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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs LARRY DEE THOMAS, M.D., 01-004406PL (2001)
Division of Administrative Hearings, Florida Filed:Winter Haven, Florida Nov. 14, 2001 Number: 01-004406PL Latest Update: Dec. 13, 2002

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

Florida Laws (5) 120.569120.5720.42455.225458.331
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs HARRY M. ROSENBLUM, M.D., 09-004639PL (2009)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Aug. 24, 2009 Number: 09-004639PL Latest Update: Oct. 06, 2024
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BOARD OF MEDICINE vs PATRICIA DEE G. STEPHENSON, 95-001560 (1995)
Division of Administrative Hearings, Florida Filed:Sarasota, Florida Mar. 30, 1995 Number: 95-001560 Latest Update: May 01, 1996

The Issue Should Respondent Patricia Dee G. Stehpenson's license to practice medicine in the State of Florida be revoked, suspended or otherwise disciplined based on the allegations contained in the Administrative Complaint filed herein?

Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant findings of fact are made: At all times material to this proceeding, the Respondent was a licensed physician in the State of Florida, having been issued license number ME 0051453. The patient, a 73 year old female, presented to Respondent on July 11, 1991, with complaints of flashes of light over the past ten years which had increased over the past two years. The patient also complained of seeing halos around street lights at night. During this visit, Respondent diagnosed the patient as having 20/30 corrected vision in her right eye and 20/40 plus 2 corrected vision in her left eye, and that the patient had cataracts. However, Respondent did not recommend cataract surgery at this time. In January, 1992, the patient took the State of Florida driver's license test, including the eye test, and received her driver's license. However, the examiner notice that the patient was having trouble with the eye test and, although the examiner gave the patient her driver's license, the examiner suggested that the patient see an opthalmologist. At the time the patient received her driver's license in January, 1992, the patient was enjoying golf, bowling and driving. Although the patient did not immediately follow the driver's license examiner's advice concerning her eyes, the patient did visit with Respondent on May 8, 1992. At this visit, the patient advised the Respondent that the flashes and floaters had improved but that her vision was interfering with her golfing and driving. Again, Respondent did not recommend removal of the cataract. The patient's vision continued to interfere with her golfing and driving, notwithstanding the patient's testimony to the contrary which I do not find to be credible. The patient's next visit with Respondent was on October 16, 1992. At this visit, the patient advised Respondent that her vision had "lessened a lot" in the left eye. Visual acuity testing indicated corrected vision of 20/30 in the right eye and 20/40 plus 2 in the left eye. However, while the level of vision at which the patient was able to perceive letters (20/40 plus 2) did not change, the refraction (stronger glasses) required to achieve that level indicated more myopia, indicating that the cataract had progressed which supports the patient's complaint that her vision had "lessened a lot". Also at the October 16, 1992, visit, Respondent tested the patient's vision using brightness acuity testing (glare test) and measured the patient's vision as 20/70, with glare in the left eye. The glare test is a method whereby the doctor shines a light in the person's eye to determine the effect of glare on the person's vision. Although some ophthalmologists consider the glare test of no value, other ophthalmologists consider the glare test as another tool to assist the surgeon in making a decision concerning the necessity for cataract surgery. During the October 16, 1992, office visit, Respondent discussed with the patient: (a) the effect the cataract was having on the patient's activities (life-style); (b) the patient's complaint that her vision had lessened; (c) the results of the glare test showing the patient's vision as 20/70 with glare and; (d) other visual acuity testing; and (e)advised the patient that cataract surgery was indicated. Also, Respondent explained the cataract surgery procedures and discussed with the patient the risks and the benefits of the surgery. The patient had no reservations or objections to the surgery and consented to the surgery in hopes of improving her eyesight as well as her life- style. For a person with cataracts, a corrected vision of 20/40 or worse is the vision level where some cataract surgeons will recommend cataract surgery, while other cataract surgeons consider a corrected vision of 20/50 or worse, with or without glare, as the vision level where cataract surgery should be recommended. However, because the vision as determined by visual acuity testing (the ability of the person to perceive letters) does not always accurately reflect the person's quality of vision (the quality of perception on a day to day basis), neither vision level referred to above when considered alone can be used as a hard and fast rule to form a basis for cataract surgery. Since the quality of vision can only be described by the person with the cataract(s), the cataract surgeon must also determine, after consultation with the person, that the cataract(s) are interfering with the person's life-style. Therefore, a person with corrected vision of somewhat better than 20/40 or 20/70 with or without glare, may be a candidate for cataract surgery, provided the cataract is causing a reduction in the person's quality of vision beyond what is indicated by visual acuity testing and thereby interfering with the person's life-style. Furthermore, there are no written standards or guidelines which set a particular vision level for the cataract surgeon to follow when making a decision to recommend cataract surgery. The surgeon must take into consideration all factors and make a decision based on the surgeon's judgment as to what is best for that person. The patient's vision level and the interference the patient was experiencing with her life-style because of the cataracts in her left eye justified Respondent's decision to recommend and perform the cataract surgery on the patient, notwithstanding any of the testimony of Dr. Leslie Monroe to the contrary. On November 3, 1992, Respondent performed phacoemulsification (removal of cataract) with posterior chamber intracular lens implant (implantation of lens) on the patient's left eye. While the patient was in the holding area being prepared for surgery there were complications with the anesthesia. The anesthesiologist, Robert Dienes, M. D., first gave the patient a retrobulbar block which was repeated apparently due to Dr. Dienes' conclusion that the first retrobulbar block was ineffective. Apparently, Dr. Dienes also concluded that the second retrobulbar block was ineffective and gave the patient a superior lid peribulbar block. After giving the peribulbar block, Dr. Dienes noticed a dissecting subconjunctival hemorrhage and notified Respondent. Upon examining the patient's eye, Respondent found the globe (whole eye) to be soft with no active bleeding, indicating the eye was not full of blood and that there was no retina tear or rupture of the globe. Respondent also noticed that "the conjunctiva was real chemotic or it had blood behind it". Respondent also measured the patient's eye pressure with a Schiotz tonameter because there was no slit-lamp in the holding area. The patient's eye pressure was 5, with a 5.5 gram weight, which was normal. The patient's medical records do not reflect an indirect ophthalmoscopy being performed by Respondent on the patient's left eye between Respondent being advised of the dissecting subjunctival hemorrhage by Dr. Diemes and the Respondent performing surgery on the patient's left eye to remove the cataract and implant the lens. Furthermore, Respondent has no independent recollection of performing an indirect ophthalmoscopy during the above period of time before surgery. Respondent's normal practice under conditions and circumstances similar to those in this case has been to perform an indirect ophthalmoscopy during the above period of time before surgery. Therefore, it is assumed that Respondent performed an indirect ophthalmoscopy on the patient after being advised of the subconjunctival hemorrhage but before surgery, notwithstanding the fact that patient's medical records do not reflect such procedure being performed or the fact that Respondent has no independent recollection of performing such procedure during the above period of time. However, assuming arguendo that Respondent did not perform the indirect ophthalmoscopy before surgery, the Agency has failed to establish facts to show that under the conditions and circumstances of this case that such failure amounted to the failure of Respondent 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. After considering the conditions and circumstances surrounding the complication that arose while the patient was being anesthetized, Respondent made a decision that it was in the best interest of the patient to go forward with the removal of the cataract and implantation of the lens. The operation was completed without any further incident and there was a successful removal of the cataract and lens transplant. Respondent's decision to go forward with the surgery had no adverse effect on the subsequent treatment of the complication that arose while the patient was being anesthetized. In fact, the result of the treatment subsequent to the cataract surgery would have been the same even if Respondent had not gone forward with the surgery. Respondent, using a ophthalmoscope, was able to see the inside of the eye more clearly and assess the complication that arose while the patient was being anesthetized. While performing this indirect ophthalmoscopy, Respondent noted undulation of the vitreous with pigmented blood cells present and that the anesthesia needle had penetrated the globe. The patient was seen the next morning, November 3, 1992, by Respondent. After assessing the condition of the patient's left eye, Respondent referred the patient to Keye Wong, M. D., a retina specialist. Upon examining the patient's left eye on November 4, 1992, Dr. Wong noted vitreous hemorrhaging and retinal detachment. Dr. Wong performed an operation on the patient's left eye in an attempt to correct the damage and attach the retina. The patient's vision is not as good as it was before the operation, and still effects the patient's life-style. The patient has difficulty tolerating sunlight, which may or may not be a result of the complication experienced while the patient was being anesthetize. Respondent's action of going forward with the surgery after becoming aware of the complication that arose while the patient was being anesthetized did not cause, complicate, aggravate or result in any of the problems the patient has suffered postoperatively. Respondent did not fail to recognize, identify or treat properly the complications that arose before, during or after the surgery. The Agency has failed to establish facts to show 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 at anytime while Respondent was treating the patient, including both preoperative and postoperative treatment.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Petitioner Agency for Health Care Administration enter a final order dismissing the Administrative Complaint filed herein against Respondent Patricia Dee G. Stephenson, M. D. DONE and ENTERED this 23rd day of January, 1996, at Tallahassee, Florida. WILLIAM R. CAVE, 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 23rd day of January, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-1560 The following constitutes my specific rulings, pursuant to Section 120.59(2), Florida Statutes, on all of the proposed findings of fact submitted by the Petitioner and the Department in this case. Agency's Proposed Findings of Fact. Proposed findings of fact 1-2 are adopted in substance as modified in Findings of Fact 1 and 2. The first sentence of proposed finding of fact 3 is adopted in Finding of Fact 3. The second and third sentence are not supported by evidence in the record. Proposed finding of fact 4 is adopted in substance as modified in Finding of Fact 5, otherwise not supported by evidence in the record. Proposed finding of fact 5 is adopted in substance as modified in Finding of Fact 7, otherwise not supported by evidence in the record. Proposed finding of fact 6 is adopted in substance as modified in Findings of Fact 12, 13, and 14, otherwise not supported by evidence in the record. Proposed findings of fact 7 and 8 are adopted in substance as modified in Findings of Fact 21 and 22, otherwise not supported by evidence in the record. Proposed finding of fact 9 is a restatement of Dr. Monroe's testimony and is not a finding of fact. However, see Findings of Fact 16 and 17. 8, Proposed findings of fact 10, 16, 17 and 19 are adopted in substance as modified in Findings of Fact 15, 16, 10, 8 and 9. Proposed finding of fact 11 is adopted in substance as modified in Finding of Fact 16, otherwise not supported by evidence in the record. Although proposed findings of fact 12, 13 and 15 are findings of fact, they are neither material nor relevant to this proceeding. See Finding of Fact 9. Proposed finding of fact 14 is a restatement of Dr. Grabow's testimony and is not stated as a finding of fact, but see Finding of Fact 10. Dr. Grabow's testimony was 20/50 vision with or without glare which is different than just 20/50 vision. 11. Proposed findings of Fact 18 and 20 are not supported by evidence in the record. Respondent's Proposed Findings of Fact. 1. Proposed findings of fact 1 through 27 are adopted in substance as modified in Findings of Fact 1 through 25. COPIES FURNISHED: Marm Harris, M. D., Executive Director Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0770 Jerome W. Hoffman, Esquire Agency for Health Care Administration Fort Knox Building Number Three 2727 Mahan Drive Tallahassee, Florida 32308 Steve Rothenburg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 William E. Partridge, Esquire Lutz, Webb, Partridge, BoBo, and Baitty One Sarasota Tower 2 North Tamiami Trail, Suite 500 Sarasota, Florida 34236

