STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF HEALTH, BOARD OF ) MEDICINE, )
)
Petitioner, )
)
vs. )
) KRISHNASAMY SOUNDARARAJAN, )
)
Respondent. )
Case No. 02-4849PL
)
RECOMMENDED ORDER
Pursuant to notice, Daniel M. Kilbride, Administrative Law Judge, Division of Administrative Hearings, held a formal hearing in the above-styled case on March 6, 2003, in Orlando, Florida.
APPEARANCES
For Petitioner: Daniel M. Lake
Assistant General Counsel Department of Health
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265
For Respondent: Michael D'Lugo, Esquire
Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A.
390 North Orange Avenue, Suite 1000 Orlando, Florida 32802
STATEMENT OF THE ISSUE
Whether disciplinary action should be taken against Respondent's license to practice medicine based on allegations
that Respondent violated the provisions of Subsections 458.331(1)(m) and (t), Florida Statutes, arising from his treatment and care of Patient M.R., as alleged in the Administrative Complaint in this proceeding.
PRELIMINARY STATEMENT
On October 15, 2002, Petitioner alleged in an Administrative Complaint that Respondent failed to practice medicine with an acceptable level of care in the treatment of Patient M.R., in one or more of the following ways:
(a) Respondent left all or part of the intra-luminal shunt in Patient M.R. in or near Patient M.R.'s right carotid artery during the first operation on November 27, 2000; (b) Respondent failed to more closely examine Patient M.R.'s right carotid artery at the close of the first surgery on November 27, 2000, to look for and retrieve any foreign bodies remaining in or near Patient M.R.'s carotid artery; (c) Respondent failed to more closely examine the area of Patient M.R.'s right carotid artery at the time of the second operation on November 28, 2000, to look for and retrieve any foreign bodies remaining in or near Patient M.R.'s carotid artery; and (d) Respondent failed to comprehend the reason for Patient M.R.'s hemodynamic instability on November 27 and 28, 2000.
Further, Petitioner alleged that Respondent failed to keep a medical record justifying the course of treatment of Patient
M.R., in one or more of the following ways: (a) Respondent's records fail to adequately identify either the origin or the location of the piece of tubing removed from the area of Patient M.R.'s right carotid artery on November 29, 2000; and (b) Respondent's records demonstrate that Respondent lacked an understanding of the reason for Patient M.R.'s hemodynamic instability on November 27 and 28, 2000. On November 14, 2002, Respondent denied the allegations and requested a formal hearing. This matter was set for hearing and discovery ensued.
At the hearing, Joint Composite Exhibit 1 (medical records of Patient M.R. from Orlando Regional Healthcare System (Orlando Regional Medical Center (ORMC)), Joint Exhibit 2 (deposition testimony of Dr. John D. Horowitz), Joint Exhibit 3 (deposition testimony of Dr. Joseph C. Muller), Joint Exhibit 4 (affidavit of Dr. Latal Bansal) Joint Exhibit 5 (affidavit of Dr. Peter Taylor, and Joint Exhibit 6 (affidavit of Registered Nurse Marita Lu) were admitted in evidence. Official Recognition was given to Petitioner's Request for Admissions and Respondent's corresponding answers. Petitioner called four witnesses to testify. Four exhibits for Petitioner were admitted in evidence: Petitioner's Exhibit 1 (Curriculum Vitiate of Petitioner's Expert Dr. James Dennis), Petitioner' s Exhibit 2 (Correspondence from the Agency for Health Care Administration to Dr. Dennis), Petitioner's Exhibit 3 (written expert opinion
by Petitioner's expert Dr. Dennis), and Petitioner's Exhibit 4 (deposition of Petitioner's expert Dr. Dennis). Two exhibits were received on behalf of Respondent, Respondent's Exhibit 1 (Respondent's Curriculum Vitiate) and Respondent's Exhibit 2 (feeding tube), which were admitted into evidence. Respondent called two witnesses on his behalf and testified in his own behalf. In addition, Respondent submitted on April 22, 2003, the deposition testimony of Morris Kerstein, M.D., a board- certified vascular surgeon whom Respondent retained as an expert. Based upon a stipulation of the parties, it was agreed that Dr. Kerstein's deposition could be taken after the conclusion of the final hearing in this matter. Dr. Kerstein's deposition testimony is considered as if it had been given as live testimony, and is afforded no more and no less weight than afforded the witnesses who testified live at the final hearing.
The parties were given 15 days from the date of the filing and posting of the official transcript or the late-filed deposition, which was filed on April 22, 2003, in which to file proposed recommended orders. Petitioner filed its Proposed Recommended Order on May 6, 2003; Respondent filed its proposals on May 7, 2003. Both parties' proposals have been given careful consideration in the preparation of this Recommended Order.
FINDINGS OF FACT
Effective July 1, 1997, Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes, and Chapters 456 and 458, Florida Statutes.
Respondent is and has been at all times material hereto a licensed physician in the State of Florida, having been issued license number ME 0077248. Respondent is a vascular surgeon, who is not board-certified in his area of practice.
