Findings Of Fact At all times material hereto, the Respondent was licensed as a general physician in the State of Florida, having been issued license number ME0031490. At times pertinent hereto, Dr. Elkadi operated the "Akbar Clinic" in Bay County, Florida. His operation of the clinic consisted generally of performing medical practice of a general nature as well as practice as a general surgeon, including outpatient surgery. He also practiced at Bay Medical Center, where he treated patients admitted under the auspices of other physicians. Dr. Elkadi had no admitting privileges at Bay Medical Center. The Petitioner is an agency of the State of Florida charged with regulating and enforcing the medical practice standards and licensure standards embodied in Chapter 458, Florida Statutes, including the standards of practice involved in the dispute in this case. Ms. Eunice Stallings was a patient of the Respondent on March 19, 1985, on which date she came to his clinic. She was 70 years of age. After performing some tests and observing the results, Dr. Elkadi informed her that she suffered from gall stones. She filled out a form in his office indicating that she had previously had a tonsillectomy, an appendectomy, a lobectomy and a hysterectomy. The doctor mentioned that she could be admitted to the hospital for surgery or could use his clinic. She elected to stay at the clinic and have the surgery there on account of the greater expense she believed involved with a hospital admission. She did not have any discussions with Dr. Elkadi concerning possible complications or risks associated with the gall bladder surgery prior to the surgery. Her daughter, Ms. Ted Cowens, went to the clinic with her on the day of the surgery. She arrived shortly after 7:00 a.m. on that day. A clinical employee escorted Ms. Stallings to the room to have her change into a surgical gown. Dr. Elkadi had discussed earlier with Ms. Stallings the possibility of staying in a nursing home or something of that nature after the surgery, for recovery. She assumed that the clinic would make the arrangements for that recovery procedure. She was not informed that she might have to stay beyond 24 hours in the clinic's facility. She was not informed prior to the surgery that Dr. Elkadi had no admitting privileges to the hospital, if complications should arise necessitating hospital admission. Ms. Cowens remained at the waiting room from 7:00 a.m. until 2:00 p.m. of March 19, 1985, while her mother-in-law was undergoing the cholecystectomy (gall bladder removal). She saw her mother-in-law at 2:00 p.m. that afternoon and observed that she was attached to a heart monitor and was breathing oxygen with difficulty. Ms. Cowens inquired about the circumstances and was informed by a person who identified herself as a nurse that Ms. Stallings had run into a problem with her lung. She was having difficulty breathing at the time. Ms. Cowens observed a person who identified herself as "Joyce" acting as a nurse right after the surgery. When she returned at 5:00 a.m. the next morning on March 20 to the clinic to see her mother-in-law, Joyce indicated that she had been the sole person on duty with Ms. Stallings during the entire night. She also indicated she had tried to get another person to be on duty, but was unable to do so. Ms. Stallings at this time was still coughing and spitting blood and continued to do so until her transfer from the Akbar Clinic to Bay Memorial Hospital by the Respondent and Dr. Albibi, based upon the other doctor's admitting privileges, at approximately 5:00, on March 20, 1985. Charles Wheelahan is an investigator for the Department of Professional Regulation and interviewed the Respondent in his Panama City office. The Respondent gave him copies of medical records regarding the Stallings case and informed him that a small respiratory problem, involving slight lung congestion, had occurred shortly after Ms. Stallings' operation, while she was still a patient in the clinic. Dr. Elkadi informed the investigator that he had made application to be licensed as a "hospital," but that license application had been denied by the Department of Health and Rehabilitative Services (HRS) and that he was in the process of applying to be licensed as a "surgical center." He also informed the investigator that the nurse on duty with Ms. Stallings on the night of March 19-20, 1985, was Joyce L. Snow. She was a Licensed Registered Nurse in Great Britain, but was unlicensed in the State of Florida. The doctor, in response to a question from Investigator Wheelahan, informed him that he did not maintain any blood supply on the clinic premises, but could obtain blood from the county hospital if needed. In any event, he informed the investigator that only a minor blood loss was expected and actually experienced during the cholecysteotomy surgery and that it would have been anywhere from 20 to 100 cc's blood loss. The investigator also established that a person known as Olga Sutter, apparently an employee of the clinic, was also present and cared for Ms. Stallings during some of the time she was a patient at the Akbar Clinic. Dr. John L. Williams testified as an expert witness on behalf of the Petitioner. He is a Florida licensed physician and general surgeon and has been in private practice in Tallahassee since 1970. He is Board-certified in surgery and belongs to numerous medical societies. His primary practice emphasis has been in direct patient care. Dr. Williams reviewed the hospital and office notes concerning Ms. Stallings, which comprise Exhibits 5A and 5B in evidence. The medical records reveal that Ms. Stallings went into respiratory distress post-operatively, which ended up as acute congestive heart failure, for which she was treated. The doctor's and nurse's notes reflect that she had become short of breath and that her blood pressure fell and that she ultimately became cyanotic. Blood gas test results proved the fact of her congestive heart failure condition. Dr. Williams felt that, although the treatment was adequate in the end result, there should have been some contingency plans developed in advance for handling any disaster or crisis that arose involving the pulmonary edema or bleeding suffered by the patient. The medical records and notes and evidence of record do not reveal that the Respondent had any such contingency plans for handling crises developing from performing such surgery in an outpatient setting. The operation, as shown by Dr. Williams, would have been more appropriately performed in a hospital setting so that the patient would have the crisis-handling ability of the hospital systems and staff during her overnight stay. It was his opinion that, given the history of lung trouble, wheezing, scarring of the chest, as well as her age, that this type of surgery should not have been done in the outpatient setting. Dr. Williams' expert opinion is accepted. Dr. Paul Lahti is an expert witness for Respondent and a retired general surgeon from Michigan. He reviewed the records of the Stallings case and found nothing inappropriate about Dr. Elkadi's care of Ms. Stallings. He stated that the doctor's actions avoided a catastrophe. He also stated that same-day surgery is recognized in 48 states. He has not practiced medicine in Florida. He also has spent a substantial amount of time writing, lecturing and advocating the cause of same-day outpatient surgery. I find his testimony significantly colored by his somewhat partisan view, advocating that a broad range of surgical procedures be performed as outpatient same-day surgery. His opinion appeared based on that and on the fact that nothing inappropriate was determined by him to have been done by the Respondent in his care of Ms. Stallings in terms of the end result. Dr. Edward Woodward, a professor of surgery, from the University of Florida, was also Respondent's expert witness. He likewise found the care of the patient itself appropriate and did not feel the problems she experienced were clinically important. Dr. Williams, the Petitioner's expert himself, however, did not find the actual techniques of the treatment afforded the patient, including that afforded her after the respiratory and congestive heart failure crisis arose, to be inappropriate. The problem was, that it was substandard medical practice, as related above, to handle such a serious surgical procedure for a patient of her age and with her previous health history as an outpatient surgical case. Appropriate medical practice would have dictated that a patient such as this be hospitalized before such surgical treatment. Dr. Woodward, one of Respondent's experts, also felt that it was the surgeon's duty in a case such as this to anticipate problems that may occur during or after surgery. Thus, in this context, and because of his more thorough review of pertinent records, Dr. Williams' expert opinion is the more valid one and is accepted over the others. Expert Witnesses Four experts were called by the Petitioner and Respondent to testify and give expert opinion testimony concerning the nine patients related to Case No. 86-1327, which will now be addressed. Dr. John L. Williams, general surgeon and expert for Petitioner, testified that he reviewed all the cases, involving hospital charts and office notes and other records, in its entirety, spending more than 30 hours reviewing them. Dr. Millard Roberts, a gastroenterologist and expert for Petitioner, read all of the hospital and office notes, which are exhibits, and spent more than 50 hours reviewing them. Dr. David Skinner is Chairman of the Department of Surgery at the University of Chicago and an expert for the Respondent. He stated in his deposition that he read abstracts of the medical records, contained in Respondent's Exhibit 7 in evidence, sent to him by the Respondent. He did not compare those prepared abstracts with the actual medical records which Dr. Williams and Dr. Roberts had reviewed. See Respondent's Exhibit 6, pages 17-21. Dr. Skinner spent approximately seven hours reviewing abstracts of the records furnished him by the Respondent himself, Dr. Edward Woodward is professor at the University of Florida. He stated that he reviewed the hospital charts, but no office records concerning the patients involved. He also looked at the Respondent's attorney's summary of notes to supplement his factual basis for rendering an opinion. The evidence did not reflect what length of time Dr. Woodward spent reviewing this material.. The Surgical Procedure at Issue Fundoplication is the surgical procedure under question in the nine cases comprising Case No. 86-1327. This procedure is designed to prevent "reflux" or regurgitation of stomach contents from the stomach up into the esophagus. "Reflux esophagitis" is the chronic inflammation of the esophagus due to the reflux of gastric juices into the esophagus for various reasons. Reflux esophagitis, if severe enough, may cause scarring or narrowing in the esophagus. Reflux esophagitis is an indication to perform the surgical procedure called fundoplication in those cases in which reflux is due to an inherent weakness in the junction of the stomach and the esophagus. The most common symptom of reflux esophagitis is a substernal burning or discomfort after eating, which is commonly referred to as heartburn. A further symptom is regurgitation of food when the patient bends over or lies flat after large meals. Other less specific symptoms of the condition involve upper abdominal pain. Ruth Cooey is a 73-year-old female who complained of epigastric pain upon admission by the Respondent. The patient had a history of taking Tagamet and antacids for one year. One year prior to admission, an upper GI examination was done which revealed an esophageal hiatal hernia and a duodenal ulcer. Her past history included arthritis with a left total hip replacement, hypertensive cardiovascular disease and a total abdominal hysterectomy. Following her admission to the hospital, Dr. Elkadi entered the case, treating the patient with Tagamet and Regulon. The patient's history contained notes of recurrent epiastic pain, nausea, choking spells and heartburn radiating behind the sternum for several years. Shortly before hospitalization, peptic ulcer had been demonstrated, as well as a hiatal hernia, which the Respondent confirmed. A "Bernstein test" was then conducted. A Bernstein test is designed to reproduce "heartburn" in most cases. The results are not always accurate. The Bernstein test was done three days after admission, with negative results. The results were not noted by Dr. Elkadi in his summary, however. Dr. Elkadi performed an endoscopy with the distal esophagus being described as compatible with chronic esophagitis. There was a "small sliding hiatal hernia with intermedial reflux." The records also reveal a description of two shallow ulcers of three to four millimeters each, in the prepyloric area and a large pyloric channel ulcer, described as being eight to ten millimeters in diameter. Biopsies taken during endoscopy showed chronic esophagitis and revealed chronic inflammation in the prepyloric mucosa. Dr. Elkadi performed a vagotomy, a pyloroplasty, and a Nissen Fundoplication on or about June 8, 1983. Dr. John Williams, the Petitioner's expert, opined that the reflux this patient had experienced was due to the primary disease of pyloric channel ulcer, which can cause reflux and thus produce symptoms of heartburn. If she had an intrinsic weakness of the esophagastric junction, a primary indication for a fundoplication procedure, then she would have had the symptoms before she was 73 years of age and not just had them occur after she had the ulcer. It was Dr. Williams' opinion that fundoplasty, the surgical procedure at issue, was really not indicated in this case. The symptoms exhibited for reflux esophagitis, which would justify the fundoplication were not present in this case. The symptoms existing were likely due to the ulcer as opposed to esophagitis. The symptoms the Respondent listed which he felt showed reflux esophagitis were pain after meals (thirty minutes to an hour and relieved by antacid), heartburn, and the epigastric pain described by Dr. Zawahry in June 1981. It might be noted that Dr. Zawahry, at that time, did not note any choking, dysphagia (difficulty in swallowing) or substernal pain, which are indications for fundoplication. The documentation of those symptoms came from the Respondent's notes. Dr. Williams felt the written records from the charts at the hospital did not justify the need for the fundoplication which was done. Her primary problem was a peptic ulcer. The esophagasoopy did show some esophagitis, which is evidence that some material was getting into the esophagus from the stomach or digestive tract below, but that was caused by the ulcer disease. Dr. Williams indicated that the treatment noted on those written records was below appropriate performance standards for a reasonable physician under reasonable similar conditions and circumstances, as there was no indication that the symptoms exhibited indicated the need for the fundoplication surgery. Dr. Millard Roberts, a gastroenterologist and licensed physician in the State of Florida, is a private practitioner in Tallahassee. He was qualified as an expert witness for the Petitioner in the field of gasroenterology. He received his undergraduate degree from the University of Florida and his medical degree from the University of Miami Medical School. He has admission privileges at Tallahassee Memorial Regional Medical Center and Tallahassee Community Hospital and presently serves on the Medical Records Review Committee of both those hospitals. He has practiced for sixteen years and attends numerous conferences and training sessions within his field of gastroenterology to keep his knowledge and skills current. He formerly practiced in that field, as well as in internal medicine, in Dothan, Alabama, His primary emphasis has been on the symptomology of the patients, which he obtains by taking a history, a physical examination, performing certain studies and arriving at impressions after completing examinations and observing the results of tests or studies. The standard practice in the medical community for determining whether or not symptoms are properly documented in records is based on rules promulgated by the Joint Commission on Accreditation of Hospitals, which method was employed by most hospitals in the country in 1985. Dr. Roberts discussed the various symptoms of esophageal reflux disease, including heartburn, difficulty in swallowing or painful swallowing (dysphagia), regurgitation or reflux of material as high as the throat or mouth. The symptoms noted in the hospital chart of the Cooey case, in his opinion, were related to ulcer, rather than to esophageal reflux disease. There was an absence of symptoms such as heartburn, dysphagia, choking and substernal pain. These symptoms were not noted in Dr. Zawahry's reports. He only reported epigastric pain. Dr. Roberts stated that it would be expected to see the other symptoms of esophageal reflux disease he noted appear in the patient's previous medical records made by Dr. Zawahry. Dr. Elkadi's consultation report is the first time these symptoms are mentioned. Dr. Roberts also pointed out that the Bernstein test is commonly used to confirm reflux esophagitis, but in Ruth Cooey's case the test was negative. It was negative on June 5, three days prior to the June 8 surgery. Dr. Roberts found nothing in the record occurring between the date of the Bernstein best and the date of the surgery three days later to confirm the necessity for doing a fundoplication. He further established that there was nothing in the radiologist's report to indicate any tertiary contractions of the esophagus, which would indicate a motility disturbance, which would be a justifying symptom. Dr. Elkadi's note is the only record he saw which is in any way supportive of the surgery. Dr. Roberts stated that the lack of symptomology to justify the fundoplication led him to conclude that the level of care and treatment fell below that of similar physicians practicing in similar conditions and circumstances. The other surgical procedure (for ulcers) should have taken care of the symptoms that were exhibited in the record without the necessity of the Respondent doing the fundoplication. The Respondent's expert, Dr. Woodward, agreed that the hospital charts and records did not give a clear history of reflux esophagitis in this patient. He also felt it was inexcusable not to have the information from the office notes on the hospital charts. He himself had reservations about the performance of the Nissen Fundoplication in this case, but would not call it malpractice. Dr, Skinner, the Respondent's other expert witness, testified in his deposition that the operation was appropriate. Based upon their greater familiarity with the circumstances of this case, including their more extensive survey and consideration of the records involved and their more direct experience in gastroenterological practice and surgery, I accept the opinions of Drs. Williams and Roberts over that of Drs. Woodward and Skinner. Debra Crosby is a 28-year-old female with a history of morbid obesity. She was admitted to Bay Memorial under the Respondent's care with a history, over the past few weeks, of nausea and dyspepsia, which is epigastric distress after eating greasy, fried foods. She had a past history of acid indigestion. The Respondent immediately ruled out gall bladder disease, the patient having been admitted for abdominal pain as well. The secondary reason for admission was for "morbid obesity," to conduct a surgery to allow the patient to reduce her obese condition. Such surgery limits the intake of food and the ability of the intestines to absorb food to some extent. The patient had surgery to correct morbid obesity. That surgery is called a "Roux-en-y" gastric bypass. That surgery involves making a small pouch near the upper part of the stomach, bringing the small intestine up and attaching it to that pouch so that the patient is only able to eat a limited amount at a time. Dr. Williams opined that that was an appropriate procedure to use for "bariatric surgery," that is, to relieve obesity, although he himself prefers the "vertical bend gastric partition procedure." No gastroesophageal reflux symptoms were documented in this case. In any event, on the 22nd of July, shortly before surgery, the patient was vomiting and suffering epigastric distress. They performed a "GI series" or barium- assisted X-ray of the upper digestive tract. While the patient was actually in the process of vomiting, a small hiatal hernia was demonstrated. Because of the vomiting, they had to abandon the upper GI series test. It was postponed until the next day, at which time another upper GI series test showed normal with no sign of hiatal hernia. So no esophageal reflux condition was demonstrated, nor was there any significant indication of hiatal hernia, which can cause a reflux condition in the esophagus. An ultrasound test of the gall bladder established that there were no gall stones, and her gall bladder appeared normal. She then had surgery for the gastric bypass procedure and also had a fundoplasty. The fundoplasty or fundoplication involved suturing the anterior wall of the stomach pouch to the anterior wall of the esophagus on one side. Only one side of the stomach was sutured up, and Dr. Williams established that fundoplasties all should be characterized by a "wrap" of some sort of the stomach around the base of the esophagus. The manner in which the surgery was described in the Respondent's operation note does not reveal that he could possibly do the appropriate fundoplication wrap procedure in that manner, with only a partial wrap. Esophageal reflux disease usually disappears with weight loss. With surgery to correct morbid obesity, accepted medical practice dictates that reflux-correcting procedures (fundoplasty) not be done. The reduction of the obesity greatly relieves the problem of reflux, and the gastric bypass surgical procedure is effective in preventing reflux of bile and juices itself. In Dr. Williams' opinion, which is accepted, there were no specific symptoms showing a reflux condition. There were some nonspecific symptoms that could possibly have been attributed to reflux involving epigastric pain or acid indigestion. The nausea and vomiting could have been due to many causes, but Dr. Williams thinks most likely that she suffered from gall bladder disease in spite of the fact that she did not have any stones. So, her symptoms could have been due to gall bladder disease, just acid indigestion, obesity or reflux. There were no clear-cut symptoms to justify the anti-reflux operation, however, because the patient had no symptoms of reflux before she had an acute illness, which caused her hospitalization. She was simply morbidly obese and correction of that problem would solve also any reflux symptoms she may have been-having. In summary, the medical records of this patient, maintained by the Respondent, did not justify an anti-reflux procedure such as fundoplasty. In any event, Dr. Williams opined that the procedure that was done would not prevent reflux anyway, even though it was unnecessary. This is so because an appropriate wrap of the stomach around the esophagus was not done. So, as established by Dr. Williams, the partial wrap, fundoplication procedure was supefuous and should not have been performed. Dr. Roberts also reviewed the Crosby case and opined that the gastroesophageal reflux condition would disappear with weight loss, brought on by the Roux-en-y procedure. When the pressure within the stomach exceeds the pressure of the lower esophagus sphincter muscle designed to prevent the reflux or regurgitation, then reflux can occur. The obesity causes a thickness and weight on the abdominal wall which pressures the stomach. The increase in the intraluminal pressure of the stomach enhances the possibility that reflux will occur. Therefore, prevention of increase of intraluminal pressure of the stomach would decrease the likelihood of reflux occurring. The documented symptoms of esophageal reflux disease, such as heartburn, dysphagia, chest pain, chronic cough and epigastric pain were not present in this patient, with the exception of some heartburn pre-operatively. Dr. Roberts established that the written records for this particular patient do not justify, by symptomology recorded, the necessity of doing a fundoplication procedure. Dr. Roberts thus corroborated the finding by Dr. Williams that the treatment and care of this particular patient fell below accepted standards for reasonable physicians under reasonable similar circumstances and conditions, since the indications for the fundoplication procedure were not present in the patient's records. Dr. Skinner opined once again that he felt the operation was appropriate. Dr. Woodward, however, questioned the necessity of the repair of the hiatus hernia and the anti-reflux operation or fundoplication. He felt that with weight loss the reflux condition would disappear with the lessening of pressure on the stomach and that therefore it was probably unnecessary, although he did not go so far as to call it a situation of malpractice. The opinion of Doctor Williams and the opinions of Drs. Roberts and Woodward, to the extent they are corroborative, are accepted. Patient Dorothy Kay was a 68-year-old female with a history of diabetes, cardiovascular disease and legal blindness. She also had some urinary and renal system dysfunction, with hyperemia. She was admitted by Dr. Kahn in June 1981 for abdominal pain, nausea and vomiting of one day duration. She had had three black bowel movements immediately before admission, but these were not tested for blood. Since her hemoglobin level was normal on admission and remained normal, Dr. Williams, in his testimony, discounted the possibility that she had gastrointestinal bleeding. She was thoroughly evaluated after admission, and her gall bladder proved normal. An upper GI examination showed a small hiatal hernia, but with no reflux, on June 15. Examinations of the kidney and a CAT scan of the abdomen were not remarkable, and a barium enema on the 22nd of June revealed some diverticulosis. She had a problem with constipation at this same time, which could have explained some of her complaints of abdominal pain, especially because the abdominal pain ceased after the barium enema, according to the nurse's notes. An endoscopy was performed on June 18 to examine the esophagus and stomach area. The esophagus showed some chronic inflammation. This can either occur as a normal occurrence or as a result of some disease process. This particular patient's history revealed that she had arthritis and had been taking a substantial dosage of Motrin, at 600 milligrams per day. Motrin is one of the drugs that can cause gastrointestinal and peptic symptoms. It can produce ulcers and bleeding. The patient had been maintained on this dosage of Motrin until two days before surgery, which is quite a significant dose. Dr. Williams also found that the abdominal pain was relieved upon administration of saline injections. H3, therefore, thinks the abdominal pain was most likely due to functional disease associated with diabetes and may well have been caused by the Motrin medication. In any event, there was no evidence in her history which would indicate that reflux esophagitis (the indication for a fundoplication procedure) was the cause of her pain. Even Dr. Elkadi's admission notes noted that her tenderness was more prominent in the lower abdomen than in the upper abdomen. The patient was operated on and had a needled biopsy of the liver and the fundoplication procedure, as well as a "lysis" of adhesions. The operation notes were not written until two months after the surgical procedures were done. Operative