Findings Of Fact John D. Elder is a site worker at Port St. Lucie High School, having first been employed by the St. Lucie County School Board as a temporary employee in the summer of 1993. When first employed, Mr. Elder rejected the option to enroll in the employer's insurance plan. In September 1993, Mr. Elder was given an employer's insurance form allowing ninety days for enrollment. On November 12, 1993, he completed the form and became eligible for certain benefits on January 1, 1994. The St. Lucie County School Board Medical Benefit Plans, in which Mr. Elder enrolled, excludes coverge for pre-existing conditions until the end of 12 months of continuous coverage. The plans include the following definitions: A pre-existing condition is an injury, sickness or pregnancy or any condition related to that injury, sickness or pregnancy, where a diagnosis, treatment, medical advice or expense was incurred within twelve (12) months prior to the effective date of this coverage. Pre-existing condition will also include any injury, sickness or pregnancy or related condition that manifested itself twelve (12) months prior to the effective date of this coverage. Pre-existing condition will also include the existence of symptoms which would cause an ordinarily prudent person to seek diagnosis, care or treatment within twelve (12) months prior to the effective date of this coverage. (Emphasis Added.) From 1985 to 1988, Mr. Elder was treated by Dr. Urban who, on March 24, 1988, performed an electrocardiogram ("EKG"), which was normal. Dr. Urban treated Mr. Elder for respiratory illnesses, such as bronchitis and pleurisy, for back and shoulder muscle spasms, bursitis/tendonitis, and for high blood pressure. On September 21, 1988, Mr. Elder first saw Dr. Richard Dube. On that day, his heart rate was 62, as compared to the normal range of 60 to 100. In October 1988, Dr. Dube treated Mr. Elder for an inflammation of the muscle behind his shoulder. In December 1988 and January 1989, he treated Mr. Elder for high blood pressure and headaches. In July 1991, Mr. Elder called an ambulance and was taken to the hospital complaining of pain in his neck, across his shoulders, and down his arms. Among other tests, an EKG was performed. The diagnosis was tendonitis in his right shoulder. Later that same year, Mr. Elder complained of heart burn. Dr. Dube treated him for epigastric distress and high blood pressure. Blood test analyses of his cholesterol and high, low and very low density lipid levels indicated a cardiac risk factor of 10.3 for Mr. Elder, which is more than twice the standard male risk factor of 5.0. Dr. Dube ordered blood tests again in January 1993, at which time Mr. Elder's cholesterol and high density lipid levels were still high, but had decreased, reducing the cardiac risk factor to 8.0. Dr. Dube also referred Mr. Elder for an ultrasound of the gallbladder, which was diagnosed on January 29, 1993, as having calcification, which could represent a gallstone, and probably having a small polyp. At the same time he treated Mr. Elder for carpal tunnel syndrome and temporomandibular joint syndrome ("TMJ"). Most recently, on July 27, 1993, the same tests were repeated. With cholesterol in the normal range, the cardiac risk factor was decreased to 6.5. In the fall of 1993, Mr. Elder's complaints were diagnosed as episgastric reflux. To reassure Mr. Elder, Dr. Dube ordered another EKG, which was performed on November 23, 1993, and was normal. On January 3, 1994, Mr. Elder's complaints of ongoing pain caused Dr. Dube, who suspected he had a hiatal hernia, to refer him to Dr. Dan G. Jacobson for an upper endoscopy. Dr. Jacobson recorded a history of episgastric/chest pain, hypertension, ulcers and arthritis. Dr. Jacobson also noted a family history described as "remarkable for heart problems, heart attack." The admitting diagnosis was "history of episgastric pain refractory to medical therapy." Dr. Jacobson performed the endoscopy and diagnosed mild stomach gastritis. Based on a two week history of epigastric and chest pain, and his conclusion that the pain was too severe to result from the endoscopy findings, Dr. Jacobson consulted a cardiologist. Dr. Robert N. Blews, a cardiologist, saw Mr. Elder in the hospital. The history taken by Dr. Blews noted (1) that Mr. Elder's father died of a heart attack at age 68, and that his mother had coronary bypass surgery at age 48 and died at age 59, (2) that the onset of "chest tightness" was approximately one year prior, and (3) that he has a history of cervical spine disease. Dr. Blews' notes also reflected a change in the pattern of the chest pains in the last one to two months, and additional changes in the last two weeks. The longest episodes of pain were lasting from 20 to 30 minutes, with associated sweating and shortness of breath. Mr. Elder also told Dr. Blews that the pain could be with exercise, at rest, could awaken him, and occurred while he was just walking to his car. The report describes Mr. Elder as having a history of smoking. The EKG which Dr. Blews ordered on January 8, 1994 showed a major blockage on the left side of the heart, and is significantly different from all of the prior EKGs, including that taken on November 23, 1993. Dr. Blews concluded that Mr. Elder was having angina, or a decrease in the blood supply to his heart two weeks, two months, and a year before January 1994. Mr. Elder's wife, Florinda Elder, has been aware of his complaints of stomach problems for 10 years, but had no knowledge of his heart problems until January 1994. She was not aware of his having ever smoked or complained of shortness of breath. Although she was at the hospital, Mrs. Elder was not in the room when Dr. Blews took her husband's medical history. Mr. Elder's shoulder and muscle aches, and cervical spine pain are the result of a serious car accident in 1969. The pains are aggravated by cold weather. Mr. Elder claims to have been under the effects of anesthesia at the time Dr. Blews took his medical history, and denies having had a year of chest tightness, shortness of breath, or difficulty walking to his car. He has not smoked for 20-25 years, which is not inconsistent with Dr. Blews' report of a "history of smoking." Mr. Elder's attempt to undermine Dr. Blews history is specifically rejected. The McCreary Corporation is the administrator of the St. Lucie County School Board's self-insurance plan, which contracts with a consultant, Independent Health Watch. Kay Trentor, R.N., reviewed the claims submitted by Mr. Elder, and concluded that his coronary artery disease was a pre-existing condition. In part, Ms. Trentor was relying on Dr. Blews history of a year of "chest tightness." Mr. Elder's records were also sent for peer review, to two other consultant organizations, Professional Peer Review, Inc. and Medical Review Institute of America, Inc. They, in turn, sent the records to Board certified cardiologists, with cardiovascular disease subspecialties. The first report concludes that Mr. Elder "should have known that he had coronary disease because he had multiple risk factors for heart disease," and that "if he was reasonably prudent he would have had this taken care of during the time he was having chest pain walking to the car." The second peer review report also notes a year of chest tightness, with symptoms worsened "over the two months preceding the admission, but . . . not recognized as cardiac until the hospitalization on January 7, 1994." The report concludes that coronary artery disease was not diagnosed until after the effective date. The second report was prepared by Ronald Jenkins, M.D., who believes that Drs. Dube and Jacobson, "seemed to be focusing on gastrointestinal diagnoses . . . and had kind of missed the boat, so to speak . . .," but that "an ordinarily prudent person with John Elder's symptoms which he reported prior to January 1, 1994, [would] have sought medical treatment for those symptoms." Coronary artery disease takes years to develop, but is erratic in manifesting itself, with some people having no symptoms to severe symptoms over a matter of hours. Dr. Dube described it as "silent" coronary disease. Dr. Blews estimates that a heart attack is the first symptom in 40 percent of patients. There is no dispute that Mr. Elder has had other medical conditions, including TMJ, arthritis, and gastroenterological problems. Dr. Jenkins believes the most important manifestation of coronary artery disease was upper precordial chest tightness going to the left upper extremity as well as to the throat. When the history indicates that the tightness occurs with exercise, according to Dr. Jenkins that gives 90 percent confidence that it is anginal chest pain. That confidence level increases to 95 percent when he notes that Mr. Elder told Dr. Blews that chest discomfort occurs when he walks to his car. Without that history, however, Dr. Jenkins would not be able to conclude that the chest discomfort is due to heart disease or that the cardiac condition manifested itself prior to January 1, 1994. Dr. Jenkins described chest heaviness, aggravated by being in cold weather, as a symptom of coronary disease. The same pain without multiple risk factors, occuring irregularly, is a reason for "looking into other alternative diagnoses." Dr. Jenkins also acknowledges that episgastric reflux can cause chest discomfort and throat pain, and that cervical spine degenerative disc disease can cause a radiation of symptoms into the upper extremities, as it did when Mr. Elder called an ambulance in 1991. Dr. Blews did not have trouble getting a complete, detailed history from Mr. Elder. He typically has to elicit a more specific description from patients complaining of chest discomfort. He gives choices such as pain, burn, stab, jab, tight, squeeze or pressure, from which Mr. Elder chose "tight." Dr. Blews also found that Mr. Elder had chest wall pain in several spots or fibrosistitis, which is not a symptom of heart disease. Chest tightness could also be attributable to asthma, according to Dr. Blews, but with radiating pain into the left arm, jaw, and throat, shortness of breath, and sweating, he was certain Mr. Elder had heart disease. All of the doctors agree that Mr. Elder's heart disease existed before January 1, 1994, and that he had no diagnosis, treatment, medical advise or expense related to heart disease in the 12 months prior to January 7, 1994. There is no evidence that he was ever evasive or uncooperative with doctors. On the contrary, Mr. Elder was consistently described in doctor's notes and hospital records as anxious or concerned about his health. Coronary artery disease had not manifested itself to Mr. Elder or his doctors prior to Dr. Jacobson's decision to consult with Dr. Blews. "Manifest" is defined in Respondent's exhibit 9, a page from the International Classification of Diseases, 9th Revision, 1995, or ICD-9, as "characteristic signs or symptoms of an illness." The doctors who testified, in person or by deposition, described every sign or symptom experienced prior to Dr. Blews' consultation, as also being a sign or symptom of Mr. Elder's other medical conditions. Mr. Elder's symptoms might have been diagnosed as also indicating that he had heart disease, if he had been referred to a cardiologist sooner. There is no factual basis to conclude that Mr. Elder, or any ordinarily prudent person, should have sought diagnosis, care, or treatment for heart disease when, in fact, his doctor reassured him that his EKG was normal.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Respondent enter a Final Order approving Petitioner's claim for payment of medical expenses in the amount stipulated by the parties. DONE AND ENTERED this 12th day of July, 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 12th day of July, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-0373 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: Petitioner's Proposed Findings of Fact. Accepted in preliminary statement and Findings of Fact 2. Accepted in Findings of Fact 3. Subordinate to Findings of Fact 3. Accepted in Findings of Fact 22. Accepted in Findings of Fact 5-8. Accepted in Findings of Fact 5-8 and 12. Accepted in Findings of Fact 7 and 10. Accepted in Conclusions of Law. Accepted in or subordinate to Findings of Fact 6. Respondent's Proposed Findings of Fact. 1. Accepted in Findings of Fact 1 and 2. 2-3. Accepted in Findings of Fact 2. 4-5. Accepted in Findings of Fact 3. Accepted as corrected in Findings of Fact 23. Accepted in Findings of Fact 9. Accepted in Findings of Fact 8 and 9. 9-12. Accepted in or subordinate to Findings of Fact 9. 13-15. Accepted in Findings of Fact 20. Accepted in Findings of Fact 22. Accepted in or subordinate to Findings of Fact 20. Accepted in or subordinate to Findings of Fact 15-23. Accepted in preliminary statement and Findings of Fact 13. Accepted in or subordinate to Findings of Fact 14-16. Accepted in Findings of Fact 14 and 15. Accepted in Findings of Fact 16. Accepted in Findings of Fact 8. Accepted in Findings of Fact 9 and 20. Accepted in Findings of Fact 23. Accepted in Findings of Fact 17. Accepted in Findings of Fact 23. Accepted, but Dr. Dube's testimony was found credible and corroborated by his notes. COPIES FURNISHED: John T. Kennedy, Esquire The Injury Law Offices of John T. Kennedy 309 East Osceola Street Suite 306 Stuart, Florida 34994 C. Deborah Bain, Esquire Wicker, Smith, Tutan, O'Hara, McCoy, Graham & Lane, P.A. 1645 Palm Beach Lakes Boulevard Suite 700 Post Office Box 2508 West Palm Beach, Florida 33401 Frank T. Brogan Commissioner of Education The Capitol Tallahassee, Florida 32399-0400 Dr. David Mosme, Superintendent St. Lucie County School Board 2909 Delaware Avenue Ft. Pierce, Florida 34947-7299
The Issue Whether Respondent, in treating Patient #1 in 1987, failed to practice medicine with that level of care, skill, and treatment which a reasonably similar physician recognizes as acceptable under similar conditions and circumstances; and whether Respondent failed to keep written medical records justifying the course of treatment of Patient #1.
