Findings Of Fact The current petition Following the entry of a final order of the Board of Medicine dismissing the administrative action previously filed against her, petitioner filed the pending request for an award of attorney's fees and costs, pursuant to Sections 57.111 and 120.57(1)(b)5, Florida Statutes. Respondent, Department of Business and Professional Regulation, Board of Medicine (Department), has conceded that: the underlying licensure disciplinary "action in Department of Professional Regulation v. Ada Gonzalez, M.D., DBPR Case No. 90-06789, was initiated by the Department of Professional Regulation (now Department of Business and Professional Regulation), a state agency, and, therefore, the Department is not a nominal party only"; the "Petitioner qualifies as a small business party as defined by Section 57.111, Florida Statutes"; the "Petitioner prevailed in the underlying case . . . in that the Board of Medicine dismissed the case with a Final Order filed on October 27, 1993"; and, the "Petitioner's claimed attorney's fees and costs [attorney's fees of $20,189.00 and costs of $3,784.95] seem reasonable; however, Respondent asserts that the statutory cap of $15,000.00 inclusive of fees and costs, is applicable." Under the circumstances, the sole issue with regard to the claim for attorney's fees and costs under Section 57.111, Florida Statutes, is whether the actions of the Department were "substantially justified" when it initiated the underlying disciplinary action and, with regard to the claim for attorney's fees and costs under Section 120.57(1)(b)5, Florida Statutes, apart from the applicability of such section to the instant case, is whether any pleading, motion or other paper was filed in the underlying proceeding for an "improper purpose." The underlying disciplinary action On or about May 22, 1990, the Department received, pursuant to statutory requirement, a closed claim report from the Department of Insurance. The report reflected that an indemnity of $160,000 had been paid to the family of Patient C. D. through a settlement within the presuit period prescribed by Section 768.57, Florida Statutes. The predicate for the claim against petitioner, Ada Gonzalez, M.D., was the apparent assertion that the patient died as a consequence of petitioner's failure to appropriately treat her. By memorandum of May 22, 1990, the Division of Medical Quality Assurance recommended to the Department of Professional Regulation's complaints department that a case be opened. That memorandum provided: DISCUSSION: This review is predicated upon receipt of a closed claim DOI report. The specific allegation is that the doctor treated the patient for PID - rule out urinary tract infection. The patient was reportedly treated with antibiotics on 11/14/88 and on 11/16/88 appeared better. However, the patient reportedly did not improve and died of a ruptured ovarian abscess on 11/18/88. There are no medical records to review and there is no history or explanation given as to what happened in the time period from the onset of the pain to the demise of the patient. * * * COMMENTS AND RECOMMENDATIONS: I recommend a case be opened. There is a question of stan dard of care. Records should be obtained and referred to a similarly placed physician for review. As a consequence of the foregoing referral, the Department opened its Case No. 90-06789, and assigned its investigator Providence Padrick to the case. The investigator obtained a copy of the Palm Avenue Physicians Center and the Fatima HMO medical records, which included the documentation reflecting petitioner's treatment of the patient; the Jackson Memorial Hospital medical records, the facility at which the patient expired; and the autopsy report. Petitioner was duly informed by the Department that the case had been opened against her, and she was offered an interview but declined. The Palm Avenue Physicians Center and Fatima HMO medical records reflect that the patient was first seen by petitioner on November 14, 1988, and presented with a complaint of bilateral flank pain radiating to the lower abdomen, frequency of urination with some tingling on urination, a yellowish vaginal discharge, and a low grade temperature; such symptoms of approximately one day duration. Examination revealed lower abdominal tenderness to palpation, cervical motion tenderness, and a brown cervical discharge. Petitioner diagnosed pelvic inflammatory disease ("PID") and possible urinary tract infection ("UTI"). As a consequence of the history and examination, petitioner ordered x- rays of the abdomen, biochemical profile, pregnancy test, syphilis test and cultures of the vaginal discharge and urine; prescribed antibiotics; made a referral for the patient to see a gynecologist in two weeks; and, advised the patient to return for a follow-up visit in two days. As for the testing results, the urine culture and sensitivity came back positive for a urinary tract infection; however, all of the other laboratory tests came back negative. The patient was next seen by petitioner on November 16, 1988, for her follow-up visit. At the time, the patient reported that she felt better, and petitioner's examination revealed less vaginal discharge and discomfort, although she still suffered a low grade fever. Petitioner confirmed her earlier diagnosis of pelvic inflammatory disease, and prescribed another antibiotic (Septra DS) for urinary tract infection. The following day, November 17, 1988, the patient returned to see petitioner complaining of severe abdominal pain over the whole abdomen, nausea and vomiting. Examination revealed that the patient was in distress, with a distended abdomen, decreased bowel sounds and positive tenderness on palpation over the abdominal area. Petitioner again diagnosed pelvic inflammatory disease and urinary tract infection, and referred the patient to the Fatima HMO for observation, IV fluids and x-rays. The patient refused, however, to go to the Fatima HMO and, in fact, evidenced her intent to cancel her membership in the HMO. At or about 6:34 p.m., November 17, 1988, the patient presented to the Jackson Memorial Hospital Emergency Room complaining of severe abdominal pain, nausea and vomiting, and yellow vaginal discharge. Routine laboratory work was undertaken, but when she was taken to the x-ray department and placed on the table she became unresponsive. Cardiopulmonary resuscitation was immediately commenced without success, and the patient was pronounced dead at 11:25 p.m. that evening. An autopsy performed by the Dade County Medical Examiner revealed the following abnormal findings: Diffuse peritonitis Ruptured left fallopian tubal abscess Crude intrauterine contraceptive device Bilateral ovarian cysts Soft liver, spleen, and kidneys Congested lungs Gallstones Scarred gallbladder The autopsy concluded that the cause of death was acute diffuse peritonitis due to ruptured fallopian tubal abscess. On August 11, 1992, the Department forwarded its investigative report and related exhibits to its expert, Stanley H. Bernstein, M.D., for review and opinion concerning petitioner's adherence to the appropriate standard of care. By letter of August 20, 1992, Dr. Bernstein responded to the Department's request as follows: The subject A. G. [petitioner] was treating this 49 year old female for symptoms related to the genito-urinary tract. The scant information noted in the medical office records suggested that the patient had a urinary tract infection as well as symptoms suggesting pelvic inflammatory disease. How ever no studies were initiated to define the extent of the infection in the pelvis. No consultations from either a urologist of [sic] gynecologist were obtained. Although antibiotic was given, there was no realization that the infection in the pelvis might have needed much more intensive therapy. The subject is unknown to me. There was no adequate assessment of the patient's condition. Since pelvic inflammatory disease was suspected, a consultant gynecologist and/or appropriate x-rays of the pelvis should have been done. Since the subject did not suspect the true diagnosis in this case, inappropriate antibiotics were given. Since appropriate diagnostic tests such as ultrasound and/or cat scan of the pelvis were not done the diagnosis could not be appreciated. The plan of treatment was inadequate. There was no adequate monitor being carried out for this patient in regard to antibiotic therapy. The written medical records were woefully inadequate. The applicable standard of care for this patient was not met since the subject did not appreciate the possibility that the patient had more extensive infection in her pelvis. The subject did note that pelvic infection was probably present but she never used appropriate consultants. This suggests that the subject had a poor understanding of the extent to which such infections can cause major catastrophic events. It seem to be that the subject needs further training-certainly in medical conditions where infection is present. On September 24, 1992, the probable cause panel of the Board of Medicine (Board) met in Tampa, Florida. Those present at the meeting were panel members Louis Murray, M.D., chairman, and Mr. Gilbert Rodriguez; Alan Grossman, Assistant Attorney General; Larry McPherson, Jr., chief medical attorney for the Department; Randolph Collete, senior attorney for the Department; and, James Reese, chief medical investigator for the Department. At the commencement of the meeting, the panel members (Dr. Murray and Mr. Rodriguez) acknowledged that they had received and reviewed the complete investigative file pertaining to, among others, the petitioner. With regard to petitioner's case, the transcript of that meeting reflects the following brief discussion: MR. COLLETTE: Item A-03 is on Ada Gonzalez, M.D., case number 90-06789. The case is before the Panel on a recommendation that probable cause be found and an adminis trative complaint be filed. It's alleged that the respondent practiced medicine below the acceptable level of care by failing to appropriately diagnose and treat the patient C. D.'s condition and mistakenly treating her for a urinary tract infection with antibiotics when, in fact, the patient was suffering from an ovarian abscess; and that the respondent failed to keep written medical records justifying the course of