On November 27, 2000, Patient M.R., a 70-year-old male, was admitted to ORMC for a right-side carotid endarterectomy.
Patient M.R. initially presented to Respondent in October 2000 with a number of health conditions, including chronic obstructive pulmonary disease (related to a 54-year history of smoking), cerebral vascular disease, atherosclerotic changes, and hypertension. Patient M.R. had a significant cardiac condition which resulted in a bypass procedure.
It was determined at that time that Patient M.R. had significant stenosis in both carotid arteries which would require Patient M.R. to undergo two separate procedures, known as carotid endarterectomies.
The left carotid artery was the subject of the first procedure in October 2000. Patient M.R. tolerated this procedure with no complications.
Subsequent to the first carotid endarterectomy, but prior to the second, Patient M.R. suffered a transient ischemic attack (TIA), which is commonly referred to as a "mini-stroke."
The symptomatic clinical presentation placed Patient
M.R. in a high-risk category for peri-operative stroke.
Respondent performed a right carotid endarterectomy on Patient M.R. on November 27, 2000. This requires the clamping of the artery in two locations, using a shunt to allow for the flow of blood. The incision must be made length wise in the controlled portion of the artery using an instrument to clear out the interior or lumen of the artery. This is done to reduce the stenosis and allow for better blood flow, without disbodying any particle from the wall of the artery. Once this is completed, the incision is patched, the clamps and shunt are removed, and the outer skin incision is closed.
During the course of the above-described carotid endarterectomy, Respondent used a patch angioplasty with intra- operative shunt, which was manufactured from a pediatric feeding tube, and peri-operative neurologic monitoring.
Immediately after the operation, the patient appeared to tolerate the procedure well, but was lethargic. Patient M.R. exhibited good movement in all four extremities and appeared to be neurologically intact, although he underwent extreme
fluctuation in blood pressure. Patient M.R. was placed on ventilator support.
The next morning, November 28, 2000, Patient M.R. had swelling and a hematoma in his neck on the right side, in the area of the incision. Respondent returned Patient M.R. to surgery, for exploration and evacuation of the hematoma.
During the course of this second operation, Respondent observed a lot of swelling and edema in the operative site, but not much blood. Respondent evacuated the hematoma, and the carotid artery was found to have good blood flow.
Later in the evening on November 28, 2000, Patient
M.R. developed an acute neurologic deficit and was returned to the intensive care unit (ICU) at ORMC.
Respondent ordered a Computerized Tomographry Scan (CT Scan) of the patient and an arteriogram. The results of the CT Scan showed a probable right occiptal infarct (stroke). The arteriogram showed significant occlusion of the right carotid artery extending to the carotid siphon.
Patient M.R. was returned to the operating room in the early morning hours of November 29, 2000. Respondent made the decision to reopen the surgical area in an effort to resume blood flow in the right carotid artery that was seen to be occluded on the angiogram. Assisting Respondent on this November 29, 2000, procedure were John Horowitz, M.D., a board-
certified vascular surgeon with nine years of experience, and Joseph Muller, M.D., a third-year general surgical resident at ORMC.
During the November 29, 2000, procedure, Respondent reopended the previous incision in the skin and partially opened the patch that had previously been used over the carotid artery itself. Respondent performed a thrombectomy using a Fogarty "balloon" catheter in an effort to extract any debris that was causing the stenosis in the carotid artery.
The balloon is placed into the carotid artery itself and is pushed up into the artery until it has passed whatever occlusion is present. Then the balloon is inflated and pulled back out, pulling with it any debris that is located within the artery.
Near the conclusion of this November 29, 2000, procedure, a small piece of tubing was discovered in the surgical field. The piece of tubing was handed to Dr. Horowitz, who examined it and then placed it on the surgical tray. This piece of tubing was the same size, slope, and material cut from the feeding tube which was used as a shunt in the first surgery on November 27, 2000.
There is conflicting testimony regarding the precise size and location of this piece of tubing that will be discussed below. What remains undisputed based upon the record in this
case is that Respondent completed the surgical procedure on November 29, 2000, by closing the incision in the carotid artery and also in the skin of the neck.
Dr. Muller is currently a surgical resident at ORMC, as he was at the time of the November 29, 2000, procedure.
Dr. Muller testified that he had approximately two years and five months of residency training prior to the procedure in question. He estimated that he had observed approximately ten to 15 carotid endarterectomies.
Dr. Muller testified that he observed a clear and slightly opaque piece of pediatric feeding tube coming out of the lumen of the artery as Respondent was evacuating debris after the inflation of the Fogarty balloon catheter and after about three passes of the catheter. Dr. Muller also testified that the piece of tubing in question was two or three centimeters in length. The other witnesses to this event testified that the piece in question was two to three millimeters in length. Dr. Muller's description of the position of the surgeon and assistant surgeon was also contrary to that of the other witnesses. Dr. Muller also testified that he did not know Patient M.R.'s medical history or his previous hospital course of treatment.