notes are customarily done at the time of surgery and on the same day if possible, so that the physician will not be as likely to forget details of the procedure as he would if they were dictated two months later. The operative notes on the fundoplasty procedure were done on August 19. The surgery was performed on June 25. Dr. Williams established that the records on this patient simply did not show symptoms of reflux esophagitis, an indication for the fundoplasty. The esophagoscopy was not valid evidence, standing alone, of reflux esophagitis, and that was the only possible suggestion that a chronic reflux condition existed. Dr. Williams established that the small degree of change observed in that procedure, due to reflux, was due to vomiting of the rather short historical duration occurring immediately prior to her admission. The Motrin medication she was taking could, itself, have caused her symptoms. The minimal chronic inflammation of the esophagus was not shown to be due to any defect in the gastroesophageal joint, but could have been due to any number of conditions in a diabetic, aged and infirmed patient like this and most likely was due to the recent vomiting, which is of undiagnosed etiology. Dr. Roberts referred to Dr. Elkadi's consultation of June 12, 1981, wherein he noted that the woman had been having abdominal pain for seven years, progressively worsening. Dr. Roberts did not feel that indicated reflux esophagitis. The reason he did not think so was because there was no mention made of any heartburn pain or difficulty in swallowing as to the upper abdominal area or chest area. There was also no mention in any of the notes or records that the patient was developing any strangling sensations or symptoms suggestions aspiration of gastric contents, bleeding or hemorrhaging, which would be suggestive of sever ulceration of the esophagus. Dr. Roberts agreed with Dr. Williams that this patient's records do not in any way indicate symptomology, clinical or otherwise, which would confirm a diagnosis of reflux esophagitis, indicative of a fundoplication procedure. Dr. Woodward, the Respondent's expert, also felt that the fundoplication was unnecessary. He found no history suggestive of reflux esophagitis and felt that such elective surgery in a person who was this sick, with diabetes and related problems, was a poor idea. He also found it unforgivable that the history was not more descriptive of the patient's problems and that the history concerning the patient's medication regime was not documented in the hospital chart. The doctor was opposed to the patient having this operation but, because of "mitigating circumstances" which he never fully explained in his testimony, would not call this a situation of malpractice either. In any event, based upon the testimony of Drs. Williams and Roberts and corroborated to some extent by that of Dr. Woodward it is found that Dr. Elkadi's treatment of this patient was inconsistent with quality medical care and fell below appropriate standards of practice for similar physicians practicing under similar conditions and circumstances. Agnes McNeil is a 42-year-old female with a history of depression, nausea, vomiting and abdominal pain. She was admitted to the hospital in October 1981 with approximately a six month history of abdominal distress and vomiting. A GI series was performed showing normal results and an upper gastrointestinal and endoscopy showed some esophagtis. There was also a finding made that she had a duodenal ulcer with some reflux. That finding was made October 31, 1981. She was admitted again on the 8th of March, 1982. On March 11, she had an "upper end endoscopy" and was said to have a hiatal hernia with reflux and duodenal ulcer, on the pylorus. The esophagus, however, was normal, and the GI series was negative once again. It showed no hiatal hernia and no reflux. She had surgery for the duodenal ulcer in the pyloric channel. The procedure done was a "highly selective vagotomy" which is done to inhibit the secretion of acid by the stomach. This is a rather new procedure and is not statistically as effective as some other procedures for the same condition. Additionally, the Respondent did a fundoplasty. The fundoplasty was not properly indicated, as established by Dr. Williams, because the significant changes in the esophagus which would indicate such a procedure were not present. The past reflux condition occurring in October 1981 was due to the acute ulcer condition. There had been no significant history of reflux prior to the onset of the peptic ulcer disease. If reflux was present, then the patient should have experienced some regurgitation upon bending over or waking up at night, as well as burning in the chest upon lying down at night, and none of this appeared in the record. A biopsy was done in this case which indicated acute esophagitis, and the patient had suffered severe weight loss, but this, in Dr. Williams' opinion, is related to the peptic ulcer condition and is justification for a vagotomy procedure, either the normal type or the new and somewhat controversial, highly selective vagotomy which Dr. Williams guardedly agreed with. In any event, however, he established that the fundoplasty was not ordered because the evidence of reflux esophagitis in the patient was directly related to the peptic ulcer disease and the procedure to effect a of that problem could be expected to alleviate the eophagitis. In any event, post-operatively, the patient still continued to have upper abdominal pain, nausea and vomiting. The obstruction in the pyloric area caused the reflux and caused the vomiting. The constant vomiting resulted in the inflammation or esophagitis condition. Pyloric channel ulcers cause obstruction which causes vomiting, and vomiting by definition is "reflux." The removal of the cause of the vomiting will also, over time, heal the esophagitis, without the necessity of a partial fundoplasty, as was done in this case. Dr. Roberts, in reviewing the McNeil patient records and notes, found that the upper GI series and the pathology in this particular case did not show significant evidence of reflux esophagitis. Three different "upper GI series" before and after she surgery, were interpreted as normal. His testimony, in effect directly corroborates that of Dr. Williams in establishing that the performance of the fundoplication as treatment in this case was below accepted standards of practice or a reasonable physician practicing under similar conditions and circumstances. Although he did not testify in his deposition that the Respondent fell below the standard and committed malpractice, Dr. Woodward, the Respondent's expert, also questioned and doubted whether the patient needed the Nissen. Fundoplication in view of the medical records he was given to review. Ms. Nguyen was a 77-year-old Vietnamese female at the time of her admission to the hospital by Dr. Kahn in December 1981. Her complaints were abdominal pain, nausea, vomiting, constipation, dehydration and fainting. She had been unable to urinate for approximately 24 hours prior to admission. These conditions are revealed by the notes, but the failure to urinate for approximately 24 hours is inconsistent with the dehydration symptom noted. In any event, she is a Vietnamese national and did not speak English. Communication with the Respondent, whose service she was admitted on, was difficult. It was thus difficult to get an adequate history from her, which made the history somewhat sparse. During her hospitalization, on December 19, Dr. Elkadi noted some "right upper quadrant tenderness." Dr. Elkadi had been consulted on the 18th of December and had noted at that time nausea, vomiting, right upper quadrant tenderness and constipation. Gall bladder X-rays showed probable gall stones or "sludge" in the gall bladder, and a GI series indicated a small hiatal hernia, without mention of reflux. An abdominal ulcer sound test was performed which showed sludge or small stones in the gall bladder. Gall bladder disease fit the physical findings of right upper quadrant tenderness, acute onset of nausea and vomiting and also the history of the patient not having a good appetite, being nauseated over the course of the year and losing a significant amount of weight. She only weighed 87 pounds upon admission. An endoscopy was performed, as a result of which Dr. Elkadi described the patient as having distal esophagitis, moderate erythema and edema, as well as a small hiatus hernia. A cholecystectomy was performed for removal of the gall bladder. There were no symptoms other than nausea and vomiting which would justify a finding that reflux esophagitis was present and that therefore anti- reflux surgery might be indicated. A small hiatal hernia was not significant, and there was minimal esophagitis shown by the endoscopy done immediately prior to surgery. What esophagitis evidence was present was due to the nausea and vomiting related to the gall bladder disease. Dr. Elkadi performed a fundoplication procedure anyway. Performance of a fundoplication is additionally risky for a person who is frequently vomiting, and the fundoplication was shown by Dr. Williams to be unnecessary in this case. The nausea and vomiting were not symptoms of reflux disease, but rather were symptoms of the gall bladder disease. The small hiatal hernia did not justify anti-reflux surgery in this case because that is frequently seen in older people and is not significant in itself. Additionally, although Dr. Elkadi's records showed that he removed a large gastric tumor, in reality that tumor was only one centimeter in diameter sitting on the surface of the stomach and was of no consequence in the patient's condition or related to any of her symptoms. The symptoms of right upper quadrant pain, nausea and vomiting, and the test results, justified the cholecystectomy (gall bladder) procedure, which is what Dr. Elkadi should have done and then stopped. He should have determined whether that alleviated the patient's symptoms, rather than doing the unnecessary fundoplication when the record did not reveal any significant reflux esophagitis indications, and since that procedure represents an additional risk to the patient. In summary, it was established by Dr. Williams that the records were not adequate to justify the fundoplication performed in this case. The performing of it unnecessarily constituted a failure to practice medicine with that degree of care and treatment required of physicians under similar circumstances. It is especially true in the case of a patient such as this, who is old and feeble at best. Performing an unnecessary operation on such a sick, 77-year-old patient increases the mortality risk somewhat and increases the post-operative morbidity risk significantly because the patient will not be able to "burp" any longer and can become subject to "gas bloat," as well as the risk of having difficulty swallowing because the "fundoplication wrap" might be too tight. The fact that it constituted malpractice to proceed forward with the unnecessary fundoplication is especially pointed up by the fact that Dr. Elkadi's own notes reveal that he was unable to understand the patient, who could not speak English, and thus was unable to get an adequate history. If the history is unclear because of a language problem and the doctor cannot understand the patient to make sure of the extent and nature of the symptoms, it is not reasonable to proceed with the operation, as opposed to trying to find an interpreter who can help the physician ascertain clearly what the symptoms are and what the indications for treatment are. Dr. Roberts, likewise, was unable to find any proof in the hospital records of the presence of any reflux esophagitis and felt that the fundoplication was unjustified. In fact, as he pointed out, Dr. Elkadi himself in his operative notes indicated that the limited history he was able to obtain from the patient was not specific enough to distinguish between gall bladder symptoms and gastroesophageal reflux symptoms. Dr. Roberts thus felt that the treatment of this patient fell below acceptable standards of a similar physician under similar circumstances. Dr. Woodward, the Respondent's expert, was unable to determine what was wrong with the patient and found that the hospital chart did not clarify it for him. The purpose of a patient history, according to Dr. Woodward, is to give a word picture of a patient's problem, and he found that the history, in addition to being inadequate, did not indicate any reflux esophagitis. He agreed with Drs. Williams and Roberts that the cholecystectomy was needed, but it was unlikely that the patient really needed anti- refluxsurgery (fundoplication). The additional operation, in addition to being unnecessary, added to the patient's mortality risk and post-operative morbidity. It has therefore been established that, as to this patient, the practice of the Respondent and his treatment of the patient fell below the acceptable standards for similar physicians practicing under similar conditions and circumstances. Rosey Peel was a 66-year-old lady admitted in May 1982 to Dr. Elkadi's service with a history of gastrojejunostomy, appendectomy, total abdominal hysterectomy, with associated adhesions. In October 1980, she had had a history of duodenal ulcer which was medically treated, as well as a history of stomach erosions and bowel gastritis treated medically in May 1981. In April 1982, she underwent an endoscopy, and the pathology report indicates the presence of chronic esophagitis and inflammation of the gastrojejunostomy. She had a history at this time of epigastric pain, nausea and vomiting. The endoscopy showed ulcers in the jejunum at the site of the gastrojejunostomy or the "rough equivalent to the pyloric channel." Thus, the patient had active peptic ulcer disease with related endoscopic evidence of bile in the stomach and in the esophagus. She underwent a vagotomy as a correction for the ulcer disease and a resection of the distal stomach, which disconnected the stomach from the duodenum in order to get rid of the problem of bile entering the stomach and causing the reflux esophagitis. The reconnection process was done in the form of a Roux-en-y procedure or gastric bypass, which has the effect of preventing the bile from entering the stomach. As opined by Dr. Williams, these procedures would alleviate her problem involving the ulcer disease, the reflux biliary gastritis and esophagitis. Consequently, she did not need the fundoplasty procedure, and it was unnecessary. The anti-reflux procedure did not have to be done, and the primary disease process, peptic ulcer disease, would have been alleviated by the Roux-en-y gastrojejunostomy and the vagotomy. Dr. Williams opined that when an operation like this that is unnecessary is done, then strictly speaking malpractice has been committed. He acknowledged, however, that it was possible to interpret her symptoms and records as indicating reflux biliary gastritis, which could have easily led the Respondent to believe that a fundoplication procedure could cure her problem. In fact, it was not necessary to cure the reflux problem she was having, as delineated above. In this particular case, standing alone, it might be said that, given the presence of reflux biliary gastritis and esophagitis, that a practitioner could make a good faith mistake in performing a fundoplication, rather than limiting the surgery to the Roux-en-y repair and the complete vagotomy. Dr. Roberts, after reviewing this patient's file, was unable to find symptomology in the record which would justify the fundoplication. The abdominal pain, nausea and vomiting, which had worsened over several months, were related, in his opinion as well as Dr. Williams', to bile reflux gastritis. Reflux in and of itself is not justification for surgery, especially when the patient is not complaining of chronic reflux esophagitis symptoms. The reflux can be due to other causes, as mentioned above, including the pyloric ulcer situation this patient suffered. He opined that the esophageal reflux situation and the delayed gastric emptying would have been relieved with just the procedures performed short of the fundoplication, as did Dr. Williams. Inasmuch as Dr. Williams felt that this single instance of performing the fundoplication, albeit necessary, could not by itself be called malpractice, since enough symptomology was present to lead a competent practitioner into performing it as a result of a good faith mistake, and since both Respondent's experts felt that the procedure was documented in this case, it cannot be found that this instance, standing alone, was gross or repeated malpractice. It has, however, been proven that the procedure was medically unnecessary. Considered together with the other unnecessary surgeries discussed in these Findings of Fact, however, the overall pattern is one of medical treatment which does not measure up to the standards of reasonable physicians performing such practice and treatment under similar conditions and circumstances. Ms. Rosey Smith is a 63-year-old female with a history of total abdominal hysterectomy, right nephrectomy and adhesion laparotomy, both of which procedures were performed in 1950; cholecystectomy performed in 1962; and hiatal hernia repair performed in 1980. She was admitted to the Respondent's service in 1981 complaining of epigastric pain. An endoscopy performed revealed moderate, chronic esophagitis, but the pathology report failed to confirm esophagitis and was interpreted as being without evidence of inflammation of either the esophagus or gastric mucosa. She was admitted by Dr. Kahn and subsequently consulted by Dr. Elkadi. She had had a Nissei Fundoplication for reflux esophagitis in November 1980. She was admitted again on this occasion in September 1981 with nausea and epigastric pain. Since her surgery in 1980, she has been unable to eat well because of fullness and pain after eating. She had upper gastrointestinal pain upon admission, and the endoscopy performed showed that she had a slight amount of esophagitis. However, biopsy of the stomach and the esophagus were normal. The upper GI series performed failed to show any reflux. It showed tertiary contractions of the esophagitis (spasms) and some delayed emptying of the stomach, as well as some deformity of the antrum of the stomach. That deformity did not have any significance, especially in view of the fact that the endoscopy failed to show any ulcers in that area. Dr. Williams did not feel that the delayed emptying of the stomach was significant either, and he found no evidence of reflux. The Respondent then performed a vagotomy after taking down the previous fundoplasty in order to get to the vagus nerve to do the vagotomy, which is indicated for peptic ulcer disease. Thereafter, he had to redo the fundoplasty, which had previously been done in 1980. Dr. Williams felt that the lady's problem was probably dysfunctional and probably related to her first surgery. After the first fundoplication, she exhibited the same complaints she had before. She had been treated previously with Tagamet and, if she did have peptic ulcer disease, the endoscopy did not reveal it to be significant. Thus she did not need this further surgery which also left her with the same complaint she had before. A month after this surgery some dysphagia or difficulty in swallowing as well as esophageal dilation was experienced. These are symptoms of the so-called "gas bloat syndrome." This is involved with fullness and pain after eating and is a complication of a fundoplication. Dr. Williams found that she did not have significant esophagitis, and the problem was more likely "gas bloat" or some undiagnosed, dysfunctional gastrointestinal disease. She did not have an active ulcer and had no significant reflux. Additionally, the "3 plus" positive standard reflux test is not in and of itself sufficient evidence to justify a fundoplication. This test can be positive and still not represent any symptomatic condition. Dr. Williams thus opined that the performance of the fundoplication being taken down, a vagotomy performed and the fundoplication being redone (which was necessary once it was "taken down") was below the acceptable standards of a reasonable physician under similar circumstances and conditions in light of the symptoms exhibited. In a like vein, Dr. Roberts found that the patient did not appear to have esophageal strictures before she had the surgery. The hospital nursing notes suggest that constipation may have been a problem because of the laxatives given during the days preceding surgery. No ulcer was found demonstrated by Dr. Roberts, only inflammation of the pyloris as a result of the endoscopy. Dr. Roberts likewise felt no fundoplicatio was justified by the patient records in this case. Dr. Woodward, Respondent's expert, likewise indicated that the history reflected in the hospital chart was characteristic of the "gas bloat syndrome." He strongly suspected that the first anti-refluxoperation (fundoplasty) was satisfactory and that she did not need any further surgery. Like Drs. Williams and Roberts, he did not think that Mrs. Smith had an ulcer either. He felt the ulcer surgery and the concomitant taking down and replacing of the previously done fundoplasty was not necessary, but did not feel he had sufficient information to opine concerning whether malpractice existed. Dr. Skinner believed the operation to be appropriate under the circumstances. The opinion of Doctor Williams and the opinions of Drs. Roberts and Woodward, to the extent they are corroborative, are accepted. Linda Turner is a 32-year-old female with a long history of medical complaints. Seven years prior to the subject admission, she had had an ovarian carcinoma which led to a hysterectomy, bilateral salplngo-oophorectomy and appendectomy. She had multiple abdominal complaints after that and was said to have ulcerative cholitis, which causes cramping and mucous in the stool. In November 1981, she was admitted with abdominal pain and was labeled as having a recurrent ulcer and right hip pain. She was admitted by Dr. Kahn from the emergency room. Her two primary complaints were sharp pain in the right hip and numbness in the leg and increased pain on hip movement, which had nothing to do with abdominal pain. She had three weeks of cramping and abdominal pain, which gradually increased with nausea and anorexia, epigastric burning with indigestion, associated with ingestion of food and liquids. She exhibited dark brown vomit on occasion, with lower abdominal tenderness. Her hemoglobin, chest X-ray, upper GI series and small bowel X-ray series was normal, as were pictures of the stomach. The barium enema she received was normal, as were her gall bladder tests, and CAT scan and PH reflux test. Dr. Elkadi was consulted, and he said that she had upper abdominal pain, nausea and vomiting for two years, which had worsened in the last three weeks. He stated that she had occasional regurgitation and dysphagia at the base of the neck. She was said to have had one tarry black stool before her admission, but Dr. Williams doubted there was any bleeding because her hemoglobin test was normal, and no positive stool was documented for blood. The doctor's notes indicated left lower quadrant pain and some stomach cramps. The pain increased with ingestion of food. She had an endoscopy on the 9th, which resulted in a normal biopsy. On one of the biopsy specimens, there was a small amount of blood under the mucosa, but this might be explained, according to Dr. Williams, by vomiting or trauma caused by the instrumentation itself during the endoscopy procedure. He saw no other evidence to indicate she had any bleeding from the esophagus. The patient had surgery on the 19th, and the operative record indicates that extensive adhesions were found in the lower abdomen. She also had a Nissen fundoplasty and a highly selective vagotomy. The vagotomy and the fundoplasty were unnecessary. The patient's primary problem was likely the abdominal adhesions which could explain the pain and cramps in the area of the lower intestine. The patient did have some symptoms that were suggestive of esophagitis in that, when she vomited, she had epigastric distress, but Dr. Williams could see no evidence of ulcer disease in her records and chart. Dr. Williams also was of the opinion that, although the lady had a record of having three tarry black stools, the fact that her hemoglobin had not changed and that no bleeding had been demonstrated after she was in the hospital, nor was any ulcer found, that the dark stools were evidently due to some other reason than bleeding. Although the endoscopy and related biopsy showed intramucosal bleeding, that was of a very slight nature and was likely due to the trauma of the instrumentation or the trauma of vomiting. There was no ulceration and no acute inflammation of the esophageal area. There was no evidence of significant hemorrhage originating in that area. Dr. Williams then opined that the patient's written records only justified an abdominal exploration. He felt that Dr. Elkadi should have stopped with the lysis of abdominal adhesions as a means of alleviating the patient's abdominal pain and cramps related to the small intestine, rather than proceeding with the fundoplasty and vagotomy in the gastroesophageal area, where there was no concrete evidence of esophagitis, ulceration or other disease. In short, the treatment given the patient was unnecessary and fell below the acceptable standards of similar physicians under similar circumstances. He exposed the patient to additional morbidity and a slight additional risk of mortality. Dr. Roberts essentially agreed with Dr. Williams' findings and stated that, other than Dr. Elkadi's own description about the endoscopy on these written records, no evidence or history suggestive of esophagitis was shown in this patient. He stated that, although the patient complained of chronic abdominal pain for three weeks, with nausea and loss of appetite, as well as epigastric "burning," he felt these were not sufficient enough to suggest chronic esophageal reflux disease indicative of a fundoplication. He opined that, on the basis of the tests done in this case, that a diagnosis of specifically what was causing the cramps, abdominal pain, nausea and loss of appetite and upper gastric burning could not be done and certainly not sufficient to support a decision to perform the surgery that was performed. The record was simply bare of any concrete evidence to suggest esophagitis being present, and he, too, felt that the treatment of this patient by the unnecessary surgery performed, fell below standards generally required of physicians under similar circumstances. Dr. Woodward, the Respondent's expert, was of the opinion that the patient's hospital chart did not support the operation and that the patient's history was not suggestive of the presence of esophagitis. He also found that the endoscopy, while being said to show esophagitis, also resulted in a normal biopsy, thus hemorrhage present was likely induced by the biopsy forceps, since you do not typically see hemorrhage caused by esophagitis, rather you see inflammation. Dr. Woodward did not think the patient had ever had esophagitis and did not think she needed the reflux preventative operation. Thus, he felt the procedures performed were unnecessary, although he would not actually state he had sufficient information to call this type and level of treatment malpractice. Once again, Dr. Skinner believed the treatment and operation to be appropriate. The opinion of Dr. Williams and the opinions of Drs. Roberts and Woodward, to the extent they are corroborative, are accepted. Felix Williams was a 62-year-old black male who was admitted in August 1981 to the service of Dr. Kahn. At that time he had a three-week history of epigastric