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 Should discipline be imposed against Respondent's license to practice medicine for violation of Section 458.331(1)(t), Florida Statutes (2003)?
Findings Of Fact Stipulated Facts Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. Respondent was (is) a licensed physician within the state of Florida, having been issued License No. 84357. At all times material to this complaint Respondent's address of record was 68 East Ludlow Place, Citrus Springs, Florida 34434. On or about May 18, 2004, Patient R.D., a 73-year-old male, presented to Citrus Memorial Hospital, Family Care Center in Lecanto, Florida. Patient R.D.'s chief complaint on May 18, 2004, was of constipation and last major bowel movement on May 16, 2004. On or about May 18, 2004, Patient R.D. was physically examined, and the examination revealed normal vital signs, moderately distended abdomen with slowed, but present bowel sounds in all four quadrants, no masses, and a nontender abdomen. On or about May 18, 2004, Respondent ordered an abdominal flat plate and upright X-ray, which showed "obstruction with stool, air fluid levels." On or about May 18, 2004, Patient R.D.'s diagnosis was constipation with partial bowel obstruction. On or about May 18, 2004, the X-rays were interpreted by a radiologist with an impression of marked dilatation of small bowel, likely due to small bowel obstruction. On or about May 18, 2004, Patient R.D. was instructed for treatment of his diagnosis to take Miralax powder as needed and milk of magnesia in between, keep fluid intake up and go to ER (emergency room) if pain increased in the abdomen or fever or vomiting develop. Respondent prescribed Miralax to Patient R.D. Section 458.331(1)(t), Florida Statutes (2003), sets forth grounds for disciplinary action by the Board of Medicine for gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Respondent's Care of Patient R.D. Respondent received his Doctor of Medicine Degree from George Washington University. He became board certified in family practice in 1980 and was recertified in 1987, 1994, and 2001. Respondent practices at the Allen Ridge Family Care Center, an urgent care facility that is part of Citrus Memorial Hospital. On May 18, 2004, a history was taken from Patient R.D. The patient complained of constant mild abdominal pain. The patient reported that he had not had a stool for two days, that his last bowel movement (bm) had occurred two days earlier. The patient was complaining that he was constipated and that his stomach felt full. When Respondent saw Patient R.D., it was their first encounter. Respondent examined the patient. When Respondent asked the patient if he had blood or black stool, Patient R.D. denied either condition. Having a complaint of GI problems, Respondent was trying to ascertain whether the patient had internal bleeding when inquiring about the condition of the stool. Respondent, when recording information on Patient R.D.'s chart, noted that the distention and constipation were mild and constant. Respondent inquired of the patient concerning diarrhea, chills, vomiting, and issues with his appetite and noted that the patient was not suffering from any of those symptoms, other than to note that the patient's appetite was slightly down. The fluid intake was noted as being adequate for purposes of hydration. A nurse practitioner had noted the nature of the medications the patient was taking. Respondent did discuss those medications with the patient. Respondent was aware of the patient's vital signs and found them to be normal, as taken by a nurse. Respondent noted that the patient was in "no apparent distress," that is, he did not look sick by appearance. Instead the patient appeared well. Respondent noted in the chart that the bowel sounds were slowed but present in all four quadrants. Respondent wanted to determine whether the patient had absent bowel sounds or very rapid sounds that would have alerted Respondent to difficulties experienced by the patient. Absent bowel sounds represent some inflammatory process in the abdominal cavity such as appendicitis or a kidney stone, whereas rapid bowel signs signify a possible obstruction. Respondent noted "negative bruits," referring to the use of the stethoscope on the abdomen to listen for arterial sounds. Respondent found the liver and spleen to be normal upon examination. There was no hernia. There was "no CVA pain," referring to pain in the back that would be accompanied by flank pain. When Respondent palpitated the patient's abdomen light and deep, the patient reported that he experienced no pain. He responded by saying that he "feels full," which Respondent understood was in association with moderate distension. Before the visit, Respondent had experience with the type of patient represented by Patient R.D. Respondent has treated patients over time who have small bowel obstructions and who have constipation. Respondent's working differential diagnosis was that the patient was probably constipated, as had been reported. Respondent decided to have an X-ray made of the patient's abdomen. The decision to order an X-ray was in view of the distension. Respondent reviewed the results of the X-rays. The X-ray series were both flat and upright. The flat X-ray refers to lying flat (supine). That approach was requested in that Respondent was trying to determine how much stool and air were in the abdomen. Respondent was using the results of the X-ray to try to determine if the patient had a potential for obstruction. Respondent's impression of the results of the X-ray was that the rectum area showed stool in it. There was some indication of stool in the colon. Respondent was unsure as to whether there was stool in the small bowel. There were air fluid bubbles in an area that probably reflected the small bowel. Ultimately Respondent reached a diagnosis of constipation with partial bowel obstruction. Respondent, when he looked at the X-rays, went back to discuss the findings with the patient and said: Your x-ray does not look good. It has air fluid levels. You could have a problem here. It does not match up with your exam and your vital signs. You got a bad x-ray. The response by the patient was something to the effect that he did not care if he had a bad X-ray. He was constipated and he wanted something for his constipation. Respondent elected to give the Petitioner Miralax powder and give him precautions if anything developed such as abdominal pain, fever, or vomiting that was not in evidence at the moment, that the patient should go to the emergency room. Based upon the X-ray results, Respondent noted in his testimony that the patient: . . . wasn't out of the woods as far as I was concerned yet. Our standard procedure on a patient like this, is you get these air . . . you get something like that back . . . . probably, went in and recommended that he go to the emergency room. Respondent goes on to say in his testimony: . . . now if everything looked o.k. on this, this guy would have his Miralax prescription, be out of the door, and I wouldn't even see him if he had a normal x- ray. I went in the room and I talked to the guy and I said, look you got this and it could be obstruction, and he goes, 'what's obstruction' I said, well, just what we've been talking about this morning, blah, blah, blah. Pain, increase, bowel sounds, vomiting, 'Do I have any of that?' Respondent then describes the verbal exchange between the patient and Respondent as to the severity of the situation, and Respondent says in his testimony ". . . he won." Respondent indicated that the patient convinced Respondent that he was not ill. In summary, the Respondent told the patient that he could be in trouble or he might be fine. Respondent was also aware of other cases as he describes: . . . a certain percentage of people admitted for partial bowel obstruction like this that go through the hospital and has got to be a significant that go home the next day. They poop and go home the next day, 30 or 40 percent, o.k. So this guy could be that guy easily because he had symptoms so -- and he is not going to the ER because he waited two hours, three hours, whatever it was. I've seen nursing home patient's x-rays twice as bad as that and they are constipated and they are not in pain, so I had experience with these patients that some of them are not in trouble. I told this guy, you could be in trouble and this is -- and he said, 'I just need something for my constipation'. Respondent recognizes that the patient was coming to him for medical care and that he was obligated to determine if the patient was ill and that he could not rely completely upon someone else's ability to convince him of the circumstances. Respondent did not find the patient to look ill and indicated through his testimony that the patient ". . . was not in any trouble." Respondent did not find the patient in acute distress at the time the patient was seen. Respondent believes that had the patient been suffering small bowel obstruction when he was seen, that instead of moderate distension there would have been severe distension, and instead of the bowel sounds slow and present, they would have either been absent or increased. There would have been tenderness in the abdomen. There may have been a mass where none was found on examination. There was no finding of colicky pain, which Respondent considers to be the gold standard of bowel obstruction, crampy abdominal pain in severe waves that "double you over." Respondent called the patient's condition constipation with partial obstruction because of the findings in the X-ray. Respondent recognizes that there was some obstruction. He attributed the bowel obstruction to constipation caused by feces. However, in making his choices for care Respondent recognizes that distension is a symptom of obstruction. The inability to defecate is a symptom of obstruction. Respondent did not rely upon the radiologist's reading and report concerning the X-rays when making his choices for Patient R.D.'s care because he did not have the report at that time. Respondent recognized the Physician's Desk Reference (PDR) available on May 18, 2004, as a reference source and in its discussion of Miralax was an authoritative source and that according to the PDR, it considered Miralax as contraindicated for patients who are known or suspected of having small bowel obstructions. Expert Opinion Dr. James Schaus is licensed to practice medicine in Florida and board certified in family practice. He was offered as an expert to express an opinion concerning Respondent's care provided Patient R.D. on May 18, 2004. To prepare him for that assignment he reviewed investigative materials from the Department, Respondent's records and other available records that pertain to Patient R.D.'s care. When asked to express an opinion concerning whether Respondent met the applicable standards of care as defined by Florida Statutes in the examination, diagnosis and treatment of Patient R.D., Dr. Schaus expressed the opinion that Respondent: . . . deviated from the standard of care in this case by failing to refer the patient to a hospital for immediate further evaluation of the small bowel as indicated on the abdominal x-ray and the physical examination finding of a distension. The abdominal x- ray revealed multiple air and fluid filled loops in the small bowel which are marketedly dilated and associated small bowel air fluid on upright films. A small amount of air, stool, within colon, impression marked dilation of small bowel likely due to small bowel obstruction. Dr. Schaus' view of the definition of "standard of care," is the "failure to practice medicine at a level of care, skill, and treatment which are [sic] recognized by a reasonably prudent similar acting physician as being acceptable under similar conditions and circumstances." Dr. Schaus went on to state the opinion: I believe that these x-ray findings taken together with the fact that the patient was distended on the physical exam and complained of some pain with the distension of abdominal wall obligated Dr. Hopkins for immediate further hospital evaluation of this patient. I also believe that Dr. Hopkins deviated from the standard of care by prescribing Miralax to the patient who had the diagnosis of partial small obstruction. In addition to expressing the opinion that Respondent should have arranged for immediate hospitalization of the patient diagnosed with partial small bowel obstruction, and the problem with Miralax, Dr. Schaus expressed the opinion that there was a deviation from the standard of care for the failure to do a digital rectal exam on the patient. Dr. Schaus expressed an opinion that Respondent should have used a digital rectal exam with this patient to determine the presence of stool, occult blood, and the condition of the prostate and to check for rectal or perianal masses. This was the standard of care that should have been pursued in this case because the patient complained of constipation and possible bowel obstruction. If an impaction of stool were found, this would aid in the diagnosis. It would be properly considered the cause and would constitute the diagnosis. If the digital rectal exam revealed gross blood that is important, or occult blood on the stool sample as detected through a chemical test, those findings would be helpful as well. Gross blood refers to visible blood. It is bright red or darker colored. If a mass is found, it might be an indication of colon cancer. As Dr. Schaus explained, the presence of blood indicates a more serious problem in that the typical constipation does not bleed. Dr. Schaus perceived the case involving Patient R.D. as one in which constipation was the patient's presenting complaint, setting up the possibility that it was in view of constipation as such or could be from bowel obstruction. Dr. Schaus expects the physician to determine that spectrum from the very benign to the very serious. In his review of the record, Dr. Schaus notes that the patient had an obstruction as evidenced by Respondent's diagnosis of obstruction. In particular he emphasizes the diagnosis of "constipation with partial bowel obstruction." In his testimony, Dr. Schaus had referred to small bowel obstruction in his impression of the findings by Respondent but later acknowledged in his testimony that Respondent had described a condition which was "partial bowel obstruction." The obstruction would be found within the intestinal tract. The nature of the blockage in Dr. Schaus' opinion can be a partial blockage that would limit the passage of stool or a complete blockage that can cause more serious problems. In this case, Dr. Schaus believed that it was clearly indicated that the patient had a significant bowel obstruction and that it was a small bowel obstruction and the patient needed to be admitted to the hospital for further evaluation and treatment. Dr. Schaus considers the terms "small bowel" to be synonymous with "small intestine." Dr. Schaus, in expressing his opinion, relies upon Respondent's interpretation of the X-ray where the Respondent notes "abdominal flat and upright obstruction with stool, air fluid levels." Dr. Schaus expressed the opinion that Respondent should have proceeded logically with the next step after discovering the small bowel obstruction, which was to make sure that the patient receives immediate evaluation and treatment in a hospital setting. The treatment that was given was on an out- patient basis with instruction for the patient to use Miralax as needed, with milk of magnesia PRN and to keep his fluid intake up and to report to the emergency room if he had problems with abdominal pain, fever, or vomiting. That approach was not acceptable in Dr. Schaus' opinion given the signs, symptoms, and radiographic findings in relation to Patient R.D. By choosing to have an abdominal X-ray performed on Patient R.D., this was an indication to Dr. Schaus that Respondent believed the patient was experiencing something other than typical constipation. A patient who has only constipation would not be subject to an abdominal X-ray. Concerning the prescription of Miralax, Dr. Schaus noted that this medication is an osmotic agent. It is considered a fairly powerful laxative. It is designed to cause the stool to retain water leading to a softer bowel movement, but it can be a dangerous treatment or contraindicated in a patient with known or suspected bowel obstruction as mentioned in the PDR. Dr. Schaus considers the PDR to be authoritative, and it is a commonly-used reference source for prescribing medications. When explaining the circumstances concerning Miralax, Dr. Schaus commented that the absorption of water is potentially dangerous in the instance where you have a blockage and you are promoting an expansion in the stool. This patient had partial bowel obstruction and Respondent prescribed the medication. Dr. Schaus believed that the patient could have had the entire spectrum from simple constipation to a complete bowel obstruction, because a patient may present with a wide variety of symptoms. In this case, the typical expectation of nausea and vomiting does not overcome the necessity for having a high- end suspicion of serious problems in the interest of not overlooking something. Dr. David A. Weiland, Jr., is licensed to practice medicine in Florida. He is board certified in internal medicine. His practice principally involves care of adult patients. In the past, he has taught family medicine for a period of almost ten years. Patient R.D. was an elderly patient, a type of patient seen in family practice. Dr. Weiland occasionally uses the PDR when he is unaware of a drug, or, if a drug is new, he will look it up in the PDR in discussing dosage or potential drug interactions. He sees the PDR as one reference source. It serves as a guide in prescribing. Dr. Weiland sees the definition of standard of care as being "that practiced by a prudent clinician in similar circumstances, with similar findings." In preparing himself to offer testimony, Dr. Weiland reviewed the Respondent's medical records in association with Patient R.D. He considered those records to be sufficient for him to render an opinion about the care provided Patient R.D. by Respondent. Dr. Weiland in his practice deals with 73-year-old males, such as Patient R.D. He deals with males who have constipation. Dr. Weiland has dealt with patients with distention of the abdomen. At present, Dr. Weiland's predominant practice is in hospice care. Many of his patients are severely constipated because of the use of narcotics due to the nature of their illness in the hospice setting. In deciding the choice of treatment, the choice of medications for addressing a 73-year- old with distention and constipation for two days, in his practice, Dr. Weiland relies on trials and failures or successes with the use of previous medications and an understanding of the illness and the degree of illness. He looks for symptoms such as diarrhea, pain associated with a fecal mass of the rectal wall, nausea, and vomiting, to guide him in deciding where the obstruction may be located and how to address the suspected