The Issue The matters presented for consideration in this action are related to an Administrative Complaint brought by the State of Florida, Department of Professional Regulation, against Dr. Lee, accusing him of having violated various provisions of Chapter 458, Florida Statutes, pertaining to his practice of medicine. The complaint accuses the Respondent of violating Section 458.331(1)(t), Florida Statutes, by gross or repeated malpractice or the failure to practice medicine with the level of care, skill and treatment which is recognized by reasonably prudent similar physician as being acceptable under similar conditions and circumstances, related to the treatment of several patients. Respondent is also accused of having failed to keep written medical records justifying the course of treatment for those patients in violation of Section 458.331(1)(n) , Florida Statutes.
Findings Of Fact William J. Lee, M.D., is a physician licensed to practice medicine in the State of Florida through a license issued by the State of Florida, Department of Professional Regulation, Board of Medical Examiners, License No. MEO12345. He has held that license at all times relevant to this case and in that time sequence has practiced general medicine and general surgery in Jacksonville Beach, Florida, in his office and at Jacksonville Beach's Hospital in that same community. Dr. Lee is 51 years old and is a graduate of Emory University in 1958, receiving his M.D. from Emory in 1964. He did an internship at the University of Florida in Gainesville, Florida, followed by a residency in general surgery at the University of Florida from 1965 through 1968 and completed his residency at Duval Medical Center in Jacksonville, Florida, in 1969. The Administrative Complaint, which is the subject of this hearing was filed on February 22, 1983. Proper service of the Administrative Complaint was effected upon the Respondent and Dr. Lee made a timely request for formal hearing pursuant to Section 120.57(1), Florida Statutes. THELMA A. PARKER From August 9 through 13, 1974, Thelma Parker was treated medically at Memorial Hospital of Jacksonville, Jacksonville, Florida, for acute diverticulitis. This treatment was provided by Dr. C. Cooksey. In particular, Dr. Cooksey's medical regime was NOP, IV fluids, and large doses of Fibramycin. A barium enema was done on the patient on August 10, 1974, and revealed diverticulosis of the sigmoid colon and one large acutely inflamed diverticulum of the mid-sigmoid level. This diverticulum was unusually long and Dr. Cooksey was of the impression that the diverticulum produced some edema of the bowel wall with low grade obstruction. Finally, Dr. Cooksey felt that at some point the diverticulum should be resected because of its size. In late August 1978, Ms. Parker, who had become a patient of the Respondent's, began to experience cramping, and diarrhea pain for which she took lomotil to slow down the bowel activity. This relieved her symptoms temporarily. Nevertheless, the symptoms persisted and on September 2, 1978, Ms. Parker went to the emergency room at Jacksonville Beach's Hospital, displaying the same type of pain and showing a mild distention. This pain was a generalized to and fro type of pain of cramping nature across the area of the abdomen. It was not localized. Dr. Lee admitted the patient to that hospital on that date. At that time, Dr. Lee was aware of the prior 1974 bout which the patient had with diverticulitis. Lee obtained an x-ray obstruction series and based upon this information felt that possible explanation was adynamic ileus versus early obstruction. He did not feel that the patient was suffering from diverticulitis in that there was no indication of lower left quadrant abdominal pain, bowel dysfunction such as constipation or obstipation and no indication of temperature elevation, indicators of diverticulitis. The symptoms she did display were not inconsistent with diverticulitis. At admission, the Respondent did note the past history of diverticulitis and the emergency room admission and hospital records indicated chronic lower quadrant abdominal pain and change in bowel habits and diarrhea, which are consistent with diverticulitis. Based upon examination of the patient, x-rays and associated materials, Respondent performed an exploratory laparotomy on September 4, 1978, for the purpose of relieving a small bowel obstruction. In the surgery, he found grossly dilated loops of the small bowel with obvious obstruction of the terminal ileum approximately 15 cm's proximal to the ibocacal valve. He found that area to be "firmly adherent to a mass of scar tissue in the sigmoid colon area of the pelvis with chronic low grade inflammatory reaction present in the region." The portion of the ileum that was involved in this was wound severely upon itself with the massive scar tissue in the area. Given the condition, he determined to resect that portion of the small bowel and effected a repair by anastomosis. No evidence was revealed in the course of the operation of any blockage of the large bowel, based upon his observations and manipulations. Gross examination was also made of the sigmoid colon and this revealed no dilation. No contrast studies were done to examine the lumen of the sigmoid colon, such as barium enema or colonscopy. Those studies would have ruled out diverticulitis in the area of the sigmoid colon. The post operative diagnosis by Dr. Lee was small bowel obstruction, secondary to diverticular disease and upon the discharge date of September 14, 1978, the diagnosis was 1) small bowel obstruction and 2) diverticular disease. The patient was seen in Dr. Lee's office on September 18, 1978 and had a fever and abdominal symptoms. She was told to see the doctor again on the next day and lacking improvement on that date was admitted to the hospital on September 19, 1978. At the time of admission on September 19, 1978, initial impression by Dr. Lee was that the patient was suffering intra-abdominal abcesses, secondary to anastomostic break or leakage in the area of the resection of the small bowel. The patient demonstrated a tenderness in the lower abdomen and had some nausea and vomiting. On rectal examination, the patient demonstrated a fluctuant area in the rectum, at the pelvic basin formed by the peritoneum. This area was determined to be an abscess and on September 26, 1978, Dr. Lee performed a procedure by going through the anus into this area of abscess and making an incision in the wall of the rectum to allow drainage of the abscess through the rectum. There was some improvement but the patient continued to have temperature elevation and abdominal pain and on October 2, 1978, further laparotocy was done and an anastonimotic break was discovered. Reanastomosis was achieved following a second resection in the area of the initial small bowel obstruction. Gross examination during the course of this surgery did not reveal any evident blockage of the large intestine or active diverticulitis. Again, no specific diagnostic work was done to determine the condition of the sigmoid colon related to diverticulitis. During the surgery, in addition to the revision of the ileostomy, abdominal abscesses were also evacuated. The patient was discharged on October 21, 1978. After her release in October 1978, the patient was seen on a number of occasions by the Respondent and indicated occasional episodes of cramping, diarrheal type stool but no localized pain in the left, lower quadrant, constipation or obstipation. The patient developed a ventral hernia in the area of the incision related to the abdominal surgery performed by the Respondent and on June 21, 1979, was admitted to the hospital to attend that condition. Exploratory laparotomy was dome on June 22, 1979 and the Respondent did further resectioning and reanastomosis in the area of the small bowel repair together with repair to the ventral incisional hernia. The large intestine in the area of the previous diverticular disease was examined and no indication, on gross examination, was given as to obstruction of the large bowel or any showing of acute inflammation in the area of the sigmoid colon suggesting diverticulitis. As was the case before, no specific examination of the sigmoid colon by a process of barium enema or otherwise was made at the time of this hospitalization. The patient was seen in the Respondent's office on July 3, 1979, and it was noted that her wound from the most recent operation was healing and that her appetite was good and bowel movements normal. A further visit of July 6, 1979, revealed a pink, serous drainage from the portion of the most recent incision and the abdomen was tender. Eventually, the patient had to be readmitted on July 23, 1979. Upon admission, it was believed that the patient was suffering intra-abdominal abscesses. She demonstrated temperature elevation and abdominal pain. The serous drainage from the incision had subsided. On this admission, particularly July 27, 1979, Dr. Lee did obtain a barium enema for purposes of examining the sigmoid colon and it showed a narrowed portion within the sigmoid colon with a communication to an abscess in the pelvis and from there a fistula to the small bowel at the site of the anastomosis. The abscess described was an abscess that had been addressed by Dr. Lee on September 26, 1978. This narrowing in the sigmoid colon was a partial obstruction, leaving an approximate functional capability of 10 percent. No dilation was observed in the bowel proximal to the area of partial obstruction and there was no distention. The narrowing was caused by the diverticular disease process. No evidence was found of an active condition of diverticulitis in the sigmoid colon. On July 30, 1979, a further surgical course was pursued by Dr. Lee and a segment of the small bowel in the area of the previous attempts at anastomosis was removed and a reanastomosis was done with a cleaning up of the previously described fistula tract and associated repairs. No attention was given to the narrowing of the sigmoid colon. On August 6, 1979, Dr. Lee opened and drained large abscesses in the abdominal wall and this was followed on August 9, 1979, with his notation of a small bowel fistula. On August 10, 1979, the patient requested consultation with another surgeon, Dr. James Corwin and was transferred to his care on August 12, 1979. Corwin advised the patient to have a loop colostomy to try and address continuing problems as described by prohibiting the sigmoid colon from contributing to those difficulties. This procedure was carried out by Dr. Corwin on August 17, 1979. Resection of the sigmoid colon was done by Dr. Corwin on September 17, 1979. (Pathology related to the sigmoid colon showed diverticulosis, indication of diverticular disease. It did not show active diverticulitis.) The patient accepted Dr. Corwin's suggestion that the colostomy and resection of the sigmoid colon were necessary, without hesitation. Respondent's suggestion by testimony or record that he had discussed with Ms. Parker the need to address her diverticular condition and possible resection of the sigmoid colon and her rejection of such diagnosis and treatment is not accepted. These discussions allegedly occurred between her release from the hospital in October 1978, and her hospitalization in June 1979. When examined in light of the facts found, specifically her willingness to submit to all other operations and procedures by Dr. Lee and to accept Corwin's treatment of the colon when suggested, Respondent is not to be believed on this subject. Ms. Parker failed to recover from the series of problems as discussed and died on October 28, 1979. The diverticular disease in the colon contributed to her demise and Dr. Lee failed to diagnose and treat that condition. Notwithstanding the fact that Ms. Parker did not take care of herself in terms of her physical condition, related to her drinking habits, Respondent was not relieved from the necessity to diagnosis and address the problem with the sigmoid colon. Dr. E. R. Woodward testified on behalf of the Petitioner, after being accepted as an expert in medicine with particular emphasis on general surgery. Dr. Woodward is a professor of surgery and former chairman of the Department of Surgery at the University of Florida, College of Medicine, and is a member of various boards, colleges and associations related to the practice of surgery and has written approximately 250 publications and authored two books in the field of general surgery. His testimony was based upon the review of hospital records related to Parker's various hospitalizations under the care of Dr. Lee that have been addressed. Dr. Woodward is of the opinion that the patient suffered diverticulitis in the sigmoid colon at times relevant to the inquiry and finds fault with Dr. Lee's failure to diagnose and treat this condition which Dr. Woodward felt was the underlying cause of the patient's problems pertaining to obstruction in the small bowel and associated anastomotic failures. Even without such diagnoistic procedures as barium enema or otherwise, Dr. Woodward feels that Dr. Lee recognized the diverticulitis of the colon in describing the chronic inflammatory reaction in the area of the sigmoid colon in his September 4, 1978, post operative report. Dr. Woodward revealed that in the September 19, 1978, admission that one of the x-rays showed air fluid levels in the right colon which is indirect evidence of a possible problem of an obstruction in the sigmoid colon. Moreover, given the fact that the intestines heal extremely well, according to Dr. Woodward, the problem with the anastomosis was possibly due to the fact that the lining of the intestine beyond the anastomosis was not open sufficiently and that there was some degree of obstruction as was revealed in the area of the sigmoid colon, which had been caused by chronic diverticulitis. By the time of the June 21, 1979, hospitalization, Dr. Woodward felt that the patient's condition was such that her recovery was not promising. Even in the face of information found after the July 27, 1979, barium enema, Dr. Lee did not address the difficulty with the narrowing in the colon by some process of diverting colostomy or other surgery of the colon. In Dr. Woodward's mind, this was necessary at the time of the September 4, 1978, surgery and continued to be a need at the time of the July 30, 1979, surgery. Risk of mortality increased from 2 percent to as high as 10 percent at the July 30, 1979, operation. Subsequent to that operation, the patient was so ill and the infection so severe that the mortality risk related to surgery was prohibitive, per Woodward. In summary, Woodward felt that the Respondent's failure to diagnose and treat the diverticular condition in the sigmoid colon led to her eventual demise and was such quality of treatment as to constitute gross or repeated malpractice and the failure to practice medicine with a level of care, skill and treatment which is recognized by reasonably prudent similar physicians as being acceptable under similar conditions or circumstances. Dr. Corwin, gave his expert opinion, as a general surgeon, after being accepted in that field. This is the same Dr. Corwin who treated Thelma Parker. Dr. Corwin feels that given a past history of diverticulitis, which the Respondent knew about and the condition which he found upon the original surgery performed in the abdomen, Respondent should have searched for the cause of that condition which most likely was the patient's diverticulitis. This opinion refers to the need for an examination by barium enema or some other form of contrast study to determine the condition of the sigmoid colon. The narrowing or obstruction in the area of the distal colon, as described, was felt by Dr. Corwin to be almost total in that the colon was reduced to an approximate 10 percent function. Corwin felt that the Respondent had made a major mistake in his treatment of the patient in not attempting to ascertain the cause of the abscesses and obstruction and to deal with the problem in the colon which he considered to be the underlying cause of her difficulties. According to Corwin, the quality of that mistake was so severe as to constitute gross mistreatment of the patient. He feels there was malpractice in that the problem in the colon was at least partially responsible for the anastomotic breaks. At minimum, Dr. Corwin felt that a diverting colostomy was necessary to address the problem with the colon and probably a resection of the sigmoid colon, which procedures were done by Corwin subsequent to assuming the case. Dr. Wiley Douglas Fowler, Jr., who is a board certified, general surgeon, practicing in the community where Respondent practices, gave testimony. He too felt that the Respondent had failed to deal with the condition in the sigmoid colon which he considered to be diverticulitis. There was a need to do a diverting colostomy and to do further definitive treatment as necessary to address the diverticular condition, per Fowler. He felt that there was a breakdown in surgical judgment to the point that the doctor was unable to perform the responsibilities of care in the case. Dr. Samuel Stephenson, who is a board certified general surgeon practicing in Jacksonville, Florida, testified. He did not find the quality of Dr. Lee's care to be-substandard related to the patient Parker. He placed emphasis on the fact that in his opinion gross signs such as dilation in the colon or large bowel were not observable and no active condition of diverticulitis was ever discovered during Parker's treatment course from the time of the Respondent's involvement to her demise. He did indicate that the barium enema results of July 27, 1983, might make one wonder if the narrowing in the sigmoid colon had caused some of the other recurring problems associated with anastomotic breaks in the small intestine. He indicated that by July 30, 1979, there might be a need for a colon resection. Stephenson was impressed with the fact that the patient died even after attempts to address the problems with the colon, i.e., the temporary colostomy and resection of the colon done by Dr. Corwin, leading him to wonder if the cause of continuing failure in the area of repair at the small bowel was due to some circumstance other than problems in the sigmoid colon. He believed that in the initial admission of September 1978, that there was a possibility of a problem with diverticulitis as well as the small bowel obstruction but no gross signs indicated an active condition of diverticulitis in the area of the colon, such as dilation. The mass that was discovered at the point of the initial laparotomy in September 1978, might have been from the colon or might not have been in the mind of Dr. Stephenson. The thrust of Dr. Stephenson's testimony seems to be that absent a clear indication that diverticulitis in the colon or the narrowing in the colon was the proximate cause of the anastomotic breaks and attendant processes of infection, there was no duty on Dr. Lee's