pain with radiation to the back. Mr. Williams had a long medical history of multiple hospital admissions and surgeries. He had previously had a vagotomy and a pyloroplasty, supposedly for duodenal ulcers, which may have been unnecessary. He also had a "Bilroth II" subtotal gasrectomy, or partial removal of the stomach and reattachment of the lower intestine, designed to better drain bile from the stomach. The patient had been taking Tagamet for two to three years before the August 1981 admission. The past surgeries did not relieve the patient's symptoms. He also had had a long history of pancreatitis, with recurring abdominal pain. He had been operated on many times with no relief and continued to have the chronic pancreatitis, related to a long history of alcoholism. After being admitted on August 1, 1981, with a history of abdominal pain, the patient's serum amylase tested as being elevated. Urine amylase was also elevated. The amylase readings were only a little above normal, however, and it is common in people who have had chronic pancreatitis for years to have only a minimal elevation of their amylase when having an acute flare-up of pancreatitis. This is because the pancreas, over the years, has pretty much destroyed itself, according to Dr. Williams. The patient's upper GI series X-rays showed hiatal hernia with some reflux, but no stricture demonstrated. Ultrasound tests of the gall bladder and pancreas showed them as being essentially normal. CAT scans of the abdomen on August 27, compared to previous CAT scans, showed less enlargement of the pancreas, although it was still enlarged, which was consistent with pancreatitis. On August 31, an endoscopy was performed by Dr. Elkadi which showed a hiatal hernia and some esophagitis, as well as some alkaline gastritis and alkaline esophagitis. The biopsy done by the pathologist showed benign gastric mucosa, and the patient had no strictures of the esophagus. Bile studies showed no calcium bilirubinate crystals. In September 1981, during this same admission, Dr. Elkadi performed a cholecystectomy, or removal of the gall bladder, because of chronic cholecystis. He also performed a Roux-en-y revision of the original surgery. That is, he converted the Bilroth II surgical procedure to a Roux-en-y and also did a fundoplasty. Dr. Williams did not feel the patient needed surgery at all, but rather his symptoms were due to chronic pancreatitis. He felt that if the person was going to be operated on, however, that the removal of the gall bladder was certainly indicated, and that this is one of the causes of pancreatitis. In this case, the man had a long history of alcoholism, which serves to cause pancreatitis which, once it gets started, tends to be self- perpetuating. Dr. Williams felt that any surgery done at this point with the patient would result in the same problem, that is not alleviating the pancreatitis and associated abdominal pain. Dr. Elkadi knew of the pancreatitis or should be presumed to have known because the CAT scan taken on August 27, 1981, as well as the amyfase test results, revealed pancreatitis. He did not strongly consider pancreatitis as the primary problem, however, and, according to his notes, thought that repairing the reflux condition he believed to exist would take care of the problem. The Roux-en-y surgical procedure, as well as the fundoplasty, however, would not address the primary problem of pancreatitis, so the abdominal pain would still continue, which in fact it proved to do after Mr. Williams recovered from surgery. The pancreatitis-induced vomiting will not occur as much after the fundoplasty because that procedure prevents vomiting, but the patient will still have the same morbidity; it will just be manifested in a different way. The opinion of Dr. Williams establishes that the gastroesophageal reflux, which was seen on the endoscopy, in reality was due to the pancreatitis, and that the fundoplasty which was performed would do nothing to alleviate the pancreatitis. It might make it be manifested somewhat differently by reducing vomiting, but the abdominal pain and elevated amylase characteristic of the pancreatitis were still there. In summary, Dr. Williams felt that the removal of the gall bladder was justified and that the Roux-en-y procedure, which is designed to move bile juices from the stomach, would be justified, but for the fact that the primary problem was pancreatitis, which surgery of that type will not correct. Dr. Williams did not feel that the Respondent misdiagnosed pancreatitis, but just that he was "overly optimistic" and should have appreciated the fact that surgical treatment of this type would not have helped the man and that the only surgical treatment for chronic pancreatitis is removal of the pancreas, which causes a severe morbidity problem in and of itself and would probably not be indicated either. Thus, Dr. Williams opined that Dr. Elkadi's treatment of Felix Williams fell below accepted standards of physicians practicing under similar circumstances and conditions. Dr. Roberts also felt that the patient's basic problem was pancreatitis, relying on the same records that Dr. Williams relied on in his testimony. The patient had epigastric pain radiating through to the back, which is a classic indication of pancreatitis, which, when coupled with elevated serum amylase, establishes the presence of acute pancreatitis. Dr. Roberts was unable to find any history of nausea or vomiting, which would suggest gastric esophageal reflux, the admitting diagnosis being simply abdominal pain and pancreatitis. Since the patient had pancreatitis, that condition is consistent with the slowness of the stomach to empty itself, which in itself could have permitted reflux with changes consistent in the esophagus with esophagitis. Dr. Roberts was of the opinion that the records did not show the necessary symptomology to justify the anti-reflux surgery which was done. He thus felt that the standards of care of a reasonable, prudent physician under similar conditions and circumstances had not been met by the Respondent. The Respondent's expert, Dr. Woodward, after reviewing the records of Felix Williams, also felt that the symptoms did not suggest reflux esophagitis, the indication for the fundoplication surgery. Dr. Woodward did not, in his testimony, discuss the fundoplication procedure specifically. Dr. Woodward opined that the symptoms did not suggest reflux esophagitis, although this was diagnosed by the endoscopy, which was performed by the Respondent himself. He also did not feel the biopsy report was very convincing and felt that "the pathologist was trying to help out the surgeon." Nevertheless, Dr. Woodward felt that there was no doubt about his having reflux alkaline gastritis, which Dr. Williams noted as well, and felt that this was due to the unnecessary surgeries already performed by past surgeons. Dr. Woodward noted that this was also associated with marked gastric retention or failure of the stomach to empty rapidly enough. He thus felt that the patient should have another operation, if nothing else, to try to get the stomach to empty better and to divert some of the duodenal fluid away and hopefully give him some degree of pain relief. This surgery was done in the form of the Roux-en-y procedure performed by the Respondent. Neither Dr. Williams nor Dr. Woodward felt that this surgery was improperly performed. Dr. Williams merely felt that it was probably unnecessary, since the root problem was pancreatitis. However, Dr. Woodward established that, at least in an effort to aid stomach emptying and avoid gastric pain associated with bile retention in the stomach, that the Roux-en-y procedure probably was necessary. None of the three doctors opined that the fundoplication was necessary, however, since reflux esophagitis was not present. In summary, it is found that the surgeries performed, consisting of the cholecystectomy and the Roux-en-y procedure were appropriately done under the circumstances, although this is a marginal case for such surgeries being indicated, based upon the totality of the expert testimony, because of the underlying problem of pancreatitis. In any event, however, the fundoplication which was done was shown to be unnecessary and not medically indicated. Thus, as to that procedure, the Respondent's practice with regard to this patient fell below the medical practice standards referenced above.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record and the pleadings and arguments of the parties, it is, therefore RECOMMENDED that a Final Order be entered by the Board of Medical Examiners suspending the Respondent's license for a period of one year, with reinstatement to active status contingent on Respondent making satisfactory showing, by completing continuing education courses, or in such manner as the Board may elect, that he has worked diligently to enhance his knowledge and skill in the area of gastroenterological surgery, including the "indications" for such. It is further recommended that the Respondent's license be placed in probationary status for two years thereafter, with such terms and conditions as the Board deems appropriate, within the guidelines of Rule 2lM-20.001(t), Florida Administrative Code. The failure to comply with any such terms and conditions should result in revocation. DONE and ORDERED this 27th day of December, 1988, In Tallahassee, Florida. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 904/488-9675 FILED with the Clerk of the Division of Administrative Hearings this 28th day of December 1988. APPENDIX TO RECOMMENDED ORDER CASE NOS. 86-1140 & 86-1327 Petitioner's Proposed Findings of Fact: 1. Accepted. 2-3. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 6-17. Accepted. 18-20. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 23-25. Accepted. 26. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 27-29. Accepted. 30. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 31 #1. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 31 #2. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. 36 #1. Accepted. 36 #2. Accepted. 37-40. Accepted. 41. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 42-44. Accepted. 45. Accepted generally, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. Respondent's Proposed Findings of Fact: 13-20. Accepted, but subordinate to the Hearing Officer's Findings of Fact on this subject matter. 21-22. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 23. Rejected as not being of probative material import. 24-25. Rejected as to its purported material import. 26-29. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. Rejected as to its purported material import. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 33-34. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 37-39. Accepted. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 42-43. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted, but not as to its purported material import. 46-47. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 48. Accepted. 49-53. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 54-56. Rejected as to its purported material import. 57. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 58-61. Accented. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. 64-65. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. Rejected as not being of probative material import. 68-69. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. Rejected as not being of probative material import. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. 74-77. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. 83-84. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 85-86. Accepted. 87-89. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 90-91. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted, but not in itself dispositive of any material Issue. 94-95. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as to its purported material import. 98-99. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 100. Rejected as to its purported material import. 101-102. Rejected as subordinate to the - Hearing Officer's Findings of Fact on this subject matter. 103-104. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 105-107. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as not in accordance with clear and convincing evidence. Rejected as not being of probative material Import. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Accepted. Accepted, but not to the extent that the fundoplication was indicated. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. Rejected as contrary to the greater weight of the evidence, as subordinate to the Hearing Officer's Findings of Fact on this subject matter, as not being of probative material import and as constituting argument of counsel. Rejected as not being of probative material import. Rejected as contrary to the greater weight of the evidence, was subordinate to the Hearing Officer's Findings of Fact on this subject matter and as not being of probative material import. 117-119. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 120. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and not of material import in itself. 121-122. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and not in itself dispositive of material issues. 123-127. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 128-130. Rejected as subordinate to the Hearing Officer's Findings of Fact on this subject matter and as to its purported material import. 131-132. Rejected as contrary to the greater weight of the evidence and as subordinate to the Hearing Officer's Findings of Fact on this subject matter. 133-142. Really amount to legal argument and recitation of testimony and evidence regarding the Motion to Dismiss, which has been dealt with supra. COPIES FURNISHED: Roosevelt Randolph, Esquire KNOWLES & RANDOLPH 528 East Park Avenue Tallahassee, Florida 32301 Spiro T. Kypreos, Esquire LEVIN, MIDDLEBROOKS, MABIE, THOMAS, MAYES & MITCHELL, P.A. 226 South Palafox Place Post OffIce Box 12308 Pensacola, Florida 32581 Harry Rein, Esquire 3803 Lake Sarah Drive Orlando, Florida 32804 Bruce D. Lamb, Esquire General Counsel Department of Professional Regulation 130 North Nonroe Street Tallahassee, Florida 32399-0750 Dorothy Faircloth Executive Director Board of Medicine Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issue for determination is whether Respondent, a licensed physician, committed violations of Chapter 458, Florida Statutes, sufficient to justify the imposition of disciplinarysanctions against her license. The resolution of this issue rests upon a determination of whether Respondent intubated the esophagus of a patient, as opposed to the patient's trachea, in the course of rendering anesthesia care; and whether Respondent then failed to provide a record justifying such a course of medical treatment.
Findings Of Fact Respondent is Saroja L. Ranpura, a licensed physician at all times pertinent to these proceedings, holding medical license number ME 0039872. Respondent was licensed in the State of Florida on April 27, 1982. She currently practices medicine in Ohio. Petitioner is the Department of Professional Regulation, Board of Medicine, the state agency charged with the regulation of physicians in the State of Florida. On August 29, 1985, Frank Snydle, M.D., performed a laparoscopy on patient C.P. at Heart of Florida Hospital in Haines City, Florida. This medical procedure was performed on an outpatient basis. As a result, C.P. came into the hospital on the day the surgery was to be performed. She met Respondent, who later provided anesthesia care to her in the course of the laparoscopy. Respondent examined C.P. at that time, prior to the surgery, and noted that C.P. had a small mouth. Later, C.P. was brought into the operating room on a stretcher and moved herself over onto the operating table. Present in the operating room at that time were Jean Allen, L.P.N., Norma Masters, R.N., and Respondent. Respondent proceeded to do an unusual procedure known as a "blind nasal intubation." The procedure requires the placement of an tube in the patient's throat through the nose, as opposed to the mouth, in order to maintain an open airway during later anesthesia administration in the process of surgery. C.P. was sedated, but awake, during this process and was intubated with a minor degree of difficulty. Prior to placement of the endotracheal tube, Respondent had the patient breath pure oxygen through a mask covering the mouth and nose. The preoxygenation process, according to Respondent, provided extra oxygen "as a reservoir and as astorage" to C.P.'s body tissues. By letting a patient breath 100 percent oxygen for three to four minutes, the resultant saturation permits a margin of four to six minutes for such an intubation to be safely completed without risk of the patient becoming hypoxic. Jean Allen, with almost 25 years of nursing experience in a surgical assistance career where she assists in 400 to 600 operations per year, observed Respondent during the entire intubation process, inclusive of the preoxygenation phase. Accepted medical practice after such an intubation requires that the person placing the tube then listen for breath sounds over each lung and over the area of the stomach. Respondent maintains that she did listen for those breath sounds with the aid of a stethoscope. The anesthesia record completed by Respondent has a notation "BEBS" for bilateral and equal breath sounds which Respondent testified that she heard with the stethoscope prior to administering additional sodium pentothal to the patient and inflating the cuff of the endotracheal tube. This testimony of Respondent is not credited in view of the testimony of Ms. Allen that she observed Respondent during this entire time and that Respondent did not listen for the breath sounds with a stethoscope prior to administering the additional sodium pentothal to the patient. Allen's testimony is also afforded the greater credibility due to her opportunity as a neutral witness to observe the events which transpired and her testimony that although she didn't observe Respondent closely after the additional sodium pentothal was administered, she maintained that she would have recalled Respondent's use of the stethoscope prior to that point. Notably, it is at that point prior to the administration of the additional sodium pentothal and inflation of the cuff of the endotracheal tube where Respondent maintains she listened for the breath sounds. Respondent, after completion of the placement of the endotracheal tube, administered additional sodium pentothal to the patient without listening for breath sounds; connected the tube to the anesthesia machine; and remarked that "it must be in place, the bag is moving" in reference to the bag on the anesthesia machine which generally inflates as the lungs of the patient deflate. While inflation or deflation of a breath bag on an anesthesia machine is one part of the procedure for checking placement of an endotracheal tube, the expert testimony of John Kruse, M.D., and David Alan Cross, M.D., establishes that this procedure alone is not a reliable method of determining proper tube placement. Frank Snydle, M.D., who had entered the operating room by this time in the sequence of events, did a manual vaginal examination of the patient, left the room, scrubbed his hands and returned. He then donned surgical gloves and gown, moved to the left side of the patient and prepared to proceed with the operation. Ms. Allen took her position at the foot of the table, between the patient's legs with an unobstructed view of Respondent. Dr. Snydle proceeded to make a small incision in the patient's abdomen through which he inserted a hollow, "Verres" needle. Carbon dioxide was then introduced to C.P.'s abdominalcavity to push the abdominal wall away from the internal organs. Next, a device known as a "trocar" and a "trocar sleeve" was inserted through the incision into the abdomen. The trocar was then withdrawn and a laparoscope was inserted into the sleeve. Built somewhat like a telescope with a built-in light source, the laparoscope permits the surgeon to look inside the abdomen and visually observe the patient's internal organs. During this procedure, Nurse Allen commented that she heard a sound like a fog horn or frogs croaking when she touched the patient's abdomen. Allen's remark is corroborated by Norma Masters and Dr. Snydle. The proof establishes, as corroborated by expert testimony of Dr. Kruse, that such sounds were associated with air, captured in C.P.'s stomach as the result of esophageal intubation, escaping from the stomach when pressure was applied. When Dr. Snydle made his first incision in the patient's abdomen, Allen observed that the blood was dark and Dr. Snydle agreed. Respondent inquired whether it could be venous blood. Snydle indicated he didn't think this was the case. Notably, the dark blood was observed, according to Respondent's medical records at 10:27 a.m. Further, Petitioner's experts, Dr. Kruse and Dr. Cross, based on their review of C.P.'s medical records, determined that the patient was initially intubated at approximately 10:15 a.m. Thus, approximately 12 minutes transpired from the beginning of the intubation process and conclusion of preoxygenation of the patient until the observation of dark bloodat the time of incision. After her inquiry regarding whether the blood could be venous, Respondent further responded that she was giving the patient 50 percent oxygen. She testified that she then increased the oxygen level to 100 percent. While the anesthesia record indicates administration of 100 percent oxygen, there is no time notation when this occurred. Blood again welled up from the incision and Nurse Allen commented that the blood appeared black. The less oxygenated blood becomes, the darker it appears. By this time, Dr. Snydle had inserted the laparoscope in C.P.'s abdomen. He observed that the internal organs were a "blueish color" ; an observation consistent with a decreasing level of oxygen in the patient's blood and an indication that the patient was hypoxic. When the patient's internal organs were discerned to be blue, Respondent asked Dr. Snydle to wait a moment and requested the assistance of Norma Masters, the circulating nurse. Masters came to the head of the operating table and was handed another endotracheal tube by Respondent. Respondent then began the process of intubating the patient with that tube through the mouth. The original nasal tube was left in place during the insertion of the second tube; an unheard of possibility, according to expert testimony, unless one tube was in the patient's esophagus and the other in the trachea. Nurse Allen's testimony establishes that the second tube, inserted via the patient's mouth, became foggy after insertion. The observation by Allen is consistent with experttestimony and establishes the fog was created by warm moist air from the patient's lungs flowing through the second tube. Respondent's testimony that she placed the second tube at the conclusion of the surgical procedure is not credited in view of the very clear, contradictory testimony of Masters and Allen that the endotracheal tube was replaced contemporaneously with the notation that the blood was dark and the patient's organs "blueish". After removal of the nasal tube and connection of the second tube to the anesthesia machine, Respondent manually squeezed the anesthesia bag to ventilate the patient. Dr. Snydle observed that the organs were turning pink again, and continued the procedure without further incident. After finishing the procedure, Snydle went out of the operating room, sat at a desk across the hall and began to write his orders. Following the procedure, the patient was wheeled to the recovery room, a short distance away. Nurses Allen and Masters did not see C.P. open her eyes during this process. Respondent's assertion that the patient opened her eyes and was responsive to commands is corroborated only by Dr. Snydle. However, while he noted in his operative report and his deposition that C.P. was awake following the operation, Snydle's observation is not credited in view of other proof establishing that his back was to the patient as she was wheeled past and that he assumed an awake state in the patient because Respondent was speaking to C.P. In view of the foregoing, Respondent's testimony that the patient was awake or responsive to commands following the surgery is not credited. After the patient was removed approximately 15 feet away to the recovery room, Respondent maintains that she informed Margaret Bloom, R.N., who was on duty there, that the patient's endotracheal tube was not to be removed, although she omitted telling Bloom about the dark blood incident. Bloom, who is also a certified registered nurse anesthetist, maintains that Respondent told her nothing about C.P.'s condition; instead, she went rapidly to the rest room in the lounge area. Bloom, left in the recovery room with the patient, then proceeded to hook up appropriate monitors and oxygen to the patient's endotracheal tube and began the process of monitoring C.P.'s vital signs. Bloom places the time of C.P.'s arrival time in the recovery room at approximately 11:05 a.m. The patient was not responsive to Bloom's spoken commands when brought to the recovery room. The patient appeared well oxygenated to Bloom; a judgement she made based on her observation of the color of C.P.'s lips and fingernails, since C.P. is a black female. Bloom rated C.P.'s circulation at twenty to fifty percent of preanesthetic pressure and determined the patient to be totally unconscious. Respondent returned to the recovery room at this time, told Bloom that she had done an "awake intubation" on the patient and that the tube should remain in place until Bloom determined that the patient was ready for it to be removed. Respondent then left the recovery room. As the result of blood tinged mucus filling the patient's endotracheal tube, Bloom removed the tube after thepatient registered breathing difficulties and attempts by Bloom to suction the mucus failed. She replaced that tube with a device known as an oral pharyngeal airway which goes in the patient's mouth and curves down the throat, holding the tongue forward. The device does not reach to the lungs. Shortly thereafter the patient began making glutteral noises and Bloom placed a venturi mask on the patient. The mask controlled the percentage of oxygen going to the patient, estimated by Bloom to be sixty to one hundred percent oxygen. The patient's breathing improved. Bloom completed replacement of the endotracheal tube with the airway device and mask shortly before Respondent again returned to the recovery room. Respondent, upset at Bloom's action in removing the endotracheal tube, proceeded to replace the oral airway device with a nasal tube. At 11:20 a.m., Bloom noted in her records that the patient's state of consciousness was unchanged. Later the patient made moaning sounds and was responsive to pain stimulation at approximately 12:20 p.m. Respondent concedes that C.P. suffered an hypoxic event at some point which resulted in damaged brain function. It is Respondent's position that such event occurred in the recovery room as the result of laryngospasm, occasioned by Bloom's removal of the endotracheal tube. Allen and Masters working in the operating room a short distance away testified that the sounds they heard emanating from the area of the recovery room were not the type of noise they associated with laryngospasm. Bloom, trained to recognize laryngospasm, testified that C.P. did not have sucha spasm. The expert testimony of David Cross, M.D., based on a study of arterial blood gases of C.P. following the surgery, establishes that the patient suffered an hypoxic episode too severe and too protracted to have been the result of a possible