obstruction. According to Dr. Weiland, you need to encourage the forward motion of the bowels in elderly patients. Dr. Weiland uses Miralax in his practice. He describes it as a promotility agent, an agent that allows the bowel to move more functionally. Miralax is not a drug that Dr. Weiland routinely prescribes. He just does not use the drug often, even though he understands it to be a very popular laxative. Dr. Weiland believes that Miralax is contraindicated for people with mechanical bowel obstruction, meaning anything mechanical that causes the bowel to be obstructed which could be cancer, adhesions, or twisting. The complete bowel obstruction, regardless of the reason, would be contraindicated for use of Miralax. With a partial obstruction, it is not clear to him whether Miralax is contraindicated. If there is stool movement forward, there is no absolute contraindication. The fact that the patient was not vomiting was an indication to Dr. Weiland that the stool was moving forward. With a complete bowel obstruction, the patient would present nausea and vomiting. Dr. Weiland agrees with the PDR warning that Miralax is contraindicated for patients who have known or suspected bowel obstructions. Symptoms suggestive of a bowel obstruction present would be nausea, vomiting, and abnormal distention and should be evaluated to rule out the bowel obstruction before using Miralax therapy, as explained in the PDR. Dr. Weiland thinks the key elements in the evaluation of those symptoms relate to nausea and vomiting and a patient with extreme nausea and vomiting should not be given promotility medication. Therefore, Dr. Weiland's opinion concerning the use of Miralax is conditioned upon those symptoms in relation to nausea and vomiting. Concerning general contraindications for using medications, Dr. Weiland is familiar with a medication by its general use, having looked it up on the PDR, and he has used other texts for medications, pharmacopeia. Dr. Weiland's response to contraindications depends on whether they are considered as absolute contraindications or relative contraindications. He sees the process of determining the use of the medication as dependent of the patient's underlying situation and the whole clinical condition. Dr. Weiland is also familiar with milk of magnesia, which is a chemical laxative. In addressing a patient's condition, Dr. Weiland treats the symptoms about 95 percent of the time. He uses additional testing when he confronts something unusual. For example, severe nausea would lead him to consider the use of X-rays. Other examples of a patient's circumstances in his experience that might cause the use of an X-ray or CT scan would be severe pain that was in association with a history of a particular malignancy known to cause complete obstruction, ovarian cancer or prostate cancer. Dr. Weiland would be impressed with passing significant amounts of blood in the stool, bloody diarrhea, high fever, nausea, and vomiting. But most constipation he treats initially, medically, and it would be necessary that he would have other of the issues that he described going on before it would warrant further investigation. Dr. Weiland explains that most treatments of small bowel obstruction are conservative initially. If the patient presents with a complete bowel obstruction as evidenced by nausea, vomiting, that patient is admitted to the hospital and the management involves bed rest and the provision of IV fluids to see if the patient resolves the situation. To determine whether there is a small bowel obstruction, two factors enter in, according to Dr. Weiland. One is the clinical presentation, which is abdominal pain, marked distension, nausea, and vomiting. If one of those factors is not present, Dr. Weiland does not believe that it would necessarily be considered as being a small bowel obstruction. He thinks that there is the possibility of confusing obstruction, in the sense of whether it is partial or complete. Dr. Weiland understands the differences between patients and the way they present abdominal pain and distension could be explained by lots of things, among them bowel obstruction. Concerning the Patient R.D. in his clinical presentation, considering the patient's appearance, vital signs, lack of nausea and vomiting no symptoms, Dr. Weiland would not have thought he was dealing with a bowel obstruction. The slow bowel that is described would not lead Dr. Weiland to conclude otherwise. The Respondent's impression concerning the bowel obstruction was based on X-ray findings, as Dr. Weiland perceives the matter. Dr. Weiland would not have gotten those X-rays. He believes that X-rays can sway you in the wrong direction and they do not always represent bowel obstruction. If the patient had presented looking "relatively toxin," Dr. Weiland would have ordered films, and, when he got those films, it would have confirmed the condition. Dr. Weiland proceeded with his opinion based upon the belief that Respondent reached the diagnosis of constipation with partial bowel obstruction after the X-ray results were known. Dr. Weiland looked at Patient R.D.'s X-rays. He found them to be abnormal in that there is evidence of dilation in the case because of striations, and there are fluid levels. In his experience, not all fluid levels are obstructions. Sometimes they are caused by other abnormalities. Dr. Weiland expressed the opinion that the standard of care for a patient like R.D. is that you look at the patient, determine the patient's symptoms, and make a clinical recommendation with a follow-up, and, if the patient systems worsen, then the patient should go to the emergency room for care. Dr. Weiland believes that partial small bowel obstruction could be a life threatening condition. If the patient were facing a life threatening condition, Dr. Weiland would hospitalize the patient. Evidence of a life-threatening condition would be nausea, vomiting, inability to keep down oral medications, and abnormal signs none of which were evidenced in this case in the case of R.D. Dr. Weiland considers abdominal distension to be a non-specific symptom in the patient, as well, abdominal distension with pain is non-specific. Dr. Weiland would not have sent the patient to the emergency room on May 18, 2004. The conservative approach was acceptable. The causation of the problem would often times resolve on its own. Dr. Weiland refers to the Respondent having the luxury of looking at the actual patient and the patient's appearance and the vitals did not appear to be toxic. Dr. Weiland agrees with the Respondent that if the patient developed fever or vomiting he should go to the emergency room. That would be evidence that the patient was experiencing a complete bowel obstruction. Dr. Weiland's reading of the Respondent's reference to partial bowel obstruction is that it is based upon information that Respondent had, including the patient had fecal material, and that the patient is obstipated. Dr. Weiland believes that the partial bowel obstruction could be caused by any number of things, that have been mentioned in his testimony and reflected in this discussion and that the patient should be treated conservatively. If the problem resolves then that ends it. If it does not, then a CAT scan should be considered, and only upon the condition becoming a bowel obstruction that is complete will surgery be necessary. Dr. Weiland agrees that the use of a rectal exam can aid in the determination of the cause of an obstruction. Dr. Weiland expresses a preference to have a rectal exam documented in the patient chart. Having considered the opinions of the medical experts in view of the choices Respondent made in caring for Patient R.D., Dr. Schaus' opinions that Respondent fell below the standard of care in prescribing Miralax with a diagnosis of partial obstruction and the opinion by Dr. Schaus that the Respondent's failure to refer the Patient R.D. to the hospital for further evaluation of bowel obstruction fell below the standard of care are accepted. Although the choice to proceed to the hospital or not would have been the patient's decision, Respondent in his approach did not create that option. Rather he deferred to perceived limitations placed on the care by the patient, commenting that he was there principally for difficulties with constipation. That response to the patient's needs was below the standard of care. Respondent left available the choice to proceed to the emergency room if the patient began to have abdominal pain, fever or vomiting. Dr. Schaus' opinion that Respondent fell below the standard of care in not performing a digital rectal examination on Patient R.D. is accepted when addressing the possibility of a bowel obstruction. Mitigation/Aggravation The record does not reveal any adverse outcome attributed to Respondent's care provided Patient R.D. on May 18, 2004. There is no indication that Respondent has ever been disciplined in Florida or other jurisdictions while practicing medicine.
Recommendation Based upon the findings of fact and conclusions of law, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes (2003), placing Respondent on a period of probation for one year, issuing a letter of reprimand and imposing an administrative fine of $5,000.00. DONE AND ENTERED this 1st day of May, 2007, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS 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 1st day of May, 2007. COPIES FURNISHED: Ephraim D. Livingston, Esquire Dory Penton, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Christopher J. Schulte, Esquire Burton, Schulte, Weekley, Hoeler & Beytin, P.A. 100 South Ashley Drive, Suite 600 Post Office Box 1772 Tampa, Florida 33602-1772 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue The issues are whether 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, and, if so, what penalty, if any, should be imposed.
Findings Of Fact 1. Stipulated Facts Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.30 and Chapters 455 and 458, Florida Statutes. Respondent is a licensed physician in Florida holding license number ME 0009772. Respondent's last known address is 9430 Turkey Lake Road, Orlando, Florida 32819-8015. Respondent is Board certified in orthopedic surgery. Respondent provided medical treatment to two male patients between 1990 and 1991. Patient 1 was treated from approximately April 29, 1991, through August 12, 1991. At the time, Patient 1 was approximately 34 years old. Patient 2 was treated from approximately May 14, 1990, through June 20, 1991. Patient 2 was approximately 29 years old. Patient 1 Patient 1 had a history of hip dislocation with aseptic necrosis, chronic back and leg pain, and foot numbness associated with degenerative disc disease and lumbar stenosis. Lumbar stenosis is compression of the spine. Spine compression was particularly significant between the fifth lumbar and first sacral vertebrae. Prior to April 29, 1991, Patient 1's treatment was conservative and nonsurgical. On April 29, 1991, Patient 1 presented to Respondent to explore alternative therapy. Patient 1 complained of pain and numbness in his back, hip, and legs. Respondent diagnosed Patient 1 with lumbar spinal stenosis and possible disc herniation. Respondent recommended a myelogram. A myelogram was performed on May 13, 1991. The myelogram confirmed Respondent's diagnosis of lumbar spinal stenosis and possible disc herniation. The myelogram revealed a disc defect on the right side of L5-S1 as well as severe spinal and lateral recess stenosis. On June 11, 1991, Respondent performed a laminectomy on Patient 1, an L5-S1 disc excision, and an internal spinal stabilization using Harrington rods attached with lamina hooks. Use of lamina hooks resulted in the compression of Patient 1's underlying neural tissue. Compression of the underlying neural tissue caused Patient 1 to suffer perineal numbness. Respondent's medical records of June 17, 1991, show that Respondent knew Patient 1's perineal numbness was a result of compression of the sacral nerve root at L5-S1. On June 17, 1991, Respondent again performed surgery on Patient 1. Respondent replaced the lamina hooks with alar hooks. Respondent also replaced and adjusted the tension of the Harrington rods. On August 1, 1991, Patient 1 was admitted to Sandlake/Orlando Regional Medical Center ("ORMC") for surgical removal of the implanted hooks and Harrington rods. Respondent surgically removed the Harrington rods and attachment hooks. On August 12, 1991, Respondent's medical records showed that Patient 1 suffered from persistent numbness of the sacral nerve root areas. The area of numbness included the perineum, scrotum, and penis. Respondent did not perform an L5-S1 bone fusion during any surgery. Patient 2 On May 14, 1990, Patient 2 presented to the Emergency Room ("ER") at ORMC with primary complaints of back and right leg pain. The ER physician diagnosed Patient 2 with a herniated nucleus pulposus at L4-L5. The nucleus pulposus is the soft central portion of the intervertebral disc. Respondent admitted Patient 2 on May 14, 1990, and treated him with intravenous muscle relaxants. On May 15, 1990, a computerized axial tomography ("CAT") scan revealed a bulging, herniating disc at L4-L5. On May 17, 1990, Respondent discharged Patient 2 with instructions regarding back care and an exercise program. On August 24, 1990, Patient 2 presented to Respondent with recurrent disabling sciatic pain. A magnetic resonance imaging ("MRI") scan was performed on August 28, 1990. The MRI revealed a prominent disc bulging at L4-L5 with material intruding into the spinal cord. On September 7, 1990, Respondent performed a lumbar laminectomy and disc excision at L4-L5. Respondent discharged Patient 2 on September 12, 1990. On December 11, 1990, Patient 2 presented to Respondent with recurrent back and right leg pain. Respondent prescribed analgesics including Soma with codeine and Naprosyn. On January 14, 1991, Patient 2 presented to Respondent with back and right leg pain. Patient 2 underwent a CAT scan to determine if recurrent disc herniation was present. The CAT scan failed to indicate any obvious asymmetric changes which would confirm Respondent's diagnosis of recurrent disc herniation. On January 21, 1991, Respondent performed a decompressive laminectomy on Patient 2. Respondent's operative report for January 21, 1991, indicates that Respondent found no evidence of a herniated disc. On February 26, 1991, Patient 2 presented to Respondent with complaints of recurrent leg and back pain. Respondent referred Patient 2 to Dr. William Bradford for treatment utilizing epidural blocks. On April 16, 1991, Patient 2 again presented to Respondent. Respondent placed Patient 2 in a molded, fiberglass body jacket. Back and leg pain subsided while Patient 2 wore the fiberglass jacket. On May 14, 1991, Respondent performed surgical stabilization of the lower lumbar spine utilizing Harrington rods. On June 17, 1991, Patient 2 presented to Respondent with persistent numbness of the perineal area as well as bowel and bladder incontinence. Respondent determined that the numbness and incontinence were caused by sacral nerve root irritation associated with the Harrington rod hooks. Respondent surgically adjusted the Harrington rods on June 20, 1991. Respondent did not perform vertebral bone fusion during any surgery. 2. Standard Of Care Respondent failed to practice medicine in his treatment of Patient 1 with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Respondent improperly seated lamina hooks in Patient 1. As a result, Patient 1 suffered compression of underlying neural tissue. Respondent improperly used Harrington rods and hooks to achieve transient spinal decompression without performing essential vertebral bone fusion. Use of Harrington rods in the lumbar spine is an obsolete technology. It is fraught with dangers. Among other things, it eliminates the lordosis, or natural spinal curvature. Respondent failed to practice medicine in his treatment of Patient 2 with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Respondent performed numerous surgeries on Patient 2 when CAT scans and other examinations failed to confirm recurrent disc herniation. In addition, Respondent failed to perform essential vertebral bone fusion on Patient 2. 3. Proximate Cause And Severity Of Injury Respondent's failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances was the proximate cause for permanent neurological damage to Patient's 1 and 2. Both patients suffered sacral nerve root paralysis. Sacral nerve roots feed functions in the pelvis, bladder bowel, and sphincter. Both patients suffered permanent incontinency, including loss of bladder and bowel function. Each patient requires a colostomy and must wear diapers. Patient 1 has suffered sexual dysfunction in that he has lost the sensation necessary for a natural erection. The neurologic injuries to Patients 1 and 2 are major and permanent. Nothing can restore the functional loss suffered by either patient.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent enter a Final Order finding Respondent guilty of violating Section 458.331(1)(t) in his treatment of Patients 1 and 2, imposing an administrative fine of $7,500, and restricting Respondent's practice as follows: Respondent shall not perform any spinal surgery on patients unless and until Respondent appears before the Board of Medicine and demonstrates to the satisfaction of the Board that he is able to do so with skill and safety; and The Board of Medicine may place other reasonable conditions on Respondent's practice of orthopedic surgery at such time as the restriction in the preceding paragraph is lifted. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 6th day of October, 1994. DANIEL MANRY 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 6th day of October, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-3966 Petitioner's Proposed Findings of Fact 1. -39. Accepted as stipulated fact 40.-41. Rejected as recited testimony Accepted in substance Rejected as recited testimony Accepted in substance 45.-51. Rejected as recited testimony Respondent's Proposed Findings of Fact Respondent stipulated to Petitioner's proposed findings of fact, paragraphs 1- 39. Respondent's only additional proposed finding of fact is unnumbered and is rejected as not supported by persuasive evidence. COPIES FURNISHED: Dr. Marm Harris, Executive Director Department of Business and Professional Regulation Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Harold D. Lewis, Esquire Agency For Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, FL 32303 Kenneth J. Metzger, Esquire Agency For Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack L. Gresham, M. D. 9430 Turkey Lake Road Orlando, Florida 32819-8015
The Issue The primary issue is whether Respondent is guilty of deviating from the applicable standard of care in practicing medicine, in violation of Section 458.331(1)(t), Florida Statutes, and, if so, the penalty. Additional issues are whether Petitioner is liable for any of Respondent's attorneys' fees and costs and the rates at which opposing parties must compensate specific expert witnesses.