Findings Of Fact At all times relevant hereto, Respondent was licensed as a medical doctor by the Florida Board of Medicine. Respondent graduated from the University of Tehran in 1961; interned at Grace Hospital in Detroit, Michigan, in 1961-62; took Residency in Internal Medicine in 1962-65; and a Fellowship in Cardiology in 1965-67, the latter two in Detroit hospitals. He is not board- certified in Cardiology. Patient #1 (hereinafter designated as "Patient") was referred to Respondent by Dr. Barker, the company physician for General Electric Company in Largo, Florida, where Patient was employed on July 23, 1976. Patient's chief complaint was a recent weight gain, tiredness, headaches and high blood pressure. Following a physician examination of the patient, the impression of hypertension was recorded (Exhibit 2), laboratory tests were performed which included a thyroid profile; and Hydrodiruil, 50 mg., was prescribed. At a second visit one week later (July 30) Hypothyroidism was documented, a thyroid scan was ordered and Patient was told to return in one week. Patient was thereafter seen by Respondent on August 10, 1976; September 7, 1976; October 12, 1976; January, March, July and October 1977; January, April, June and November 1978; February, May and December 1979; March, June and September 1980; January, April, July and October 1981; January, April, July, September, October, November and December 1982; February, March, April, May, August, September, October, November and December 1983; January, March, April (3), June, August and November 1984; February, May, August and November, 1985; February, April, May, June, July and October 1986; January, February and March (2), 1987. In January 1982 Patient reported pain in the right shoulder and neck region. In July he reported chest pain and was prescribed nitroglycerin. In November he again reported three to five minute chest pains. No significant changes were reported in 1983. Patient was taking Synthroid daily during this period. Although not reported in doctor's notes, on December 4, 1984, a routine electrocardiogram reviewed by Dr. Paul Phillips was reported as abnormal (Exhibit 2, page 72). On the May 13, 1986, visit, a stress test was ordered for Patient which was administered 5/21/86. The test was stopped after 6.2 minutes because the exercise resulted in leg fatigue and shortness of breath. The report (Exhibit 2, page 55) shows: I. Limited aerobic capacity; II. Normal resting and exercise EKG, and III. No detectable symptomatic ischemic heart disease. A subsequent EKG taken January 7, 1987, viewed by the same doctor, was reported as abnormal (Exhibit 2, page 26). The January 15, 1987 entry in Exhibit 2 states EKG with no change. No additional tests were ordered. During the period after January 1987, the patient began experiencing more chest pains and inability to withstand exertion, although Respondent's notes for the February 23, 1987, visit states "EKG normal, walks three miles a day with no problem in the past two weeks." This information can only have come from the patient and tends to refute the patient's wife's testimony that Patient was experiencing severe chest pains in February 1987. On the other hand, the wife testified that in February 1987 they visited a son in Atlanta, Georgia, and the patient and his son went to the park to exercise. The first day the patient walked briskly without discomfort, but his pulse did not rise. The following day when he attempted the same walk, the pain was so severe he could not walk. On March 2, 1982, as noted in Exhibit 2, Patient still complained of lower sternal discomfort. An echocardiogram was ordered which, as best I can read the handwritten notes (Exhibit 2, page 40) indicates normal findings. Patient returned to Respondent's office on March 10, 1987, complaining of chest pains on and off. Procordia was ordered, and Patient was directed to return in one week. On March 11, 1987, Patient went to work as usual. When he didn't telephone his wife to say he had arrived safely, the wife called the patient who reported he had great difficulty walking from his parked car to the office and that he was in a lot of pain. On March 12, 1987, Patient did not go to work. Sometime that morning, either Patient or his wife telephoned Respondent but were unable to reach him. Word was left for Respondent to call. The call from Respondent came around 10 p.m., March 12, and Patient was advised to go to the hospital. Patient was admitted to the emergency room at Humana Hospital, St. Petersburg, Florida, at 11:53 p.m., March 12, 1987, after arriving at 10:45 p.m. On March 13, 1987, Patient had occasional chest pains and cardiac enzymes were elevated. He was medicated with Inderal, Isurdil, Xanax, Morphine and Zantac. The hospital medication chart (Exhibit 3, page 15) shows Patient was administered Nitroglycerine at 0330, 0805 and 1830; that he was administered Morphine Sulphate at 0923 and 1530; Demoral at 0810; Lasix at 1930; and Heparin at 1940. Exhibit 3 on page 16 indicates Patient received Inogral, Isordil, Maalox, Zomax, Zantac and Tigen, but does not indicate when. Exhibit 3, Page 17 indicates Patient received D5W, Dopamine, Heparin, Lanoxin and Varapimal on March 13, 1987. The patient remained in the Emergency Room until 2030, March 13, due to no bed available. He apparently suffered a massive heart attack around 7:45 p.m. while in the Emergency Room. Nurses notes for March 13, 1987, indicates Patient was sleeping during the early morning hours, was given Nitroglycerine at 0330 for chest pain and Morphine Sulphate at 0400; at 0730. Patient appeared in no discomfort; at 0805. Patient complained of pressure sensation in midsternal area and was medicated with Nitroglycerine but continued to complain of chest discomfort and was given Demoral; at 0930 Patient complained of heart burn after eating breakfast relieved with burping; at 1010 Patient complained of slight chest pressure, given Nitroglycerine; seen by Respondent and wife at 1045 and 1400; 1530 complained of pain and was given Morphine Sulphate; 1815 vomited two basins full; 1830 Patient sweating profusely (diaphoretic), given Nitroglycerine, and at 1845 Morphine Sulphate for chest pain and discomfort; at 1850 an emergency EKG was done and Respondent was paged; at 1905 EKG reviewed and Dopamine drip began; at 1920 Dopamine drip increased 10 cc.; 1930 Lasix administered; 1940 Heparine administered, 7500 units IVP; 2000 Dopamine increased to 15 cc.; 2015 Lanoxin given and Dopamine increased to 25 cc.; 2030 patient vomited approximately 500 cc. reddish fluid; 2035 Verapamil given; 2110 Lanoxin 25 mg. repeated and Dopamine increased to 35 cc.; 2125 patient extremely restless, respiration labored - Valium and Atropine given; and code called. Discharge summary shows that at 1945 Patient developed acute respiratory distress, profuse perspiration and no chest pain. The patient was intubated, subclavian catheter was inserted in the right atrium, Patient was given full CPR, Epinephrine injection and intravenous bicarbonate. Patient expired at 2219. Petitioner's expert witness opined that prior to January 1987 Respondent's treatment of the patient met the prescribed standard of care for physicians, but subsequent thereto it did not. This opinion is predicated upon the worsening of Patient's condition in January, February and March 1987. Although there was an abnormal EKG in 1984, no evidence was presented that this EKG changed when subsequent EKGs were taken. Respondent's notes state no change in the EKGs taken through January 15, 1987. The entry made January 15, 1987, specifically found no change in EKG. Abnormal EKGs were reported in 1984 and on January 7, 1987. No evidence was presented to contradict the July 15, 1987, entry that there was no change in the EKG. The increase in cardiac enzymes found March 13, 1987, is evidence that damage to the heart muscle had occurred. Petitioner's expert faults Respondent for not ordering an angiogram at this time to determine the condition of the blood vessels to and from the patient's heart. Despite the fact that Patient was at Humana Hospital which did not have a cardio-cath lab, Petitioner's expert opined that the patient should have been transferred to a tertiary care hospital in the area with such facilities. Respondent, on the other hand, contends that invasive procedures at that time would have been fatal to this patient. In his testimony Respondent opined that the patient had chronic stable angina before he was even forty. Further, that the patient fit in the category of the population with a single coronary artery disease that have a malignant course; that this patient, who had this type of artery disease, was foredoomed to die, and nothing could have saved him, and that any invasive procedure would have resulted in the death of the patient. Respondent contends that the autopsy report confirms this opinion. Despite this testimony a majority of the publications presented by Respondent as late-filed exhibits contained discussions regarding the treatment of patients with unstable angina. Petitioner's expert witness opined that the rapidly deterioration of the patient on March 11, 1992, clearly demonstrated the patient needed to be hospitalized and invasive procedures initiated to determine the condition of the patient's arteries. It is the failure to initiate such procedures that rendered the treatment of this patient below the minimum acceptable standards of treatment recognized by a reasonably prudent similar physician as being acceptable under similar circumstances and conditions. Petitioner's witness further opined that the physician's records regarding this patient were insufficient to justify the course of treatment of the patient. This opinion was based upon the fact he found Respondent's records "rather limited, often almost illegible, and did not really reflect the collection of subjective and objective data that could lead one then to follow the process of evaluation and management of either gastrointestinal problems or cardiac problems." He further concluded that these records did not reflect a cardiac diagnosis of the patient.
Recommendation It is recommended that a Final Order be entered finding Si H. Azar guilty of violation of Section 458.331(t) and not guilty of violating Section 458.331(1)(m), Florida Statutes; that he be placed on probation for a period of three years under such terms and conditions as the Board of Medicine deems appropriate; and that he be required to take additional continuing education courses in the use of invasive procedures and in diagnosis and treatment of cardiac patients. ENTERED this 2nd day of, July 1992, in Tallahassee, Florida. K. N. AYERS Hearing Officer Division of Administrative Hearings The Desoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of July, 1992. COPIES FURNISHED: Michael K. Blazicek, Esquire Jack McRay, Esquire Department of Professional General Counsel Regulation Department of Professional 730 S. Sterling Avenue Regulation Tampa, FL 33609-4582 1940 N. Monroe Street Suite 60 Si H. Azar Tallahassee, FL 32399-0792 3820 Gulf Boulevard, Apt. 1003 St. Petersburg Beach, FL 33706 Dorothy Faircloth Executive Director Board of Medicine Northwood Centre 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0792
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.
The Issue Whether disciplinary action should be taken against Respondent's license to practice medicine based on allegations that Respondent violated the provisions of Subsections 458.331(1)(m) and (t), Florida Statutes, arising from his treatment and care of Patient M.R., as alleged in the Administrative Complaint in this proceeding.