part to rule out the possible involvement of the sigmoid colon as an explanation for the problems with the healing process in this patient. Upon reflection, the impressions gained by Drs. Woodward, Corwin and Fowler, witnesses for the Petitioner, are more compelling than those of Dr. Stephenson, on the subject of culpability by the Respondent related to the patient's care. Evidence reported establishes that the Respondent should have examined the colon by barium enema or some similar process at the point of the initial surgery and certainly before her final admission in July 1979, and when finally so examined the colon was not treated. This failure is excerbated by the fact that the Respondent knew that the patient had a history of diverticulitis. The diverticular condition in the colon, to include the partial obstruction by narrowing, based upon the opinions of the third party experts, is found to have been a contributor to the continuing problems of anastomotic leakages, abscesses and other conditions which would not allow a successful treatment course for the patient. Even if diverticulitis in the colon or the diverticular condition in that organ did not cause failure in her treatment results, per the physicians, whose opinion is accepted, the circumstance in the colon should have been examined and ruled out at a minimum. The idea expressed by Dr. Stephenson, that in the absence of being able to clearly establish that the colon's condition caused the patient's demise, the Respondent may not be held accountable, is unacceptable. Having determined that the diagnosis should have been made, Respondent should have performed the diverting colostomy to be followed by a resection of the colon if necessary, again in keeping with the opinions of Petitioner's experts. Finally, the opinion related to Respondent's malpractice and failure to perform at an acceptable standard for same or similar physicians, as attributed to Dr. Woodward and supported in concept by Dr. Corwin, is accepted. Respondent is accused of having failed to keep adequate medical records pertaining to the patient Parker. Although there was some demonstrated ambiguity in his record keeping, that ambiguity does not rise to the level of finding facts showing a violation related to record keeping on this patient. JOHN WILLIAM PHILLIPS On July 2, 1979, John William Phillips had an accident in which he fell off of a ladder and came to the emergency room at Beach's Hospital for treatment. An admission was made on July 3, 1979, and Dr. Lee undertook the care of the patient. The patient suffered multiple fractures of the ribs, had a contusion of the left shoulder, was demonstrating slight tenderness in the left flank and evidenced a large swollen and contused area in the left chest wall posterior with tenderness. He showed a normal abdomen with bowel signs present but hypo-active. The patient suffered nausea, abdominal distention and tachycardia. From admission through July 12, 1979, the patient waxed and waned. He received fluids and pain medication and a series of x-rays were taken to better understand his condition. On July 12, 1979, a liver scan was made which demonstrated a cold area in the left lobe of the liver, leaving Dr. Lee in the position of ruling out hemotoma versus tumor versus cyst, though he believed the condition to be benign and unrelated to the accident. The cold spot on the x- ray appeared as a smooth contoured defect. The patient continued to show distention following the liver scan and continued to evidence tachycardia and vomiting for the next several days. Respondent did not choose to verify his preliminary clinical impression of the condition of the liver related to the defect, by use of sonogram or angiogram, electing instead to wait for the patient's condition to change for better or worse. On July 15, the patient showed marked increase in temperature. On that date, a chest x-ray demonstrated plate-like atelectasis in the right lung and an elevated diaphragm. With the advent of the temperature elevation on July 15, the patient was transferred to the CCU unit of the hospital and among other matters prescribed, a broad spectrum antibiotic was ordered. The patient was showing an elevated blood count at that time. Following the liver scan, the patient had also developed rapid pulse and shown mental confusion. By the morning of July 15, the patient's condition was one approaching septic shock if not in that condition. Clinically, there was indication of sepsis or septicemia. The family of the patient requested a second opinion and the patient was subsequently transferred to Dr. Corwin. Dr. Woodward gave his opinion about the treatment of Phillips, expressing the belief that the problems evidenced related to this patient were too long and severe and too related to an abdominal condition to be associated solely with the injury in the chest. Given the location of the injury, Dr. Woodward felt like the defect in the liver, seen on the scan, may have been related to the injury. Dr. Woodward felt that the Respondent should have established whether or not the lesion in the liver was caused by the accident, either by exploratory laparotomy or selective arteriogram. To do otherwise would be less than expected of a prudent general surgeon, according to Dr. Woodward. In essence, Dr. Woodward felt that something should have been done to verify the character of the defect shown on the liver scan and whether that defect was associated with injury suffered by the patient. Dr. Corwin testified about the treatment afforded Phillips. He felt that at the time that he took over the case on July 15, that the quality of the septicemia suffered by the patient was such that he was in septic shock and that an operation was necessary to address the defect in the liver. An operation was undertaken to remove that defect and when first visualized, Dr. Corwin was not sure whether the defect was a cystic hemangioma or not, although it gave an appearance of being that condition. (At the time of the liver scan, given the location of the liver defect, Corwin felt that most probable explanation was hematoma or tear in the left lobe of liver, cystic hemangioma being a rare occurrence in liver.) After removal of this cyst, the patient began to improve and Dr. Corwin believes that the removal of the cyst contributed to that improvement. He thinks that the area of the cyst became a seed bed for the septicemia in the sense of aiding in the circulation of bacteria in the patient's system. Dr. Corwin had criticism of Dr. Lee in the treatment of Mr. Phillips in the sense that once the patient's condition began to decline, approaching the place and time at which Corwin was substituted as the physician, Dr. Lee should have done more to determine the true nature of the patient's problem. He does not feel that the Respondent's treatment can be described as malpractice. He is simply of the opinion that the case was not handled very well and showed poor judgment by the treating physician. Dr. Fowler testified about the care of the patient Phillips after examining the records of hospitalization. He indicated that given the deteriorating condition of the patient, that there was an indecisive action pattern on the part of Dr. Lee but it was not of such proportions as to constitute a breakdown in the care of the patient. He had no specific opinion as to whether this conduct by Dr. Lee constituted gross or repeated malpractice. Stephenson's opinion of the Respondent's treatment of Phillips was to the effect that it was not substandard. Given the appearance of the cold spot on the liver scan, he felt certain that this was a cyst or hemangioma and not a hematoma. He indicated that uncertainty in this regard could have been confirmed by a sonogram. He did not find the necessity to conduct surgery to discover the condition of the liver. Having considered the facts of the treatment of Phillips and the opinions of the experts, while the Respondent's reactions to Mr. Phillips' condition were less than sterling, they did not reach the level of constituting gross or repeated malpractice or care unworthy of a same or similar physician. Again, the records kept by the Respondent related to the care of Mr. Phillips were sufficient. CLIFTON WORCESTER On January 31, 1977, Respondent conducted surgery on Clifton Worcester to patch a perforated duodenal ulcer. Worcester had further hospital admissions on June 21, 1978 and August 1, 1978, for recurrent ulcer symptoms. On these occasions he was treated medically. On December 27, 1978 through January 4, 1979, the patient was admitted for the treatment of pneumonia. On September 6, 1979, Worcester was admitted to the hospital under the Respondent's care for conditions which preliminarily seemed to be related to respiratory and cardiac problems. At that time, the patient was 74 years old and was in a deteriorated condition suffering from a variety of maladies to include cardiac and respiratory conditions as well as the peptic ulcer disease. On September 9, 1979, Respondent after diagnosis determined that the patient was suffering from ulcer disease and an operation was done to repair the perforated pyloric ulcer. A Graham closure was used with omental patch and permanent silk sutures were employed. This ulcer was the same ulcer as had caused problems for the patient in 1977. On the morning of September 12, 1979, blood was visualized from the nasogastric tube which had been placed in the patient and when the patient was later irrigated, a large amount of blood appeared. The initial impression by Dr. Lee was that this blood was either due to the active peptic ulcer or possibly gastritis. To ascertain the source of bleeding, Dr. Corwin was called in to do a gastroscopy. That procedure was done around 7:00 pm. on September 12, 1979. Although the entire area of the stomach could not be visualized, Dr. Corwin was of the impression that the cause of the bleeding was not gastritis, leaving the most probable explanation to be that the patient had a problem of a bleeding ulcer. Dr. Corwin made it known to the Respondent that the bleeding was probably due to an ulcer as explanation for the lesion and Dr. Lee acknowledged that the probable source of bleeding was an ulcer condition. In the early morning hours of September 13, 1979, Dr. Lee again operated on the patient, envisualized the prior pyloric ulcer and was satisfied that the sutures in that ulcer were holding fast. He also discovered a gastric ulcer. The gastric ulcer measured approximately 8 centimeters in diameter. The gastric ulcer was shallow in its depth. There was present in the patient 1200-1500 cc's of old blood and a clot in the duodenum. No active bleeding was seen at that time and no major vessels were present in the ulcer beds. Dr. Lee waited 15 to 20 minutes to see if any active bleeding would occur and failing such appearance, he placed a tube gastrostomy. After cleaning out the blood and placing the gastrostomy tube, the patient was closed. No direct attention was given to the ulcers either in the oversewing of the ulcers or by more definitive surgery addressing both ulcer beds. The reason given for not conducting some form of definitive surgery was to the effect, according to Dr. Lee, that he was worried that the patient would not survive the time it would take to conclude such surgery. The surgery that was done took two hours and twenty minutes to achieve. On reflection, Dr. Lee believes that he should have at least sutured the gastric ulcer by oversewing it like a baseball, being unable to identify a bleeding point. This is in opposition to what he did which was to hope that the patient would not rebleed after the operation of September 13, 1979. That hope was not realized because on September 15, 1979, the patient again experienced massive bleeding between 2:00 and 4:00 p.m. Dr. Lee had tried to treat the ulcers with Tagamet and irrigation through the gastrostomy tube. On September 16, 1979, Respondent operated and performed a vagotomy and antrectomy related to the pyloric and gastric ulcers. At that time, the patient was not better able to tolerate that operation than he would have been on September 13, 1979. In fact, between those two operations, he lost a considerable amount of blood, further weakening his resistance. In view of the relative condition of the patient, that is to say, generally poor health, the effects of the bleeding ulcers and associated insult caused by the surgeries, the patient died on September 27, 1979. Among the problems experienced by the patient, in the waning days of his life, were an anastomotic leak and peritonitis. Dr. Woodward, after review of the patient's hospital records, was of the opinion that the bleeding experienced by the patient on September 13, 1979, was from one of the ulcers and not because of gastritis. This belief is held notwithstanding the failure of the ulcers to bleed in the course of the operation on September 13, 1979. Bleeding sometimes subsides during surgery. Given the patient's circumstance related to bleeding ulcers, the least acceptable approach by the treating physician would have been to oversew and/or excise the ulcer craters. The excision would relate to the gastric ulcer. In addition, if possible, Respondent should have done a vagotomy and antrectomy or vagotomy and pyloroplasty during the September 13, 1979, surgery. Alternatively, the ulcers could have been treated medically after oversewing or excision. Use of Tagamet and irrigation would not stop the ulcers from bleeding, in Woodward's opinion. Woodward felt that a patient such as Worcester, who was in distress during the course of the operation, and had lost a great volume of blood, was a patient in greater need of the aforementioned procedures than the average patient, based upon the patient's inability to tolerate additional blood loss if the ulcer started to rebleed after he had been sewn up. At the time of the September 13, 1979, operation, there was evidence that the patient was in shock, which might cause the surgeon to stabilize the patient before conducting the minimum procedures identified, according to Dr. Woodward, but this would not cause the closure of the patient without addressing the bleeding ulcer or ulcers. The shock in Woodward's opinion was due to blood loss. In summary, in Dr. Woodward's mind, to visualize the ulcers on September 13, 1979, having recognized that they were the source of bleeding and to do nothing to stem that bleeding, was unacceptable Performance by the surgeon. Per Woodward, the procedures of September 16, 1979, a vagotomy and antrectomy, were correct but too late. The risk of mortality on September 13, 1979, as opposed to September 16, 1979, was 10 to 20 percent versus a prohibitive chance for recovery. Dr. Woodward found the treatment of Clifton Worcester to be clearly substandard in the face of the requirement to practice medicine with the level of care, skill and treatment which is recognized by reasonably prudent similar physician as being unacceptable under similar conditions and circumstances. Dr. Woodward's opinions as stated herein are accepted with the exception that pyloroplasty was not an appropriate choice given the location of the pyloric ulcer. Antrectomy would have been the substitute choice. Dr. Corwin, with the knowledge that Dr. Lee had been informed of the results of the gastroscope indicating that the source of bleeding on September 13, 1979, was probably an ulcer, felt that the Respondent, when he opened the patient on September 13, 1979, even though the ulcers were not bleeding, should have dealt with those ulcers to prohibit rebleeding, as opposed to cleaning out the ulcer beds and closing the patient. The minimum response would have been oversewing the ulcers with nonabsorbable sutures, and the aging condition of the patient should not have deterred Dr. Lee in that task. When asked if Dr. Woodward had performed the level of care, skill and treatment which is recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances, Corwin was of the opinion that the patient had received very poor treatment and that most any physician practicing as a surgeon would have done differently. Corwin did not think there was any value to the irrigation of blood within the stomach and the treatment of the ulcers by Tagamet through the gastrostomy tube. The treatment of the patient in failing to correct the bleeding constituted gross malpractice according to Dr. Corwin. The opinions of Corwin are accepted. Dr. Fowler also believed that to simply open the patient on September 13, 1979, and close without treating the bleeding ulcer in the sense of definitive suturing was unacceptable. While the antrectomy and vagotomy were recognized as appropriate responses, in terms of surgical technique, Dr. Fowler felt that in the sense of appropriate judgment, those procedures came too late, having followed another bleeding episode after. the September 13, 1979, surgery. According to Dr. Fowler, when asked the question about whether this conduct by Dr. Lee in his September 13, 1979, operation in his treatment of Worcester was at the level of care, skill and treatment which is recognized by reasonably prudent, similar health care providers as being acceptable under similar conditions and circumstances, he was of the opinion that the breakdown in surgical judgment was to the point that the doctor was unable to fully perform the full responsibilities of care in the case. Dr. Fowler's opinions are also accepted. Dr. Stephenson felt that the choices made on September 13, 1979, to close the patient and treat with Tagament and to irrigate were appropriate. He felt that the source of the bleeding might have been gastritis but was most likely from the ulcers. To him, conservative treatment of the patient in not further addressing the ulcers was acceptable given the condition of the patient. Had the patient been in better health, Dr. Stephenson said he might have taken a chance in addressing the ulcers. He felt that when you cannot visualize the source of the bleeding oversewing isn't particularly helpful because you don't know whether anything is achieved. Given this patient's condition, he felt that the chances were one in three that the patient would not rebleed. Dr. Stephenson's opinion as to the acceptability of the Respondent's conduct at the time of the surgery of September 13, 1979, is not accepted. Even this physician recognized that the patient's source of bleeding was most likely the ulcer beds and that there was a great likelihood that he would rebleed and this considered together with the fact of the tremendous amount of blood that the patient had already lost prior to the September 13, 1979, surgery causes a rejection of the opinion of this physician about Respondent's performance. The related charge of failure to keep written medical records justifying the course of treatment of patient Worcester has not been shown. There is ample information to gain an understanding of the patient's condition, as evidenced by the ability of the experts to give opinion testimony.