laryngospasm in the recovery room and that, in his expert opinion, she did not have a recovery room laryngospasm. Respondent's defense that C.P.'s survival of such a lengthy esophageal intubation in the operating room is an impossibility, is not persuasive. The opinion of Respondent's expert, Dr. Gilbert Stone, that no esophageal intubation occurred in the operating room is predicated on his belief that the tube was not changed during the surgery. Dr. Stone conceded that replacement of the tube during surgery at the time the dark blood was noticed with resultant improvement in the patient's condition permits a conclusion that esophageal intubation was the cause of the hypoxia. Testimony of Petitioner's experts, Dr. Cross and Dr. Kruse, are consistent in their conclusions that C.P. was esophageally intubated by Respondent, although they differ in their reasons for C.P.'s survival of the event. The opinion of these experts, coupled with the eye witness testimony of Allen and Masters, further support a finding of Respondent's esophageal intubation of the patient in the operating room and that she failed to recognize such intubation in a timely manner as a reasonable and prudent physician should have. The expert opinion testimony of Dr. Cross establishes that C.P. was intubated in her esophagus and survivedas a result of oxygen, going into her stomach under pressure, being forced back up her esophagus into the pharynx and then drawn by negative pressure into the lungs. This resulted in a effect similar to, but not as efficient as, the technique known as apneic oxygenation. The technique, once used to provide marginally adequate oxygen levels to maintain a patient's neurological and cardiac status, has fell into disfavor since patients suffered from respiratory acidosis due to the buildup of carbon dioxide in the lungs. Cross also pointed out that the heart can function for a much longer period of time without adequate oxygen than is possible for the brain. Cross's testimony provides an explanation for C.P.'s neurological damage without similar cardiac impairment. Cross also noted that the preoxygenation process which C.P. initially underwent after entering the operating room added to the time she was able to undergo oxygen deprivation before the onset of tissue damage. Respondent notes the discovery of a tumor in C.P.'s throat some months later as a possible contributor to the patient's hypoxic event during surgery. Another of Respondent's experts, Dr. Deane Briggs, an otolaryngologist specializing in diseases of the ears, nose and throat, treated C.P. in October of 1985, following the August, 1985 surgery. He discovered the existence of a sub-glottic tumor in the patient's throat. However, the existence of the tumor at the time of the initial surgery is not established. Testimony of anesthesiologist experts, including Respondent's own expert, Dr. Stone, do not support a finding that the tumor, if itexisted, had any effect during the operation. Further, Dr. Briggs' opinion that Respondent probably intubated the patient's right stem bronchus, as opposed to the esophagus, and that neurological damage therefore occurred in the recovery room is not credited in view of the conflict of this testimony with that of other witnesses and expert opinions. A finding that C.P.'s neurological impairment following surgery may have been exacerbated by a possible laryngospasm in the recovery room is relevant only with regard to mitigation of the severity of penalty to be imposed for Respondent's misconduct. Respondent's esophageal intubation of the patient in the operating room, and the resultant hypoxic event are established by clear and convincing evidence. The fact that C.P. suffered brain damage is undisputed by the parties. The proof clearly and convincingly establishes that the severe and protracted hypoxic episode sustained by the patient resulted not from a possible mild recovery room laryngospasm, but from Respondent's esophageal intubation of that patient in the operating room. It is concluded with respect to treatment of C.P., Respondent failed 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. Respondent failed to keep medical records which justified her course of treatment of the patient, C.P. This finding is based upon the testimony of Dr. Cross that Respondent'smedical records did not justify her course of treatment, as well as the testimony of Respondent's expert, Dr. Stone. While testifying that he did not believe Respondent had intubated the patient's esophagus, Stone also acknowledged that Respondent's records would be inadequate if such had indeed occurred.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered for Respondent's violation of Section 458.331(1)(t), Florida Statutes, placing Respondent's license on probation for a period of three years upon terms and conditions to be determined by the Board of Medicine, including, but not limited to, a condition requiring Respondent's participation in appropriate continuing medical education courses; and imposing an administrative fine of $2,000. IT IS FURTHER RECOMMENDED that such Final Order impose a penalty for Respondent's violation of Section 458.331(1)(m), Florida Statutes, of an administrative fine of $500 and a letter of reprimand. DONE AND ENTERED this 28th day of August, 1989, in Tallahassee, Leon County, Florida. DON W.DAVIS Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Fl 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 28th day of August, 1989. APPENDIX The following constitutes my specific rulings, in accordance with Section 120.59, Florida Statutes, on findings of fact submitted by the parties. Petitioner's Proposed Findings. 1.-28. Accepted. 29. Unnecessary to result. 30.-31. Accepted. 32.-34. Adopted by reference. 35.-61. Adopted in substance. 62. Unnecessary to result. 63.-68. Adopted in substance. 69.-87. Adopted by reference. Respondent's Proposed Findings. 1.-3. Rejected, not supported by the evidence. 4.-5. Rejected, not supported by the evidence, Further, proposed findings that records were adequate constitute legal conclusions. 6. Rejected, not supported by the evidence. COPIES FURNISHED: David G. Pius, Esq. Department of Professional Regulation The Northwood Centre, Suite 60 1940 N. Monroe St. Tallahassee, FL 32399-0750 Sidney L. Matthew, Esq. Suite 100 135 South Monroe St. Tallahassee, FL 32302 Kenneth Easley, Esq. General Counsel Department of Professional Regulation The Northwood Centre, Suite 60 1940 N. Monroe St. Tallahassee, FL 32399-0750 Dorothy Faircloth Executive Director Board of Medicine Department of Professional Regulation The Northwood Centre 1940 N. Monroe St. Tallahassee, FL 32399-0750
Findings Of Fact The Respondent, Stephen L. Watson, M.D., has been practicing medicine in Lakeland, Florida, since 1945. Since 1950, he has been board-certified in obstetrics and gynecology. Until this case, he has not been the subject of any Board of Medicine disciplinary proceeding. He recently closed his practice of medicine due to his own poor health. The Respondent saw B. D., as a gynecology patient, for the first time in December, 1983. She was 33 years old at the time and was obese, weighing 184 pounds and standing only approximately five feet, four inches. She also had borderline high blood pressure, at 140/90. On the patient's second visit in July, 1984, the Respondent discussed her weight and gave her a book on diet and weight loss entitled, "The Lighter Side of Life, the Doctor's Program that Really Works." He discussed the contents of the book with her, emphasizing certain parts of it. He also prescribed a month's supply of an appetite suppressant called Fastin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient's next visit was a weight conference on January 2, 1987. On this visit the patient weighed 212; her blood pressure was 140/90. The Respondent again discussed weight and diet with the patient and prescribed a month's supply of another appetite suppressant called Didrex, to be taken in conjunction with the diet recommendations, along with a diuretic. Didrex contains the anorectic agent benzphetamine hydrochloride. It is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include some central nervous system stimulation and elevation of blood pressure. Didrex is contraindicated in patients with moderate to severe hypertension, and caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. At the visit on January 2, 1987, it also was arranged that the Respondent would have blood work done on January 6, a pelvic examination on January 7, and another weight conference on January 29, 1987. As often would happen during the long doctor-patient relationship, the patient missed all three appointments and did not request a refill of her medications. The patient's next visit was for another weight conference on February 10, 1987. She had lost 12 pounds (down to 200), and her blood pressure reading was down to 130/88. The Respondent's course of treatment seemed to be effective. The Respondent prescribed another month's supply of Didrex, to be taken in conjunction with the diet recommendations, along with a diuretic. Ten days later, the patient came in complaining of "nerves" after taking her medications. The Respondent discontinued the Didrex and the diuretic and scheduled the patient for another weight conference for March 10, 1987. The patient missed the March 10, 1987, appointment as well as the next two rescheduled appointments, and she did not request a refill of her medications. Finally, the patient kept the third rescheduled appointment for a weight conference, for May 6, 1987. By this time, the patient's weight was back up to 208. Her blood pressure reading was 120/80. The Respondent prescribed a month's supply of another appetite suppressant called Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her weight conference scheduled for June 3, 1987, and did not request a refill of her medications. The patient kept her rescheduled appointment for a weight conference, for June 11, 1987. This time, her weight was back down, to 197, and her blood pressure reading was 120/80. The Respondent's course of treatment seemed to be effective. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient again missed her next scheduled weight conference, for July 9, 1987, and did not request a refill of her medications. The patient kept her rescheduled appointment for a weight conference, for July 13, 1987. This time, her weight was down further, to 187, and her blood pressure reading again was 120/80. The Respondent's course of treatment continued to seem to be effective. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient's next weight conference was on August 17, 1987. Her weight was down a little more, to 183.5, and her blood pressure reading remained at 120/80. The Respondent's course of treatment continued to seem to be effective, although the patient's rate of weight loss was decreasing. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, but discontinued the diuretic apparently due to a bladder problem. The patient missed her next scheduled weight conference, for September 15, 1987, and did not request a refill of her medications. The patient's next rescheduled weight conference was on October 9, 1987. Her weight was up a little, to 184.75. Her blood pressure reading again was 120/80. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her next scheduled weight conference, for November 6, 1987, and did not request a refill of her medications. The patient's next rescheduled weight conference was on December 7, 1987. Her weight was down a little, to 183. Her blood pressure reading again was 120/80. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her next scheduled weight conference, for January 5, 1988, and did not request a refill of her medications. The patient's next rescheduled weight conference was on February 18, 1988. Her weight was up a little, to 187.5. Her blood pressure reading was 130/80. The Respondent prescribed a month's supply of another appetite suppressant called Tenuate Dospan, to be taken in conjunction with the diet recommendations, along with a diuretic. Tenuate Dospan contains the anorectic agent diethylpropion hydrochloride. Like Didrex, it is a sympathomimetic amine with some pharmacologic activity similar to that of the prototype drugs of this class used in obesity, the amphetamines. Actions include some central nervous system stimulation and elevation of blood pressure. It is contraindicated in patients with severe hypertension, and caution is to be exercised in prescribing it for any patient with hypertension. The Respondent did not see the patient again for weight control, or prescribe any more medication, until May 3, 1988, when the patient was seen for bladder problems. Her weight was down a little, to 181.5, and her blood pressure reading was 120/80. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, but discontinued the diuretic again apparently due to a bladder problem. The patient preferred Tenuate Dospan, and the Respondent changed the prescription to another month's supply of Tenuate Dospan. The patient missed the next two conferences, scheduled for August 8 and rescheduled for August 9, 1988, and did not request a refill of her medications. She did not see the Respondent or get any more medications from him until a weight conference on December 2, 1988. Her weight was up a little, to 185. Her blood pressure reading was 130/80. The Respondent prescribed a month's supply of Tenuate Dospan, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her next four scheduled appointments and did not request a refill of her medications. She did not see the Respondent or get any more medications from him until a blood pressure conference on June 28, 1989. Her weight was up significantly, to 200, and her blood pressure reading was up significantly, to 140/100. Although the patient still was relatively young (approximatly 39), and the Respondent believed there was a causal connection between the patient's weight and blood pressure, the Respondent prescribed only a month's supply of Enduron, a medication for hypertension. The patient missed her next two scheduled blood pressure conferences and did not request a refill of her blood pressure medications, or request any other medications. She did not see the Respondent or get any more medications from him until she saw him for blood in the urine on October 3, 1989, and had a urinalysis and conference. At the time, her weight was up a little more, to 203, and her blood pressure reading was 140/90. The Respondent prescribed an antibiotic and, for reasons not apparent from the evidence, a month's supply of a mild antidepressant, called Elavil. On or about October 23, 1989, the patient telephoned for a refill of her Enduron prescription, which was about to run out, and the Respondent prescribed another month's supply. The patient again missed her next weight conference scheduled for October 30, 1989, and did not request any other medications. She did not see the Respondent or get any more medications from him until a rescheduled weight conference on December 11, 1989. By this time her weight was up to 217, and her blood pressure reading was 140/98. The Respondent was aware that amphetamine-like appetite suppressants should be used with caution with patients having moderately high blood pressure, as the patient had by December 11, 1989. But he also continued to believe that there was a causal connection between the patient's weight and blood pressure and that, given the patient's relative youth and the past success with the treatment, it was worth trying appetite suppressants, in conjunction with diet recommendations, to help reduce both the patient's weight and her blood pressure. He prescribed a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic. (Tenuate is essentially the same drug as Tenuate Dospan but is shorter lasting.) On January 5, 1990, the patient telephoned the Respondent with a complaint of "nerves." The Respondent prescribed another month's supply of Elavil, with authority for two refills. The patient's next weight conference was on January 24, 1990. Her weight was up a little more, to 220, and her blood pressure reading was 160/98. At that point, it seemed that perhaps the Tenuate Dospan was not effective. Although there could be other explanations why the patient was not losing weight, and it was possible that all appetite suppressants had become ineffective, the Respondent decided to switch the patient to Didrex, which seemed to have been effective in the past, and prescribed a month's supply, to be taken in conjunction with the diet recommendations, along with a diuretic. He also changed her blood pressure medication to Wytensin. The patient missed her next weight conference, scheduled for January 31, 1990, and did not request any additional medications. The patient did not see the Respondent again, or get any additional medications from him, until March 21, 1990, when she saw him to get a letter for employment purposes certifying that she was disease-free. Her weight was up to 226, and her blood pressure was 164/96. The Respondent prescribed another month's supply of Didrex, to be taken in conjunction with the diet recommendations, along with a diuretic and another month's supply of Wytensin. The patient did not see the Respondent again, or get any additional medications from him until August 28, 1991, when she saw him to complain of blood in the urine. At this time, her weight was 234, and her blood pressure reading was 140/90. In addition to treating the urine problem, the Respondent prescribed a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic and a month's supply of Wytensin. The patient missed her appointment for a pelvic examination on September 5, 1991, and did not see the Respondent, or get any additional medications from him until she went to a weight conference on December 11, 1989. Her weight was 234.5, and her blood pressure reading was 140/94. The Respondent prescribed a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic. (It is not clear from the evidence why no blood pressure medication was prescribed.) The patient missed her appointment for a pelvic exam on December 17, 1991, and missed scheduled weight conferences for February 10, 11, and 19, 1992. She did not request any additional medications during this time. The patient made her next scheduled appointment on March 16, 1992, when the Respondent discussed her weight, blood pressure and complaint of headaches. Both her weight and her blood pressure were at their highest: weight, 237; blood pressure reading, 150/110. At this point, there was a real question whether the appetite suppressants still were effective in controlling the patient's weight and thereby helping reduce the patient's blood pressure. On the other hand, the patient continued to miss weight conferences and not follow through on the Respondent's instructions, and it was not clear whether the patient ever had followed the Respondent's weight control treatment long enough to give it a fair chance to work. The patient's blood pressure now was moderately to severely high; on the other hand, she still was only about 42 years of age, and her weight still could have been contributing to her high blood pressure. Nonetheless, the Respondent decided to prescribe only Wytensin on March 16; he also scheduled a complete physical for March 20, 1992. On March 20, 1992, the Respondent had the patient undergo a complete physical. Her weight still was 237, and her blood pressure reading was 160/120. He switched her blood pressure medication to Accupril and decided not to prescribe any appetite suppressants at that time. He scheduled the patient for a weight conference on April 3, 1992. On April 3, 1992, the patient's weight still was 237, but her blood pressure reading was 150/110. Although the patient's blood pressure still was moderately to severely high, the Respondent decided to try an appetite suppressant to reduce her weight in the hopes of, together with the blood pressure medication, effecting a lasting reduction in her blood pressure. He prescribed a month's supply of Tenuate Dospan, to be taken in conjunction with the diet recommendations, along with a diuretic. On April 14, 1992, the patient telephoned the Respondent to report that her blood pressure still was up and that she continued to suffer from headaches. The Respondent decided that it was time to refer the patient to a specialist in internal medicine and made an appointment for her. The patient missed her next scheduled weight conference on April 16, 1992, and missed the appointment with the internist which the Respondent had scheduled for her. She never saw the internist. The patient's next appointment was on May 6, 1992. The Respondent discussed the patient's weight and her hypertension. Her weight was 236, and her blood pressure reading was down to 144/100. The Respondent decided to prescribe a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient overdosed on a pain medication (not the appetite suppressant) and was hospitalized on June 4, 1992. She missed the next scheduled weight conference on June 15, 1992. She did not request any additional medications. The patient's next appointment with the Respondent was on June 18, 1992. She weighed 230, and her blood pressure reading was 140/110. The Respondent prescribed only Accupril and an iron supplement. The Respondent only saw the patient once more, on July 17, 1992, for gynecological problems, and referred the patient to a specialist. He did not prescribe any medications. The patient's blood pressure was 130/100. Her weight was not recorded. The evidence does not reflect that the patient, B. D., grew progressively dependent on the appetite suppressants the Respondent prescribed for her. There was no evidence that the patient ever asked for a refill or new prescription early. She often missed scheduled appointments, resulting in gaps of time between prescriptions when the patient presumably had no appetite suppressants available to her. There also were extended periods of time between visits during which time the patient presumably had no appetite suppressants available to her. Some reputable physicians now seriously question the use of appetite suppressants. There is some evidence that patients lose as much weight and maintain as much weight loss without them as with them. The trend in the late 1980s and early 1990s has been to treat patients for obesity with behavior modification (essentially, diet and exercise) only. But there is no evidence that it is below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances to treat patients for obesity by prescribing appetite suppressants in conjunction with diet recommendations. It is true that the Respondent prescribed appetite suppressants for longer periods of time than recommended in the medical and pharmaceutical literature. The literature recommends using appetite suppressants only during the early weeks of a weight reduction program. The reasons are twofold and related: first, the patient generally builds a tolerance to the appetite suppressant, making them less effective; second, the patient can become dependent on them. The goal is to use appetite suppressants to begin reducing caloric intake for initial weight loss, while changing eating habits for long term reduction in caloric intake and weight. The problem confronting the Respondent in this case lay in the nature of the patient's noncompliance. She would begin the program but not follow it or continue with it for long. When she returned to the Respondent after a long hiatus, it was like starting the program over again. The evidence did not prove that it was below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances for the Respondent to repeatedly restart his treatment for obesity, namely by prescribing appetite suppressants in conjunction with diet recommendations. There were occasions when the Respondent prescribed an appetite suppressant when the patient's blood pressure reading was high. According to the medical and pharmaceutical literature and the expert medical testimony, caution should be exercised in prescribing these medications for patients with high blood pressure. But the exercise of that caution is a matter of medical judgment, based on an overall knowledge and understanding of the patient and circumstances involved. Only once, on April 3, 1992, did the Respondent prescribe an appetite suppressant (Tenuate Dospan) when the patient's blood pressure reading was so high (150/110) as to clearly contraindicate the use of the appetite suppressant. On all other occasions, the patient's blood pressure would be considered mildly or moderately high, requiring the Respondent to exercise caution, which he did. In all cases, the Respondent believed that there was a causal connection between the patient's weight and blood pressure and that, given the patient's relative youth and the past success with the treatment, it was worth trying appetite suppressants, in conjunction with diet recommendations, to help reduce both the patient's weight and her blood pressure. Although some physicians would disagree with the Respondent's medical judgments, except for April 3, 1992, it was not proven that the Respondent's medical judgment in this case fell below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. However, it is found that it was below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances for the Respondent to prescribe Tenuate Dospan on April 3, 1992. It was not proven that it was below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances for the Respondent not to refer the patient to a specialist for hypertension before April 14, 1992. The first evidence of severe hypertension appeared on her visit on March 16, 1992. But the Respondent had not seen the patient since December, 1991, due to missed appointments, and it was reasonable at that point for the Respondent not to refer immediately. It could be argued that he should have referred the patient after one of the next two visits, but the delay until April 14, 1992, was fairly short. It was not the Respondent's fault that the patient did not keep the appointment with the specialist which he made for her. It should be noted that the patient does not complain about the level of care and treatment given by the Respondent. Nor is there any evidence that the Respondent's care and treatment harmed the patient. Apparently, while the patient was hospitalized for overdosing on pain medication unrelated to the Respondent's care and treatment, the patient's medical records were brought to the attention of the predecessor of the AHCA, and it appeared to that agency (and to the AHCA) that the Respondent was guilty of worse practice of medicine than ultimately was proven in this case.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order: (1) finding the Respondent guilty of a single violation, on April 3, 1992, of Section 458.331(1)(t), which also resulted in a technical violation of Section 458.331(1)(q), Fla. Stat. (1993); (2) requiring the Respondent to notify the Board or the AHCA if he reopens his practice of medicine; (3) placing the Respondent on probation on appropriate terms in the event the Respondent reopens his practice; and (4) fining the Respondent $500. RECOMMENDED this 15th day of November, 1994, in Tallahassee, Florida. J. LAWRENCE JOHNSTON 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 15th day of November, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-2375 To comply with the requirements of Section 120.59(2), Fla. Stat. (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1.-8. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven. Rejected as not proven. (The Respondent testified.) Accepted but subordinate and unnecessary. Accepted. First sentence, subordinate to facts contrary to those found; second sentence, subordinate to facts found. Rejected as not proven that the patient's hypertension was severe. Otherwise, accepted but subordinate to facts contrary to those found. 14.-19. Accepted and incorporated. Rejected as not proven, except for patients with severe hypertension. First sentence, rejected as not proven. (He believed it permissible because the patient's blood pressure was not stable.) Second sentence, accepted but subordinate to facts contrary to those found. Third sentence, accepted but subordinate to facts contrary to those found, and unnecessary. First sentence, accepted but subordinate to facts contrary to those found. Second sentence, rejected as not proven. Accepted. Subordinate to facts found. Accepted but subordinate to facts contrary to those found. First sentence, accepted but subordinate to facts contrary to those found. Second sentence, rejected as not proven as to Didrex after 1990; otherwise, accepted and incorporated. First sentence, accepted and incorporated. Second sentence, accepted but subordinate to facts contrary to those found, and unnecessary. (The AHCA did not charge inadequate records.) 27.-29. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven. Accepted but subordinate to facts contrary to those found. Accepted and incorporated to the extent not subordinate or unnecessary. (The question is not whether a referral would have been appropriate but rather whether not referring was inappropriate.) Accepted and incorporated. Rejected as not proven that referral was required in 1984 or that the patient's weight and blood pressure did not respond to treatment before 1988. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. (The question is not whether a referral would have been appropriate but rather whether not referring was inappropriate.) Accepted but subordinate and unnecessary. Rejected. They knew it to the extent that it is the same as for an internist. 37.-38. Accepted but subordinate and unnecessary. 39. Rejected as not proven and as contrary to the facts found. Respondent's Proposed Findings of Fact. 1.-4. Accepted and incorporated to the extent not subordinate or unnecessary. 5. Accepted but subordinate and unnecessary. 6.-20. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to the greater weight of the evidence. Accepted but subordinate and unnecessary. 23.-28. Accepted and incorporated to the extent not subordinate or unnecessary. Other than evidence that she may have become nervous on occasion from the appetite suppressants, accepted and incorporated to the extent not subordinate or unnecessary. Accepted. The second occasion is irrelevant, having occurred after the events in issue in this case. The first is accepted and incorporated to the extent not subordinate or unnecessary. 31.-32. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to the greater weight of the evidence. Accepted and incorporated. Accepted but subordinate and unnecessary. 36.-37. Accepted and incorporated. 38.-40. Accepted. Subordinate to facts found. First sentence, accepted and incorporated. Second sentence, accepted but subordinate and unnecessary. Accepted (that it is not necessarily inappropriate) and incorporated. Accepted. First two sentences, incorporated; second, subordinate to facts found. Accepted. Subordinate to facts found. Rejected as to April 3, 1992, as contrary to facts found and to the greater weight of the evidence. Otherwise, accepted but subordinate to facts found. 46.-47. Accepted and incorporated. 48. Rejected as to April 3, 1992, as contrary to facts found and to the greater weight of the evidence. Otherwise, accepted and incorporated. COPIES FURNISHED: Alex D. Barker, Esquire Elaine Lucas, Esquire Agency for Health Care Administration 7960 Arlington Expressway Suite 230 Jacksonville, Florida 32211-7466 John A. Naser, Esquire 1401 South Florida Avenue Suite 201 Lakeland, Florida 33802 Dr. Marm Harris Executive Director, Board of Medicine Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Harold D. Lewis, Esquire Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