Dr. Horowitz, the senior physician assisting, is a board-certified vascular surgeon who has performed several
hundred carotid endarterectomies. He testified that he was called in by Respondent to assist on the surgical procedure which took place in the early morning hours of November 29, 2000. He found the piece of tubing located somewhere within the surgical field, remote from the carotid artery. He was certain that it was after Respondent had cleared the artery with the use of the Fogarty balloon catheter and had cleared the surgical wound. Dr. Horowitz testified that he saw a piece of tubing among the debris that had been evacuated from the surgical wound. It was not in the lumen of the artery. He picked up the piece of tubing in question with his thumb and forefinger and examined it. He testified that it was approximately two to three millimeters in length. He agreed that the material was consistent with the pediatric feeding tube that was used to create a shunt for the first procedure. Dr. Horowitz's testimony is credible and persuasive.
Dr. Horowitz also gave his opinion that based upon his observation of the November 29, 2000, procedure, he did not believe that Respondent deviated from the standard of care in his treatment and care of Patient M.R.
Patient M.R. was returned to the ICU, where he deteriorated and showed evidence of complete lack of brain stem reflexes. Patient M.R. was later pronounced brain dead, and he subsequently died on November 30, 2000.
Gregory Schreiber, M.D., was the anesthesiologist who was present for a portion of the November 29, 2000, procedure. Dr. Schreiber testified that he was present during the beginning portion and the end portion of the procedure, when anesthesia is introduced and when anesthesia is abated. He was not present in the operating room when the piece of tubing was found. Further, there was a drape that separates the operative field from the anesthesiologist during the course of this procedure, which would have prevented Dr. Schreiber or his assistant from being able to see into the operative field directly.
Dr. Schreiber noted that Patient M.R. was considered a very high-risk patient, whose multiple co-existent diseases posed a constant threat to his life when he presented for this surgery.
In addition to the testimony outlined above, Petitioner also introduced three affidavits into evidence. One affidavit was that of Lata Bansal, M.D., a neurologist who was brought in for consultation after the November 29, 2000, procedure. Dr. Bansal swore in her affidavit that when she first saw Patient M.R. he was already brain dead. She otherwise did not have specific recollection of Patient M.R. The affidavit of Peter D. Taylor, M.D., a cardiac specialist, stated that he recommended a Thallium stress test for Patient M.R. prior to carotid surgery. The stress test was conducted on
October 17, 2000, and revealed no ischemia but moderately decreased left ventricle function. Because he had no ischemia, Dr. Taylor opined that Patient M.R. was at an increased but acceptable risk for carotid surgery. The affidavit of Marita Lu, Registered Nurse, who was present during the November 29, 2000, procedure, stated that she could remember very few details of Patient M.R.'s case, other than she has the "impression" that something was recovered from the wound and that when she asked whether there was a specimen, she was told there was no specimen. Nothing in her affidavit indicates to whom she asked this question regarding the specimen nor is there any indication who responded to her question.
Respondent is a board-certified general surgeon who is eligible for a special certification in vascular surgery and who was working at a vascular surgery group in Orlando, Florida, as of October and November of 2000. Respondent no longer practices in the State of Florida. He currently is an assistant professor of surgery and director of endovascular surgery at Creighton University in Omaha, Nebraska.
Respondent described in detail each of the three procedures he performed. On November 27, 2000, the original procedure on the right carotid artery proceeded in routine fashion. Respondent provided an exemplar, which was admitted into evidence, of a pediatric feeding tube which is
substantially similar to the pediatric feeding tube utilized in the November 27, 2000, procedure on Patient M.R. He utilizes a portion of the pediatric feeding tube as a shunt in his carotid endarterectomy procedures. He demonstrated at the final hearing that the pediatric feeding tube itself is so flexible as to be incapable of breaking. The only means of cutting it down is through the use of surgical instruments. He also indicated that there was no way to further cut down the tubing once it had been placed.
The scrub technician cut the pediatric feeding tube into the appropriate length to be used as a shunt during the November 27, 2000, procedure. Respondent recalled that prior to this particular procedure, the tubing in question was not originally cut down to the appropriate size. It had to be cut down while in the operating room. It is during this cutting of the tubing that a tiny sliver, approximately two to three millimeters in length, was removed from the larger piece of tubing and entered the surgical field. Respondent did not know and did not have any way of knowing that the piece of tubing had entered the surgical field, as he was focused on preparing the artery itself for its incision while this tubing was cut. Respondent testified that the pediatric feeding tube in question was cut down to size before any incision was made in the carotid artery itself.
Respondent performed the November 27, 2000, procedure as he normally does. After the procedure, Patient M.R. experienced extreme fluctuations in blood pressure. This can occur in patients due to multiple factors involving the nervous tissue and blood flow in the carotid artery, but there is no specific explanation for why it does happen. Subsequent to the November 27, 2000, procedure, Respondent monitored Patient M.R., addressing the extreme fluctuations in blood pressure along with the consulting physicians referred to above.
