STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF HEALTH, )
BOARD OF MEDICINE, )
)
Petitioner, )
)
vs. ) Case No. 00-2584
)
NARI T. SADARANGANI, M.D., )
)
Respondent. )
)
RECOMMENDED ORDER
Pursuant to notice, a formal hearing was held in this case on January 9, 2001, in Tallahassee, Florida, before Patricia Hart Malono, a duly-designated Administrative Law Judge of the Division of Administrative Hearings.
APPEARANCES
For Petitioner: Robert C. Byerts, Esquire
Agency for Health Care Administration Post Office Box 14229
Tallahassee, Florida 32317-4229
For Respondent: Brian A. Newman, Esquire
Pennington, Moore, Wilkinson, Bell & Dunbar, P.A.
Post Office Box 10095 Tallahassee, Florida 32302-2095
STATEMENT OF THE ISSUE
Whether the Respondent committed the violations alleged in the Administrative Complaint dated May 23, 2000, and, if so, the penalty that should be imposed.
PRELIMINARY STATEMENT
In an Administrative Complaint dated May 23, 2000, the Department of Health ("Department") charged that Nari T. Sadarangani, M.D., failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent physician as being acceptable under similar conditions and circumstances, in violation of Section 458.331(1)(t), Florida Statutes (1993). The charge arose out of treatment Dr. Sadarangani provided to patient W.R. during surgery to repair an abdominal aortic aneurysm. Dr. Sadarangani disputed the facts alleged in the Administrative Complaint and requested an administrative hearing. The Department transmitted the matter to the Division of Administrative Hearings for assignment of an administrative law judge, and pursuant to notice, a hearing was held on January 9, 2001.
At the hearing, the Department presented the testimony of James W. Dennis, M.D., in the form of the transcript and videotape of Dr. Dennis's deposition, which was offered into evidence and received as Petitioner's Exhibit 1.
Dr. Sadarangani testified in his own behalf and presented the testimony of Michael J. Carmichael, M.D., in the form of the transcript and videotape of Dr. Carmichael's deposition, which was offered into evidence and received as Respondent's
Exhibit 1. The parties offered into evidence Joint Exhibits 1
through 9, which were received into evidence, and official recognition was given to Section 458.331, Florida Statutes (1993), and the version of Rule 21M-20.001, Florida Administrative Code, in effect in 1993.
The two-volume transcript of the proceedings was filed with the Division of Administrative Hearings on January 23, 2001, and the parties timely filed proposed findings of fact and conclusions of law, which have been considered in preparing this Recommended Order.
FINDINGS OF FACT
Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made:
The Department of Health, Board of Medicine, is the state agency charged with regulating the practice of medicine in Florida. Section 20.43; Chapters 455 and 458, Florida Statutes (2000).
Dr. Sadarangani is, and was at the times material to this proceeding, a physician licensed to practice medicine in Florida, having been issued license number ME 0041985. He maintained a private practice in Fort Lauderdale, Florida, from 1984 until 1997. He was board certified in 1981 in cardio- thoracic surgery by the American Board of Thoracic Surgery and was re-certified in 1990. In his practice, Dr. Sadarangani
performed between 20 and 25 aneurysm repairs each year.
Dr. Sadarangani has not practiced surgery since 1997 because of his health.
General anatomy of the abdominal blood vessels.
The arterial system.
The aorta is the main blood vessel leaving the heart and going through the chest and pelvic area. The aorta carries the majority of the blood to the body and provides blood to the body's main organs. The renal arteries branch off of the aorta and provide blood to the kidneys.
In the pelvic area, the aorta branches into two iliac arteries that carry blood to the pelvic organs and to the legs. The iliac arteries are referred to as the common femoral arteries when they reach the groin. As they descend into the leg, the common femoral arteries branch into the superficial femoral arteries, which continue below the knee and into the lower leg, and into the profundus femoris arteries, which provide blood to the muscles of the thighs.
The lumbar arteries extend in pairs from the posterior of the aorta in the abdomen to the lumbar musculature.
The venous system.
The vena cava is the very large vein in the abdominal cavity that drains blood from the legs and the abdominal organs and returns it to the heart. It is located on the right side of
the aorta. In very rare cases, a person is born with two vena cavas, one located on the left side of the aorta and one on the right side, into which blood drains from the left and right kidneys, respectively.