The Issue During the course of the hearing, the Respondent raised the timeliness of the proceedings against him and argued that the delay by the Department in bringing the charges against him had prejudiced his ability to defend the charges. This motion was taken under advisement, and, because the Department had released its investigator who was knowledgeable of the events relating to the delay, both sides were given the opportunity to present testimony in writing. This process has delayed the entry of this order. 1/ The facts reveal that the Department became aware of the incident involving Ms. McCardell in April 1980 and even had her examined by a physician in May of that year; yet the investigation was not forwarded to the Department until November 1981. No real explanation of this delay was offered, and, as a result, the Administrative Complaint did not issue until May 1982. Therefore, the Respondent was prejudiced by the failure of the Department to charge him when the Department had full knowledge of the facts upon which the complaint is based. However, to prevent further delay in the resolution of this matter which might occur upon appeal of this case on a recommended order of dismissal, and because a full hearing on the merits was conducted, a full finding on the case will be presented. The sole issue is whether the Respondent is guilty of the charges as alleged.
Findings Of Fact The Respondent, Rudolph C. Freyeisen, is a licensed masseur holding licenses number MA 0003363 and MA 000141 issued by the Department of Professional Regulation. On March 31, 1980, the Respondent administered a colonic irrigation to Debra McCardell (now Ballard) at Natural Health Center, Inc., 1515 Southeast 46th Lane, Cape Coral, Florida. Ms. McCardell had sought treatment at the Center because of extreme constipation. She had called for an appointment prior to going to the Center with her husband. The Respondent told Ms. McCardell that there was a doctor available on the premises and that he could contact the doctor and have him available. (Tr. 17-18.) A doctor, who practiced in the same building, normally supported the Center; however, at the time of Ms. McCardell's visit, this doctor was not seeing patients due to an injury. Another doctor, who was seeing his patients, was on call and was available by appointment to see clients of the Center. (Tr. 197-198.) The Respondent gave Ms. McCardell a proper pretreatment examination and found no contradictions which would have required Ms. McCardell to be seen by a doctor. At the time of this proctological examination, Ms. McCardell had no observable hemorrhoids. The Respondent did feel hardened stool in Ms. McCardell's colon. The Respondent used a colonic irrigation machine to administer the treatment to Ms. McCardell. This machine functions by inducing water into the colon through a polished metal speculum, approximately four inches long and five-eighths of an inch in diameter, which is inserted into the rectum. The water pressure is not more than two pounds per square inch, and the speculum is designed to be forced out of the rectum by a pressure greater than two pounds per square inch. (Tr. 174.) Normally, after water is placed in the colon, the masseur massages the abdomen in a circular motion descending along the large colon. This loosens fecal matter and assists the client in passing stool. Properly performed, the procedure cannot harm the body. (Tr. 91.) Discomfort from the natural distention of the colon and from cramps caused by gas are frequently associated with the treatment and are expected, as with an enema. The pressure of the water and gas are released by operation of a valve, which permits the water to flow out of the colon. (Tr. 97, 172.) When Ms. McCardell saw the Respondent, she was complaining of severe constipation and a prolonged history of bowel problems. During her treatment, the speculum was forced out of the colon on several occasions, and the pressure was released on several other occasions. The Respondent discontinued the treatment after Ms. McCardell continued to complain of discomfort and pain. At the conclusion of the unsuccessful treatment, Ms. McCardell defecated. (Tr. 19.) Passage of an enlarged, hardened stool can cause hemorrhoids to appear. (Tr. 101.) After treatment and defecation, Ms. McCardell experienced pain in her rectum. She determined that she had severe hemorrhoids and contacted the Center desiring to see the doctor. The Respondent advised her that she could see the doctor in two or three days (she could not recall exactly) when he was scheduled to be at the Center. Ms. McCardell refused this offer and, after four days, saw Dr. Drulans. She delayed seeking medical assistance because her husband did not like to pay her medical bills. The examination at the hospital revealed that she had severe hemorrhoids and bruises in the rectal area. She was also seen by Dr. Mufdi for the same complaint during the month of May. She complained of a bloody discharge and pain; however, Dr. Drulans determined that the bleeding was vaginal in nature. (Tr. 27, 54-55.) Ms. McCardell saw Dr. Rectine on May 5, 1980, through arrangements with the Department's investigator as part of the investigation of Respondent. At the time, Ms. McCardell was complaining of tenderness and swelling in the area of the right ovary and fallopian tube. Dr. Rectine discovered objective evidence of swelling in her physical examination of Ms. McCardell; however, external and internal examination, x-ray examination, ultrasound examination, and, ultimately, a laparoscopy did not reveal any trauma to the colon or chronic disease. Based upon Ms. McCardell's description to her of the manner in which the speculum was inserted and Ms. McCardell's association of the onset of the symptoms with the colonic treatment, Dr. Rectine concluded that it was possible that the treatment had caused Ms. McCardell's problem. It would be difficult to insert the speculum in the rectum with a client in the position Ms. McCardell was in, as described by Dr. Rectine, and impossible to do so without some trauma to the bowel. Having participated in a demonstration of the technique used to insert the speculum and having seen it, Dr. Rectine was inconclusive about the ability of the procedure to have caused Ms. McCardell's problem. (Tr. 106-107, 107-110.) Ms. McCardell did not state at hearing the manner in which the speculum was inserted. She did not mention any discomfort related to insertion of the speculum to the Respondent or in her testimony about the incident. Based upon the size of the speculum and upon the demonstration by Dr. Rectine and the Respondent, it would have been impossible for the speculum to have contacted Ms. McCardell's ovary. The speculum could not have caused the bruises to the rectum. The hemorrhoids were not caused by the speculum, but by downward; pressure, most likely when passing the stool after the treatment. Ms. McCardell's husband had a history of assaulting her. It is as likely that any injury to her abdomen was from her husband's assaultive conduct as from the Respondent's treatment, and no evidence of trauma from any source was ever discovered. (Tr. 52, 53.)
Recommendation Having found the Respondent, Rudolph C. Freyeisen, not guilty of the allegations contained in the Administrative Complaint, it is recommended that the Administrative Complaint filed against the Respondent be dismissed. DONE and RECOMMENDED this 29th day of November, 1983, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 29th day of November, 1983.
The Issue The issues to be determined in this proceeding are whether Respondent violated section 458.331(1)(t)1., Florida Statutes (2012), and if so, what penalties should be imposed.
Findings Of Fact Based upon the Stipulation of the parties and the evaluation of the evidence presented at hearing, the following facts are found: At all times material to the allegations in the Administrative Complaint, Respondent was a licensed medical doctor within the State of Florida and held license number ME 109501. Respondent’s address of record is 216 Elm Drive, Chattahoochee, Florida 32324. The Department presented no evidence of prior discipline against his license. In 2013, Respondent was under contract to furnish health care services to inmates at Suwannee Correctional Institution (SCI). This case involves the care and treatment for hypertension that Respondent provided to R.G. while R.G. was an inmate at SCI in June and July 2013. David Libert, M.D., who testified on behalf of the Department, is a Board-certified family practice physician who has been licensed in Florida since 1983. Dr. Libert sees patients in a clinical setting approximately three days a week but has never practiced in a correctional institution setting. Dr. Libert testified that a “perfect” blood pressure reading is 120/80. A reading that is under 140/90 is considered acceptable, but blood pressure that is consistently above 140/90 indicates hypertension. Malignant hypertension, or hypertensive emergency, is an acute elevation of blood pressure that is associated with end organ damage. End organ damage is the affect that the high blood pressure has on certain parts of the body, such as the brain, heart, and kidneys. The traditional benchmark reading that signals malignant hypertension is 180/120, which Dr. Libert testified is an arbitrary number but represents the “old” definition of the condition. According to Dr. Libert, newer studies define malignant hypertension as an acute rise on the height in blood pressure associated with end organ damage, even if the blood pressure reading does not go as high as the 180/120 measure recognized in older literature. The record is not clear when the change in definition took place, and if that change reflects the standard of practice in June 2013. Dr. Libert did not describe what constitutes an acute rise in blood pressure, either in terms of the length of time by which it is measured, or how much of a change in blood pressure constitutes an acute rise. The systolic reading is the top number in a blood pressure reading and represents the maximum pressure that is exerted on the arteries with the contraction of the heart. The diastolic reading represents the pressure after the heart has relaxed from its beat and is the lower number in a blood pressure reading. While 180/140 is the traditional reading identified as a signal for malignant hypertension in “older” literature, there was no testimony as to whether systolic and diastolic readings are equally important, or whether one is more important than the other when determining that a patient’s blood pressure is too high. In other words, no testimony was presented to answer the question of whether, for example a blood pressure reading of 185/96 or 170/133 would be considered a symptom of malignant hypertension. While there is no question both readings would indicate hypertension, the evidence did not indicate whether it is enough to have one of the two pressure readings above the 180/120 level to signal the possibility of malignant hypertension. The Department of Corrections has protocols for treatment of different systems of the body. The form for the Hypertension Protocol, which is included several times within R.G.’s medical records from Suwannee, includes several categories of information to be addressed by treating personnel, such as Subjective (which includes the patient’s chief complaint and current symptoms); Objective (which requires notation of vital signs, such as temperature, pulse, respiration, blood pressure, oxygen saturation and weight); Findings Requiring Immediate Clinician Notification; Plan; and Education. Under the heading “Findings Requiring Immediate Clinician Notification,” there are several factors that a health care provider (typically in this setting, a nurse) would check before the need to contact a physician arises. Those factors are blood pressure greater than 160/100 (see PLAN first); oxygen saturation less than 93 percent; heart rate less than 60 or greater than 110; wheezing (chest congestion); blurred vision; pedal edema extending to above the knees; severe headache OR headache not relieved after two hours of OTC pain med; or other. The PLAN portion of the protocol provides the following treatment alternatives: For mild to moderate headache give: Acetaminophen 325mg two tablets every 4-6 hours as needed for pain, OR Ibuprofen 200mg two tablets every 6 hours as needed for pain Put patient in a quiet environment; recheck blood pressure in 15 minutes x2. Notify clinician if BP remains greater than 160/100. 1st blood pressure recheck: / , at . 2nd blood pressure recheck: / , at . Bed rest lay-in x24 hours Blood pressure recheck in 24 hours Return to clinic for BP check Pass Other Respondent was responsible for patient R.G.’s medical care at SCI and had access to all of R.G.’s medical records from SCI’s medical clinic. R.G. was a 61-year-old male inmate who presented to the clinic at SCI for treatment. On or about June 7, 2013, R.G. presented to SCI’s clinic with a blood pressure reading of 164/96, and complaining of a headache. R.G. was given 10 mg Lisinopril to reduce his blood pressure, a pass for three days of bedrest, and a follow-up appointment for June 10, 2013. The medical record entitled Hypertension Protocol does not contain Respondent’s name and he did not see R.G. that day. However, from the Physician’s Order Sheet, it appears that he was consulted and approved the administration of Lisinopril, and prescribed 10 mg of Lisinopril daily for three months. On June 9, 2013, R.G. presented at the clinic complaining about his blood pressure. The medical record notes that he had a headache. His blood pressure reading was 151/90, and the section entitled Findings Requiring Immediate Clinician Notification did not have any symptoms checked. The medical record does not indicate that Respondent saw R.G. on June 9, 2013, and he was not consulted about his care. The PLAN section of the Hypertension Protocol says “No treatment required.” On June 10, 2013, it appears that R.G. may have been seen at the clinic more than once. The initial entry in his medical records for that date, which does not have a time recorded, indicates that his blood pressure was 158/98. The second entry, recorded at approximately 2:00 p.m., indicates that R.G. presented to the clinic with a blood pressure reading of 173/98. Respondent ordered a one-time dose of .2 mg Clonidine, and 10 mg of Lisinopril and directed that his blood pressure be taken again in an hour. Respondent tried to find the underlying cause for the rise in R.G.’s blood pressure by sending him for blood work, and a thyroid and cardiovascular evaluation by the cardiac clinic. Respondent also directed that his blood pressure be checked twice weekly for an indecipherable number of weeks. When R.G.’s blood pressure was rechecked at approximately 4:00 p.m., it was 158/89. Respondent again ordered administration of 10 mg Lisinopril, increased his prescription for Lisinopril to 20 mg for three months, and ordered 600 mg of Ibuprofen to treat R.G.’s headache. R.G. next presented to the clinic on June 11, 2013, at 10:00 a.m. At that time, his blood pressure was noted as 152/94. There is no indication in the medical record that Respondent saw R.G. during that visit, and there is no documentation in the Physician’s Order Sheet to indicate that Respondent ordered any prescriptions for him. On June 18, 2013, R.G. went to the clinic complaining of a headache and vomiting. He listed his pain level at 6 out of 10. At his initial presentation at noon, his blood pressure was 197/105 in the left arm, and 186/86 in the right. Under the PLAN heading, the medical record indicates R.G. was given 200mg Ibuprofen for his headache, and 0.2 mg of Conidine for blood pressure. His blood pressure was rechecked at 1:00 p.m. and had lowered to 139/84. The medical record for June 18, 2013, does not indicate that Dr. Alaka saw R.G. or that he was consulted about him. The Department of Corrections Physician Order Sheet for R.G. has an entry dated June 18, 2013, but part of the record is indecipherable, and there is no doctor Signature/stamp completed for the entry. In addition, the portion of the entry that is readable refers to a Dr. Gonzalez, as opposed to Dr. Alaka. On June 20, 2013, R.G. returned to the clinic, this time complaining that he was stumbling and had a headache. A protocol sheet for Neurological Changes/Deficits was used in the medical records as opposed to the Hypertension Protocol. At this visit, his blood pressure was 120/62. There is no indication on the medical record for this date that Dr. Alaka saw R.G. R.G. returned to the clinic on June 25, 2013, at 5:39 p.m. The medical record indicates that he had a slight headache, a small amount of pitting/extremity swelling, fatigue, and had vomited that morning. His blood pressure was 165/94 in the left arm and 175/91 in the right. Pedal edema was noted to stop at the mid to upper shins, and the records indicate that R.G. had slept only three hours or less in the previous 24-hour period. R.G. was given acetaminophen for his headache, and his blood pressure was rechecked at 5:59 p.m. and 6:15 p.m.. His blood pressure at the first recheck was 165/94, and at the second recheck was 164/93. The Hypertension Protocol indicates that R.G. was administered 10 mg of Lisinopril, was instructed to comply with all prescribed medications, and not to sit with his legs crossed. The Physician’s Order Sheet indicates that per Respondent’s discussion with the nurse who saw R.G.,1 the prescription for 20 mg of Lisinopril was discontinued and replaced with a prescription for the same drug at 10 mg daily for three months. There was speculation throughout the hearing that R.G. did not always take his medications as prescribed, and there are notations in the medical records that R.G. sometimes refused recommended medical treatments, such as a referral for a urologist and a cardiac workup. There was no clear and convincing evidence that R.G. was also failing to take his blood pressure medications as required, although it is certainly a possibility. There is no indication in the medical records that R.G. went to the clinic for treatment after June 25, 2013.2 On July 2, 2013, R.G. was found unresponsive on the floor. He was transferred to ShandsLiveOak Regional Medical Center, and from there, transferred to Jacksonville Memorial on 1 The Administrative Complaint alleges that R.G. was seen by an ARNP during this visit. The signature of the health care provider indicates that he or she was an SRN, not an ARNP. The ARNP who reviewed the records and made what was referred to as an incidental entry (one where the record is reviewed but the patient is not seen) the following day is a different provider. 2 There is an entry for June 28, 2013, entitled Pre-Special Housing Health Assessment. Dr. Alaka testified he did not know what that meant. It appears from the record that the purpose of the assessment was to extend R.G.’s low bunk pass. At that time, his blood pressure was recorded as 158/92. It is not clear who conducted the assessment. July 3, 2013. R.G. died on July 5, 2013. The Medical Examiner’s Report lists R.G.’s cause of death as hypertension. Dr. Libert reviewed the medical records related to R.G.’s treatment. He opined that Respondent did not meet the applicable standard of care in his care and treatment of R.G. because he did not arrange for transportation to the hospital on June 18, 2013. He also opined that Respondent should have transferred R.G. on later dates prior to the transfer that occurred on July 2, 2013. He further opined that Respondent failed to recognize the signs and symptoms of malignant hypertension and failed to diagnose it. Dr. Libert also testified that Respondent failed to order basic blood tests that should have been ordered for a patient with hypertension. However, as noted above, Respondent did order blood work on June 10, 2013. There is no indication in the medical records that Dr. Alaka saw R.G. on June 18, 2013. With respect to the June 25 visit, Dr. Alaka would have received a phone call from staff, but did not see R.G. in person. Dr. Alaka has no independent recollection of seeing R.G., and had to rely solely on his review of the medical records for his account of what happened. The treatment of this patient occurred over eight years prior to the hearing in this case. Dr. Alaka did not believe that treatment in a prison setting is the same as the treatment rendered in a typical outpatient setting, and testified that in an outpatient setting, physician groups are free to set their own protocols. In a correctional setting, physicians were required to follow the protocols established by the Department of Corrections. Dr. Alaka testified that following the protocols was a condition of employment. Dr. Alaka testified that he did not create or maintain the medical records for patients at the facility, but would have access to the records when treating a patient. It is not clear, however, whether he had access to the records when he was not at the facility but received a telephone call regarding the treatment of a patient. Based upon the medical records in evidence, Dr. Alaka saw R.G. on June 10; was consulted about R.G. on June 7 and June 25; and was neither present nor consulted regarding R.G. on June 9, June 11, June 18, and June 20, 2013. The only time that the medical records indicate R.G.’s blood pressure may have been above the standard of 180/120 for malignant hypertension was June 18, 2013, and when rechecked, the pressure went down to 139/84. As noted above, the medical records do not indicate that Dr. Alaka either saw R.G. or was consulted about his care on that day. On June 25, 2013, R.G.’s blood pressure, while still considered high, was well below the standard identified for consideration of malignant hypertension. Dr. Alaka also testified that one must always consider the possibility of malignant hypertension when taking a patient’s blood pressure, but did not believe R.G.’s blood pressure reached that level. He tried to prevent it through the use of medication but did not believe that you needed to transfer a patient because of swelling, vomiting, or headache combined with high blood pressure, because those symptoms can occur with a variety of conditions. In his view, there should be concrete blood pressure readings, with indications of organ disturbance or stress. Organ damage would be substantiated through blood work and treated with medication while waiting for results. If the blood pressure is sustained, then he would call his supervisor and report the blood pressure; that it is not coming down; what medications were given; and request a transfer. He testified he did not request a transfer in this case because the blood pressure came down with treatment. In addition, Dr. Alaka noted that blood pressure readings can vary within the same hour, depending on who took the reading, the size of the cuff used, operator error, etc. Dr. Alaka also testified, credibly, that transfers to facilities outside the prison setting required approval by the regional medical director, and that was a condition for working at SCI. The Department did not provide any evidence to rebut the statement that Respondent did not have the authority to order transfer out of the facility, or that following the protocols reflected in the medical records was not required for employment at the facility. Dr. Alaka’s view of what blood pressure reading would have triggered a diagnosis of malignant hypertension is higher than Dr. Libert’s. Based on the evidence presented, Dr. Libert’s definition appears to be more reasonable. However, based on the totality of the evidence presented, the Department did not present clear and convincing evidence to show that Respondent’s care and treatment of R.G. violated the prevailing standard of care as alleged in the Administrative Complaint.