Respondent noted that Patient M.R. developed a hematoma subsequent to the first procedure. He made a determination that the best course for Patient M.R. would be to evacuate the hematoma. In Respondent's opinion, evacuating the hematoma would speed up the healing process. Respondent performed this procedure on November 28, 2000. Patient M.R. tolerated this procedure well, and there was nothing remarkable about the procedure itself. Respondent palpated Patient M.R.'s artery during the course of this procedure and used the Doppler to reinforce his findings on palpation. A Doppler signal gives more specific information about the varied nature of blood flow in the internal and external carotid arteries. It was not Respondent's standard practice, nor is it necessary, to create a medical record that palpation of the artery has occurred, since
it is such a basic and common occurrence that its notation on the record is not deemed to be necessary.
Respondent continued to follow Patient M.R. subsequent to the November 28, 2000, procedure. When it was determined that Patient M.R. had suffered a stroke, Respondent was left with a choice of either doing nothing, or reopening the artery in an effort to save Patient M.R.'s life. Respondent chose to reopen the artery in an effort to determine whether anything could be done to save Patient M.R. Respondent opened the prior incision in the carotid artery on November 29, 2000, and inserted the Fogarty catheter in order to evacuate any debris that was located within the carotid artery. Respondent testified that it was at about this time that the piece of tubing was found; however, he further testified that he did not see the tubing in question come from the lumen of the carotid artery. Respondent's testimony is credible.
It was Respondent's opinion testimony that the piece of tubing in question was located in the subcutaneous tissue outside of the artery. Its exact location within the various layers of subcutaneous tissue was not observed during the procedure. It was not possible for the piece of tubing in question to have entered the artery at this time. There was no evidence to suggest that the piece could have migrated into the artery at a later time.
James Dennis, M.D., is a board-certified vascular surgeon who is the chief of the vascular surgery department at the University of Florida in Jacksonville, Florida. Dr. Dennis has sufficient education, training, and experience to qualify as an expert in vascular surgery under Florida law.
Dr. Dennis testified that he reviewed all of the pertinent medical records concerning the treatment and care provided by Respondent to Patient M.R. and that based upon his review of these records and based upon his education, training, and experience, it was his opinion to within a reasonable degree of medical probability that Respondent deviated from the accepted standard of care in his treatment and care of Patient M.R., which constituted a violation of Subsection 458.331(1)(t), Florida Statutes. Dr. Dennis also testified that in his opinion, Respondent violated Subsection 458.331(1)(m), Florida Statutes, in that he failed to compile appropriate medical records reflecting the treatment and care provided to Patient M.R.
Dr. Dennis' standard of care opinions were based on several factors. First, it was Dr. Dennis' opinion that based upon the contents of the chart, the only time that the piece of pediatric feeding tube could have entered Patient M.R. was during the course of the November 27, 2000, procedure.
Dr. Dennis testified that in his opinion, Respondent deviated from the standard of care in allowing the piece of pediatric feeding tube to enter Patient M.R.'s body. This would be his opinion even if Respondent did not see the sliver of tubing in question enter Patient M.R.'s body and even if the piece of tubing in question were so small and translucent as to be practically invisible.
Dr. Dennis also testified that in his opinion, Respondent deviated from the standard of care during the November 28, 2000, procedure in that he failed to adequately palpate the carotid artery. Dr. Dennis was critical of Respondent's use of a Doppler to assess Patient M.R.'s pulse. In Dr. Dennis' opinion, the use of the Doppler was indicative a weakening pulse rate and that the proper practice would have been to palpate the artery by touch rather than by using a Doppler instrument. Dr. Dennis was also critical of Respondent during the November 28, 2000, procedure for his failure to find
the piece of tubing in question. It is Dr. Dennis' opinion that the piece of tubing had to have been located within the lumen of the artery and that had Respondent adequately palpated the entire length of the carotid artery during the November 28, 2000, procedure, he would have located the piece of tubing within the artery and could have taken appropriate steps to remove the piece of tubing before Patient M.R. suffered his
stroke later that night or during the early morning hours of November 29, 2000.
Dr. Dennis' opinion that the piece of tubing in question had to have been located in the lumen of the artery was also based upon his assessment of the procedures performed. He discounted the theory that the piece of tubing was located within subcutaneous tissue outside of the artery because, in his opinion, the piece of tubing would have been discovered either during the November 28, 2000, procedure or earlier in the November 29, 2000, procedure if it had been outside the artery. However, according to Dr. Dennis, based upon the timing of when the piece of tubing was found, the tubing itself had to have been located within the lumen of the artery until it was removed in the November 29, 2000, procedure.
