06/82 Seconal 3/11/82 Valium 4/08/82 Seconal 8/28/82 Seconal 8/28/82 Valium Respondent saw this patient 12 times in approximately 2 years and accepted David G.'s representation that he had been previously prescribed Ativan, a controlled substance of the same chemical family as Valium. Although Respondent claims he verified all prior medications, the verification here is not reflected in his record. The records themselves do not reflect for most occasions why this patient was being treated nor do they set forth an assessment of why Respondent switched from less to more addictive sedative hypnotics. Ativan is a tranquilizer on Schedule III. Seconal is a sedative on Schedule II. In an isolated response, Dr. Breland testified that if the Respondent's initial diagnosis of insomnia and anxiety neurosis had been arrived at after taking a proper history and after a proper physical examination which was not recorded, he would not find Respondent's use of these medications, including Seconal, improper, because there are doctors in the same geographical area who would also use Seconal. However, the ultimate opinion of both of Petitioner's experts is accepted that in the absence of a recorded initial physical examination and a recorded history beyond merely recording height and weight and an unverified former medical treatment, the course of this patient's treatment was not justified by the records kept. DAN G. (Counts IX; XV) The records stipulated in evidence reveal at least the following controlled substances were prescribed by Respondent to his patient, Dan G., Jr., between January 9, 1979, and April 22, 1983. DATE APPROXIMATE CONTROLLED QUANTITY SUBSTANCE 01/09/79 Percodan 02/22/79 Talwin (50 mg) 11/18/81 Percodan 11/30/81 Percodan 01/02/82 Percodan 01/19/82 Percodan 02/05/82 Percodan 03/30/82 Percodan 04/12/82 Percodan 05/01/82 Percodan 05/01/82 Valium 05/18/82 24 Percodan 06/05/82 Valium 06/22/82 Percodan Demi 06/22/82 Darvon Compound 06/22/82 Valium 07/24/82 Percodan 07/24/82 Valium 08/28/82 Percodan Demi 08/28/82 Valium 09/25/82 Percodan 09/25/82 Valium 10/30/82 Valium 10/30/82 Percodan 12/03/82 Percodan 02/19/83 Percocet 03/26/83 Percodan 03/26/83 Valium 04/22/83 Tylox 04/22/83 Valium Respondent's records for this single patient sometimes specify "Jr." and sometimes do not. The initial record indicates a surgical incision along the lateral aspect of both femurs and pain on palpation of both hips, and records a history of total hip arthroplasty (two total hip replacements) in 1979 with the patient evidencing pain secondary to a post-operative procedure to correct aseptic necrosis of both femurs. At formal hearing, Respondent stated that this patient first presented in a wheel chair and returned frequently, due to chronic pain and was already on Demerol when first seen by Respondent. The chronic pain was not always repeatedly recorded in Respondent's records. Both of Petitioner's experts concede that prescriptions of Percodan would be consistent if that were all that were relieving the pain when the patient presented to Respondent, and Dr. Cohen opined that Percodan and Talwin were possibly consistent with aseptic necrosis of a femur. Respondent had admitted (R-1), a hospital summary of subsequent surgery (conversion of left total hip arthoplasty to girdlestone on 8/19/83) at the Veteran's Administration Hospital in Gainesville. This exhibit of subsequent surgery corroborates the previous 1979 history taken by Respondent which indicated that medications on discharge from the VA Hospital included Demerol 50 mg. po q 4h prn for pain. In light of no evidence of patient addiction and no evidence of poor response by this patient to Respondent's prescribing and treatment, the opinions of Dr. Breland and Dr. Cohen that Respondent's prescribing was excessive and necessarily addictive and therefore was unjustified are rejected, however the undersigned accepts their mutual opinions that the Respondent's records by themselves without the subsequent corroboration of the VA Hospital report do not justify the treatment Respondent administered to Dan G. Respondent admits R-1 was not relied on in treating this patient. C. R. (Counts X; XI; XV) The records stipulated in evidence reveal at least the following controlled substances were prescribed by Respondent to his patient, C.R., between July 3, 1978, and April 22, 1983: 2/ DATE APPROXIMATE CONTROLLED QUANTITY SUBSTANCES 07/03/78 Percodan 07/03/78 Percodan Compound 07/20/78 30 Percodan 08/14/78 30 Percodan 11/01/78 30 Percodan 12/05/79 Desoxyn 12/05/79 Percodan 01/02/79 Desoxyn 02/05/79 Percodan 02/12/79 18 Percodan 03/28/79 Percodan 04/16/79 Percodan 05/03/79 Percodan 05/17/79 Percodan 05/17/79 Darvon Compound 05/17/79 Percodan 05/17/79 Darvon Compound 06/14/79 6 Percodan 06/14/79 24 Desoxyn 09/18/79 Desoxyn 10/04/79 Percodan 11/10/79 Preludin 01/28/80 P 06/12/80 Preludin (75 mg.) 09/18/80 Preludin (75 mg.) 11/17/80 Percodan 01/27/81 Darvon Compound 04/27/81 Percodan 07/28/81 Percodan 08/31/81 24 Percodan 09/21/81 24 Percodan 12/16/81 Percodan 01/06/82 Percodan 01/29/82 Percodan 03/02/82 Percodan Demi 03/02/82 03/28/82 Percodan 04/20/82 Percodan 05/13/82 06/04/82 Percodan Demi 07/03/82 Percodan Demi 08/03/82 36 Percodan Demi 08/28/82 Percodan 08/28/82 Valium 12/20/82 24 Percocet 5 12/20/82 30 Valium (10mg) 01/15/83 6 Tylenol #6 01/22/83 Percodan Preludin and Desoxyn are amphetamine drugs. Desoxyn was legitimately prescribed for weight control in 1978. Respondent's prescription of both drugs was ostensibly to modify the amount of weight supported by the patient's leg bones. Dr. Breland is not sure whether both drugs were reclassified for control in 1979 or not but this is an issue of law resolved in "Conclusions of Law" supra. Despite Dr. Breland's