Conclusions For Petitioner: Hunter M. Pattison, Esquire Michael Jovane Williams, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 For Respondent: Edmond Olatunde Alaka, M.D., pro se 216 Elm Drive Chattahoochee, Florida 32324
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Administrative Complaint against Respondent be dismissed. DONE AND ENTERED this 20th day of December, 2021, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of December, 2021. COPIES FURNISHED: Hunter M. Pattison, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Edmond Olatunde Alaka, M.D. 216 Elm Drive Chattahoochee, Florida 32324 Paul A. Vazquez, JD, Executive Director Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 Michael Jovane Williams, Esquire Department of Health Prosecution Services Unit Bin C-65 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Louise St. Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399
The Issue The issue in this case is whether Respondent committed certain disciplinary violations and, if so, what penalty should be imposed.
Findings Of Fact Respondent is a licensed dentist in the State of Florida, holding license number DN 0008830. He was granted a parenteral conscious sedation permit on February 27, 1988. Respondent has been licensed in the State of Florida since August 3, 1981. There is no evidence that he has been the subject of prior disciplinary proceedings. J. C. was born November 28, 1980. J.C. died August 17, 1989, at 7:10 p.m. due to anoxic encephalopathy, which is brain damage from lack of oxygen. Anoxic encephalopathy was due to complications of preparation for dental extractions. Two years prior to visiting Respondent, J. C. had been seen by another dentist, Alexander S. Nurrell. Complaining of a toothache, J. C., who was six years old, was seeing a dentist for the first time. The medical and dental history, which was provided by J. C.'s mother, revealed nothing material to this case. The mother noted that the child had never experienced an "unhappy" reaction of a dental or medical procedure. Following an examination, Dr. Nurrell determined that J. C. had been "neglected," at least in terms of her dental needs, which were considerable. Due to the scope of the work required by J. C., which involved repairs to 11 teeth, Dr. Nurrell intended to hospitalize J. C. in order to provide the necessary dental treatment. About one week after the visit to Dr. Nurrell, J.C.'s father took her to another dentist, Peter Weisbruch. Again, her complaint involved a toothache, which apparently had not been treated by Dr. Nurrell. Dr. Weisbruch commenced a dental treatment plan that J. C. followed for some time. Dr. Weisbruch administered a local anesthetic to J.C. on three occasions. On the first visit, Dr. Weisbruch administered an anesthetic, but failed to record the type or amount. On April 26, 1988, Dr. Weisbruch, while extracting one of J.C.'s teeth, administered 0.9 cc of 3% Carbocaine, which is a brand name of mepivicaine. On May 14, 1988, Dr. Weisbruch administered 0.9 cc of 2% lidocaine, as well as 0.9 cc of 1:100,000 epinephrine solution. On no occasion did J. C. exhibit an unusual reaction to any local anesthetic. She was, however, an uncooperative patient. On June 1, 1988, J. C.'s father informed Dr. Weisbruch's office that J. C.'s mother would be resuming responsibility for ensuring that J. C. received adequate dental care and that J. C. would not be returning to Dr. Weisbruch's office. Financial constraints limited the ability of J.C.'s parents to obtain dental services for their daughter. By June, 1989, however, her mother was prepared to recommence J.C.'s dental treatment. She looked for a dentist in the yellow pages based on physical proximity to their home. When she found Respondent's advertisement, she was impressed by its emphasis upon patient comfort, including such features as stereo headphones and anaesthesia. Aside from her dental problems, J. C.'s health at the time that she first saw Respondent was good. She had been seen periodically by a pediatrician for a well visit and then for a couple of common viral complaints. When she first contacted Respondent's office, J.C.'s mother told the receptionist that she needed to be able to pay for the dental work by periodic payments. The receptionist advised the mother to bring in J. C. for an initial consultation. J. C. and her mother first visited Respondent on June 29, 1989. The medical and dental history revealed nothing unusual except that J. C. had "extensive" dental complaints. Respondent took x-rays and fitted J. C. for a retainer on her first and second visits, with the latter taking place on July 5, 1989. J. C.'s mother paid $157 on July 10, leaving a balance of $125, which was to be paid over 90 days. As a result of his examination of J. C.'s teeth, Respondent advised J. C. and her mother that J. C. should have eight primary teeth removed. He apparently prescribed an antibiotic to treat a dental infection, but this treatment is irrelevant to the case. In any event, Respondent's office gave J. C. an appointment for August 9, 1989, for the extraction of the eight teeth. On August 8, Respondent's receptionist called J.C.'s mother and told her that Respondent had decided to put J.C. asleep during the extractions. Thus, he wanted an early morning appointment. They agreed to reschedule the appointment for August 16 at 8:30 a.m. J. C. was excited about going to the dentist. She intended to go out for the cheerleading squad once school started. She and her mother arrived at Respondent's office just before 8:30 a.m. J. C. sat on her mother's lap and was a little nervous, but they did not have to wait long. J. C. weighed 50- 55 pounds at this time. No later than 8:30 a.m., dental assistant Terri Neff came out to the waiting room and took J. C. and her mother into Operatory #2. Operatory ##2 and 3 are identical in terms of equipment and size. Respondent, who apparently was the only dentist practicing in his office, also used a third operatory, which is smaller and lacked a dental assistant chair. Ms. Neff was, at the time of the incident, a certified dental assistant. She had been for the preceding five years and had assisted in dental procedures and monitored patients in anaesthesia. She also held current certification in dental radiology, the administration of nitrous oxide, and cardiopulmonary resuscitation (CPR). As was the case with all of Respondent's employees, Ms. Neff had never attended the course entitled "Guidelines for Teaching Comprehensive Control of Pain and Anxiety." Just before J. C. was seated in the examination chair, Ms. Neff gave her a glass of water, which J. C. drank. As Ms. Neff explained to J.C.'s mother, the water contained five ml of Phenergan, which Respondent had prescribed to control the nausea occasionally experienced by patients from nitrous oxide. J. C. drank the Phenergan solution at 8:35 a.m. Phenergan, or promethazine, is an antiemetic used to control nausea in patients about to receive nitrous oxide. A central nervous system depressant, Phenergan is an antihistamine with a minor sedative effect. The drug manufacturer's literature, which is inserted into each box or carton of the drug, warns that the sedative action of Phenergan is "additive to the sedative effects of central nervous system depressants; therefore, agents such as . . . narcotic analgesics . . . should either be eliminated or given in reduced dosage in the presence of [Phenergan]." The drug insert advises that the dose of meperidine or Demerol be reduced by one-quarter to one-half. The drug insert also advises: [Phenergan] may lower seizure threshold. This should be taken into consideration when administering to persons with known seizure disorders or when in combination with narcotics or local anesthetics which may also affect seizure threshold. Five ml of Phenergan contains 6.25 mg of promethazine. Used in isolation, this dosage of Phenergan was appropriate and bordered on the low end of a safe and effective dosage. For preoperative medication, the recommended dose is 0.5 mg per pound in combination with an equal dose of meperidine and an "appropriate dose of an atroprinelike drug," according to the drug insert. In J. C.'s case, the recommended dose is thus 27.5 mg, and she received only about 23% of the recommended maximum dose of Phenergan. The same amount is the recommended dose when Phenergan is used in isolation to control nausea. Ms. Neff next placed a nasal mask over J. C.'s nose preparing to administer nitrous oxide. The mask was supposed to have a bubble gum smell, which is intended to please pediatric patients. When Ms. Neff asked J. C. if she could smell the bubble gum, the girl said she could not, so Ms. Neff replaced the mask with a strawberry-scented one. J. C. said she could smell this one, although her mother thought she might be humoring them. The nasal mask does not cover the mouth. It is made of rubber and is not heavy. The mask, which was a child's size, fit tightly on J. C.'s face. The nitrous oxide machine has settings for nitrous and oxygen. Each unit represents one liter of gas delivered per minute. Pursuant to Respondent's direction as to initial mix and time of commencement, Ms. Neff turned on the nitrous oxide machine shortly after placing the mask on J. C. The initial setting was 1:3 nitrous to oxygen. Nitrous oxide is a central nervous system depressant. J. C. was fidgety in the chair. After the mask was applied, she touched the mask frequently. She said that the mask felt funny and made her nose itch. She remained quite talkative. After the nitrous oxide had been administered to J. C. for about 30 minutes, Respondent entered the operatory to check on the girl. He waited awhile, noting that J. C. was still not calm enough to proceed. He then advised Ms. Neff that they would need to give J. C. an injection of Demerol. At about 9:02 a.m., Respondent gave J. C. an injection of 50 mg Demerol, or meperidine, in her right deltoid muscle. J. C. cried upon receiving the injection. Demerol is a narcotic analgesic similar in effect to morphine. Demerol is a central nervous system depressant. The drug insert warns prominently that "[Demerol] should be used with great caution and in reduced dosage in patients who are concurrently receiving . . . other CNS depressants . . .. Respiratory depression, hypotension, and profound sedation or coma may result." In isolation, the maximum dose is 0.8 mg per pound of body weight when the drug is used as premedication, which is how Respondent used the drug in this case, although the drug insert states that the "usual dosage" is 0.5 mg per pound when Demerol is used for preoperative medication. Using the rate of 0.8 mg per pound, the maximum dosage was 44 mg., if the Demerol had been used in isolation. No expert opined that the amount of Demerol administered to J. C. would have been excessive, if the drug had been used in isolation. However, when used, as here, in connection with one or more other central nervous system depressants, the dosage of Demerol was excessive, especially when combined with the administration of mepivicaine, as discussed below. J. C. cried when she received the injection. Respondent left the room, and J. C., evidently agitated, asked her mother, "is this how Grandma died?" Her mother tried to reassure her that everything was alright. After receiving the injection, J.C. began to rub around her eyes and face. This itchiness was due to a combination of one or more of the following: fidgetiness, continued resistance or possibly minor reaction to the mask, and a short-term release of histamines caused by the administration of the Demerol. However, the itchiness was not evidence of a serious allergic or anaphylactic reaction for reasons discussed below. Respondent's testimony that he noticed itchiness to an extent that he had not previously seen is discredited by, among other things, his failure to chart what would have been an unprecedented observation. At about the time of the Demerol injection, the nitrous oxide mix was changed, by Respondent's instructions, to 3:5. 1/ Ms. Neff remained with the mother and J. C. for about 30 minutes, waiting for J. C. to relax sufficiently so Respondent could proceed to administer the local anesthetic and begin the extractions. J. C. remained talkative during this period. While Ms. Neff was waiting with the mother and J.C. for the Demerol to take effect, someone told Ms. Neff that she was needed by another patient. Another assistant, Sarah Staley, joined J. C. and her mother at this time. At about this time, J. C. began to become more subdued. Aside from the receptionist, Ms. Staley was the least trained of Respondent's employees. First employed by Respondent about one year earlier, Ms. Staley had no prior dental experience. She had not undergone any formal training as a dental assistant or in CPR. Her position was best described as a business assistant/clerk. Ms. Staley was not trained to recognize any symptoms of a patient in sedation. At about 9:35 a.m., Respondent returned to Operatory #2. Finding J. C. sufficiently calm to proceed, Respondent began the process of administering mepivicaine. Mepivicaine, which is also a central nervous system depressant, is a local anesthetic. The drug insert warns: "Great care must be exercised in adhering to safe concentrations and dosages for pedodontic administration." The drug insert adds: If sedatives are employed to reduce patient apprehension, use reduced doses, since local anesthetic agents, like sedatives, are central nervous system depressants which in combination may have an additive effect. Young children should be given minimal doses of each agent. Injection of repeated doses of mepivicaine may cause significant increases in blood levels with each repeated dosage due to slow accumulation of the drug or its metabolites, or due to slower metabolic degradation than normal. Tolerance varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their weight and physical status. As to adverse reactions, the drug insert states: Reactions involving the central nervous system are characterized by excitation and/or depression. Nervousness, dizziness, blurred vision, or tremors may occur followed by drowsiness, convulsions, unconsciousness, and possible respiratory arrest. . . . Reactions involving the cardiovascular system include depression of the myocardium, hypotension, bradycardia, and even cardiac arrest. Allergic reactions are rare and may occur as a result of sensitivity to the local anesthetic. . . . As with other local anesthetics, anaphylactoid reactions to Mepivicaine have occurred rarely. The reaction may be abrupt and severe and is not usually dose related. The drug insert states that the "lowest dosage needed to provide effective anesthesia should be administered." The drug insert specifies the dosage as follows: "A dose of up to 3 mg per pound of body weight may be administered." Respondent injected mepivicaine into the area of the upper and lower jaws. Neither Ms. Staley nor the mother noted the number of cartridges of anesthetic that Respondent used. As the injections started, J. C. began to cry, and her mother held her hand to calm her. A cartridge, or carpule, is a glass tube containing medication in solution form. The cartridge in this case contained a 3% solution of mepivicaine. Each cartridge contained 1.8 cc of the medication or 54 mg. of mepivicaine. The cartridge is placed in the syringe, a negligible amount is expressed to eliminate any air bubbles and to ensure proper operation of the syringe, and then the remainder is available to be injected into the patient. The evidence is contradictory as to the amount of mepivicaine actually injected into J. C. There are two reasons for this. First, there is conflicting evidence as to the number of cartridges. Second, there is some evidence that less than an entire cartridge was injected each time. Although not arriving in the operatory until at least 10 minutes after the completion of the mepivicaine injections, dental assistant Kathleen Lyttle charted the entry, "mepivicaine 3%." Respondent later charted the remaining information concerning the number of cartridges of mepivicaine. Respondent first noted that he had used eight cartridges from 9:30 a.m. to 9:50 a.m. He made entries showing injections into the upper and lower left and right jaws. Although no number was placed next to each location, obviously a pair of injections in each of the four locations would result in eight cartridges. Respondent then made two interlineations. First, he wrote above the notes for the two upper-jaw entries the following notation: "x2," meaning that two cartridges each were injected in the upper left and right jaw for a total of six cartridges. The effect of this addition is to imply that only one was injected lower left and right jaw. Second, Respondent crossed out the number "8" and added, above the crossed-out "8," the notation, "5-6," meaning that a total of five to six cartridges were injected. In a conversation with the Orange County Medical Examiner shortly after the incident, Respondent stated that five to six cartridges were administered. Respondent told the medical examiner that he first completed the injections into the upper and lower left and right jaws, then injected a little more. In a written statement to the medical examiner, Respondent stated that six cartridges were administered. Petitioner has proved by clear and convincing evidence that Respondent administered to J. C. no less than six cartridges of mepivicaine. This number is consistent with the written statement that Respondent provided the medical examiner. This number is also consistent with the detailed itemization Respondent noted on the dental chart where he showed one injection each in the lower left and right jaw and then two injections each in the upper left and right jaw. The second issue is whether Respondent injected the entire contents of each cartridge. In his practice, Respondent often did not empty a cartridge of local anesthetic but instead left up to 20% of the contents uninjected. Petitioner has proved by clear and convincing evidence that Respondent injected the entire contents of the first four cartridges used in the upper right and left jaw, except for the negligible amount expressed for the reasons set forth above. Respondent had concluded that J. C. was an uncooperative patient. He had already chosen what he testified was the "upper limit" for the Demerol, which in fact was excessive in view of the prior administration of Phenergan. Respondent had also increased the nitrous oxide ratio to administer more nitrous. Most important, Respondent testified that, during his eight-year career, he had ignored maximum recommended dosages of local anesthetics. Nothing in the record suggests that, in the use of local anesthetics and central nervous system depressants, Respondent subscribed to the maxim, "Start low, go slow." Also, the consequences of the administration of the mepivicaine, which, as noted below, demonstrate local anesthetic toxicity rather than allergic reaction, are strong proof that Respondent administered a dosage of mepivicaine far in excess of the maximum recommended dosage. As to the final two cartridges, Petitioner has proved by clear and convincing evidence that Respondent did not withhold more than 20% of the contents of each cartridge. There is substantial evidence, as set forth in the preceding paragraph, that Respondent withheld less in this case. However, the results would be the same, based on the following findings. Respondent's testimony that he administered no more than about 200 mg of mepivicaine is discredited. This would represent the contents from 3.75 cartridges. By the time that Respondent spoke with the medical examiner, he had had more than enough time to reflect on the possibility that J. C. may have suffered a toxic reaction to a local anesthetic. Given that possibility, and the obvious ramifications that it held for Respondent, he certainly would have carefully reflected upon the actual amount of mepivicaine administered to J. C. It is inconceivable that if, instead of 5-6 cartridges, he determined that he had injected only 3.75 net cartridges, he would not have so informed the medical examiner at that time. It is more likely that the netting process, in order to reflect the unused contents of a cartridge, resulted in a reduction from eight to six cartridges. Based on the foregoing, the least amount of mepivicaine that Respondent actually injected into J. C. is four full cartridges into the upper and lower jaws followed by not less than four-fifths of a cartridge each injected into the upper right and left jaw. This yields a total of 5.6 cartridges or about 300 mg of mepivicaine. The finding of 5.6 cartridges or 300 mg of mepivicaine corresponds to Respondent's estimate of 5-6 cartridges. Petitioner has proved by clear and convincing evidence that Respondent's estimate is already reduced by at least the amount of medication that Respondent actually withheld. There is significant evidence, although not clear and convincing, that Respondent injected eight cartridges, which, assuming a 20% reduction even in each injection, means that he administered 6.4 cartridges or about 345 mg of mepivicaine. When used in isolation, mepivicaine is administered at the rate of not more than three mg per pound of body weight. 2/ In the case of J. C., the maximum recommended dosage would have been 165 mg of mepivicaine, if the drug had been used without any other medications. When used in connection with other central nervous system depressants or sedatives, like Phenergan, nitrous oxide, and Demerol, mepivicaine's maximum recommended dosage is not more than two mg per pound of body weight. In this case, then, the maximum recommended dosage for J. C. was 110 mg because the drug's effect would be potentiated by the other medications already given J. C. If J. C. had not been given other drugs, the dosage that she received was 1.8 times more than the recommended maximum dosage. Because she had already received other central nervous system depressants, the dosage that she received was 2.7 times the recommended maximum dosage. 