Findings Of Fact Effective July 1, 1997, Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes, and Chapters 456 and 458, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME 0077248. Respondent is a vascular surgeon, who is not board-certified in his area of practice. On November 27, 2000, Patient M.R., a 70-year-old male, was admitted to ORMC for a right-side carotid endarterectomy. Patient M.R. initially presented to Respondent in October 2000 with a number of health conditions, including chronic obstructive pulmonary disease (related to a 54-year history of smoking), cerebral vascular disease, atherosclerotic changes, and hypertension. Patient M.R. had a significant cardiac condition which resulted in a bypass procedure. It was determined at that time that Patient M.R. had significant stenosis in both carotid arteries which would require Patient M.R. to undergo two separate procedures, known as carotid endarterectomies. The left carotid artery was the subject of the first procedure in October 2000. Patient M.R. tolerated this procedure with no complications. Subsequent to the first carotid endarterectomy, but prior to the second, Patient M.R. suffered a transient ischemic attack (TIA), which is commonly referred to as a "mini-stroke." The symptomatic clinical presentation placed Patient M.R. in a high-risk category for peri-operative stroke. Respondent performed a right carotid endarterectomy on Patient M.R. on November 27, 2000. This requires the clamping of the artery in two locations, using a shunt to allow for the flow of blood. The incision must be made length wise in the controlled portion of the artery using an instrument to clear out the interior or lumen of the artery. This is done to reduce the stenosis and allow for better blood flow, without disbodying any particle from the wall of the artery. Once this is completed, the incision is patched, the clamps and shunt are removed, and the outer skin incision is closed. During the course of the above-described carotid endarterectomy, Respondent used a patch angioplasty with intra- operative shunt, which was manufactured from a pediatric feeding tube, and peri-operative neurologic monitoring. Immediately after the operation, the patient appeared to tolerate the procedure well, but was lethargic. Patient M.R. exhibited good movement in all four extremities and appeared to be neurologically intact, although he underwent extreme fluctuation in blood pressure. Patient M.R. was placed on ventilator support. The next morning, November 28, 2000, Patient M.R. had swelling and a hematoma in his neck on the right side, in the area of the incision. Respondent returned Patient M.R. to surgery, for exploration and evacuation of the hematoma. During the course of this second operation, Respondent observed a lot of swelling and edema in the operative site, but not much blood. Respondent evacuated the hematoma, and the carotid artery was found to have good blood flow. Later in the evening on November 28, 2000, Patient M.R. developed an acute neurologic deficit and was returned to the intensive care unit (ICU) at ORMC. Respondent ordered a Computerized Tomographry Scan (CT Scan) of the patient and an arteriogram. The results of the CT Scan showed a probable right occiptal infarct (stroke). The arteriogram showed significant occlusion of the right carotid artery extending to the carotid siphon. Patient M.R. was returned to the operating room in the early morning hours of November 29, 2000. Respondent made the decision to reopen the surgical area in an effort to resume blood flow in the right carotid artery that was seen to be occluded on the angiogram. Assisting Respondent on this November 29, 2000, procedure were John Horowitz, M.D., a board- certified vascular surgeon with nine years of experience, and Joseph Muller, M.D., a third-year general surgical resident at ORMC. During the November 29, 2000, procedure, Respondent reopended the previous incision in the skin and partially opened the patch that had previously been used over the carotid artery itself. Respondent performed a thrombectomy using a Fogarty "balloon" catheter in an effort to extract any debris that was causing the stenosis in the carotid artery. The balloon is placed into the carotid artery itself and is pushed up into the artery until it has passed whatever occlusion is present. Then the balloon is inflated and pulled back out, pulling with it any debris that is located within the artery. Near the conclusion of this November 29, 2000, procedure, a small piece of tubing was discovered in the surgical field. The piece of tubing was handed to Dr. Horowitz, who examined it and then placed it on the surgical tray. This piece of tubing was the same size, slope, and material cut from the feeding tube which was used as a shunt in the first surgery on November 27, 2000. There is conflicting testimony regarding the precise size and location of this piece of tubing that will be discussed below. What remains undisputed based upon the record in this case is that Respondent completed the surgical procedure on November 29, 2000, by closing the incision in the carotid artery and also in the skin of the neck. Dr. Muller is currently a surgical resident at ORMC, as he was at the time of the November 29, 2000, procedure. Dr. Muller testified that he had approximately two years and five months of residency training prior to the procedure in question. He estimated that he had observed approximately ten to 15 carotid endarterectomies. Dr. Muller testified that he observed a clear and slightly opaque piece of pediatric feeding tube coming out of the lumen of the artery as Respondent was evacuating debris after the inflation of the Fogarty balloon catheter and after about three passes of the catheter. Dr. Muller also testified that the piece of tubing in question was two or three centimeters in length. The other witnesses to this event testified that the piece in question was two to three millimeters in length. Dr. Muller's description of the position of the surgeon and assistant surgeon was also contrary to that of the other witnesses. Dr. Muller also testified that he did not know Patient M.R.'s medical history or his previous hospital course of treatment. Dr. Horowitz, the senior physician assisting, is a board-certified vascular surgeon who has performed several hundred carotid endarterectomies. He testified that he was called in by Respondent to assist on the surgical procedure which took place in the early morning hours of November 29, 2000. He found the piece of tubing located somewhere within the surgical field, remote from the carotid artery. He was certain that it was after Respondent had cleared the artery with the use of the Fogarty balloon catheter and had cleared the surgical wound. Dr. Horowitz testified that he saw a piece of tubing among the debris that had been evacuated from the surgical wound. It was not in the lumen of the artery. He picked up the piece of tubing in question with his thumb and forefinger and examined it. He testified that it was approximately two to three millimeters in length. He agreed that the material was consistent with the pediatric feeding tube that was used to create a shunt for the first procedure. Dr. Horowitz's testimony is credible and persuasive. Dr. Horowitz also gave his opinion that based upon his observation of the November 29, 2000, procedure, he did not believe that Respondent deviated from the standard of care in his treatment and care of Patient M.R. Patient M.R. was returned to the ICU, where he deteriorated and showed evidence of complete lack of brain stem reflexes. Patient M.R. was later pronounced brain dead, and he subsequently died on November 30, 2000. Gregory Schreiber, M.D., was the anesthesiologist who was present for a portion of the November 29, 2000, procedure. Dr. Schreiber testified that he was present during the beginning portion and the end portion of the procedure, when anesthesia is introduced and when anesthesia is abated. He was not present in the operating room when the piece of tubing was found. Further, there was a drape that separates the operative field from the anesthesiologist during the course of this procedure, which would have prevented Dr. Schreiber or his assistant from being able to see into the operative field directly. Dr. Schreiber noted that Patient M.R. was considered a very high-risk patient, whose multiple co-existent diseases posed a constant threat to his life when he presented for this surgery. In addition to the testimony outlined above, Petitioner also introduced three affidavits into evidence. One affidavit was that of Lata Bansal, M.D., a neurologist who was brought in for consultation after the November 29, 2000, procedure. Dr. Bansal swore in her affidavit that when she first saw Patient M.R. he was already brain dead. She otherwise did not have specific recollection of Patient M.R. The affidavit of Peter D. Taylor, M.D., a cardiac specialist, stated that he recommended a Thallium stress test for Patient M.R. prior to carotid surgery. The stress test was conducted on October 17, 2000, and revealed no ischemia but moderately decreased left ventricle function. Because he had no ischemia, Dr. Taylor opined that Patient M.R. was at an increased but acceptable risk for carotid surgery. The affidavit of Marita Lu, Registered Nurse, who was present during the November 29, 2000, procedure, stated that she could remember very few details of Patient M.R.'s case, other than she has the "impression" that something was recovered from the wound and that when she asked whether there was a specimen, she was told there was no specimen. Nothing in her affidavit indicates to whom she asked this question regarding the specimen nor is there any indication who responded to her question. Respondent is a board-certified general surgeon who is eligible for a special certification in vascular surgery and who was working at a vascular surgery group in Orlando, Florida, as of October and November of 2000. Respondent no longer practices in the State of Florida. He currently is an assistant professor of surgery and director of endovascular surgery at Creighton University in Omaha, Nebraska. Respondent described in detail each of the three procedures he performed. On November 27, 2000, the original procedure on the right carotid artery proceeded in routine fashion. Respondent provided an exemplar, which was admitted into evidence, of a pediatric feeding tube which is substantially similar to the pediatric feeding tube utilized in the November 27, 2000, procedure on Patient M.R. He utilizes a portion of the pediatric feeding tube as a shunt in his carotid endarterectomy procedures. He demonstrated at the final hearing that the pediatric feeding tube itself is so flexible as to be incapable of breaking. The only means of cutting it down is through the use of surgical instruments. He also indicated that there was no way to further cut down the tubing once it had been placed. The scrub technician cut the pediatric feeding tube into the appropriate length to be used as a shunt during the November 27, 2000, procedure. Respondent recalled that prior to this particular procedure, the tubing in question was not originally cut down to the appropriate size. It had to be cut down while in the operating room. It is during this cutting of the tubing that a tiny sliver, approximately two to three millimeters in length, was removed from the larger piece of tubing and entered the surgical field. Respondent did not know and did not have any way of knowing that the piece of tubing had entered the surgical field, as he was focused on preparing the artery itself for its incision while this tubing was cut. Respondent testified that the pediatric feeding tube in question was cut down to size before any incision was made in the carotid artery itself. Respondent performed the November 27, 2000, procedure as he normally does. After the procedure, Patient M.R. experienced extreme fluctuations in blood pressure. This can occur in patients due to multiple factors involving the nervous tissue and blood flow in the carotid artery, but there is no specific explanation for why it does happen. Subsequent to the November 27, 2000, procedure, Respondent monitored Patient M.R., addressing the extreme fluctuations in blood pressure along with the consulting physicians referred to above. Respondent noted that Patient M.R. developed a hematoma subsequent to the first procedure. He made a determination that the best course for Patient M.R. would be to evacuate the hematoma. In Respondent's opinion, evacuating the hematoma would speed up the healing process. Respondent performed this procedure on November 28, 2000. Patient M.R. tolerated this procedure well, and there was nothing remarkable about the procedure itself. Respondent palpated Patient M.R.'s artery during the course of this procedure and used the Doppler to reinforce his findings on palpation. A Doppler signal gives more specific information about the varied nature of blood flow in the internal and external carotid arteries. It was not Respondent's standard practice, nor is it necessary, to create a medical record that palpation of the artery has occurred, since it is such a basic and common occurrence that its notation on the record is not deemed to be necessary. Respondent continued to follow Patient M.R. subsequent to the November 28, 2000, procedure. When it was determined that Patient M.R. had suffered a stroke, Respondent was left with a choice of either doing nothing, or reopening the artery in an effort to save Patient M.R.'s life. Respondent chose to reopen the artery in an effort to determine whether anything could be done to save Patient M.R. Respondent opened the prior incision in the carotid artery on November 29, 2000, and inserted the Fogarty catheter in order to evacuate any debris that was located within the carotid artery. Respondent testified that it was at about this time that the piece of tubing was found; however, he further testified that he did not see the tubing in question come from the lumen of the carotid artery. Respondent's testimony is credible. It was Respondent's opinion testimony that the piece of tubing in question was located in the subcutaneous tissue outside of the artery. Its exact location within the various layers of subcutaneous tissue was not observed during the procedure. It was not possible for the piece of tubing in question to have entered the artery at this time. There was no evidence to suggest that the piece could have migrated into the artery at a later time. James Dennis, M.D., is a board-certified vascular surgeon who is the chief of the vascular surgery department at the University of Florida in Jacksonville, Florida. Dr. Dennis has sufficient education, training, and experience to qualify as an expert in vascular surgery under Florida law. Dr. Dennis testified that he reviewed all of the pertinent medical records concerning the treatment and care provided by Respondent to Patient M.R. and that based upon his review of these records and based upon his education, training, and experience, it was his opinion to within a reasonable degree of medical probability that Respondent deviated from the accepted standard of care in his treatment and care of Patient M.R., which constituted a violation of Subsection 458.331(1)(t), Florida Statutes. Dr. Dennis also testified that in his opinion, Respondent violated Subsection 458.331(1)(m), Florida Statutes, in that he failed to compile appropriate medical records reflecting the treatment and care provided to Patient M.R. Dr. Dennis' standard of care opinions were based on several factors. First, it was Dr. Dennis' opinion that based upon the contents of the chart, the only time that the piece of pediatric feeding tube could have entered Patient M.R. was during the course of the November 27, 2000, procedure. Dr. Dennis testified that in his opinion, Respondent deviated from the standard of care in allowing the piece of pediatric feeding tube to enter Patient M.R.'s body. This would be his opinion even if Respondent did not see the sliver of tubing in question enter Patient M.R.'s body and even if the piece of tubing in question were so small and translucent as to be practically invisible. Dr. Dennis also testified that in his opinion, Respondent deviated from the standard of care during the November 28, 2000, procedure in that he failed to adequately palpate the carotid artery. Dr. Dennis was critical of Respondent's use of a Doppler to assess Patient M.R.'s pulse. In Dr. Dennis' opinion, the use of the Doppler was indicative a weakening pulse rate and that the proper practice would have been to palpate the artery by touch rather than by using a Doppler instrument. Dr. Dennis