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
The Issue Whether Petitioner's request for authorization for the autologous chondrocyte implantation procedure should be approved pursuant to worker's compensation laws and rules.
Findings Of Fact Petitioner's Injury At all times, the Petitioner has been employed as a Ladies Wear Department Manager for K-Mart Corporation. On July 21, 1998, Petitioner, while in the course and scope of her employment, was injured when she fell on a metal ladder as she attempted to hang clothes on a rail. Her left knee struck a metal bar on the second step of the ladder, causing immediate pain. On August 26, 1998, Petitioner consulted Dr. Jeffery Friedman, M.D., an orthopedic surgeon, who specializes in knee and shoulder surgery. Dr. Friedman was recognized as an expert in the field of orthopedic surgery. On or about September 4, 1998, Petitioner underwent arthroscopic surgery performed by Dr. Friedman to remove a loose body from the knee. Dr. Friedman found grade III chondromalacia and debrided the area using an arthroscopic shaver. He also found loose articular cartilage at the patella. Dr. Friedman's records describe the area of grade III chondromalacia as "fairly large" and involving " the apex of the patella." However, neither the size nor the shape of the injury is disclosed. Dr. Friedman also debrided flake of articular cartilage from the tibial plateau and removed a calcific loose body from the posteromedial compartment. His post-operative diagnosis was left knee loose body, chrondromalacia, and intracruciate ligament strain. Petitioner returned to work with K-Mart after the arthroscopic surgery, and was placed on light duty. While performing her duties, Petitioner is required to stand most of the time, and is unable to sit. Prior to her injury, Petitioner worked 40 hours per week. After her injury, due to her physical limitations resulting from the accident, Petitioner is only able to work 24 hours per week. Petitioner's pain limits her ability to work 40 hours per week. Petitioner cannot put her full weight down on the left knee while going up steps or a ladder or it causes sharp shooting pains. In addition, continuous walking results in continuous aching pain. The reduction in Petitioner's work hours was due to her injury. Petitioner is now unable to perform all of the duties that were required of her before the injury. Dr. Friedman found Petitioner to have reached maximum medical improvement in December 1998. In early 1999, Petitioner sought treatment for continued pain. An MRI was performed on or about March 5, 1999, which suggested a small defect in the articular cartilage, thinning of the patellar cartilage, and narrowing of the medical femoral tibial joint consistent with the early stages of osteoarthritis. In June, 1999, Petitioner underwent steroid injections for continued pain. In September, 1999, Petitioner returned to Dr, Friedman because of continued pain. Dr. Friedman reviewed a video tape that he had made of the arthroscopic surgery and fount that the Petitioner had a fairly large chondral defect of the patella. Dr. Friedman determined that Petitioner was a candidate for ACI, also known as the Genzyme Carticel Procedure (Genzyme Procedure). Dr. Friedman believed that the ACI procedure would benefit Petitioner by providing long-term symptomatic relief with joint pain and mechanical disturbances and improved joint motion function, eliminating the complaints of grinding and catching, and furthering the goal of returning the patient to regular and even strenuous activity. Petitioner then requested authorization for the ACI procedure. The Employer/Carrier denied the request and referred it to the Agency for Health Care Administration for review in accordance with Florida law. The Agency consulted with the University of Florida Faculty Practice Group, and Dr. B. Hudson Berrey, Chair of the Department of Orthopaedics and Rehabilitation, rendered an opinion that the procedure is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. Dr. Berrey further opined that there was not reliable evidence that ACI would provide significant benefit to the recovery and well-being of the injured employee within the meaning of Rule 59B-11.004(3), Florida Administrative Code. The documents and information forwarded to Dr. Berrey by Respondent included Petitioner's medical records provided by Intervenor, K-Mart carrier. Dr. Berrey did not review any actual MRI films, did not review any films taken at the time of the arthroscopic procedure, and in fact only reviewed certain documentation that was supplied to him by the agency. Petitioner was denied her right to present information to Dr. Berrey prior to his forming his opinion for the agency. This was a violation of Rule 59B-11.003, Florida