treatment; and that the records are sketchy and inadequate. Based upon these facts, the Department is alleging a violation of 458.331(1)(t) and (m), and recommends that probable cause be found and an administrative complaint be filed. MR. RODRIGUEZ: Move a finding of probable cause and the filing of an administrative complaint. MR. MURRAY: Second. MR. MURRAY: So moved a finding of probable cause and the filing of an administrative complaint, seconded, and passed without objection. On October 8, 1992, an administrative complaint was filed against petitioner alleging that she violated the Medical Practices Act, Section 458.331(1)(m) and (t), Florida Statutes, by failing to practice medicine at the accepted standard of care in that petitioner was guilty of "mistakenly treating [the patient] for a urinary tract infection with antibiotics, when in fact [the patient] was suffering from an ovarian abscess," and that petitioner's "medical records are sketchy and inadequate in that they fail to justify [her] course of treatment." Subsequent to the filing of the administrative complaint, petitioner's counsel employed an expert, Martin Arostegui, M.D., to review the matter and render an opinion regarding the merits of the claim against petitioner. Based on his review of the investigative file and an interview with petitioner, Dr. Arostegui concluded: . . . As a result of my extensive review, I have come to an opinion that is substantially different from that of the other physician who previously reviewed this file. I attribute this difference to the level and intensity of my review and scrutiny of the file records and my interview with Dr. Gonzalez who I found to be very professional, concerned and wholly credible. CONCLUSION: Dr. Ada Gonzalez was faced with a very difficult patient who was obese and, as a result, difficult to examine and who appeared to be clinically less sick than she really was. This patient developed a severe pelvic infection as a result of a home made intrauterine contraceptive device which probably was placed illegally and without regard for patient safety. The device was not disclosed to Dr. Gonzalez by the patient and it is reasonable to expect that Dr. Gonzalez would not uncover the device under the circumstances. Dr. Gonzalez attempted to get proper surgical evaluation and care for this patient but the patient refused, went home and, at least six hours later, appeared at an emergency department where the continuity of communication with Dr. Gonzalez was broken, the diagnosis was completely missed and the patient expired. In my opinion, Dr. Ada Gonzalez' care did not fall below community standards. However, Dr. Gonzalez did a less than satisfactory job of documenting her care of this patient and this probably had a role in the formulation of the different opinion by the other reviewing physician. It is particularly worth noting that the physician reviewer did not mention the existence of the home made intrauterine contraceptive device. On or about February 11, 1993, petitioner's counsel provided the Department a copy of their expert's report with the understanding that the Department would provide the report to its expert and if the expert's opinion was materially changed as a result the Department "would entertain taking this case back to probable cause, perhaps dismissing it or softening at least the consent agreement by eliminating perhaps probation or other items" [TR. pp. 15- 16]. Upon receipt and review of the aforesaid report, the Department amended the administrative complaint to correct certain factual inaccuracies. In this regard, paragraphs three, four and five of the original compliant, which had inaccurately averred that petitioner had treated the patient on October 8 and 31, 1988, were dropped; paragraph 7 of the original complaint, now paragraph 4 of the amended complaint, was amended to reflect that petitioner had "referred her [the patient] to a gynecologist in two weeks, and asked her to return in two days," as opposed to having simply "scheduled her to see a gynecologist" as alleged in the original complaint; and paragraph 10 of the original complaint, now paragraph 7 of the amended complaint, was amended to correctly reflect that petitioner referred the patient to Fatima HMO for observation, as opposed to referring her to Jackson Memorial Hospital as alleged in the original complaint. Other than such factual corrections, the premise for the charges leveled against petitioner remained unchanged. On April 16, 1993, the Department forwarded a copy of the amended complaint, which had been filed that date with its clerk, and a copy of petitioner's expert report to Dr. Bernstein for review. The cover letter that accompanied such materials concluded "Please read over the enclosed materials. If you see anything that you want to bring to my attention, please give me a call . . . ." Here, the proof fails to demonstrate any change in Dr. Bernstein's opinion as a consequence of his review of the materials, but fails to explicate why no change occurred. 2/ By letter of April 19, 1993, the Department advised petitioner's counsel of the amendment of the complaint, consequent to her review of his expert's analysis, and encouraged petitioner's agreement to a proposed stipulation for settlement of the case. Ultimately, in September 1993, the parties entered into a written consent agreement, subject to Board approval, to resolve the subject dispute. On or about October 2, 1993, the consent agreement was presented to the Board of Medicine for consideration. Present were fourteen members of the Board; however, one member, Dr. Louis Murray, was excused from participating since he had served on the probable cause panel. Pertinent to this case, the transcript of the Board meeting reflects the following comments by Board members: CHAIRMAN DAUER: Thank you. I just want to make a few opening comments here. I was a little bit disturbed when I saw the materials here, and let me express my concerns here. I think the doctor in this case probably did everything right. You had a patient that she first saw on November 14th, she ordered a beta HCG, it's clearly on the order here, the pregnancy test came back negative, there's no history of the IUD, she appropriately treated her, I think her medical records are adequate, and what happened, she even referred her to a gynecologist. She got the patient back in 48 hours, and I think it was an incident that could not be expected. There's no way to expect this woman to have a ruptured tubal with the results she had done, the history that was not adequate. I think this doctor did everything right. I looked at this case material and I said why is this even here. I think the case should have been dismissed. * * * DR. ECHEVARRIA: I thoroughly agree with your comments, Mr. Chairman. As I read the original AC, I made a note to take issue with the Administrative Complaint to start with, and I really feel that she did things according to the book and it is an unfortunate final ending in this case, and I'm kind of wondering why peritonitis with a ruptured tubal would kill her this quickly. We see people with ruptured diverticulitis, ruptured appendices that linger on and on and on, and it doesn't kill them. So I don't know why the death occurred so quickly without a lot of other symptoms being associated with it. So I think there may have been something like toxic shock or whatever, as a result of the foreign body. I would agree, I would certainly favor a move to dismiss. Following such dialogue, a motion was made by a member of the Board to reject the consent agreement and dismiss the case. The motion passed unanimously, and by final order dated October 8, 1993, filed with the Department of Professional Regulation October 27, 1993, the consent agreement was formally rejected and the case dismissed. Whether the action of the agency was substantially justified or other special circumstances exist which would make an award of attorney's fees and costs unjust. Here, facially, the probable cause panel had before it evidence in the form of its expert's report that would, if his opinions were credited at final hearing, suggest that petitioner had failed to maintain adequate medical records and had failed to maintain the appropriate standard of care. The reliability or efficacy of that expert's opinions has, however, been rendered suspect by the Board's unanimous conclusion that petitioner's medical records and treatment were appropriate. Under such circumstances, and the Department having failed to demonstrate, at hearing, that the information upon which the Board based its decision differed in some marked degree from that considered by the probable cause panel or to offer proof to explicate the basis or reasonableness of the expert's conclusions, the expert's report cannot be accepted at face value as reasonably indicating that the violations had occurred. Therefore, it must be concluded that the Department has failed to demonstrate that its decision to initiate the underlying action was substantially justified or special circumstances exist which would make an award of attorney's fees and costs unjust. While the Department may have failed in its burden to demonstrate that its action was substantially justified, such does not compel the conclusion that any pleading or paper filed by the Department was interposed for an "improper purpose," such that attorney's fees and costs would be appropriately awarded under Section 120.57(1)(b)5, Florida Statutes. To the contrary, the proof fails to support such conclusion. Moreover, and most importantly, the proof fails to demonstrate that the subject charges ever pended before the Division of Administrative Hearings and, therefore, as discussed in the Conclusions of Law, there is no basis upon which to assess attorney's fees and costs under Section 120.57(1)(b)5, Florida Statutes.