The renal veins are the main venous structures that carry blood from the kidneys to the vena cava. There are normally two renal veins, one draining the right kidney into the vena cava, and one draining the left kidney into the vena cava. The renal veins are two of the largest veins in the body, and, because the kidneys absorb 20 percent of the heart's output of blood, the renal system contains a high volume of blood. The right renal vein is short and is not located near the aorta because it attaches to the vena cava to the right of the aorta. The left renal vein normally crosses over the anterior, or front, surface of the aorta to join the vena cava. In rare cases, the left renal vein crosses posterior to, or in back of, the aorta to join the vena cava; such a vein is referred to as a retroaortic renal vein.
Aortic aneurysms.
An aortic aneurysm is an area of the aorta where the vessel wall has dilated and expanded abnormally, like a balloon; it appears as a markedly enlarged blood vessel. A normal aorta is between 1.5 and two centimeters in diameter; if an area of the aorta expands to between 2.5 and three centimeters, it is
referred to as a dilated aorta. It is only after the aorta has dilated to four centimeters that the area of dilation is referred to as an aneurysm. An aneurysm is often life threatening because it can burst, resulting in massive blood loss and, in many cases, death.
The repair of an aneurysm involves the replacement of the part of the blood vessel that is aneurysmal with a bypass graft. The graft is an artificial prosthesis that is pre-made and comes as a straight tube or a bifurcated tube, that is, a tube that splits into two smaller tubes. Once in place, the graft allows the blood to flow through the area where the aneurysm is located, but the aneurysm is no longer a part of the blood vessel, and there is no danger that the aneurysm will rupture. The repair of an aortic aneurysm that is located in the abdomen is a major surgical procedure.
There are three types of bypass procedures used to repair abdominal aortic aneurysms:
An aortic tube bypass is appropriate when the aneurysm is limited to the aorta. In this procedure, a tube graft is attached to the aorta above the aneurysm and below the aneurysm, and the walls of the aneurysm are sutured closed over the graft. With this type of procedure, the surgeon first makes an incision in the abdomen and enters the abdominal cavity. After retractors are placed and the bowel is moved to the side, the
blood vessels above and below the aneurysm are separated, or dissected, from the surrounding fatty and connective tissue using both sharp and blunt instruments. Although it is possible to tear blood vessels, especially veins, using blunt dissection techniques, the use of good surgical techniques will minimize the number of vessel tears.1
An aortic-biiliac bypass is appropriate when the aneurysm extends into the upper iliac arteries or when there is a blockage of the upper iliac arteries. In this procedure, the aneurysm is replaced with a bifurcated tube graft attached to the aorta above the aneurysm and to each iliac artery below the aneurysm or blockage. When performing an aortic-biiliac bypass, the surgeon proceeds in the same manner as when performing an aortic tube bypass, but extends the abdominal incision to dissect the iliac arteries in the pelvic area. The iliac arteries lie very deep and must be dissected from the veins that lie next to these arteries and from the ureter.
An aortic-bifemoral bypass is appropriate when the patient has occlusive disease, or a blockage, of the iliac arteries or when it would be difficult to work in the pelvic area where the iliac arteries are located as a result of significant scarring. The iliac arteries are bypassed in this procedure, and a bifurcated tube graft is attached to the aorta above the aneurysm and to each common femoral artery below the
blockage. When performing an aortic-bifemoral bypass, the surgeon usually begins with incisions in each side of the groin and dissection of the common femoral arteries. The abdominal incision and dissection of the aorta is done after the common femoral arteries are dissected in order to reduce the amount of time the abdomen is open.
Prior to surgery, an aortogram, or arteriogram, is performed to establish the anatomy of the patient's arteries. An arteriogram is a procedure in which a dye is injected into the aorta by means of a catheter, and X-rays are taken showing the pathway of the dye through the arteries from the diaphragm to the feet so that any blockages or abnormalities in the vessels can be identified. An arteriogram is the most accurate way of determining that blood is flowing through a particular blood vessel, and the type of bypass to be performed is
determined on the basis of the anatomy of the patient's arteries as revealed by the arteriogram.
Patient W.R.
Patient W.R. was a 71-year-old male who was referred to Dr. Sadarangani after he was diagnosed with an abdominal aortic aneurysm. W.R. had a history of coronary artery disease, diabetes mellitus, high blood pressure, and mild chronic obstructive pulmonary disease. He weighed approximately 212 pounds at the time Dr. Sadarangani first examined him.
An ultrasound indicated that W.R.'s aneurysm was increasing in size, and Dr. Sadarangani recommended surgery to repair the aneurysm. Because of W.R.'s weight and his medical history, Dr. Sadarangani did not classify him as a normal patient, and he was a medium-level anesthesiology risk.