Findings Of Fact Respondent is a licensed physician, holding license number ME 0040000. Respondent has not previously been the subject of disciplinary action. Respondent has been Board certified in orthopedic surgery since 1984 and has held a subspeciality certificate in hand surgery since 1995. After completing a residency in orthopedic surgery, Respondent entered private practice in Sebring in 1989. From 1981 to 1998, Respondent performed 6-10 total knee replacements annually. A couple of years ago, Respondent restricted her practice to surgery on the upper extremities, especially the hand, and discontinued performing surgery on the lower extremities. In the past couple of years, Respondent has done most of the hand surgery in Sebring. Respondent first examined M. V. on April 18, 1996. M. V. was a 78-year-old female referred by her treating physician for severe pain in both of her knees. M. V. suffered from severe pulmonary edema, severe osteoarthritis of both knees and hips, borderline Type II diabetes, chronic renal failure, and severe arteriosclerotic heart disease with cardiomegaly. The osteoarthritis caused her significant pain and forced her, since 1981, to rely on a walker or wheelchair to ambulate. Because of the osteoarthritis, M. V.’s knees were fixed and had a limited range of motion of about 30 degrees from 30-60 degrees. M. V. is also deaf and speaks only Spanish, but her bilingual daughter remained with M. V. much of the time that M. V. was in the hospital. M. V.’s primary physician had recommended a bilateral knee replacement in order to relieve the pain from which M. V. was suffering. The primary physician cleared M. V. for surgery immediately before her hospitalization. Following the April 18, 1996, office visit, Respondent scheduled M. V. for surgery on May 6, 1996. Respondent decided to replace the right knee first and, after M. V. had recovered, replace the left knee. M. V. was admitted to Highlands Regional Medical Center in Sebring on May 6, but, shortly after her admission, became very nervous, exhibiting shortness of breath, respiratory distress, and atrial fibrillation. Rather than perform the knee replacement, it became necessary to intubate M. V. for a couple of days and retain her in this hospital for one week. It appears that M. V. suffered a panic attack, which precipitated an asthma- like attack, which put M. V. into severe congestive heart failure. Two findings from physical examinations during M. V.’s one-week hospitalization are relevant. On May 5, 1996, the examining physician found that M. V.’s pulses were felt equally “on both sides” of otherwise unidentified “extremities.” On May 13, 1996, a different examining physician noted that M. V.’s pulses were “faint” at unidentified “extremities.” The record does not disclose whether “extremities” means the patient’s legs or arms or both legs and arms, but they probably involve the legs. Following M. V.’s discharge from the hospital on May 13, Respondent next saw her when she was readmitted to Highlands Regional Medical Center for a second attempt at replacing the right knee. The surgery was scheduled for May 29, 1996, but Respondent had M. V. admitted the prior evening to reduce her anxiety and allow the anesthesiologist to administer sedation to prevent another panic attack. Pulses are of crucial importance in this case. There are two relevant means of taking pulses: palpation or Doppler. A person takes a Doppler pulse by means of an augmented listening device. A person takes a palpated pulse by means of touch, such as at the wrist. For taking pulses, there are several locations of importance in this case. The dorsalis pedis pulse is taken from the top of the foot from at or below the ankle. The posterior tibial pulse is taken from the back of the leg below the knee and above the ankle. A radial pulse is taken at the wrist. An apical pulse is taken by listening directly to the heartbeat. The most important anatomical feature in this case is the popliteal artery. This is the artery that starts at the adductor at the end of the femoral artery above the knee, proceeds behind the knee, and ends at a branch, which marks the upper end of the anterior and posterior tibial arteries. Another important anatomical feature in this case is collateral circulation. Collaterals are compensating, secondary circulatory vessels subordinate to the primary vessel of an artery. Other terms of importance in this case are distal and proximal locations. When referring to arterial blood flow, this recommended order sometimes refers to these terms, respectively, as downstream and upstream. In this case, a distal location is toward the foot, and a proximal location is toward the main trunk. Following M. V.’s second admission, the initial nursing assessment performed at 8:25 p.m. on May 28 discloses no edema and “clear” pulses on the right and left, but otherwise unidentified, extremities. However, about four hours later, the nursing assessment reports edema and only “faint” pulses on the right and left extremities. At neither time, though, was there a notation of coldness or discoloration of the extremities. At about midnight, M. V.’s vital signs were temperature--98.3, pulse--82, respiration--16, and blood pressure--132/64. References to “extremities” in the nursing assessments are to the lower extremities. The nursing assessment form lists, under “Cardiovascular,” several items under “Pulse.” The first and second rows are “Apical” and “or Radial” with adjoining columns supplying places for the nurse to mark whether the pulse is regular or irregular and strong or faint. The third row is “Extremity pulse.” Next to this item is a single place for a nurse to mark “NA,” which is either not available or not applicable. However, immediately beneath this item are two rows--one marked left and one marked right--and three strength levels: clear, faint, and absent. Immediately under these three strength levels are four additional rows: “Extremity feels cold,” “Extremity is discolored,” “Edema is present,” and "pitting or nonpitting." Thus, analysis of the nursing assessment form reveals that nurses chart pulses in the upper extremities in the row marked “Apical” or “Radial” and pulses in the lower extremities in the rows beside and under “Extremity pulse.” Other facts also support the interpretation of “extremities” on the nursing assessment forms as legs or feet, not arms or hands. As noted below, at midnight following the surgery, the nursing assessment reports no pulse in the left or right extremity. At no time did M. V. ever lose her pulse in the upper extremities, so this reference is clearly limited to the lower extremities. Also, it is highly unlikely that the nursing staff would not take pulses in the lower extremities, below the knee, after a knee replacement. Lastly, the nurse’s narratives for midnight and 4:30 a.m., which are attached to the nursing assessments, reveal the nurse was taking a pedial pulse. For these reasons, this Recommended Order treats all pulse data from extremities in the nursing assessments as pulse data from the foot or leg below the knee. Respondent commenced the surgery to replace the right knee on May 29 at 11:00 a.m. The surgery proceeded uneventfully and ended at 12:45 p.m. The anesthesiologist administered spinal anesthesia to M. V. Respondent used a foot holder to flex the knee. Respondent then exsanginuated the right leg using an Esmarch, wrapping the leg from the toes to the tourniquet, to force the blood back into the trunk. Respondent inflated the tourniquet, which was placed as high toward the groin as possible. The inflated tourniquet remained in place for 102 minutes. After making a straight midline cut to the extended knee, Respondent flexed the knee up, to push the artery away from the back of the knee. After opening up the knee joint, the first major task that Respondent performed was to prepare the end of the femur for a rod, after which she worked with the tibia, pulling it forward and preparing it. Using preoperative X-rays to guide the cutting angle, Respondent attached a cutting jig to the top of the tibia. Respondent applied retractors behind the knee to remove the artery, veins, and nerve from the reach of the blade. The veins and artery travel together through the knee, and the nerve is posterior to the veins and artery. The artery, veins, and nerve are encapsulated by soft tissue that surrounds the knee. The sawblade that Respondent used is too short to reach the back of the knee. The sawblade would chew up, rather than cut, soft tissue, such as an artery, due to the blade’s oscillating teeth, which are intended to cut bone. M. V.’s right knee already had undergone considerable erosion in the tibia, so Respondent was not required to do much cutting ,if any, to prepare the tibia to accept the prosthesis. In general, Respondent described the entire surgical procedure as proceeding more smoothly than typical knee-replacement surgery. After installing the prosthesis, Respondent placed a drain, sewed the capsules, sewed the subcutaneous skin, sewed the skin, dressed the wound, wrapped the wound in a couple of Ace bandages, and deflated the tourniquet. Respondent wrapped the second Ace bandage a little tighter to prevent tissue oozing and eliminate the need for a transfusion. Respondent then directed that ice bags be placed around the right knee. The purposes of the drain are to remove blood that could cause bacterial infection into the knee and to identify pools of occult blood. M. V.’s drain received an average to low- average volume of blood, which is consistent with a smooth surgical procedure. The color of the drained blood was dark, suggesting that the bleeding was from a vein in the bone marrow or tissues, rather than from an artery. M. V. was taken to the recovery room at 1:00 p.m. and remained in the post-anesthesia care unit until 4:00 p.m. When Respondent visited M. V. in the recovery room, a nurse informed Respondent that M. V. was cool and the nurse was having trouble finding a pulse in the lower extremity. After being told by a nurse in the recovery room that she was having trouble detecting a pulse in M. V.’s lower leg, Respondent determined that M. V. was unlikely suffering from a cardiovascular problem because her blood pressure was normal. Deciding to check the dressing to see if it was too tight, Respondent removed the second Ace bandage, which had been in place only 15 minutes, but found that the dressing was not too tight. Respondent found a pulse in the right foot by Doppler, although not by palpation. In addition to a weak pulse, M. V. was also cold, pale, and shivering, despite the nurses’ attempts to warm her. Respondent ordered a nurse to apply a warmed blanket to M. V.’s leg for a few minutes to improve circulation. Ordering a pulse oximeter reading, Respondent found that M. V.’s oxygen level was only 86 percent at the right foot, while she averaged 96 percent in the hand. A reading of oxygen saturation of arterial blood, pulse oximeter values normally are 95-99 percent. However, Respondent claims that she thought at the time that vascular insufficiency in M. V.’s lower extremity could account for the difference in oxygen levels because a pulse oximeter does not efficiently register oxygen levels in static blood. The anesthesiologist testified that an 86 percent reading is not unusual for a person suffering from severe peripheral vascular disease. On the other hand, M. V. was receiving oxygen, which could have generated an artificially high reading. Soon, however, M. V. began to warm, and her lower- extremity pulse strengthened. Respondent left the recovery room, and M. V.’s remaining time in the recovery room was uneventful. When M. V. returned to her room at 4:00 p.m. on May 29, her vital signs were temperature--96.6; pulse--80; respiration--20; and blood pressure--200/100. The drain continued to capture dark red blood. M. V. was receiving fluids intravenously and still receiving oxygen. She cried out in pain whenever her right leg was touched, although this is not unusual after knee-replacement surgery. The nursing assessment done at 4:00 p.m. on May 29 states that M. V.’s pulses were “clear” on the right and left legs, although edema remained. At 4:15 p.m., M. V. began to receive 6 mg of morphine intramuscularly every four hours for pain. A physical therapist also installed a CPM machine, which, by moving the right lower extremity, assists in the recovery process. M. V.’s attempts to disconnect the intravenous line and oxygen necessitated the administration of wrist restraints. At 4:30 p.m., the nurses paged Respondent due to M. V.’s elevated blood pressure. Respondent ratified the earlier decision to apply wrist restraints, ordered the nurses to check M. V.’s circulation every two hours and loosen the restraints as needed, and advised the nurses to contact M. V.’s physician concerning the elevated blood pressure. Except for the hypertension, which responded to medication by 2:20 a.m. on May 30, M. V. did not present anything unusual for the next seven hours. At midnight, the nurse noticed that M. V.’s right foot was “cold to touch,” and the nurse could not find a pedial pulse by palpation. The nursing assessment reports absent pulses in both legs. M. V.’s “feet nailbeds” were cyanotic. Her vital signs were temperature--98; pulse--92; respiration--20; and blood pressure--208/104. M. V. continued to complain of pain upon movement, the CPM was still flexing the right lower extremity, and the knee remained packed in ice. When a nurse telephoned Respondent at about 12:15 a.m. on May 30 and informed her of M. V.’s condition, Respondent immediately dressed and came into the hospital. Examining M. V. at 12:40 a.m., Respondent removed the dressing to examine the wound and perhaps improve circulation if the dressing had bunched up. Because the sling of the CPM machine can impede circulation in the calf branches from the popliteal artery, Respondent disconnected the CPM machine and directed the nurses not to reconnect it. Respondent was unable to detect, by palpation or Doppler, a pulse in the right ankle, but she found a pulse in the right popliteal artery. Based on her assessment of the sound of the pulse, Respondent concluded that M. V. had a functioning right popliteal artery or substantial collaterals compensating for a blocked popliteal artery. Respondent hypothesized that M. V. was experiencing a blockage somewhere between the knee and ankle. Respondent examined M. V.’s calf to check for arterial bleeding or swelling sufficient to block an artery. However, the calf was soft and exhibited no swelling or tightness. Notwithstanding M. V.’s disorientation from pain medication and anesthesia, Respondent was able to determine that M. V.’s gross sensation was intact. Aware that M. V. was suffering from some sort of vascular problem, but unsure what it was, Respondent called Dr. Albert Bajohr, a local vascular surgeon. She informed Dr. Bajohr that M. V. was a 78-year-old diabetic with faint pulses in the foot. Respondent stated that M. V. had undergone a total knee replacement without any problems, but, following surgery, the patient had chilled and lost her pulse, although the nurses had warmed her and her pulse had returned. Respondent concluded her description of the patient by stating that M. V. had remained in satisfactory condition until midnight when she had again lost her pulse below the popliteal artery and had become cooler, although she had retained gross sensation. Dr. Bajohr recommended Heparin and, at Respondent’s suggestion, Hydergine, which would prevent clotting and might help collateral circulation. Dr. Bajohr stated that he would see M. V. early the following morning, unless he was needed sooner. The nursing assessment done at 4:30 a.m. on May 30 reveals that M. V.’s pedial pulse remained undetectable by palpation and that her foot remained “cold to touch.” The nursing assessment done at 5:40 a.m. reveals that M. V.’s pedial pulse was undetectable by palpation or Doppler, and her foot was “purple” and “cool to touch.” Her foot had cooled even more since midnight. A nurse called Respondent, who directed the nurse to call Dr. Bajohr. At 6:30 a.m., Dr. Bajohr ordered an immediate arteriogram. Due to the misunderstanding of the radiologist, who scheduled the arteriogram for May 31, the radiology department did not perform the arteriogram for at least three hours. The nursing assessment done at 7:00 a.m. on May 30 reports that the pulse for the left leg was clear, but the pulse for the right leg was absent, and the right leg was cold and discolored. At some point during May 30, probably before the performance of the arteriogram, M. V.’s primary physician examined her. His report notes that M. V.’s right foot was “clammy and cold,” pulses below the right knee were absent, and femoral and popliteal pulses “seemed to be present” in the right leg. Among his diagnoses were arteriosclerotic heart disease and to rule out congestive heart failure and peripheral vascular disease of the right foot. A right femoral arteriogram revealed “peripheral vascular disease with occlusion.” The report, which was dictated on May 30 and transcribed on May 31, finds “severe atheromatous plaque with total occlusion at the distal end of the superficial femoral artery near the adductor canal region.” The report adds: “Extensive collateral vessels are noted in the knee and calf area; however, no significant reconstitution of any of the major calf vessels were[sic] evident.” The arteriogram exposures did not visualize the popliteal artery, although they did reveal that no dye had entered the surrounding tissues anywhere in the exposed area. This fact is consistent with the finding that the artery immediately proximal, or upstream, of the occlusion was intact. The radiologist determined from the arteriogram that the calf vessels were also occluded and that collateral circulation had not reached the calf vessels. The radiologist identified the location of the occlusion at 3 cm above the start of the popliteal artery and noted that a 3-4 inch clot upstream of the popliteal artery would prevent leakage from that artery into surrounding tissue, if the artery were cut. The prospects of saving M. V.’s leg had diminished by the time that Respondent and Dr. Bajohr received the arteriogram report. Declining to attempt bypass surgery himself, Dr. Bajohr suggested to Respondent that she contact an Orlando vascular surgeon, Dr. Stephen Schreiber, who had considerable experience with bypass procedures and might be able to save the leg. Respondent telephoned Dr. Schreiber, who agreed to treat M. V. Respondent then arranged for M. V. to be transferred to Florida Hospital South in Orlando. However, the time involved in obtaining consents from M. V.’s family, Dr. Schreiber, and Florida Hospital South and transport M. V. from Sebring to Orlando occupied much of the day, so that M. V. was not admitted to Florida Hospital South until 4:30 p.m. on May 30. According to Dr. Schreiber's report, Dr. Schreiber attempted a revascularization on May 30 of M.V.'s left leg. Dr. Schreiber made a longitudinal cut, inserted a Fogarty catheter, and removed a large thrombotic plug. The artery produced “vigorous” bleeding, and Dr. Schreiber suspected a proximal, or upstream, arterial injury. He controlled the bleeding with digital pressure, quickly exposed more of the artery, and found “a large, essentially almost complete transection of the artery involving approximately three-quarters of the arterial wall just in the popliteal space.” Bypassing the injured artery, Dr. Schreiber reestablished blood flow and detected a strong pulse in the graft, as well as distally, or downstream, in the tibial vessels. He found good capillary refill downstream, but could not detect a Doppler pulse. Dr. Schreiber concluded that M. V. suffered either from spasm or significant disease. Due to the advanced deterioration of the lower leg from a prolonged period of ischemia, Dr. Schreiber was unable to complete a bypass. The following day, another surgeon amputated M. V.’s right leg above the knee. The pathology report states that, after dissection, the popliteal, posterior tibial, and anterior tibial arteries all displayed “severe arteriosclerosis and calcification.” Dr. Schreiber did not describe the condition of the capsule, which would have been between the artery and the sawblade. Nor did he describe the condition of the vein; although behind the artery, which is like a hose, the vein, which is like tissue paper, would likely have been injured if the artery had been cut. For the reasons noted in the Preliminary Statement, Dr. Schreiber’s testimony is not part of the record. The record indisputably reveals poor vascularization of both of M. V.’s legs. The post-amputation examination of the vessels revealed that M. V.’s right leg suffered “severe arteroisclerosis and calcification.” Pre-operatively, M. V. displayed faint pulses in both extremities upon her discharge from the initial hospitalization on May 13. Post-operatively, M. V.’s underlying circulatory problems manifested themselves, bilaterally, in the absence of pulses both legs following the knee-replacement surgery on May 29, the deterioration of pulses in both legs from clear to faint on the evening prior to the surgery, and the absence of pulses in both legs at midnight during the night following surgery. These circulatory deficits in the left leg, on which no surgery took place, establish a baseline of significant peripheral vascular