was also critical of Respondent during the November 28, 2000, procedure for his failure to find the piece of tubing in question. It is Dr. Dennis' opinion that the piece of tubing had to have been located within the lumen of the artery and that had Respondent adequately palpated the entire length of the carotid artery during the November 28, 2000, procedure, he would have located the piece of tubing within the artery and could have taken appropriate steps to remove the piece of tubing before Patient M.R. suffered his stroke later that night or during the early morning hours of November 29, 2000. Dr. Dennis' opinion that the piece of tubing in question had to have been located in the lumen of the artery was also based upon his assessment of the procedures performed. He discounted the theory that the piece of tubing was located within subcutaneous tissue outside of the artery because, in his opinion, the piece of tubing would have been discovered either during the November 28, 2000, procedure or earlier in the November 29, 2000, procedure if it had been outside the artery. However, according to Dr. Dennis, based upon the timing of when the piece of tubing was found, the tubing itself had to have been located within the lumen of the artery until it was removed in the November 29, 2000, procedure. Dr. Dennis also rendered the opinion that not only was the piece of tubing located within the lumen of the carotid artery, but that the piece of tubing is directly related to the stroke which Patient M.R. suffered later that day or the following morning, which caused his death. Dr. Dennis testified that the piece of tubing became lodged in Patient M.R.'s carotid artery and that as blood flowed by it, platelets attached to the tubing, slowly building up with the carotid artery, until Patient M.R. experienced 100 percent stenosis in the right carotid artery, leading to his stroke. In sum, Dr. Dennis' opinion was that Respondent deviated from the standard of care by allowing a piece of tubing to enter Patient M.R.'s carotid artery and that it was this tubing which lead to Patient M.R.'s stroke and ultimately his death. This is in spite of the fact that Dr. Dennis was not able to state within any degree of medical probability how the sliver of tubing could have entered the artery. Dr. Dennis also rendered an opinion during his final hearing testimony that Respondent deviated from the standard of care because he did not secure the piece of tubing at issue in this case and see to it that the tubing was sent to the pathology laboratory at ORMC for analysis. Morris Kerstein, M.D., a board-certified vascular surgeon, reviewed all of the pertinent medical records reflecting the treatment and care Respondent provided to Patient M.R. Dr. Kerstein had been practicing for 35 years, and he is currently the chief of the vascular surgery department at the Veteran's Administration Hospital in Philadelphia, Pennsylvania. Dr. Kerstein has sufficient education, training, and experience to qualify as an expert in vascular surgery under Florida law. Dr. Kerstein's opinion based upon his education, training, and experience is that Respondent did not deviate from the standard of care in his treatment of Patient M.R. First, Dr. Kerstein testified that in his opinion, Respondent's conduct during all three procedures at issue was appropriate. As to the November 27, 2000, procedure, there was no way for Respondent to be aware that the piece of pediatric feeding tube had entered the operative field. It was too small to be noticed, and it was of a translucent color which made locating it extremely difficult. He was not critical of Respondent for not cutting the tubing himself. He testified that if, in fact, the sliver of tubing entered the surgical area as a result of the scrub technician cutting the tubing, and a two to three millimeter fragment jettisoned into the surgical field, this would not constitute a deviation from the standard of care by Respondent. Dr. Kerstein testified that he felt the November 28, 2000, procedure was performed appropriately as well. He testified that it was not a deviation for Respondent to use a Doppler to feel for pulses in the arteries, and to the contrary, it reveals that Respondent was being meticulous beyond what the standard of care requires. He opined that Respondent certainly would have palpated the arteries in question, and to suggest otherwise based on the absence of a note to that effect is not an appropriate conclusion to draw. Dr. Kerstein rendered the opinion that he did not believe that the piece of tubing in question was located within the lumen of the artery of Patient M.R. He testified that there was no way for the tubing to enter the artery because the sliver in question came off of the longer tubing before an incision was made in the carotid artery. There is therefore no reasonable explanation as to how the piece in question could have entered the carotid artery in the first place. Dr. Kerstein also disputed the theory that not only was the piece of tubing located within the lumen of the artery, but also the piece in question actually caused Patient M.R.'s stroke. Dr. Kerstein relied principally on the radiographic studies. Both the CT Scan of the brain and the angiogram taken late in the evening of November 28, 2000, revealed a right posterior occipital infarct. The posterior of the brain is the back of the brain, and if the infarct was located there, it means that the cause of the stroke had to be something other than an occlusion in the carotid artery. This is because the arteries that feed the back portion of the brain are the basilar and vertebral arteries, not the carotid artery. Therefore, there could be no possible causal connection between the sliver in question and Patient M.R.'s stroke. Dr. Kerstein's opinion as to the cause of Patient M.R.'s stroke focused on his personal history rather than on the events of November 27, 2000. He noted that Patient M.R. presented with severe atherosclerotic changes, indicative of an advanced disease process. He noted that Patient M.R. suffered from chronic obstructive pulmonary disease, which was the product of his 54-year smoking history. He also noted Patient M.R.'s significant cerebrovascular disease. He also stated that thrombosis (or clotting of the blood) is a known complication of this procedure and can happen for several plausible reasons other than a sliver of tubing in the artery. All of these conditions conspired to predispose Patient M.R. to suffer a significant event such as the stroke he suffered on November 28 through 29, 2000. Dr. Kerstein also noted that the piece of tubing was completely inert, and given its size and its location in the subcutaneous tissue outside of the carotid artery, the tubing would have had no impact whatsoever on Patient M.R.'s prognosis. The tubing in question is an example of inert material that can remain inside the body, such as the case of a bullet which is located too close to the spinal cord to allow for an operation to remove it, without causing the body any harm. Dr. Kerstein had no criticism of the medical records Respondent kept regarding the treatment he provided to Patient M.R. He specifically noted that the records were accurate and honestly reflected what had occurred during the procedure. The fact that no foreign object was noted in the first two procedures was appropriate because at that point, he had no reason to suspect the presence of a foreign object. The lack of reference to a cause of Patient M.R.'s atypical post-operative course was appropriate because in fact Respondent could not have defined a single reason why Patient M.R. was reacting the way he did. Finally, the operative note from the November 29, 2000, procedure was appropriate, as it also honestly and accurately depicted what had occurred; he made a specific comment on Respondent's note that the sliver was not indeed from the lumen, but that the exact location was unclear, finding this to be an unambiguous statement of fact. Dr. Kerstein also disagreed with the state's position with regard to the responsibility for maintaining possession of the piece of tubing post-operatively. Dr. Kerstein testified that it was the responsibility of the circulating nurse, an employee of the hospital, to arrange for the piece of tubing to be sent to the pathology lab for examination. The evidence is insufficient to support Petitioner's contention that the pediatric feeding tube sliver at issue caused Patient M.R. to suffer a stroke because of its location within the carotid artery itself. Radiographic studies were performed on Patient M.R. after the stroke. A CT Scan performed on November 28, 2000, revealed an acute right posterior cerebral artery distribution infarct. Further, a cerebral angiogram was performed on November 28, 2000, and revealed "markedly diseased circulation particularly in the right vertebral and basilar arteries." This note also revealed: "Severely diseased posterior fossa circulation." Based upon the location of the infarct in Patient M.R.'s brain, the cause of the stroke had to have been either the vertebral or basilar arteries that supply blood to the posterior part of the brain. In view of all the evidence, the expert testimony of Dr. Kerstein, together with that of Dr. Horowitz, was more persuasive than that of Dr. Dennis in regard to the standard of care and Respondent's actions in this matter.
Recommendation Based on all the evidence of record, it is RECOMMENDED that the Board of Medicine enter a final order holding that the evidence is not clear and convincing that Respondent has violated either Subsections 458.331(t) or (m), Florida Statutes, in his treatment of Patient M.R. and that the Administrative Complaint be dismissed. DONE AND ENTERED this 9th day of June, 2003, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE 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 9th day of June, 2003. COPIES FURNISHED: Michael D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A. 390 North Orange Avenue Suite 1000 Orlando, Florida 32802 Daniel Lake, Esquire Department of Health 4052 Bald Cypress Way Bin C-65 Tallahassee, Florida 32399-3265 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
Findings Of Fact I. Respondents Are Licensed General Surgeons. At all times material hereto, respondents SPIEGEL and EBKEN were licensed to practice medicine in Florida as general surgeons. They practiced as a professional association, with offices located at 9299 Coral Reef Drive, Miami, Florida. They worked closely together, frequently assisting each other in surgical procedures. The respondents are charged with professional misconduct in connection with surgery they performed on Caroline Pedraza, 25, respondent SPIEGEL's patient. (Hereafter she will be referred to as "the Patient.") In four separate courts, the DEPARTMENT accuses them of failing to conform to standards of acceptable and prevailing medical practice in their area of expertise (general surgery). Count I alleges that respondent SPIEGEL, assisted by respondent EBKEN, surgically removed the Patient's uterus (a procedure commonly referred to as a hysterectomy) together with her right ovary, and that, based on what respondent SPIEGEL knew of the Patient's medical history and symptoms, such surgery was unjustified and unnecessary. II. Count I: Removal of the Patient's Uterus and Right Ovary The Patient first saw respondent SPIEGEL on August 1, 1977, pursuant to a referral by Marilyn Marcus, M.D., a general practitioner who also practices office gynecology. As explained by the Patient, Dr. Marcus had referred her to respondent SPIEGEL for a hysterectomy, subject to his decision that such an operation was appropriate. (Testimony of Spiegel; P-3) Upon questioning, the Patient appeared to be troubled and uncomfortable. She complained of irregular menses; severe pain, cramps, and blood spotting during menses; headaches before and during menses; and severe pain during sexual intercourse ("dyspareunia"). She explained that she had experienced these symptoms since her sterilization (by tubal ligation) three years earlier; that a D and C ("dilation and curettage," a procedure by which the cervix is dilated and the inside of the uterus is curetted to obtain tissues for pathologic diagnosis) had been performed on her one year earlier and fibroids had been removed; and that her last menses had lasted three weeks. Respondent SPIEGEL then physically examined her. (Testimony of Spiegel; P-3) His examination revealed, and his office notes document, that the lower portion of the Patient's abdomen was tender. Pelvic examination indicated that her external genitalia, the Bartholin, and the urethra were normal; the cervix showed chronic cystic cervicitis; the ovary (right or left) was of normal size but tender; and the uterus was large, retroverted and retroflexed. When a uterus is retroverted and retroflexed, it is tipped backwards, can impinge on the colon, and is frequently associated with symptoms similar to those complained of by the Patient. (Testimony of Spiegel; P-3) The uterus serves to carry babies and is vital to the birthing process. When a female is sterilized, the uterus no longer serves a useful purpose. Rather, it remains and becomes a potential source of bleeding, infection and cancer. Based on the Patient's complaints and his physical examination, respondent SPIEGEL recommended that she have a hysterectomy, reasoning that removal of the uterus would end her dysfunctional uterine bleeding and cramps; that the Patient's symptoms had been chronic and progressive during the last three years; and that a D and C had previously been performed and fibroids removed. The Patient agreed to the operation and appeared pleased to have some potential for relief. (Testimony of Spiegel, Ebken; R-3) On August 9, 1977, several days later, respondent SPIEGEL admitted her to Miami-Dade General Hospital for the purpose of performing the hysterectomy. The next day he performed the operation and, at his request, respondent EBKEN acted as a surgical assistant. Respondent EBKEN functioned solely as a surgical assistant in this operation; his role was narrow and limited. He did not know the patient, had not talked with her prior to her admission, and was unfamiliar with her medical condition. His lack of knowledge about the Patient was consistent with prevailing and acceptable standards of medical care governing general surgery, which do not require surgical assistants to examine the patients prior to surgery, review their records, or ascertain whether the surgery is justified or necessary. (Testimony of Caster, Ebken, Spiegel) Before performing the hysterectomy on the Patient, respondent SPIEGEL performed a D and C to check for cancer -- the result was negative. (If a cancer had been discovered, he would have first treated the uterus with radiation therapy.) As a precaution he also performed a pregnancy test. Then he commenced surgery. On opening the Patient, respondent SPIEGEL noted that the left ovary looked normal, but that the right ovary was enlarged and appeared to have a corpus lutiem cyst. He judged it appropriate to remove the right ovary, the tubes, and the uterus, but leave the left ovary intact. (Testimony of Spiegel; P-3) He removed the right ovary because it was cystic and enlarged. Normal ovary size is 4 centimeters, which it exceeded. Further, when he manipulated the ovary, it was friable or bled -- an abnormal condition. (Testimony of Spiegel; P-3) The DEPARTMENT contends that respondent SPIEGEL is guilty of misconduct, claiming that the right ovary and uterus were normal and that the operation was unnecessary and unjustified. This contention is unsupported by the weight of the evidence, and is rejected. Under the circumstances of this case, removal of the Patient's uterus and right ovary conformed to, and did not deviate from, standards of acceptable and prevailing medical practice in the area of general surgery. Respondent SPIEGEL's decision to recommend and perform a hysterectomy was consistent with the Patient's complaints, symptoms and medical history; it was a reasonable and permissible exercise of medical judgment. During the operation, the right ovary was observed to be abnormal, enlarged, cystic, and friable. The decision to remove it was also a reasonable, justifiable and permissible exercise of medical judgment. (Testimony of Spiegel, Ebken; R-3) Respondent EBKEN, as a surgical assistant, assisted with the operation. He observed that the Patient's uterus looked normal, but did not protest or question respondent SPIEGEL concerning the purpose or necessity of the operation. (Testimony of Ebken, Spiegel) Respondent EBKEN's conduct as a surgical assistant was proper and conformed to standards of