In a letter dated August 3, 1993, W.R.'s cardiologist cleared him for surgery based on the results of a cardiac catheterization and a thallium stress test. In his letter, W.R.'s cardiologist stated that W.R. had coronary artery disease of the right coronary system and that, during surgery, "careful attention [should be] paid to hemodynamic status "2
W.R.'s fitness for surgery was also evaluated by a pulmonologist, who cleared W.R. for the surgery based on the results of a pulmonary function test.
On August 12, 1993, W.R. underwent an abdominal aortogram and bilateral lower extremity runoff arteriogram in order to establish the anatomy of the arteries in his abdomen and legs. The aortogram revealed a fusiform aneurysm of the distal abdominal aorta that was 5.7 centimeters in diameter; the craniocaudel length of the aneurysm was approximately seven centimeters. It was noted in the report of the aortogram that "[b]oth renal arteries are well demonstrated. The aneurysm originates approximately 5 cm. below the origin of the lowest
renal artery. The iliac arteries are not involved. Aortic bifurcation is normal."
The bilateral lower extremity runoff arteriogram revealed that the "internal iliac and external iliac arteries bilaterally show normal liminal [sic] filling with no abnormality. The common femoral arteries are also normal." It was noted in the report of the arteriogram that the superficial femoral arteries filled normally, but bilateral segmental stenosis, or occlusive disease, of the distal superficial femoral arteries was observed, with 80-to-90 percent stenotic lesion in the left distal superficial femoral artery and
50-to-60 percent stenotic lesion in the right distal superficial femoral artery.
Because the aortogram and arteriogram revealed that the aneurysm ended above the point where the aorta bifurcated into the iliac arteries and because they revealed that there were no abnormalities in the iliac arteries, an aortic tube bypass to repair W.R.'s aneurysm would be the indicated procedure. This was the type of bypass Dr. Sadarangani intended to perform when he began the surgery.
Anesthesia was administered to W.R. at 8:15 a.m. and, after W.R. was prepared, Dr. Sadarangani began surgery at 9:10
a.m. Dr. Sadarangani first made an incision into the abdomen and dissected into the abdominal cavity. After isolating and
putting aside the abdominal organs, Dr. Sadarangani, as is his usual practice, dissected and isolated the iliac arteries. He then dissected up around each side of the aorta until he reached the neck, or upper edge, of the aneurysm. Dr. Sadarangani did not visualize the left renal vein as he dissected around the sides of the aorta, and he remarked on this to Dr. Robert McGuire, the surgeon who was assisting with the procedure.
The left renal vein is the first blood vessel the surgeon must locate after the aorta has been exposed. It is crucial for the left renal vein to be identified for two reasons. First, it is a major vein carrying a substantial blood flow from the left kidney, and it must be visualized so that the surgeon can avoid injuring it. Second, the aorta must be clamped below the renal arteries, and the left renal vein marks the spot where the renal arteries branch off of the aorta.3 If the left renal vein is not visualized in front of the aorta, the surgeon must assume that the patient has either a duplicate vena cava or a retroaortic renal vein. In such a circumstance, the surgeon must be very careful not to tear the left renal vein when dissecting out the aorta from the surrounding tissues and veins.
Even though he had not located the left renal vein, Dr. Sadarangani followed his usual procedure when dissecting the aorta at the neck of the aneurysm, and he ran his thumb along
one side of the aorta and his finger along the other side, pulling the aorta forward to clear it from the tissues behind it. Dr. Sadarangani continued to work his thumb and finger around the aorta, pulling the vessel forward, until his thumb and finger met behind the aorta and it pulled free from the vessels and tissue surrounding it. In choosing to use this technique, Dr. Sadarangani relied on his experience that there normally are no adhesions or scar tissue present in the tissues surrounding the aorta.
As soon as Dr. Sadarangani removed his fingers from around W.R.'s aorta, he noticed bleeding that appeared to originate behind the aorta. He did not know the source of the bleeding but believed that it might originate in the lumbar veins because he observed only a small amount of blood.
Dr. Sadarangani inserted a four-by-four sponge in the area of the bleeding and applied pressure for about five minutes. He removed the sponge, and the area again filled with blood.
Dr. Sadarangani then tried to stop the bleeding by applying a mixture of gel foam and Thrombin to the area, and he applied pressure with a four-by-four sponge for an additional five minutes at the location of the bleeding. Dr. Sadarangani repeated this procedure two or three times and was not able to stop the bleeding.