Florida Laws (2) 120.57458.331
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BOARD OF MEDICINE vs WILLIAM O. DEWEESE, 98-004462 (1998)
Division of Administrative Hearings, Florida Filed:Tampa, Florida Oct. 08, 1998 Number: 98-004462 Latest Update: Jan. 05, 2000

The Issue The issue in this case is whether the Respondent should be disciplined for allegedly practicing medicine below the generally accepted standard of care when he performed a laminectomy and discectomy at the incorrect level of a patient's lumbar spine.

Findings Of Fact Respondent, William O. DeWeese, is a Florida licensed physician, having been issued license number ME 0025687. Respondent is Board-certified in Neurological Surgery and is a Fellow of the American College of Surgeons. He has practiced medicine since graduating from medical school in 1968. He received his Florida license in 1975 and established his practice in Tampa where he has continuously practiced medicine ever since. In twenty-four years of practice, the Florida Board of Medicine has never disciplined Respondent. Respondent's Standard Practice Respondent conducts his practice primarily through two local hospitals, St. Joseph’s Hospital and University Community Hospital. He has a typical practice common to neurological surgery. On average, Respondent performs three to four laminectomy-discectomy procedures each week. Before performing surgery on the spine, Respondent’s protocol is to review available medical records and films (CT, MRI, X-ray), obtain an EKG, obtain chest X-rays, and blood work. During surgery, he routinely obtains "real time" radiological confirmation of the level of the spine where he intends to operate based on his initial pre-surgical work-up. Respondent does this by marking the level where surgery is to take place with radio-opaque material (usually a cottonoid sponge), and has an X-ray film of the patient's spine and the marker exposed and developed in the operatory (OR). Respondent reviews the X-ray in the OR before having the X-ray technician take it to the radiology department for review by a radiologist. The radiologist on duty reviews the X-ray and usually writes on the X-ray to label the location of the marker and has the technician bring the labeled X-ray back to the OR; he then calls the OR, usually on a speaker telephone, to inform the surgeon as to the radiologist's interpretation of the film. Any question as to the level of surgery is resolved at that time. If Respondent is not at the intended level of the spine, he makes the appropriate adjustment in the surgical procedure and completes the surgery at the correct level. The First Surgery S.D. first presented to Respondent in November 1989 with complaints and symptoms of intractable back and left leg pain. She had been seen previously by other physicians but had not experienced any relief. At the time she presented to Respondent, S.D. was 5 feet 5 inches tall and obese (at 175 pounds). Unbeknownst to Respondent at the time, the patient also had an anatomical anomaly of six lumbar vertebrae instead of the more common five. As a result of the patient's anatomical anomaly, physicians could easily be misled, fooled, or misunderstood in reporting the level of spine being evaluated or treated. Depending upon awareness of the patient's specific anomaly and terminology used, the same location on the spine could be referred to as L4-L5, as L5-S1, or as L5-L6. Usually, neurosurgeons can predict the location of nerve root pathology fairly accurately based solely on a patient's complaints, objective examination, and symptoms. Specific nerves innervate specific areas of the body, and a deficit in one area of the body can reasonably lead a physician to suspect nerve root pathology at a particular level of the spine. Because Respondent was unable to determine from initial review of the patient's prior MRI that she had a sixth vertebra, he expected to find nerve root pathology at the L5-S1 level of the spine based on S.D.'s complaints, objective examination, and symptoms. But on X-ray and re-review of the MRI with benefit of the radiologist’s report, Respondent noted the sixth vertebra. Following a complete examination of S.D., including review of a recent CT scan, her prior MRI study, and X-ray films, Respondent believed that S.D. had a "large disc protrusion" at the L5-L6 level of the spine and a "small disc bulge" at the L4- L5 level. The patient's extra lumbar vertebra helped explain the location of the patient's nerve root pathology in relation to her complaints, objective examination, and symptoms. Respondent recommended that S.D. undergo lumbar surgery to explore the disc spaces, remove extruded disc material, and free any entrapped nerves. He expected to have to remove disc material only at the L5-L6 level. His pre-operative diagnosis was: degenerative lumbar disc with lateral angle stenosis (narrowing) at L5-L6; and possible disc protrusion at the L4-L5 level on the left. Respondent performed surgery on S.D. on December 4, 1989. The operation consisted of: a left laminectomy, exploration and inspection of the L4-L5 disc; and a laminotomy, foraminotomy, and partial discectomy at L5-L6. To accomplish the surgery, Respondent dissected away the soft tissues above L4, L5, L6, and S1. He then followed his protocol by placing radio-opaque cotton underneath the ligament at the level he believed was L4-L5 for radiological confirmation. After "real time" radiological confirmation that he was at L4-L5, Respondent removed enough lamina at L4-L5 to inspect the disc and nerve root. He did not observe any entrapment of the nerve and did nothing further at L4-L5. He next proceeded to L5- L6, where he repeated the same procedure but noted entrapment at the posterior aspect of the nerve root. The majority of the pressure on the nerve came from the neural foramen, and this was removed with osteotomy. Some disc material also was removed to free the nerve root. While inspecting the disc space at L5-L6, Respondent observed that the disc space was so narrow that a spinal needle was the thickest instrument that the disc space would receive; a straight pituitary curet could not be placed into the disc space. Respondent recorded these observations in his surgical notes. Similarly, the radiologist's report noted "considerable narrowing of the interspace at the L5-L6 level." Respondent completed the operation by performing a foraminotomy (removal of bone surrounding the point of exit of the nerve from the vertebras of the spinal column). The operation in December 1989 was uneventful; S.D. did well post-operatively and was discharged from the hospital after a normal stay. The Second Surgery S.D. returned to Respondent in March 1993 because of recurrent severe back pain and left leg pain. Following appropriate diagnostic tests and examination of S.D., which revealed what was thought to be a herniated disc on the left side at L5-L6, Respondent planned to "re-do" a laminectomy and discectomy at L5-L6. By the time of the patient's second surgery on May 10, 1993, she had gained about 40 pounds (up to 215 pounds.) The planned surgery was made more difficult by S.D.'s weight gain, as well as by her previous surgery. Additional fatty tissue decreased the operative field of view, as well as the quality of the intra- operative X-ray. S.D.'s anatomical landmarks had been altered as a result of the December 1989 surgery, and there was considerable scaring in the area to be explored during surgery, which obscured the remaining landmarks. Without the presence of normal landmarks and with heavy scaring and weight gain, Respondent had fewer tools to locate the correct level, making the second surgery more difficult. One landmark still available to Respondent to aid in the second surgery was the very narrow interspace at the L5-L6 level. However, Respondent did not the read surgical notes from the first surgery carefully enough to recall the landmark; or, if he read them and recalled the landmark, he attached little significance to the notes and landmark, as compared with other factors influencing his decisions during surgery. One of the reasons Respondent and his expert gave for not attaching more significance to the December 1989 findings as to the remarkably narrow L5-L6 interspace was that a patient's position on the Wilson laminectomy holder and the operation of the holder can alter the apparent width of lumbar interspaces. The holder is a special, adjustable operating table that can be made to "bridge up" in a continuous arc to force the patient (lying on the stomach) to stretch over the "bridge" and make the vertebral interspaces widen for easier access during surgery. While theoretically position on and operation of the holder can affect the width of the interspaces, in practice the surgeon always positions the patient and operates the holder so as to maximize the interspaces. One would not expect the positioning and operation of the holder in two operations at the same level of the lumbar spine to significantly widen an interspace as narrow as the one described in the December 1989 surgical notes. But it might reduce the relative importance of the landmark, compared to other information available to the surgeon, such as radiological confirmation and visual examination of the site. Through answers to his attorney's questions on direct, Respondent also initially attempted to take the position that the patient's weight gain between the two surgeries was enough to warrant ignoring the December 1989 surgical note as to the narrow L5-L6 interspace. But the Department's expert opined that the added weight would not make a significant difference, and on cross- examination Respondent admitted that he actually did not have the patient's weight gain in mind as a reason to gloss over the December 1989 surgical note as to the narrow L5-L6 interspace. Indeed, consistent with Respondent's admission on cross- examination, both Respondent and his expert, Dr. Maniscalco, opined that, if anything, the added weight probably would tend to reduce the maximum flexion obtainable through use of the Wilson laminectomy holder and make the interspaces at the surgical site appear narrower, not wider. Nonetheless, depending on its distribution on the patient, weight gain could possibly alter the apparent width of the interspace during surgery on a Wilson laminectomy holder, and this could also reduce the relative importance of the landmark, compared to other information available to the surgeon, such as radiological confirmation and visual examination of the site. While conceding that he really did not pay much attention to the December 1989 findings as to the remarkable narrowing of the L5-L6 interspace, Respondent also attempted to take the position in testimony that the L4-L5 interspace was fairly narrow itself, as compared for example to the L3-4 interspace. But the L5-L6 interspace clearly was much narrower than L4-L5 and could have been used as a landmark. See Findings 25 and 29, infra. Nonetheless, as previously mentioned, the relatively narrow interspace at L-5-L6 was just one factor to be considered, along with radiological confirmation and visual examination. As Respondent wrote in his notes on May 10, 1993, he thought: "The previous laminectomy site was easily identified and confirmed with a lateral X-ray." The Department's expert took the use of the singular "previous laminectomy site" as evidence that Respondent was unaware of the previous laminectomy at L4-L5. But Respondent testified convincingly that he had reviewed the patient's medical records and was fully aware of both previous laminectomies--at both L5-L6 and L4-L5. (Respondent also testified that his use of the singular, "previous laminectomy site" was intended to mean the general site of both previous laminectomies. But it was the L5-L6 laminectomy site that he thought was "confirmed with a lateral X-ray," so it seems that the language used probably actually referred to the site of the intended surgery. In that respect, the wording of Respondent's surgical notes was ambiguous, if not erroneous.) As usual, an X-ray technician took the lateral X-ray, developed the film, and