acceptable and prevailing medical practice in the area of general surgery. The primary surgeon is the decision maker in the operating room; an assisting surgeon may give advice, but his main role is to provide assistance to the primary surgeon. A patient's uterus may (and often does) look totally normal on an operating table, yet is properly removed. The decision to remove is arrived at by using a variety of diagnostic tools other than visualization. (Testimony of Spiegel, Ebken; R-3) The DEPARTMENT contends that respondent EBKEN has a medical duty to protest or question respondent SPIEGEL about the necessity for the hysterectomy because the uterus looked "normal." This contention is also unsupported by the weight of the evidence and is rejected. The testimony of Milton P. Caster, M.O. on this question is equivocal and unconvincing. Acceptable and prevailing standards of medical practice in the area of general surgery did not impose such a duty on respondent EBKEN. The retroverted uterus, alone, could have caused some of the symptoms complained of by the Patient and provided justification for its removal. Finally, given the symptoms and medical history of the Patient, the surgery performed by respondent SPIEGEL conformed to prevailing and acceptable standards of medical practice; it follows that respondent EBKEN cannot be guilty of misconduct by virtue of his surgical assistance. (Testimony of Joseph, Spiegel, Ebken; R-3) III. Count II: Performance of Bilateral Subcutaneous Mastectomy In Count II, the DEPARTMENT charges that respondent SPIEGEL, assisted by respondent EBKEN, performed a bilateral subcutaneous mastectomy (removal of internal breast tissue without damaging skin or nipple) on both breasts of the Patient; that this surgery was unnecessary; that neither respondent SPIEGEL nor EBKEN explained the possible adverse effects of surgery to the Patient; and that respondent EBKEN provided surgical assistance without questioning the need for the surgery. Such conduct, the DEPARTMENT alleges, violated acceptable and prevailing standards of medical practice in the area of general surgery, in violation of Section 458.331(1) Florida Statutes (1981). Respondent SPIEGEL next saw the Patient on August 19, 1977, when she came to his office complaining of soreness when she slept on her abdomen and a mass or lump on her left breast. Upon examination, he detected a lump or mass at 2 o'clock on her left breast, preliminarily diagnosed it as fibrocystic disease, and told her to return in two weeks for reexamination. (Testimony of Spiegel; P-3) On September 6, 1977, she returned to his office complaining of a week-long headache, and pain in her left breast. Explaining that she had a family history of breast cancer, she was nervous and jumpy. His examination of her left breast indicated that the lump was larger, dominant, and more tender. Because the lump had become larger and more defined, he recommended a biopsy, to which she agreed. He explained that the biopsy would lead to one of three alternatives. First: If, on examination, the pathologist determined that the breast lump was benign, they would close the incision and send her home. Second: If, instead, the tissue is found to be malignant (cancerous) he recommended the immediate performance of a radical mastectomy--removal of the entire breast, including the skin, nipple, and the pectoralis major and minor chest muscles. He explained that there were alternative cancer treatments which would cause less disfigurement -- radiation, lumpectomy, and a modified radical mastectomy -- but that, in his opinion, the radical mastectomy was the most statistically effective method for eliminating breast cancer. She agreed that if her breast was found to be cancerous, he should immediately perform a radical mastectomy. Third: If the pathologist, for one reason or another, is unable to definitively determine whether the breast lump is benign or cancerous, no further surgery would be performed until a definite conclusion was forthcoming. (Testimony of Spiegel; P-3) On September 9, 1977, the Patient was admitted to Miami-Dade General Hospital for the scheduled biopsy. Before it was performed, a hospital physician did a patient history and physical on her -- a procedure the hospital routinely followed prior to surgery. The history described her illness: Patient is a 25-year-old white female admitted to Miami-Dade Hospital with left breast mass. Patient has strong family history of carcinoma of the breast and is scheduled for biopsy and frozen section in the A. M. and possible mastectomy. Patient states that she noticed the lump two years ago and on [sic] the past two months she has been getting pain and increase in size. Patient states lump is in the lower left quadrant of the left breast (TR 112-113) Respondent SPIEGEL then performed the biopsy. (Respondent EBKEN did not attend, assist, or have any involvement with, the biopsy.) The pathologist, who was at first unable to make a definite determination, ultimately determined that the breast lump was not cancerous; that, rather, it indicated three diseases: fibrocystic disease, intraductal papillomatosis, and sclerosing adenosis of the breast. These are "pre-malignant" diseases. (Testimony of Spiegel, Ebken; P-3) Respondent EBKEN visited the Patient in the hospital the day after the biopsy (a Saturday), since he had agreed to cover respondent SPIEGEL's patients that weekend. Respondent EBKEN discussed the pathology reports with the pathologist, then met with the Patient and told her that she did not have cancer. He explained the significance of the three "pre-malignant" diseases and described alternative treatments, including monitoring and frequent breast examination, and a subcutaneous mastectomy. The nurses' progress notes confirm that respondent EBKEN explained the pathology report to the Patient at that time, and the patient's denial that this occurred is rejected. Respondent EBKEN also wrote a progress note on the Patient, then issued an order authorizing her discharge from the hospital. (Testimony of Spiegel, Ebken, Waltuck; P-5, R-1, R-3) On September 19, 1977, the Patient visited respondents' offices for the removal of the biopsy sutures. She asked respondent EBKEN (because respondent Spiegel was absent) about breast cancer, stating that she had two maternal aunts who had breast cancer and that she had decided to "go ahead" with the subcutaneous mastectomy (with implants), the procedure which he had earlier discussed with her in the hospital. He removed her sutures and told her to return in three weeks and discuss the matter further with respondent SPIEGEL. (Respondent EBKEN did not see or talk with the Patient again until May, 1978, subsequent to her undergoing a subcutaneous mastectomy in October, 1977, and a left oophorectomy (removal of left ovary) in May, 1978.)(Testimony of Ebken, Spiegel; P-3) As instructed by respondent EBKEN, the Patient returned on October 5, 1977, and talked to respondent SPIEGEL. She told him that she wanted a subcutaneous mastectomy, with implants, something that SPIEGEL had not previously discussed with her. Although it appeared that she had already made up her mind, he described the risks and benefits of such surgery and told her that, if he performed the operation, he required the assistance of a plastic surgeon. He described alternative treatment methods such as follow-up monitoring and frequent reexamination, and the potential for future biopsies. She indicated that she was anxious to proceed with the subcutaneous mastectomies, that she did not want more biopsies or further worry, that she wanted to end her breast pain and have steps taken which were most likely to eliminate the possibility of her getting breast cancer. She understood that her diagnosed breast diseases increased the likelihood of her getting cancer; her fear of cancer had some basis. Intraductal papillomatosis is a pre-malignant lesion which significantly increases the risk of getting breast cancer. (Testimony of Spiegel, Ebken, Coury; R-3) On October 6, 1977,--at respondent SPIEGEL's request--the Patient and her husband visited Frederick C. Swenson, M.D., the plastic surgeon scheduled to assist with the breast reconstruction phase of the mastectomy. Dr. Swenson discussed the proposed surgery, including breast implants and reconstruction, and gave them an opportunity to ask questions and express their concerns. (Testimony of Spiegel; R-1) On October 10, 1977, respondent SPIEGEL admitted the Patient to Miami- Dade General Hospital for the subcutaneous mastectomy and implants. Prior to surgery, a hospital physician took a medical-history of the Patient which indicated that she had breast masses, "with previous papillomatosis of left breast, fibrocystic disease and adenosis of breast. Patient has family history of cancer of the breast . . . ." (TR 129) Respondent SPIEGEL's note on her admission to the hospital contained a similar description, reciting that the Patient had a "family history of breast cancer and cancer phobia." (Testimony of Spiegel, Ebken; P-3) On that day, October 10, 1977, the bilateral subcutaneous mastectomy, with implants, was performed on the Patient by respondent SPIEGEL; Dr. Swenson assisted with placing the implants and reconstructing the breasts. The surgery was uneventful, and the DEPARTMENT does not allege that the results were other than promised or reasonably expected. (Testimony of Spiegel, Ebken; R-1; P-3) Rather, the DEPARTMENT contends that, under the circumstances, the bilateral subcutaneous mastectomy of both breasts was inappropriate, unjustified, and violated standards of acceptable and prevailing medical practice in the area of general surgery. This contention is unsubstantiated by the weight of the evidence and is rejected. General surgeons are allowed a wide range in the exercise of judgment and discretion on whether to perform a mastectomy when the breast is not malignant but other indicators are present which increase the likelihood of cancer occurring in the future. Here, the indicators were: a strong family history of cancer, multiple papillomatosis, severe lump in the breast, severe breast pain, and extreme fear of cancer. The pre-malignant diseases in the Patient's breast increased her risk of acquiring cancer in the future by three to five times that of the general public. The DEPARTMENT has shown that reasonably prudent similar physicians would have recommended treatment different than that recommended by respondent SPIEGEL, and refused to perform the mastectomies. Conversely, the evidence shows, with equal force, that other reasonably prudent similar physicians agree with, and have no objection to respondent SPIEGEL's actions. Since the evidence does not convincingly show, with the requisite substantiality, that respondent SPIEGEL's conduct violated the standard of acceptable and prevailing medical practice in the area of general surgery, it must be concluded that his actions constituted a permissible exercise of medical judgment and discretion. (Testimony of Coury, M.D., Joseph, M.D.; R-4) As to the conduct of respondent EBKEN, the evidence is insufficient to prove that he was negligent or guilty of professional misconduct toward the Patient. He informed her of the results of the pathology report, described a bilateral subcutaneous mastectomy and alternative treatments, including risks and benefits; he did not assist in the actual surgery. (Testimony of Ebken) IV. Count III: Alleged Misrepresentation in Obtaining Patient's Consent to Mastectomy In Count III, the DEPARTMENT alleges that the respondents induced the Patient to consent to the mastectomy by telling her that her left breast was malignant and that a mastectomy was an absolute necessity; that such misrepresentation deviates from standards of acceptable and prevailing medical practice in the area of general surgery. This charge, too, is unsupported by the weight of the evidence. As already established, the respondents described to the Patient, prior to surgery, the true nature of her breast disease -- that her breast was not malignant, although the diseases were considered pre-malignant. The Patient's own statements believe the allegation that respondents told her she had breast cancer. On separate occasions, she acknowledged to Oswald Coury, M.D., Bernard Waltuck, M.D., and Robert Hartog, M.D. that she knew, prior to surgery, that her breast was not cancerous. The physicians' and nurses' notes made during her hospitalization also corroborate respondents' assertion that they had told the Patient, and she was aware, that her breast was not cancerous. (Testimony of Coury, Hartog, Waltuck, Ebken, Spiegel; P-3, P-5) The only evidence offered to substantiate this charge is the deposition testimony of the Patient. She was an interested witness, having already sued respondents for civil damages. Her testimony was marked by evasiveness and uncertainty; she had difficulty recalling, and responding to questions about the facts. Her testimony lacks credibility. Count IV: Removal of the Patient's Left Ovary In Count IV, the DEPARTMENT alleges that respondent SPIEGEL surgically removed the patient's left ovary without medical justification. On October 28, 1977, the Patient returned to respondent SPIEGEL's office complaining of hot flashes, and pain in her breasts. The breasts appeared to be healing normally. Tubal ligations and hysterectomies may affect the supply of blood to the ovaries. (Knotting-off some of the nearby vessels may affect the functioning of an ovary.) Respondent SPIEGEL concluded that she had a hormone deficiency because the remaining left ovary was not functioning properly. As treatment, he prescribed Premarin, an estrogen-type (hormonal) medication to be taken the first 25 days of each month. (Testimony of Spiegel; P-3) On November 18, 1977, the Patient returned to respondent SPIEGEL's office with more complaints of hot flashes. He doubled the Premarin dosage. (Testimony of Spiegel; P-3) On December 16, 1977, the Patient returned to respondent SPIEGEL's office complaining of pain on the lower left side of her abdomen. He conducted a pelvic examination and found her left side tender but could not detect a mass. She appeared otherwise to be normal. As treatment, he increased the Premarin, prescribed an antibiotic, and suggested warm douches. (Testimony of Spiegel; P- 3) When she returned on January 17, 1978, she again complained of pain in the lower left quadrant of her abdomen. On examination, respondent SPIEGEL found tenderness, the left ovary was palpable and tender. He told her to return in two months for reexamination. (Testimony of Spiegel; P-3) She returned to his office in May, 1978, complaining of continued pain and tenderness in the lower left part of her abdomen, where the left ovary is located. He conducted another pelvic examination, this time finding that the left ovary was tender, and larger than four centimeters. He concluded, based on his seven months of treatment, that she had developed a pathologically enlarged left ovary. He discussed and recommended surgical removal of the remaining left ovary, explaining that such surgery would require her to take hormone supplements on a continuing basis. (Testimony of Spiegel; P-3) She consented to the surgical removal of her left ovary, a technique known as a left oophorectomy. Respondent SPIEGEL admitted her to the hospital, and, on May 10, 1978, performed the left oophorectomy. The left ovary was shown to be larger than normal, cystic and suggestive of endometriosis, a painful ovarian abnormality. The surgery was uneventful, and properly performed. (Testimony of Spiegel; P-3, P-5) This surgical procedure unequivocally provided the Patient relief from her abdomen pain, her complaints ceased. (Testimony of Spiegel; P-3) This charge, too, is unsubstantiated by the requisite quantum of evidence. The Patient's left ovary was enlarged, cystic, tender, and a source of chronic pain from December, 1977 to May, 1978. Its sole function was to produce female hormones, but since the Patient's right ovary had already been removed, she required, in any case, hormone supplements. Under these circumstances, respondent SPIEGEL's performance of a left oophorectomy conformed to, and did not deviate from, standards of acceptable and prevailing medical practice in the area of general surgery 2/ . The surgery, in fact, relieved the Patient of the chronic pain she had been suffering during the preceding six months. (Testimony of Spiegel, Joseph; P-3)
Recommendation Based on the foregoing, it is RECOMMENDED: That all administrative charges against respondents be Dismissed. DONE and ENTERED this 10th day of June, 1983, in Tallahassee, Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 10th day of June, 1983.