Dr. Sadarangani still did not know the source of the bleeding, although he knew it was venous blood because of its dark color, and he thought the bleeding might be coming from a lumbar vein.4 The only thing Dr. Sadarangani knew for certain was that the bleeding was coming from behind the aneurysm, so he moved it to the right in an attempt to see the source of the bleeding. As soon as he did so, blood gushed from W.R.'s abdomen, and his blood pressure dropped precipitously.
Dr. Sadarangani moved the aneurysm back to its original position and applied pressure on the top of the aneurysm to stop the bleeding. At the same time, the anesthesiologist began transfusing blood and fluids. After about five to seven minutes, Dr. Sadarangani decided to move the aneurysm to the left to see if he could find the source of the bleeding. As soon as he moved the aneurysm to the left, blood gushed again, W.R.'s blood pressure dropped, and, according to
Dr. Sadarangani, "the anesthesiologist started screaming."
Dr. Sadarangani moved the aneurysm back to its original position and again applied pressure to the top of the aneurysm to stop the bleeding.
Dr. Sadarangani was not able to stop the bleeding.
Because he still had not identified the source of the bleeding, he decided to clamp the aorta above the aneurysm, sever the
aorta below the clamp, and peel back the aneurysm to expose the structure behind it.
Before undertaking this procedure, because he would be handling the aneurysm and did not want to dislodge any clotted material from the aneurysm into the blood stream,
Dr. Sadarangani ordered the anesthesiologist to administer 7,000 units of Heparin to W.R., about three-quarters of the dose he would normally have given a patient of W.R.'s size. On
Dr. Sadarangani's orders, the anesthesiologist administered the Heparin at 11:02 a.m.
Heparin is an anticoagulant blood thinner used to prevent the formation of blood clots whenever a blood vessel is clamped off and the blood flow in the vessel stopped.
Dr. Sadarangani was not concerned about giving a blood thinner and anticoagulant to W.R. even though he was experiencing severe blood loss because W.R.'s blood was being collected by the cell saver5 and re-transfused. In addition to the cell saver,
Dr. Sadarangani had ordered six units of blood typed and cross- matched for W.R. Before he clamped the aorta, he told the anesthesiologist to order all six units of blood to the operating room and to tell the blood bank to type and cross- match more blood.
After the Heparin was administered and the blood ordered, Dr. Sadarangani clamped off the iliac arteries, and
then, at 11:08 a.m., he clamped off the aorta above the neck of the aneurysm. The aneurysm became soft with the decrease in pressure, and the blood flow from behind the aneurysm increased because the aneurysm no longer exerted pressure on the vessels behind it. Dr. Sadarangani then cut horizontally through the aorta and retracted down the aneurysmic portion of the aorta.
At this, W.R.'s abdominal cavity began filling with blood.
Dr. Sadarangani suctioned the blood into the cell saver, and he was able to see that there was a large amount of blood coming from both the right and the left side of the abdomen. There was also some bleeding from behind the aneurysm, and Dr. Sadarangani deflected the aneurysm down further and saw bleeding from another vein.
Once he had suctioned the blood out of the abdominal cavity, Dr. Sadarangani was able to see that one source of bleeding was a long tear in the left renal vein, which was located behind the aorta; blood was also draining from what Dr. Sadarangani described as an abnormally large lumbar vein
joining the left renal vein. The left renal vein was completely open behind the aorta, and the blood was coming from both the vena cava and from the left kidney. Dr. Sadarangani theorized that the lumbar vein and the renal vein had been adhered to the back of the aneurysm and had torn when he manipulated the aneurysm to the left and right.
Normally, the aneurysm itself is not manipulated or resected because there is a lot of tissue adhering to the back portion of the aneurysm.
Dr. Sadarangani temporarily controlled the bleeding by clamping the left renal vein to the right of the aorta, at the point where it joined the vena cava; clamping the left renal vein to the left of the aorta, distal to, or in front of, the adrenal vein and the testicular vein, both of which branch off the left renal vein before it enters the left kidney; and clamping the lumbar vein where it joined the left renal vein.
Although the clamps stopped the bleeding from the veins, there was bleeding from the lumbar arteries that attached to the aneurysmic portion of the aorta. Consequently,
Dr. Sadarangani removed the plaque and clotted material from the wall of the aneurysm, and he sutured the bleeding lumbar arteries. This procedure took between ten and 15 minutes.
Dr. Sadarangani then had to decide how to repair the left renal vein and the lumbar vein. The renal vein was not very tense after Dr. Sadarangani finished suturing the lumbar arteries, and he noticed that the adrenal and testicular veins were becoming larger. He concluded, therefore, that the blood from the left kidney was draining through the adrenal and testicular veins. Dr. Sadarangani decided to excise the torn portion of the left renal vein and to suture it closed both at
the point where it joined the vena cava and at the point distal to the adrenal and testicular veins.6 Dr. Sadarangani also sutured closed the bleeding lumbar vein.