testimony that if he did not have to base his opinion on the Respondent's inadequate recorded history and findings, he would term the prescribing of Percodan and Roboxin as recorded to be borderline acceptable, the undersigned accepts his and Dr. Cohen's mutual opinion that the frequent prescriptions of Percodan, Percodan- demi or Percocet (narcotic analgesics) for the Respondent's recorded diagnosis of arthritis and right leg pain resulting from previous right thigh surgery are unjustified by the records. Their respective opinions that this pattern of prescribing was excessive and unjustified in light of the potentially addictive nature of these drugs is also accepted. B. W. (Counts XII; XIII; IV) The records stipulated in evidence reveal at least the following controlled substances were prescribed by Respondent to his patient, B.W. between June 7, 1979, and January 29, 1983. 3/ DATE APPROXIMATE QUANTITY CONTROLLED SUBSTANCE 10/01/79 Valium 10/15/79 Tylenol #3 06/19/80 Tylenol #3 06/08/81 Ritalin (20mg) 08/11/81 Valium 08/15/81 Valium 09/15/81 Talwin 11/14/81 Talwin 12/07/81 24 Ritalin (20 mg) 12/20/81 Talwin 01/23/82 Talwin 02/12/82 Percodan Demi 02/27/82 Tylenol #4 03/04/82 Ritalin 03/18/82 Percodan Demi 04/02/82 30 Talwin 07/03/82 24 Ritalin 08/28/82 30 Ritalin 09/22/82 24 Percodan 10/14/82 Talwin (50mg) 12/21/82 24 Percodan 01/29/83 Tylox Ritalin is a sympathomimetric amine drug, which may only be properly prescribed in certain types of cases more specifically set out in the following "Conclusions of Law." Respondent's diagnosis, that this patient had chronic anxiety and back pain, is reflected in his written records. This is essentially the only recorded history on this patient. Respondent did not record a diagnosis of narcolepsy. Respondent did, however, introduce R-2, a consultation report to a Dr. Yankovich dated 1/5/82 from a Dr. Elzawahry which states the impression: "narcolepsy; low back syndrome. . . maintain on Ritalin 10 mg. po tid." Respondent testified that he had received similar information concerning the narcolepsy and psychiatric disturbance earlier than 1/5/82 first by telephone and then by written reports thereon from consulting neurologists, surgeons, and psychiatrists, and that through inadvertence this document was not turned over to Petitioner's investigator. However, Respondent did not explain why his files did not contain these other consultants' reports or why he did not write-up their contents or the dates they were received by him or why his prescriptions of 20 mg were so much greater than those recommended by Dr. Elzawahry. Dr. Breland felt that if Respondent were aware when he first prescribed Ritalin to this patient that the consultant had recommended it because of a good response, then Respondent's Ritalin prescriptions would be justified. It was also noted by Dr. Breland that Ritalin once was believed by the medical profession to be appropriately prescribed in the treatment of depression but that method had ceased and was statutorily proscribed by the time periods in question. Dr. Breland's expert opinion on prior belief of the medical profession is accepted. His conclusions of law invade the province of the hearing officer and are rejected in part and accepted in part as set out in the "Conclusions of Law." Dr. Breland did not feel under the circumstances that the Ritalin was contraindicated. Accordingly, Dr. Cohen's testimony that Ritalin is very dangerous if prescribed for chronic anxiety and depression is hereby discounted in that unlike Dr. Breland, he did not have the benefit of R-2 when testifying by earlier deposition. Dr. Cohen felt Valium was useful for chronic anxiety and that Tylenol #3 and Talwin were useful for pain but that there were excessive prescriptions of these drugs with few or no notations indicating any pain. In most instances all that is noted in Respondent's records on this patient is a prescription listed beside the date. Dr. Breland remarked that even the forms used by Respondent did not include a space for physical findings. J. M. (Counts XIV; XV) The records stipulated in evidence reveal at least the following controlled substances were prescribed by Respondent to his patient, J. M., between October 25, 1980, and March 9, 1982: 4/ DATE APPROXIMATE QUANTITY CONTROLLED SUBSTANCE 10/25/80 Percodan 01/05/81 Percodan 05/19/81 Emprin #4 06/03/81 Emprin #4 07/29/81 18 Percodan 09/25/81 12 Percodan 09/25/81 18 Tylenol #3 11/07/81 24 Tylox 11/21/81 Percodan 12/17/81 Percodan 01/02/82 Percodan 02/22/82 Percodan 03/09/82 Percodan The records of history and findings on this patient are reasonably complete and were faulted by Dr. Breland mostly because without appropriate dates one cannot tell if the history was taken on the initial visit as it should have been or later, and because the dates given are frequently out of order. In Dr. Breland's opinion, some of the modes of therapy utilized by Respondent were not of his choice but Dr. Breland only seriously objected to Respondent's continued and excessive use of Percodan as unsafe. Dr. Cohen's opinion was that the Respondent's conduct constituted mal- prescribing over malpractice. Dr. Breland's opinion was that Respondent's overall conduct with regard to these eleven patients constituted malpractice in that it was the failure to practice medicine with that level of care, skill and treatment of a reasonably prudent similar physician, under similar circumstances. Dr. Breland has had the benefit of reviewing all of Respondent's exhibits and he practices in the same geographical locale as Respondent. His opinion in this regard is accepted as to the overall pattern of practice with these eleven patients, despite his previous opinions that specific cases might not evidence malpractice.