Dr. Dennis also rendered the opinion that not only was the piece of tubing located within the lumen of the carotid artery, but that the piece of tubing is directly related to the stroke which Patient M.R. suffered later that day or the following morning, which caused his death. Dr. Dennis testified that the piece of tubing became lodged in Patient M.R.'s carotid artery and that as blood flowed by it, platelets attached to the tubing, slowly building up with the carotid artery, until Patient M.R. experienced 100 percent stenosis in the right carotid artery, leading to his stroke. In sum, Dr. Dennis'
opinion was that Respondent deviated from the standard of care by allowing a piece of tubing to enter Patient M.R.'s carotid artery and that it was this tubing which lead to Patient M.R.'s stroke and ultimately his death. This is in spite of the fact that Dr. Dennis was not able to state within any degree of medical probability how the sliver of tubing could have entered the artery.
Dr. Dennis also rendered an opinion during his final hearing testimony that Respondent deviated from the standard of care because he did not secure the piece of tubing at issue in this case and see to it that the tubing was sent to the pathology laboratory at ORMC for analysis.
Morris Kerstein, M.D., a board-certified vascular surgeon, reviewed all of the pertinent medical records reflecting the treatment and care Respondent provided to Patient
M.R. Dr. Kerstein had been practicing for 35 years, and he is currently the chief of the vascular surgery department at the Veteran's Administration Hospital in Philadelphia, Pennsylvania. Dr. Kerstein has sufficient education, training, and experience to qualify as an expert in vascular surgery under Florida law.
Dr. Kerstein's opinion based upon his education, training, and experience is that Respondent did not deviate from the standard of care in his treatment of Patient M.R. First, Dr. Kerstein testified that in his opinion, Respondent's conduct
during all three procedures at issue was appropriate. As to the November 27, 2000, procedure, there was no way for Respondent to be aware that the piece of pediatric feeding tube had entered the operative field. It was too small to be noticed, and it was of a translucent color which made locating it extremely difficult. He was not critical of Respondent for not cutting the tubing himself. He testified that if, in fact, the sliver of tubing entered the surgical area as a result of the scrub technician cutting the tubing, and a two to three millimeter fragment jettisoned into the surgical field, this would not constitute a deviation from the standard of care by Respondent.
Dr. Kerstein testified that he felt the November 28, 2000, procedure was performed appropriately as well. He testified that it was not a deviation for Respondent to use a Doppler to feel for pulses in the arteries, and to the contrary, it reveals that Respondent was being meticulous beyond what the standard of care requires. He opined that Respondent certainly would have palpated the arteries in question, and to suggest otherwise based on the absence of a note to that effect is not an appropriate conclusion to draw.
Dr. Kerstein rendered the opinion that he did not believe that the piece of tubing in question was located within the lumen of the artery of Patient M.R. He testified that there was no way for the tubing to enter the artery because the sliver
in question came off of the longer tubing before an incision was made in the carotid artery. There is therefore no reasonable explanation as to how the piece in question could have entered the carotid artery in the first place.
Dr. Kerstein also disputed the theory that not only was the piece of tubing located within the lumen of the artery, but also the piece in question actually caused Patient M.R.'s stroke. Dr. Kerstein relied principally on the radiographic studies. Both the CT Scan of the brain and the angiogram taken late in the evening of November 28, 2000, revealed a right posterior occipital infarct. The posterior of the brain is the back of the brain, and if the infarct was located there, it means that the cause of the stroke had to be something other than an occlusion in the carotid artery. This is because the arteries that feed the back portion of the brain are the basilar and vertebral arteries, not the carotid artery. Therefore, there could be no possible causal connection between the sliver in question and Patient M.R.'s stroke.
Dr. Kerstein's opinion as to the cause of Patient M.R.'s stroke focused on his personal history rather than on the events of November 27, 2000. He noted that Patient M.R. presented with severe atherosclerotic changes, indicative of an advanced disease process. He noted that Patient M.R. suffered from chronic obstructive pulmonary disease, which was the
product of his 54-year smoking history. He also noted Patient M.R.'s significant cerebrovascular disease. He also stated that thrombosis (or clotting of the blood) is a known complication of this procedure and can happen for several plausible reasons other than a sliver of tubing in the artery. All of these conditions conspired to predispose Patient M.R. to suffer a significant event such as the stroke he suffered on November 28 through 29, 2000.
Dr. Kerstein also noted that the piece of tubing was completely inert, and given its size and its location in the subcutaneous tissue outside of the carotid artery, the tubing would have had no impact whatsoever on Patient M.R.'s prognosis. The tubing in question is an example of inert material that can remain inside the body, such as the case of a bullet which is located too close to the spinal cord to allow for an operation to remove it, without causing the body any harm.
Dr. Kerstein had no criticism of the medical records Respondent kept regarding the treatment he provided to Patient
M.R. He specifically noted that the records were accurate and honestly reflected what had occurred during the procedure. The fact that no foreign object was noted in the first two procedures was appropriate because at that point, he had no reason to suspect the presence of a foreign object. The lack of reference to a cause of Patient M.R.'s atypical post-operative
course was appropriate because in fact Respondent could not have defined a single reason why Patient M.R. was reacting the way he did. Finally, the operative note from the November 29, 2000, procedure was appropriate, as it also honestly and accurately depicted what had occurred; he made a specific comment on Respondent's note that the sliver was not indeed from the lumen, but that the exact location was unclear, finding this to be an unambiguous statement of fact.