Administrative Code. The agency rendered a decision based upon Dr. Berrey's opinion, declining to order the Employer/Carrier to provide ACI to Petitioner. Autologous Chondrocyte Implantation The ACI procedure was initially developed in Sweden by Dr. Lars Peterson. ACI is a surgical procedure whereby a sample of cartilage is harvested from another area of the joint. The harvesting of the cartilage is performed during an arthroscopic surgical operation. The sample is sent to Boston to the laboratory of Genzyme Tissue Repair, Inc. ("Genzyme"), the owner of the process. Genzyme uses its proprietary process to culture the cells into an estimated 12 million chondrocytes over a period of approximately two months. Genzyme then returns the cultured chondrocytes to the surgeon. The surgeon then performs an open surgical operation. The surgeon creates a periosteal flap. In addition, the injury is debrided and the chondrocytes are implanted on the wounded cartilage and covered with the periosteal flap. The ACI procedure thus requires two surgical operations, one arthroscopic procedure and one open procedure. The claimed benefit of ACI is that the cartilage that is generated and implanted onto the knee will be hyaline cartilage or hyaline-like cartilage rather than fibrocartilage. Hyaline cartilage is composed both of the cartilage cells of an extra-cellular matrix. It has greater ability than fibrocartilage to withstand compression and shearing forces. ACI has been shown to produce "hyaline-like" cartilage in some patients. However, it does not reproduce the extra- cellular matrix in which the chondrocytes are found in naturally occurring hyaline cartilage. Alternative Treatments Other available treatments for a defect in articular cartilage of the knees include abrasion chondroplasty, arthroscopic microfracture, and arthroscopic drilling. Many patients get relief with one or more of these alternative procedures and do not need another operation. In addition, a surgical procedure to elevate the tibial tubercle and remove some of the weight from the patella might also alleviate the Petitioner's pain and improve her functioning. Dr. Friedman performed an abrasion chondroplasty during the arthroscopic surgery of September 4, 1998. Dr. Friedman did not offer Petitioner either the microfracture or the drilling procedures. Dr. Friedman had considered performing a tibial tubercle elevation but has not recommended that the Petitioner undergo that procedure either before the ACI is approved or independently of the ACI. Dr. Friedman views the primary purpose of this procedure as assuring the best possible results from the ACI. Dr. Friedman indicated there were no appropriate alternative medical procedures, other then the ACI procedure, available for Petitioner's injury. Dr. Friedman opined that the only viable option of putting back normal articular cartilage underneath the kneecap would be with the ACI procedure. In this opinion, the alternative procedures are not appropriate for and would not benefit Petitioner, as they were merely temporary procedures. Moreover, he emphatically stated that the ACI procedure is the procedure which is appropriate for an would benefit Petitioner. The Evidence That ACI Remains Investigative The Agency for Health Care Administration has not promulgated, endorsed, or approved any particular treatment for injuries to the articular cartilage of the knee in accordance with Sections 440.13(15) or 408.02, Florida Statutes; therefore, there was no Agency-approved protocol for Dr. Berrey to consider in rendering his opinion. Dr. Berrey testified that he could find no articles or publications describing controlled studies in which the effectiveness of ACI compared to any other procedure. Dr. Berrey further testified that he could find no articles about the ACI procedure in peer-reviewed journals in which the authors used objective measures of outcome which compared the patients' condition before and after treatment. The use of blinded or controlled studies is important so that possible confounding factors or variables can be controlled or accounted for and the results measured objectively. Dr. Berrey found that the publications cited by the proponents of the procedure discussed research which was funded by Genzyme, the owner of the process by which the chondrocytes were cultured. The funding of the research by the owner of the process was an additional factor in his determination that the evidence supporting the efficacy of the procedure was not reliable. The Cartilage Repair Registry and the results reported therein do not constitute reliable evidence of the benefits of ACI when compared to other available procedures for two reasons. First, the potentially confounding variables are neither controlled nor