3/ Respondent injected the mepivicaine from 9:35 a.m until about 9:52 a.m. He then left the operatory. As the mother and Ms. Staley watched over J. C., she said, "I love you, mommy." She then turned her head to the side and seemed to fall asleep, lying back in the chair. Respondent's testimony that, immediately following the injections, J. C. began to experience extremely bad itching around her eyes and face is discredited. If J. C. had experienced such a remarkable response, Respondent would have at least charted it, if not remained in the operatory until the phenomenon resolved itself. At best, Respondent has confused the onset of the itching, which in fact began with the application of the nitrous oxide mask. After Respondent left the operatory, the mother and Ms. Staley chatted about their preparations for the new schoolyear. Suddenly, at about 9:57 a.m., J. C. sat straight up in the chair with her eyes open unnaturally wide, trying to catch a breath, but unable to do so. After a few seconds, she slumped back into the chair and her arms and legs began shaking violently. After a few more seconds, her posturing and convulsions ended. Ms. Staley immediately summoned Respondent. Ms. Neff had by chance just been entering Operatory #2 at the moment that J. C. had sat upright in the chair. Ms. Neff immediately turned the nitrous oxide machine to 100% oxygen at its maximum setting of 10+ liters per minute. Ms. Neff testified that she was unaware that anything was wrong at this time and only thought that J. C. might need to go to the bathroom. Even after a few moments in the operatory, Ms. Neff continued to think that the they simply had "a nervous little girl in the chair." Another dental assistant, Lisa Ann Barlette, who was in the operatory across the hall, happened to see out of the corner of her eye J. C. when she had sat upright. Ms. Barlette had almost two years' experience as a dental assistant and was currently certified in CPR and dental radiology. Immediately excusing herself from her patient, Ms. Barlette started to walk across the hall into Operatory #2 and saw J. C.'s hands trying unsuccessfully to push the nitrous oxide mask up over her nose. Respondent entered the operatory immediately ahead of Ms. Barlette, who remained in the doorway. Respondent and Ms. Staley were telling J. C. to calm down. Upon entering Operatory #2, Respondent immediately tilted J. C.'s head back and chin up so as to establish an airway and eliminate any upper airway obstructions. He also began to take her pulse. Respondent noted that J. C. was in "severe respiratory distress." At about 10:03 a.m., J.C. had a second seizure in which she stiffened and then shook violently. She had a third seizure at about 10:04 a.m. and a fourth at about 10:05 a.m. She suffered a fifth seizure, of somewhat lesser intensity, at about 10:07 a.m. and a more intense seizure at about 10:09 a.m. During these seizures, J. C. gasped, as though sobbing, and continued to breathe as though she was trying to catch her breath. Between seizures, she responded to her mother with eye movements and by squeezing her hand. When told by her mother or Respondent to relax, J. C. responded by relaxing her grip. These were the limits of J. C.'s responses following the onset of the convulsions. At about 10:04 a.m., Respondent ordered that a rubber bite block be inserted to help control the upper airway during the seizures. After a few minutes following the first seizure, Ms. Staley began to suction mucous secretions from J. C. and continued to do so while J. C. remained in the chair. Entering Operatory #2 shortly after the clinical emergency began, Kathleen Lyttle, who later charted the mepivicaine, asked Respondent if he wanted her to take J.C.'s vital signs. Respondent nodded yes, and, because the blood pressure cuff in Operatory #2 was behind Ms. Staley and difficult to reach, Ms. Lyttle obtained one from another operatory. Ms. Lyttle was currently certified in dental radiology and CPR. She seemed to be the most experienced among Respondent's employees in handling a clinical emergency. Respondent administered at about 10:12 a.m. 4/ one cc of Narcan (0.4 mg/ml) by injection into the jaw. Narcan is a narcotic antagonist capable of counteracting the Demerol within seconds. At this time, J. C.'s respirations were beginning to decrease and she began to become cyanotic from a lack of oxygen. About a minute after injecting the Narcan, Respondent administered one ml of adrenalin chloride 1:1000 in the form of epinephrine solution by injection below the tongue. Attaching the blood pressure cuff on J.C.'s right thigh, Ms. Lyttle took her first reading of J. C.'s vital signs at about 10:13 a.m. J. C.'s blood pressure was 160/90, her pulse was 160, and her respiration was irregular. The vital signs were unchanged one minute later. By 10:15 a.m., the pulse and respiration were unchanged, but the blood pressure had dropped to 115/44. The interval between seizures was increasing, the seizures seemed to be lessening in intensity, and J.C. continued to respond between seizures in the manners described above. At about this point, Ms. Lyttle then turned to the mother and asked if J. C. had epilepsy. When told that she did not, Ms. Lyttle said, "Well, she's having an epileptic seizure." Since the first seizure, the mother had been standing in front of J. C. holding her arms or, as instructed by Ms. Lyttle shortly after she entered the operatory, massaging her daughter's chest. She could see her daughter's eyes moving wildly, then focusing as though on something in the distance that the rest of them could not see. Sometime after Ms. Lyttle had asked about epilepsy, which probably was after 10:15 a.m., the mother told Respondent to call the hospital, but no one responded. Ms. Barlette had earlier expressed the possibility of contacting emergency medical services. At about 10:00 a.m., Ms. Barlette caught Respondent's eyes and mouthed the words, "Do you want me to call?" She did not give voice to the words to avoid further alarming the mother. Staring at him, Ms. Barlette saw no response. It is not clear that Respondent comprehended what Ms. Barlette was trying to communicate. Within 30 seconds after her voiceless request, Ms. Barlette, noting that J. C. was turning red, caught Respondent's attention and asked audibly, "Do you want me to call 911?" About one minute later, or no later than 10:02 a.m., by which time J.C. had turned purple, Ms. Barlette repeated her request. Responding to neither request, Respondent evidently was so preoccupied that he either did not hear the requests or their meaning did not register with him. Despite the clear clinical emergency, the only vital sign taken was J. C.'s pulse until 10:13 a.m., when Ms. Lyttle first read J. C.'s vital signs. Surprisingly, the chronologies prepared by Respondent, the dental chart, and the testimony fail to disclose any meaningful activity during the period from 10:15 a.m. through 10:30 a.m. By the end of this 15-minute period, the seizures, which had evidently decreased in frequency and intensity, reintensified to the degree to which they resembled the early seizures. The next entry on the chart following 10:13 a.m. is 10:30 a.m., at which time J. C.'s vital signs are blood pressure 115/44, pulse 180, and respiration irregular. The notes add, "cardiac irreg[ular with] arrhythmia." Respondent's oral and written statements to the medical examiner add that J. C. was cyanotic or becoming cyanotic at this time. Five minutes later the vitals are 90/54, 200 and climbing, and irregular respiration. In the meantime, at about 10:34 a.m., Ms. Neff took the mother out of the room so she could make any telephone calls that she thought necessary, such as to alert J.C.'s father. The mother went into a nearby conference room for a few minutes, but was unable to make any calls because she could not remember anyone's telephone number. At 10:36 a.m., the chart notes for the first time "bronchial spasms [with] laryngeal spasms." The vitals are 60/44, 200 and climbing, and irregular respiration with tachycardia. The pulse is now thready and shallow. At 10:38 or 10:39 a.m., Ms. Lyttle stated that the blood pressure had "bottomed out." J. C. was in respiratory and cardiac arrest. Ms. Lyttle asked, "Call 911?" Respondent answered, "Go." Ms. Lyttle called 911 at about 10:41 or 10:42 a.m. and summarized the situation. Ms. Barlette later helped with the call. In the meantime, Respondent had taken J. C. from the chair and placed her on the floor where he could begin CPR. She vomited and aspirated the vomit and some mucous before Respondent cleared the vomit from her mouth and upper throat. Respondent began mouth-to-mouth and Ms. Lyttle, who had left Ms. Barlette with the phone, returned and immediately commenced compressing J. C.'s chest. As the mother was returning to Operatory #2, the mother heard Ms. Barlette on the telephone saying something about "Demerol." When she reentered the operatory, she saw that her daughter was now on the floor undergoing CPR. Although still without any pulse, J. C.'s color began to return to normal. The first ambulance arrived at 10:51 a.m. The paramedics found that J. C. was unconscious. Her lung sounds were clear, her pupils dilated, and her skin warm and dry. She still had no pulse, respiration, or blood pressure. Within a couple of minutes, the paramedics, after one failed attempt, successfully intubated J. C. and began ventilating her with an ambu bag that is attached to a portable oxygen cylinder. J. C. tried unsuccessfully to take a couple of breaths. After placing MAST pants on her to force the blood from her lower extremities, the paramedics quickly placed her on a rigid back board and transported her to Florida Hospital-- Altamonte Springs. From Florida Hospital--Altamonte Springs, J. C. was transferred by helicopter to Florida Hospital--South. However, she never regained consciousness and expired the evening of the following day. At 11:09 a.m., Respondent's office informed Florida Hospital-- Altamonte Springs of the medications given. In addition to noting aspects of the emergency treatment that J. C. received from the paramedics while still in Respondent's office, including being placed on oxygen under a positive pressure delivery system, the dental chart notes at the bottom: "1) anaphylactic response . . . to Demerol." Under this entry is "2) mepivicaine." The second entry is then crossed out. The internal examination of the autopsy revealed, as to the lungs, "moderate pulmonary congestion and edema . . .." As to the brain, there was "marked generalized brain swelling and softening." As for the brain-stem, cerebellum, and portion of the cerebrum, there was "severe generalized edema and softening." Upon microscopic examination, the autopsy reveals, as to the central nervous system, no evidence of chronic hypoxia, but "diffuse marked edema and hypoxic injury . . .." The lungs show "much pulmonary edema and congestion . . . with multifocal early bronchopneumonia . . .." The report continues: The changes in the lungs are consistent with acute bronchopneumonia, due to gastric aspiration, or due to reduced pulmonary toilet from being on a respirator with a greatly decreased mental status with or without gastric aspiration. Numerous factors compel the rejection of Respondent's theories that J. C. suffered an allergic, anaphylactic, or anaphylactoid reaction, perhaps in combination with an asthma attack. The evidence is clear and convincing that Respondent administered J. C. mepivicaine in excess of the maximum recommended dosage and, as a result of the overdose, J.C. suffered a toxic reaction to the local anesthetic. In dentistry, the overadministration of a drug, including a local anesthetic, accounts for about 85% of all adverse drug reactions. Drug allergies account for only about 15% of adverse drug reactions. Drug overdoses are even slightly more common in children than in adults. The central fact is that Respondent administered an overdose of mepivicaine to J. C. of 2.7 times the maximum recommended safe dosage. The patient's young age raised the possibility of higher blood levels per unit dose due to the greater likelihood that the functions of absorption, metabolism, and excretion in a child may be imperfectly developed. Another predisposing factor of which Respondent was aware was the stress and anxiety that J.C. has previously displayed. The local- anesthetic seizure threshold is reduced in such patients. The ensuing signs and symptoms are further evidence that J. C. died due to local anesthetic toxicity caused by the administration of an overdose of mepivicaine. The first effect of a toxic reaction to mepivicaine would be to depress the central nervous system. This effect manifested itself in J. C.'s case by the first objective signs: posturing and convulsions. Characteristic of toxic reactions to local anesthetics, such as mepivicaine, is a central nervous system excitatory phase. The reason for an excitatory phase is that the neurons in the central nervous system associated with excitation or stimulation are the last to be depressed by plasma levels of local anesthetics. Once unrestrained by the now-depressed inhibitory neurons, the electrical activity proceeds freely along the stimulatory pathways and stimulates muscle tissue, which may result in convulsions. The patient suffering an allergic reaction would not experience seizures until he had suffered hypoxia, which is an oxygen deficiency. At the time of J. C.'s initial seizures, which were due to the depression of aspects of the central nervous system, her breathing was still sufficient to preclude allergy-induced hypoxia. The depression of the central nervous system also affects respiration and blood pressure, as basic brain activities begin to decrease. During the early stages of the clinical emergency, J. C. continued to try to breathe. Contrary to Respondent's assertions, these efforts coupled with labored breathing were not evidence of an allergic reaction, but were entirely characteristic of central nervous system depression. The course of a toxic reaction to a local anesthetic proceeds to respiratory depression, where, as Respondent acknowledges, the desire to breathe is decreased. Then, the patient proceeds to respiratory arrest, followed by cardiac depression and cardiac arrest. This process is the result of reduced oxygen to the brain. The central nervous system depression initiates the reduction of oxygen to the brain. The seizures themselves exacerbate the problem. The convulsing brain requires increased oxygen to continue functioning. During the seizure, the patient breathes little, if at all. Once the brain activity has been impaired to the extent that respiratory depression begins, obviously the flow of oxygen is impaired even further, which further raises the likelihood of seizures. The flow of oxygen to the brain obviously ends completely with respiratory arrest. Within four to five minutes, the oxygen-deprived brain sustains irreversible damage. The evidence of allergy, including an anaphylactic reaction, is insubstantial. As noted above, Respondent administered an excessive amount of mepivicaine to J. C., and allergic reactions are very rare relative to drug overdoses. In addition, seizures and central nervous system excitement are not typically associated with allergic or anaphylactic reactions. Likewise, high blood pressure readings are uncharacteristic of allergic or anaphylactic reactions. The patient suffering an allergic reaction, such as an anaphylactic reaction, typically suffers only depressed blood pressure. The person suffering a toxic reaction to a local anesthetic experiences, as did J. C., first high blood pressure and then decreased blood pressure. Respondent asserts that several signs suggest the presence of an allergic or anaphylactic reaction. Itching is a classic sign of an allergic reaction. However, the itching in this case has been explained above. At most, J. C. may have experienced a minor reaction to the Demerol or a substance in the mask. The timing of J. C.'s subsequent symptoms is too delayed to be attributed as an allergic or anaphylactic reaction to the Demerol, nitrous oxide, or mask itself. Because the itchiness preexisted the administration of the mepivicaine, the local anesthetic could not have caused the itching. Another classic sign of an allergic reaction is a rash, but no rash was reported in this case. The tenacious mucous that Respondent reports did not appear initially. Such mucous is nonspecific and normally attends dental procedures, especially when the patient is a child under sedation. Moreover, when the body is undergoing a crisis of the type suffered by J.C., such mucosal secretions are normal. There is no reliable evidence of significant pulmonary edema, which is the accumulation of fluids within the air cells of the lungs, until at a stage of the clinical emergency at which the sign becomes quite nonspecific. Although associated with allergic reactions, pulmonary edema and congestion may also accompany local anesthetic toxicity, especially following the onset of respiratory depression. In any event, pulmonary edema and congestion are extremely common when persons die other than suddenly, as edema and congestion are associated with the failure of the respiratory and cardiovascular systems. The evidence of bronchial spasms and wheezing offered by Respondent is unpersuasive. Although normally associated with allergic or anaphylactic reactions, bronchial spasms and wheezing, to whatever extent they existed at all, do not appear to have been defining signs or symptoms of J. C.'s clinical emergency. A case report appearing in the November-December 1991 issue of the Journal of Dentistry for Children describes a case featuring many similarities with that of J. C. In the reported case, a five year old girl was being prepared for multiple extractions. After receiving five minutes of nitrous oxide at an unknown concentration, she then received five cartridges of 3% mepivicaine or 270 mg of the drug. Ten minutes later the girl experienced "'stiffening and shaking' of all extremities that lasted approximately ten seconds." She then underwent another convulsive episode, after which she was placed on 100% oxygen. After a third convulsive episode, the patient was still breathing on her own but was no longer responsive to verbal commands. Ten minutes after the first convulsion, she was transferred to a physician's office where she arrived in cardiac and respiratory arrest. Following CPR, the patient was given sodium bicarbonate, epinephrine, calcium gluconate, and atropine about 55 minutes after being given the local anesthetic. She was then transferred to a hospital where she was intubated due to lack of spontaneous respirations. Four days later, she was declared brain dead due to anoxic brain injury secondary to cardiopulmonary arrest following an overdose of mepivicaine. The article quotes "Malamed," who is the author of Respondent Exhibit 2, as advising that the maximum safe dose of mepivicaine is two mg per pound of body weight. 5/ The case report notes that higher blood levels of mepivicaine, resulting from more high overdoses, may result in convulsions due to an initial blockage of inhibitory neurons in the CNS, thus leaving the excitatory neurons firing unopposed. Still further increases in blood levels lead to unconsciousness and respiratory depression. The cardiovascular effects of a local anesthetic overdose include vasodilation, which in turn can lead to a drop in systemic blood pressure. There is also a direct depressant effect on the myocardial cell membrane, which can cause a progressive bradycardia and full cardiac arrest. Death can occur due to either respiratory depression or cardiac arrest. It is also important to realize the narcotic sedative regimens lower the convulsive threshold of local anesthetic and increase the likelihood of respiratory depression. The case report explains that average peak blood levels of 3% mepivicaine usually appear within 15-30 minutes following injection, and the plasma half-life is 90-120 minutes. The report concludes that, based on injection volumes, the maximum safe dosages are more rapidly reached with 3% mepivicaine than with 2% lidocaine plus epinephrin, which extends the effectiveness of the local anesthetic. In addition to confirming signs and symptoms described above, the article provides evidence that, in terms of the timing of signs and symptoms, J.C. suffered from a toxic reaction to an overdose of a local anesthetic. The first seizure took place 22 minutes after the first injection and five minutes after the last, which corresponds both to the timeframe for average peak blood levels and the 10-minute delay in the reported case. Not only did Respondent clearly fail to attain the minimum standards of performance in diagnosis and treatment when measured against prevailing peer performance (Standard of Care) in administering an overdose of mepivicaine to J. C., he then failed to attain the Standard of Care in equipping himself for detecting and managing such a clinical emergency and in the actual management of the crisis. The preparation of J. C. in this case is an example of the use parenteral conscious sedation. Parenteral conscious sedation, which alters a patient's awareness, does not render the patient unconscious or affect his active reflexes, such as a choking response. This type of sedation is defined further in the Conclusions of Law. First, Respondent's office lacked a pulse oximeter. This noninvasive device constantly measures the subject's pulse and oxygen saturation level in the peripheral blood. The failure to have and use a pulse oximeter while administering parenteral conscious sedation is in itself a failure to attain the Standard of Care. With such a device in J.C.'s case, Respondent probably would have been able to detect reduced oxygen levels, as a result of central nervous system depression, well in advance of the first convulsion. With proper treatment, Respondent possibly could have prevented the convulsions and averted the ensuing clinical emergency. Second, Respondent's office lacked a positive pressure oxygen delivery device. Unlike the pulse oximeter, which is a diagnostic device, the positive pressure oxygen device is used to treat certain patients who are suffering respiratory distress. The importance of this device is underscored by the fact that it is not unusual for a patient under parenteral conscious sedation to stop breathing or require breathing assistance. The dentist must then inflate the patient's lungs, typically using one of two devices: the demand valve mask or the breathing bag. The failure to have a positive pressure oxygen delivery system during the parenteral conscious sedation of a patient is in itself a failure to attain the Standard of Care. A dentist with ready access to a pulse oximeter and positive pressure oxygen delivery device should have been able to manage J. C.'s toxic reaction to the mepivicaine without the loss of life or even serious injury. Even without a pulse oximeter, a dentist should have been able to manage this clinical emergency without the loss of life or even serious injury. The proper management of the clinical emergency requires a thorough understanding of the process by which the body reacts to an overdose of a local anesthetic. Respondent tragically failed to apprehend the significance of the mepivicaine overdose that he had administered, evidently thinking instead that J. C. was exhibiting signs of an allergic or anaphylactic reaction, possibly to the mepivicaine. The Standard of Care requires that a dentist determine in the first five minutes following a convulsion if he is going to require emergency medical services and, if so, to summon such services at that time. The first thing the dentist must do after a patient suffers a convulsion is to establish an airway, which is a direct line from the patient's mouth to his lungs. If all that is required is to tilt the head back and chin up, as Respondent did, then such action is of course is sufficient. If, as here, such action is insufficient, the Standard of Care demands that a dentist using parenteral conscious sedation be prepared and able to insert an endotracheal tube or nasal airway in order to create a path for oxygen to reach the lungs. Responding to a question concerning Respondent's care in diagnosing and treating J. C. after the onset of convulsions, Respondent's expert, Dr. Wecht, conceded that Respondent failed to attain the Standard of Care: I think, with the time sequence here, given the circumstances, the panic, the anxiety, you know, were all understandable. I don't see anything dramatically negligent here in terms of wanton gross neglect, criminal negligence and so on. I just don't see it. Could this case be argued in the context of plain, unadorned negligence, could it be a bona fide malpractice case? Those are reasonable observations and inquiries, and I would be the first one to say that the answer to that could, indeed, be yes . . .. Respondent Exhibit 6, page 43. Respondent failed to manage the clinical emergency in a manner consistent with the Standard of Care. The evidence is overwhelming that he did not in fact maintain an effective airway. He was critically handicapped by the absence of a positive pressure oxygen delivery system. Switching the nitrous oxide machine to 100% oxygen did not help J. C., whose inspirations had become so impaired that she required ventilation. Had Respondent commenced CPR within the first few minutes of the onset of the convulsions, rather than about 45 minutes later, the brain injury might have been minimal. However, by the time Respondent commenced CPR, it was too late. By this time, ventilating the patient with 100% oxygen, as the paramedics did upon their arrival 12 minutes later, could do nothing for the severe brain damage that J. C. had already suffered. Respondent again failed to attain the Standard of Care by not summoning paramedics for about 45 minutes after the initial convulsion. Had he heeded the request of Ms. Barlette to call 911, there is a good chance that J. C. would not have died, notwithstanding Respondent's administration of an overdose of mepivicaine, absence of vital equipment, and evident inability to diagnose and treat the ensuing clinical emergency. Malamed, quoting Goodson and Moore, "Life Threatening Reactions after Pedontic Sedation: an Assessment of Narcotic, Local-Anesthetic, and Antiemetic Drug Interaction," in the Journal of American Dental Association, 107:239, 1983, states that the use of sedative techniques accompanied by the administration of narcotics requires continual monitoring of the cardiovascular and respiratory systems, ability of the practitioner to recognize and control the respiratory arrest and convulsions that are "easily induce[d]" by multiple sedative drug techniques, careful selection of dosages based on the body weight of the patient, and readiness to change the technique of sedation or choice of drugs at a later appointment rather than merely increasing the dosage when the initial dosage proves inadequate. Malamed reports that a recent three-year study attributed most deaths occurring in the dental practice related to the administration of drugs involved three factors: Improper preoperative evaluation of the patient. Lack of knowledge of drug pharmacology by the doctor. Lack of adequate monitoring during the procedure. Id. at p. 299. Malamed concludes: . . . with care on the part of the doctor, the incidence of [an overdose reaction to the administration of CNS-depressant drugs] should be extremely low, and a successful outcome should occur virtually every time. Id. On March 28, 1991, Respondent was indicted for the second degree felony of manslaughter in connection with the death of J. C. In a supplemental statement of particulars, the State of Florida alleged that Respondent administered an inappropriately high dosage of mepivicaine, Respondent's office was not equipped with a pulse oximeter or positive pressure oxygen delivery system, Respondent failed timely to contact emergency medical services, and Respondent thereby displayed a reckless disregard for human life. By plea agreement signed October 31, 1991, Respondent pleaded nolo contendere to the charge of manslaughter and waived his right to appeal any pretrial rulings. He was adjudicated guilty by judgment entered the same day and sentenced, pursuant to the agreement, to six months' community control followed by five years' supervised probation, together with various costs.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that the Board of Dentistry enter a final order revoking the license of Respondent. ENTERED this 24th day of February, 1992, in Tallahassee, Florida. ROBERT E. MEALE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of February, 1992.