showed it to Respondent in the OR. Respondent testified that he then had the X-ray technician take the film to the radiology department, along with the pre-operative MRI, and that a radiologist on duty confirmed for him that he was at the "correct level" before he proceeded with the surgery. When Respondent proceeded with the surgery, he widened the laminectomy site and found a disc fragment (which he presumed to be recurrent) underneath and entrapping the nerve root. The nerve root was retracted medially, and the disc space was entered. A large fragment of disc was found in the subligamentous position. Respondent removed the large fragment; then more disc material was removed from the interspace, freeing the nerve. Respondent then performed a foraminotomy and completed the surgery. The pathology found during the second surgery was not inconsistent with the general kind of pathology Respondent expected to find at the L5-L6 level. Relying on visual examination and radiological confirmation, Respondent believed that he was operating at L5-L6. He did not notice, or attached no significance to, the ease of access to the disc space in May 1993, as compared to the narrow interspace encountered at L5-L6 in the first surgery. The Third Surgery After normal recuperation in the hospital, the patient noticed apparent improvement and began regular walking. However, approximately six to eight weeks after surgery, back and leg pain recurred, and the patient returned to Respondent for consultation. Respondent ordered another MRI and scheduled the patient for an appointment in August 1993. When Respondent reviewed the post- operative MRI with the patient, he realized that he had operated at L4-L5 instead of L5-L6. He asked the patient to go to the hospital and get the intra-operative X-ray to help him understand what had happened. It was his belief that the X-ray would show that he had radiological confirmation. With the patient's help, Respondent obtained the X-ray the same day. See Finding 35, infra. Instead of showing radiological confirmation, the X-ray's labeling showed someone's interpretation that the radio-opaque marker on the X-ray was at L4- L5. (There was no evidence as to who labeled the interpretation. Id.) When Respondent saw the writing on the X-ray, he immediately conceded that he had operated at the wrong level and began the process of scheduling a third surgery (the second at L5-L6). Respondent performed the patient's third surgery free-of- charge on September 17, 1993. He had three X-rays taken during the third surgery. The first one apparently was taken before any incision was made. The second was made to confirm that the Respondent was at L5-L6 this time. Instead, the X-ray showed that he was at L6-S1. Respondent tried again, and a third X-ray confirmed L5-L6. Respondent continued with the operation as planned. Findings during the third surgery supported the reasonableness of using the narrow L5-L6 interspace as a landmark during the second surgery. Once again, Respondent found cause to note significant narrowing at L5-L6, stating: "A needle was placed exactly in the interspace, which was small and tight." (The patient weighed 217 pounds at the time of the third surgery--two pounds more than for the second surgery.) The third surgery was otherwise uneventful and apparently successful. The patient discharged after a short stay. The Questionable X-ray Confirmation Although it appears in hindsight that Respondent should have attached more significance to the notes from the first surgery as to the remarkably narrow disc space at L5-L6, even the Department's expert conceded that Respondent should not be found to have practiced below the generally accepted standard of care if he received "real time" radiological confirmation before proceeding with the second surgery. (The Department's expert assumed from the medical records that there was no radiological confirmation. See Finding 33, infra.) Excepting the possibility of an obvious and clear error by the radiologist, the generally accepted standard of care entitles a surgeon to rely on a radiologist's "real time" reading of an intra-operative X-ray. The radiologist's specialty is interpreting X-rays, and the viewing equipment and lighting in the radiology department is far superior to what is available to the surgeon in OR. The question becomes the truth of Respondent's claim of having had "real time" radiological confirmation in the context of the other evidence presented in the case. The radiologist normally would have conveyed the "real time" confirmation of the correct level to the surgeon over a speaker telephone in the OR. But no one else present at the time of the surgery testified. (The patient testified by deposition, but she was under general anesthesia during surgery and could not testify as to radiological confirmation.) Respondent could not remember the name of the radiologist he says confirmed the correct level, and he was unable to show through any other means who confirmed the correct level for Respondent. Meanwhile, the Department did not present any direct evidence to dispute Respondent's claim of "real time" radiological confirmation in the OR. But there was circumstantial evidence that raised questions as to the veracity of the claim. In a hospital radiology report on the intra-operative X- ray, a radiologist named Robert G. Isbell, M.D., stated: "Film was not available for interpretation in the radiology department. The film will be read upon its return." This report was dated May 17, 1993; it was not clear from the evidence whether the report was dictated on that date, released on that date, or both. This could indicate that the X-ray was not taken to the radiology department during the surgery on May 10, 1993, since standard procedure would be for the radiologist to dictate the report immediately after calling down to the OR to confirm the correct level for the surgeon. (The Department's expert assumed from this report that there was no radiological confirmation.) However, it also is possible that an unknown radiologist confirmed the correct level for Respondent and then failed to follow the normal procedure, and either he forgot to dictate the report, or the dictation got lost or for some other reason did not result in a transcribed report to go in the patient's file "jacket" in the radiology department. If there was radiological confirmation in the OR, the radiologist apparently did not label the film and have it sent back to the OR, as usual, because the X-ray apparently was not labeled until later. See Findings 35-36, infra. When the patient went to St. Joseph’s Hospital in August 1993 at the Respondent's request to ask for her X-ray, she was told that a doctor had just asked for it to be sent over to the hospital (apparently from where it ordinarily would have been kept.) S.D. was surprised and somewhat suspicious that the hospital was familiar with her X-ray by name and that it coincidentally had just been requested by a doctor. There was no evidence as to the identity of the doctor who requested the X-ray. S.D. insisted on receiving her X-ray immediately and waited until it was returned to her. When she got it, there appeared to be fresh "grease pen" writing on it. As previously mentioned, the grease pen writing labeled the X-ray and clearly indicated someone's interpretation that the radio-opaque marker on the X-ray was at L4-L5. Respondent has maintained that he had never seen the grease pen writing before the X-ray was brought to him by the patient in August 1993. This is consistent with the patient's testimony that the grease pen writing appeared to her to be fresh, and it seems clear from the evidence that the writing was placed on the X-ray shortly before S.D. retrieved it, contrary to normal procedures. This evidence also makes it possible that the X-ray never was sent to the radiology department during surgery, again contrary to normal procedures. It is not clear from the evidence where the X-ray had been between the time of the May 1993 surgery and the time S.D. picked it up with the fresh grease pen writing. There was no evidence as to who put the markings on the X-ray, or at whose request. There was no evidence of any hospital radiology report recording the mysterious August 1993 "reading" of the X-ray as reflected by the new grease pen writing. It also is not clear from the evidence exactly what was written on the X-ray in August 1993 when S.D. retrieved the film from the hospital, or what that particular X-ray looked like. While S.D. retained the X-ray until some time during her subsequent civil action against Respondent and the hospital, she then gave it to the hospital's risk manager, who was supposed to make her a copy. When S.D. went to retrieve the X-ray for her deposition in this administrative proceeding, she found several X-rays apparently given to her by her lawyer after disposition of the civil action, including one labeled "original" and bearing writing in addition to, or other than, the writing S.D. recalled from August 1993. The writing on the X-ray used in this administrative proceeding may have been placed on the "original" X- ray by experts in the civil action. The other X-rays in S.D.'s possession were not produced for use in this administrative proceeding, and it is not clear which, if any of them, is the X-ray labeled as when S.D. retrieved it in August 1993. The X-ray used in this administrative was of poor quality and actually did not show what was below the marked interspace. (As the Respondent described the lower part of the film, "It looks like a snowstorm.") As a result, it actually would not have been possible to confirm the correct level using that particular X-ray. But X-rays can deteriorate over time, and there is no way of knowing if the intra-operative X-ray as it existed on May 10, 1993, or when seen again by Respondent in August 1993, also was of such poor quality as to be virtually useless. If an unknown radiologist in fact called the OR to confirm the correct level for Respondent, it also is possible that there was a miscommunication. Respondent in his testimony made a point of explaining that he only used the terminology "correct level" in talking to the radiologist "to avoid confusion." But if Respondent just asked if he was at the "correct" level, and the radiologist just said, "yes, you're at the correct level," the radiologist actually either would be simply assuming that the level marked on the X-ray was the "correct" level, or he would be saying that pathology visible on the MRI matched the marked location on the X-ray. If the latter, the radiologist may have thought there was enough pathology showing on the MRI matching the marked interspace in this case (actually L4-L5) to justify surgery there. Taking all of this evidence into consideration, it cannot be found that the Department proved by clear and convincing evidence that Respondent did not receive "real time" radiological confirmation on which he was entitled to rely in proceeding with the second surgery. Without such proof, it cannot be found that Respondent practiced below the generally accepted standard of care, notwithstanding the little attention he paid to his December 1993 surgical notes as to the remarkably narrow interspace at L5-L6.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint in this case. DONE AND ENTERED this 27th day of September, 1999, in Tallahassee, Leon County, Florida. J. LAWRENCE JOHNSTON 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 27th day of September, 1999. COPIES FURNISHED: Britt Thomas, Esquire Agency for Health Care Administration 1580 Waldo Palmer Lane Tallahassee, Florida 32308 Jon M. Pellett, Esquire Grover C. Freeman, Esquire Freeman, Hunter & Malloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602 Pete Peterson, General Counsel Department of Health 2020 Capital Circle, Southeast, Bin A02 Tallahassee, Florida 32399-1703 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast, Bin A02 Tallahassee, Florida 32399-1703 Tayna Williams, Executive Director Board of Medicine Department of Health Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750