accounted for. Second, each surgeon evaluates his or her own work, so that there is no objective, independent measurement or assessment of the condition of each patient before and after surgery. Although the premise on which ACI is based is that the patient's implant will consist of hyaline cartilage rather than fibrocartilage, the available data does not indicate that the results are comprised only, or even primarily, of genuine hyaline cartilage. Rather, the evidence is that some patients develop "hyaline-like" cartilage, or cartilage composed partly of hyaline tissue. It cannot be determined whether hyaline or hyaline- like cartilage has filled a patient's defect without performing a biopsy and a histological evaluation of the tissue. The published reports described in the testimony contain discussions of post-surgical histological performed on very small numbers of patients. The published reports concerning the use of ACI to treat defects of the patella show that the results are not as favorable as those claimed for treatment of the femoral condyle. After the proponents of the procedure began to perform other procedures with the ACI to assure that any defects in the alignment of the patella are repaired, improved results were reported. Dr, Friedman testified about the published results of histological evaluations of 37 patients. Of those, seven underwent ACI to treat defects of the patella. Only one of the seven showed the development of hyaline-like tissue. Further, only two of the seven patella patients reported surgical results classified as good or better. Dr. Friedman opined that the histological data resulting from treatment of defects of the patella had improved since the study described in the preceding paragraph. However, he could not give any reference to the basis for his opinion. Dr. Friedman further testified that the more recent articles discussed the results of patients who had been followed from nine to 15 years. However, the articles and presentations from 1997 to 2000 report on follow-up of the first hundred patients between two and nine years after their surgery. Dr. Billings testified that Dr. Peterson's presentation discussed follow-ups of ACI patients occurring as long as 15 years after surgery. Yet, the March 2000 presentation to the American Academy of Orthopedic Surgeons focused on 40 patients who had been evaluated three or more years after their surgery. The FDA granted an accelerated approval of the Carticel product in 1997. The original accelerated FDA approval was granted for defects of the femoral condyle, the trochlear groove, and the patella. The terms of the approval require that controlled studies be conducted which compare the procedure to other procedures available for the treatment of focal chondral defects, specifically, microfracture and the creation of a periosteal flap without the injection of the cultured chondrocytes. None of the expert witnesses had found in their literature search any published reports of the progress of the controlled studies required under the terms of the accelerated FDA approval. In February, 2000, the FDA approval was modified. Genzyme is no longer permitted to market the ACI procedure or its Carticel product for treatment of defects to the patella. The requirements of Rule 59B-11.004, Florida Administrative Code, differ significantly from those of the accelerated FDA approval process, so that the granting of accelerated approval does not determine the answer to the question whether a treatment is investigative under that rule. The FDA's inquiry addresses the issues of safety and efficacy. However, the accelerated FDA approval process does not address the issues of whether a particular product is more effective than currently existing treatments or is equally cost-effective. Based upon all the evidence, the performance of the ACI procedure on the defects located in the patella is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. The Probability That ACI Would be of Significant Benefit in Returning Petitioner to Work Both of Petitioner's expert witnesses testified that if she does not undergo ACI, it is likely that she will need a total knee replacement. However, neither witness testified that Petitioner currently requires a total knee replacement. No testimony was presented as to when Petitioner might require a total knee replacement. Despite the testimony that ACI has been studied for 20 years, the published reports follow patients only for nine years after surgery. From the current state of the research, it is not possible to conclude that patients who undergo ACI avoid the need for subsequent surgery in ten or more years. The published studies of the results of ACI going out nine years from the date of surgery do not state the number of