disease, pre- operatively, in both legs. Undoubtedly, M. V.’s peripheral vascular disease complicated her recovery from the trauma of knee-replacement surgery. During the initial hospitalization, merely the anxious anticipation of the surgery probably produced a variety of adverse physical effects. Actually undergoing surgery, M. V. suffered, among other traumas, exsanguination of the left leg through the application of an Esmarch, application of a tourniquet for 102 minutes, and chilling in an operating room for nearly two hours. None of these factors would have had a positive effect upon M. V.’s already-compromised circulatory system in her lower extremities. In fact, subsequent to the time in question, use of the Esmarch on a patient with M. V.’s circulatory complications was contraindicated. It is impossible to determine whether Respondent accidentally transected the popliteal artery during surgery. Normally, such a transection would be obvious, as blood would surge from the severed artery, at least after the release of the tourniquet. However, a largely or intermittently occluded artery would not produce such a flow of blood. Several factors militate against a finding that Respondent accidentally cut M. V.’s popliteal artery during surgery. Although M. V.’s right leg suffered circulatory problems, as reflected by pulse and temperature, in the recovery room, a short time later the circulatory problems resolved themselves with the conservative treatment of warming the leg. Although M. V. continued to suffer serious circulatory problems in her right leg, these problems were accompanied by the presence, intermittently, of a good pulse from the popliteal artery or a vigorous set of collaterals, according to the examination by Respondent at 12:40 a.m. on the night following the surgery and the examination by M. V.’s personal physician six to ten hours later. A good pulse in the popliteal artery is inconsistent with its severance. A good pulse in collaterals around an occluded popliteal artery is inconsistent with subsequent damage from ischemia to distal portions of the anatomy arising from the severance of an occluded popliteal artery. Also, as noted above, the display of intermittent disruptions of pulse in both lower extremities was not unusual for M. V. Nonetheless, M. V.’s popliteal artery suffered a cut, which was discovered shortly after Respondent had replaced her right knee. It is unlikely that the sawblade would have made such a cut because the blade chews up soft tissue, and Dr. Schreiber would have presumably described a chewed-up artery. There is no indication of the severance of other features, such as the capsule or veins, which likely would have been cut if Respondent had cut the popliteal artery. Respondent suggests that Dr. Schreiber may have cut the artery. However, his incision is longitudinal, or perpendicular to the transverse cut actually found on the artery, so it is unlikely that Dr. Schreiber caused the damage to the artery. Other possible explanations are some injury to the artery during the exsanguination of the leg, application of the tourniquet, or operation of the CPM machine post-operatively. However, the record does not establish any of these elements as the cause of the injury to the artery, even one as calcified and diseased as M. V.’s popliteal artery. One puzzling aspect of this case is Dr. Schreiber’s description of his findings. He reported backbleeding when he removed the clot. However, it appears that the bleeding was infill bleeding, which is downstream from the heart, rather than backbleeding, which is upstream toward the heart. The bleeding was quite vigorous, and, as already noted, Dr. Schreiber immediately suspected a proximal, or upstream, injury to the artery. However, if the bleeding and cut were proximal, or upstream, of the occlusion, the relationship between the cut and the occlusion would be reversed. As reported by the arteriogram, M. V. had a clot just proximal, or upstream, of the popliteal artery, and Dr. Schreiber removed this clot, which, again, was just upstream of the popliteal area. Thus, it does not make any sense that Dr. Schreiber found the cut upstream of the clot; nothing in the arteriogram disclosed bleeding in this area, nor did Respondent cut tissue upstream of the clot. Additionally, if the cut were actually upstream of the clot, then, absent a showing that the clot formed after the cut, the cut may not have had any bearing on the health of the distal portion of the right lower extremity. If, on the other hand, Dr. Schreiber were actually controlling backbleeding, then the cut would be in the proper relationship to the occlusion--i.e., distal or downstream. However, this situation is undermined by Dr. Schreiber’s description of his suspicion of bleeding from an upstream location. One of Petitioner’s expert witnesses seemed to have had trouble with these contradictory findings. Dr. Alvin Stein testified at the final hearing that the bleeding encountered by Dr. Schreiber emerged from a cut upstream of the occlusion. However, he admitted that, during his deposition, he had testified that the bleeding was actually backbleeding, from a cut downstream of the occlusion. At the final hearing, Petitioner’s other expert witness, Dr. Martin Hale agreed that the bleeding encountered by Dr. Schreiber had emerged from a cut upstream of the occlusion. A more important variability in expert testimony, though, took place between Dr. Stein and Dr. Hale. Dr. Stein opined that the deviation from the standard of care was in Respondent’s failure to recognize timely that she had cut the popliteal artery, not in the laceration of the artery itself. Dr. Hale opined that the deviation from the standard of care was in Respondent’s cutting of the popliteal artery, not in the post- operative decisionmaking. Dr. Stein and Dr. Hale are both orthopedists with little recent experience in knee replacements and no significant experience in vascular surgery. Dr. Stein discontinued his surgical practice at the end of October 1995, after having done 2-4 knee replacements annually before that time. Dr. Hale has not performed a knee replacement for at least five or six years and did only 1-2 such procedures annually prior to that time. Dr. Hale testified that he was unconvinced that the loss of M. V.’s leg was caused by the laceration of the artery by Respondent. He opined that the right leg was close to nonviable before the surgery and that the swelling from the surgery and the occlusion of the femoral artery exacerbated the situation. Dr. Hale added that he based his opinion that Respondent cut the popliteal artery on Dr. Schreiber’s notes and that nothing in the other records compels such a finding. Dr. Hale concluded that, absent Dr. Schreiber’s finding of a transected artery, Dr. Hale would testify that Respondent met the standard of care. In sum, one of Petitioner’s experts testified that Respondent’s transection of the artery was not a deviation from the standard of care, and one of Petitioner’s experts testified that Respondent’s post-operative handling of M. V. was not a deviation from the standard of care. Both of Respondent’s experts testified that Respondent did not deviate from the standard of care in any respect. The Administrative Law Judge credits the testimony of Dr. Hale, as well as that of Respondent’s experts, that Respondent’s post-operative care of M. V. met the standard of care in all respects. Respondent adequately responded to her patient’s needs. Although conservative in her response, Respondent did not unreasonably delay in consulting with a vascular surgeon, especially given the earlier success enjoyed by her conservative approach in the recovery room when Respondent ordered only the application of a warming blanket. Perhaps the most serious delay was in the failure of the nursing staff to advise Respondent or Dr. Bijou of M. V.’s continued poor status following Respondent’s visit shortly after midnight. Turning to the question of the laceration of the artery, it is impossible to determine, even by a preponderance of the evidence, that Respondent transected the popliteal artery. Vascular expertise might have developed the nature of the transection of the artery, the condition of the surrounding tissues, and the likely sources of such an injury--e.g., operatively in Sebring, by means of the sawblade, scalpel, retractor, Esmarch, tourniquet, or manipulation of the leg during surgery; post-operatively in Sebring, by means of the CPM; or post-operatively in Orlando, by means of the scalpel or Fogarty catheter. Absent such evidence, there are entirely too many factual questions remaining to assign the source of the arterial injury to Respondent. Likewise, there are entirely too many factual questions remaining to assign the source of the amputation to Respondent’s acts or omissions. As Dr. Hale testified, M. V.’s right leg bordered on nonviable before the surgery, and any one of several factors may have pushed it past the point of sustainability. The parties have presented disputes concerning expert witness fees for the depositions of three physicians and attorneys’ fees for Respondent’s counsel. The expert witness fees are for Drs. Stein and Hale, who testified by deposition and at the final hearing, as well as one of Respondent’s expert witnesses, Dr. Jeffrey Penner, who testified exclusively by deposition. The Administrative Law Judge bifurcated the actual amount of the attorneys’ fees, if any, for separate hearing. Dr. Stein seeks an expert witness fee of $1000 per hour for deposition testimony. He billed Respondent $1750 for his one and three-quarter hour deposition and seeks an order requiring Respondent to pay this sum. Dr. Stein is certified by the American Board of Orthopedic Surgery and American Board of Quality Assurance Utilization Review. Dr. Stein works in Plantation, Florida. The last contract into which Dr. Stein entered with Petitioner covered the fiscal year ending June 30, 1998. This contract called for $100 per hour for “time spent on the witness stand under oath” and $75 per hour for all other time. Among the services described by the contract to be performed by Dr. Stein were testifying at depositions and hearings upon the request of Petitioner. The 1998 contract with Dr. Stein omitted mention of testifying at depositions or hearings at the request of the opposing party. However, the 1998 contract noted that the fees reflect the physician’s wish to provide a public service by assisting in the regulation of professions at a cost far below what is economically fair market standards. The contract shall in no way be deemed to establish the specified fees as being reasonable for the purpose of costs to be assessed if [the physician] is deposed by a person other than [Petitioner]. The 1997 contract with Dr. Stein provided for $100 per hour for “testifying at depositions and hearings” upon the request of Petitioner, “or upon subpoena issued by the subject of an investigation.” The contract had no other cited rate for services. Dr. Hale seeks an expert witness fee of $650 per hour for each hour or part of an hour. Deviating from his partial- hour policy, Dr. Hale billed Respondent $975 for his one and one- half hour deposition. Dr. Hale testified, without contradiction, that an hourly rate of $650 is in the lower one-third of fees in his community. Dr. Hale practices in Plantation, Florida. The last contract into which Dr. Hale entered with Petitioner covers the fiscal year ending June 30, 2000. This contract calls for $125 per hour for “testimony at depositions and hearings” upon the request of Petitioner. The contract has no other cited rate for services, but contains a public-service provision substantially identical to that cited above in Dr. Stein’s 1998 contract. Dr. Penner seeks an expert witness fee of $800 per hour. Dr. Penner billed Petitioner an undisclosed sum for a deposition that took place for an undisclosed period. Dr. Penner charges the same fee, regardless whether the party retaining him or the opposing party calls him. Dr. Penner practices in Palm Beach County, Florida. Dr. Penner testified that similar physicians in Palm Beach County charge between $600 and $1000 per hour for deposition testimony. Dr. Penner is certified by the American Board of Orthopedic Surgeons and American Board of Quality Assurance and Utilization Review Physicians, Inc. and holds a license as a Florida Certified Health Care Risk Manager. Dr. Stein appears to have considerable background in the practice of medicine, but his lack of recent relevant work undermined his value in this case. As he admitted in his deposition, he does not derive significant income from the practice of medicine. Dr. Stein undermined the value of his deposition testimony by changing his testimony in two important respects between the time of the deposition and the time of the final hearing: 1) he later opined that Dr. Schreiber actually observed infill bleeding, not backbleeding and 2) he later opined that Respondent’s transection of the popliteal artery during surgery was not, in itself, a deviation from the standard of care (although, at one point during his deposition, Dr. Stein appeared to admit as much, contradicting two other statements during his deposition that the transection was a deviation). Dr. Stein further undermined the value of his testimony by his elaboration of a third alternative basis for liability-- unsuitability for knee-replacement surgery--which Petitioner wisely declined to pursue. At one point, Dr. Stein admitted to using illegible records in preparing his written report, despite the standard agency request to alert it to any illegible records before preparing his written report. At times, Dr. Stein’s deposition testimony, such as his discussion of tourniquet time, inspired some doubt as to whether his ultimate opinions and conclusions were adequately informed by the underlying data and analysis. The maximum reasonable fee for Dr. Stein’s time while being deposed is $150 per hour with fractional hours charged proportionately. Dr. Hale also lacks recent relevant work, but his value to resolution of the case is much greater due to his willingness to express consistently succinctly, at deposition (as well as at final hearing), his candid analysis of the facts of the case. As is consistent with the case law, described below, Dr. Hale should not be penalized for his willingness to provide services at a discounted rate to Petitioner to assist Petitioner in discharging its important regulatory duties. The maximum reasonable fee for Dr. Hale’s time while being deposed is $300 per hour with fractional hours charged proportionately. Dr. Penner practices in one of two relevant specialties, and the Administrative Law Judge found his testimony useful, candid, responsive, authoritative, and succinct. Setting Dr. Penner’s fee, especially based on a slim record, is difficult. As is consistent with the case law, described below, setting a reasonable fee for Dr. Penner requires a balancing of the right of a licensee to obtain as qualified an expert witness as he or she can afford against the need not to allow a licensee to spend Petitioner into submission. The maximum reasonable fee for Dr. Penner’s time while being deposed is $500 per hour with fractional hours charged proportionately. In setting these maximum reasonable rates, the Administrative Law Judge is aware that the record is devoid of any evidence whatsoever directly rebutting the obviously self- serving testimony of each expert that his fees are reasonable in amount. In addressing this obvious omission from the record, the Administrative Law Judge has considered the rates set in the case law described below. The last issue is whether Petitioner is liable to pay Respondent’s attorneys’ fees and costs. First, Respondent claims that Petitioner brought this case for an improper purpose. Respondent places considerable emphasis in this claim on Petitioner’s failure to comply with Respondent’s request that Petitioner timely obtain and review the arteriograms, which showed no bleeding immediately proximal, or upstream, of the occlusion. Respondent also bases her claim upon Petitioner’s reliance upon the opinions of two experts, Drs. Stein and Hale, whom Respondent contends were unqualified to testify against Respondent because they had not recently performed knee replacements and had performed only a small number of such procedures in the past. Finally, Respondent contends that Petitioner’s failure to supply these experts with the arteriograms before the preparation of their written opinions and testimony at deposition deprived Petitioner of a reasonable basis for relying on their expert opinions and prosecuting the case against Respondent. Respondent places too much emphasis on the importance of analysis of the arteriograms when she argues, in her proposed recommended order, that these films do not reveal an injury to the popliteal artery. These films do not expose the popliteal artery; they expose the femoral artery, which is proximal, or upstream of, the popliteal artery. These films do reveal that there was no bleeding at the location of the occlusion at the distal end of the femoral artery, just proximal of the popliteal artery, and, in so doing, these films tend to call into doubt Dr. Schreiber’s finding of an transection just proximal of the occlusion, as well as other of his critical findings. Even an early identification of the questions surrounding Dr. Schreiber’s key findings would not have eliminated the question of Respondent’s post-operative care of M. V. Serious fact questions remained as to whether Respondent was too conservative in her post-operative responses to a patient whose peripheral vascular system was compromised even before the trauma of knee-replacement surgery. In the alternative, Respondent claims attorneys’ fees and costs in establishing the truth of certain items in her first and second requests for admission. In the first set of requests for admission, Petitioner denied requests stating the following: Vascular injuries as a result of total knee replacement with tourniquet are known complications from the procedure. It is not a deviation from an applicable standard of care for a vascular injury to occur as the result of a total knee replacement with tourniquet procedure. 16. Petitioner is aware of no facts that would show that Respondent failed to consult a vascular surgeon appropriately or formulate a conservative treatment plan for M. V. following completion of her surgery on May 29, 1996. The arteriogram performed on May 30, 1996 does not indicate there was a transection of an artery. The arteriogram performed on May 30, 1996 demonstrates evidence of a clot formation in the distal femoral artery. Petitioner is aware of no facts showing that M. V. did not have a thrombus formation in the distal superficial femoral artery on May 30, 1996. Petitioner denied paragraphs 13, 14, 16, and 19 as vague and the remaining paragraphs with a reference to the expert opinions. Petitioner denied paragraphs 5-7 of the second set of requests for admission. These paragraphs are essentially the same as paragraphs 19-21 above. The reasons for the denial were vagueness and reliance on the expert reports. Additionally, Petitioner denied paragraph 12 of the second set of requests for admission. This request asks Petitioner to deny that the arteriogram bears an incorrect date for the procedure performed on May 30, 1996. Petitioner responded only that the hospital records contain an arteriogram bearing a date of May 31, 1996. Several requests for admission pertain to the distribution of the arteriogram, but, as already noted, the arteriogram does not rise to the level of importance assumed by Respondent. Other requests concern complex (sometimes ultimate) factual issues, which would essentially serve as interrogatories if Petitioner had attempted to admit with conditions. However, as to the ten identified requests for admission discussed above, Petitioner denied matters that were true, and the denials suggest either an unacceptable unfamiliarity with the file on the part of the person preparing the responses or an unacceptable unfamiliarity with the requirements of the Florida Rules of Civil Procedure governing responses to requests for admission. However, the Administrative Law Judge finds that these unfair denials did not cause Respondent to incur more expenses for expert witnesses or treating physician witnesses. The radiologist needed to testify as to the area of artery covered by the arteriogram and absence of leakage in that area. The experts needed to testify about numerous details of the knee-replacement procedure and subsequent handling of the case. These witnesses needed to time to deal with the relatively simple matters raised in the 10 requests for admission. On the other hand, counsel for Respondent was unfairly required to address the matters raised in the 10 requests for admission. In an effort to assist the parties in settling, without an additional evidentiary hearing, the question of fees arising out of Petitioner’s improper responses to these ten requests for admission, absent additional evidence, the Administrative Law Judge would find that four hours of attorney time represent a fair allocation of time to deal with these matters, which overlapped numerous other factual issues that Respondent’s counsel had to address in any event.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the Amended Administrative Complaint against Respondent.