Florida Laws (2) 455.2273458.331
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BOARD OF MEDICINE vs JONATHAN M. FRANTZ, 96-004750 (1996)
Division of Administrative Hearings, Florida Filed:Fort Myers Beach, Florida Oct. 09, 1996 Number: 96-004750 Latest Update: Sep. 25, 1997

The Issue The issue is whether Respondent failed to practice medicine with the required standard of care, in violation of Section 458.331(1)(t), Florida Statutes, and failed to keep required written medical records, in violation of Section 458.331(1)(m), Florida Statutes. If so, an additional issue is what penalty should be imposed.

Findings Of Fact At all material times, Respondent has been a licensed physician in Florida, having been issued license number ME 0022608. Respondent is board-certified in ophthalmology. He was the principal investigator in the Excimer Laser Research Study. He is a fellow with the American College of Surgeons. He has published extensively in prominent medical and ophthalmologic journals. While still receiving medical training, Respondent gained experience in treating the ophthalmologic conditions of patients who suffer from Down Syndrome. While in practice, Respondent has continued to gain considerable experience in treating the ophthalmologic conditions of patients with Down Syndrome. Respondent has never previously been disciplined. U. V. was born on January 6, 1973. He suffered from Down Syndrome. As a young child, U. V. was diagnosed with inoperable congestive heart failure. Suffering from damage to two chambers of his heart and irreversible lung damage, U. V. had been in “terminal” condition since about the age of seven. Despite his serious medical problems, which are common to Down Syndrome patients, U. V. was a happy young man, who developed and matured as a teenager. He communicated his feelings and interacted with others, especially with his family. His mother adopted him when he was about five years old; previously, she had cared for him after his biological family had abandoned him. In March 1992, U. V. became quite ill. His physician discussed with U. V.’s mother the possibility of a Do Not Resuscitate order, but no order was ever given or entered into his medical records. U. V. rallied from his illness. His cardiologist found, after an office visit on October 13, 1992, that U. V. had made “tremendous progress” and was “doing quite well at this point in time.” This was the last time that U. V. visited his personal physician prior to the cataract surgery nearly a year later. In April of 1993, U. V. received home health care through the Hospices of Palm Beach. During this time, the hospice nurse who visited U. V. at home noted that he was sensitive about his Down Syndrome and social isolation. On July 14, 1993, the hospice nurse noted that she found U. V. to be “alert, ambulatory, cheerful.” U. V.’s mother told the nurse that U. V. wanted an eye surgeon to treat a cataract that had developed in his left eye, and the family would be willing to pay for the operation in installments, if health coverage would not pay for the surgery. Ten days later, during another home visit by the hospice nurse, U. V.’s mother again stated her concern about his cataract. The nurse told her to take U. V. to his primary care physician for a referral. U. V.’s family took U. V. to his family physician, who sent him to an optometrist. The optometrist determined that U. V. had a cataract in his left eye and was starting to develop one in his right eye too. The optometrist told them that surgery could correct the condition and referred U. V. to Respondent. About a month later, in late August, U. V.’s mother informed the hospice nurse that they had an appointment with an eye surgeon and hoped that he would remove the cataract from U. V.’s left eye. At this time, U. V. was still leading an active life, largely due to the support and assistance of his loving family. He was happy and enjoyed dancing at weddings and parties and watching television. The family thought that surgery would help him see better with his left eye. Respondent first examined U. V. on August 31, 1993. He found a hypermature cataract in U. V.’s left eye. U. V.’s eye was totally opacified by the cataract to such an extent that he could see only hand motion. Respondent was immediately concerned with the possibility of phacolytic glaucoma. This is a condition in which the cataract liquifies and may leak through the lens capsule, resulting in an immunological reaction. Phacolytic glaucoma is extremely painful. It is impossible to predict the precise onset of phacolytic glaucoma, but Respondent reasonably determined that the condition could develop in as little time as hours or days, although it was possibly months away. Respondent was also concerned with U. V.’s right eye. Respondent found a cataract in the right eye in the lens where all the light rays pass into the eye. This type of cataract advances rapidly, so much so that it might overtake in seriousness the older cataract in U. V.’s left eye. Respondent performed a comprehensive examination of both eyes. He discussed cataract surgery with U. V.’s mother. Respondent agreed to perform the surgery for the Medicaid payment. He carefully explained the condition of U. V.’s left eye and the risks and benefits of surgery and general anesthesia. To assist in communicating with U. V.’s Spanish-speaking mother, Respondent had someone in the office translate for the mother. After hearing the explanation, U. V.’s mother agreed to the surgery, and Respondent set up the surgery for September 7, 1993. After returning home, U. V. began complaining of problems with his right eye. His sight was deteriorating at this time, heightening his feeling of isolation from the world around him. In the meantime, Respondent had the laboratory work done in preparation for the surgery. His office contacted U. V.’s physicians to get medical information in preparation for the cataract surgery. But they were unable to get such information from the physicians’ offices. On September 7, U. V. and his family returned to Ft. Myers for the surgery. The board-certified anesthesiologist examined U. V. and found that he had wheezing respiration, so the anesthesiologist told Respondent that the surgery had to be postponed. Respondent rescheduled the surgery for September 15, 1993. Respondent and the anesthesiologist then discussed the possibility of using a local anesthetic, which would present fewer risks to U. V. than would be posed by a general anesthetic. But, as is typical with Down patients, U. V. had been fidgety during the August 31 office visit and was a poor candidate for local anesthesia during the extremely delicate cataract surgery that he was about to undergo. Respondent and the anesthesiologist agreed that U. V. would receive general anesthesia for the surgery. After the first surgery was canceled, the anesthesiologist undertook the task of obtaining the medical clearances for general anesthesia. He spoke with U. V.’s primary physician, who practices in the small town where U. V. lived at the south end of Lake Okeechobee between Clewiston and Belle Glade. U. V.’s primary physician appeared as a witness at the hearing. He seemed to suffer from communication problems not entirely attributable to obvious difficulties with the English language. Not surprisingly, the anesthesiologist obtained little useful information from the physician. The anesthesiologist’s nurse called the cardiologist’s office several times on September 15 prior to the surgery. Unable to reach the cardiologist or any of his partners, the anesthesiologist spoke with one of the cardiologist’s office nurses and had her read him U. V.’s chart. Especially interested in U. V.’s cardiac malformations, the anesthesiologist satisfied himself that U. V. could withstand the rigors of general anesthesia and developed a plan, after discussing the case with his partners, to use special drugs and techniques so as to affect V.’s heart and lungs as little as possible. The anesthesiologist also studied either a chest xray taken on September 6, 1993, or a report of the chest xray taken on that date. He examined the xray or report to determine if U. was suffering from any reversible heart problems that might resolve themselves if surgery were postponed. The anesthesiologist found no cardiac problems of this type. Prior to the administration of the general anesthesia, the anesthesiologist spent several hours with U. V. and his family discussing the risks and benefits of general anesthesia. U. V.’s mother accepted the risks and agreed to the use of the general anesthesia. U. V.’s cardiologist testified that, if asked about the surgery and general anesthesia, he would have cautioned Respondent and the anesthesiologist of the risks of surgery, but he would not have offered an opinion on the advisability of using general anesthesia on U. V. The cardiologist would have left the decision on this matter to the anesthesiologist. On September 15, 1993, Respondent removed the cardiac from U. V.’s left eye. The surgery was flawless. During the surgery, U. V. was stable and tolerated the anesthesia. Following the surgery, U. V. awoke in the recovery room, where he was alert and following commands. Once U. V. began to breathe better on his own, the ventilator machine was turned off. U. V. suddenly developed cardiac arrhythmia and died within an hour. Respondent did not deviate from the applicable standard of care in his diagnosis and treatment of U. V. Respondent’s medical records amply memorialize his diagnosis and fully justify the surgery undertaken on September 15, 1993.

Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the administrative complaint against Respondent. ENTERED in Tallahassee, Florida, on June 4, 1997. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings on June 4, 1997. COPIES FURNISHED: Britt Thomas, Senior Attorney Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 John F. Lauro, Esquire John F. Lauro, P.A. Suite 3950 101 East Kennedy Boulevard Tampa, Florida 33602 Dr. Marm Harris Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0972 Jerome Hoffman, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403

Florida Laws (2) 120.57458.331
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs ALLEN C. DUKES, M.D., 06-002033PL (2006)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Jun. 12, 2006 Number: 06-002033PL Latest Update: Oct. 06, 2024
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BOARD OF MEDICAL EXAMINERS vs. LEON LANE, 82-001010 (1982)
Division of Administrative Hearings, Florida Number: 82-001010 Latest Update: Dec. 08, 1983