The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint dated May 23, 2000, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department of Health, Board of Medicine, is the state agency charged with regulating the practice of medicine in Florida. Section 20.43; Chapters 455 and 458, Florida Statutes (2000). Dr. Sadarangani is, and was at the times material to this proceeding, a physician licensed to practice medicine in Florida, having been issued license number ME 0041985. He maintained a private practice in Fort Lauderdale, Florida, from 1984 until 1997. He was board certified in 1981 in cardio- thoracic surgery by the American Board of Thoracic Surgery and was re-certified in 1990. In his practice, Dr. Sadarangani performed between 20 and 25 aneurysm repairs each year. Dr. Sadarangani has not practiced surgery since 1997 because of his health. General anatomy of the abdominal blood vessels. The arterial system. The aorta is the main blood vessel leaving the heart and going through the chest and pelvic area. The aorta carries the majority of the blood to the body and provides blood to the body's main organs. The renal arteries branch off of the aorta and provide blood to the kidneys. In the pelvic area, the aorta branches into two iliac arteries that carry blood to the pelvic organs and to the legs. The iliac arteries are referred to as the common femoral arteries when they reach the groin. As they descend into the leg, the common femoral arteries branch into the superficial femoral arteries, which continue below the knee and into the lower leg, and into the profundus femoris arteries, which provide blood to the muscles of the thighs. The lumbar arteries extend in pairs from the posterior of the aorta in the abdomen to the lumbar musculature. The venous system. The vena cava is the very large vein in the abdominal cavity that drains blood from the legs and the abdominal organs and returns it to the heart. It is located on the right side of the aorta. In very rare cases, a person is born with two vena cavas, one located on the left side of the aorta and one on the right side, into which blood drains from the left and right kidneys, respectively. The renal veins are the main venous structures that carry blood from the kidneys to the vena cava. There are normally two renal veins, one draining the right kidney into the vena cava, and one draining the left kidney into the vena cava. The renal veins are two of the largest veins in the body, and, because the kidneys absorb 20 percent of the heart's output of blood, the renal system contains a high volume of blood. The right renal vein is short and is not located near the aorta because it attaches to the vena cava to the right of the aorta. The left renal vein normally crosses over the anterior, or front, surface of the aorta to join the vena cava. In rare cases, the left renal vein crosses posterior to, or in back of, the aorta to join the vena cava; such a vein is referred to as a retroaortic renal vein. Aortic aneurysms. An aortic aneurysm is an area of the aorta where the vessel wall has dilated and expanded abnormally, like a balloon; it appears as a markedly enlarged blood vessel. A normal aorta is between 1.5 and two centimeters in diameter; if an area of the aorta expands to between 2.5 and three centimeters, it is referred to as a dilated aorta. It is only after the aorta has dilated to four centimeters that the area of dilation is referred to as an aneurysm. An aneurysm is often life threatening because it can burst, resulting in massive blood loss and, in many cases, death. The repair of an aneurysm involves the replacement of the part of the blood vessel that is aneurysmal with a bypass graft. The graft is an artificial prosthesis that is pre-made and comes as a straight tube or a bifurcated tube, that is, a tube that splits into two smaller tubes. Once in place, the graft allows the blood to flow through the area where the aneurysm is located, but the aneurysm is no longer a part of the blood vessel, and there is no danger that the aneurysm will rupture. The repair of an aortic aneurysm that is located in the abdomen is a major surgical procedure. There are three types of bypass procedures used to repair abdominal aortic aneurysms: An aortic tube bypass is appropriate when the aneurysm is limited to the aorta. In this procedure, a tube graft is attached to the aorta above the aneurysm and below the aneurysm, and the walls of the aneurysm are sutured closed over the graft. With this type of procedure, the surgeon first makes an incision in the abdomen and enters the abdominal cavity. After retractors are placed and the bowel is moved to the side, the blood vessels above and below the aneurysm are separated, or dissected, from the surrounding fatty and connective tissue using both sharp and blunt instruments. Although it is possible to tear blood vessels, especially veins, using blunt dissection techniques, the use of good surgical techniques will minimize the number of vessel tears.1 An aortic-biiliac bypass is appropriate when the aneurysm extends into the upper iliac arteries or when there is a blockage of the upper iliac arteries. In this procedure, the aneurysm is replaced with a bifurcated tube graft attached to the aorta above the aneurysm and to each iliac artery below the aneurysm or blockage. When performing an aortic-biiliac bypass, the surgeon proceeds in the same manner as when performing an aortic tube bypass, but extends the abdominal incision to dissect the iliac arteries in the pelvic area. The iliac arteries lie very deep and must be dissected from the veins that lie next to these arteries and from the ureter. An aortic-bifemoral bypass is appropriate when the patient has occlusive disease, or a blockage, of the iliac arteries or when it would be difficult to work in the pelvic area where the iliac arteries are located as a result of significant scarring. The iliac arteries are bypassed in this procedure, and a bifurcated tube graft is attached to the aorta above the aneurysm and to each common femoral artery below the blockage. When performing an aortic-bifemoral bypass, the surgeon usually begins with incisions in each side of the groin and dissection of the common femoral arteries. The abdominal incision and dissection of the aorta is done after the common femoral arteries are dissected in order to reduce the amount of time the abdomen is open. Prior to surgery, an aortogram, or arteriogram, is performed to establish the anatomy of the patient's arteries. An arteriogram is a procedure in which a dye is injected into the aorta by means of a catheter, and X-rays are taken showing the pathway of the dye through the arteries from the diaphragm to the feet so that any blockages or abnormalities in the vessels can be identified. An arteriogram is the most accurate way of determining that blood is flowing through a particular blood vessel, and the type of bypass to be performed is determined on the basis of the anatomy of the patient's arteries as revealed by the arteriogram. Patient W.R. Patient W.R. was a 71-year-old male who was referred to Dr. Sadarangani after he was diagnosed with an abdominal aortic aneurysm. W.R. had a history of coronary artery disease, diabetes mellitus, high blood pressure, and mild chronic obstructive pulmonary disease. He weighed approximately 212 pounds at the time Dr. Sadarangani first examined him. An ultrasound indicated that W.R.'s aneurysm was increasing in size, and Dr. Sadarangani recommended surgery to repair the aneurysm. Because of W.R.'s weight and his medical history, Dr. Sadarangani did not classify him as a normal patient, and he was a medium-level anesthesiology risk. In a letter dated August 3, 1993, W.R.'s cardiologist cleared him for surgery based on the results of a cardiac catheterization and a thallium stress test. In his letter, W.R.'s cardiologist stated that W.R. had coronary artery disease of the right coronary system and that, during surgery, "careful attention [should be] paid to hemodynamic status "2 W.R.'s fitness for surgery was also evaluated by a pulmonologist, who cleared W.R. for the surgery based on the results of a pulmonary function test. On August 12, 1993, W.R. underwent an abdominal aortogram and bilateral lower extremity runoff arteriogram in order to establish the anatomy of the arteries in his abdomen and legs. The aortogram revealed a fusiform aneurysm of the distal abdominal aorta that was 5.7 centimeters in diameter; the craniocaudel length of the aneurysm was approximately seven centimeters. It was noted in the report of the aortogram that "[b]oth renal arteries are well demonstrated. The aneurysm originates approximately 5 cm. below the origin of the lowest renal artery. The iliac arteries are not involved. Aortic bifurcation is normal." The bilateral lower extremity runoff arteriogram revealed that the "internal iliac and external iliac arteries bilaterally show normal liminal [sic] filling with no abnormality. The common femoral arteries are also normal." It was noted in the report of the arteriogram that the superficial femoral arteries filled normally, but bilateral segmental stenosis, or occlusive disease, of the distal superficial femoral arteries was observed, with 80-to-90 percent stenotic lesion in the left distal superficial femoral artery and 50-to-60 percent stenotic lesion in the right distal superficial femoral artery. Because the aortogram and arteriogram revealed that the aneurysm ended above the point where the aorta bifurcated into the iliac arteries and because they revealed that there were no abnormalities in the iliac arteries, an aortic tube bypass to repair W.R.'s aneurysm would be the indicated procedure. This was the type of bypass Dr. Sadarangani intended to perform when he began the surgery. Anesthesia was administered to W.R. at 8:15 a.m. and, after W.R. was prepared, Dr. Sadarangani began surgery at 9:10 a.m. Dr. Sadarangani first made an incision into the abdomen and dissected into the abdominal cavity. After isolating and putting aside the abdominal organs, Dr. Sadarangani, as is his usual practice, dissected and isolated the iliac arteries. He then dissected up around each side of the aorta until he reached the neck, or upper edge, of the aneurysm. Dr. Sadarangani did not visualize the left renal vein as he dissected around the sides of the aorta, and he remarked on this to Dr. Robert McGuire, the surgeon who was assisting with the procedure. The left renal vein is the first blood vessel the surgeon must locate after the aorta has been exposed. It is crucial for the left renal vein to be identified for two reasons. First, it is a major vein carrying a substantial blood flow from the left kidney, and it must be visualized so that the surgeon can avoid injuring it. Second, the aorta must be clamped below the renal arteries, and the left renal vein marks the spot where the renal arteries branch off of the aorta.3 If the left renal vein is not visualized in front of the aorta, the surgeon must assume that the patient has either a duplicate vena cava or a retroaortic renal vein. In such a circumstance, the surgeon must be very careful not to tear the left renal vein when dissecting out the aorta from the surrounding tissues and veins. Even though he had not located the left renal vein, Dr. Sadarangani followed his usual procedure when dissecting the aorta at the neck of the aneurysm, and he ran his thumb along one side of the aorta and his finger along the other side, pulling the aorta forward to clear it from the tissues behind it. Dr. Sadarangani continued to work his thumb and finger around the aorta, pulling the vessel forward, until his thumb and finger met behind the aorta and it pulled free from the vessels and tissue surrounding it. In choosing to use this technique, Dr. Sadarangani relied on his experience that there normally are no adhesions or scar tissue present in the tissues surrounding the aorta. As soon as Dr. Sadarangani removed his fingers from around W.R.'s aorta, he noticed bleeding that appeared to originate behind the aorta. He did not know the source of the bleeding but believed that it might originate in the lumbar veins because he observed only a small amount of blood. Dr. Sadarangani inserted a four-by-four sponge in the area of the bleeding and applied pressure for about five minutes. He removed the sponge, and the area again filled with blood. Dr. Sadarangani then tried to stop the bleeding by applying a mixture of gel foam and Thrombin to the area, and he applied pressure with a four-by-four sponge for an additional five minutes at the location of the bleeding. Dr. Sadarangani repeated this procedure two or three times and was not able to stop the bleeding. Dr. Sadarangani still did not know the source of the bleeding, although he knew it was venous blood because of its dark color, and he thought the bleeding might be coming from a lumbar vein.4 The only thing Dr. Sadarangani knew for certain was that the bleeding was coming from behind the aneurysm, so he moved it to the right in an attempt to see the source of the bleeding. As soon as he did so, blood gushed from W.R.'s abdomen, and