Dr. Sadarangani worked for several hours to stop the bleeding from the left renal and lumbar veins. During this time, W.R.'s blood pressure dropped precipitously several times, and W.R. suffered severe hypovolemia, that is, severe shock.
With the bleeding controlled, Dr. Sadarangani proceeded with the repair of the aneurysm. He completed the anastomosis, or connection of the graft to the aorta, above the aneurysm. He then tested the anastomosis to ensure that there was no bleeding and clamped off the two limbs of the bifurcated tube graft he had chosen to use for the bypass.
Dr. Sadarangani had originally intended to use an aortic tube bypass to repair W.R.'s aneurysm, but when he palpated the aorta below the aneurysm, the aorta felt hard. Dr. Sadarangani also noted that the iliac arteries below the bifurcation of the aorta also felt hard. He decided that it would take too long to remove the plaque from the walls of the aorta and abandoned the idea of using a tube bypass.
Dr. Sadarangani felt along the iliac arteries until he reached soft spots on the anterior of both the left and right iliac arteries. He made a small incision in the soft spot on the right iliac artery, below the clamp, and noted that there
was no retrograde bleeding from the artery.7 He inserted his forceps inside the artery to be sure the walls were separated, and, when he removed the forceps, he saw blood clots inside the artery. Dr. Sadarangani was surprised to see blood clots, and, because it had been several hours since the initial 7,000 units of Heparin had been administered, Dr. Sadarangani ordered the anesthesiologist to administer an additional 2,000 units of Heparin. This dose of Heparin was administered at 1:15 p.m.
Dr. Sadarangani concluded from the lack of retrograde bleeding and from the presence of clots in the iliac artery that
W.R. had blood clots in his lower leg that were blocking the blood flow. Accordingly, Dr. Sadarangani passed a small Fogarty catheter into the right iliac artery several times.8
Dr. Sadarangani chose a small catheter because he wanted the catheter to pass through W.R.'s iliac artery and the femoral artery into the arteries serving the leg, all the way to W.R.'s ankle. Even though he was unable to pass the catheter to the ankle, he brought up blood clots with the first two or three passes of the Fogarty catheter through the right iliac artery, but he did not bring up any clots on the next two or three passes of the catheter.
Dr. Sadarangani noted some retrograde bleeding from the right iliac artery after he removed blood clots with the catheter, but the bleeding quickly stopped. Dr. Sadarangani
inferred from this that there were more blood clots deeper in the femoral artery.
Dr. Sadarangani opened the left iliac artery. He could not pass a Fogarty catheter to W.R.'s ankle through the left iliac artery, but he did bring up blood clots from that artery.
The difficulty could be attributed to the fact that the iliac arteries follow a very tortuous path. The difficulty could also be attributed to the fact that the pre-operative arteriogram established that W.R. had some blockage in the femoral arteries.
Because of the blood clots and his inability to pass the Fogarty catheter deep into W.R.'s leg, Dr. Sadarangani decided to do an aortic-bifemoral bypass instead of an aortic- biiliac bypass. He reasoned that, once he dissected out and opened up the common femoral artery, he would be able to visualize the deep femoral artery and the superficial femoral artery and pass a Fogarty catheter directly into those arteries to eliminate any blood clots in W.R.'s legs. Dr. Sadarangani was particularly concerned about leaving blood clots in W.R.'s arteries because, if clots of a significant size are left in the arteries, they can block blood flow once it is re-established after the bypass graft is attached and the clamps released. If clots block the blood flow in the graft or in the legs, it is
necessary to perform another surgical procedure to remove the clots, and Dr. Sadarangani believed that W.R. could not tolerate a second surgical procedure.
Dr. Sadarangani anticipated that it would take between ten and 15 minutes to open up W.R.'s groin and to expose and get control of the common femoral arteries; it would normally take between ten and 15 minutes per side, but Dr. Sadarangani intended to have Dr. McGuire open the left groin. In
Dr. Sadarangani's opinion, this procedure would be quicker than a biiliac bypass because the iliac arteries are deep, and it is difficult to complete the anastomoses.