Findings Of Fact At all times material hereto, Respondent was a licensed medical doctor in the State of Florida having been issued License No. 0020340. Respondent specializes in the practice of ophthalmology, and is board-certified in that specialty. As indicated above, Respondent has been charged in a three-count complaint with various violations concerning his treatment of three patients. For purposes of clarity, the Findings of Fact section of this Recommended Order will, therefore, treat each such patient separately. ETTA ROSE Respondent first saw Etta Rose as a patient on March 17, 1980. At that time Ms. Rose gave a history of having had "floaters" in both eyes, in her left eye for three months and in her right eye for approximately the past three years. She also indicated a history of hypertension of five years duration. On her initial visit, Ms. Rose informed Respondent that she had last had an eye examination in December of 1978, but could not recall the name of the examining doctor. Upon physical examination on the initial visit of March 17, Respondent determined that the patient had intraocular pressures of 25 in her right eye and 26 in her left eye. In this connection, intraocular pressures of from 12 to 21 are considered roughly normal in a general patient population, and any readings above those levels are generally considered to be elevated. In addition to the above-noted intraocular pressures, Respondent also determined-on this initial visit that the patient had asymmetric nerve heads, the nerve heads in her left eye being markedly larger than those in the right. This degree of difference, according to Respondent's determination, could not be attributed to a congenital defect. Since this degree of differential in the size of the optic nerve heads occurs in less than one percent of the population, this fact, taken together with the patient's elevated intraocular pressures, resulted in Respondent's diagnosis of probable glaucoma. As a result of Respondent's physical findings as outlined above, together with the lack of information from prior treating physicians, Respondent determined that in order to avoid potentially irreversible damage to the patient's eyes, he needed to administer as high a dosage of medication to bring down the patient's intraocular pressures as rapidly as possible. Accordingly, on March 17, 1980, Respondent prescribed a one percent solution of pilocarpine to be administered to the patient's eyes every four hours. Pilocarpine is an old conservative glaucoma medication used specifically to reduce intraocular pressures. A one percent pilocarpine solution' is a relatively light dosage. Therefore, on March 20, 1980, Respondent increased the dosage of pilocarpine to two percent every four hours, and on March 24, 1980, again increased the dosage of pilocarpine to four percent every four hours. Additionally, on March 28, 1980, Respondent added the drug timolol to his attempted medical management of the patient's pressures. It is not medically advisable to start a patient directly on a four percent pilocarpine solution because of the distinct danger of side effects, such as headaches and dimness of vision. As a result, Respondent utilized a process known as "titrating," by starting the patient on a lowered dosage of medication, and rapidly bringing the patient to a maximum dosage, watching carefully during this period for evidence of side effects. The patient in this case apparently experienced no such ill side effects. During his second office visit with the patient on March 20, 1980, Respondent performed a gonioscopy to evaluate the angle where the patient's cornea touched near the iris. This procedure showed the patient to have wide open angles and no scarring. Respondent therefore concluded that the patient suffered from chronic open-angle glaucoma, which was consistent with his initial diagnosis on the first visit of March 17, 1980. On March 20, 1980, the patient's intraocular pressures were 21 in the right eye and 23 in the left eye. During the entire course of his treatment of this patient, Respondent saw the patient in his office on the following dates: March 17, 20, 24, and 28, 1980; April 3, 8, and 22, 1980; May 20, 1980; and June 24, 26, and 27, 1980. Because of the asymmetry in the patient's optic nerve heads, her elevated pressures, and her lack of medical history to demonstrate the progress, if any, of glaucoma, Respondent determined it to be necessary to develop as accurate a profile on the patient as quickly as possible. The purpose of these office visits, which occurred at different times during the day, was to approximate a "diurnal curve." A diurnal curve is a method for determining fluctuating intraocular pressures of a patient, and is customarily obtained by admitting the patient to a hospital, and checking pressures in the patient's eyes approximately every two hours over a 24-hour period. The purpose of the procedure is to obtain an accurate 24-hour reading of the patient's pressures, since pressures within the eye can fluctuate markedly during different times of the day. Respondent determined admitting Ms. Rose to the hospital to be impractical, and set upon a course of seeing her in his office on several rather closely spaced days at different times of the day in order to get a more accurate understanding of her condition. By the time Respondent last saw the patient in his office on June 26, 1980, the patient was on a four percent pilocarpine solution four times a day, .5 percent timolol, and diomox b.i.d., and her pressure in her left eye still remained 26. At that time Respondent determined that he had the option of continuing to carry the patient on these dosages of medication, in which case he determined that the patient would probably go on to progressive damage, or, alternatively, surgical intervention. Respondent determined this amount of medication to have maximized medical therapy and, as a result, recommended a trabeculectomy to attempt to lower the patient's pressures. This surgical recommendation was made on June 27, 1980, at which time Respondent invited the patient to seek a second opinion, recommending that she consult ophthalmologists at the Bascom Palmer Eye Institute at the University of Miami Medical School. The patient sought such an opinion, and elected not to undergo the surgery recommended by Respondent. As a result, the office visit of June 27, 1980, was the last time Respondent saw Etta Rose as a patient. Respondent's diagnosis of the patient at the last visit was chronic open-angle glaucoma that was uncontrollable on medical therapy. The patient was apparently seen by an ophithalmologist on May 15, 1981, and again in January of 1982. The physician who last examined the patient determined that the patient, although she had slightly elevated intraocular pressures, "probably" did not have glaucoma, but should be followed as a "glaucoma suspect" because of the difference in the size of her optic nerves. The record in this cause establishes that there are three parameters generally accepted for diagnosing glaucoma: intraocular pressures; visual fields; and the appearance of the optic nerve. As previously indicated pressures above 21 are generally considered elevated. Throughout Respondent's treatment of Ms. Rose it appears that her intraocular pressures were at all times elevated, and that the optic nerve heads in her left eye were markedly larger than those in her right eye. The record also demonstrates that she evidenced no visual field loss while being treated by Respondent or thereafter. A trabeculectomy is a surgical procedure used in the treatment of glaucoma as a last resort when all other treatment modalities have been exhausted. There is some degree of danger inherent in the procedure, and it is associated with a high failure and complication rate, and can lead to the formation of cataracts. As indicated above, Respondent is charged in the Administrative Complaint with requiring Ms. Rose to come to his office an excessive number of times, with prescribing excessive medication for her condition, and with recommending unnecessary surgery. With respect to the charge of requiring excessive office visits, it is specifically concluded that Respondent exercised that level of care, skill, and treatment which was reasonable under the circumstances given the fact that the patient had elevated intraocular pressures, asymmetric optic nerve heads, and was unable to furnish Respondent with a history that would justify less aggressive treatment than the methods employed by Respondent. Because of these factors, Respondent reasonably determined that the patient should be seen often during the initial stages of therapy particularly in order to evaluate fluctuations in the patient's intraocular pressures. At final hearing, Petitioner adduced credible testimony from two board-certified ophthalmologists that Respondent prescribed excessive medication to Ms. Rose over his period of treatment of that patient. Specifically, these physicians took exception to Respondent's increasing the dosages of pilocarpine from one percent to a four percent solution over an approximately 11-day period. These physicians felt the better practice would have been to proceed more slowly to determine how the patient's pressures were reacting to medication. Equally credible, however, was testimony from the Respondent himself and from another board-certified ophthalmologist that the procedure known as "titrating" whereby the patient is started on a lower dosage and worked to a higher dosage over a short span of time was also reasonable medical treatment under the circumstances. The patient was seen frequently so that any side effects from this increase in medication could be monitored by Respondent. In addition, because of the high degree