his blood pressure dropped precipitously. Dr. Sadarangani moved the aneurysm back to its original position and applied pressure on the top of the aneurysm to stop the bleeding. At the same time, the anesthesiologist began transfusing blood and fluids. After about five to seven minutes, Dr. Sadarangani decided to move the aneurysm to the left to see if he could find the source of the bleeding. As soon as he moved the aneurysm to the left, blood gushed again, W.R.'s blood pressure dropped, and, according to Dr. Sadarangani, "the anesthesiologist started screaming." Dr. Sadarangani moved the aneurysm back to its original position and again applied pressure to the top of the aneurysm to stop the bleeding. Dr. Sadarangani was not able to stop the bleeding. Because he still had not identified the source of the bleeding, he decided to clamp the aorta above the aneurysm, sever the aorta below the clamp, and peel back the aneurysm to expose the structure behind it. Before undertaking this procedure, because he would be handling the aneurysm and did not want to dislodge any clotted material from the aneurysm into the blood stream, Dr. Sadarangani ordered the anesthesiologist to administer 7,000 units of Heparin to W.R., about three-quarters of the dose he would normally have given a patient of W.R.'s size. On Dr. Sadarangani's orders, the anesthesiologist administered the Heparin at 11:02 a.m. Heparin is an anticoagulant blood thinner used to prevent the formation of blood clots whenever a blood vessel is clamped off and the blood flow in the vessel stopped. Dr. Sadarangani was not concerned about giving a blood thinner and anticoagulant to W.R. even though he was experiencing severe blood loss because W.R.'s blood was being collected by the cell saver5 and re-transfused. In addition to the cell saver, Dr. Sadarangani had ordered six units of blood typed and cross- matched for W.R. Before he clamped the aorta, he told the anesthesiologist to order all six units of blood to the operating room and to tell the blood bank to type and cross- match more blood. After the Heparin was administered and the blood ordered, Dr. Sadarangani clamped off the iliac arteries, and then, at 11:08 a.m., he clamped off the aorta above the neck of the aneurysm. The aneurysm became soft with the decrease in pressure, and the blood flow from behind the aneurysm increased because the aneurysm no longer exerted pressure on the vessels behind it. Dr. Sadarangani then cut horizontally through the aorta and retracted down the aneurysmic portion of the aorta. At this, W.R.'s abdominal cavity began filling with blood. Dr. Sadarangani suctioned the blood into the cell saver, and he was able to see that there was a large amount of blood coming from both the right and the left side of the abdomen. There was also some bleeding from behind the aneurysm, and Dr. Sadarangani deflected the aneurysm down further and saw bleeding from another vein. Once he had suctioned the blood out of the abdominal cavity, Dr. Sadarangani was able to see that one source of bleeding was a long tear in the left renal vein, which was located behind the aorta; blood was also draining from what Dr. Sadarangani described as an abnormally large lumbar vein joining the left renal vein. The left renal vein was completely open behind the aorta, and the blood was coming from both the vena cava and from the left kidney. Dr. Sadarangani theorized that the lumbar vein and the renal vein had been adhered to the back of the aneurysm and had torn when he manipulated the aneurysm to the left and right. Normally, the aneurysm itself is not manipulated or resected because there is a lot of tissue adhering to the back portion of the aneurysm. Dr. Sadarangani temporarily controlled the bleeding by clamping the left renal vein to the right of the aorta, at the point where it joined the vena cava; clamping the left renal vein to the left of the aorta, distal to, or in front of, the adrenal vein and the testicular vein, both of which branch off the left renal vein before it enters the left kidney; and clamping the lumbar vein where it joined the left renal vein. Although the clamps stopped the bleeding from the veins, there was bleeding from the lumbar arteries that attached to the aneurysmic portion of the aorta. Consequently, Dr. Sadarangani removed the plaque and clotted material from the wall of the aneurysm, and he sutured the bleeding lumbar arteries. This procedure took between ten and 15 minutes. Dr. Sadarangani then had to decide how to repair the left renal vein and the lumbar vein. The renal vein was not very tense after Dr. Sadarangani finished suturing the lumbar arteries, and he noticed that the adrenal and testicular veins were becoming larger. He concluded, therefore, that the blood from the left kidney was draining through the adrenal and testicular veins. Dr. Sadarangani decided to excise the torn portion of the left renal vein and to suture it closed both at the point where it joined the vena cava and at the point distal to the adrenal and testicular veins.6 Dr. Sadarangani also sutured closed the bleeding lumbar vein. Dr. Sadarangani worked for several hours to stop the bleeding from the left renal and lumbar veins. During this time, W.R.'s blood pressure dropped precipitously several times, and W.R. suffered severe hypovolemia, that is, severe shock. With the bleeding controlled, Dr. Sadarangani proceeded with the repair of the aneurysm. He completed the anastomosis, or connection of the graft to the aorta, above the aneurysm. He then tested the anastomosis to ensure that there was no bleeding and clamped off the two limbs of the bifurcated tube graft he had chosen to use for the bypass. Dr. Sadarangani had originally intended to use an aortic tube bypass to repair W.R.'s aneurysm, but when he palpated the aorta below the aneurysm, the aorta felt hard. Dr. Sadarangani also noted that the iliac arteries below the bifurcation of the aorta also felt hard. He decided that it would take too long to remove the plaque from the walls of the aorta and abandoned the idea of using a tube bypass. Dr. Sadarangani felt along the iliac arteries until he reached soft spots on the anterior of both the left and right iliac arteries. He made a small incision in the soft spot on the right iliac artery, below the clamp, and noted that there was no retrograde bleeding from the artery.7 He inserted his forceps inside the artery to be sure the walls were separated, and, when he removed the forceps, he saw blood clots inside the artery. Dr. Sadarangani was surprised to see blood clots, and, because it had been several hours since the initial 7,000 units of Heparin had been administered, Dr. Sadarangani ordered the anesthesiologist to administer an additional 2,000 units of Heparin. This dose of Heparin was administered at 1:15 p.m. Dr. Sadarangani concluded from the lack of retrograde bleeding and from the presence of clots in the iliac artery that W.R. had blood clots in his lower leg that were blocking the blood flow. Accordingly, Dr. Sadarangani passed a small Fogarty catheter into the right iliac artery several times.8 Dr. Sadarangani chose a small catheter because he wanted the catheter to pass through W.R.'s iliac artery and the femoral artery into the arteries serving the leg, all the way to W.R.'s ankle. Even though he was unable to pass the catheter to the ankle, he brought up blood clots with the first two or three passes of the Fogarty catheter through the right iliac artery, but he did not bring up any clots on the next two or three passes of the catheter. Dr. Sadarangani noted some retrograde bleeding from the right iliac artery after he removed blood clots with the catheter, but the bleeding quickly stopped. Dr. Sadarangani inferred from this that there were more blood clots deeper in the femoral artery. Dr. Sadarangani opened the left iliac artery. He could not pass a Fogarty catheter to W.R.'s ankle through the left iliac artery, but he did bring up blood clots from that artery. The difficulty could be attributed to the fact that the iliac arteries follow a very tortuous path. The difficulty could also be attributed to the fact that the pre-operative arteriogram established that W.R. had some blockage in the femoral arteries. Because of the blood clots and his inability to pass the Fogarty catheter deep into W.R.'s leg, Dr. Sadarangani decided to do an aortic-bifemoral bypass instead of an aortic- biiliac bypass. He reasoned that, once he dissected out and opened up the common femoral artery, he would be able to visualize the deep femoral artery and the superficial femoral artery and pass a Fogarty catheter directly into those arteries to eliminate any blood clots in W.R.'s legs. Dr. Sadarangani was particularly concerned about leaving blood clots in W.R.'s arteries because, if clots of a significant size are left in the arteries, they can block blood flow once it is re-established after the bypass graft is attached and the clamps released. If clots block the blood flow in the graft or in the legs, it is necessary to perform another surgical procedure to remove the clots, and Dr. Sadarangani believed that W.R. could not tolerate a second surgical procedure. Dr. Sadarangani anticipated that it would take between ten and 15 minutes to open up W.R.'s groin and to expose and get control of the common femoral arteries; it would normally take between ten and 15 minutes per side, but Dr. Sadarangani intended to have Dr. McGuire open the left groin. In Dr. Sadarangani's opinion, this procedure would be quicker than a biiliac bypass because the iliac arteries are deep, and it is difficult to complete the anastomoses. Unfortunately, Dr. Sadarangani and Dr. McGuire unexpectedly encountered severe scar tissue when dissecting down to the common femoral arteries, and it took approximately 45 minutes to isolate these arteries. Once Dr. Sadarangani and Dr. McGuire had visualized and dissected out the common femoral arteries, Dr. Sadarangani inserted a Fogarty catheter into the right and then the left superficial femoral arteries, all the way to W.R.'s ankles and assured himself that there were no clots present in W.R.'s legs. Dr. Sadarangani performed the same procedure with the Fogarty catheter into the profundus femoris arteries and into the deep femoral arteries and assured himself that there were no clots below the incisions in the common femoral arteries. When performing an aortic-bifemoral bypass, it is necessary for the surgeon to make tunnels from the abdominal cavity to the femoral arteries through which the ends of the graft are passed. This is accomplished by the surgeon inserting one finger in the groin and one finger in the abdominal cavity and penetrating the retroperitoneal tissue until the fingers touch. Once the surgeon's fingers touch, a clamp and umbilical tape are passed through the tunnels, the bypass grafts are passed into each side of the groin, and the ends of the grafts are sewn onto the femoral arteries using the same procedure as that used for the iliac arteries with an aortic-biiliac bypass. After he made the tunnel to the right common femoral artery, Dr. Sadarangani completed the anastomosis and restored blood flow to the right leg. Between 30 and 35 minutes later, Dr. Sadarangani finished the anastomosis on the left common femoral artery, and he unclamped the left femoral artery at 2:55 p.m. Dr. Sadarangani estimates that it took him approximately 30 minutes longer to complete the aortic-bifemoral bypass than it would have taken him to complete an aortic-biiliac bypass. After blood flow was restored, Dr. Sadarangani flushed W.R.'s groin and abdominal cavity with antibiotic solution, returned his abdominal organs to their proper positions, and closed the incisions. W.R. was under anesthesia from 8:15 a.m. until 5:10 p.m.; W.R. was actually in surgery from 9:10 a.m. until 4:50 p.m.9 W.R. became hypovolemic approximately three hours into the surgery, when he suffered massive blood loss, and he suffered ongoing complications from the hypovolemia. W.R.'s total estimated blood loss was 8,600 milliliters of blood, IAT (Intraoperative Autologous Transfusion); W.R. received transfusions of 3,200 milliliters of blood during surgery, and his actual blood loss was 5,400 milliliters.10 W.R. was taken from surgery directly to intensive care. His condition deteriorated, and he died on the evening of August 24, 1993, from hyperkalemia with renal failure.11 The blood loss W.R. experienced during surgery, and the resulting hypovolemia, contributed to the renal failure. No matter how good the surgical technique, there is always some blood loss during the repair of an abdominal aortic aneurysm. Because of the need to create tunnels through the retroperitoneal tissue in the groin, an aortic-bifemoral bypass increases the amount of blood loss during surgery, especially in a patient who has received an anticoagulant. The most critical factor affecting a patient's ability to survive the repair of an abdominal aortic aneurysm is the amount of time the aorta is clamped shut, with the blood flow through the body interrupted. Stress is placed on the heart because there is higher