procedures performed on the patella. No witnesses testified regarding any published studies of the effectiveness of ACI that addressed the extent to which patients had been able to return to work as a result of the procedure. There is insufficient evidence from which to conclude that the ACI is more likely to enable the Petitioner to return to her duties that other available procedures. The Likelihood That the Benefits of ACI Would Outweigh the Risks and the Costs The testimony compared the cost and benefit of ACI with chondroplasty, microfracture or drilling, and, to some extent, a Macquet procedure or tibial tubercle elevation. Each of the other procedures requires only one surgical operation. ACI requires an arthroscopic surgical procedure to harvest cartilage, culturing of the chondrocytes at the Genzyme laboratory in Boston, and followed by an open surgical procedure to create a periosteal flap and to implant the chondrocytes. Petitioner's expert testified that the cost of culturing the chondrocytes alone was between $8,000 and $10,000, in addition to the two surgical procedures. Petitioner's expert compared the cost of ACI to that of a total knee replacement. However, that comparison is not appropriate under the rule because there is no evidence that Petitioner currently needs a knee replacement or that a knee replacement is the treatment generally used to treat her current condition. The cost of the abrasion chondroplasty, the microfracture or drilling procedure would approximate the cost of the first stage of ACI, approximately $2,300. Dr. Billings testified that the cost of the second stage of ACI was greater than that of the first stage. The second stage is an open surgical operation rather than an arthroscopic one. The total cost of the ACI procedure, including therapy, is probably close to the $30,000 required for a total knee replacement, including the therapy required for the total knee replacement. Dr. Berrey testified that published reports of the cost of ACI are as high as $37,000. The ACI requires extensive physical therapy; Petitioner presented no evidence as to the extent to which the cost of this aspect of treatment was included in the total cost of ACI. ACI has been established to be safe, so that the benefits of the procedure outweigh the risks. However, there is insufficient evidence from which to conclude that the benefits of ACI outweigh the additional costs.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order denying approval of the autologous chondrocyte implantation for Petitioner Rebecca Crane. DONE AND ENTERED this 27th day of November, 2000, 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 27th day of November, 2000. COPIES FURNISHED: Jeffrey J. Bordulis, Esquire 570 Crown Oak Centre Drive Longwood, Florida 32750 Lisa J. Hurley, Esquire Pyle, Jones, Hurley & Hand, P.A. 1069 West Morse Boulevard Winter Park, Florida 32789 Michelle L. Oxman, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308 Ruben J. King-Shaw, Jr., Director Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3116 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308
The Issue Whether Respondent's license as a physician should be disciplined for the alleged violation of Section 458.331(1)(t), Florida Statutes, in that Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, by failing to treat the patient's preoperative coagulopathy and/or failing to use an alternate vein that would have allowed visualization of the shunt placement into the vein thereby reducing the risk of causing a hemorrhage given the patient's preoperative history, and, if so, what penalty should be imposed. AS TO CASE NO. 01-4407PL Whether Respondent's license as a physician should be disciplined for the alleged violation of Section 458.331(1)(t), Florida Statutes, by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances by failing to distally clamp part of the arteries prior to manipulation of the aneurysm and by failing to ensure periodic monitoring of the patient's condition postoperatively for evidence of ischemia or other problems and, if so, what penalty should be imposed.