of difference in the size of the optic nerve heads in the patient's two eyes, Respondent reasonably assumed that glaucoma, if it were present, had progressed to such an extent that it was necessary to get the patient's intraocular pressures under control as rapidly as possible. Respondent reasoned that, should the pressures be brought under control at a higher level of medication, the medication could always be cut back, whereas, if he proceeded more slowly irreversible damage might occur in the interim. This record simply reflects that reasonable ophthalmologists might disagree with respect to the proper administration of medication in this context and, as a result, it cannot be determined from this record that Respondent acted unreasonably in his course of prescribing medications to Etta Rose. Finally, Petitioner adduced credible testimony at final hearing that the trabeculectomy recommended by Respondent was improper because Respondent had not reached maximum medical management of the patients condition in that he had not utilized oral diuretics or epinephrine as treatment modalities. The reasoning here is that until maximum medical management proves unsuccessful in controlling a patient's pressures, a remedy as drastic as a trabeculectomy should not be utilized. Petitioner's witnesses testified that based on the patient's marginally elevated pressures and the fact that she demonstrated no visual field loss, surgical intervention was improper. Again, equally credible testimony from both the Respondent and another board-certified ophthalmologist called as a witness by Respondent establishes that an equally reasonable interpretation of the data available to Respondent was that the patient was, indeed, under maximum medical management, and her intraocular pressures had not responded appropriately to this treatment regime. Further, the record also establishes that it is very unusual to find the degree of difference in the size of the optic nerve heads in this patient without visual field loss. Patients who demonstrate this size differential without visual field loss often do not develop visual field loss until relatively late in the progress of the disease, but when that loss occurs it occurs abruptly and profoundly. Thus, it appears that the risk of performing a trabeculectomy had to be weighed against the danger of irreversible damage from the progress of glaucoma. Under these circumstances, it was reasonable for Respondent to recommend surgery. It should be noted also that at the time Respondent recommended the surgical procedure, he also advised the patient that she was free to seek a second opinion. In addition, Respondent also adduced credible testimony that based on the drugs which he had prescribed medical management of this patient's condition would not have been furthered by adding epinephrine to his course of treatment. Accordingly, the facts of record in this cause do not establish that Respondent caused Etta Rose to visit his office an excessive number of times, that he prescribed excessive medication for his treatment of that patient, or that unnecessary surgery was recommended by Respondent. ALBERT MILLER Respondent first saw Albert Miller as a patient on September 29, 1976. Upon physical examination of the patient, Respondent had no reason to suspect the presence of glaucoma. The patient was next seen on March 16, 1977, for a check of his retina because of his history of diabetes. In addition to diabetes, the patient also had a history of hypertension. There were no changes in the patient's condition on the March 16, 1977, visit, and Respondent instituted no treatment. The patient was next seen for an annual check on May 22, 1978. The patient's vision with his glasses had worsened in both eyes at that time. The patient's history indicates that the patient's diabetes had been high just two months prior to this examination. The diabetes had apparently also affected the patient's intraocular pressures because they were found to be 20 in both eyes on this examination, whereas they had been 17 in the right eye and 16 in the left eye on September 29, 1976, when the patient was first seen by Respondent. Respondent chose not to institute active treatment of the patient after the May 22, 1978, visit. The patient was next seen on July 17, 1979. At that time his pressures were still 20 in both eyes and Respondent noted some slight increase in cataract formation and the presence of retinal hemorrhages in the patient's right eye, indicating some diabetic retinal changes that could make the patient's eyes more susceptible to disease. The patient was next seen on July 15, 1980, at which time his intraocular pressures were measured to be 26 in the right eye and 24 in the left eye. Although there is a notation in Respondent's record that the patient was "squeezing," which can artificially elevate pressures, the Respondent testified without contradiction that the "squeezing" noted in his records did not affect the accuracy of these recorded pressures. As of the July 15, 1980, office visit, Respondent diagnosed the patient as a "glaucoma suspect," which is someone who, because of existing physical factors, runs a substantial chance of developing future glaucoma. As a result of this diagnosis, the Respondent scheduled the patient for visual fields on July 17, 1980, and a gonioscopy on July 18, 1980. Visual fields performed by Respondent showed visual field defects which were suggestive of actual visual field loss on threshold stimulus testing. As a result the Respondent concluded that the patient might already have had early visual field loss, and started the patient on a one percent pilocarpine solution in both eyes, every four hours. The patient was next seen on July 22, 1980, at which time his pressures were measured to be 22 in the right eye and 20 in the left eye at 1:35 p.m. The patient was next seen on July 25, 1980, at which time his pressures were 24 in the right eye and 18 in the left eye. Respondent did not feel that a pressure of 24 in the right eye was adequate medical control, so he increased the patient's medication to two percent pilocarpine solution, and scheduled the patient to return on July 29, 1980. The July 25, 1980, pressure readings were conducted at 8:55 a.m., so the patient was scheduled to return in the early afternoon on July 29, 1980, in order to obtain pressure readings at a different time of day. On that occasion, the patient's pressures were 20 in the right eye and 22 in the left eye, which Respondent still determined not to be adequate medical management. Accordingly, Respondent increased the dosage of pilocarpine to a four percent solution. The patient was next seen on August 1, 1980, at which time his pressures were 21 in the right eye and 22 in the left eye. Respondent concluded the reading of 22 in the left eye, in light of possible visual field defects, was not adequate medical management, so he added 0.25 percent timolol to the four percent pilocarpine prescription. The effect of timolol is usually observable within 48 hours. The patient was next seen on August 5, 1980, at which time his pressures were 17 in the right eye and 18 in the left eye. Respondent was pleased with the lowering of the patient's pressures, and scheduled the patient to return on August 11, 1980. At that time the patient's pressure was 20 in both eyes. Respondent was pleased with these results, and felt that he did not need to see the patient again for a two-week period. The patient never returned. The last time the patient was seen by Respondent on August 11, 1980, the Respondent's diagnosis was "glaucoma suspect," although Respondent felt that he needed to follow the patient longer to monitor his visual fields and optic nerve heads. However, with the patient's history of diabetes, myopia, hypertension, and Respondent's determination that he showed early visual field changes, Respondent felt confident with his final diagnosis of "glaucoma suspect." The patient was subsequently examined by another ophthalmologist in the Fort Lauderdale area on August 28, 1980. At that time the patient's pressures were 19 in the right eye and 20 in the left eye. The patient was given a complete examination, which showed presence of dot and blot hemorrhages throughout the entire retina of both eyes, which was to be expected of a patient who was diabetic for the past 15 years, and had been taking insulin for that condition for the past eight years. The patient's optic nerves were normal, and the patient's cup to disc ratio was also normal. Because the patient's optic nerves were normal, he was taken off the pilocarpine which had been prescribed for him by the Respondent. A visual field test was also administered to the patient to determine the presence of any visual field loss secondary to glaucoma, but that test indicated normal vision. The normal cup to disc ratio found by the subsequent treating physician in examining the patient has remained stable throughout his entire course of treating the patient. The patient was last seen by the subsequent treating physician on May 25, 1982, at which time he had intraocular pressures of 16 in the right eye and 18 in the left eye without medication. Another visual field test was performed on that date, which again disclosed normal vision. The subsequent treating physician, like Respondent, diagnosed the patient to be a potential "glaucoma suspect." In the Administrative Complaint, Respondent is charged with requiring Mr. Miller to make an excessive and unnecessary number of office visits. The Respondent is also charged with failing to maintain records revealing the frequency of use of the pilocarpine prescribed for Mr. Miller, and further with failing to maintain records indicating the percentage dosage of timolol and the date of beginning of use