pressure in the upper body because the heart is profusing only half of the body while the aorta is clamped. In addition, half of the body is not receiving significant blood flow, which leads to pooling of blood and metabolic stresses that can decrease cardiac output. In this case, W.R.'s aorta was clamped shut from approximately 11:00 a.m. until approximately 3:00 p.m., a period of four hours. Normally, the aorta is clamped approximately two to three hours during an aortic-bifemoral bypass. Summary. The evidence presented by the Department is sufficient to establish that a reasonably prudent cardio-thoracic surgeon would have located the left renal vein before beginning to dissect around the aorta and separate it from the surrounding tissues. In this case, Dr. Sadarangani did not visualize the left renal vein when he dissected down to the aorta. Even though he knew it was possible that W.R. had a retroaortic left renal vein, Dr. Sadarangani nonetheless proceeded with the blunt dissection of the aorta at the neck of the aneurysm, slipping his fingers behind the aorta and pulling it forward. Dr. Sadarangani also failed to recognize that the bleeding from behind the aorta might have originated from the left renal vein. By moving the aneurysm to the left and then to the right, Dr. Sadarangani most likely exacerbated the tear in the renal vein, and by retracting the aneurysm forward, he completely opened that portion of the left renal vein lying behind the aneurysm. While this latter procedure was necessary to expose the source of the bleeding in order to ultimately control it, Dr. Sadarangani should have identified the left renal vein before dissecting forward the aorta at the neck of the aneurysm. The evidence presented by the Department is sufficient to establish that a reasonably prudent cardio-thoracic surgeon would not have administered Heparin to a patient who was experiencing massive blood loss as a result of a torn left renal vein. It is not appropriate to administer Heparin to a patient who is experiencing or has experienced uncontrolled bleeding. Massive blood loss during surgery is life threatening, and the surgeon's foremost concern should be controlling the bleeding. Administering a blood thinner when a patient is bleeding uncontrollably is contraindicated, especially since massive blood loss in itself thins the blood. It should also be noted that Dr. Sadarangani had manipulated the aneurysm by moving it to the left and the right before he told the anesthesiologist to administer the Heparin. The evidence presented by the Department is not sufficient to establish that a reasonably prudent cardio- thoracic surgeon, under the circumstances presented to Dr. Sadarangani, would have performed an aortic-biiliac bypass rather than an aortic-bifemoral bypass. It was not unreasonable for Dr. Sadarangani to be concerned about blood clots in W.R.'s legs given the lack of retrograde bleeding and the presence of blood clots in the iliac arteries. Both the lack of retrograde bleeding and the presence of blood clots could be indicative of clots further down in the leg, and Dr. Sadarangani's decision to perform an aortic-bifemoral bypass was not unreasonable since he was unable to insert the Fogarty catheter far enough into W.R.'s arteries to assure himself that no clots were present in W.R.'s lower legs. Dr. Sadarangani's decision was based on the particular circumstances he encountered in this case, and the Department has failed to establish that his decisions departed from the acceptable standard of care.
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 Nari T. Sadarangani, M.D., violated Section 458.331(1)(t), Florida Statutes (1993), issuing a reprimand to Dr. Sadarangani, and imposing an administrative fine in the amount of $1,200.00 DONE AND ENTERED this 29th day of March, 2001, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO 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 March, 2001.
The Issue The issue is whether Respondent failed to practice medicine at the level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances and, if not, the penalty.
Findings Of Fact Respondent is a licensed physician, holding license number ME 0026784. He is Board-certified in radiology. On January 30, 1997, T. D., a 30-year-old female who was eight months pregnant, presented to the emergency room of the Columbia Largo Medical Center complaining of pain in the left flank radiating to the left groin, together with nausea and vomiting. She also reported a prior history of kidney stones. A urologist diagnosed T. D. as suffering from kidney stones and severe hydronephrosis, which is the dilation of the kidney due to an obstruction in the flow of urine. The urologist was unable to pass a stent and catheter by the stones to drain the urine and relieve the pressure on the kidney, so he asked Respondent to perform a left percutaneous nephrostomy. A percutaneous nephrostomy is a procedure in which a physician places a tube through the skin and into the collecting system of the kidney to drain the kidney. The tube remains in place until the obstruction is removed. On February 1, Respondent performed a left percutaneous nephrostomy under local anaesthesia. For guidance in placing the tube, Respondent used ultrasound, rather than ultrasound and a flouroscopy. Respondent has performed 100-150 nephrostomies. As is the common practice, he normally does not rely exclusively ultrasound in guiding the placement of the tube in the kidney. In this case, the urologist asked that he not use a flouroscopy, in deference to the patient's pregnancy and the duration of x-ray exposure in a flouroscopy. Respondent was comfortable doing the procedure in this manner, although he decided that, if he encountered any problems in placement, he would resort to flouroscopy. Respondent proceeded to perform the percutaneous nephrostomy in the morning. As is typical, the radiology technician helped position T. D. on the table for the procedure. T. D.'s advanced pregnancy necessitated a slight adjustment to the normal posture of patients being prepared for this procedure, so T. D. lay slightly more up on her side than is usual. However, this did not change the point of entry chosen by Respondent. And, regardless of her precise position, the location of the spinal canal relative to the kidney relative to the point of entry into the skin remains constant: an imaginary line from the kidney to the spinal canal is perpendicular to an imaginary line from the point of entry to the kidney. The point of entry is on the lower back of the patient. T. D. is thin and her pregnancy did not manifest itself on her back, so the length of tube used by Respondent was relatively short. T. D.'s thin build makes it less likely that Respondent would have placed sufficient excess tube into the patient so as to permit the tube to run from the kidney to the spinal cord. Upon placement of the tube, at least 100 cc of fluid drained through the tube. This is well within the range of urine that would be expected under the circumstances. The color was well within the range of color for urine. The preponderance of the evidence indicates that the fluid was urine and that Respondent had placed the tube correctly in the kidney. At the end of the procedure, T. D. appeared a lot more comfortable. Late in the afternoon, someone called Respondent and told him that the drainage had slowed to a very small amount or nothing at all. This is not uncommon, as moving the patient or over-energetic nurses may accidentally dislodge the stent in the kidney. It is also possible that the tube has rested in a part of the kidney that does not facilitate maximum drainage. Using ultrasound, Respondent confirmed that the tube remained in place in the kidney, although he could not tell whether the stent had come to rest in a narrow place in the kidney or possibly even against a stone. Even with this uncertainty, Respondent still was able to determine that the stent was predominantly in the collecting system. Because T. D. was resting comfortably, she said that she felt fine, her fever was going down, and the hydronephrosis had decreased, Respondent decided to do nothing until after re-examining T. D. the next morning. However, at about 11:00 p.m. or midnight, Respondent, who was visiting a nearby patient, dropped in on T. D. The nurse said that she was fine and her kidney was draining a little better. T. D. also said that she was feeling fine. About three or four hours later, T. D. reported a feeling of some paralysis. Petitioner's expert testified that this was linked to the misplacement of the stent in the spinal canal, but he was unaware that T. D. had undergone a spinal block for the percutaneous nephrostomy and that a problem with the first anaesthetic procedure had necessitated a second. It is more likely that T. D.'s paralysis was in response to the two spinal blocks. At 9:00 a.m. the next day, Respondent returned and examined T. D. He found that she was still doing better, and her urologist was preparing to discharge her from the hospital. She looked better, and her urine flow had improved. He told her to call him if she had any problems, but he never heard from her again or even about her until he learned from the urologist that T. D. had been admitted to another hospital where a radiologist had inserted contrast material into the tube to locate the stent and found it in the spinal canal. The father of the baby picked up T. D. at the Columbia Largo Medical Center. He picked her up out of the wheelchair and placed her in the car. Her condition deteriorated once she got home. A hospital nurse directed the father to change the collection bag, if it filled prior to the visit of the home health care nurse. In the three or four days that T. D. remained at home, he changed the bag several times. He daily checked the site at which the tube entered T. D.'s skin and noticed that it had pulled out a little bit. However, he testified that he did not try to adjust the length of tube inside T. D., nor did he change the setting on the tube, which had "open" and "closed" settings for the pigtail at the end of the tube. The proper setting was closed, as the pigtail is not to be open once the stent has reached its destination in the kidney. On February 5, the father took T. D. to the emergency room of the Columbia St. Petersburg Medical Center, where she presented with complaints of severe back pain. An ultrasound confirmed the presence of kidney stones, whose removal had been deferred until the delivery of the baby. In an effort to locate the end of the tube, a radiologist inserted radiographic contrast dye, which showed that the end of the tube was in the intrathecal space of the spine. A urologist removed the tube. However, T. D. suffered a seizure. Another physician attempted an emergency C-section, but the baby did not live. There are two alternatives to explain how the stent at the end of the tube found its way into the spinal canal. First, Respondent placed it there during the procedure. Second, it migrated from the kidney, where Respondent placed it, to the spinal canal. If not unprecedented, both alternatives are extremely rare. The drainage during the procedure and initial improvement of the distended kidney are consistent with the proper initial placement of the stent. The difficulty of inadvertently turning a relatively short length of tube 90 degrees from the kidney to the spinal canal also militates against a finding that Respondent misinserted the tube. Problems with the first spinal tap may have contributed to some of the complaints, such as paralysis, that T. D. experienced after the procedure. Although unlikely, the migration alternative would be consistent with well-intended, but incorrect, attempts by the baby's father or a home health care nurse to ensure that the tube did not travel too far in or our of the point of entry. Migration would be facilitated if either the father or nurse misread the "open" and "closed" settings and turned to "open," in the hope of improving drainage, when such a setting opens the pigtail, which would increase the possibility that the stent could migrate into the spinal canal. In a case requiring proof that is clear and convincing, it is impossible to find that Petitioner has adequately proved that Respondent misinserted the tube during the procedure. Likewise, the evidence is not clear and convincing that Respondent should have recognized at anytime prior to T. D.'s discharge from the Columbia Largo Medical Center that something was wrong with the procedure that he had performed or that he needed to confirm by x-ray the location of the stent at the end of the tube.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 2nd day of August, 1999, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of August, 1999. COPIES FURNISHED: Britt Thomas, Senior Attorney Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 William B. Taylor, IV Macfarlane, Ferguson & McMullen Post Office Box 1531 Tampa, Florida 33601-1531 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Pete Peterson, General Counsel Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750