The Issue Whether osteochondral autograft transplant surgery should be authorized for Petitioner pursuant to Workers' Compensation Law.
Findings Of Fact In 1998, Jackson fell at work and sustained an injury to her left knee. Jackson made a workers' compensation claim for the treatment of the injuries. She underwent treatment for her injuries, and her treating physician requested authorization from Jackson's Employer/Carrier to perform a surgical procedure commonly referred to by the trade name of OATS, but also known as mosaicplasty. The Employer/Carrier denied the authorization on the ground that OATS was investigative or experimental within the meaning of Rule 59B-11.002, Florida Administrative Code, and referred the request to the Agency for a determination under Section 440.13(1)(m), Florida Statutes, and Rule 59B-11.002(4), Florida Administrative Code. The Agency requested Dr. B. Hudson Berrey, the Chair of the Department of Orthopedics and Rehabilitation at Shands Hospital and Clinic at the University of Florida, to review Jackson's case to determine whether the procedure was investigative and whether the procedure would provide significant benefits to the recovery and well-being of Jackson. Dr. Berrey has been board certified in orthopedic surgery since 1982. After three years of practice, he took a fellowship in orthopedic oncology at Massachusetts General Hospital in Boston, Massachusetts. He then served as Chief of Orthopedic Oncology and, later, as Chief of Orthopedic Surgery at Walter Reed Army Medical Center in Washington, D. C. After his retirement in 1993, he served on the faculty of the University of Texas Southwestern Medical Center. He has been the Chair of the Department of Orthopedics and Rehabilitation at the University of Florida College of Medicine since 1996. In addition to his teaching duties, he continues to see patients weekly and to perform orthopedic surgery twice a week. His duties require him to keep abreast of developments in the field of orthopedic surgery. In preparation for rendering his opinion for the Agency, Dr. Berrey reviewed the medical literature, seeking articles discussing clinical trials of OATS. A clinical trial is an investigation in which patients with a certain condition may receive a treatment under study if they meet certain objective standards for inclusion. The treatment parameters are defined and outcomes are assessed according to objective criteria. Dr. Berrey found very little in peer-reviewed literature discussing clinical trials of OATS or mosiacplasty. Instead he found retrospective reviews and case reports. Based on his review of the medical literature, Dr. Berrey formed the opinion that mosaicplasty may be safe and efficacious; however, because the procedure has not been subjected to clinical trials, the procedure remains investigative. OATS involves the transfer of a patient's cartilage from one portion of the knee that is not considered weight- bearing or that is considered as having a minimal weight-bearing load to an area that receives greater force or is more weight- bearing. Dr. Berrey is of the opinion that OATS may be effective to treat isolated chondral defects on the weight- bearing surface of the knee. He describes the type of injury for which the procedure is effective as a focal lesion in an otherwise normal knee. Three components comprise the knee: the patella, the femoral articulating surface, or femoral condyle, and the tibial articulating surface or tibial plateau. The femoral condyle and tibial plateau are bony structures lined with articular cartilage that provide the gliding surface of the knee. The patella articulates with the femur at the patellar femoral joint, and the tibia articulates with the femur at the tibial femoral joint. The tibial femoral joint is made up of medial and lateral components. Other structures present in and about the knee include the menisici, the cruciate ligaments, and the collateral ligaments. Jackson's medical records, including the MRI report, show that there is a subchondral cyst and/or osteochondral defect on the anterior articular margin of the mid-media femoral condyle. There are subchondral cysts along the posterior portion of the mid-tibial plateau. In addition, there is a prominent osteochondral defect involving the patella. Jackson has articular damage to all three compartments of the knee: the femoral condyle, the patella, and the tibial plateau. Based on the degenerative changes in all three compartments of the knee, Jackson's changes are probably generalized. She does not have a focal defect of the articular cartilage of the knee. Her symptoms relate primarily to the patellar femoral joint. Her medical records describe her injuries as including chondromalacia of the patella. The term "chondromalacia" applies to a continuum of deterioration of the articular cartilage of the patella, from softening to frank fraying to fibrillation where the cartilage may be worn down to the bare bone. OATS or mosiacplasty is designed to address a localized, focal lesion. Because of the generalized nature of the diseased condition of Jackson's knee and the probability that her symptoms are related to the deterioration of her patellar femoral joint, the proposed procedure is not likely to improve her condition or to enable her to return to work.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered denying authorization for the OATS or mosaicplasty to be performed on Virginia Jackson. DONE AND ENTERED this 14th day of June, 2000, 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 14th day of June, 2000. COPIES FURNISHED: Michelle L. Oxman, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Building 3, Suite 3421 Tallahassee, Florida 32308-5403 Virginia Jackson 5555 Northwest 17th Avenue Apartment 2 Miami, Florida 33142 Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403 Julie Gallagher, General Counsel Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308-5403
The Issue The issue in this case is whether Petitioner is entitled to an award of attorneys' fees and costs pursuant to Section 57.111, Florida Statutes, and Rule 60Q-2.035, Florida Administrative Code.
Findings Of Fact Based upon the record in this proceeding, the following findings of fact are made: At all times pertinent to this proceeding, Petitioner, Jules G. Minkes, was licensed as an osteopathic physician in the State of Florida having been issued license number 0S001516. For purposes of this proceeding, there is no dispute that Dr. Minkes qualifies as a small business party as defined in the FEAJA. In approximately May of 1988, the Department of Insurance notified the Department of Professional Regulation of a closed claim regarding Dr. Minkes. 2/ Specifically, the notice advised that an indemnity had been paid on behalf of Dr. Minkes to a patient T. G. (the "Patient") in the amount of $150,000 in settlement of a claim that Dr. Minkes had allegedly failed to diagnose and treat the Patient's basal cell carcinoma. The Department assigned an investigator to the case who notified Dr. Minkes of the investigation by letter dated June 26, 1988. The investigator interviewed Dr. Minkes and Dr. Munzer, a dermatologist who treated the Patient upon Dr. Minkes' referral. The Investigator also obtained the Patient's medical records from Dr. Minkes and several other physicians who treated her. From the outset of the Investigation, Dr. Minkes' maintained that the Patient had lied in connection with her claim. The investigator did not interview the Patient nor her husband, nor did the Investigator contact any of the individuals identified by Dr. Minkes as having knowledge of the case. The notes of the Investigator's interview with Dr. Minkes and the Patient's medical records were sent to an osteopathic physician with similar credentials to Dr. Minkes, a specialist in internal medicine. Joseph H. Rosin, D. O., was the expert retained by the Department to review Dr. Minkes' treatment of the Patient. In a report dated January 18, 1989, Dr. Rosin opined that Dr. Minkes' care of the Patient did not meet community standards. In particular, the Report noted that the Patient had a clear history of invasive basal cell carcinoma and Dr. Minkes failed to provide adequate treatment when it was known to have reoccurred. Dr. Rosin stated that it was not the standard of care in the community for an internist such as Dr. Minkes to treat extensive basal cell carcinoma, that surgical intervention and proper follow-up care by a dermatologist was necessary and the Patient's locally invasive carcinoma, which had been confirmed by a biopsy performed by Petitioner, should have been treated in a more timely and appropriate manner. After the consultant's report was obtained, the investigative file was completed and sent to Tallahassee for review by the investigator's supervisors in Tallahassee. The complete investigative report was reviewed and approved by the investigator's supervisor on January 31, 1989. On June 7, 1989, the Department's investigative file was forwarded to members of the Probable Cause Panel (the "Panel") of the Board along with a copy of the Department's recommendation to find probable cause and a copy of a proposed Administrative Complaint. The Panel, consisting of one lay member from the Board who was serving as chairman of the Panel and a licensed osteopathic physician, met on June 16, 1989. Both members acknowledged that they had received the materials sent to them and had reviewed the materials prior to the meeting. An assistant attorney general was present to answer any questions concerning the Panel's duties and/or the proper interpretation of the applicable laws or rules. A prosecuting attorney for the Board was also present to discuss the Department's recommendation to file an Administrative Complaint. The transcript of the June 16, 1989 Panel meeting reflects little discussion of the case. The Panel members concurred with the Department's recommendation and authorized the filing of the Administrative Complaint against Dr. Minkes. The Department filed the Administrative Complaint against Dr. Minkes' license to practice osteopathic medicine on or about June 20, 1989. That Administrative Complaint included three charges. Count I charged Dr. Minkes with violating Section 459.015(1)(r), Florida Statutes, as a result of his alleged failure to refer the Patient to a specialist for adequate treatment of her basal cell carcinoma, thus exploiting her for his own financial gain. Count II charged Dr. Minkes with violating Section 459.015(1)(p), Florida Statutes, by failing to keep medical records justifying his course of treatment of the Patient. Count III charged Dr. Minkes with violating Section 459.015(1)(y), Florida Statutes, by failing to practice osteopathic medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances. Although the allegations in the Administrative Complaint are somewhat vague and ambiguous, it arguably charges Dr. Minkes with malpractice because he failed to refer the Patient for proper treatment of her basal cell carcinoma, he attempted to treat the Patient's growing recurring basal cell carcinoma himself even though it was a condition which the Administrative Complaint alleges should have been treated by a specialist in that area of medicine, and he ignored the Patient's basal cell carcinoma. Most of the allegations contained in the Administrative Complaint were consistent with and apparently based upon the allegations made in the civil complaint filed by the Patient and her husband against Dr. Minkes. A copy of the civil complaint was contained in the Department's Investigative File. (It was the settlement of that civil law suit which prompted the investigation by the Department.) The charge that Dr. Minkes had not referred the Patient to a specialist for treatment was also supported by the Department investigator's conversation with Dr. Munzer, whom Dr. Minkes had identified as the specialist to whom he had referred the Patient. A formal administrative hearing was held before the undersigned Hearing Officer pursuant to Section 120.57(1), Florida Statutes. Following the conclusion of that hearing, a Recommended Order was issued on December 13, 1990, recommending the dismissal of Count I, but recommending that a Final Order be entered finding Petitioner guilty of Counts II and III. As noted above, the Department's investigative file does not include any interviews with the Patient or her husband to confirm the allegations that were made in the civil law suit. However, the Department presented the testimony of the Patient's husband during the hearing in the Underlying Proceeding and, in addition, the previously transcribed testimony of the Patient was also accepted into evidence. (The Patient had died of unrelated causes prior to the hearing in the Underlying Proceeding.) As noted in Finding of Fact 35 of the Recommended Order, both the Patient and her husband testified that Dr. Minkes advised them that he could treat the Patient's basal cell carcinoma and that he in fact attempted to do so. If this testimony had been accepted as credible, it would have been sufficient when considered with the other evidence presented, to establish that Dr. Minkes was guilty of all of the allegations contained in the Administrative Complaint. However, after considering all of the evidence, that testimony was specifically rejected. Notwithstanding the conclusion that Dr. Minkes did not attempt to treat the Patient's basal cell carcinoma himself as alleged in the Administrative Complaint, the Recommended Order concluded that certain violations had been established. As set forth in paragraphs 8 through 13 of the Conclusions of Law, the undersigned Hearing Officer concluded that Dr. Minkes' records regarding the Patient were deficient and that his treatment fell below the standard of care expected of a reasonably prudent physician under similar conditions and circumstances. Dr. Minkes filed exceptions to the Recommended Order arguing that the factual grounds for the violations found in the Recommended Order were not specifically alleged in the Administrative Complaint. The Board apparently agreed with this contention since, in its Final Order, the Board adopted all of the Findings of Fact in the Recommended Order, but dismissed the charges in the Administrative Complaint. Some of the charges in the Administrative Complaint presume that Dr. Minkes attempted to treat the Patient's basal cell carcinoma. In particular, the Administrative Complaint refers to several instances when Dr. Minkes hyfercated lesions on the Patient's forehead. The Administrative Complaint suggests that these instances were improper attempts to treat the Patient's basal cell carcinoma. The evidence presented at the hearing was insufficient to overcome Dr. Minkes contention that his clinical observations justified his conclusions that these lesions were keratotic and not related to the Patient's basal cell carcinoma. This testimony by Dr. Minkes and the rejection of the testimony of the Patient and her husband on this matter undermined some of the fundamental presumptions in the Administrative Complaint. Nonetheless, the undersigned Hearing Officer concluded that the evidence was still sufficient to establish violations of the statutory provisions cited in Counts II and III of the Administrative Complaint. The Board's apparent determination that the violations found in the Recommended Order were not adequately alleged in the Administrative Complaint does not obviate the conclusion that violations of the charged statutes were found to have in fact occurred. Dr. Minkes complains that the consultant's opinion which led to the Panel's finding of probable cause indicates that Dr. Minkes did not refer the Patient to a specialist for treatment when, in fact, such a referral was made to Dr. Munzer. This matter was recognized in Findings of Fact 67 of the Recommended Order. As noted in that Finding, the consultant subsequently acknowledged the referral to Dr. Munzer and amended his opinion. The consultant still felt that Dr. Minkes failed to meet the applicable standard of care because he failed to take adequate steps to insure that the Patient's basal cell carcinoma was treated. It should be noted that there are many unresolved questions regarding the scope of Dr. Minkes' referral to Dr. Munzer. Dr. Munzer's statement to the Department's investigator and his deposition testimony offered into evidence during the Underlying Proceeding regarding his treatment of the Patient differed greatly from Dr. Minkes' version of the referral. Dr. Munzer claimed that he did nothing more than evaluate the Patient's biopsy. He claimed that he told Dr. Minkes that the Patient needed chemosurgery, but Dr. Minkes continued to treat her. Dr. Munzer disclaimed any responsibility for treating the Patient's basal cell carcinoma and states that he would not have agreed to treat her condition because he was not qualified to do so. In determining whether probable cause existed to file the Administrative Complaint, the Panel was not required to, and did not attempt to, reconcile this discrepancy between Dr. Minkes and Dr. Munzer. Dr. Minkes also points out that Dr. Tytler, whose opinion was not available at the time the Administrative Complaint was filed but whose subsequent deposition was accepted into evidence at the final hearing, testified that there was no indication in the Patient's medical records that Dr. Minkes ever treated or attempted to treat the Patient's basal cell carcinoma as alleged in the Administrative Complaint. However, Dr. Tytler did testify that Dr. Minkes' treatment of the Patient did not meet community standards in certain respects. Without question, there were some gaps and/or oversights in the Department's investigation. In retrospect, the Department perhaps should have recognized the possibility that the Patient's version of events might not be accepted in its entirety in which case the Administrative Complaint could have been drafted in a manner that would have minimized the impact of such a conclusion. Notwithstanding these deficiencies, there was sufficient evidence for the Panel to conclude that the Patient had received substandard care. Even if the Patient's own decisions contributed to the delay in treating her basal cell carcinoma, there was clearly a lack of understanding and/or miscommunication between Dr. Minkes and Dr. Munzer as to how the Patient was to be treated. While there were conflicting versions as to who was responsible for this breakdown in communication, there was some evidence considered by the Panel which would reasonably indicate that the violations alleged had indeed occurred. After considering all of the circumstances, it is concluded that the Department was substantially justified in filing the Administrative Complaint.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is ORDERED that Dr. Minkes' Petition for Attorney's Fees and Costs is DENIED. DONE AND ENTERED this 27th day of February 1995 in Tallahassee, Leon County, Florida. J. STEPHEN MENTON 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 27th day of February 1995.