The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been a physician licensed in the State of Florida and has been Board- certified in obstetrics and gynecology. On May 7, 1998, Patient A. J. underwent a laparoscopic procedure due to a complex left ovarian cyst at Columbia Surgical Park Center, an ambulatory care center located in Miami, Florida. The operation consisted of a laparoscopy with laparoscopic lysis of adhesions and a laparoscopic left ovarian cystectomy. Respondent performed the surgical procedure under general anesthesia. Gerald Kranis, M.D., was the anesthesiologist during the procedure. Respondent made a small vertical incision in the umbilicus and insufflated the abdomen with carbon dioxide gas. Respondent then entered the abdomen through a visiport with a 10-millimeter scope. He initially examined the upper abdomen. The patient’s liver and gall bladder appeared normal. Respondent next turned the laparoscope caudally. Inspection of the pelvic organs revealed numerous adhesions of the omentum and bowel to the anterior abdominal wall and to the uterus. Respondent took down the adhesions with sharp dissection with no bleeding. Respondent noted that there was adherence of the bowel to the anterior uterus. This was dissected away with sharp dissection. Inspection of the right adnexa showed a hemmoraghic cyst of the left ovary, and this was dissected by sharp dissection. In the process, the cyst ruptured extruding chocolate-appearing material. The cyst wall was grasped with an atraumatic grasper and teased out. Hemostasis was secure, and the cyst was retained to be sent to pathology. Inspection of the cul-de-sac revealed numerous adhesions of the bowel to the posterior uterus, and these were lysed with sharp dissection. At the end of the procedure, just before Respondent exited the abdomen, the patient’s blood pressure dropped. Inspection of the abdomen revealed no increased bleeding, but there was one area when viewed through the laparoscope that was suspicious of a hematoma. Respondent removed the laparoscope and placed a Foley catheter in the bladder. Respondent then performed a laparotomy, entering the abdomen through a Pfannenstiel incision. There were numerous adhesions of the bowel to the anterior abdominal wall, and Respondent lysed them with sharp dissection. Respondent then discovered a retroperitoneal hematoma. Respondent applied pressure on this area, and a vascular surgeon was summoned. Although the medical records do not specify that pressure was applied with a wet pad, the Department’s expert and Respondent’s expert interpret the description in the medical records to show that Respondent applied direct pressure with a wet pad. Upon his arrival, Manuel Torres-Salich, M.D., a vascular surgeon, assumed responsibility for managing the patient. He noted that the systolic pressure was 60 MMHG, and he extended the Pfannenstiel incision to a long midline vertical incision. Upon entering the abdominal cavity, he noticed a massive amount of blood throughout the abdominal cavity. However, he did not quantify the amount of blood he observed. Dr. Torres-Salich attempted the surgical repair of the patient’s vascular injuries. He discovered a large anterior laceration of the right proximal common iliac artery at the bifurcation of the aorta and a laceration of the anterior wall of the iliac vein. During the course of the surgical repairs, the patient experienced cardiac arrest, and CPR was administered while the vascular surgical repairs continued. As Dr. Torres-Salich continued to repair the vascular injuries, the patient experienced further cardiac complications. Cardiac massage and CPR were performed. The patient did not respond and expired. No evidence was offered as to the medical equipment available at Columbia Surgical Park Center. Specifically, no evidence was offered as to whether vascular clamps were available for use by Respondent, and, if available, whether these were the type of clamps appropriate for controlling a vascular injury of the iliac artery or iliac vein by a gynecologist. Further, no evidence was offered as to the types of medical personnel available at Columbia Surgical Park Center to assist Respondent other than anesthesia personnel. The record in this cause is clear, however, that a vascular surgeon was not in attendance at Columbia Surgical Park Center during patient A. J.’s procedure but was summoned on an emergency basis. The vascular surgeon arrived within about 20 to 25 minutes after the vascular emergency was discovered. The vascular lacerations that occurred to the iliac artery and iliac vein were lacerations to two of the largest blood vessels in the body. There is no evidence that any improper technique by Respondent during the laparoscopic procedure caused the lacerations of the iliac artery and iliac vein. The exact cause of these lacerations is not known. However, there are three possible causes: from insertion of the Voorhees needle, from insertion of the trocar, or from dissection of adhesions. A gynecologist who experiences a significant vascular injury, such as a laceration of an iliac artery, is trained to abandon the laparoscopic approach immediately, make an incision via laparotomy, and place direct pressure right on the area with a hand or pack. Respondent handled the laparoscopic complication appropriately by performing a laparotomy and applying direct pressure to the retroperitoneal hematoma. Respondent also handled the laparoscopic complication appropriately by calling for the emergency assistance of a vascular surgeon. General gynecologists are not trained to repair vascular injuries, and the immediate objective of a gynecologist once a vascular injury is identified is to do one of two things: apply direct pressure to the area of the bleed or try to clamp the vessel. Visualization of the specific vessel causing the bleed is required to properly use a clamp. Visualization of the specific blood vessels causing this patient’s retroperitoneal hematoma would require Respondent to perform a retroperitoneal dissection, which general gynecologists are not trained to perform. The standard of care in such a situation is for the gynecologist to summon a vascular surgeon. Further, if a gynecologist is not able to identify the exact point of injury, then direct pressure to the hematoma is sufficient and within the standard of care. There is no evidence that Respondent ever attended a gynecologic oncology fellowship where a general gynecologist would get additional training to be able to perform a retroperitoneal dissection. Respondent did not deviate from the standard of care by failing to perform a retroperitoneal dissection to visualize the specific blood vessels causing the hematoma. Respondent did not deviate from the prevailing standard of care by failing to apply pressure above the injury to stop the bleeding. Respondent’s application of pressure at the site of the hematoma was proper. Respondent did not fail to adequately prepare for and deal with a known complication of laparoscopy. He complied with the standard of care by stopping the laparoscopic approach, performing a laparotomy, applying pressure to the bleeding site, and immediately calling a vascular surgeon.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding Respondent not guilty of the allegations contained in the Administrative Complaint and dismissing the Administrative Complaint filed against him in this cause. DONE AND ENTERED this 28th day of March, 2001, in Tallahassee, Leon County, Florida. LINDA M. RIGOT 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 28th day of March, 2001. COPIES FURNISHED: Kim M. Kluck, Esquire Agency for Health Care Administration 2727 Mahan Drive Building Three, Suite 3431 Post Office Box 14229 Tallahassee, Florida 32317-4229 Mark A. Dresnick, Esquire Sean M. Ellsworth, Esquire Dresnick, Ellsworth & Felder, P.A. SunTrust Plaza, Suite 701 201 Alhambra Circle Coral Gables, Florida 33134 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701
The Issue Whether Respondent violated Section 458.331(1)(t), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact At all times material to this proceeding, Dr. Ford was a licensed physician in the State of Florida. His license, numbered ME 0051042, was issued on July 8, 1987. Patient R.A.L, presented to the Emergency Department of Winter Haven Hospital (Hospital) at approximately 1:35 p.m. on October 9, 1997. R.A.L.'s initial chief complaint was right flank pain since 9:00 a.m. that day. He reported a history of vomiting and diarrhea and stated that it felt like a kidney stone, of which R.A.L. had a history. Right flank pain is common with a patient having a kidney stone or kidney problem. R.A.L. was initially examined by Dr. David Siegel about 30 minutes after R.A.L. came to the emergency room. On physical examination palpation, there was no flank pain, but R.A.L. did have moderate pain diffusely throughout all areas of his abdomen. His abdomen was not acutely distended, and there were normal bowel sounds. On Dr. Siegel's order R.A.L. was given Toradol intravenously at 2:22 p.m. to relieve the pain. Toradol is a non-steroidal anti-inflammatory drug. R.A.L. was also given fluids intravenously. R.A.L.'s symptoms did not provide Dr. Siegel with a definitive diagnosis. Dr. Siegel ordered the following tests to be performed: a complete blood count, an amylase, a urinalysis, a PTPDT, and X-rays of the abdomen. The complete blood count was done to make sure that the patient was not anemic and to see if there was an elevated white blood count, which would be indicative of some type of infection or acute abdominal process. The complete blood count showed a significantly elevated white blood cell count of 24.3. The test also revealed that there was a left shift of a differential, which means that there was a high differential percentage-wise of segmented and banded white blood cells. The combination of the significantly elevated white blood cell count and the left shift indicated that there was an acute infectious process or an acute illness. The amalyse test measures a serum enzyme that is secreted from the pancreas. If the serum enzyme is elevated, it could be indicative of pancreatitis. The amalyse test was normal. The urinalysis would show whether there was an infection and would show some abnormalities if there were a kidney stone. R.A.L.'s urine checked out normal. At 3:00 p.m. R.A.L. voided. His urine was strained, but there were no kidney stones present. R.A.L. did not have an adequate response to the Toradol. He was given Demerol intravenously at 3:10 p.m. Based on the test results, Dr. Siegel was unable to make a definitive diagnosis. Because of R.A.L.'s clinical condition and his continued pain, Dr. Siegel ordered an abdominal Computed Tomography (CT) scan to see if he could further define what was going on in R.A.L.'s abdomen. Because of the absence of flank pain, the elevated white blood cell count, and the normal urinalysis report, Dr. Siegel did not rule out the possibility of kidney stones, but did feel that some abdominal process of significance was higher on the list of possible diagnoses than kidney stones. Dr. Siegel went off duty at 5:30 p.m. and turned the care of R.A.L. over to Dr. Ronald Barbour. Dr. Siegel gave Dr. Barbour an oral report of his findings and indicated that he was primarily concerned about a serious intra-abdominal process. Before finishing his shift, Dr. Siegel dictated a written report, which was immediately transcribed and placed in R.A.L.'s chart. Dr. Siegel expected Dr. Barbour to get the results of the CT scan and determine whether the results would allow a diagnosis. When Dr. Barbour came on duty, he went to see R.A.L., who told Dr. Barbour that he was still having some pain. R.A.L. asked for something to relieve the pain, and Dr. Barbour ordered Demerol for him. Dr. Barbour received a call from the radiologist, who said that the CT scan was consistent with a small bowel obstruction. Dr. Barbour told R.A.L. that it appeared he had a bowel obstruction and that he would be admitted to the Hospital. It is the Hospital's policy to contact a patient's primary care physician when a patient is being admitted to the Hospital from the Emergency Department. Dr. Ford was R.A.L.'s primary care physician. Dr. Ford was called by an Emergency Department nurse. Dr. Barbour spoke with Dr. Ford and advised him that the CT scan showed a small bowel obstruction. Dr. Ford stated that he would admit R.A.L. No mention was made of a surgical consult during the conversation. Dr. Barbour did not call a surgeon for a consult because normally if the patient has a primary care physician, the primary care physician would choose the surgeon should a surgical consult be necessary. R.A.L. was admitted to the Hospital at approximately 8:45 p.m. At that point, the responsibility for the care and treatment of the patient shifted from Dr. Barbour to Dr. Ford. Dr. Ford gave admission orders to Lorina Duncan, a nurse in the Emergency Department. The orders included administering Demerol and Phenergan as needed and giving the patient a saline solution intravenously. Dr. Ford also ordered tests to be done the following morning. The nurse's notes do not indicate that Dr. Ford told her to order a surgical consult for the next morning. R.A.L. was given Demerol and Phenergan in the Emergency Department at 9:55 p.m. At 10:10 p.m. R.A.L. was signed out of the Emergency Department to the medical/surgical floor of the Street Building, which is known as Street One. When R.A.L. was admitted to the Hospital, his abdomen was not distended. By the time he was admitted to Street One, his abdomen was distended and firm, and he was complaining of abdominal pain and nausea. When he was placed in his bed, he positioned himself in a fetal position, which is indicative of being in pain. He had no bowel sounds. While the nurse was getting a medical history, R.A.L. was lethargic and would drift off in the middle of the admission questions. His breathing was shallow and rapid. It took the nurse over an hour to complete the admission assessment on R.A.L. after he had come to Street One. At 11:50 p.m., R.A.L. was complaining that his pain had increased throughout his stomach. He indicated that his nausea was better. R.A.L. requested a patient-control anesthetic (PCA), which allows the patient to administer a metered dose of pain medication to himself by pushing a button. Around midnight the nurse had the hospital operator page Dr. Ford. He returned the nurse's call. She told Dr. Ford that R.A.L.'s abdomen was distended and that he was lethargic. R.A.L. had had no pain medication administered since being admitted to Street One, and his next dose of pain medication was to be given at 1:00 a.m. The nurse told Dr. Ford that R.A.L. was complaining of pain and wanted to have a PCA. Dr. Ford gave an order for a Demerol PCA, which would allow a five-milligram dose every five minutes with a maximum of 150 milligrams in four hours. The nurse told Dr. Ford that R.A.L. had been complaining of nausea. Dr. Ford asked whether R.A.L. had vomited, and she advised the doctor that R.A.L. had not. They discussed the possible use of a naso-gastric (NG) tube, which extends from the nose down to the stomach. It is used to aspirate the contents of the stomach, which decreases nausea and distention. Dr. Ford did not order a NG tube. At 12:30 a.m., October 10, 1997, the Demerol PCA was started. At 4:30 a.m., R.A.L. was complaining of shortness of breath. His abdomen was more distended and firm. Dr. Ford was paged, and he gave orders for lab work to be done. At 4:45 a.m. R.A.L. went into distress and died. Dr. Ford arrived at the Hospital about 5:05 a.m. A small bowel obstruction is a condition characterized by the inability of gastrointestinal fluid and material to pass through the small bowel due to some sort of blockage. Symptoms include pain, nausea, vomiting and a change in or cessation of bowel sounds. Small bowel obstructions generally cause the bowels to become inflamed and swollen, which can lead to a cut off of the blood supply to the bowel and result in the rupture of the bowel. If the bowel ruptures, it is a very acute, life-threatening situation which must be treated rapidly. Small bowel obstructions are generally classified as a partial or simple obstruction, and a complete or strangulated obstruction. A strangulated small bowel obstruction means the vascular system has been compromised and the blood supply to a part of the bowel has been cut off. If the blood supply has been cut off, the bowel tissue will become gangrenous, then necrotic, and finally die. Surgery can alleviate the strangulation. Strangulated small bowel obstructions represent 20 to 40 percent of all small bowel obstructions. Post-operative adhesions, bands of scar tissue which form inside the abdomen, are the predominate cause of strangulated bowel obstructions. Severe and constant pain, as opposed to cramping, intermittent pain, can characterize a strangulated small bowel. A strangulated small bowel is a very serious condition. Diagnosis requires obtaining a careful history, recognition of previous operations, a "hands on" physical examination and diagnostic testing. With a small bowel obstruction, a patient’s condition can change rapidly, sometimes in a matter of hours. Because any change in the condition of the patient can indicate a significant problem, serial abdominal examinations are important. Early detection and evaluation of complications from small bowel obstructions are also important. In the case of R.A.L., the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances would have been for Dr. Ford to come to the Hospital and physically examine R.A.L. when the patient was admitted to the Hospital under his care and after Dr. Ford was called by the nurse around midnight, apprising him of R.A.L.’s condition. Dr. Ford did not come to the Hospital to examine from the time R.A.L. was admitted to the Hospital under his care to the time R.A.L. died. A strangulated bowel is a surgical emergency. If a physician fails to diagnose and treat a strangulated small bowel, the patient will likely die. The physician will normally consult a surgeon when the patient presents with a small bowel obstruction. In performing a surgical consult, the surgeon will make the determination of whether and when to perform surgery. The sooner the surgeon is involved, the less the chances of compromising the patient’s bowel or general physical condition. Calling a surgeon early in the course of treating a patient with a small bowel obstruction is the prudent thing to do. In the case of R.A.L., the level of care, skill, and treatment, which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, would have been for Dr. Ford to call for a surgical consult when R.A.L. was admitted to the Hospital under his care. Dr. Ford did not call for a surgical consult from the time R.A.L. was admitted to the Hospital under his care to the time R.A.L. died.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding that Ronald A. Ford, M.D. violated Section 458.331(1)(t), Florida Statutes, placing him on two years' probation, imposing an administrative fine of $5,000, and requiring him to take five hours of continuing medical education in the area of risk management and 16 hours of continuing medical education in the area of diagnosing and treating abdominal and gastrointestinal disorders. DONE AND ENTERED this 5th day of February, 2002, in Tallahassee, Leon County, Florida. ___________________________________ SUSAN B. KIRKLAND 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 5th day of February, 2002. COPIES FURNISHED: Robert C. Byerts, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 William B. Taylor, IV, Esquire McFarland, Ferguson & McMullen 400 North Tampa Street Suite 2300 Tampa, Florida 33620 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