The Issue Whether Respondent's license as a physician should be disciplined for the alleged violation of Section 458.331(1)(t), Florida Statutes, in that Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, by failing to treat the patient's preoperative coagulopathy and/or failing to use an alternate vein that would have allowed visualization of the shunt placement into the vein thereby reducing the risk of causing a hemorrhage given the patient's preoperative history, and, if so, what penalty should be imposed. AS TO CASE NO. 01-4407PL Whether Respondent's license as a physician should be disciplined for the alleged violation of Section 458.331(1)(t), Florida Statutes, by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances by failing to distally clamp part of the arteries prior to manipulation of the aneurysm and by failing to ensure periodic monitoring of the patient's condition postoperatively for evidence of ischemia or other problems and, if so, what penalty should be imposed.
Findings Of Fact Based on the evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: FACTS COMMON TO BOTH CASES Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes, Chapters 456 and 458, Florida Statutes. At all times relevant to this proceeding, Respondent was a licensed physician in the State of Florida, having been issued license number ME 0036360. Respondent is board-certified in thoracic and general surgery. FACTS RELATED TO CASE NO. 01-4406PL Patient D.J.P. was a 54-year-old female with a history of liver resection for carcinoma. Patient D.J.P. had contracted Hepatitis C in the 1960s from a blood transfusion, after being the victim of a gun shot wound during a robbery at a convenience store. Patient D.J.P. subsequently had developed cirrhosis secondary to the Hepatitis C. Cirrhosis is a scarring process of the liver that results in the displacement of the normally functioning liver tissue. A healthy liver processes lymphatic fluid back into the bloodstream. However, a cirrhotic liver cannot properly process the lymphatic fluid back into the bloodstream. Therefore, lymphatic fluid backs up within the liver and weeps out the covering over the liver and into the abdominal cavity. Patient D.J.P. presented to Respondent on February 1, 1994, after being referred to Respondent by Michael Carey, M.D., the primary care physician, for evaluation for implanting a peritoneal venous shunt. A venous shunt is a conduit designed to take ascitic fluid from the abdomen and put it back in the vascular system. The shunt removes the fluid from the abdominal cavity and transports it to the vascular system where it can be absorbed. The procedure is for the patient's comfort and does not prolong the patient's life. The procedure is for patients with end stage liver disease. After obtaining a medical history and conducting a physical examination, Respondent's assessment of the Patient D.J.P. was massive ascites secondary to cirrhosis and previous liver resection. Respondent believed that Patient D.J.P. was a candidate for a venous shunt procedure due to the fact that she was very symptomatic from her massive ascites and she was on the maximum medical therapy. The mortality rate for this type of procedure is between 5 and 25 percent or at the very least, one-in-twenty patients would die from this procedure. Complications associated with this type of procedure include disseminated intravascular coagulopathy (hereinafter referred to as "DIC") which may lead to the general worsening of the disease or death. The patient was informed of this mortality rate as well as of the complications associated with this procedure. Patient D.J.P. decided to think about the procedure and contact Respondent's office when she wanted the shunt inserted. On February 10, 1994, Patient D.J.P. called Respondent's office and asked to have the shunt inserted as soon as possible. Respondent scheduled the procedure for February 14, 1994, and signed the written surgical consent form. Prior to the surgery, lab tests were performed on Patient D.J.P. The lab report indicated that the patient's prothrombin time was 14.3, with a normal range being 10.7-12.8. Prothrombin time ("PT") is a measurement of one aspect of the blood clotting mechanism. This was considered slightly abnormal and not an indication of a clotting problem or coagulopathy. Respondent decided it was not necessary to address Patient D.J.P.'s abnormal PT prior to the procedure by preoperatively administering Vitamin K or fresh frozen plasma. On February 14, 1994, Patient D.J.P. was transported to the operating room at approximately 12:10 p.m. After Patient D.J.P. was placed under general anesthesia, Respondent began the venous shunt operation at approximately 12:34 p.m. Respondent attempted to access the right jugular vein to insert the shunt. He found this vein to be unusable because it was too scarred from previous surgeries. Respondent then proceeded to access the right subclavian area to insert the shunt. Once the shunt was inserted into the subclavian area, Respondent positioned it in the superior vena cava. The shunt was noted to be in position in the superior vena cava. Respondent then removed eight liters of ascitic fluid from the abdominal cavity. After removing the ascitic fluid, he then put one liter of saline into the abdominal cavity to dilute any remaining ascitic fluid which allowed any remaining fluid to be more easily absorbed into the vascular system. The Patient's central venous pressure dropped from 8 to 2. Hespan and Albumin were then administered to replace any lost volume and it helped to increase the colloidomotic pressure. At this point, Patient D.J.P.'s central venous pressure (CVP) increased from 2 to 14 or 15. This is a faster than normal rate. Upon finding that the shunt was operating well, Respondent closed the abdominal portion and the patient was extubated. Petitioner claimed that fluoroscopy was not used to ensure that the shunt was positioned in the proper place. A Fluoroscope is like a real-time X-ray. A fluoroscope has two parts to it: a C-arm, which goes above the patient and underneath the bed, and two screens where the doctor can see what is going on. The C-arm is approximately 5-and-a-half feet tall. It is below the standard of care to do a venous shunt procedure without using a fluoroscope. It would enable Respondent to visualize the placement of the shunt. Felicia Whitmer, a scrub technician, and Rene Myers, a circulating nurse, prepared the operating room for Patient D.J.P.'s procedure on February 14, 1994. Both Felicia Whitmer and Rene Myers testified that there was no fluoroscope in the operating room on February 14, 1994. Respondent testified that there was a fluoroscope in the operating room on February 14, 1994, during Patient D.J.P.'s procedure and that he used it to assist him. The evidence is not clear and convincing that the fluoroscope was not used during the course of the operation. It is considered within the accepted standard of care to access the right subclavian vein to insert a shunt of this type because this vein follows a gentle curve or path. With this gentle curve in the vein, there is less risk of damage, i.e. puncture, to the vein. In contrast, the left jugular vein follows a more sharp-angled 70-degree bend-curve in the vein where one risks the danger of the shunt coming out of the bottom of the vein or perforation and, thereby, damaging the vein. Respondent ordered an X-ray to confirm placement of the shunt and catheter. The X-ray revealed that the shunt had good positioning but the right lung was filled with fluid. The patient was re-intubated and Respondent inserted a chest tube into the patient which would expand the patient's lung, oxygenate the patient and allow for fluid removal. Three or four liters of fluid were removed. The fluid was originally serous and pink tinged and shortly thereafter, turned bloody. Respondent noted that there was bruising around the wounds. Additionally, the patient's breathing became shallow and her blood pressure began to deteriorate. Resuscitative efforts were performed and Respondent re- entered the shunt area to clamp the shunt to prevent any ascites from flowing into the venous system and to prevent further coagulation and massive bleeding. Despite heroic resuscitative efforts, the patient's condition continued to deteriorate and the patient died. The cause of death was determined to be DIC and severe coagulopathy from drainage of the ascitic fluid into the venous system. Respondent made the determination that the patient did not have preoperative coagulopathy. Respondent testified that if the patient did have preoperative coagulopathy, he would not have performed the procedure because the patient would not be able to make the clotting factors well enough for problems that would occur after the shunt was inserted. It was Respondent's opinion that the patient did not have a serious clotting problem. Based on her lab report, Patient D.J.P. had a slightly abnormal PT and this was not an indication of a clotting problem. Respondent reviewed the lab reports and determined the PT (the measurement of one aspect of blood clotting mechanism), to be only slightly elevated. It measured 14.3 with a normal range being 10.7-12.8. Moreover, the PT International Normalized Ratio (INR) (which is the standardized measurement of PT) was 1.63 where the therapeutic range was 2-3. Therefore, this was slightly below average. Dr. Yahr testified that an abnormal clotting problem is a clinically evident problem and not an incident of a lab number. If Patient D.J.P. had a clotting abnormality, adverse conditions or symptoms would have been evident with the incisions that were made prior to the shunt being opened. Rather, normal clotting reactions occurred. Coagulation occurred right after the shunt was opened and the ascitic fluid began to flow into the atrium. Dr. Yahr testified that the etiology of the coagulation was the body's reaction to the ascitic fluid after the shunt was opened. Accordingly, it was Dr. Yahr's opinion that Respondent did not fail to treat the preoperative coagulopathy because upon his examination of the patient, he determined that no such preoperative coagulopathy existed prior to the procedure. Dr. Yahr testified that the patient did not have abnormal bleeding. Her liver failure was the result of scarring and abnormal liver function. Therefore, administration of clotting factors such as Vitamin K and fresh frozen plasma was not indicated or medically necessary. Petitioner presented the expert testimony of John W. Kilkenny, III, M.D. Dr. Kilkenny is board-certified in general surgery and has been for 11 years and is currently a professor with the University of Florida College of Medicine, Department of Surgery in Jacksonville, Florida, a position which he has held for the last six years. According to Dr. Kilkenny, Patient D.J.P.'s elevated PT was a cause for concern in that it was an indication that the patient's ability to clot or coagulate was diminished. It is not clear and convincing that the standard of care required that the elevated PT be treated by infusing fresh frozen plasma or Vitamin K. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by failing to use an alternate vein that would allow visualization of the placement of the shunt. Respondent first attempted to access the right jugular vein to insert the shunt but found it be unusable because it was too scarred. Respondent, acting as a reasonably prudent physician and using sound medical judgment, accessed the right subclavian area to insert the shunt. After the shunt was inserted into he subclavian vein, Respondent claimed he was able to visualize the placement of the shunt by the use of fluoroscopy. Furthermore, the operative notes seemed to indicated that the procedure was performed under fluoroscopic control and the shunt was found to be in position. Therefore, Respondent accessed an appropriate alterative vein-the subclavian vein, which allowed visualization, with the assistance of fluoroscopy, of the placement of the shunt. As to the second issue, Dr. Kilkenny opined that the standard of care requires direct visualization for insertion of the shunt. By not accessing a vein under direct visualization, such as with Respondent's subclavian approach, the surgeon is, in essence, hunting for the vein, and risking damage to the wall of the vein that may not be evident immediately. The rapid rise in CVP from 2 to 14 or 15 was also a concern for Dr. Kilkenny because it was not normal, and did not mean that the shunt was placed correctly of that the shunt was functioning properly. Dr. Kilkenny noted that it was unlikely that the bleeding in the chest cavity was caused by damage to an intercostals vessel when the chest tube was inserted because the chest X-ray that was taken prior to insertion of the chest tube showed a complete opacification of the right side and a shifting of the major vessels within the middle of the chest over to the left side. According to Dr. Kilkenny, the chest X-ray indicated that there had already been some sort of bleeding in the right chest prior to the insertion of the chest tube. Dr. Kilkenny disputed Respondent's theory that Patient D.J.P. died as a result of DIC. Dr. Kilkenny asserted that Respondent fell below the standard lf care in that, given Patient D.J.P.'s rapid decompensation, he failed to consider whether the patient's subclavian vein had been damaged, a condition which could have been addressed surgically. Dr. Yahr opined that Patient D.J.P. died of DIC that occurred within a short period of time after Respondent opened up the shunt and ascitic fluid was introduced into the atrium of the heart. Although Dr. Yahr further admitted that the bleeding in the chest could have occurred as a result of damage to the subclavian vein, and that it was below the standard of care to access the subclavian vein without using fluoroscopy, the evidence is not clear and convincing that either event occurred. It is found that Petitioner has failed to establish by clear and convincing evidence that the standard of care required Respondent to use an access site that allowed direct visualization of the placement of the shunt into the vein, or that Respondent failed to use fluoroscopy in order to directly visualize insertion of the shunt into the subclavian vein. AS TO CASE NO. 01-4407PL On August 22, 1997, Patient H.H., a 55-year-old female, was diagnosed with an abdominal aortic aneurysm measuring approximately 4.5 cm transverse diameter and beginning approximately 1-2 cm below an enlargement or swelling, of a blood vessel resulting in a weakening or thinning out of the vessel wall. On November 28, 1997, Patient H.H.'s aneurysm had grown to 5 cm within a three-month period and was occluded with partial thrombosis with a true lumen around 2.7 cm and extended down to the bifurcation of the abdominal iliac. This put the patient at risk for rupture of the aneurysm. Thrombosis is a blood clot within a vessel or within the vascular system. It does not embolize (travel) from another part of the body. It starts in a particular vessel and causes its damage from there. It is an acute clot that occurs in the vessel secondary to stasis (non-moving ) or some kind of coagulation or clotting deficiency or abnormality. Thrombotic activity most often begins by occluding the smaller vessels in the vascular system, such as those smaller veins located in the feet. On December 2, 1997, Patient H.H. first met with Respondent, who performed a complete medical history and physical examination and confirmed the presence of a 5 cm abdominal aneurysm. Patient H.H. was a 55-year-old female who smoked 1- and-a-half packs of cigarettes per day, had a blood pressure of 182/104 despite the fact that she was taking 50 mg Atenolol for hypertension (high blood pressure), and had a 30 percent blockage of the coronary artery. Previously, she had a cardiac catheterization, followed by an angioplasty of the femoral vessel in her left leg. Patient H.H. advised Respondent that her legs gave out on her after she walked two blocks, but that she did not have associated chest pain. Respondent confirmed earlier diagnosis of Patient H.H.'s medical condition as single vessel coronary artery disease, abdominal aortic aneurysm, hypertension, and claudication with femoral occlusive disease. Respondent also found diminished femoral pulses and palpable Dorsal pedal pulses present in both feet. Patient H.H.'s medical records indicated that this smoker of 30 years suffered from diabetes, peripheral vascular disease, intermittent clottication of the leg, hypertension, atherosclerotic disease, hypercoagulopathy, anthithrombin III deficiency, high cholesterol, and diminished protein and pH levels. Respondent prescribed prescription medication, Procardia to lower Patient H.H.'s blood pressure and Zyban to help her stop smoking. He recommended that the patient return in a week for follow-up. On December 15, 1997, Respondent continued to prepare Patient H.H for surgery. He again advised her to stop smoking and to purchase and take medication to help her stop smoking. Patient H.H.'s blood pressure was lower, 144/84, and although she had not purchased or taken the medication, she reduced her smoking down to one-half pack of cigarettes per day. Respondent then advised Patient H.H. to make plans to undergo the abdominal aortic aneurysm ("AAA") repair. Patient H.H. informed Respondent that she wanted to wait a little longer while she made financial arrangements to pay for the surgery. Respondent advised Patient H.H. to completely quit smoking before the surgery and advised her to return in one month for additional preoperative evaluation. On January 12, 1998, Respondent continued to prepare Patient H.H. for surgery by ordering a cardiac clearance (thallium evaluation) of the patient's heart to ensure she could tolerate the surgery before attempting the AAA repair. On February 3, 1998, Patient H.H. presented for the thallium evaluation of the heart and, on February 9, 1998, obtained cardiac clearance for repair of the AAA. On February 11, 1998, Respondent continued to prepare Patient H.H. for AAA surgery and suggested she donate two units of blood which would be used during the surgical procedure. Respondent scheduled AAA repair surgery for March 6, 1998. Respondent advised Patient H.H. of the risks associated with AAA surgery and specifically mentioned the risk of a heart attack, bleeding, kidney damage and loss of legs. He also advised that the risks associated with intra-operative AAA repair include spontaneous rupture, embolization of material from the wall distally, myocardial infarction, bleeding, injury to viscera of the small vessels, devascularization of the colon causing ischemic colitis, death, kidney blockage. Patient H.H. indicated she understood the risks and despite the risks associated with this type of surgical procedure, including the risk of death, she agreed to the procedure. Preoperative testing by angiogram was not required for Patient H.H. The aneurysm was a massive aneurysm presenting a very serious health risk of imminent rupture. The size of Patient H.H.'s aneurysm (5 cm) made AAA repair an emergency in a sense because there was almost a 100 percent chance of rupture with in the next six months. Any findings determined by angiogram would not have changed the outcome of the case because Respondent had to definitively treat the aneurysm first. Additionally, an angiogram is a very expensive test and Patient H.H. expressed a concern about her financial situation with respect to the AAA repair. It is reasonable to not do studies that a physician does not feel are absolutely necessary. The patient's financial concerns are part of the pathology. On March 6, 1998, Patient H.H. was admitted to Winter Haven Hospital and filled out and signed the Special Authorization for Medical and/or Surgical Treatment form indicating her consent to the surgical procedure which Respondent was to perform. She indicated that she understood the risks associated with such surgical procedure. Paragraph two of the informed consent form states in pertinent part: I hereby certify that I have given complete and informed consent for the above named operation and/or procedures, and Dr. L. Thomas has explained to me the reason why the above-named operation and/or procedure are considered appropriate, its advantages and possible complication, if any, as well as possible alternative modes of treatment. I also certify that no guarantee or assurance has been made as to the results that may be obtained. The operative procedure on the consent form was signed by Patient H.H. at 6:10 a.m. on March 6, 1998. Surgery indicated on the consent form was for a resection abdominal aortic aneurysm (AAA repair). After Patient H.H. was taken to the operating room and administration of anesthesia began, Respondent performed his routine preoperative check of femoral and pedal pulses. Checking for femoral and pedal pulses is the type of preoperative work-up Respondent routinely performs while he waits for the anesthesia to take its effect on the patient. The operative report indicates that the abdominal aneurysm was "very