Findings Of Fact Based on the evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: FACTS COMMON TO BOTH CASES Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes, Chapters 456 and 458, Florida Statutes. At all times relevant to this proceeding, Respondent was a licensed physician in the State of Florida, having been issued license number ME 0036360. Respondent is board-certified in thoracic and general surgery. FACTS RELATED TO CASE NO. 01-4406PL Patient D.J.P. was a 54-year-old female with a history of liver resection for carcinoma. Patient D.J.P. had contracted Hepatitis C in the 1960s from a blood transfusion, after being the victim of a gun shot wound during a robbery at a convenience store. Patient D.J.P. subsequently had developed cirrhosis secondary to the Hepatitis C. Cirrhosis is a scarring process of the liver that results in the displacement of the normally functioning liver tissue. A healthy liver processes lymphatic fluid back into the bloodstream. However, a cirrhotic liver cannot properly process the lymphatic fluid back into the bloodstream. Therefore, lymphatic fluid backs up within the liver and weeps out the covering over the liver and into the abdominal cavity. Patient D.J.P. presented to Respondent on February 1, 1994, after being referred to Respondent by Michael Carey, M.D., the primary care physician, for evaluation for implanting a peritoneal venous shunt. A venous shunt is a conduit designed to take ascitic fluid from the abdomen and put it back in the vascular system. The shunt removes the fluid from the abdominal cavity and transports it to the vascular system where it can be absorbed. The procedure is for the patient's comfort and does not prolong the patient's life. The procedure is for patients with end stage liver disease. After obtaining a medical history and conducting a physical examination, Respondent's assessment of the Patient D.J.P. was massive ascites secondary to cirrhosis and previous liver resection. Respondent believed that Patient D.J.P. was a candidate for a venous shunt procedure due to the fact that she was very symptomatic from her massive ascites and she was on the maximum medical therapy. The mortality rate for this type of procedure is between 5 and 25 percent or at the very least, one-in-twenty patients would die from this procedure. Complications associated with this type of procedure include disseminated intravascular coagulopathy (hereinafter referred to as "DIC") which may lead to the general worsening of the disease or death. The patient was informed of this mortality rate as well as of the complications associated with this procedure. Patient D.J.P. decided to think about the procedure and contact Respondent's office when she wanted the shunt inserted. On February 10, 1994, Patient D.J.P. called Respondent's office and asked to have the shunt inserted as soon as possible. Respondent scheduled the procedure for February 14, 1994, and signed the written surgical consent form. Prior to the surgery, lab tests were performed on Patient D.J.P. The lab report indicated that the patient's prothrombin time was 14.3, with a normal range being 10.7-12.8. Prothrombin time ("PT") is a measurement of one aspect of the blood clotting mechanism. This was considered slightly abnormal and not an indication of a clotting problem or coagulopathy. Respondent decided it was not necessary to address Patient D.J.P.'s abnormal PT prior to the procedure by preoperatively administering Vitamin K or fresh frozen plasma. On February 14, 1994, Patient D.J.P. was transported to the operating room at approximately 12:10 p.m. After Patient D.J.P. was placed under general anesthesia, Respondent began the venous shunt operation at approximately 12:34 p.m. Respondent attempted to access the right jugular vein to insert the shunt. He found this vein to be unusable because it was too scarred from previous surgeries. Respondent then proceeded to access the right subclavian area to insert the shunt. Once the shunt was inserted into the subclavian area, Respondent positioned it in the superior vena cava. The shunt was noted to be in position in the superior vena cava. Respondent then removed eight liters of ascitic fluid from the abdominal cavity. After removing the ascitic fluid, he then put one liter of saline into the abdominal cavity to dilute any remaining ascitic fluid which allowed any remaining fluid to be more easily absorbed into the vascular system. The Patient's central venous pressure dropped from 8 to 2. Hespan and Albumin were then administered to replace any lost volume and it helped to increase the colloidomotic pressure. At this point, Patient D.J.P.'s central venous pressure (CVP) increased from 2 to 14 or 15. This is a faster than normal rate. Upon finding that the shunt was operating well, Respondent closed the abdominal portion and the patient was extubated. Petitioner claimed that fluoroscopy was not used to ensure that the shunt was positioned in the proper place. A Fluoroscope is like a real-time X-ray. A fluoroscope has two parts to it: a C-arm, which goes above the patient and underneath the bed, and two screens where the doctor can see what is going on. The C-arm is approximately 5-and-a-half feet tall. It is below the standard of care to do a venous shunt procedure without using a fluoroscope. It would enable Respondent to visualize the placement of the shunt. Felicia Whitmer, a scrub technician, and Rene Myers, a