of that drug. With respect to the latter charge, the record contains no facts to substantiate those allegations and, in fact, contains evidence that Respondent clearly noted in his records the information charged as lacking in the Administrative Complaint. The Administrative Complaint also charges Respondent with having required the patient to visit his office a total of ten times between July 17, 1980, and August 11, 1980, which is alleged to be ". . . an excessive an[sic] unnecessary number of office visits." The record in this cause establishes that the patient visited Respondent's office a total of eight times during that period. As indicated above, the patient had been seen by Respondent over a period of approximately four years before there was ever any indication of even marginally elevated pressures. Given the patient's history of diabetes and hypertension Respondent, in the exercise of his clinical judgment, determined to treat the condition with medication. Although the record in this cause contains credible testimony that some physicians would not have treated the condition at all, or would have seen the patient at most once a week, equally credible evidence contained in this record establishes that once the decision to treat was made and the patient was started on medication, it was entirely proper to monitor the patient closely to determine the effect that the medication was having on the patient's pressures. It should be noted that the Respondent is not charged in the Administrative Complaint with prescribing excessive or unnecessary medication. Based upon the foregoing, it is therefore concluded that there is an insufficient factual basis in the record in this proceeding to establish that, under the conditions present here, the Respondent departed from reasonable medical practice in seeing the' patient on eight occasions during approximately a one-month period. ELEANOR DRAGER This patient was first seen by Respondent on January 7, 1980. At that time the patient gave a history of having had her vision go blurry for 15 to 20 minutes on two occasions since the beginning of the year. An examination of the patient's eyes showed her vision to be 20/29 in her right eye and 20/100 in her left eye. Intraocular pressures were 30 in her right eye and 28 in the left eye, both of which are considered to be quite high. The patient's last eye examination had been in October of 1978. The patient was next seen on January 9, 1980, at which time Respondent determined it necessary to perform cataract surgery and to implant an intraocular lens. The surgery was performed on January 30, 1980, and, in addition to removing a cataract and implanting a lens, Respondent performed a posterior sclerotomy, a procedure performed by making a tiny hole in the eye wall and inserting a needle to aspirate vitreous fluid, thereby allowing the remaining vitreous to resume a normal position. The patient was seen postoperatively on February 1, 1980, and again on February 7, 1900. Respondent's practice is to visit frequently with postoperative patients in order to closely monitor the patient's condition. On the February 7, 1980, examination, the patient's vision was 20/70 in her left eye, which Respondent considered excellent for one week postsurgery. The pressure in the eye was 20 and there were no other changes of note. The patient was next seen on February 13, 1980, at which time her vision was only 20/200 in her left eye. The only other finding of note on this date was that the lens implant had shifted to a position closer to the cornea. The patient was next seen on March 13, 1980, at which time her vision was still 20/290 in the left eye, and her pressures were 22 in the right eye and 44 in the left eye. Respondent improved the patient's vision to 20/60 in her left eye with a lens change in her glasses. The patient was next seen on March 25, 1980, in response to a call from the patient indicating that on the previous day she had experienced foggy vision in her left eye, and within an hour could see nothing at all out of the eye., The patient had treated the problem herself with eye drops and, within a couple of hours, her vision had improved. Upon examination, Respondent discovered the patient's vision to be 20/200 in the left eye, with a pressure of Respondent restored the patient's vision to 20/25 with a glasses change, leading him to suspect, in view of the patient's recent surgery, that there was a possibility of retinal detachment or retinal tear with possible vitreous hemorrhage. Respondent was unable to see the entirety of the back of the Patient's eye in order to determine the presence of a retinal tear because a view of certain portions of the eye was blocked by the intraocular lens implant. The patient was next seen on March 31, 1980, complaining of "haze" over her left eye. The patient's vision has worsened to 20/40 in her left eye, and her intraocular pressures were 26 in both eyes. The Respondent again changed the lenses in the patient's glasses, restoring her vision to 20/25 in the left eye. The patient was next seen on April 14, 1980, still complaining of the "haze" over her left eye and an additional complaint of many black dots in the left eye since her last visit. Respondent dilated the eye, and found a large number of vitreous floaters present. Respondent concluded from the presence of these floaters that the patient had probably suffered a vitreous hemorrhage. The most common reason for floaters to be present in a postsurgical cataract patient with a vitreous hemorrhage is retinal tear. Respondent could not, however, actually see the retinal tear upon visual examination. The patient was seen again on April 16 and on April 18, 1980, complaining of an increase of black soots in her left eye. Upon examination, Respondent noted the presence of vitreous traction in the left eye, and determined that the patient should be scheduled for cryo-pexy surgery to be performed in his office on April 21, 1980. Cryo-pexy surgery is an operation that involves the application of cold, in this case a local drop of opthane, to the eyeball in order to produce a tissue destruction to release adhesions thereby avoiding potential retinal tear or detachment. The procedure can be performed in a physician's office, as opposed to a hospital, and requires only 10 to 15 minutes to perform. At the time cryo-pexy surgery was to be performed, Respondent had been unable to actually observe a retinal tear, although he had noted the presence of retinal traction. Respondent felt, however, that a retinal tear could have been caused by the placement of the needle through the pars plana during the course of performing the posterior sclerotomy on January 30, 1980. In fact, many ophthalmalogists perform cryo- pexy at the same time as a posterior schlerotomy in order to prevent a retinal tear from developing as a result of that procedure. Respondent chose to recommend cryo-pexy surgery for a variety of reasons. Among them were the recent cataract surgery, the implantation of an intraocular lens, the performance of the posterior sclerotomy, and the' patient's history of heart disease which would have made it more complicated to perform cutting surgery as opposed to cryo-pexy should an actual retinal detachment occur. The patient had a history of recent phlebitis which had hospitalized her, so that the possibility of placing her under general anesthesia in order to perform major surgery for a retinal detachment thereby leaving her inactive in a hospital bed for a period of days could have resulted in a complication of her phlebitis. The decision to perform cryo-pexy surgery involved the exercise of clinical judgment. Respondent, by necessity, had to weigh the dangers of performing the surgery against problems that might be associated with failure to perform the procedure. The three principal reasons advanced in this record for not performing this procedure were that Respondent's records indicated only the presence of "floaters" and not an actual vitreous hemorrhage; Respondent could not actually visualize the retinal tear prior to recommending surgery; and, the performance of cryo-pexy could have further traumatized an eye which had already been subjected to considerable surgical manipulation. In response to these considerations, Respondent testified, without contradiction, that he considered the presence of "floaters" to be synonymous with vitreous hemorrhage and, therefore, saw no reason to actually note the presence of hemorrhage in his notes. Further, although Respondent could not actually see a retinal tear in the patient's eye, based on his course of treatment of the patient he was aware of the site through which he had placed the needle in performing the posterior sclerotomy, and reasonably concluded that the performance of that procedure, in the presence of so great a quantity of floaters in the patient's eye, could have resulted in a retinal tear. In short, the patient's symptoms were consistent with development of a vitreous hemorrhage following cataract extraction. In light of the fact that the cataract extraction included the performance of a posterior sclerotomy through the pars plana, there was every reason to believe that the patient might have had a hole somewhere in the region of the sclerotomy site. Under these conditions cryo-pexy is an acceptable means of treating this condition despite being unable to see an actual retinal tear. The risk in delaying the performance of the cryo-pexy was that the retina could detach and the problem thereby become more difficult to manage. In making the decision to perform cryo-pexy, the Respondent weighed the risk of performing the procedure against the risk of not performing it, and reasonably determined that the best course of treatment was to perform the procedure.