The Issue Whether Respondent, Steven A. Magilen, M.D., violated Sections 458.331(1)(m) and (t), Florida Statutes, as alleged in an Administrative Complaint signed April 2, 2001, and filed with the Department of Health on April 3, 2001, and, if so, the penalty that should be imposed.
Findings Of Fact The Department of Health, Board of Medicine, is the state agency charged with regulating the practice of medicine in Florida. Section 20.43; Chapters 456 and 458, Florida Statutes. Steven A. Magilen, M.D., is, and was at the times material to this proceeding, a physician licensed to practice medicine in Florida, having been issued license number ME 002082. Dr. Magilen received his medical degree from the University of Brussels in Belgium in June 1972. He received his license to practice medicine in Florida in 1973 and completed a residency in general surgery at Mount Sinai Medical Center, Miami, Florida, in June 1976. He has maintained a private practice in Florida since 1976. Dr. Magilen is board certified in general surgery. His general surgical practice focuses on colorectal surgery and proctology. He is experienced in the use of colonoscopy, having performed an average of between 250 and 300 colonoscopies per year since approximately 1979. Dr. Magilen's address is 21150 Biscayne Boulevard, Suite 400, Aventura, Florida 33180. Dr. Magilen has not previously been the subject of a disciplinary proceeding.1 D. M., a female, was initially seen by Eugene Eisman, M.D.,2 an internist, who has continued to see D. M. for at least the past ten years. As early as 1991, D. M. related a five-year history of intermittent abdominal pain. D. M. was referred by Dr. Eisman to Dr. Magilen in June 1995,3 complaining of years of constipation, which she indicated was becoming worse. She also complained of rectal bleeding. D. M. was in her mid-60's in 1995. Rectal bleeding is one of the most common problems seen by Dr. Magilen, who sees primarily older patients. Rectal bleeding can be caused by colonic (relating to the colon) disorders or anal disorders. The typical anal disorder found in adults which results in bleeding is hemorrhoids. Colonic disorders which cause rectal bleeding include polyps, colon carcinoma (cancer), inflammatory bowel disease, ulcerative colitis, Crohn's Disease, diverticulosis, diverticulitis, and appendicitis. While rectal bleeding may occur with diverticulitis, it is less likely than with only diverticulosis.4 The disorder which is most threatening to a patient of the disorders that can cause rectal bleeding is colon cancer. If not timely identified, colon cancer can spread to an extent that surgical intervention will be ineffective and the patient will ultimately die. The typical signs of colon cancer include a change in bowel pattern, such as diarrhea or constipation, rectal bleeding, abdominal pain, and, in later stages, weight loss. Because D. M. had reported rectal bleeding, Dr. Magilen first looked for signs of hemorrhoids. After finding no such signs, Dr. Magilen recommended to D. M. that she undergo a colonoscopy to explore whether she was suffering from a colonic disorder. A colonoscopy is one of the diagnostic tools available to determine whether polyps or colon cancer are present in a patient experiencing rectal bleeding. A colonoscopy allows the physician to visually evaluate subtleties of mucosal changes of the colon by visually inspecting the lumen, or inside lining of the colon. Any problematic or suspicious tissue can be collected during the colonoscopy for later biopsy. The colonoscopy is performed by inserting a flexible tube with fiber optic capabilities into the rectum and up through the colon. The colon is the lower six to eight feet of the gastrointestinal tract, which runs from the mouth to the anus. The colon consists of a muscular wall with an inner lining of mucosa and an outer layer of serosa tissue. Typically, approximately 50% of the colon is attached to the inside of the belly cavity (the abdomen) by a suspensory fibrous tissue. Colon cancer typically is found in the mucosal surface of the colon and is most prevalent in the left colon (the rectum, sigmoid colon, the descending colon, and the distal transverse colon). Because a colonoscopy is an invasive procedure, it is not without risks. Among the risks of performing a colonoscopy is the possibility that the patient's colon will be perforated. Despite Dr. Magilen's concern over D. M.'s rectal bleeding, D. M. ignored Dr. Magilen's recommendation and declined to undergo a colonoscopy in 1995. D. M. was next seen by Dr. Magilen in April 1996. D. M. complained of constipation and bright red bleeding on the toilet paper in the bowl. At Dr. Magilen's urging, D. M. agreed to and did undergo a colonoscopy on April 23, 1996. As a result of the procedure, Dr. Magilen found and removed a 3 millimeter benign sessile polyp5 and noted the presence of a small amount of diverticuli in her sigmoid colon.6 The sigmoid colon, which makes up the last portion of the colon and attaches to the rectum, is so-named because of its "S" shape. The sigmoid colon is more mobile and, therefore, has more variability in its position. It is, however, usually located on the lower left side of the abdomen. Diverticuli are "out-pockets" or bulges in the intestine. Their presence is referred to more specifically as "diverticulosis." In adults over the age of 65 years, approximately 75% have diverticuli somewhere in the colon. A finding of diverticulosis in older adults is, therefore, not an uncommon finding. D. M. next presented to Dr. Magilen on July 14, 1997. She was 68 years of age. She complained of upper and lower abdominal pain, a change in bowel habits, occasional bright red blood from her rectum, and nausea (without vomiting). The abdominal pain, which she reported had started approximately a week and a half prior to July 14th, was reported to be mainly in the upper abdomen. D. M.'s change in bowel habits were reported to be constipation despite an increase from one bowel movement a day to four to five bowel movements per day. She was considered constipated, even with the increased number of bowel movements, because she had also reported a sensation of incomplete evacuation, that her stool consisted of hard balls, and she had witnessed bright red blood on occasion. Dr. Magilen obtained D. M.'s medical history and conducted a physical examination on July 14th. D. M.'s pertinent medical history included the following: (a) she was a heavy smoker for 26 years (3 1/2 packs a day until she quit in 1981); (b) she consumed alcohol regularly (at least 3 glasses of wine per day); (c) she had previous lumpectomies of her breasts for benign tumors; (d) she had a cavernous hemangioma on her right thigh that was treated with radiation therapy and for which she suffered a recurrence and malignancy; (e) she had cancer removed from her toe; (f) she had several D & C's of her uterus; (g) she had a sessile polyp removed from her colon in 1996; and (h) she has diverticulosis. Dr. Magilen's physical examination of D. M. revealed that she had diffuse, non-localized abdominal tenderness with no masses or organomegaly. A vaginal and rectal examination of D. M. revealed uterine tenderness with no masses. An anoscopic examination of her rectum revealed internal hemorrhoids. Dr. Magilen found no indication of acute blood loss or bowel obstruction, and no signs, symptoms, or indications of acute decompensation from a colonic malignancy. Dr. Magilen's impression of D. M. on July 14th was that she was suffering from acute abdominal pain and that uterine pathology needed to be ruled out as the source of her problem. Dr. Magilen, therefore, planned to obtain a pelvic ultrasound, admit D. M. to the hospital for 23 hours, and obtain a gynecological consult. The pelvic ultrasound, which was performed outpatient on July 14th, revealed the presence of an ovarian cyst on D. M.'s left ovary and no masses in her uterus.7 No other abnormalities, malignancies, or uterine pathology were revealed by the ultrasound. At approximately 4:30 p.m. of July 14th, D. M. presented and was admitted to Aventura Hospital. A blood chemistry profile, a complete blood count, abdomen X-rays, abdomen and pelvis Computed Axial Tomography ("CAT" or "CT") Scans and a gynecological consult with Dr. Gross, a gynecologist, were ordered. A complete blood count was also ordered for July 15, 1997. D. M. was placed on "NPO" (nothing by mouth), meaning that she was allowed no food or liquids by mouth. She was also given Vistaril, a common relaxant, to help with her complaints of pain. D. M. was not suffering from fever at the time of her admission. Her blood chemistry and the complete blood count failed to reveal any increase in her white blood cell count or an increase in immature white blood cells, commonly referred to as a "shift to the left." D. M. was found to be evidencing signs of anemia, based upon a drop in her hemoglobin. D. M.'s hemoglobin as of April 1996 had been 12.7. As of her admission to Aventura in July 1997, D. M.'s hemoglobin had fallen to 11.4. D. M.'s X-rays were unremarkable. No significant distention or the presence of free air, soft tissue masses, or abnormal calcifications were indicated. The CT Scan was produced on July 14, 1997. The image of the CT Scan was transmitted to an on-call radiologist, Dr. Maria Rodriguez, for a preliminary interpretation. Although Dr. Rodriguez issued a preliminary fax report of her findings, Dr. Magilen did not receive the report. Dr. Magilen was, therefore, unaware of the findings made by Dr. Rodriguez when he made the decision at issue in this case. The CT Scan image was also reviewed by Karl Drehobl, M.D. Dr. Drehobl's findings and impressions were provided to Dr. Magilen in a written report. That written report was received and considered by Dr. Magilen. With regard to D. M.'s colon, Dr. Drehobl's report included the following findings and impression as a result of his review of the CT Scan image: . . . . THERE IS SIGMOID DIVERTICULOSIS PRESENT. THERE IS EVIDENCE OF SIGMOID WALL THICKENING. THERE IS INCREASED DENSITY IN THE REGION OF THE SIGMOID MESENTERY. NO DISCRETE FLUID COLLECTION OR ABSCESS IS NOTED. FINDINGS ARE SUGGESTIVE OF SIGMOID DIVERTICULITIS. NO FREE AIR OR FREE FLUID IS IDENTIFIED. THE REMAINDER OF THE BOWEL AND MESENTERY ARE NORMAL. IMPRESSION: FINDINGS SUSPICIOUS FOR SIGMOID DIVERTICULITIS. NO FREE AIR OR DISCRETE ABSCESS COLLECTION. . . . . Dr. Drehobl's findings8 were consistent with those reported by Dr. Rodriguez. Dr. Drehobl's finding of "increased density in the region of the sigmoid mesentery" meant that the fat adjacent to the colon was swollen or inflamed. Dr. Drehobl's finding of sigmoid wall thickening meant that there was an abnormal thickening of the wall of the colon and small bowel. Dr. Drehobl's impression of D. M., taking into account his findings from reading the CT Scan, the fact that there were diverticuli present in the same area, D. M.'s age, and her history of abdominal pain, was that there was a "strong possibility" that D. M. was suffering from "diverticulitis or inflammation of the diverticuli in that region." See page 20, lines 12-14, Petitioner's Exhibit 2. "Diverticulitis" is the inflammation of one or more diverticuli. The diverticuli become inflamed when an out-pocket becomes blocked. Fluid from the mucosal lining of the intestine becomes captured in the blocked out-pocket. Infection and/or inflammation then occurs. If untreated, in the later stages of diverticulitis, a blocked diverticuli can rupture into the pericolonic fat and/or form an abscess.9 CT Scans can be 85 to 90% accurate in diagnosing diverticulitis. Even so, the results of a CT Scan are only a guide, one of a number of tests available to the physician, which must be correlated by the treating physician with all the clinical findings concerning the patient, including the results of the physical examination, the patient's clinical symptoms and history, the results of other diagnostic tests, and the results of laboratory studies. Dr. Drehobl's findings and impression were, therefore, not dispositive. Dr. Magilen was required to take Dr. Drehobl's findings into consideration along with his clinical findings. Dr. Magilen, after speaking with Dr. Drehobl personally about his report, did just that. Dr. Magilen was not convinced that D. M. was suffering from diverticulitis. This conclusion was based upon a number of factors: Dr. Drehobl did not find any of the more specific signs of diverticulitis which CT Scans can show such as marked edema around the colon, abscesses within the mesentery, or segmental thickening. Dr. Drehobl's findings of increased density in the region of the sigmoid mesentery and sigmoid wall thickening were equivocal findings. Persons with diverticulosis, which D. M. was known to have, almost consistently evidence some thickening of the wall of the sigmoid colon; Because the results of the CT Scan were equivocal, the findings, in addition to supporting an impression of diverticulitis, also supported an impression of a number of other disorders, in and outside the colon, which Dr. Magilen had not yet been able to rule out: inflammation in another organ, such as the appendix or an adjacent loop or intestine; inflammation in a fallopian tube or an ovary; colon neoplasm, colitis, or