circulating nurse, prepared the operating room for Patient D.J.P.'s procedure on February 14, 1994. Both Felicia Whitmer and Rene Myers testified that there was no fluoroscope in the operating room on February 14, 1994. Respondent testified that there was a fluoroscope in the operating room on February 14, 1994, during Patient D.J.P.'s procedure and that he used it to assist him. The evidence is not clear and convincing that the fluoroscope was not used during the course of the operation. It is considered within the accepted standard of care to access the right subclavian vein to insert a shunt of this type because this vein follows a gentle curve or path. With this gentle curve in the vein, there is less risk of damage, i.e. puncture, to the vein. In contrast, the left jugular vein follows a more sharp-angled 70-degree bend-curve in the vein where one risks the danger of the shunt coming out of the bottom of the vein or perforation and, thereby, damaging the vein. Respondent ordered an X-ray to confirm placement of the shunt and catheter. The X-ray revealed that the shunt had good positioning but the right lung was filled with fluid. The patient was re-intubated and Respondent inserted a chest tube into the patient which would expand the patient's lung, oxygenate the patient and allow for fluid removal. Three or four liters of fluid were removed. The fluid was originally serous and pink tinged and shortly thereafter, turned bloody. Respondent noted that there was bruising around the wounds. Additionally, the patient's breathing became shallow and her blood pressure began to deteriorate. Resuscitative efforts were performed and Respondent re- entered the shunt area to clamp the shunt to prevent any ascites from flowing into the venous system and to prevent further coagulation and massive bleeding. Despite heroic resuscitative efforts, the patient's condition continued to deteriorate and the patient died. The cause of death was determined to be DIC and severe coagulopathy from drainage of the ascitic fluid into the venous system. Respondent made the determination that the patient did not have preoperative coagulopathy. Respondent testified that if the patient did have preoperative coagulopathy, he would not have performed the procedure because the patient would not be able to make the clotting factors well enough for problems that would occur after the shunt was inserted. It was Respondent's opinion that the patient did not have a serious clotting problem. Based on her lab report, Patient D.J.P. had a slightly abnormal PT and this was not an indication of a clotting problem. Respondent reviewed the lab reports and determined the PT (the measurement of one aspect of blood clotting mechanism), to be only slightly elevated. It measured 14.3 with a normal range being 10.7-12.8. Moreover, the PT International Normalized Ratio (INR) (which is the standardized measurement of PT) was 1.63 where the therapeutic range was 2-3. Therefore, this was slightly below average. Dr. Yahr testified that an abnormal clotting problem is a clinically evident problem and not an incident of a lab number. If Patient D.J.P. had a clotting abnormality, adverse conditions or symptoms would have been evident with the incisions that were made prior to the shunt being opened. Rather, normal clotting reactions occurred. Coagulation occurred right after the shunt was opened and the ascitic fluid began to flow into the atrium. Dr. Yahr testified that the etiology of the coagulation was the body's reaction to the ascitic fluid after the shunt was opened. Accordingly, it was Dr. Yahr's opinion that Respondent did not fail to treat the preoperative coagulopathy because upon his examination of the patient, he determined that no such preoperative coagulopathy existed prior to the procedure. Dr. Yahr testified that the patient did not have abnormal bleeding. Her liver failure was the result of scarring and abnormal liver function. Therefore, administration of clotting factors such as Vitamin K and fresh frozen plasma was not indicated or medically necessary. Petitioner presented the expert testimony of John W. Kilkenny, III, M.D. Dr. Kilkenny is board-certified in general surgery and has been for 11 years and is currently a professor with the University of Florida College of Medicine, Department of Surgery in Jacksonville, Florida, a position which he has held for the last six years. According to Dr. Kilkenny, Patient D.J.P.'s elevated PT was a cause for concern in that it was an indication that the patient's ability to clot or coagulate was diminished. It is not clear and convincing that the standard of care required that the elevated PT be treated by infusing fresh frozen plasma or Vitamin K. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by failing to use an alternate vein that would allow visualization of the placement of the shunt. Respondent first attempted to access the right jugular vein to insert the shunt but found it be unusable because it was too scarred. Respondent, acting as a reasonably prudent physician and using sound medical judgment, accessed the right subclavian area to insert the shunt. After the shunt was inserted into he subclavian vein, Respondent claimed he was able to visualize the placement of the shunt by the use of fluoroscopy. Furthermore, the operative notes seemed to indicated that the procedure was performed under fluoroscopic control and the shunt was found to be in position. Therefore, Respondent accessed an appropriate alterative vein-the subclavian vein, which allowed visualization, with the assistance of fluoroscopy, of the placement of the shunt. As to the second issue, Dr. Kilkenny opined that the standard of care requires direct visualization for insertion of the shunt. By not accessing a vein under direct visualization, such as with Respondent's subclavian approach, the surgeon is, in essence, hunting for the vein, and risking damage to the wall of the vein that may not be evident immediately. The rapid rise in CVP from 2 to 14 or 15 was also a concern for Dr. Kilkenny because it was not normal, and did not mean that the shunt was placed correctly of that the shunt was functioning properly. Dr. Kilkenny noted that it was unlikely that the bleeding in the chest cavity was caused by damage to an intercostals vessel when the chest tube was inserted because the chest X-ray that was taken prior to insertion of the chest tube showed a complete opacification of the right side and a shifting of the major vessels within the middle of the chest over to the left side. According to Dr. Kilkenny, the chest X-ray indicated that there had already been some sort of bleeding in the right chest prior to the insertion of the chest tube. Dr. Kilkenny disputed Respondent's theory that Patient D.J.P. died as a result of DIC. Dr. Kilkenny asserted that Respondent fell below the standard lf care in that, given Patient D.J.P.'s rapid decompensation, he failed to consider whether the patient's subclavian vein had been damaged, a condition which could have been addressed surgically. Dr. Yahr opined that Patient D.J.P. died of DIC that occurred within a short period of time after Respondent opened up the shunt and ascitic fluid was introduced into the atrium of the heart. Although Dr. Yahr further admitted that the bleeding in the chest could have occurred as a result of damage to the subclavian vein, and that it was below the standard of care to access the subclavian vein without using fluoroscopy, the evidence is not clear and convincing that either event occurred. It is found that Petitioner has failed to establish by clear and convincing evidence that the standard of care required Respondent to use an access site that allowed direct visualization of the placement of the shunt into the vein, or that Respondent failed to use fluoroscopy in order to directly visualize insertion of the shunt into the subclavian vein. AS TO CASE NO. 01-4407PL On August 22, 1997, Patient H.H., a 55-year-old female, was diagnosed with an abdominal aortic aneurysm measuring approximately 4.5 cm transverse diameter and beginning approximately 1-2 cm below an enlargement or swelling, of a blood vessel resulting in a weakening or thinning out of the vessel wall. On November 28, 1997, Patient H.H.'s aneurysm had grown to 5 cm within a three-month period and was occluded with partial thrombosis with a true lumen around 2.7 cm and extended down to the bifurcation of the abdominal iliac. This put the patient at risk for rupture of the aneurysm. Thrombosis is a blood clot within a vessel or within the vascular system. It does not embolize (travel) from another part of the body. It starts in a particular vessel and causes its damage from there. It is an acute clot that occurs in the vessel secondary to stasis (non-moving ) or some kind of coagulation or clotting deficiency or abnormality. Thrombotic activity most often begins by occluding the smaller vessels in the vascular system, such as those smaller veins located in the feet. On December 2, 1997, Patient H.H. first met with Respondent, who performed a complete medical history and physical examination and confirmed the presence of a 5 cm abdominal aneurysm. Patient H.H. was a 55-year-old female who smoked 1- and-a-half packs of cigarettes per day, had a blood pressure of 182/104 despite the fact that she was taking 50 mg Atenolol for hypertension (high blood pressure), and had a 30 percent blockage of the coronary artery. Previously, she had a cardiac catheterization, followed by an angioplasty of the femoral vessel in