Dr. Kerstein also disagreed with the state's position with regard to the responsibility for maintaining possession of the piece of tubing post-operatively. Dr. Kerstein testified that it was the responsibility of the circulating nurse, an employee of the hospital, to arrange for the piece of tubing to be sent to the pathology lab for examination.
The evidence is insufficient to support Petitioner's contention that the pediatric feeding tube sliver at issue caused Patient M.R. to suffer a stroke because of its location within the carotid artery itself. Radiographic studies were performed on Patient M.R. after the stroke. A CT Scan performed on November 28, 2000, revealed an acute right posterior cerebral artery distribution infarct. Further, a cerebral angiogram was performed on November 28, 2000, and revealed "markedly diseased circulation particularly in the right vertebral and basilar
arteries." This note also revealed: "Severely diseased posterior fossa circulation."
Based upon the location of the infarct in Patient M.R.'s brain, the cause of the stroke had to have been either the vertebral or basilar arteries that supply blood to the posterior part of the brain.
In view of all the evidence, the expert testimony of Dr. Kerstein, together with that of Dr. Horowitz, was more persuasive than that of Dr. Dennis in regard to the standard of care and Respondent's actions in this matter.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties and subject matter of this proceeding, pursuant to Subsection 120.57(1) and Section 120.569, Florida Statutes, and Section 456.073(5), Florida Statutes.
Pursuant to Subsection 458.331(2), Florida Statutes, the Board of Medicine is empowered to revoke, suspend or otherwise discipline the license of a physician for the following violations of Subsections 458.331(1)(m) and (t), Florida Statutes:
(m) Failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician or the physician extender and supervising physician by name and
professional title who is or are responsible for rendering, ordering, supervising, or billing for each diagnostic or treatment procedure and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drug prescribed, dispensed or administered; and reports of consultations and hospitalizations.
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(t) Gross or repeated malpractice or the failure to practice medicine with that level or care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. . . .
Rule 64B8-9.003(2), Florida Administrative Code, requires that medical records contain, "sufficient detail to clearly demonstrate why the course of treatment was undertaken or why an apparently indicated course of treatment was not undertaken."
Rule 64B8-9.003(3), Florida Administrative Code, requires that the medical record "shall contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at
the request for the physician and relied upon by the physician in determining the appropriate treatment of the patient."
Patient records must contain a sufficient amount of information so that "neutral third parties can observe what transpired during the course of treatment of a patient." Robertson v. Dept. of Professional Regulation, Board of
Medicine, 574 So. 2d 153, 156 (Fla. 1st DCA 1987).
When the Board finds any person guilty of any of the grounds set forth in Subsection 458.331(1), Florida Statutes, it may enter an order imposing one or more of the following
penalties:
Revocation or suspension of a
license.
Restriction of practice.
Imposition of an administrative fine not to exceed $10,000 for each count or separate offense.
Issuance of a reprimand.
Placement of the physician on probation for such a period of time and subject to such conditions as the board may specify, including, but not limited to, requiring the physician to submit to treatment, to attend continuing education courses, to submit to reexamination, or to work under the supervision of another physician.
Corrective action.
Rule 64B8-8.001(2), Florida Administrative Code, the recommended range of penalty for various violations of Subsection 458.331(2), Florida Statutes, which reads in pertinent part:
64B8-8.001 Disciplinary Guidelines.
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(2) Violations and Range of Penalties. . . .
VIOLATION
(m) Failure to Keep appropriate written medical records. (458.331(1)(m), F.S.)
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(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. (458.331(1)(t), F.S.)
FIRST OFFENSE
(m) From a reprimand to denial or two (2) years suspension followed by probation, and an administrative fine from $1,000.00 to
$10,000.00.
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(t) From two (2) years probation to revocation or denial, and an administrative fine from $1,000.00 to $10,000.00
License disciplinary proceedings are penal in nature.
State ex rel, Vining v. Florida Real Estate Commission, 281 So.
2d 487 (Fla. 1973). In this disciplinary proceeding, Petitioner must prove the alleged violations of Subsections 458.331(1)(m) and (t), Florida Statutes, by clear and convincing evidence.
Department of Banking and Finance, Division of Securities and Investor Protection v. Osborne, Stern & Co., 670 So. 2d 932 (Fla. 1996); Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987).
The definition of "clear and convincing" evidence is adopted from Solomowitz v. Walker, 429 So. 2d 797, 800 (Fla. 4th DCA 1983), which provides:
[Clear] and convincing evidence requires that the evidence must be found to be credible; the facts to which the witnesses testify must be distinctly remembered, the testimony must be precise and explicit and the witnesses must be lacking in confusion as to the facts in issue. The evidence must be of such weight that it produces in the mind of the trier of fact a firm belief or conviction, without hesitancy, as to the truth of the allegations sought to be established.
See also Evans Packing Co. v. Department of Agriculture and Consumer, 550 So. 2d 112, 116 n.5 (Fla. 1st DCA 1989).