other tumor of the colon; ischemic colitis, Crohn's disease, and inflammatory bowel disease; D. M. was not evidencing the classic symptoms of diverticulitis: Left-lower quadrant pain; Fever; and Increased white blood cells and a "shift to the left." The presence or absence of any one or more of these symptoms alone does not reasonably support a finding of diverticulitis or the absence thereof. But the absence of all three significantly reduced the possibility that D. M. was suffering from diverticulitis; and D. M.'s symptoms, including rectal pain, bright-red rectal bleeding (which is less likely to occur with diverticulitis) associated with bowel passage, vague abdominal discomfort that was not localized to any particular quadrant of the abdomen, and her sensation of incomplete evacuation could not all be explained by diverticulitis and were suggestive of other diagnosis which Dr. Magilen had not been able to rule out. D. M.'s hemoglobin, which had dropped from 12.7 in April 1996 to 11.4 upon her admission to the hospital, indicated some loss of blood which her body was not able to replace, could also have been symptomatic of the other problems suggested by the results of the CT Scan. Based upon the foregoing, and following a consult with Dr. Gross, Dr. Magilen's impression was that D. M.'s pathology was coming from her uterus and ovarian tubes. Between the evening of July 14, 1997, and the morning of July 15, 1997, D. M.'s condition improved. She exhibited minimal abdominal tenderness, she had a normal white blood cell count, she had no fever, and she was able to eat. Dr. Magilen decided to increase her diet and to discharge her home with directions to follow-up with Dr. Magilen and her gynecologist. Dr. Magilen prescribed Cipro, a broad spectrum antibiotic, to address what he believed was her pelvic inflammatory process. The day after she was released from the hospital, July 16, 1997, D. M. presented to Dr. Eisman. She complained that the abdominal pain had returned during the night of July 15th. Dr. Eisman conducted a physical examination of D. M. Dr. Eisman found an increase in pain on palpation of the cervix and generalized mild tenderness of the abdomen. Because the pain in D. M.'s abdomen was not located in the lower left- quadrant and in light of the pain on palpation of her cervix, Dr. Eisman was of the opinion that the likely cause of her pain was pelvic inflammatory disease. The etiology of her pain was, however, still unknown. Dr. Eisman had D. M. readmitted to Aventura and notified Dr. Magilen of the change in her condition. D. M. was readmitted with orders for blood chemistry and complete blood count, ultrasound of the pelvis, X-rays of the abdomen, CT Scan of the abdomen and pelvis, and NPO (except ice chips). She was given Phenergan and Demerol for pain and nausea. Dr. Magilen examined D. M. upon her admission to the hospital. He found that her abdomen was soft with minimal tenderness. A vaginal and rectal examination revealed uterine tenderness with no masses. These findings were consistent with those of Dr. Eisman and Dr. Gross. D. M. was still not experiencing fever. Flat and upright X-rays of D. M.'s abdomen revealed no significant abnormalities. D. M.'s blood chemistry studies and complete blood count indicated the presence of anemia, a significantly elevated sedimentation rate with no increase in white blood cell count and no "shift to the left." The CT Scan revealed some evidence of diverticulosis and slight edematous changes within the fat adjacent to the sigmoid colon consistent with diverticulitis. Dr. Magilen again discussed the CT Scan findings with the radiologist. Dr. Magilen was still concerned about those findings for most of the reasons indicated in Finding of Fact 41, supra. The radiologist's findings were still equivocal; the findings were still consistent with other disorders, which the radiologist acknowledged to Dr. Magilen, including a carcinoma or other inflammatory process inside or outside the colon; D. M. was not evidencing the three classic signs of diverticulitis; and her symptoms continued to support other findings. The ultrasound of D. M.'s pelvis was performed on July 17, 1997. The following findings and impressions were made as a result of the ultrasound: . . . . THERE IS A FIBROID LESION WITHIN THE LOWER UTERINE SEGMENT ADJACENT TO THE CERVIX MEASURING 2.7 X 2.3 X 2.6 CM. NORMAL ENDOMETRIAL STRIPE IS NOTED. NO ADDITIONAL UTERINE MASSES ARE NOTED. BOTH OVARIES ARE UNREMARKABLE IN APPEARANCE. THE RIGHT OVARY MEASURES 1.6 X .9 X 1.1 CM AND THE LEFT OVARY MEASURES 1.8 X 1 X 1 CM. NO ADNEXAL MASSES ARE NOTED. SMALL AMOUNT OF FREE FLUID IS NOTED WITHIN THE CUL-DE-SAC. IMPRESSION: LOWER UTERINE FIBROID LESION MEASURING 2.7 X 2.3 X 2.6 CM. NO ADNEXAL MASSES. SMALL AMOUNT OF FREE FLUID. The July 17, 1997, ultrasound found that the cyst which had been disclosed by the July 14, 1997, ultrasound was now gone. This fact, coupled with the fluid found in D. M.'s cul-de-sac (located in the rectal-uterine space, between the rectum and the posterior wall of the uterus and the vagina), could mean that the cyst had ruptured. The ultrasound also indicated that the uterus was 20 percent larger and that there was a two to three centimeter myoma or tumor in the lower uterine segment. These changes, which apparently took place over a two to three day period, and the results of D. M.'s physical examination (uterine tenderness and tenderness in the cul-de-sac), are consistent with pelvic inflammatory disease. The findings of the July 17, 1997, ultrasound could also explain the findings of edema and the change in sigmoid mesentery found by the CT Scan. Both Dr. Gross10 and Dr. Magilen concluded that it was likely that D. M. was, at least in part, exhibiting signs of pelvic inflammatory disease. Dr. Gross also concluded that, if her condition did not soon improve, a laproscopy11 would probably be required to determine the specific cause of D. M.'s complaints. Dr. Magilen was still concerned about the possibility of colon cancer or some other colonic disorder which the CT Scan and the ultrasound did not explain. Dr. Magilen's concern was based upon the following factors, which his conclusion about pelvic inflammatory disease and the CT Scans of July 14th and July 16th had not ruled out: The findings of the CT Scans and the impressions of the radiologists concerning diverticulitis had not ruled out the possibility that D. M. was suffering from some other colonic disorder, as explained in findings of fact 41 and 52; D. M. had undergone at least some treatment with antibiotics upon her release from the hospital on July 15th and undergone some bowel rest while in the hospital between July 14th and July 15th, and yet her complaints had persisted; and D. M.'s history (she is at some risk of cancer) and her complaints: she had unexplained or undefined abdominal and pelvic pain that had lasted for a week or two; she had been bleeding from the rectum and had rectal pain; she had had a change in her bowel pattern; and she had shown signs of anemia. Dr. Magilen decided to perform a colonoscopy on D. M. to be sure that D. M. was not suffering from a colonic disorder in addition to what he suspected was a pelvic inflammatory disease. The procedure was performed on July 18, 1997. It was performed easily and without apparent complication at the time. Dr. Magilen found uncomplicated diverticulosis but no other pathology, including colonic neoplasm, lesions, or malignancy. Subsequent to the completion of the colonoscopy on July 18th, D. M.'s condition rapidly deteriorated. D. M. experienced an acute abdomen, which is consistent with a possible perforation of the colon as a result of the colonoscopy. An abdominal X-ray, however, failed to reveal a perforation or the presence of free air in D. M.'s abdomen. D. M.'s condition did not improve on July 19th. Therefore, on July 20, 1997, Dr. Magilen performed exploratory surgery on D. M.'s abdomen. Dr. Magilen observed inflammation and abscesses on the outside of D. M.'s colon. Dr. Magilen also reported observing two perforations of her sigmoid colon. Dr. Magilen also found inflammation of the right ovary and tube and the presence of pus in the cul-de-sac. The pus was sampled for culture. Because of the two perforations Dr. Magilen believed he had observed, Dr. Magilen removed a large portion of the colon; he resected and placed a colostomy. Pathology of the resected portion of D. M.'s colon determined that the colon evidenced focal fibrinous hemorrhagic exudate, numerous deep diverticuli, and no neoplasm. Culture of the pus did not produce bacteria that would be expected from ruptured diverticuli. The culture was, however, consistent with a gynecologic origin. Pathology also failed to confirm Dr. Magilen's belief that there were two perforations in D. M.'s colon. These findings suggest that D. M. was suffering from a pelvic inflammatory disease, in particular, a tube and ovary on the right side; and that the inflammation may have adhered the tube and ovary to the sigmoid colon causing the symptoms evidenced by D. M. as opposed to diverticulitis. Conducting a colonoscopy in a patient with diverticulitis is generally considered counterindicated and may under certain circumstances constitute a deviation from the standard of care. A colonoscopy is counterindicated because it poses a greater risk of perforation by mechanical trauma-- disruption of the inside of the bowel wall by the scope used to perform the colonoscopy--for a patient suffering from diverticulitis. The colonoscopy also requires the injection of air into the colon which results in the colon being firmer and, thus, more prone to damage, especially if the patient is suffering from diverticulitis. A perforation of the colon can result in serious complications and can lead to death. Under normal circumstances, the preferred treatment of diverticulitis is to prescribe antibiotics, serial clinical examinations, and bowel rest. Absent some reasonable basis for deviation, the most prudent treatment of a patient suffering from acute diverticulitis who may also be suffering from a colonic disorder would be to treat the patient for the diverticulitis first and then, if deemed medically necessary, perform a colonoscopy after the diverticulitis has been resolved. Usually, the four to days it takes for antibiotics to be effective in treating diverticulitis, will not make any difference in a patient's oncologic situation. Even where it is suspected that there is another pathology in the colon, it may be prudent to calm the bowel and address the diverticulitis first before performing a colonoscopy. Despite the foregoing, if it is questionable whether a patient is in fact suffering from diverticulitis as opposed to some other process, the need for additional information concerning the patient must be weighed against the risk of performing a colonoscopy. Under these circumstances, clinical judgment concerning whether the colonoscopy should be performed must be exercised. The evidence in this case failed to prove that Dr. Magilen did not have a reasonable basis for proceeding with a colonoscopy of D. M. on July 18, 1997, despite the "suspicion" of diverticulitis reported as a result of the CT Scans of July 14th and July 16th. The normal course of treatment for diverticulitis was not followed in D. M.'s case by Dr. Magilen because Dr. Magilen was not convinced that D. M. was suffering from diverticulitis. As found, supra, Dr. Magilen concluded that D. M.'s clinical picture was unclear at best. In light of D. M.'s unclear clinical picture and Dr. Magilen's conclusions concerning the CT Scan findings, the evidence failed to prove that Dr. Magilen failed to realize that D. M.'s history, physical examination, and radiologic studies were consistent with a diagnosis of probable diverticulitis. In addition to D. M.'s unclear clinical picture and Dr. Magilen's reasonable conclusions concerning the CT Scan findings, Dr. Magilen was faced with the knowledge that Dr. Gross would in all probability perform a laproscopy on D. M. It was, therefore, reasonable for Dr. Magilen to proceed with the colonoscopy on July 18th without first treating D. M. with antibiotics and bowel rest. Dr. Magilen reasonably decided that it would be better to determine if there was any colonic disorder before the laproscopy was performed. Dr. Magilen wanted to avoid D. M. being placed under a general anesthesia and having some surprise problem with her colon discovered after the laproscopy was begun. The evidence, therefore, failed to prove that Dr. Magilen failed to practice medicine with the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances because Dr. Magilen failed to treat D. M. for diverticulitis with intravenous antibiotics and serial clinical examinations before performing the colonoscopy on July 18, 1997. Finally, the evidence failed to prove that Dr. Magilen failed to document justification for proceeding to perform a colonoscopy on D. M. on July 18, 1997.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered dismissing the Administrative Complaint against Steven A. Magilen, M.D. DONE AND ENTERED this 29th day of October, 2001, in Tallahassee, Leon County, Florida. LARRY J. SARTIN 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 29th day of October, 2001.