Unfortunately, Dr. Sadarangani and Dr. McGuire unexpectedly encountered severe scar tissue when dissecting down to the common femoral arteries, and it took approximately 45 minutes to isolate these arteries. Once Dr. Sadarangani and Dr. McGuire had visualized and dissected out the common femoral arteries, Dr. Sadarangani inserted a Fogarty catheter into the right and then the left superficial femoral arteries, all the way to W.R.'s ankles and assured himself that there were no clots present in W.R.'s legs. Dr. Sadarangani performed the same procedure with the Fogarty catheter into the profundus femoris arteries and into the deep femoral arteries and assured himself that there were no clots below the incisions in the common femoral arteries.
When performing an aortic-bifemoral bypass, it is necessary for the surgeon to make tunnels from the abdominal cavity to the femoral arteries through which the ends of the graft are passed. This is accomplished by the surgeon inserting one finger in the groin and one finger in the abdominal cavity and penetrating the retroperitoneal tissue until the fingers touch. Once the surgeon's fingers touch, a clamp and umbilical tape are passed through the tunnels, the bypass grafts are passed into each side of the groin, and the ends of the grafts are sewn onto the femoral arteries using the same procedure as that used for the iliac arteries with an aortic-biiliac bypass.
After he made the tunnel to the right common femoral artery, Dr. Sadarangani completed the anastomosis and restored blood flow to the right leg. Between 30 and 35 minutes later, Dr. Sadarangani finished the anastomosis on the left common femoral artery, and he unclamped the left femoral artery at 2:55
p.m. Dr. Sadarangani estimates that it took him approximately
30 minutes longer to complete the aortic-bifemoral bypass than it would have taken him to complete an aortic-biiliac bypass.
After blood flow was restored, Dr. Sadarangani flushed W.R.'s groin and abdominal cavity with antibiotic solution, returned his abdominal organs to their proper positions, and closed the incisions.
W.R. was under anesthesia from 8:15 a.m. until 5:10 p.m.; W.R. was actually in surgery from 9:10 a.m. until 4:50 p.m.9 W.R. became hypovolemic approximately three hours
into the surgery, when he suffered massive blood loss, and he suffered ongoing complications from the hypovolemia. W.R.'s total estimated blood loss was 8,600 milliliters of blood, IAT (Intraoperative Autologous Transfusion); W.R. received transfusions of 3,200 milliliters of blood during surgery, and his actual blood loss was 5,400 milliliters.10
W.R. was taken from surgery directly to intensive care. His condition deteriorated, and he died on the evening of August 24, 1993, from hyperkalemia with renal failure.11 The blood loss W.R. experienced during surgery, and the resulting hypovolemia, contributed to the renal failure.
No matter how good the surgical technique, there is always some blood loss during the repair of an abdominal aortic aneurysm. Because of the need to create tunnels through the retroperitoneal tissue in the groin, an aortic-bifemoral bypass increases the amount of blood loss during surgery, especially in a patient who has received an anticoagulant.
The most critical factor affecting a patient's ability to survive the repair of an abdominal aortic aneurysm is the amount of time the aorta is clamped shut, with the blood flow through the body interrupted. Stress is placed on the heart
because there is higher pressure in the upper body because the heart is profusing only half of the body while the aorta is clamped. In addition, half of the body is not receiving significant blood flow, which leads to pooling of blood and metabolic stresses that can decrease cardiac output. In this case, W.R.'s aorta was clamped shut from approximately 11:00
a.m. until approximately 3:00 p.m., a period of four hours.
Normally, the aorta is clamped approximately two to three hours during an aortic-bifemoral bypass.
Summary.
The evidence presented by the Department is sufficient to establish that a reasonably prudent cardio-thoracic surgeon would have located the left renal vein before beginning to dissect around the aorta and separate it from the surrounding tissues. In this case, Dr. Sadarangani did not visualize the left renal vein when he dissected down to the aorta. Even though he knew it was possible that W.R. had a retroaortic left renal vein, Dr. Sadarangani nonetheless proceeded with the blunt dissection of the aorta at the neck of the aneurysm, slipping his fingers behind the aorta and pulling it forward.
Dr. Sadarangani also failed to recognize that the bleeding from behind the aorta might have originated from the left renal vein. By moving the aneurysm to the left and then to the right,
Dr. Sadarangani most likely exacerbated the tear in the renal
vein, and by retracting the aneurysm forward, he completely opened that portion of the left renal vein lying behind the aneurysm. While this latter procedure was necessary to expose the source of the bleeding in order to ultimately control it, Dr. Sadarangani should have identified the left renal vein before dissecting forward the aorta at the neck of the aneurysm.