The determination of whether a physician deviated from the applicable standard of care requires consideration of the factual circumstances of each case. As recently held in Gross v. Department of Health, 819 So. 2d 997 (Fla. 5th DCA 2002), the determination of whether a physician has violated the applicable
standard of care is a fact question for the Administrative Law Jude.
Petitioner has alleged 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, in the following ways:
Leaving all or part of the intra- luminal shunt in M.R.'s right carotid artery during the first operation on November 27, 2000;
Failing to more closely examine M.R.'s right carotid artery at the close of the first surgery on November 27, 2000, to look for and retrieve any foreign bodies remaining in or near M.R.'s carotid artery;
Failing to more closely examine the area of M.R.'s right carotid artery at the time of the second operation on November 28, 2000, to look for and retrieve any foreign bodies remaining in or near M.R.'s carotid artery; and
Failing to comprehend the reason for the patient's hemodynamic instability on November 27 and 28, 2000.
The clear and convincing standard must be utilized in this case which holds, based upon the entire record in this case, that the proof presented by Petitioner must produce a firm belief or conviction, without hesitancy, that Respondent deviated from the standard of care in this case. The record
demonstrated that, at best, the evidence is conflicting as to whether such a deviation occurred.
The crux of Petitioner's case is that a piece of tubing was found within Patient M.R. on November 29, 2000, and that it was this tubing which caused Patient M.R. to suffer a stroke and ultimately die. In support of its case, three doctors were called as witnesses who were present at the November 29, 2000, procedure during which the piece of tubing was recovered. Dr. Schreiber testified that he was not present in the operating room when the piece of tubing was found;
Dr. Horowitz testified that the piece of tubing was not from the lumen of the artery and that it was not clear where it was in the surgical field; and Dr. Muller testified that he saw the piece of tubing within the lumen of Patient M.R.'s carotid artery. Respondent testified on his own behalf that the piece of tubing was not from the lumen of the artery and had to have been located within the subcutaneous tissue in the area of the surgical site, but outside the lumen of the artery. Thus, there is no consensus among the physicians who were in the operating room where this piece of tubing was located at the moment it was discovered.
Under the clear and convincing evidence standard set forth above, this lack of consensus, by itself, could absolve Respondent in this case. However, what is equally important is
that Petitioner cannot prove, by clear and convincing evidence or by any other standard, how the piece of tubing came to be in Paitent M.R.'s body in the first place. This is critical, because the physical location of the piece of tubing in question is of utmost importance in this case. Petitioner offered no evidence addressing how the piece of tubing entered the surgical field. The only testimony heard on this issue was from Respondent himself, who testified that it was his belief that the piece of tubing entered the surgical field when a scrub technician who was cutting the longer pediatric feeding tube into an appropriate length for use as a shunt, cut off a sliver, which entered the operative field without Respondent's knowledge. Respondent also testified that he did not cut the shunt himself because he was preparing the artery at the moment the scrub technician was fashioning the shunt in question. This means the incision of the carotid artery had not yet been made.
Based on this series of facts, it has not been shown by clear and convincing evidence that the piece of tubing in question was left within the lumen of Patient M.R.'s carotid artery. There is no competent evidence to explain how the piece of tubing could have entered the carotid artery in the first place.
In further support of this conclusion is the testimony of Dr. Kerstein regarding the interpretation of two distinct
radiographic studies performed on Patient M.R. late in the evening of November 28, 2000. Both of these studies, a cerebral angiogram and a CT Scan of the brain, revealed that the stroke which Patient M.R. had suffered was located in the rear of the brain, as indicated by the CT Scan report which identifies a "right posterior cerebral artery distribution infarct." Both Respondent and Dr. Kerstein testified that the location of the damaged portion of the brain of Patient M.R. as a result of the stroke could only have been caused by occlusion in the basilar or vertebral arteries, the arteries that feed this portion of the brain. The damage in the rear portion of the brain could not have been caused by any stroke caused by blockage in the carotid artery, which is the central focus of Petitioner's case. This testimony, in conjunction with the testimony from Respondent that the piece of tubing in question was too miniscule and completely inert and, therefore, would not produce an adverse reaction in the body, leads to the conclusion that Petitioner has not proven by clear and convincing evidence that the piece of tubing at issue was located within Patient M.R.'s carotid artery.
It is found, however, that Petitioner has proven by clear and convincing evidence that the piece of tubing in question was located within Patient M.R.'s body between the November 27, 2000, procedure and the November 29, 2000,
procedure. The question this raises is whether Petitioner has established its case that Respondent deviated from the standard of care in violation of Subsection 458.331(1)(t), Florida Statutes, based merely on the presence of this piece of tubing within Patient M.R., regardless of its exact location.