large" extending quite high within 1-2 cm from the renal vein and down to and involving the common and hypogastric arteries and noted to be "quite saccular" with "impending rupture in the near future at the neck." The common iliacs were noted to be "quite large and aneurysmatic." The external iliacs were soft but extremely small, "approximately 4-5 mm in size, certainly less than half, more like 1/4 the size of a normal iliac" but nevertheless usable vessels to make his anastomosis. As Respondent was bluntly dissecting (separating the tissues using the fingers) the aortic aneurysm from the venous plexus to position his proximal clamp when one of the lumbar veins was encountered and mass bleeding occurred. The venous plexus is a grouping of veins located under the aorta that can best be described as a wagon wheel. The system has a hub and all the veins in the grouping extend outward from the hub. If one of the veins in the grouping is injured, it will bleed heavily, but the bleeding is controllable. The lumbar veins are part of the venous plexus and a tear of the lumbar vein is a known risk during this type of surgery. Patient H.H. suffered the loss of three times the amount of blood as would have been routinely expected. The sudden blood loss caused the patient's condition to rapidly deteriorate. Dr. Wickstrom-Hill, Anesthesiologist, testified that had Respondent not controlled the blood loss, and had not maintained Patient H.H.'s vital signs, she would have died. Using sound medical judgment, Respondent elected to bypass the aneurysmatic common iliacs and make his anastomosis of the graft to the external iliacs in order to not disconnect or separate the aortic or common iliac aneurysms from the iliac vein. This is a very fragile vessel and could have resulted in further massive bleeding and possible death of the patient. A reasonable prudent physician faced with a similar circumstance and situation would not attempt to mobilize the aneurysm further if doing so would cause additional massive blood loss and possible death of the patient. The hypogastric arteries (a/k/a the internal iliacs) serve to provide the pelvic viscera (bladder, rectum, etc.) with blood. During the AAA repair, Respondent performed an embolectomy on both legs following manipulation of the aneurysm. The purpose of this procedure was to remove any debris which may have dislodged from the aneurysm and flowed distally to the legs. The procedure involves running a Fogarty catheter down the femoral arteries as far as the catheter will go, then inflating a balloon located at the end of the catheter. Once the balloon is inflated, the surgeon will extract the catheter, pulling the debris out of the artery. This process is repeated as necessary to remove all debris. Fresh clot was obtained from both legs, indicating a lack of debris. Prior to completing the anastomosis of the bifurcated graft to the aorta and external iliacs respectively, Respondent ran a Fogarty catheter down proximal (back into the graft itself), to remove any debris in the graft itself. Finally, he back-bled the graft (allowed blood to flow out of the graft, to, again, ensure that there existed no debris in the graft). On March 7, 1998, Patient H.H.'s medical condition stabilized such that Respondent felt it safe to return Patient H.H. to the operating room to undergo an additional embolectomy of the legs and an endarterectomy of the right femoral artery. The record demonstrates that Respondent believed he collected embolic debris from the femoral arteries. However, based upon the pathology report and the testimony of Dr. Zeller, the debris removed from Patient H.H. during this procedure was acute blood clots and atherosclerotic plaque. This finding is consistent with thrombotic material and not a result of debris coming from another location as it tends to demonstrate that Patient H.H. had a clotting disorder consistent with her medical history. The record also demonstrates that upon completion of the procedure, Patient H.H. was noted to have excellent pulses in the superficial and profunda femoral arteries distal to the anastomosis with good emptying and filing of the vessels. Before, during, and after the AAA repair, Respondent used Heparin (an anti-clotting drug) in an effort to prevent the formation of clots throughout Patient H.H.'s vascular system. Intraoperatively, on March 3, 1998, Respondent administered 10,000 units of Heparin. Normally a patient will respond to 5,000 units. Despite giving Patient H.H. twice the normal amount of Heparin, Patient H.H. continued to have a lowered clotting time. It is noted in the medical record that Patient H.H. had an Antithrombin III deficiency. Antithrombin III is one of the factors that control how blood in the human body clots. Patient H.H.'s Antithrombin III deficiency is a hereditary defect that contributed significantly to her continued clotting despite the use of pharmacological intervention (substantial amount of Heparin). Respondent testified that in his medical training and experience, Patient H.H.'s Antithrombin III deficiency level was near fatal. Because Patient H.H. was hypercoagulative, thus causing the small vessels to clot off, on March 13, 1998, Patient H.H. underwent bilateral above the knee amputations. Hypercoagulopathy is a tendency to clot without anything being done - the blood just clots. This can be caused by a lower-than- normal blood pressure for a period of time and by having an Antithrombin III deficiency. Respondent observed during the surgery that this patient was hypercoagulative because he could see the blood clotting in the wound despite the fact that Patient H.H. was on twice the normal amount of Heparin. Respondent practiced within the standard of care at all times during the treatment of Patient H.H. Blood-flow going retrograde back into the common and iliac aneurismal sacs did not place Patient H.H. at a risk of rupture. The operative report clearly demonstrates that the aortic aneurysm involved the common iliacs and extended below the hypogastric arteries. The operative report also demonstrates that the external iliacs were extremely small, approximately one-quarter of the normal size. A reasonable and prudent surgeon, faced with a similarly situated patient with a massive sized aneurysm and the extremely small size of the distal external iliacs, would conclude that the pressure gradient now being carried to the graft rather than to the aneurysm would diminish flow to the aneurysms making the possibility of rupture unlikely. Moreover, the aneurysms were filled with calcified atherosclerotic plaque and other thrombotic (non-mobile) material. Dr. Begelman testified that calcified aneurysms do not tend to rupture as much. On direct examination, Dr. Begelman, Petitioner's expert, could not conclusively determine whether Respondent's surgical treatment of Patient H.H. fell below the standard of care and that distal clamping is an intra-operative decision to be made by the surgeon. Dr. Begelman who testified that he accepted Respondent's opinion that the iliacs were too large or too thin walled and could not distally clamp the aneurysm and that such decisions are those made by the surgeon on the case. Drs. Begelman and Seller and Respondent testified that it is usual and customary during this type of surgical procedure to distally clamp the aorta and that it is expected of a reasonable and prudent surgeon to make every attempt to do so. Nevertheless, all three doctors recognized that there are times when you cannot or should not distally clamp if to do so would cause further injury to the patient or death. Patient H.H. presented with very massive aneurysms of both the aorta and common iliacs making distal clamping impossible without sacrificing the hypogastric arteries thus placing Patient H.H. at risk for further injury or death. Petitioner's expert accepted Respondent's assessment of the condition of the iliacs and that Respondent did not want to dissect the iliacs off the iliac vein, which one needs to do in order to tie off distally. Dr. Begelman testified that he could not ascertain whether Respondent fell below the standard of care with respect to Respondent's treatment of Patient H.H. intraoperatively. Respondent acted within the standard of care and, therefore, did not violate Section 458.331(1)(t), Florida Statutes, when he did not clamp the distal arteries before manipulation of the aneurysm. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by sewing the bifurcated graft to the external iliacs and making no attempt to disconnect the aneurysm from the common and internal (a/k/a hypogastric) iliacs. The common and internal iliac tissues were also diseased because of their involvement with the aneurysms coupled with the fact that the aneurysm and surrounding tissue was inflamed. Inflammation causes the tissues of the surrounding viscera to become sticky and by that, stick together making separation difficult and more prone to bleeding on manipulation. Normally, the surgeon must bluntly dissect (lift up) the distal end of the aorta in order to place the distal clamps on the aorta below the aneurysm. However, the inflammation present in Patient H.H.'s aorta made it impossible to mobilize (lift up) the distal aorta for clamping because the tissue was stuck to the iliac vein which could have caused Patient H.H. to suffer a lethal blood loss. Normally, blood loss associated with this type of surgery amounts to 500 ccs for the total surgery. Patient H.H. lost 1500 ccs during the manipulation of the aortic aneurysm to place the proximal clamp and a total of 2400 ccs during the entire surgery which represented a blood loss of nearly 25-40 percent respectively of her estimated total blood volume. Respondent used sound medical judgment by making no attempt to dissect the common iliac from the subordinate tissue because, in his training and experience, the separation of tissues would have caused further, possible lethal bleeding. Drs. Begelman and Zeller, experts for Petitioner and Respondent respectively, testified that a reasonably prudent surgeon would not clamp below the common iliacs if to do so would sacrifice the hypogastric arteries and thereby cause irreparable harm or death to the patient. Dr. Zeller testified that the hypogastric arteries are of such importance that not clamping them, even at the risk of