Findings Of Fact The decedent, James C. Daniels, was employed as a fire fighter with the Village of Miami Shores, Florida, in April of 1972. The Miami Shores Fire Department was subsequently assimilated by Metropolitan Dade County, Florida, and at the time of the decedent's death on July 20, 1976, he was employed by Dade County as a fire fighter/emergency medical technician. On November 4, 1975, the decedent received a physical examination which showed no evidence of heart disease, and an electrocardiogram, the results of which were within "normal" limits. The decedent had no history of heart disease or circulatory problems, did not drink, and began smoking only in 1974 or 975. At the time of his death, the decedent's customary work routine involved 24 hours on duty, from 7:00 a.m. to 7:00 a.m., followed by 48 hours off duty. The decedent's duties included answering emergency calls along with his partner in a rescue vehicle. These calls included such incidences as automobile accidents, fires, violent crimes involving injuries to persons, and various and sundry other emergency situations. Upon answering an emergency call, the decedent was required by his job to carry heavy equipment, sometimes weighing as much as 80 pounds, to the place where the injured person was located. On occasion, the decedent would transport injured persons from the scene to local hospitals. At the time of his death, the decedent appeared outwardly to be in good physical condition. In fact, he engaged in a regular program of physical exercise. During the approximately two months prior to his death, the decedent participated in a busy work schedule which often included numerous rescues, in addition to false alarms and other drills required of his unit. In fact, only four days prior to his death, the decedent and his partner during one twenty- four hour shift, were involved in 13 rescues and one building fire. During that day, the decedent worked for 24 straight hours, apparently without sleep. On July 19, 1976, at 7:00 a.m., the decedent began his last work shift prior to his death. During that day, the decedent's unit participated in two rescues and two drills. That evening, several of decedent's fellow workers noticed that he looked "bad", "tired" or "drawn out". During the night, decedent was observed getting out of bed from three to five times, and holding his left arm, left side or armpit. At 7:00 a.m. on July 20, 1976, the decedent went off duty and returned home. Upon returning home, he ate breakfast, and later washed down a new brick fireplace at his home. After showering, resting and eating a lunch, he joined several other men near his home whom he had agreed to help in pouring cement for some new construction. The decedent mentioned pains in his neck and shoulder to these men before the truck carrying the cement arrived. The decedent mentioned that he had been under a lot of tension and pressure as a result of the busy work schedule at the fire station. When the cement truck arrived, cement was poured into several wheelbarrows and several of the men, including the decedent, pushed the wheelbarrows to the rear of the structure on which they were working. It appears that the decedent pushed approximately four wheelbarrow loads of cement weighing about 75 pounds each to the rear of the structure. Approximately one-half hour elapsed during the time that the decedent was engaged in this activity. Soon thereafter, the decedent was observed to collapse and fall to the ground. He was given emergency medical treatment and transported to Palmetto General Hospital, where he was pronounced dead at 5:24 p.m. on July 20, 1976. An autopsy was performed on the deceased on July 21, 1976 by Dr. Peter L. Lardizabal, the Assistant Medical Examiner for Dade County, Florida. In pertinent part, the autopsy showed moderate arteriosclerosis of the aorta, and severe occlusive arteriosclerosis of the proximal third of the anterior descending coronary artery in which the lumen, or opening, through which the blood passes through the artery was hardly discernible. The remaining coronary arteries appeared unaffected by the arteriosclerosis. The decedent's certificate of death, which was also signed by Dr. Lardizabal, listed the immediate cause of death as acute myocardial infarction due to severe occlusive arteriosclerosis of the left coronary artery. Dr. Lardizabal performed the autopsy examination of the decedent by "gross" observation, that is, without the benefit of microscopic analysis. However, microscopic slides were made during the course of the autopsy which were subsequently examined by other physicians whose testimony is contained in the record of this proceeding. Findings contained in the autopsy report, together with an evaluation of the aforementioned microscopic slides, establish that the myocardial infarction suffered by the decedent occurred at least 24 hours, and possible as many as 48 hours, prior to the decedent's death. This conclusion is based upon the existence of heart muscle necrosis, or tissue death, which would not have been discernible had the decedent died immediately following a coronary occlusion. In fact, for a myocardial infarction to he "grossly" observable at autopsy, that is, without the benefit of microscopic examination, it appears from the record that such an infarction would have to occur a substantial period of time prior to the death of the remainder of the body. Otherwise, the actual necrosis of heart muscle tissue would not be susceptible to observation with the naked eye. Although it appears probable from the evidence that the decedent went into a type of cardiac arrhythmia called ventricular fibrillation which led to his death, the actual proximate cause of his death was the underlying myocardial infarction, which in turn was a result of arteriosclerosis which had virtually shut off the supply of blood to the affected area of his heart. Although the causes of arteriosclerosis are not presently known to A medical science, it appears clear from the record that acute myocardial infarctions can be caused by emotional or physical stress, and that the decedent's myocardial infarction was, in fact, caused by the stress and strain of his job as a fire fighter and emergency medical technician. In fact, it appears from the medical testimony in this proceeding that the decedent was having a heart attack which led to the myocardial infarction on the night of July 19, 1976, or in the early morning hours of July 20, 1976, while he was still on duty. It further appears that, although physical exertion, such as the pushing of the wheelbarrow loads of cement by the decedent, might act as a "triggering mechanism" for ventricular fibrillation, the decedent's activities on the afternoon of July 20, 1976, had very little to do with his death. The type of lesion present in the decedent's heart, which had occurred as much as 48 hours prior to his death, was of such magnitude that he would likely have died regardless of the type of physical activity in which he engaged on July 20, 1976. Petitioner, Dolores A. Daniels, is the surviving spouse of James C. Daniels.
The Issue The issues for determination are whether Respondent Bernard Zaragoza, M.D., violated Section 456.072(1)(bb), Florida Statutes (2007), as alleged in an Administrative Complaint filed by the Department of Health before the Board of Medicine on June 30, 2008; and, if so, what disciplinary action should be taken against his license to practice medicine in the State of Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, Bernard J. Zaragoza, M.D., is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 67920. Dr. Zaragoza’s address of record is 3100 Coral Hills Drive, Suite 207, Coral Springs, Florida 33065. Dr. Zaragoza is certified in general surgery by the American Board of Surgery. Dr. Zaragoza has not been the subject of any investigation, claim, or complaint relating to his professional career other than this matter. Dr. Zaragoza graduated, Summa Cum Laude, from the University of Miami with a bachelors degree. He earned his medical degree from Harvard Medical School. Dr. Zaragoza performed a five-year surgical residency program at New York Medical College’s Westchester County Medical Center. During his residency, Dr. Zaragoza performed hundreds of laparoscopic procedures, including laparoscopic cholechstectomies (removal of the gallbladder). A laparoscopic surgery is a technique in which the abdomen is entered through small incisions rather than “opening up” the abdomen. Normally, for abdominal laparoscopic surgery, incisions are made at the belly button. This is the point which is usually closest to the peritoneal cavity, thus reducing the distance from the skin the surgeon must work through and the surgeon has a broader view of the abdomen. By October 2007, Dr. Zaragoza had performed in excess of 2,000 laparoscopic cholecystectomy procedures. Patient J.C. On October 1, 2007, Patient J.C., a male, 83 years of age, presented at Northwest Medical Center, located in Margate, Florida, for treatment of abdominal pain and vomiting. Patient J.C. had reported with the same symptoms a month earlier and had been diagnosed with chronic cholecystitis, a chronic inflammation of the gallbladder due to the blockage of the bile ducts by gall stones. It is a life-threatening condition. Patient J.C. was admitted by Rafael Rodriguez, M.D., who requested a consultation by Mark Shachner, M.D., Dr. Zaragoza’s partner. Dr. Shachner confirmed a diagnosis of acute cholecystitis and, in light of the failed conservative therapy which Patient J.C. had undergone since his first visit and the potential threat to his life, Dr. Shachner recommended surgery. It was concluded that Patient J.C. would undergo an attempted laparoscopic cholecystectomy. Dr. Zaragoza was to perform the procedure. It was concluded that a laparoscopic procedure was the appropriate procedure for Patient J.C. due to his medical history: atrial fibrillation, Alzheimer’s disease, hypertension, and diabetes. He had also undergone prior abdominal procedures. The parties did not dispute that a laparoscopic procedure, because it was likely to reduce post- operative complications, was the best type of surgical procedure for Patient J.C. Patient J.C., as a result of a prior gastrectomy, had a long midline incision extending from the Xiphoid upper abdomen to below the belly button. As a result of this surgery, Patient J.C. had extensive adhesions of tissue up to the midline. Patient J.C. had also undergone an appendectomy. It was concluded that, due to Patient J.C.’s condition and abdominal surgical history, rather than entering at the belly button and risking injury to any structures that were adhesed to the midline, a “right-sided” incision point would be used. The Department does not dispute the appropriateness of this decision. Unfortunately, by using a right-sided incision point, Dr. Zaragoza’s visualization of Patient J.C.’s abdominal cavity was reduced. Patient J.C. and his family were fully informed of the nature of the proposed surgical procedure and the risks, after which Patient J.C. signed a written consent for surgery. The written consent included an authorization to “take whatever action(s) and to perform whatever procedures(s) they deem necessary and advisable, which may be in addition to or different from those now planned” and an acknowledgement that the surgery to be performed “may result in perforation or injury to adjacent organs or structures.” None of the witnesses convincingly testified that the authorization included the authority to remove healthy organs or that the acknowledgement included any suggestion that a healthy organ might be completely removed. Surgery was scheduled for October 2, 2007. Dr. Zaragoza began the surgery with a right-sided approach, freeing up the area and attempting to identify important structures in the right upper quadrant of the abdomen. In particular, the important structures Dr. Zaragoza attempted to locate were the liver, colon, and the gallbladder. Dr. Zaragoza encountered extremely heavy adhesions (8 on a scale of 1 to 10) in Patient J.C.’s abdomen. Dr. Zaragoza considered the risks of continuing or switching to an open abdomen procedure and correctly concluded it was best to proceed. Dr. Zaragoza freed up extensive adhesions and was able to correctly identify the liver. Unable to identify the gallbladder and due to the extensive adhesions in the area of the intestine, Dr. Zaragoza stopped the procedure in order to retrieve a CT scan of the area and personally evaluate the images. In order to expedite receipt of the CT study, Dr. Zaragoza scrubbed out and personally walked to the radiology suite. After returning, Dr. Zaragoza read the CT scan and the radiologist’s interpretation, which indicated that the gallbladder was posterior to the transverse colon. Dr. Zaragoza returned to Patient J.C., mobilized the colon to free it from the liver and attempted to locate the gallbladder behind the colon where he expected it to be. What Dr. Zaragoza found behind the transverse colon was a dark, thickened, and solid structure in the anatomical position which the CT scan and radiologist report suggested the gallbladder would be located. While the gallbladder, which consists of a water sac, is normally soft, pink, and pliable, this is not the case with an inflamed and infected one. Given Patient J.C.’s history of chronic cholecystitis with an acute cholecystitis secondary to the blockage of bile ducts by gallstones, Dr. Zaragoza was expecting to find a dark, thickened, and solid gallbladder in Patient J.C. Concluding that the structure he had located was the gallbladder, Dr. Zaragoza freed the organ of surrounding tissue, freeing away without incision adhesions to the organ, bringing the organ into position for removal. As Dr. Zaragoza began to free up the fat tissue around what he believed were the bile duct and blood vessels of the gallbladder, the organ ruptured, revealing a solid mass. Dr. Zaragoza believed that the mass was a tumor, which Dr. Zaragoza had encountered in other gallbladder surgeries. Dr. Zaragoza continued the procedure, separating the gallbladder for removal. While dividing what he believed was a cystic duct, Dr. Zaragoza encountered a bifurcation that did not correspond to the anatomy of the gallbladder. At this point, Dr. Zaragoza decided that surgery needed to be converted from laparoscopic to an open procedure. After doing so, a frozen section of the organ was sent to pathology for evaluation, in order to obtain a rapid evaluation of the tissue. The pathology report revealed that the organ that Dr. Zaragoza had removed from Patient J.C. was a healthy kidney. Dr. Zaragoza thereupon located the gallbladder by examining the dense adhesions around the colon, a risky procedure. Ultimately Dr. Zaragoza was required to cut into the transverse colon where he located the gallbladder, which had eroded into the transverse colon. Dr. Zaragoza then completed the surgical procedure, removing the gallbladder. Patient J.C.’s family was immediately advised of what had taken place; that Dr. Zaragoza had removed a kidney, in addition to successfully removing the gallbladder. The removal of a healthy kidney involves a medical procedure totally unrelated to removal of an unhealthy gallbladder. Removal of a healthy kidney is not a known or expected complication of gallbladder removal. Dr. Zaragoza’s removal of Patient J.C.’s kidney during gallbladder surgery constituted a “a wrong-site procedure, wrong procedure, or an unauthorized procedure, or a procedure that is medically unnecessary or otherwise unrelated to the patient’s diagnosis or medical condition.” The Department’s proposed findings of fact 12 through 20 contained in the Department’s Proposed Recommended Order, are accurate, support the ultimate findings of fact made in this paragraph and are subordinate thereto. Proposed findings of fact 36 through 38 of Respondent’s Proposed Order in large part accurately reflect the difficulty of the surgery performed on Patient J.C. Even the Department’s own expert noted that he thanked God Patient J.C. had not been his patient. The suggestion in paragraph 26 that the removal of the kidney was “simply an unwanted complication associated with this cholecystectomy procedure” is, however, not supported by the weight of the evidence.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Board of Medicine finding that Bernard J. Zaragoza, M.D., has violated Section 456.072(1)(bb), Florida Statutes, as alleged in the Administrative Complaint; imposing a fine of $5,000.00; issuing a letter of concern; requiring the completion of five hours of risk management education; and requiring that he perform 50 hours of community service. DONE AND ENTERED this 6th day of April, 2010, in Tallahassee, Leon County, Florida. LARRY J. SARTIN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings This 6th day of April, 2010. COPIES FURNISHED: Rolando A. Diaz, Esquire Kubicki & Draper 25 West Flagler Street, Penthouse Miami, Florida 33130 Robert A. Milne, Esquire Department of Health Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Diane K. Kiesling, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Dr. Ana M. Viamonte Ros, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact The Respondent, Charles P. Shook, M.D., is a medical doctor having been issued license number 0020414, pursuant to Chapter 458, Florida Statutes. He is board certified in the areas of general and peripheral vascular surgery and practices in those specialty areas in Fort Myers, Lee County, Florida. He has been practicing in Lee County since 1973. The Petitioner is an agency of the State of Florida, charged with enforcing the licensure and practice standards embodied in Chapter 458, Florida Statutes and related statutes and rules and imposing disciplinary measures for departure from those standards by physicians licensed in Florida when such are proven. Mrs. Betty A. Fiore, at times pertinent hereto, was an obese, 47-year old female, with a history of thrombo-phlebitis and progressively enlarging and painful bilaterial varicosities of the veins in her right and left legs. She was admitted to Fort Myers Community Hospital on January 28, 1979, by the Respondent, for performance of a bilateral "vein-stripping" surgical procedure. Her medical history reflected that she had had a similar vein-stripping procedure performed over 20 years previously. The patient was operated on by the Respondent on January 29, 1979, beginning at approximately 9:25 a.m. The procedure was quite lengthy due to certain complications and lasted until 1:25 p.m. that day. After normal preparations, under general anesthesia, the Respondent began the operation by performing an oblique groin incision on the left leg just below the inquinal liagment, approximately ten centimeters in length. The incision penetrated the subcutaneous tissue and, as the "fossa-ovalis" was approached, the Respondent noted a significant amount of scar tissue, apparently related to the earlier surgical procedure, which obliterated and concealed much of the normal anatomy and structure in the area of surgery. It was of such a dense nature that only a faintly palpable pulse could be felt in the vessel. The Respondent dissected out the various venous branches in the area and individually ligated them. During his dissection process, the distal common femoral artery was injured by being slightly nicked with the surgical instrument. Repair procedures for the injury to the artery were carried out as will be described below. In any event, the "codman stripper" was employed in carrying out the stripping operation on the vein in question and additionally, several incisions were made around the calf of the leg to alleviate smaller varicosities. One large perforating vein in the malleolar area had to be ligated after the superficial portion had been stripped away. The Respondent then began to perform a similar procedure on the right leg, in spite of the initial difficulties he had had on the left leg, because he did not expect such severe scar tissue involvement with the anatomical structures in the area of incision on both legs. When he carried out the incision on the right leg however, he found that the anatomy of the right leg was essentially the same as that of the left and that substantial scar tissue reaction had occurred, related to prior surgery, with obliteration of much of the normal anatomy, including concealment of the femoral artery. Due in large part to these anatomical changes and complications involved in dissecting out the various venous branches involved in the stripping procedure, the right femoral artery was also slightly nicked by the scalpel. The Respondent attempted to suture the femoral arteries nicked in both legs at the time these injuries occurred, but the sutures would not hold in the arteries due to some then unknown, medical condition. After the same failure to hold sutures was encountered with regard to both femoral arteries, the Respondent sent samples of the arteries to the pathologist for evaluation. The pathologist report indicated that the arteries were "normal." Parenthetically it should he noted that the "complaining witness," Mrs. Fiore, has been found to exhibit symptoms of diabetes mellitus. Her testimony was somewhat evasive concerning the degree to which she may suffer from this malady, which can have a detrimental effect on the vascular system. In any event, when working first on the left leg, the Respondent elected to resect back along the artery for approximately a half-inch on each side of the wound and after that resection, to repair the femoral artery with the insertion of a 6 millimeter gortex graft. Likewise, with regard to the right leg, the Respondent found the sutures would not hold in the damaged artery (which was of a "cheese-like" consistency). He therefore performed a similar resection and insertion of a 6 millimeter gortex graft to repair the injury. The surgical procedure was then successfully concluded. Post-operatively the patient encountered some complications involving infection in the groin area, requiring two additional admissions to Fort Myers Community Hospital. Subsequently, she was transferred to Methodist Hospital in Houston, Texas, where she underwent two additional surgical procedures. The Petitioner presented the opinions of two expert witnesses, Dr. Alexander Braze and Dr. E. William Reiber. Dr. Braze's expert opinion is predicated on the review of Mrs. Fiore's office records from the Respondent's office, the hospital charts for her three admissions to Fort Myers Community Hospital, and summaries of her two admissions to the Methodist Hospital in Houston, Texas. His opinion is not based on any examination of the patient involved. Dr. Braze thus opined that because of the previous surgery on the greater saphenous vein, bilaterally, there would be obvious and considerable scarring and scar tissue in the subcutaneous area which would distort and conceal the individual anatomical structures. He himself has never nicked a femoral artery while doing a vein-stripping operation but, although he acknowledges it is an "uncommon complication, he has heard of it occurring. He was unable to render an opinion concerning whether or not the operation was performed properly because this was not a typical vein ligation and stripping procedure, due to the presence of extensive scar tissue, and resulting difficulty involved. The dense scar tissue precluded identification of the structures in the area of the surgical incision and meant that the Respondent had to proceed slowly and very meticulously with a careful dissection, deviation from which careful procedure could cause difficulty. The doctor's procedure was slow and meticulous. The procedure (for both legs) took approximately four hours. Although the Respondent proceeded with care, he nicked the arteries anyway. Dr. Braze could not state that such a complication, albeit uncommon, constituted a departure from standards normally recognized in the medical community. With regard to the doctor's judgmental decision to proceed to the right leg after nicking and repairing the artery in the left leg and completing the vein stripping procedure in the left leg. Dr. Braze opined that he was acting as a reasonable physician in proceeding to the other leg since he had already corrected the initial injury, especially since it was the leg in which she was having her chief complaints. In any event, Dr. Braze was unable to render an opinion as to whether or not the procedure up to the point of nicking the artery was properly or improperly done, although he acknowledged that the lengthy time taken to perform the total procedure indicates that the doctor was proceeding slowly and with greater than normal difficulties. In any event, after the arteries were nicked, the procedure followed by the Respondent was excellent and the repair work was competently and efficiently performed. Dr. Reiber, Petitioner's other expert witness, testified by deposition, which was stipulated into evidence. His expert opinion was based on a review of the deposition of the Respondent, the Fort Myers Community Hospital records of the patient, and the depositions of the patient, Betty Fiore, Arnold Flare and Quillen Jones. Additionally, he reviewed the records dealing with Mrs. Flare's treatment in Houston, Texas. He thus opined that the Respondent made two technical errors when he injured the arteries in each leg and he felt that it was an error in judgment to have performed the procedure on the right leg after having encountered difficulty in the initial procedure on the left leg. He was unable to opine however, that the treatment rendered the patient by Respondent fell below the appropriate standard of care accepted by similar physicians in the community. Moreover, he also opined that the Respondent's treatment after nicking the arteries affirmatively met the standard of care for reasonably prudent physicians in such circumstances. The expert witnesses presented on behalf of the Respondent were Drs. Peter M. Sidell and Luis A. Ruilova. Both witnesses opined, in effect, that, given the obesity of the patient and the difficult surgical process that alone entailed, coupled with the significant involvement of scar tissue in the area of the incision, that the complications associated with this procedure could occur in the hands of even the most renowned surgeon. The fact that the Respondent experienced these complications does not render his practice in this regard to be below the standard of care for vascular surgeons in that community or area of practice. They further opined that it is a matter of personal judgment on whether to proceed to the other leg after encountering these difficulties. A reasonable judgment would have been to explore the groin area on the other side, after accomplishing repair of the first injured artery, which was done. The initial arterial injury having been repaired in a successful manner, both of the Respondent's experts opined that, the patient then being stabilized, the Respondent was justified in proceeding to the other leg and performing the procedure on that side. The main purpose of the operation was to remove the veins of the patient since the patient was symptomatic with varicosities. It therefore would be poor judgment to simply repair the nicked artery and proceed no further, since the symptomatic vein would remain uncorrected. In short, both experts for Respondent opined that neither the vein-stripping procedure, the repair of the damaged arteries nor post-operative management for which Respondent was responsible were performed in a manner below the appropriate standard of care of reasonably prudent physicians in the community. Thus, although the patient unfortunately experienced difficulties during a procedure involving the accidental nicking of her femoral arteries and, after the grafts repairing those injured arteries were performed, later suffered an infection at the operative site necessitating further hospitalization, no expert witness could describe the treatment and care afforded this patient as being below the appropriate standard of care exercised by a reasonably prudent physician performing such vascular surgical practice in the Fort Myers community or area. The Respondent has never encountered this difficulty either before or since this occasion in his practice, which is characterized by frequent vascular surgical procedures. Additionally, Dr. Ruilova established that the nicking of the femoral arteries during such a procedure, although not a common occurrence, is well documented in the literature and not at all unheard of. Indeed, Dr. Ruilova, when assisting a distinguished surgeon who was chief of surgery at the Mayo Clinic at the time, observed that expert surgeon nick a femoral artery in a vein- stripping procedure on two occasions. Finally, it is noted that the Respondent's practice has been characterized by a high level of professional expertise, competence and compassion in caring for his patients, both before and since the occasion in question. He has never before been subjected to disciplinary action.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, it is, therefore RECOMMENDED that a Final Order be entered by the Board of Medical Examiners dismissing the complaint in its entirety. DONE and ENTERED this 11th day of October, 1984, in Tallahassee, Florida. P. MICHAEL RUFF 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 11th day of October, 1984. COPIES FURNISHED: Barbara K. Hobbs, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Patrick Geraghty, Esquire HENDERSON, FRANKLIN, STARNES & HOLT Post Office Box 280 Fort Myers, Florida 33902 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issue to be resolved in this proceeding concerns whether Respondent's license to practice medicine should be subject to sanctions based upon alleged violations of Section 458.331(1)(m) and 458.331(1)(t), Florida Statutes. Specifically, it must be determined whether he departed from the appropriate standard of medical care and treatment of a patient in the course of his practice of ophthalmology and whether his record keeping with regard to the care and treatment of that patient met appropriate standards.
Findings Of Fact Stipulated Facts The Petitioner is the state agency charged with regulating the practice of medicine, pursuant to Section 20.30, Florida Statutes, and Chapter 455, Florida Statutes. The Respondent is, and at all times material hereto, has been a licensed medical doctor in the State of Florida, having been issued license number ME0004933. The Respondent's address is 820 Prudential Drive, Suite 712, Jacksonville, Florida. On or about September 13, 1989, patient D.P., a 65-year-old-female, presented to the Respondent for evaluation regarding extremely high intra-ocular pressure and severe pain in both eyes. Patient D.P. had undergone abdominal surgery two days prior to the Respondent's examination, which was her second abdominal surgery in two weeks. The Respondent examined patient D.P. and diagnosed her with acute angle closure glaucoma, which had been present since the time of her second abdominal surgery, two days earlier. The Respondent treated patient D.P. with topical medications to decrease the intra-ocular pressure. Patient D.P.'s left eye responded to treatment with decreased pressure. The intra-ocular pressure in the right eye remained extremely high, in excess of 70 millimeters. On or about September 13, 1989, the Respondent performed a vitreous tap of the patient D.P.'s right eye, which immediately relieved the intra-ocular pressure. The Respondent did not consult patient D.P.'s surgeons or internists prior to performing the vitreous tap, regarding the possible use of intravenous medications. On or about September 14, 1989, the Respondent consulted Dr. James Staman, a retinal specialist, due to the patient's diminished vision in her right eye. Dr. Staman examined patient D.P. and diagnosed her with a vitreous hemorrhage. (End of stipulated facts). The Respondent has been licensed to practice medicine in the State of Florida since 1954 and has practiced in the field of ophthalmology since 1966. He has been board certified in the field of ophthalmology since 1969. He has never been investigated or disciplined by the Department of Business and Professional Regulation or any predecessor agency charged with regulating the licensure and practice standards of medical doctors in Florida. The Respondent maintains hospital staff privileges appropriate to his practice and has never had hospital staff privileges denied, revoked, or suspended at any hospital at which he has had privileges. Patient D.P. is a 65-year-old-female, who presented to the Respondent on September 13, 1989 complaining of severe pain in both eyes and with regard to which the Respondent immediately determined the presence of extremely intra- ocular pressure in both eyes. Patient D.P. had recently undergone a gastrectomy, a major abdominal surgical procedure, within 48 hours prior to presenting to the Respondent. This was the second abdominal surgery she had undergone within the past two weeks. When she presented to the Respondent on that date, she was in severe pain from the increased intra-ocular pressure in both eyes and appeared to be weak and in great discomfort. Pursuant to order of her doctors who attended and treated her with regard to the abdominal condition and surgery, the patient was and had been "NPO" for four weeks. This condition or situation means that she was forbidden from taking food or liquids of any type by mouth during this period of time. Upon evaluating the pressure in her eyes, the Respondent determined that the intra-ocular pressure in her left eye was 35 millimeters of mercury and in excess of 70 millimeters of mercury in the right eye. This is because the standard instrument with which her pressure was tested by the Respondent only depicts a maximum pressure of 70 millimeters of mercury. The normal intra- ocular pressure for such a patient would be 17-18 millimeters of mercury. Upon evaluating and examining the patient, the Respondent determined her condition to be bilateral acute angle closure glaucoma. He determined that the condition had been present since her surgery 48 hours earlier. The anesthesia from the surgery had precipitated dilation in both eyes which, in turn, precipitated the acute angle closure glaucoma. This occurred because, upon the dilation of the pupils of both eyes caused by the anesthesia, the iris folded back as the pupil expanded, and the folds of the iris occluded or blocked the drain structure by which fluid can drain from within the eye. The inability of the fluid to drain thus caused the severe increase in intra-ocular pressure and thus the glaucoma condition. The Respondent initially treated the acute angle closure glaucoma in both eyes with glycerin. This is a topical medication designed to reduce the amount of swelling in the cornea and to increase absorption of medication into the eye. The Respondent also initially treated the condition with pilocarpine. This is a topical medication administered to constrict the pupil and thus open the channel in the trabecular meshwork (the drainage structure) in an attempt to break the attack of acute angle closure glaucoma by allowing the eye fluid to drain and thus relieve the pressure. The intent is that by constricting the pupil, the iris will stretch with the pupil's closure so as to remove its folds from the position of blocking the channel in the trabecular meshwork. The Respondent initially administered a "beta blocker" medication in an attempt to open the trabecular meshwork by cutting down on the amount of aqueous fluid produced by the ciliary body. The topical medications, indeed, broke the attack of glaucoma in the left eye and the intra-ocular pressure in that eye returned to normal levels. However, after approximately a four-hour trial of the array of topical medications used by the Respondent, the attack of glaucoma in the right eye had not subsided at all. Prolonged elevated intra-ocular pressure of the magnitude of over 70 millimeters of mercury in the right eye posed a great danger of loss of vision in that eye due to potential occlusion of the ocular artery supplying blood to the eye and concomitant permanent damage to the optic nerve. The artery can be occluded or closed off due to such excessive pressure because the pressure at that level will exceed the blood pressure generated by the heart through the vascular system, including the artery supplying that eye. This results in the ocular pressure overcoming the blood pressure within the artery, thus constricting the artery and, therefore, the blood supply to the eye. The loss of blood supply to the eye in a short time, possibly 90 minutes or less, can cause the eye tissue normally served by the artery to become necrotic (i.e. to die). Necrosis of the internal eye tissue, in turn, can cause complications by weakening the pertinent structures of the eye, such as the tissue by which the retina is attached and held in position. The Respondent observed the patient and performed this clinical treatment for approximately four hours without being able to relieve the elevated intra-ocular pressure in the right eye. The Respondent knew, given the symptoms and history with which the patient presented, that severe pain had been experienced by the patient in her eyes since she awakened from the anesthesia administered for her surgery. Thus, he knew that for approximately two days, the glaucoma condition had been operating on the structures of the eye. Accordingly, he knew that time was of the essence if he was going to be able to relieve the glaucoma and thus save the vision, or some of it, in her eye. After these hours of clinical attempts to cure her condition, and in view of the state of urgency the Respondent recognized in the patient, who had already experienced severely-elevated intra-ocular pressure for two days, the Respondent determined that the emergency nature of the patient's situation precluded use of the time necessary to consult with her surgeon and anesthesiologist, to attempt to hospitalize her, to administer a general anesthetic, and perform an alternative surgical procedure. The Respondent, therefore, elected to perform a "vitreous tap". The vitreous tap involves using a hypodermic needle with a "guarded needle" (meaning that the needle is protected so that only a small portion of the point of the needle projects from the guard structure) to withdraw a small amount of the vitreous fluid. This was done to reduce the pressure, open the angles at the trabecular structure in the eye and thus break the attack of acute angle closure glaucoma and return the eye to normal intra-ocular pressure. The vitreous tap was performed at approximately 4:05 that afternoon and was successful. It immediately broke the attack of acute angle closure glaucoma and the intra-ocular pressure returned to a normal range. However, a vitreous hemorrhage resulted from the vitreous tap caused by the needle striking a small blood vessel in the