Based upon all of the evidence of record, it is concluded that Petitioner has not made the requisite showing in order to prove by clear and convincing evidence that Respondent violated Subsection 458.331(1)(t), Florida Statutes, in his treatment of Patient M.R. The only testimony presented as to how the piece of tubing entered Patient M.R.'s body indicated that Respondent had no idea this event had occurred, and there was no way he could have been aware of this event occurring. The only credible testimony in this regard indicated that the sliver of tubing came off when the scrub technician was cutting down the longer pediatric feeding tube, outside of Respondent's field of vision. The piece of tubing in question was two or three millimeters in length, and it was essentially translucent, making it difficult, if not impossible, to see. Once the piece was in the body, Respondent had no reason to believe that it was there, so any criticism of Respondent for failing to look for it or appreciate it in subsequent procedures seems to be without basis. In short, Petitioner has failed to demonstrate by clear and convincing evidence that Respondent knew or should have
known of the presence of this piece of tubing within the body of Patient M.R. In the absence of such a showing, Petitioner cannot establish a violation of Subsection 458.331(1)(t), Florida Statutes.
In reaching this conclusion, it is also noted that the testimony also creates significant doubt as to what impact, if any, this piece of tubing had on Patient M.R. As noted above, the evidence is not convincing that the piece of tubing in question was located within the lumen of the artery or that the piece of tubing created any harm to Patient M.R., if it had been simply embedded in his subcutaneous tissue. The material at issue is intended for use inside the body. It is designed to be as inert as possible, so that there will be no adverse reaction by the body once it is placed. Based on these factors, it does not appear that the piece of tubing in question can be said by clear and convincing evidence to have had any impact on Patient M.R.
Based on the foregoing, Petitioner has failed to prove by clear and convincing evidence that Respondent violated Subsection 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.
Petitioner has alleged that Respondent's medical records of the care and treatment of Patient M.R. are inadequate in that they fail to properly identify the course of treatment or justify Respondent's treatment of M.R. in one or more of the following ways:
The records fail to adequately identify either the origin or the location of the piece of tubing removed from the area of the Patient's right carotid artery on November 29, 2000;
The records demonstrate that the Respondent lacked an understanding of the reason for the patient's hemodynamic instability on November 27 and 28, 2000;
The records do not accurately identify what the piece of tubing was, although the Respondent clearly knew it was the shunt from the first operation; and
Failing to document how the shunt was disposed of, or where the shunt was placed after removal from the patient.
It is found that Petitioner has failed to demonstrate by clear and convincing evidence that Respondent failed to maintain accurate medical records in violation of Subsection 458.331(1)(m), Florida Statutes. Petitioner's argument that Respondent failed to maintain accurate medical records is tied directly to the standard of care claim. If Petitioner's argument is accepted that Respondent deviated from the standard of care in allowing this piece of tubing to enter the body, then a violation for failure to accurately document the cause of
Patient M.R.'s declining condition would necessarily follow. However, Petitioner's standard of care argument is rejected and the medical records argument must be rejected as well. The records reflect both Patient M.R.'s condition, and Respondent's response to that condition. Respondent testified that he did not know the precise cause of Patient M.R.'s instability after the November 27, 2000, procedure and that is reflected in the records. He testified that he did not know the exact location of the piece of tubing outside the artery when it was found on November 29, 2000, and that, too, is accurately reflected in the records. Finally, Dr. Kerstein rendered the opinion that he found no deviation from the standard of care in the contents of Respondent's records and that to the contrary, he felt that the records kept in this case were exemplary. In light of the testimony elicited and all the evidence presented in this case, it is found that Petitioner has failed to demonstrate by clear and convincing evidence that Respondent violated Subsection 458.331(1)(m), Florida Statutes.
Based on all the evidence of record, it is RECOMMENDED that the Board of Medicine enter a final order holding that the evidence is not clear and convincing that Respondent has violated either Subsections 458.331(t) or (m), Florida Statutes,
in his treatment of Patient M.R. and that the Administrative Complaint be dismissed.
DONE AND ENTERED this 9th day of June, 2003, in Tallahassee, Leon County, Florida.
DANIEL M. KILBRIDE
Administrative Law Judge
Division of Administrative Hearings The DeSoto Building
1230 Apalachee Parkway
Tallahassee, Florida 32399-3060
(850) 488-9675 SUNCOM 278-9675
Fax Filing (850) 921-6847 www.doah.state.fl.us
Filed with the Clerk of the Division of Administrative Hearings this 9th day of June, 2003.
COPIES FURNISHED:
Michael D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy,
Graham & Ford, P.A.
390 North Orange Avenue Suite 1000
Orlando, Florida 32802
Daniel Lake, Esquire Department of Health 4052 Bald Cypress Way Bin C-65
Tallahassee, Florida 32399-3265
William W. Large, General Counsel Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Larry McPherson, Executive Director Board of Medicine
Department of Health 4052 Bald Cypress Way
Tallahassee, Florida 32399-1701
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 |
|---|---|---|
| Aug. 14, 2003 | Agency Final Order | |
| Jun. 09, 2003 | Recommended Order | In a close case, Petitioner failed to prove that Respondent deviated from standard of care during three operations on patient`s carotid artery; medical records adequate; dismiss. |
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