The evidence presented by the Department is sufficient to establish that a reasonably prudent cardio-thoracic surgeon would not have administered Heparin to a patient who was experiencing massive blood loss as a result of a torn left renal vein. It is not appropriate to administer Heparin to a patient who is experiencing or has experienced uncontrolled bleeding. Massive blood loss during surgery is life threatening, and the surgeon's foremost concern should be controlling the bleeding. Administering a blood thinner when a patient is bleeding uncontrollably is contraindicated, especially since massive blood loss in itself thins the blood. It should also be noted that Dr. Sadarangani had manipulated the aneurysm by moving it to the left and the right before he told the anesthesiologist to administer the Heparin.
The evidence presented by the Department is not sufficient to establish that a reasonably prudent cardio- thoracic surgeon, under the circumstances presented to
Dr. Sadarangani, would have performed an aortic-biiliac bypass
rather than an aortic-bifemoral bypass. It was not unreasonable for Dr. Sadarangani to be concerned about blood clots in W.R.'s legs given the lack of retrograde bleeding and the presence of blood clots in the iliac arteries. Both the lack of retrograde bleeding and the presence of blood clots could be indicative of clots further down in the leg, and Dr. Sadarangani's decision to perform an aortic-bifemoral bypass was not unreasonable since he was unable to insert the Fogarty catheter far enough into W.R.'s arteries to assure himself that no clots were present in W.R.'s lower legs. Dr. Sadarangani's decision was based on the particular circumstances he encountered in this case, and the Department has failed to establish that his decisions departed from the acceptable standard of care.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the subject matter of this proceeding and of the parties thereto pursuant to Sections 120.569 and 120.57(1), Florida Statutes (1999).
Section 458.331, Florida Statutes (1993), provides in pertinent part as follows:
The following acts shall constitute grounds for which the disciplinary actions specified in subsection (2) may be taken:
* * *
(t) Gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The board shall give great weight to the provisions of
s. 766.102 when enforcing this paragraph. As used in this paragraph, "repeated malpractice" includes, but is not limited to, three or more claims for medical malpractice within the previous 5-year period resulting in indemnities being paid
in excess of $10,000 each to the claimant in a judgment or settlement and which incidents involved negligent conduct by the physician. As used in this paragraph, "gross malpractice" or "the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances," shall not be construed so as to require more than one instance, event, or act. Nothing in this paragraph shall be construed to require that a physician be incompetent to practice medicine in order to be disciplined pursuant to this paragraph.
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(3) In any administrative action against a physician which does not involve revocation or suspension of license, the division shall have the burden, by the greater weight of the evidence, to establish the existence of grounds for disciplinary action. The division shall establish grounds for revocation or suspension of license by clear and convincing evidence.
In its Administrative Complaint, the Department sought, among other penalties, the revocation or suspension of Dr. Sadarangani's license to practice medicine. Therefore, the
Department has the burden of proving the allegations in the Administrative Complaint by clear and convincing evidence. Section 458.331(3), Florida Statutes (1993). See also Department of Banking and Finance, Division of Securities and Investor Protection v. Osborne Stern and Co., 670 So. 2d 932
(Fla. 1996); Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987).
Judge Sharp, in her dissenting opinion in Walker v.
Florida Department of Business and Professional Regulation, 705 So. 2d 652, 655 (Fla. 5th DCA 1998)(Sharp, J., dissenting), reviewed recent pronouncements regarding clear and convincing evidence:
Clear and convincing evidence requires more proof than preponderance of evidence, but less than beyond a reasonable doubt. In re Inquiry Concerning a Judge re Graziano, 696 So. 2d 744 (Fla. 1997). It is an intermediate level of proof that entails both qualitative and quantative [sic] elements. In re Adoption of Baby E.A.W., 658 So. 2d 961, 967 (Fla. 1995), cert.
denied, 516 U.S. 1051, 116 S. Ct. 719, 133
L. Ed. 2d 672 (1996). The sum total of evidence must be sufficient to convince the trier of fact without any hesitancy. Id. It must produce in the mind of the trier of fact a firm belief or conviction as to the truth of the allegations sought to be established. Inquiry Concerning Davie, 645 So. 2d 398, 404 (Fla. 1994).
The Department's burden with respect to its charge that Dr. Sadarangani violated Section 458.331(1)(t), Florida Statutes (1993), is proof by clear and convincing evidence that
Dr. Sadarangani 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." Based on the findings of fact herein, the Department has satisfied this burden with respect to Dr. Sadarangani's failure to locate W.R.'s left renal vein before commencing the dissection of the neck of the aneurysm and with respect to his decision to administer Heparin to W.R. while he was suffering massive blood loss from the torn left renal vein and lumbar vein.