pars plana area of the eye. This area cannot be visualized when performing the vitreous tap because it is inside the eye. A vitreous hemorrhage is a known and accepted complication or risk of a vitreous procedure. However, it has a low incidence of occurrence of approximately 3-5 percent. Upon determining that the hemorrhage condition was present and on or about September 14, 1989, the Respondent obtained a consultation with Dr. James Staman, a vitreal-retinal surgeon, due to the diminished vision in the patient's right eye. Dr. Staman examined the patient and diagnosed a vitreous hemorrhage in her right eye. The incidence of retinal detachment from a vitrectomy is approximately 5-10 percent. It would have had a higher risk in this patient's case, due to the probability of her already suffering permanent damage to the eye and eye tissue caused by necrosis, which was caused by loss of blood supply to the eye during the extended period of high intra-ocular pressure. This likely damaged the optic nerve and occluded the ocular artery serving that eye or portion of the eye. Dr. Staman performed a vitrectomy and removed the hemorrhage or blood from the patient's eye. Unfortunately, a retinal detachment occurred as a complication of that vitrectomy. This chain of events ultimately resulted in the patient losing the vision in her right eye. This was because of the determination that the retinal detachment could not be repaired without causing the loss of vision itself. Dr. Doyle testified as an expert witness for the Respondent. Dr. Doyle is a board certified ophthalmologist specializing in the field of glaucoma and particularly in the sub-specialty area of glaucoma management, including surgical glaucoma management. Additionally, Dr. Doyle is a holder of a fellowship, involving further specialty training in the field of treatment and management of glaucoma and surgical alleviation and management of glaucoma. He is determined to be the most qualified expert witness by training, education and experience in the particular specialty concerning glaucoma, with which this patient's condition is characterized, as is provided in his testimony depicted in the transcript of this proceeding and in his curriculum vitae in evidence. This depiction of his training, education and experience is adopted, by reference, as fact. According to Dr. Doyle, the loss of vision in the right eye was not caused by the vitreous tap. Rather, the precipitating factor was the retinal detachment which occurred as the result of the direct vitrectomy surgery. A vitreous hemorrhage is a known complication of a vitreous tap and a retinal detachment is a known complication of a vitrectomy. The Respondent and all of the expert witnesses agreed that the patient had probably already suffered permanent damage to the right eye, prior to the performance of the vitreous tap, in the form of corneal decomposition, cataract formation and optic nerve damage. Dr. Doyle's testimony, as corroborated by that of the Respondent, established that, in all likelihood, significant necrosis of the eye tissue involved in the structure by which the retina is attached had occurred due to occlusion of the artery supplying blood to that area of the eye by the 48 hours or more of elevated intra-ocular pressure. The elevated intra-ocular pressure occurred as a result of the anesthesia administered to the patient during her abdominal surgery. The Respondent and all expert witnesses agreed that the Respondent had utilized an appropriate and proper procedure in performing the vitreous tap. However, Drs. Baumann and Berg, testifying for the Petitioner, do not agree that the vitreous tap should have been performed to relieve the attack of acute angle closure glaucoma in the right eye. Standard of Care The Respondent met the standard of care under the circumstances with which this patient presented, in his care and treatment of patient D.P. when he performed the vitreous tap to break the attack of acute angle closure glaucoma in patient D.P.'s right eye. The usual treatment options or alternatives for the treatment of acute angle closure glaucoma were not available to the Respondent due to the extremely unusual set of precipitating circumstances with which the patient presented to him. The patient had already had extreme intra- ocular pressure of approximately 48 hours duration, based upon all of the evidence available to the doctor in performing his diagnosis and examination of treatment options. Dr. Baumann admitted that the situation was "urgent", and Dr. Berg admitted that the situation was an "emergency" and that the Respondent's "back was up against the wall" under the circumstances. Because of this, the treatment, including surgical options preferred by Drs. Baumann and Berg, was not effectively available to the Respondent in an attempt to save the vision in the patient's eye. This is because, in order for a general anesthetic to be administered and the patient prepared, monitored and evaluated for the surgery, she would have had to be hospitalized, with accompanying consultation with her internal medicine physician, her abdominal surgeon, and the anesthesiologist. All of this process would have taken approximately six hours, from the time the decision was made to perform the vitreous tap, which was made when the topical medications failed to alleviate the attack, until the surgery could be performed in the hospital. Even if the patient's eye was not already significantly damaged by the 48 hours of elevated intra-ocular pressure when she presented to the Respondent at his office, substantial damage to her vision would have occurred as a medical certainty if another six hours had elapsed after the unsuccessful conclusion of conservative, clinical treatment between 4:00 p.m. and 4:30 p.m. The first treatment option in an angle closure glaucoma case is topical therapy in an attempt to reduce the production of fluid by the ciliary body in the eye and to cause the iris to constrict and thus open the angle and its drainage structure. The Respondent initially treated the angle closure glaucoma in both eyes with topical medications, including pilocarpine, glycerin and a beta blocker. He repeated this topical therapy for approximately three hours at the appropriate intervals which all testifying physicians, including Dr. Doyle, agree was "normal, appropriate care". Under ordinary circumstances, if the topical medications failed to lower the intra-ocular pressure, the use of diamox or mannitol would be the next treatment alternative to try. However, diamox, a carbonic anhydrase inhibitor, which affects the ciliary body to reduce the production of fluid, would not have produced any greater benefit than the topical medications which had failed already. Mannitol is a hyperosmotic medication. It is ordinarily administered by mouth, which allows the body's stomach and intestines to regulate and gradually accomplish a safe absorption of the medication. However, oral mannitol was not an option to this patient because, under her previous doctor's orders, she was not allowed to take anything by mouth at times pertinent to this proceeding, including the day and times when the Respondent was treating her for the glaucoma. Mannitol reduces vitreous volume by reducing water everywhere in the body, including the eyes. The fluid is drawn into the blood stream, which, however, increases blood volume. Administration of mannitol intravenously would have put the patient at significant risk for an overload of volume in the blood which would have caused readily increased blood pressure with attendant possible medical complications, massive congestive heart failure, or kidney problems. These are life-threatening risks which would have necessitated hospitalization, evaluation and monitoring in the hospital before and during administering of intravenous mannitol. By the time this could have been accomplished, the vision in the eye would have already been lost. Dr. Doyle and the Petitioner's expert, Dr. Baumann, both agreed that administration of intravenous mannitol would have been dangerous for this patient. Intravenous mannitol is only 50 percent effective in such a situation, in any event, and is contra-indicated in patients such as D.P., who are post- gastrectomy surgery. This 65-year-old patient, weakened by her second gastrectomy surgery in a four-week period, involving the use of general anesthetics, was simply not a safe candidate for the administration of mannitol under the risky intravenous method which would have been necessary with the patient. The risk of kidney or heart failure and other complications was simply too great. The Petitioner's expert, Dr. Baumann, admitted that it was reasonable for the Respondent to have these concerns about the use of diamox and intravenous mannitol and further that the Respondent was not negligent in deciding not to use those medications. Under ordinary circumstances, if the topical therapy and the administration of medication failed to relieve an attack of acute angle closure glaucoma, the next course of treatment to be considered would be an argon or YAG laser iridectomy or an irridoplasty in order to place a small hole in the iris to relieve the pressure differential in the eye. A laser is a focused beam of light, at high energy, which can insert the necessary hole in the eye to relieve the intra-ocular pressure. It requires a clear media over the iris in order to penetrate the eye and make the hole in the required position. In this case, due to the extraordinary high intra-ocular pressure over a two-day period, the cornea was very cloudy and hazy. This precluded the laser being effective and created the potential for damage to the cornea had the laser been directed against the eye. Dr. Doyle and the Petitioner's experts, Dr. Berg and Dr. Baumann, all agreed, that in a patient such as D.P., with intra-ocular pressure of over 70 millimeters of mercury extending for 48 hours, the cornea would be very cloudy. The Respondent's testimony confirms this. After the vitreous tap was performed and the intra- ocular pressure relieved, the edema and cloudiness of the cornea resolved itself so that the Respondent was able to perform a successful argon laser iridectomy the following day and a YAG laser irridoplasty in his office five days later, to prevent a recurrence of the problem by providing an additional means of fluid drainage. Under ordinary circumstances where topical therapy, medication therapy, and laser iridectomy had either failed or were not viable options, then surgical treatment would be the next consideration. The surgery would include either surgical iridectomy or a trabeculectomy. A surgical iridectomy creates a small hole in the iris which relieves the pressure. A trabeculectomy creates a secondary drain for the eye. The Respondent was justified in not pursuing a surgical iridectomy or trabeculectomy in that the surgery could not have been done under a local anesthetic and would have required general anesthesia. This is undisputed. This would have required surgery in the hospital operating room, including the necessity for insertion of a tube, which might have caused risk to her recent abdominal surgery. It would have necessitated contacting her surgeon, her internal medicine physician, and her anesthesiologist for pre-surgical evaluation and clearance. This would have taken considerable time, at least six hours, thereby, within reasonable medical certainty causing permanent significant damage or entire loss of vision to the eye. A surgical iridectomy or trabeculectomy are not benign procedures and carry the highest complication rate of any ophthalmic procedure, when used for malignant glaucoma and, indeed, the accepted treatment for malignant glaucoma (albeit a different type of glaucoma condition) is a vitreous tap. Either surgical procedure would have had a risk of complication resulting in loss of vision in the eye of at least 3-5 percent or more, thus, the same or greater level of risk than that attendant to the vitreous tap procedure. Paracentesis, a surgical procedure to make a small hole in the anterior chamber of the eye, was itself not a reasonable treatment alternative under the circumstances. It was simply not feasible because the anterior chamber of the eye had virtually ceased to exist because the iris diaphragm had bulged forward through the space normally occupied by the anterior chamber because of the great pressure behind it. Dr. Doyle established that the Respondent's vitreous tap effected a complete cure of the glaucoma condition in patient D.P. A vitreous tap is a procedure recognized in the medical literature as a treatment for several ophthalmic conditions, including malignant glaucoma, positive pressure during cataract surgery, and for the purpose of obtaining vitreous material for pathological testing (biopsy). The medical literature, indeed, does not address the use of a vitreous tap as treatment for acute angle closure glaucoma because the medical literature and text books tend to deal with more common presentations of all diseases. None of the literature addresses treatment of acute angle closure glaucoma under the unusual set of emergency circumstances presented with this case. The Respondent's expert, Dr. William Doyle, is a board-certified ophthalmologist who has a sub-specialty in glaucoma management and treatment, including surgical management thereof. He is one of only a handful of fellowship-trained glaucoma specialists in the State of Florida and the only one in the North Florida area. He sees patients on referral from other doctors in Florida and South Georgia, who have unusual glaucoma-related problems. Dr. Doyle is an assistant professor of ophthalmology at the University of Florida and is responsible for teaching glaucoma management and treatment. He has authored some twelve article, book chapters, and other publications specifically in the field of glaucoma management and treatment. According to Dr. Doyle, if the vitreous tap procedure had been successful, the Respondent "should have written it out for the literature as a viable, interesting way to cure a disease". The Petitioner's expert, Dr. Berg, in his report attached to his deposition, referenced an article in International Ophthalmology Clinics, by Kevin C. Greenridge, M.D., of the Metropolitan Hospital Center, Department of Ophthalmology, New York, New York, and which Dr. Berg admitted was authoritative in the field of acute angle closure glaucoma. The article specifically states that in cases of acute angle closure glaucoma, for a duration of more than 24 hours, the eyes are more inflamed and have evidence of corneal decomposition, which are relative contra indications to argon laser iridectomy. Since the acute angle closure glaucoma had a duration of 48 hours when the Respondent first saw the patient, corneal decomposition could have been significantly advanced by that point such that the set of conditions requisite to causing the retinal detachment, which ultimately led to the loss of the patient's sight in that eye, were likely already in place. Thus, the vitreous hemorrhage caused by the vitreous tap may not itself have been the cause of the loss of sight. Medical Record Issue The Respondent's office records note "Vitreous tap. 4:30 p.m., immediately patient felt better". The Respondent also made an entry in the patient's hospital chart on the date of the vitreous tap which noted: Acute angle closure glaucoma right eye. Totally unresponsive to treatment. Pressure of 70 unaffected by treatment. Pars plana 1/2 cc vitreous tap done with immediate relief. Both eyes very shallow [referring to anterior chamber]. Started on pilocarpine and both eyes will need argon laser iridectomy soon. A copy of the hospital note was included and contained in the Respondent's records of the patient. In addition, the Respondent obtained a signed, written, informed consent for the procedure. The Respondent's records, including his office records and the note in the hospital chart, adequately document the course of therapy leading up to the vitreous tap and the vitreous tap procedure itself such that the Respondent's medical record keeping would adequately inform the Respondent in the future when reviewing the patient's records with a view toward further follow-up and treatment of the patient's entire status. They would also adequately inform any physician to whom the patient was later referred by the Respondent of her status, the treatment and procedures performed, and the symptoms and diagnosis involved in the patient's care and treatment.
Recommendation Based on the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is RECOMMENDED that the Respondent be found not guilty of violating Sections 458.331(1)(m) or (t), Florida Statutes, and that the Administrative Complaint against the Respondent be dismissed in its entirety. DONE AND ENTERED this 7th day of September, 1994, in Tallahassee, Florida. P. MICHAEL RUFF 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 7th day of September, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-5990 Petitioner's Proposed Findings of Fact 1-16. Accepted, but not necessarily for their purported material import. Rejected, as contrary to the preponderant, probative evidence. Accepted. Accepted, but not itself dispositive of the material issues presented. Accepted. 21-26. Accepted, but not necessarily for their purported material import and subordinate to the Hearing Officer's findings of fact on this subject matter. 27. Accepted, but subordinate to the Hearing Officer's findings of fact on this subject matter and as not probative of the medical records being inadequate as a matter of fact and law. 28-29. Accepted. 30. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter and not entirely in accordance with the preponderant weight of the evidence. 31-41. Accepted, but subordinate to the Hearing Officer's findings of fact on this subject matter and not dispositive of the material issues presented. 42-43. Rejected, as contrary to the preponderant weight of the evidence and subordinate to the Hearing Officer's findings of fact on this subject matter. 44-46. Rejected, as contrary to the preponderant weight of the evidence and subordinate to the Hearing Officer's findings of fact on this subject matter, and for the additional reason that these proposed findings are not dispositive of the material issues presented. 47-50. Accepted, in part, but not as materially dispositive of the issues presented for resolution and as subordinate to the Hearing Officer's findings of fact on this subject matter. Rejected, as contrary to the preponderant weight of the evidence and subordinate to the Hearing Officer's findings of fact on this subject matter. Accepted. Rejected, as subordinate to the Hearing Officer's findings of fact on this subject matter. Respondent's Proposed Findings of Fact 1-55. Accepted, to the extent not rejected by or subordinate to the Hearing Officer's findings of fact. Those proposed findings of fact not treated in the Hearing Officer's findings of fact are rejected as unnecessary or immaterial. COPIES FURNISHED: Alex D. Barker, Esquire Department of Business and Professional Regulation 7960 Arlington Expressway Suite 230 Jacksonville, Florida 32211 Jeptha F. Barbour, Esquire Post Office Box 447 Jacksonville, Florida 32201 Dr. Marm Harris Executive Director Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue The issue is whether Respondent's license as a medical doctor should be disciplined for the reasons given in the Administrative Complaint filed on October 25, 2000.
Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: Background At all times material hereto, Respondent, David Lowell Williams (Respondent or Dr. Williams), was a licensed medical doctor having been issued license number ME 0035686 by Petitioner, Department of Health, Board of Medicine (Board). The Board is charged with the responsibility of regulating the practice of medicine in the State of Florida. Respondent is board-certified in cardiovascular disease and internal medicine and has practiced his specialty in Ormond Beach, Florida, since 1983. In 1990, Respondent accepted a position as a cardiologist with Florida Health Care Plan, Inc. Except for the charges raised in this proceeding, there is no evidence that Respondent has ever been involved in a prior disciplinary action. Based on a complaint filed with the Board by an attorney representing the family of a former patient, S.T., on October 25, 2000, the Department of Health, acting on behalf of the Board, filed an Administrative Complaint against Respondent generally alleging that in April 1995 he had failed to practice medicine with the level of skill and care required of a reasonably prudent physician, and that he failed to keep written medical records justifying the course of treatment of S.T. Respondent has denied the charges and contends that he practiced medicine within the standard of care and that the documentation related to the patient justified the course of treatment. In determining whether a deviation from the appropriate standard has occurred, the undersigned has considered the conflicting testimony presented by the witnesses and has accepted the more credible evidence, as reflected in the findings below. In doing so, the undersigned has discounted Petitioner's contention that Respondent's expert, Dr. Henderson, is a close friend of Respondent and therefore his testimony is clearly biased. Although the two once practiced together for a few years in the 1980's, Dr. Henderson acknowledged that they "don't get along very well right now." The treatment of the patient Over a period of years, S.T. was treated by several doctors, including Respondent, who participated in the Florida Health Care Plan, Inc. network. The medical records for that treatment have been received in evidence as Joint Exhibit No. Because they are not in chronological order, contain matters relating to treatment by physicians other than Respondent, and include some partially illigible pages, the records are somewhat difficult for the reader to navigate. They do show, however, that S.T. occasionally cancelled appointments, would not always accept his doctor's advice, sometimes refused to take prescribed medications, and was perhaps not totally candid at all times with the treating physician regarding his symptoms. The records reflect that Respondent first began treating S.T. on March 29, 1989, on referral from his primary care doctor, Dr. Moussly, due to complaints of "burning in chest with exercise." S.T., then a sixty-year-old male, underwent a stress test on the treadmill which was terminated after three and one-half minutes due to fatigue and shortness of breath. The test revealed "significant ST segment depression" and was consistent with ischemia (inadequate blood flow to the heart). Respondent prescribed Lopressor (a beta- blocking agent used in the treatment of hypertension and angina) and a Nitro-patch (transdermal nitroglycerin delivery system). Dr. Williams also recommended that the patient have a cardiac catherization. Even though the records show that the patient was "reluctant to do this at this point in time," they indicate that a coronary angiogram was performed by Respondent on April 26, 1989, and that "a high-grade stenosis of approximately 90 [percent] . . . with deeply ulcerated plaque" was exhibited in the left anterior descending artery. S.T. was again referred by Dr. Moussly to Respondent on March 7, 1990, "on an urgent basis." However, S.T. cancelled his appointment and accepted another appointment on April 4, 1990. Despite the urgency of the referral, S.T. reported to Dr. Williams that he was doing well with no symptoms since his last visit one year earlier. His records reflect that his blood pressure was 136/86, his weight 258, his pulse was 60 and regular, his lungs were clear, and a cardiovascular examination was unremarkable. Dr. Williams concluded that S.T. was stable at that time with minimal chest discomfort, and he recommended that S.T. undergo a routine treadmill exercise test to further evaluate his coronary heart disease. A stress test was performed on May 11, 1990, but it was terminated after three minutes due to shortness of breath. Another stress test was conducted on July 5, 1990, the results of which were "significant for ischemia." Although a cardiac catherization was recommended, "[t]he patient again refuses at this point in time." On May 1, 1991, S.T. was again seen by Respondent (after cancelling an earlier appointment) at which time he indicated he was feeling well and was essentially asymptomatic. He specifically denied having any shortness of breath, light-headedness, dizziness, or chest pain, and he reported that he had skipped taking his prescribed Cardizem on numerous occasions without undergoing any significant change in his symptoms. On that date, his blood pressure was 150/90, his weight 259, his lungs were clear, and the cardiovascular examination revealed no murmur. Dr. Williams concluded that the patient "seems to be stable at this point in time," and allowed S.T. to discontinue Cardizem as a therapeutic trial, and if he had no further symptoms, he would continue on Lopressor only. Otherwise, he would need to start up on that medication again. Finally, Dr. Williams offered S.T. the opportunity to participate in a beta blocker angina trial for which he would be evaluated the following week. The patient apparently declined this offer. The patient did not return to Respondent's office until December 21, 1994, or more than three years later, after he was given a "[r]outine referral for a stress test" by Dr. Moussly. S.T. had seen Dr. Moussly on a "routine followup" on December 1, 1994, at which time he denied having chest pain or shortness of breath. On his visit with Respondent, S.T. underwent another treadmill test that was terminated after two minutes due to the development of ST- segment depression. S.T. also experienced tightness in his chest. The treadmill tests were positive for ischemia "at low exercise tolerance." Based on the above results, S.T. agreed to undergo cardiac catherization. On December 28, 1994, Respondent performed the cardiac catherization on S.T., which revealed that the main coronary artery was very short, but was essentially normal. The left anterior descending artery (one of the three main arteries to the heart) exhibited a proximal 90 percent stenosis (stricture of a canal or narrowing of a cardiac valve). A second 75 percent stenosis was present in the distal portion of the artery. No other significant lesions were noted. The left circumflex artery was a large and dominant system. A stenosis in the distal portion of the parent circumflex of approximately 30 percent was present with no other significant lesions noted. The right coronary artery was a nondominant artery with no significant lesions noted. Based upon the results of the cardiac catherization, Dr. Williams concluded that P.T. demonstrated mild coronary artery disease in the left circumflex artery and "rather severe disease" in the left anterior descending artery. Respondent advised S.T. that he was a candidate for angioplasty (reconstitution or recanalization of a blood vessel) of the left anterior descending artery. On January 4, 1995, Respondent performed the angioplasty of S.T.'s left anterior descending artery, which contained two lesions. The proximal lesion was reduced from approximately 95 percent stenosis to around 10 percent, and the distal lesion was likewise reduced from approximately 75 percent stenosis to around 10 percent. On February 8, 1995, S.T. made a follow-up visit to Respondent's office. According to the patient notes, S.T.'s vital signs were normal, and he stated that he was "doing very well." Respondent's plan of treatment was to have him follow- up on an as-needed basis. In addition, Respondent discussed the "signs and symptoms of recurrence of chest discomfort" and the importance of stopping smoking as well as having good dietary practice and daily exercise. On March 7, 1995, Dr. Moussly again referred S.T. to Dr. Williams for a stress test due to the patient's "having very non[-]specific chest discomfort; non[-]exertional, non[-] radiating [pain that was] apparently . . . different than the pain he had prior to his angioplasty." Dr. Moussly also noted in his records that even though the patient had elevated cholesterol, he refused to take Pravachol, which had been prescribed by Dr. Moussly on December 1, 1994. Pursuant to the referral, on March 15, 1995, S.T. made a follow-up visit to Respondent complaining of "chest discomfort." He underwent another treadmill test which was terminated after three minutes due to chest discomfort and ST- segment depression. The test was positive for ischemia, which meant that restenosis of an artery had likely occurred. Respondent recommended repeat cardiac catheterization and angioplasty. Given S.T.'s age, progression of disease, and risk factors, which included "virtually every one known to man," restenosis was not particularly surprising since Respondent's expert established that "the restenosis rate for this [type of] patient was probably in excess of 50 percent." On March 17, 1995, Respondent performed a second angioplasty of S.T.'s left anterior descending artery and reduced the stenosis from 75 percent to 10 percent in both the proximal and distal lesions. There were no complications from this procedure, which S.T. tolerated well. On April 3, 1995, S.T. visited Respondent's office for a follow-up at which time he complained of chest discomfort. At that time, S.T. was "very vague about his discomfort" in terms of how often it occurred, how long it lasted, whether there were accompanying symptoms present, and whether the Nitroglycerin provided relief. S.T. did acknowledge, however, that the discomfort was "very infrequent." The records for that visit read as follows: Mr. T. since his last visit is having some chest discomfort, although, it has been better. He has taken some sublingual Nitroglycerin on a number of occasions, but is unable to recall exactly how often. His episodes are not exertionally related, different in type and severity than prior to his angioplasty. I feel he may be having coronary spasm, although, I cannot totally rule out restenosis. In any event, his symptoms are relatively mild. I have asked him to continue as we're doing. He wil [sic] return in two more weeks for follow-up examination. I have asked him to call should he get worse and he has, otherwise, been asked to keep a diary so that we can more objectively quantify his Nitroglycerin usage. Although S.T.'s vital signs are not recorded in the above note, Dr. Williams performed a physical examination of the patient that day, and he recorded the vital signs on a separate office record entitled "Vital Sign Sheet." He also maintained a separate patient medication chart, which reflected the various medications taken by all his patients; however, due to its age, that chart has been purged in the normal course of business. A stress test was not ordered by Respondent since he considered the patient's chest discomfort to be "very mild," and the patient described the pain as "completely different" than his previous angina. Also, the pain was not exertionally related, and restenosis was unlikely "at this early date following an angioplasty." Dr. Williams concluded that more than likely the pain was a coronary spasm (a muscular contraction of the wall of the artery), which typically occurs up to 30 to 60 days after the procedure, and he would wait "to see if [the symptoms are going] to go away . . . [w]hich they frequently do after an angioplasty." Finally, Respondent noted that the cardinal indicators of ischemic heart disease (a blockage) were not present - - exertional pain, relief from Nitroglycerin, and a similarity with pain experienced before the angioplasty was performed. He accordingly advised S.T. to continue his present course of treatment and to follow-up in two weeks, or if his condition worsened, to return sooner or go to an emergency room. On Friday, April 7, 1995, S.T. went to the Halifax Hospital Emergency Room in Daytona Beach, Florida, complaining of chest pressure, accompanied by an episode of dizziness, weakness, diaphoresis, and nausea. He also advised that he had been taking several Nitroglycerines on a regular basis. Respondent was not present at the facility, and was not the on-call cardiologist on this date. S.T. was seen by Dr. David E. Stibbins, who observed that S.T. was bradycardic and had low blood pressure. Like the information given to Dr. Williams on April 3, here the patient gave vague information regarding his chest discomfort. The records suggest that Dr. Stibbins opined that the patient's discomfort was not cardiac related and was probably due to anxiety. A cardiac consultation was requested, but not conducted, and S.T. was kept in the hospital overnight for observation. Around 1:15 a.m., S.T. reported a few "twinges" in his chest to the nurse, but he told her the pain was not serious enough to wake up his doctor. After denying that he had experienced any chest pain other than the few twinges described above, on the afternoon of April 8, 1995, S.T. was discharged from the hospital in stable condition (without ever being seen by a cardiologist) and advised to follow-up with Respondent in two days (the following Monday). On Sunday, April 9, 1995, the patient suffered a cardiac event and expired. The cause of death on his certificate of death is probable sudden death as a result of coronary artery disease, but neither expert in this case could give a precise reason for S.T.'s demise. The standard of care In the aftermath of an angioplasty, a variety of things can occur causing chest discomfort in the patient. While the beneficial effects of an angioplasty "can last . . . [up] to 20 years," three to five percent of patients experience an acute closure within a matter of minutes or hours, which is the sudden and complete obstruction of the artery. Because of this risk, after a procedure is performed, patients are kept in the hospital at least over night for observation. An acute closure often occurs in patients with a 70 to 80 percent narrowing of the artery. During the first few weeks after a procedure, acute thrombosis to the vessel at the site of the injury sometimes occurs, but a patient with that condition would experience "intense discomfort that's exactly the same as the patient's pre-intervention discomfort." Without such symptoms, that diagnosis would be "down [on] the list of considerations" by the treating physician. Between six and eight weeks and four months after the procedure, up to a third of balloon angioplasty patients experience a subacute closure (or restenosis) of the artery. Typically, these patients return to the physician's office with clinical symptoms of angina chest pain (similar to that experienced before the procedure) and require a repeat procedure. If restenosis has occurred, the patient is at risk for additional cardiac complications, such as myocardial infarction (heart attack). In some cases, within 30 to 60 days after a procedure, a patient will experience a "different type of sensation" in the chest due to the mechanical stretching of the vessel wall during the procedure. Other patients experience an artery spasm (cramping of the vessel wall), which occurs when the muscle cells go into spasm and constrict the artery. In both of these situations, the discomfort is dissimilar to that experienced before the procedure. Given the foregoing, if a patient presents himself to the doctor within a matter of weeks after an angioplasty with vague, non-ischemic related chest discomfort, it is not a deviation from the standard of care for the physician to choose a course of treatment consisting of "medical management" of the patient, that is, the close monitoring of the patient in the following days and weeks, and treating the patient with beta blockers, nitrates, and aspirin to ameliorate his symptoms. Conversely, if a patient presents himself to the physician with chest discomfort which is ischemic in nature, the ordering of further tests, including an exercise EKG, would be appropriate, with possible referral to a hospital for another cardiac catherization. Other considerations in determining the appropriate course of treatment of a patient include the cardiologist's familiarity with the patient's prior symptoms and history and the symptoms presented at the current time. In addition, the physician must rely upon his experience, knowledge, and education in the field. Taking into account all of these circumstances and considerations, the more convincing evidence establishes that Respondent did not deviate from the standard of care. c. The adequacy of the patient's records The Board has also alleged that Respondent failed to keep adequate medical records on the April 3, 1995, office visit in that he failed to document a physical examination or the results of any ancillary tests, and that the records as a whole fail to justify the course of treatment of the patient. The criticisms of Dr. Williams are based upon the testimony of the Board's expert, Dr. Dormois, who presented deposition testimony in this matter. In his deposition, however, Dr. Dormois withdrew his earlier criticisms of the records, and he indicated that the records provided by Dr. Williams "are generally adequate." He also concluded that this case "is not an issue of a medical record deficiency," but rather is "a deficiency of [a] failure to make clinical decisions." When these admissions are coupled with the testimony of Dr. Henderson, who concluded that the records were adequate, it is found that the Respondent kept written medical records justifying the course of treatment of the patient.
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. DONE AND ENTERED this 30th day of August, 2001, in Tallahassee, Leon County, Florida. ___________________________________ DONALD R. ALEXANDER 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 30th day of August, 2001. COPIES FURNISHED: Kim M. Kluck, Esquire Agency for Health Care Administration Post Office Box 4229 Tallahassee, Florida 32317-4229 Michael R. D'Lugo, Esquire Wicker, Smith, Tutan, O'Hara, McCoy, Graham & Ford, P.A. Bank of America Center, Suite 1000 390 North Orange Avenue Orlando, Florida 32802-1646 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701