embolization, would nevertheless be within the standard of care. Respondent closely monitored Patient H.H. postoperatively. A reasonable and prudent surgeon is not expected to remain in the recovery room with his post-surgical patient until the patient becomes stable. Rather, the reasonable and prudent surgeon is expected to utilize the nursing staff who are charged with attending to the patient and to keep the physician updated on the patient's medical condition. Petitioner's witness, Doris Gutierrez, was the recovery room nurse on duty on March 6, 1998. Her duties included monitoring and reporting changes in Patient H.H.'s condition to Respondent. The record demonstrates that Respondent closely monitored Patient H.H. postoperatively by being in contact with the nursing staff and thereby giving orders for care and treatment to the nursing staff, either by telephone orders ("TO") or in person by verbal orders ("VO") to stabilize the patient. While in the recovery room, Patient H.H. was intubated, on a respirator. Petitioner's witnesses, Doris Gutierrez, confirmed Respondent's monitoring of Patient H.H. when she testified that she called Respondent several times to provide updates on Patient H.H.'s condition. The record demonstrates that postoperatively on March 6, 1998, Respondent wrote his initial order to the nursing staff at 12:30 p.m. while sitting in post-surgical recovery with Patient H.H. Thereafter, Respondent continued to monitor Patient H.H.'s condition and remained in communication with the nursing staff and wrote orders at 1:30 p.m., 2:30 p.m., 3:25 p.m., 5:00 p.m., 5:15 p.m., 8:15 p.m., and again on March 7, 1998 at 12:24 a.m. Following his TO on March 7, 1998, at 12:24 a.m., Respondent next saw Patient H.H. 7 1/2 hours later, at 8:00 a.m., prior to taking Patient H.H. to the surgery room to perform the endarterectomy and embolectomy. Ms. Gutierrez testified that she does not always note when the doctor comes back into the recovery room to give orders. She could not testify as to events that took place after Patient H.H. was transferred to the Surgical Intensive Care Unit ("SICU"). She also stated she did not know how many times Respondent went to SICU because she did not work in SICU when Patient H.H. was transferred out of the recovery room. Ms. Gutierrez was also unable to testify as to when the last time was that Respondent came to the recovery room. Respondent testified that there is a difference between a TO and a VO, the latter indicating that the physician was present in the room at the time he gave his order to the nurse. The evidence is not clear and convincing that Respondent did not provide appropriate postoperative monitoring of Patient H.H.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine: Enter a final order dismissing with prejudice the Administrative Complaint filed against Respondent in DOAH Case No. 01-4406PL, and DOH Case No. 1994-12341. Enter a final order dismissing with prejudice the Administrative Complaint filed against Respondent in DOAH Case No. 01-4407PL, and DOH Case No. 1999-57795. DONE AND ENTERED this 8th day of August, 2002, 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 8th day of August, 2002. COPIES FURNISHED: William R. Huseman, Esquire Romualdo C. Marquinez, Esquire Huseman, Marquinez & Schlegal, P.A. 6320 St. Augustine Road, Building 12 Jacksonville, Florida 32217 Kim Kluck, Esquire Richard J. Shoop, Esquire Agency for Health Care Administration Post Office Box 14229, Mail Stop 39A Tallahassee, Florida 32317-4229 Dr. John O. Agwunobi, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue The issue is whether Respondent failed to practice medicine with the required standard of care, in violation of Section 458.331(1)(t), Florida Statutes, and failed to keep required written medical records, in violation of Section 458.331(1)(m), Florida Statutes. If so, an additional issue is what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician in Florida, having been issued license number ME 0022608. Respondent is board-certified in ophthalmology. He was the principal investigator in the Excimer Laser Research Study. He is a fellow with the American College of Surgeons. He has published extensively in prominent medical and ophthalmologic journals. While still receiving medical training, Respondent gained experience in treating the ophthalmologic conditions of patients who suffer from Down Syndrome. While in practice, Respondent has continued to gain considerable experience in treating the ophthalmologic conditions of patients with Down Syndrome. Respondent has never previously been disciplined. U. V. was born on January 6, 1973. He suffered from Down Syndrome. As a young child, U. V. was diagnosed with inoperable congestive heart failure. Suffering from damage to two chambers of his heart and irreversible lung damage, U. V. had been in “terminal” condition since about the age of seven. Despite his serious medical problems, which are common to Down Syndrome patients, U. V. was a happy young man, who developed and matured as a teenager. He communicated his feelings and interacted with others, especially with his family. His mother adopted him when he was about five years old; previously, she had cared for him after his biological family had abandoned him. In March 1992, U. V. became quite ill. His physician discussed with U. V.’s mother the possibility of a Do Not Resuscitate order, but no order was ever given or entered into his medical records. U. V. rallied from his illness. His cardiologist found, after an office visit on October 13, 1992, that U. V. had made “tremendous progress” and was “doing quite well at this point in time.” This was the last time that U. V. visited his personal physician prior to the cataract surgery nearly a year later. In April of 1993, U. V. received home health care through the Hospices of Palm Beach. During this time, the hospice nurse who visited U. V. at home noted that he was sensitive about his Down Syndrome and social isolation. On July 14, 1993, the hospice nurse noted that she found U. V. to be “alert, ambulatory, cheerful.” U. V.’s mother told the nurse that U. V. wanted an eye surgeon to treat a cataract that had developed in his left eye, and the family would be willing to pay for the operation in installments, if health coverage would not pay for the surgery. Ten days later, during another home visit by the hospice nurse, U. V.’s mother again stated her concern about his cataract. The nurse told her to take U. V. to his primary care physician for a referral. U. V.’s family took U. V. to his family physician, who sent him to an optometrist. The optometrist determined that U. V. had a cataract in his left eye and was starting to develop one in his right eye too. The optometrist told them that surgery could correct the condition and referred U. V. to Respondent. About a month later, in late August, U. V.’s mother informed the hospice nurse that they had an appointment with an eye surgeon and hoped that he would remove the cataract from U. V.’s left eye. At this time, U. V. was still leading an active life, largely due to the support and assistance of his loving family. He was happy and enjoyed dancing at weddings and parties and watching television. The family thought that surgery would help him see better with his left eye. Respondent first examined U. V. on August 31, 1993. He found a hypermature cataract in U. V.’s left eye. U. V.’s eye was totally opacified by the cataract to such an extent that he could see only hand motion. Respondent was immediately concerned with the possibility of phacolytic glaucoma. This is a condition in which the cataract liquifies and may leak through the lens capsule, resulting in an immunological reaction. Phacolytic glaucoma is extremely painful. It is impossible to predict the precise onset of phacolytic glaucoma, but Respondent reasonably determined that the condition could develop in as little time as hours or days, although it was possibly months away. Respondent was also concerned with U. V.’s right eye. Respondent found a cataract in the right eye in the lens where all the light rays pass into the eye. This type of cataract advances rapidly, so much so that it might overtake in seriousness the older cataract in U. V.’s left eye. Respondent performed a comprehensive examination of both eyes. He discussed cataract surgery with U. V.’s mother. Respondent agreed to perform the surgery for the Medicaid payment. He carefully explained the condition of U. V.’s left eye and the risks and benefits of surgery and general anesthesia. To assist in communicating with U. V.’s Spanish-speaking mother, Respondent had someone in the office translate for the mother. After hearing the explanation, U. V.’s mother agreed to the surgery, and Respondent set up the surgery for September 7, 1993. After returning home, U. V. began complaining of problems with his right eye. His sight was deteriorating at this time, heightening his feeling of isolation from the world around him. In the meantime, Respondent had the laboratory work done in preparation for the surgery. His office contacted U. V.’s physicians to get medical information in preparation for the cataract surgery. But they were unable to get such information from the physicians’ offices. On September 7, U. V. and his family returned to Ft. Myers for the surgery. The board-certified anesthesiologist examined U. V. and found that he had wheezing respiration, so the anesthesiologist told Respondent that the surgery had to be postponed. Respondent rescheduled the surgery for September 15, 1993. Respondent and the anesthesiologist then discussed the possibility of using a local anesthetic, which would present fewer risks to U. V. than would be posed by a general anesthetic. But, as is typical with Down patients, U. V. had been fidgety during the August 31 office visit and was a poor candidate for local anesthesia during the extremely delicate cataract surgery that he was about to undergo. Respondent and the anesthesiologist agreed that U. V. would receive general anesthesia for the surgery. After the first surgery was canceled, the anesthesiologist undertook the task of obtaining the medical clearances for general anesthesia. He spoke with U. V.’s primary physician, who practices in the small town where U. V. lived at the south end of Lake Okeechobee between