In its Proposed Recommended Order, the Department has recommended imposing a penalty against Dr. Sadarangani consisting of a reprimand and the payment of an administrative fine of $2,000.00. Having considered the penalty range set forth in Rule 21M-20.001(2)(t), Florida Administrative Code, for a violation of Section 458.331(1)(t), and having weighed the aggravating and mitigating circumstances set forth in Rule 21M- 20.001(3), Florida Administrative Code, it is concluded that the penalty recommended by the Department is appropriate.
Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Nari T. Sadarangani, M.D., violated
Section 458.331(1)(t), Florida Statutes (1993), issuing a
reprimand to Dr. Sadarangani, and imposing an administrative fine in the amount of $1,200.00
DONE AND ENTERED this 29th day of March, 2001, in Tallahassee, Leon County, Florida.
PATRICIA HART MALONO
Administrative Law Judge
Division of Administrative Hearings The DeSoto Building
1230 Apalachee Parkway
Tallahassee, Florida 32399-3060
(850) 488-9675 SUNCOM 278-9675
Fax Filing (850) 921-6847 www.doah.state.fl.us
Filed with the Clerk of the Division of Administrative Hearings this 29th day of March, 2001.
ENDNOTES
1/ Arteries have relatively thick walls and are less prone to tearing than veins, which have thinner walls.
2/ Hemodynamic status refers to the blood pressure and pulse.
3/ In 95 percent of the cases, the abdominal aortic aneurysm is located below the renal arteries. A serious complication with the repair of an abdominal aneurysm exists when the aneurysm extends above the renal arteries because it is then necessary to clamp off these arteries, thereby cutting off blood flow to the kidneys and potentially causing renal failure.
4/ A lumbar vein is a very small vein that drains the lumbar musculature into the vena cava.
5/ A cell saver is a machine that collects the blood a patient loses as surgery progresses. The blood flows into a chamber where it is mixed with Heparin. It is then washed with a saline solution, filtered to remove clots and loose plaque, and collected by a technician, who again mixes the blood with
anticoagulant. The technician then gives the blood to the anesthesiologist for transfusion back into the patient.
6/ Had the blood not been draining from the kidney through these veins, Dr. Sadarangani would have had no choice but to repair the left renal vein and lumbar vein by pulling together the sides of the left renal vein and the lumbar vein and suturing the sides together to make the vessels whole again, a procedure that would have taken between 30 and 45 minutes.
7/ Retrograde bleeding is "backward" bleeding, caused by blood that is flowing in the opposite direction from the direction in which it normally flows. Retrograde bleeding from the iliac arteries during the repair of an aneurysm results from venous blood pressure building up in the arteries of the lower body while the arteries are clamped shut.
8/ A Fogarty catheter is used to extract blood clots from blood vessels. It is a catheter with a balloon on one end that is passed into and threaded down a blood vessel. The balloon is blown up and the catheter is pulled back through the blood vessel.
9/ The anesthesiologist's report indicates that the surgery time was from 8:15 until 18:50, or 6:50 p.m.; this appears to be an error, and the correct time the surgery ended was 16:50, or
4:50 p.m.
10/ A man of W.R.'s size would have between 7,500 and 8,000 milliliters of blood circulating in his system.
11/ Hyperkalemia is an excess of potassium in the blood caused by the kidney's failure to excrete potassium. When there is a high level of potassium in the blood, the heart cannot contract, and the patient has cardiac fibrillation.
COPIES FURNISHED:
Robert C. Byerts, Esquire
Agency for Health Care Administration Post Office Box 14229
Tallahassee, Florida 32317-4229
Brian A. Newman, Esquire Pennington, Moore, Wilkinson,
Bell & Dunbar, P.A. Post Office Box 10095
Tallahassee, Florida 32302-2095
Theodore M. Henderson, Agency Clerk Department of Health
4052 Bald Cypress Way Bin A00
Tallahassee, Florida 32399-1701
Tanya Williams, Executive Director Board of Medicine
Department of Health 4052 Bald Cypress Way
Tallahassee, Florida 32399-1701
NOTICE OF RIGHT TO SUBMIT EXCEPTIONS
All parties have the right to submit written exceptions within
15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.
| Issue Date | Document | Summary |
|---|---|---|
| Jun. 27, 2001 | Agency Final Order | |
| Mar. 29, 2001 | Recommended Order | Department established that surgeon performing surgery to repair abdominal aneurysm failed to use reasonable care when dissecting aorta and by ordering Heparin be administered to patient bleeding uncontrollably from left renal artery. |
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