Florida Laws (2) 120.57458.331
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BOARD OF MEDICINE vs HOWARD BRUCE RUBIN, M.D., 99-000306 (1999)
Division of Administrative Hearings, Florida Filed:Tampa, Florida Jan. 25, 1999 Number: 99-000306 Latest Update: Jul. 06, 2004

The Issue The issue is whether Respondent failed to practice medicine at the level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances and, if not, the penalty.

Findings Of Fact Respondent is a licensed physician, holding license number ME 0026784. He is Board-certified in radiology. On January 30, 1997, T. D., a 30-year-old female who was eight months pregnant, presented to the emergency room of the Columbia Largo Medical Center complaining of pain in the left flank radiating to the left groin, together with nausea and vomiting. She also reported a prior history of kidney stones. A urologist diagnosed T. D. as suffering from kidney stones and severe hydronephrosis, which is the dilation of the kidney due to an obstruction in the flow of urine. The urologist was unable to pass a stent and catheter by the stones to drain the urine and relieve the pressure on the kidney, so he asked Respondent to perform a left percutaneous nephrostomy. A percutaneous nephrostomy is a procedure in which a physician places a tube through the skin and into the collecting system of the kidney to drain the kidney. The tube remains in place until the obstruction is removed. On February 1, Respondent performed a left percutaneous nephrostomy under local anaesthesia. For guidance in placing the tube, Respondent used ultrasound, rather than ultrasound and a flouroscopy. Respondent has performed 100-150 nephrostomies. As is the common practice, he normally does not rely exclusively ultrasound in guiding the placement of the tube in the kidney. In this case, the urologist asked that he not use a flouroscopy, in deference to the patient's pregnancy and the duration of x-ray exposure in a flouroscopy. Respondent was comfortable doing the procedure in this manner, although he decided that, if he encountered any problems in placement, he would resort to flouroscopy. Respondent proceeded to perform the percutaneous nephrostomy in the morning. As is typical, the radiology technician helped position T. D. on the table for the procedure. T. D.'s advanced pregnancy necessitated a slight adjustment to the normal posture of patients being prepared for this procedure, so T. D. lay slightly more up on her side than is usual. However, this did not change the point of entry chosen by Respondent. And, regardless of her precise position, the location of the spinal canal relative to the kidney relative to the point of entry into the skin remains constant: an imaginary line from the kidney to the spinal canal is perpendicular to an imaginary line from the point of entry to the kidney. The point of entry is on the lower back of the patient. T. D. is thin and her pregnancy did not manifest itself on her back, so the length of tube used by Respondent was relatively short. T. D.'s thin build makes it less likely that Respondent would have placed sufficient excess tube into the patient so as to permit the tube to run from the kidney to the spinal cord. Upon placement of the tube, at least 100 cc of fluid drained through the tube. This is well within the range of urine that would be expected under the circumstances. The color was well within the range of color for urine. The preponderance of the evidence indicates that the fluid was urine and that Respondent had placed the tube correctly in the kidney. At the end of the procedure, T. D. appeared a lot more comfortable. Late in the afternoon, someone called Respondent and told him that the drainage had slowed to a very small amount or nothing at all. This is not uncommon, as moving the patient or over-energetic nurses may accidentally dislodge the stent in the kidney. It is also possible that the tube has rested in a part of the kidney that does not facilitate maximum drainage. Using ultrasound, Respondent confirmed that the tube remained in place in the kidney, although he could not tell whether the stent had come to rest in a narrow place in the kidney or possibly even against a stone. Even with this uncertainty, Respondent still was able to determine that the stent was predominantly in the collecting system. Because T. D. was resting comfortably, she said that she felt fine, her fever was going down, and the hydronephrosis had decreased, Respondent decided to do nothing until after re-examining T. D. the next morning. However, at about 11:00 p.m. or midnight, Respondent, who was visiting a nearby patient, dropped in on T. D. The nurse said that she was fine and her kidney was draining a little better. T. D. also said that she was feeling fine. About three or four hours later, T. D. reported a feeling of some paralysis. Petitioner's expert testified that this was linked to the misplacement of the stent in the spinal canal, but he was unaware that T. D. had undergone a spinal block for the percutaneous nephrostomy and that a problem with the first anaesthetic procedure had necessitated a second. It is more likely that T. D.'s paralysis was in response to the two spinal blocks. At 9:00 a.m. the next day, Respondent returned and examined T. D. He found that she was still doing better, and her urologist was preparing to discharge her from the hospital. She looked better, and her urine flow had improved. He told her to call him if she had any problems, but he never heard from her again or even about her until he learned from the urologist that T. D. had been admitted to another hospital where a radiologist had inserted contrast material into the tube to locate the stent and found it in the spinal canal. The father of the baby picked up T. D. at the Columbia Largo Medical Center. He picked her up out of the wheelchair and placed her in the car. Her condition deteriorated once she got home. A hospital nurse directed the father to change the collection bag, if it filled prior to the visit of the home health care nurse. In the three or four days that T. D. remained at home, he changed the bag several times. He daily checked the site at which the tube entered T. D.'s skin and noticed that it had pulled out a little bit. However, he testified that he did not try to adjust the length of tube inside T. D., nor did he change the setting on the tube, which had "open" and "closed" settings for the pigtail at the end of the tube. The proper setting was closed, as the pigtail is not to be open once the stent has reached its destination in the kidney. On February 5, the father took T. D. to the emergency room of the Columbia St. Petersburg Medical Center, where she presented with complaints of severe back pain. An ultrasound confirmed the presence of kidney stones, whose removal had been deferred until the delivery of the baby. In an effort to locate the end of the tube, a radiologist inserted radiographic contrast dye, which showed that the end of the tube was in the intrathecal space of the spine. A urologist removed the tube. However, T. D. suffered a seizure. Another physician attempted an emergency C-section, but the baby did not live. There are two alternatives to explain how the stent at the end of the tube found its way into the spinal canal. First, Respondent placed it there during the procedure. Second, it migrated from the kidney, where Respondent placed it, to the spinal canal. If not unprecedented, both alternatives are extremely rare. The drainage during the procedure and initial improvement of the distended kidney are consistent with the proper initial placement of the stent. The difficulty of inadvertently turning a relatively short length of tube 90 degrees from the kidney to the spinal canal also militates against a finding that Respondent misinserted the tube. Problems with the first spinal tap may have contributed to some of the complaints, such as paralysis, that T. D. experienced after the procedure. Although unlikely, the migration alternative would be consistent with well-intended, but incorrect, attempts by the baby's father or a home health care nurse to ensure that the tube did not travel too far in or our of the point of entry. Migration would be facilitated if either the father or nurse misread the "open" and "closed" settings and turned to "open," in the hope of improving drainage, when such a setting opens the pigtail, which would increase the possibility that the stent could migrate into the spinal canal. In a case requiring proof that is clear and convincing, it is impossible to find that Petitioner has adequately proved that Respondent misinserted the tube during the procedure. Likewise, the evidence is not clear and convincing that Respondent should have recognized at anytime prior to T. D.'s discharge from the Columbia Largo Medical Center that something was wrong with the procedure that he had performed or that he needed to confirm by x-ray the location of the stent at the end of the tube.

Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 2nd day of August, 1999, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of August, 1999. COPIES FURNISHED: Britt Thomas, Senior Attorney Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 William B. Taylor, IV Macfarlane, Ferguson & McMullen Post Office Box 1531 Tampa, Florida 33601-1531 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Pete Peterson, General Counsel Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750

Florida Laws (3) 120.57458.331766.102
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