Findings Of Fact Orlando Regional Healthcare System, Inc. ("ORHS") filed a letter of intent to apply for certificate of need ("CON") 8039 for the approval of a bone marrow transplantation program. ORHS also submitted a Notice of Filing the letter of intent for publication in The Orlando Sentinel newspaper. The notice, which is as follows, did not include the capital expenditure cost of the project. PUBLIC NOTIFICATION NOTICE OF FILING The applicant, Orlando Regional Healthcare System, Inc., which is authorized to operate Orlando Regional Medical Center, announces its intent to file a certificate of need application on March 22, 1995 with the Agency for Health Care Administration to establish Bone Marrow Transplantation Services at Orlando Regional Medical Center, located in Orlando, FL, the Agency's District 7, Orange County Subdistrict, which is designated as Organ Transplant Planning Area 3 by the Agency's Certificate of Need Program Office. The project, if granted is expected to become operational in 1996. Signed: /s/ Garry J. Singleton Garry J. Singleton Vice President of Acute Care Operations Orlando Regional Healthcare System, Inc. 1414 Kuhl Avenue Orlando, Fl. 32806 The Agency For Health Care Administration ("AHCA") is the state agency that administers the CON program. AHCA published notice of receiving ORHS' letter of intent in Vol. 21, Number 10 of Florida Administrative Weekly on March 10, 1995. AHCA's notices do not contain cost estimates. AHCA deemed ORHS' application incomplete and withdrew it from consideration due to omission of capital costs from the published notice in the newspaper. AHCA relied on the requirements on Rule 59C-1.008(1)(i) and (j), Florida Administrative Code. See, Conclusion of Law 11, infra. There is no evidence that The Orlando Sentinel made an error in the publication of the Notice of Filing. Capital expenditure costs, when estimated in letters of intent and in notices of filing letters of intent, are often inflated. That is done because CON applications, filed subsequently with higher capital expenditure costs than those stated in the letter of intent, are rejected. Rule 59C-1.008(1)(k)3, Florida Administrative Code. Because the capital costs are often inflated in letters of intent, ORHS' expert concluded that notices of capital expenditure costs are meaningless, and that the omission of such costs from the newspaper notice is insignificant. Therefore, he asserts that the ORHS' notice of filing its letter of intent substantially complied with the requirements of the rule. ORHS' expert also notes that the publication rule requires the notice to include eleven different items, and that ORHS' notice omitted only one of the eleven. AHCA does not always require letters of intent or newspaper notices. They are not required for expedited applications, and errors in notices are excused if made by the newspaper and not the applicant. However, there are no batching cycles or comparative review of expedited CON applications.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that AHCA enter a final order withdrawing from consideration CON application 8039 filed by ORHS. DONE AND ENTERED this 11th day of August, 1995, in Tallahassee, Leon County, Florida. ELEANOR M. HUNTER 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 11th day of August, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-3059 To comply with the requirements of Section 120.59(2), Florida Statutes (1993), the following rulings are made on the parties' proposed findings of fact: ORHS' Proposed Findings of Fact. Accepted in Findings of Fact 1. Accepted in Findings of Fact 3. Subordinate to Findings of Fact 3. Accepted in Findings of Fact 3. Accepted in or subordinate to Findings of Fact 5 (as $5,000,000 each in proposed project costs in Exhibit 3 and approximately $5,000 total actual costs in Exhibit 4). Accepted in or subordinate to Findings of Fact 7. Accepted in Findings of Fact 5. Accepted in or subordinate to Findings of Fact 2 and conclusions of law 11. Accepted in Findings of Fact 5. Rejected in conclusions of law 13. 11-13. Accepted in Findings of Fact 5. Accepted in or subordinate to Findings of Fact 5 (as $5,000,000 each in proposed project costs in Exhibit 3 and approximately $5,000 total actual costs in Exhibit 4). Accepted in Findings of Fact 5 and Conclusions of Law 13. 16-17. Accepted in Findings of Fact 8. Accepted. Conclusion rejected in conclusions of law 11. See, 5 supra. AHCA's Proposed Findings of Fact. Accepted in Findings of Fact 2. Accepted in Findings of Fact 3 and 4. 3-5. Accepted in Findings of Fact 5-8. COPIES FURNISHED: John Gilroy, Esquire Senior Attorney Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 James M. Barclay, Esquire Cobb, Cole & Bell 131 North Gadsden Street Tallahassee, Florida 32301 R. S. Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Tom Wallace Assistant Director Agency For Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403
The Issue The issues in this case are whether Respondents performed a wrong procedure on patient C.C., as set forth in the second amended administrative complaints, and if so, what is the appropriate sanction.
Findings Of Fact The Department of Health, Board of Medicine, is the state agency charged with regulating the practice of medicine in the state of Florida, pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to this proceeding, Respondents were licensed physicians within the state, with Dr. Kenneth D. Stahl having been issued license number ME79521 and Dr. Eddie Ward Manning having been issued license number ME110105. Dr. Stahl has been licensed to practice medicine in Florida since 1999 and in California since 1987. He has never had disciplinary action taken against either license. Dr. Stahl is board certified by the American College of Surgeons in general surgery, cardiac and thoracic surgery, and trauma and critical care surgery. Dr. Stahl's address of record is 3040 Paddock Road, Fort Lauderdale, Florida 33141. Dr. Manning has been licensed to practice medicine in Florida since May 31, 2011. He has never had disciplinary action taken against his license. On June 23, 2011, Dr. Manning was a resident in general surgery. Dr. Manning's address of record is 1900 South Treasure Drive, Apartment 6R, North Bay Village, Florida 33141. In February 2011, patient C.C., a 52-year-old female, was admitted to Jackson Memorial Hospital (JMH) with a diagnosis of perforated appendicitis. She also had a perirectal abscess. Her records indicate that she was treated with percutaneous drainage and a course of intravenous (IV) antibiotics. She was discharged on March 4, 2011. On June 22, 2011, patient C.C. presented to the JMH Emergency Department complaining of 12 hours of abdominal pain in her right lower quadrant with associated nausea and vomiting. Shortly after her arrival she described her pain to a nurse as "10" on a scale of one to ten. A computed tomography (CT) scan of patient C.C.'s abdomen was conducted. The CT report noted that the "the uterus is surgically absent," and "the ovaries are not identified." It noted that "the perirectal abscess that was drained previously is no longer visualized" and that the "appendix appears inflamed and dilated." No other inflamed organs were noted. The radiologist's impression was that the findings of the CT scan were consistent with non-perforated appendicitis. Patient C.C.'s pre-operative history listed a "total abdominal hysterectomy" on May 4, 2005. Patient C.C.'s prior surgeries and earlier infections had resulted in extensive scar tissue in her abdomen. Dr. Stahl later described her anatomy as "very distorted." Patient C.C. was scheduled for an emergency appendectomy, and patient C.C. signed a "Consent to Operations or Procedures" form for performance of a laparoscopic appendectomy, possible open appendectomy, and other indicated procedures. Patient C.C. was taken to surgery at approximately 1:00 a.m. on June 23, 2011. Dr. Stahl was the attending physician, Dr. Manning was the chief or senior resident, and Dr. Castillo was the junior resident. Notes indicate that Dr. Stahl was present throughout the critical steps of the procedure. Dr. Stahl had little recollection of the procedure, but did testify that he recalled: looking at the video image and seeing a tremendous amount of infection and inflammation and I pulled-–I recall that I myself went into the computer program and pulled up the CT scan and put that on the screen right next to the video screen that's being transmitted from the laparoscope and put them side-to-side and compared what the radiologists were pointing to as the cause of this acute infection and seeing on the laparoscopic video image that that indeed matched what I saw in the CT scan and I said, well, let's dissect this out and get it out of her so we can fix the problem. Dr. Stahl further testified that the infected, hollow organ that was dissected and removed was adherent laterally in the abdomen and was located where the appendix would normally be. He recalled that an abscess cavity was broken into and the infected, "pus-containing" organ that was removed was right in the middle of this abscess cavity. Dr. Stahl also recalled the residents stapling across the base of the infected organ and above the terminal ileum and the cecum and removing it. The Operative Report was dictated by Dr. Manning after the surgery and electronically signed by Dr. Stahl on June 23, 2011. The report documents the postoperative diagnosis as "acute on chronic appendicitis" and describes the dissected and removed organ as the appendix. Progress notes completed by the nursing staff record that on June 23, 2011, at 8:00 a.m., patient C.C. "denies pain," and that the laparoscopic incision is intact. Similar notes indicate that at 5:00 p.m. on June 23, 2011, patient C.C. "tolerated well reg diet" and was waiting for approval for discharge. Patient C.C. was discharged on June 24, 2011, a little after noon, in stable condition. On June 24, 2011, the Surgical Pathology Report indicated that the specimen removed from patient C.C. was not an appendix, but instead was an ovary and a portion of a fallopian tube. The report noted that inflammatory cells were seen. Surgery to remove an ovary is an oophorectomy and surgery to remove a fallopian tube is a salpingectomy. On Friday, June 24, 2011, Dr. Namias, chief of the Division of Acute Care Surgery, Trauma, and Critical Care, was notified by the pathologist of the results of the pathology report, because Dr. Stahl had left on vacation. Dr. Namias arranged a meeting with patient C.C. in the clinic the following Monday. At the meeting, patient C.C. made statements to Dr. Namias regarding her then-existing physical condition, including that she was not in pain, was tolerating her diet, and had no complaints. Dr. Namias explained to patient C.C. that her pain may have been caused by the inflamed ovary and fallopian tube or may have been caused by appendicitis that resolved medically, and she might have appendicitis again. He explained that her options were to undergo a second operation at that time and search for the appendix or wait and see if appendicitis recurred. He advised against the immediate surgery option because she was "asymptomatic." The second amended administrative complaints allege that Dr. Stahl and Dr. Manning performed a wrong procedure when they performed an appendectomy which resulted in the removal of her ovary and a portion of her fallopian tube. It is clear that Dr. Stahl and Dr. Manning did not perform an appendectomy on patient C.C. on June 23, 2011. Dr. Stahl and Dr. Manning instead performed an oophorectomy and salpingectomy. It was not clearly shown that an appendectomy was the right procedure to treat patient C.C. on June 23, 2011. The Department did convincingly show that patient C.C. had a history of medical problems and that she had earlier been diagnosed with appendicitis, had been suffering severe pain for 12 hours with associated nausea and vomiting, that she suffered from an infection in her right lower quadrant, that the initial diagnosis was acute appendicitis, and that the treatment that was recommended was an appendectomy. However, substantial evidence after the operation suggests that an appendectomy was not the right procedure. The infected and inflamed organ that was removed from the site of a prior abscess was not an appendix. After the procedure, patient C.C. no longer felt severe pain in her lower right quadrant, with associated nausea and vomiting. She was discharged the following day and was asymptomatic. It is, in short, likely that the original diagnosis on June 22, 2011, was incorrect to the extent that it identified the infected organ as the appendix. The pre-operative diagnosis that patient C.C.'s severe pain and vomiting were caused by a severe infection in an organ in her lower right quadrant was correct. Surgical removal of that infected organ was the right procedure for patient C.C. If that inflamed organ was misidentified as the appendix before and during the operation, that would not fundamentally change the correctness of the surgical procedure that was performed. The evidence did not clearly show that the wrong procedure was performed. It is more likely that exactly the right procedure was performed on patient C.C. That is, it is likely that an oophorectomy and salpingectomy were the right procedures to address the abdominal pain that caused patient C.C. to present at the JMH emergency room, but that the right procedure was incorrectly initially denominated as an "appendectomy," as a result of patient history and interpretation of the CT scan.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Medicine, enter a final order dismissing the second amended administrative complaints against the professional licenses of Dr. Kenneth D. Stahl and Dr. Eddie Ward Manning. DONE AND ENTERED this 15th day of July, 2015, in Tallahassee, Leon County, Florida. S F. SCOTT BOYD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of July, 2015.