Clewiston and Belle Glade. U. V.’s primary physician appeared as a witness at the hearing. He seemed to suffer from communication problems not entirely attributable to obvious difficulties with the English language. Not surprisingly, the anesthesiologist obtained little useful information from the physician. The anesthesiologist’s nurse called the cardiologist’s office several times on September 15 prior to the surgery. Unable to reach the cardiologist or any of his partners, the anesthesiologist spoke with one of the cardiologist’s office nurses and had her read him U. V.’s chart. Especially interested in U. V.’s cardiac malformations, the anesthesiologist satisfied himself that U. V. could withstand the rigors of general anesthesia and developed a plan, after discussing the case with his partners, to use special drugs and techniques so as to affect V.’s heart and lungs as little as possible. The anesthesiologist also studied either a chest xray taken on September 6, 1993, or a report of the chest xray taken on that date. He examined the xray or report to determine if U. was suffering from any reversible heart problems that might resolve themselves if surgery were postponed. The anesthesiologist found no cardiac problems of this type. Prior to the administration of the general anesthesia, the anesthesiologist spent several hours with U. V. and his family discussing the risks and benefits of general anesthesia. U. V.’s mother accepted the risks and agreed to the use of the general anesthesia. U. V.’s cardiologist testified that, if asked about the surgery and general anesthesia, he would have cautioned Respondent and the anesthesiologist of the risks of surgery, but he would not have offered an opinion on the advisability of using general anesthesia on U. V. The cardiologist would have left the decision on this matter to the anesthesiologist. On September 15, 1993, Respondent removed the cardiac from U. V.’s left eye. The surgery was flawless. During the surgery, U. V. was stable and tolerated the anesthesia. Following the surgery, U. V. awoke in the recovery room, where he was alert and following commands. Once U. V. began to breathe better on his own, the ventilator machine was turned off. U. V. suddenly developed cardiac arrhythmia and died within an hour. Respondent did not deviate from the applicable standard of care in his diagnosis and treatment of U. V. Respondent’s medical records amply memorialize his diagnosis and fully justify the surgery undertaken on September 15, 1993.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the administrative complaint against Respondent. ENTERED in Tallahassee, Florida, on June 4, 1997. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings on June 4, 1997. COPIES FURNISHED: Britt Thomas, Senior Attorney Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 John F. Lauro, Esquire John F. Lauro, P.A. Suite 3950 101 East Kennedy Boulevard Tampa, Florida 33602 Dr. Marm Harris Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0972 Jerome Hoffman, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403
Findings Of Fact The Petitioner is the state agency charged by statute with regulating the practice of medicine in Florida. At all times material to this case, John Isaac Delgado (Respondent) has been a physician in the state, holding Florida license number ME 0054871. The Respondent's last address of record is 7820 North Armenia Avenue, Tampa, Florida, 33629. The Respondent has been licensed to practice in Florida since 1989. At about 8:30 p.m. on February 9, 1992, Patient W. S. (Patient) presented to the Emergency Room at St. Joseph's Hospital, Tampa, apparently complaining of right lower quadrant pain. Immediately prior to being seen at the emergency room, the Patient had been playing cards with friends and had apparently fainted. The Patient, a 74 year old obese white male, had a history of diabetes, coronary artery disease and had a previous myocardial infarction. At the emergency room, the Patient was initially examined by John C. Siano, M.D. Dr. Siano ordered chest and abdominal x-rays. The Respondent was the internist on call at the time the Patient was examined in the emergency room. Dr. Siano contacted the Respondent and notified him of the situation. The Respondent examined the Patient at about 10 p.m. The examination was extensively documented. At the time the Respondent initially examined the Patient, the Patient provided an incomplete summary of his symptoms. The Patient had apparently informed emergency room personnel of severe pain; however, this information was not provided to the Respondent. The Respondent was aware only of intermittent abdominal pain. The Patient's emergency room records were missing at the time of the Respondent's examination. The Respondent unsuccessfully attempted to locate the Patient's records during his examination of the patient. Upon examination, the Respondent determined that the Patient's blood pressure was within normal range and was stable. The Patient was alert and oriented. Vital signs were normal. The patient appeared to be in stable condition. While in the emergency room, the Patient had a bowel movement which tested positive for the presence of blood. A nasogastric tube exiting from the Patient indicated "coffee grounds" material. These factors are indicative of a gastrointestinal problem. The presence of blood in the intestinal tract and abdominal pain is indicative of a gastrointestinal disorder. The evidence fails to establish that the patient presented an emergency condition at the time of the Respondent's examination. Back pain is a symptom of an expanding abdominal aortic aneurysm. An expanding aneurysm presses against nerves and muscle in the back and sides of a patient. In this case, the aneurysm was of considerable size; nonetheless, the evidence fails to establish that the Patient informed the Respondent of severe back pain. Severe continuing abdominal pain may be a symptom of a ruptured abdominal aortic aneurysm. The evidence fails to establish that the Patient informed the Respondent of severe continuing abdominal pain. There was no palpable pulsatile mass in the Patient's abdomen which would have been indicative of an aneurysm. There was no "bruit" sound emanating from the patient's abdomen. Such sounds are indicative of an aneurysm. There was no asymmetry of pulses in the Patient's legs which would have been indicative of the aneurysm. Hypotension, such as may result in fainting, can be indicative of an aneurysm. The patient was hypotensive when he arrived at the emergency room; however, treatment with intravenous fluids brought the Patient's pressure back to a normal range within a few minutes, indicating that internal bleeding was not significant. Based on the symptoms described by the patient and on review of the patient's condition, the Respondent's tentative diagnosis was upper gastrointestinal bleeding, likely peptic ulcer disease with bleeding secondary to chronic aspirin usage and colonic polyps. There was also a suggestion of acute diverticulitis with associated bleeding. The Respondent ordered a series of abdominal x-rays be taken. The Respondent ordered appropriate diagnostic studies based on his tentative diagnosis. The tests were scheduled for the morning. The Respondent also requested a surgical consultation, which was also scheduled for the morning. Based on the examination and discussion with Dr. Siano, the Respondent admitted the Patient to a regular floor for further observation. At the time the Patient was admitted, the Respondent had not reviewed the results of the abdominal x-rays. The Respondent did not review the x-rays prior to leaving the hospital that night. The evidence is insufficient to establish that the Respondent's failure to review the x-rays prior to admission or prior to leaving the hospital for the night violated the acceptable standard of care. Based on the patient's condition as expressed to the Respondent and on the results of the examination, the evidence fails to establish that the Respondent should have diagnosed the situation as an aneurysm. The mere existence of an aneurysm is not a surgical emergency. Whether to surgically treat an aneurysm depends on a number of other factors. A ruptured aneurysm is an emergency life threatening condition. Time is critical when responding to a ruptured aneurysm. The evidence is insufficient to establish that the Respondent knew or should have known that the Patient was suffering from a ruptured aneurysm. In the morning of February 10, 1992, a general surgical consultation was done by Frederick Reddy, M.D. Dr. Reddy examined the patient and reviewed the abdominal x-rays which had been taken on the Respondent's orders. According to Dr. Reddy, at the time of his exam the patient complained of intermittent abdominal pain, and said that he had a history of back pain, but did not complain of back pain at that time. Dr. Reddy's review of the x-rays indicated the presence of calcification. While calcification is indicative of an possible aneurysm, the evidence fails to establish that the Patient's aneurysm is clearly indicated by the x-rays. Dr. Reddy saw no indication of rupture, but referred the case to a radiologist and ordered a CT scan on the radiologist's recommendation. The CT scan indicated that an aneurysm had ruptured. The Patient was taken to surgery where G. K. James, M.D. repaired the ruptured aneurysm and performed an aortobifemoral bypass graft. The Patient's condition deteriorated and he expired on February 10, 1992. The evidence fails to establish that the outcome of the case would have been different had the Respondent diagnosed the problem as a ruptured abdominal aortic aneurysm or had the surgical procedure been performed at an earlier time after the Patient's arrival at the hospital emergency room.