The Issue The issues in this case are whether Respondent, Carlos S. Contreras, M.D., violated Section 458.331(1)(c), Florida Statutes (2008), as alleged in the Administrative Complaint, filed with Petitioner, the Department of Health, on August 31, 2009, in DOH Case Number 2008-14221, and, if so, what disciplinary action should be taken against his license to practice medicine in the State of Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, Carlos S. Contreras, M.D., is, and was at all times material to this matter, a physician licensed to practice medicine in Florida pursuant to Chapter 458, Florida Statutes, having been issued license number 43908, on or about May 19, 1984. Indictment and Conviction of Dr. Contreras. On or about June 2, 2008, Dr. Contreras was indicted in United States of America v. Carlos Contreras and Ramon Pichardo, United States District Court, Southern District of Florida, Case No. 08-20443 CR - Moreno (hereinafter referred to as the "Indictment"). Generally, the Indictment alleges that Dr. Contreras was involved in a conspiracy to submit fraudulent claims to Medicare for purported Human Immunodeficiency Virus infusion therapy. As it relates to Dr. Contreras, the Indictment was predicated, in part, upon the following “General Allegation”: C.N.C. Medical Corp. (“CNC Medical”) was a Florida corporation, purportedly doing business at 1393 S.W. 1st Avenue, Suite #320, Miami, Florida. . . . CNC Medical was a medical clinic that purported to specialize in treating patients with HIV by providing infusion therapy. From in and around November 2002 through in or around April 2004, approximately $6.8 million in claims were submitted to the Medicare program for HIV infusion services allegedly rendered at CNC Medical. Defendant CONTRARES, a resident of Miami-Dade County, was a medical doctor who purported to order and provide HIV infusion services to Medicare beneficiaries at CNC Medical. CONTRERAS was also the president, director, and registered agent of CNC Medical. Relevant to this matter, Count 2 of the 12-Count Indictment charged Dr. Contreras with conspiracy to commit health care fraud in violation of 18 U.S.C. § 1349 On or about September 11, 2008, Dr. Contreras entered into a Plea Agreement in which he pled guilty to Count 2 of the Indictment, thereby admitting that he was guilty of “knowingly and willfully conspiring with others to execute a scheme and artifice to defraud and to obtain by means of materially false and fraudulent pretenses, representations, and promises money owned by, and under the custody and control of a health care benefits program (as defined as [sic] in Title 18, United States Code, Section 24(b)), in violation of Title 18, United States Code, Section 1347.” On the same date that the Plea Agreement was executed, Dr. Contreras, along with his legal representative, executed and acknowledged the following “Agreed Factual Basis for Guilty Plea”: Beginning in approximately November 2002, and continuing through approximately April 2004, the defendant, Dr. Carlos Contreras (“Contreras”), willfully conspired with his co-defendants, Ramon Pichardo, Carlos Benitez, Luis Benitez, Thomas McKenzie, and others to commit health care fraud, in violation of 18 U.S.C. § 1349. Medicare is a “health care benefit program” of the United States, as defined in 18 U.S.C. § 24. Furthermore, Medicare is a health care benefit program affecting commerce. Contreras was a medical doctor and owned a medical clinic named CNC Medical Corp. (“CNC”). At CNC, Contreras also employed Dr. Ramon Pichardo. CNC purported to specialize in treating patients with Human Immunodeficiency Virus (“HIV”). From approximately November 2002 through approximately April 2004, Contreras approved approximately $6.8 million worth of fraudulent medical bills, signed documents containing false information about treatments purportedly provided to HIV patients, and approved medically unnecessary treatments. As a result of Contreras’ conduct, the Medicare Program (“Medicare”) paid approximately $4.2 million worth of fraudulent bills to CNC and Contreras. CNC was a Florida corporation purportedly doing business at 1393 S.W. 1st Street, Suite #320, Miami, Florida. Corporate records display a business address of 1383 S.W. 1st Street, Suite #320, Miami, Florida. From approximately November 2002 through approximately April 2004, CNC billed the Medicare Program approximately $6.8 million under Contreras’ Medicare provider number, and actually received approximately $4.2 million in payments. Contreras signed checks drawn on CNC bank accounts and would use these checks to transfer funds to various corporate entities owned and controlled by Carlos and Luis Benitez, and others. In total, Contreras transferred approximately $1.7 million dollars [sic] to the Benitez brothers. In or about November 2002, Contreras agreed with his co-conspirators, including Dr. Ramon Pichardo, Carlos Benitez, Luis Benitez, and Thomas McKenzie, to accept HIV patients at CNC and to allow fraudulent bills to be submitted to the Medicare Program under his provided number. Co- conspirators Carlos Benitez and Luis Benitez agreed to provide the staff necessary to operate CNC as an HIV infusion clinic, the Medicare patients that CNC would utilize to bill to the Medicare program, and the transportation for the HIV patients, in return for a share of CNC’s profits. At that time, Contreras knew that CNC would need to pay kickbacks to the patients who visited the clinics, and that the CNC would bill Medicare for HIV infusion services three times a week, for up to three months, for each patient. Contreras’s primary job at the CNC was to see patients, sign medical records, and approve expensive and medically unnecessary HIV infusion treatments. Prior to purportedly treating HIV patients at CNC, Contreras worked at one other Benitez controlled HIV infusion therapy clinic, named AH Medical Office, Inc. At th[is clinic], he learned from the Benitez brothers and McKenzie how to make medical records appear legitimate and how to authorize treatments and sign medical analysis and diagnosis forms for HIV patients, without regard to medical necessity or the patients’ particular ailments. Contreras authorized and approved the use of the drug WinRho (also known as Rho D), along with a mix of various vitamin supplements for most HIV patients he was seeing, knowing that the HIV patients did not need WinRho. . . . . The Agreed Factual Basis for Guilty Plea executed by Dr. Contreras contained the following acknowledgement just above his signature: The preceding statement is a summary, made for the purpose of providing the Court with a factual basis for my guilty plea to the charges against me. It does not include all of the facts known to me concerning criminal activity in which I and others engaged. I make this statement knowingly and voluntarily and because I am in fact guilty of the crimes charged. On or about November 20, 2008, Dr. Contreras entered a plea of “guilty” to Count 2 of the Indictment. The court adjudicated him guilty, dismissed the other charges, and sentenced Dr. Contreras consistent with the Plea Agreement. At the time of the final hearing of this matter, Dr. Contreras was in the custody of the United States Bureau of Prisons serving a 37-month sentence. Based upon the admissions contained in the Agreed Factual Basis for Guilty Plea quoted in Finding of Fact 8, it is clear that the crime for which Dr. Contreras’ was adjudicated guilty involved a conspiracy in which he actually engaged in health care fraud, and not just a plan to do so. The Relationship of Dr. Contreras’ Convictions to the Practice of Medicine. In light of Dr. Contreras’ guilty plea to Count 2 of the Indictment and his acknowledgement of the Agreed Factual Basis for Guilty Plea, there is no doubt that Dr. Contreras engaged in the activities outlined in the Agreed Factual Basis for Guilty Plea. It is also clear that all of those activities related to the practice of medicine. As the Department points out in Petitioner’s Proposed Recommended Order, “[b]ut for Respondent’s license to practice medicine in the state of Florida, he would not have been able to commit the crimes [sic] for which he pled guilty. It was his license to practice medicine that allowed him to work as a physician at CNC Medical Corp., to obtain a [Medicare] provider number, to see patients, to sign medical records, to approve expensive and medically unnecessary HIV infusion treatments and to fully participate in the Medicare program. The foregoing activities were made possible and were a direct result of his status as a licensed Florida physician.” Without his license to practice medicine, there could have been no conspiracy to commit health care fraud. Dr. Contreras relies upon a number of “facts” in support of his argument that the crime for which he pled guilty does not relate directly to the practice of medicine: First, Dr. Contreras argues that the crime involved “conspiracy” to commit health care fraud rather than the actual act of health care fraud. Even if technically correct, the Agreed Factual Basis for Guilty Plea clearly outlines activities involving medical care necessary for the conspiracy to exist. Additionally, but for his license to practice medicine, there would have been no conspiracy; Secondly, Dr. Contreras points out that no restrictions were placed on his practice of medicine or his involvement in the Medicare Program or the Medicaid Program in the Plea Agreement. While correct, the emphasis of the criminal matter was on Dr. Contreras’ activities relating to defrauding the United States government of millions of dollars, rather than his activities as a physician. The government’s interest was a financial one and, therefore, it correctly left his actual practice of medicine to the governmental agencies charged with the responsibility of regulating the practice of medicine; Thirdly, Dr. Contreras points out that the Plea Agreement makes no mention of any breach of the physician- patient relationship. Again, the emphasis of the criminal matter was on Dr. Contreras’ efforts to “steal” government funds rather than the quality or lack thereof of his medical care; and Finally, Dr. Contreras relies upon the testimony of Joseph S. Rosenbaum, Esquire, who represented Dr. Contreras in the criminal matter. According to Dr. Contreras, Mr. Rosenbaum’s testimony was presented in order to “explain the meaning of the documents and background (facts) of the underlying criminal case.” According to Mr. Rosenbaum, Dr. Contreras was “’duped’” and “’used’ by unscrupulous businessmen more clever and ruthless then the Respondent.” Mr. Rosenbaum’s testimony, for which little in the way of predicate was offered, is rejected as contrary to the facts stipulated to by Dr. Contreras quoted in Finding of Fact 8. The crime for which Dr. Contreras was convicted is a crime that “directly relates to the practice of medicine.”
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Medicine finding that Carlos S. Contreras, M.D., has violated Section 458.331(1)(c), Florida Statutes, as described in this Recommended Order, permanently revoking his license to practice medicine in Florida, and imposing a fine of $10,000.00. DONE AND ENTERED this 22nd day of April, 2010, in Tallahassee, Leon County, Florida. LARRY J. SARTIN 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 22nd day of April, 2010. COPIES FURNISHED: Ephraim D. Livingston, Esquire Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-3265 Craig Brand, Esquire Brand Law Firm, P.A. 2816 East Robinson Street, Second Floor Orlando, Florida 32802 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Dr. Ana M. Viamonte Ros, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue Whether Respondent, a licensed physician, violated the applicable standard of care by diagnosing prostate cancer in four patients, and recommending and participating in a course of treatment for these patients, without confirming prostate cancer through tissue biopsy results; and, if so, what is the appropriate penalty?
Findings Of Fact Petitioner is responsible for the investigation and prosecution of complaints against medical doctors licensed in the state of Florida, who are accused of violating chapters 456 and 458 of the Florida Statutes. Respondent is licensed as a medical doctor in Florida, having been issued license number ME 46625. Respondent is not board-certified in any specialty recognized by the Florida Board of Medicine. Respondent has never had disciplinary action against his license to practice medicine. Respondent's Practice Since his residency concluded in 1985, Respondent has practiced urology. For more than 20 years, the focus of his practice has been prostate disease, its diagnosis, and treatment. In 2006, Respondent became the lead investigator for a General Electric study regarding its 3-Tesla magnetic resonance spectroscopy imaging machine (3T MRI-s) as part of an Institutional Review Board measuring the heat generated by the machine to ensure the safety of patients. Between 2006 and 2010, 1,600 prostates were scanned with a 3T MRI-s as part of the study. Respondent reviewed the results of each radiology report associated with these scans and compared them to the clinical data he had for each patient. Respondent also completed a double-blind study of 200 of these patients who had prostate biopsies during 2008 and 2009, as well as the 3T MRI-s, correlated the results of the biopsies and the scans, and became convinced that the 3T MRI-s technology alone is a positive predictor of prostate cancer 95 percent of the time. According to both parties' experts, as well as Respondent, the standard of care in Florida and throughout the United States is to use a needle tissue biopsy to identify prostate cancer. As admitted by Respondent, medical schools teach that needle biopsy is "the way" to diagnose prostate cancer. Absent a biopsy showing malignant tissue, it is not possible for a reasonably prudent physician to diagnose or treat prostate cancer. Biopsies are usually performed to diagnose prostate cancer if a man has a combination of risk factors, such as family history, an abnormal digital rectal exam, and/or increasing levels of Prostate Specific Antigen (PSA). However, needle biopsies for prostate cancer carry a false negative rate of 20 to 50 percent, which means that a standard 12-point needle biopsy (where 12 samples of tissue from different locations in the prostate are sampled) often misses cancerous tissue. Prostate needle biopsies are sometimes painful and carry a risk of complications, including common complications such as bleeding and infection, and the unlikely complications of septic shock and death. Respondent is convinced that there is a significant risk from a prostate needle biopsy to spread prostate cancer cells outside the prostate capsule, which is referred to as "seeding" or "needle tracking." Respondent's belief is founded upon a one-page 2002 article published in the American Urological Association, Inc.'s Journal of Urology (Journal), which refers to two cases in which a tumor was discovered in the rectal wall after prostate biopsies and cryoblation.1/ The tumors were suspected of being the result of needle tracking from prostate cancer biopsies. Significantly, this article makes clear that needle tracking resulting from prostate biopsies are rare and "exceedingly uncommon." Respondent's concern, regarding prostate biopsies spreading prostate cancer, is also in part founded upon a one-paragraph 1991 Journal abstract reporting a Johns Hopkins University School of Medicine study of 350 patients in which needle tracking was suspected in seven patients (two percent).2/ According to Respondent, his belief that prostate biopsies spread prostate cancer is "intuitive," although he acknowledges this is not the prevailing view in Florida. Respondent argues that doctors do not want to believe needle tracking takes place with prostate biopsies and suggests there is a financial motivation for doctors to require a positive biopsy before definitively diagnosing prostate cancer. Respondent is so convinced of the dangers of needle biopsies for prostate cancer that he published a book, Men at Risk: the Dirty Little Secret – Prostate Biopsies Really Do Spread Prostate Cancer Cells, in 2012, which he provides to all his patients. In his book, Respondent states: For me, a 3T MRI scan is the best objective marker to a diagnosis of prostate cancer. To summarize, patients must answer one question. Should I agree to a prostate biopsy procedure where it has been proven to spread prostate cancer cells or do I keep my fingers and toes crossed, hoping for the best? In two words, . . . "absolutely not." To me, the decision is easy – the literature validates avoiding random biopsies and supports imaging with a 3 T magnet. There is no other organ in the human body where diagnosis is dependent on sticking needles randomly and blindly into a delicate organ in an attempt to find cancer. This practice is archaic, patently barbaric, unacceptable and preferentially favored by virtually all urologists. Beyond the obvious benefit to being able to see a cancer and its pattern of invasion with the 3.0 Tesla MRI scan, there is no other exam or scan that competes in terms of diagnostic accuracy or predictability. The discerning patient will soon recognize that guessing where cancer is located, through random biopsies, is for the less informed.