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Agency for Health Care Administration enter a Final Order dismissing the Administrative Complaint filed in this case. DONE and ENTERED this 27th day of February, 1996, in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM, Hearing Officer Division of Administrative Hearing The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of February, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-1981 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. The Petitioner's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 1. Rejected, not supported by cited evidence. Petitioner's exhibit Number 1 identifies the Respondent's address as set forth herein. Rejected. The greater weight of evidence fails to establish that the x-rays revealed the presence of a ruptured aneurysm. The ruptured aneurysm was diagnosed after a CT scan and review by a radiologist. Rejected, subordinate. While the statement that the cited physician always reads his ordered x-rays is correct, the evidence fails to establish that failure to do so is a violation of the acceptable standard of care. Rejected. The cited evidence does not establish that the x-ray "very clearly" suggests the aneurysm. Rejected. The greater weight of the evidence fails to establish that the Patient described pain indicative of an aneurysm to the Respondent. Rejected. No evidence that the Respondent was aware of the statement made by the Patient. Rejected. The greater weight of the evidence fails to establish that the Patient described pain indicative of an aneurysm to the Respondent. Rejected. The greater weight of the evidence fails to establish that the Patient's condition as determined by the Respondent required an immediate consultation. Rejected. The greater weight of the evidence fails to establish that the Patient's condition as determined by the Respondent indicated a course of treatment other than as set by the Respondent. Rejected, subordinate. Rejected. Not supported by the greater weight of credible and persuasive evidence. Respondent's Proposed Findings of Fact. The Respondent's proposed findings of fact are set forth in unnumbered paragraphs, many of which fail to contain citation to the record as required by Rule 60Q-2.031(3), Florida Administrative Code. Proposed findings which cite to the record are accepted as modified and incorporated in the Recommended Order, or are otherwise rejected as subordinate or as recitation of testimony. COPIES FURNISHED: Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Jerome W. Hoffman General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Dr. Marm Harris, Executive Director Board of Medicine Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Steve Rothenburg Senior Attorney Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 Clifford L. Somers, Esquire 3242 Henderson Boulevard, Suite 301 Tampa, Florida 33609
The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been a physician licensed in the State of Florida and has been Board- certified in obstetrics and gynecology. On May 7, 1998, Patient A. J. underwent a laparoscopic procedure due to a complex left ovarian cyst at Columbia Surgical Park Center, an ambulatory care center located in Miami, Florida. The operation consisted of a laparoscopy with laparoscopic lysis of adhesions and a laparoscopic left ovarian cystectomy. Respondent performed the surgical procedure under general anesthesia. Gerald Kranis, M.D., was the anesthesiologist during the procedure. Respondent made a small vertical incision in the umbilicus and insufflated the abdomen with carbon dioxide gas. Respondent then entered the abdomen through a visiport with a 10-millimeter scope. He initially examined the upper abdomen. The patient’s liver and gall bladder appeared normal. Respondent next turned the laparoscope caudally. Inspection of the pelvic organs revealed numerous adhesions of the omentum and bowel to the anterior abdominal wall and to the uterus. Respondent took down the adhesions with sharp dissection with no bleeding. Respondent noted that there was adherence of the bowel to the anterior uterus. This was dissected away with sharp dissection. Inspection of the right adnexa showed a hemmoraghic cyst of the left ovary, and this was dissected by sharp dissection. In the process, the cyst ruptured extruding chocolate-appearing material. The cyst wall was grasped with an atraumatic grasper and teased out. Hemostasis was secure, and the cyst was retained to be sent to pathology. Inspection of the cul-de-sac revealed numerous adhesions of the bowel to the posterior uterus, and these were lysed with sharp dissection. At the end of the procedure, just before Respondent exited the abdomen, the patient’s blood pressure dropped. Inspection of the abdomen revealed no increased bleeding, but there was one area when viewed through the laparoscope that was suspicious of a hematoma. Respondent removed the laparoscope and placed a Foley catheter in the bladder. Respondent then performed a laparotomy, entering the abdomen through a Pfannenstiel incision. There were numerous adhesions of the bowel to the anterior abdominal wall, and Respondent lysed them with sharp dissection. Respondent then discovered a retroperitoneal hematoma. Respondent applied pressure on this area, and a vascular surgeon was summoned. Although the medical records do not specify that pressure was applied with a wet pad, the Department’s expert and Respondent’s expert interpret the description in the medical records to show that Respondent applied direct pressure with a wet pad. Upon his arrival, Manuel Torres-Salich, M.D., a vascular surgeon, assumed responsibility for managing the patient. He noted that the systolic pressure was 60 MMHG, and he extended the Pfannenstiel incision to a long midline vertical incision. Upon entering the abdominal cavity, he noticed a massive amount of blood throughout the abdominal cavity. However, he did not quantify the amount of blood he observed. Dr. Torres-Salich attempted the surgical repair of the patient’s vascular injuries. He discovered a large anterior laceration of the right proximal common iliac artery at the bifurcation of the aorta and a laceration of the anterior wall of the iliac vein. During the course of the surgical repairs, the patient experienced cardiac arrest, and CPR was administered while the vascular surgical repairs continued. As Dr. Torres-Salich continued to repair the vascular injuries, the patient experienced further cardiac complications. Cardiac massage and CPR were performed. The patient did not respond and expired. No evidence was offered as to the medical equipment available at Columbia Surgical Park Center. Specifically, no evidence was offered as to whether vascular clamps were available for use by Respondent, and, if available, whether these were the type of clamps appropriate for controlling a vascular injury of the iliac artery or iliac vein by a gynecologist. Further, no evidence was offered as to the types of medical personnel available at Columbia Surgical Park Center to assist Respondent other than anesthesia personnel. The record in this cause is clear, however, that a vascular surgeon was not in attendance at Columbia Surgical Park Center during patient A. J.’s procedure but was summoned on an emergency basis. The vascular surgeon arrived within about 20 to 25 minutes after the vascular emergency was discovered. The vascular lacerations that occurred to the iliac artery and iliac vein were lacerations to two of the largest blood vessels in the body. There is no evidence that any improper technique by Respondent during the laparoscopic procedure caused the lacerations of the iliac artery and iliac vein. The exact cause of these lacerations is not known. However, there are three possible causes: from insertion of the Voorhees needle, from insertion of the trocar, or from dissection of adhesions. A gynecologist who experiences a significant vascular injury, such as a laceration of an iliac artery, is trained to abandon the laparoscopic approach immediately, make an incision via laparotomy, and place direct pressure right on the area with a hand or pack. Respondent handled the laparoscopic complication appropriately by performing a laparotomy and applying direct pressure to the retroperitoneal hematoma. Respondent also handled the laparoscopic complication appropriately by calling for the emergency assistance of a vascular surgeon. General gynecologists are not trained to repair vascular injuries, and the immediate objective of a gynecologist once a vascular injury is identified is to do one of two things: apply direct pressure to the area of the bleed or try to clamp the vessel. Visualization of the specific vessel causing the bleed is required to properly use a clamp. Visualization of the specific blood vessels causing this patient’s retroperitoneal hematoma would require Respondent to perform a retroperitoneal dissection, which general gynecologists are not trained to perform. The standard of care in such a situation is for the gynecologist to summon a vascular surgeon. Further, if a gynecologist is not able to identify the exact point of injury, then direct pressure to the hematoma is sufficient and within the standard of care. There is no evidence that Respondent ever attended a gynecologic oncology fellowship where a general gynecologist would get additional training to be able to perform a retroperitoneal dissection. Respondent did not deviate from the standard of care by failing to perform a retroperitoneal dissection to visualize the specific blood vessels causing the hematoma. Respondent did not deviate from the prevailing standard of care by failing to apply pressure above the injury to stop the bleeding. Respondent’s application of pressure at the site of the hematoma was proper. Respondent did not fail to adequately prepare for and deal with a known complication of laparoscopy. He complied with the standard of care by stopping the laparoscopic approach, performing a laparotomy, applying pressure to the bleeding site, and immediately calling a vascular surgeon.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding Respondent not guilty of the allegations contained in the Administrative Complaint and dismissing the Administrative Complaint filed against him in this cause. DONE AND ENTERED this 28th day of March, 2001, in Tallahassee, Leon County, Florida. LINDA M. RIGOT Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of March, 2001. COPIES FURNISHED: Kim M. Kluck, Esquire Agency for Health Care Administration 2727 Mahan Drive Building Three, Suite 3431 Post Office Box 14229 Tallahassee, Florida 32317-4229 Mark A. Dresnick, Esquire Sean M. Ellsworth, Esquire Dresnick, Ellsworth & Felder, P.A. SunTrust Plaza, Suite 701 201 Alhambra Circle Coral Gables, Florida 33134 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701