[3] Respondent refers to the use of 3T MRI-s as the "truth serum" of prostate cancer diagnosis. During all times material hereto, Respondent held himself out as a urologist who could diagnose and treat prostate cancer without a needle biopsy. In fact, the four patients at issue in this case found Respondent through an Internet search. Respondent defines his office, the Diagnostic Center for Disease (DCD) as, "A comprehensive prostate cancer diagnostic center in Sarasota, Florida specializing in non-invasive diagnostics (MRI/MRIS) without biopsy as an integral part of the diagnostic evaluation of prostate cancer."4/ Respondent also advertised himself as "a world expert in High Intensity Focused Ultrasound (HIFU), having diagnosed and treated more patients for prostate cancer from more countries than any other treating doctor in the world."5/ HIFU is a treatment alternative to brachytherapy (the insertion of radioactive seeds into the prostate), radiation, and prostatectomy (the surgical removal of the prostate gland) for prostate cancer and uses highly focused ultrasound waves in a small area to create intense heat, which destroys prostate cancer tissue. HIFU was not an approved treatment for prostate cancer in the United States until October 9, 2015, at which time the Food and Drug Administration (FDA) approved the use of the Sonablate machine for prostate tissue ablation. Prior to that time, Respondent referred his patients to treatment facilities in Mexico and the Caribbean where he performed HIFU treatments. The standard of care in Florida precludes treating prostate cancer with HIFU in the absence of a tissue biopsy confirming the presence of cancer. In order to be eligible for HIFU treatment, in addition to a positive diagnosis, the patient's prostate gland must be less than 40 grams. HIFU is not appropriate on patients with multiple calcifications in their prostate because they interfere with the treatment. Because a smaller prostate gland is easier to work with, prior to undergoing HIFU treatment, patients are often prescribed Bicalutamide (also known by its brand name, Casodex) and Trelstar. Bicalutamide suppresses the uptake of testosterone and Trelstar suppresses the production of testosterone, with both drugs having the effect of shrinking the prostate gland. Side effects of these drugs include hot flashes, weakness, and a sense of a loss of well-being. Facts Related to Patient G.P. Patient G.P., a 69 year-old retiree, had a prostate biopsy performed in December 2005 after a rise in his PSA level. This biopsy was negative for prostate cancer, but Patient G.P. was diagnosed with an enlarged prostate and benign prostate hyperplasty (BPH). In May 2008, Patient G.P. learned through a physical exam for a life insurance policy that his PSA level was elevated. After another check of his PSA level in November 2008, Patient G.P. was advised to undergo another prostate biopsy. Because his first prostate biopsy was painful, Patient G.P. searched the Internet for alternatives to biopsy and learned of Respondent and his use of the 3T MRI-s at the DCD in Sarasota for diagnosing prostate cancer. Patient G.P. traveled to Florida from Michigan to meet with Respondent on January 5, 2009. Patient G.P. underwent a 3T MRI-s scan at Respondent's office. Respondent told Patient G.P. that he was unsure of the results because they were consistent with BPH and not prostate cancer. However, Respondent advised Patient G.P. was considered "high risk" because his father died from prostate cancer in 2002. Rather than undergoing any treatment at that time, Patient G.P. was prescribed Avodart for his BPH and agreed to active surveillance (A.S.) whereby he would receive regular PSA screening. When Patient G.P.'s December 2009 PSA level went up after being on Avodart for most of the year, he was concerned and telephoned Respondent's office. Respondent prescribed Casodex based upon his telephone call with Patient G.P. on January 15, 2010. By February 2010, G.P.'s PSA level decreased significantly, but not as much as he believed it should have after taking Casodex for several weeks. Patient G.P. also experienced urinary frequency problems and pain. He returned to Respondent's office where Respondent performed an ultrasound and digital rectal exam. Respondent told Patient G.P. it was likely he had prostate cancer, but that he could not be sure without a biopsy. However, Respondent's medical records reflect that Respondent diagnosed Patient G.P. as having prostate cancer without a tissue biopsy.6/ Respondent offered to do a targeted biopsy based on an MRI scan. Respondent also discussed his concerns regarding needle tracking from biopsies with Patient G.P. Patient G.P. made it clear he did not want a biopsy, and he wanted to proceed to HIFU. Respondent advised Patient G.P. of the risk of erectile dysfunction following HIFU, but did not discuss the possibility of urinary stricture problems. In April 2010, Patient G.P. traveled to Mexico where the HIFU procedure was performed by Respondent. In March 2011, Patient G.P. saw a urologist in Michigan about his diminished urinary stream and pain. The urologist used a reamer to open Patient G.P's urethra, but on April 15, 2011, he went to the emergency room because he was completely unable to urinate. Patient G.P. was catheterized and subsequently underwent electro-vaporization on April 25, 2011, to relieve the urinary stricture. In August 2011, Patient G.P. also underwent hydro- dilating in an attempt to relieve the symptoms of his urinary stricture. In September 2011, Patient G.P. saw board-certified urologist Dr. Joel Gelman, who specializes in urethral reconstruction. At that time, Patient G.P. was advised that his urinary stricture, caused by the HIFU treatment, was a significant problem because his urethra was closed off almost to the bladder neck. Dr. Gelman performed a transurethral resection of the prostate (TURP). As part of the TURP procedure, Dr. Gelman took samples of Patient G.P.'s prostate tissue and no evidence was found of prostate cancer. Although Patient G.P. had no complaints regarding his course of treatment from Respondent, Dr. Gelman filed a complaint against Respondent because he was concerned that Respondent prescribed medications and performed HIFU on Patient G.P. for prostate cancer without a tissue biopsy. Facts Related to Patient J.W. Patient J.W., a 74 year-old retired dentist, had two biopsies performed in 2005 and 2007 ordered by his urologist in Alabama in response to elevated PSA levels. No evidence of malignancy was found. Patient J.W.'s PSA level was again elevated when tested in March 2012. He was reluctant to have another biopsy because the first two were painful. Patient J.W. was told about Respondent by a friend, and he viewed Respondent's website. Patient J.W. was interested in consulting with Respondent because Respondent advertised he had an MRI machine that could detect cancer cells, and Respondent believed prostate biopsies spread cancer. Patient J.W. traveled from Alabama to meet with Respondent at the DCD on May 14 and 15, 2012. After a sonogram and MRI, Respondent diagnosed Patient J.W. with prostate cancer. Respondent discussed a treatment plan which included what Respondent called "chemical castration" for a period of six months, to be followed with a trip to Mexico for HIFU treatment at the cost of $32,000.00. Respondent did not suggest any other treatment options to Patient J.W. or recommend a tissue biopsy. The idea of "chemical castration" scared Patient J.W., who sought a second opinion in June 2012 from another urologist, Dr. M. Eric Brewer. Dr. Brewer told J.W. that HIFU was not an accepted treatment in the United States for prostate cancer. Patient J.W. declined to go forward with treatment by Respondent. Dr. Brewer recommended A.S. and, as recommended by Dr. Brewer, Patient J.W. has his PSA level checked every six months. Patient J.W.'s PSA levels have decreased without any treatment. Dr. Brewer discussed Patient J.W.'s case with his partners, the tumor board, the president of the Southeastern Urological Association, and the president of the American Board of Urology, who unanimously advised Dr. Brewer to file a complaint with Petitioner against Respondent for cancer diagnosis and recommending treatment in the absence of a pathologic specimen. Facts Related to Patient K.S. Patient K.S. is a 62-year-old video producer and editor from Tennessee. He has no family history of prostate cancer. Patient K.S. had his PSA level tested in 2005 and 2009, at which time it was considered elevated. Patient K.S. was referred to a urologist by his primary care physician. After again showing elevated PSA levels, Patient K.S. underwent a prostate biopsy in 2011 and 2012. Neither biopsy was positive for prostate cancer. However, Patient K.S. and his wife were concerned about his rising PSA level and sought a second opinion. Patient K.S.' wife was concerned that if her husband had prostate cancer, his local urologist would recommend removal of the prostate. She researched alternative treatments on the Internet and found Respondent's website. On October 15, 2012, Patient K.S. and his wife traveled to the DCD in Sarasota to meet with Respondent. Respondent initially performed an ultrasound on Patient K.S. and then told Patient K.S. he was "concerned" Patient K.S. had prostate cancer. He recommended HIFU treatment to Patient K.S. Respondent made it clear to Patient K.S. that Respondent would not perform a needle biopsy because it pushes cancer further into the prostate. Respondent told Patient K.S. that the MRI would make it clear whether Patient K.S. had prostate cancer. Later that same day, Patient K.S. had an MRI performed at the DCD. Approximately a week later, Patient K.S. received a telephone call from Respondent with the MRI results who told Patient K.S. that based on the MRI, he had Gleason 7 prostate cancer, a fairly aggressive form of prostate cancer that could be treated with HIFU in Mexico the following month. This was followed up with an e-mail from the DCD to Patient K.S. demanding a payment of $32,000.00 within three days to schedule the HIFU procedure in Mexico. Patient K.S.' wife immediately secured a bank loan for the $32,000.00 Due to the seriousness of the diagnosis and the rush for payment for HIFU, Patient K.S. visited his primary care doctor for another opinion. Patient K.S' primary care doctor, Dr. Jeffrey Jump, told him that no one can diagnose prostate cancer as a Gleason 7 without a tissue biopsy. Further, it was a "red flag" to Dr. Jump that a cash payment of $32,000.00 was expected in such a short time frame to schedule treatment. After speaking to Dr. Jump, Patient K.S. decided not to have HIFU and instead opted for A.S. Subsequent PSA level tests for Patient K.S. have shown a decrease in his PSA level. Patient K.S.' wife filed a complaint with the Petitioner against Respondent. Facts Related to Patient V.P. Patient V.P. is a 63-year-old construction worker and guide from Alaska. He has no family history of prostate cancer. In August 2013, at age 60, Patient V.P. had his first physical examination. As part of the exam, he took a PSA test, which showed an elevated PSA level of 6.3. As a result, Patient V.P. was referred to a urologist who recommended a biopsy. Patient V.P. heard from friends that prostate biopsies are painful, so he looked on the Internet for alternatives. Patient V.P. found Respondent's website, which claimed Respondent could diagnose prostate cancer without a biopsy by using new MRI technology. Patient V.P. traveled to Sarasota to meet Respondent on September 11, 2013. Respondent performed a digital rectal exam and told Patient V.P. that his prostate was much enlarged. Respondent next performed a prostate ultrasound on Patient V.P. Immediately after the ultrasound, Respondent told Patient V.P., "I'm telling you right now you have prostate cancer." Respondent provided Patient V.P. with a prescription for Bicalutamide and Trelstar, which Respondent said would wipe out Patient V.P.'s testosterone and slow the growth of the cancer. Respondent told Patient V.P. that prostate biopsies are dangerous and metastasize cancer cells. Respondent said that even though he knew Patient V.P. had cancer, he wanted an MRI to see the amount of cancer. Respondent also offered Patient V.P. the opportunity to participate in a private placement offering for a HIFU company he was forming for a minimum investment of $50,000.00. The following day, Patient V.P. had an MRI and then met with Respondent to review the results. Respondent showed Patient V.P. his MRI images and pointed to areas of concern. Respondent told Patient V.P. he had extensive prostate cancer and that Patient V.P. did not have much time to decide whether to have HIFU because the cancer was about to metastasize. Respondent told Patient V.P. to take the Bicalutamide for ten days and then return for an injection of Trelstar to atrophy his prostate and make him ready for HIFU in 90 days. At Respondent's direction, Patient V.P. began the Bicalutamide and then returned to the DCD on September 20, 2013, for a three-month injection of Trelstar. During this visit, Patient V.P. questioned the cost if the HIFU was not successful in getting all the cancer and he needed further treatment. Respondent told Patient V.P. that he "doesn't miss," but an additional treatment of HIFU would cost another $10,000.00 to $12,000.00, in addition to the $32,000.00 for the initial treatment. Concerned about these costs, Patient V.P. asked about going to Loma Linda, California, for proton therapy as an alternative. Respondent told Patient V.P. that proton therapy would cause bladder cancer and any alternative to HIFU would require a needle biopsy first. Respondent actively discouraged Patient V.P. from any non-HIFU treatment for prostate cancer. As soon as Patient V.P. questioned Respondent about alternatives to HIFU, he was suddenly fast-tracked for HIFU scheduled October 24 through 26, 2013. He was told he needed to make a $10,000.00 deposit to hold the date and the total cost was $32,000.00. Despite his concerns regarding the expedited scheduling of his procedure and the cost of the HIFU treatment, Patient V.P. returned to the office with a check for $10,000.00 to cover the cost of the deposit to hold the October treatment date. While waiting to hand the check to Respondent's receptionist, Patient V.P. overheard Respondent on a speakerphone arguing with a radiologist concerning an MRI report. Respondent was insisting the radiologist include the word "cancer" on MRI reports and the radiologist insisted it was not possible for him to make such a diagnosis. After hearing this conversation, Patient V.P. immediately left Respondent's office with his check. Patient V.P. subsequently discussed his experience with a trusted friend who practiced as a nurse in a cancer clinic. She, too, expressed concerns about diagnosing and treating prostate cancer without a biopsy. Patient V.P. was referred by this friend to Dr. Vipul Patel, a physician specializing in urologic cancer in Orlando. Patient V.P. met with Dr. Patel on October 18, 2013. Dr. Patel advised Patient V.P. that it was not possible to diagnose prostate cancer without a biopsy. Dr. Patel also disputed that prostate biopsies can spread prostate cancer. Dr. Patel performed a digital rectal exam and found Patient V.P.'s prostate to be slightly enlarged (which is not abnormal for a man of Patient V.P.'s age), normal, and smooth. Dr. Patel told Patient V.P. that he doubted he had prostate cancer. Patient V.P. then underwent a prostate biopsy by Dr. Patel, which was negative for prostate cancer. This was surprising to Patient V.P. because Respondent led him to believe, based on the MRI, that his prostate was full of cancer. Patient V.P. experienced significant side effects as a result of taking the medications ordered by Respondent. The Bicalutamide caused Patient V.P. to experience overwhelming depression, shakes, hot flashes, tunnel vision, and headaches. The Trelstar caused erectile dysfunction, increased frequency of hot flashes, night sweats, and made Patient V.P. so weak he was unable to work for eight months. Standard of Care As discussed above, the experts who provided depositions or live testimony in this case were unanimous in their conclusions that the standard of care in Florida from 2008 through 2013 precluded diagnosis or treatment of prostate cancer in the absence of a tissue biopsy. A reasonably prudent physician would not tell a patient he had prostate cancer based upon an ultrasound and/or MRI. A reasonably prudent physician would not prescribe medication, suggest treatment, or participate in treating a patient for prostate cancer, based upon an ultrasound or MRI. Respondent claims that in each of these cases, he advised the patient that a needle biopsy was the definitive test for prostate cancer, but it was a method he did not favor due to the possibility of needle tracking. Respondent's testimony in this regard is not credible in light of the credible testimony of the three patients that Respondent made clear he would not perform a needle biopsy and actively discouraged them from anything other than diagnosis by MRI and subsequent HIFU treatment. Respondent's suggestion, that he offered needle biopsy as an option, is wholly inconsistent with the title, theme, and contents of his own book, and the manner in which he defined his method of diagnosing prostate cancer at the DCD in his book and on his website. It is self-evident that a patient's perceptions regarding the safety and efficacy of needle biopsies for prostate cancer detection are at least, in part, influenced by the discussion with the physician. Respondent's active efforts to dissuade these patients from having the one definitive test for prostate cancer, by dramatically over-inflating the infinitesimally small possibility of needle tracking, were wholly inconsistent with the standard of care. Respondent claims that these four patients insisted they did not want a needle biopsy, therefore, it was appropriate to diagnose them on the basis of "a preponderance of the evidence and concordance of data" and move forward with a treatment plan, including medications and HIFU. The standard of care in Florida during 2008 through 2013, for a situation in which a patient suspected of having prostate cancer refused a needle biopsy, was to prescribe a course of A.S., including regular and frequent PSA testing, and to offer no other treatment.7/ Ultimate Factual Determinations Petitioner established by clear and convincing evidence that Respondent committed medical malpractice in his treatment of Patients G.P., J.W., K.S., and V.P. by the following violations of the standard of care: failing to obtain and review prostate biopsy results before confirming the patient had, or diagnosing the patient with, prostate cancer (Patients G.P., J.W., K.S., and V.P.); prescribing Bicalutamide/Casodex to a patient without first confirming through a prostate tissue biopsy that the patient has prostate cancer (Patients G.P. and V.P); prescribing, injecting, or authorizing the injection of Trelstar to a patient without first confirming through biopsy results that the patient has prostate cancer (Patient V.P); recommending and/or attempting to facilitate HIFU treatment without first confirming through biopsy results that the patient has prostate cancer (Patients G.P., J.W., K.S., and V.P.); and participating in, and/or assisting with the performance of HIFU treatment for a patient without first confirming through biopsy results that the patient has prostate cancer (Patient G.P.). Accordingly, Respondent is guilty of the offense defined in section 458.331(1)(t), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Respondent violated section 458.331(1)(t), Florida Statutes, as charged in Amended Administrative Complaints; imposing a fine of $30,000.00; revoking Respondent's medical license; and imposing costs of the investigation and prosecution of this case. DONE AND ENTERED this 24th day of February, 2017, in Tallahassee, Leon County, Florida. S MARY LI CREASY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 24th day of February, 2017.