her left leg. Patient H.H. advised Respondent that her legs gave out on her after she walked two blocks, but that she did not have associated chest pain. Respondent confirmed earlier diagnosis of Patient H.H.'s medical condition as single vessel coronary artery disease, abdominal aortic aneurysm, hypertension, and claudication with femoral occlusive disease. Respondent also found diminished femoral pulses and palpable Dorsal pedal pulses present in both feet. Patient H.H.'s medical records indicated that this smoker of 30 years suffered from diabetes, peripheral vascular disease, intermittent clottication of the leg, hypertension, atherosclerotic disease, hypercoagulopathy, anthithrombin III deficiency, high cholesterol, and diminished protein and pH levels. Respondent prescribed prescription medication, Procardia to lower Patient H.H.'s blood pressure and Zyban to help her stop smoking. He recommended that the patient return in a week for follow-up. On December 15, 1997, Respondent continued to prepare Patient H.H for surgery. He again advised her to stop smoking and to purchase and take medication to help her stop smoking. Patient H.H.'s blood pressure was lower, 144/84, and although she had not purchased or taken the medication, she reduced her smoking down to one-half pack of cigarettes per day. Respondent then advised Patient H.H. to make plans to undergo the abdominal aortic aneurysm ("AAA") repair. Patient H.H. informed Respondent that she wanted to wait a little longer while she made financial arrangements to pay for the surgery. Respondent advised Patient H.H. to completely quit smoking before the surgery and advised her to return in one month for additional preoperative evaluation. On January 12, 1998, Respondent continued to prepare Patient H.H. for surgery by ordering a cardiac clearance (thallium evaluation) of the patient's heart to ensure she could tolerate the surgery before attempting the AAA repair. On February 3, 1998, Patient H.H. presented for the thallium evaluation of the heart and, on February 9, 1998, obtained cardiac clearance for repair of the AAA. On February 11, 1998, Respondent continued to prepare Patient H.H. for AAA surgery and suggested she donate two units of blood which would be used during the surgical procedure. Respondent scheduled AAA repair surgery for March 6, 1998. Respondent advised Patient H.H. of the risks associated with AAA surgery and specifically mentioned the risk of a heart attack, bleeding, kidney damage and loss of legs. He also advised that the risks associated with intra-operative AAA repair include spontaneous rupture, embolization of material from the wall distally, myocardial infarction, bleeding, injury to viscera of the small vessels, devascularization of the colon causing ischemic colitis, death, kidney blockage. Patient H.H. indicated she understood the risks and despite the risks associated with this type of surgical procedure, including the risk of death, she agreed to the procedure. Preoperative testing by angiogram was not required for Patient H.H. The aneurysm was a massive aneurysm presenting a very serious health risk of imminent rupture. The size of Patient H.H.'s aneurysm (5 cm) made AAA repair an emergency in a sense because there was almost a 100 percent chance of rupture with in the next six months. Any findings determined by angiogram would not have changed the outcome of the case because Respondent had to definitively treat the aneurysm first. Additionally, an angiogram is a very expensive test and Patient H.H. expressed a concern about her financial situation with respect to the AAA repair. It is reasonable to not do studies that a physician does not feel are absolutely necessary. The patient's financial concerns are part of the pathology. On March 6, 1998, Patient H.H. was admitted to Winter Haven Hospital and filled out and signed the Special Authorization for Medical and/or Surgical Treatment form indicating her consent to the surgical procedure which Respondent was to perform. She indicated that she understood the risks associated with such surgical procedure. Paragraph two of the informed consent form states in pertinent part: I hereby certify that I have given complete and informed consent for the above named operation and/or procedures, and Dr. L. Thomas has explained to me the reason why the above-named operation and/or procedure are considered appropriate, its advantages and possible complication, if any, as well as possible alternative modes of treatment. I also certify that no guarantee or assurance has been made as to the results that may be obtained. The operative procedure on the consent form was signed by Patient H.H. at 6:10 a.m. on March 6, 1998. Surgery indicated on the consent form was for a resection abdominal aortic aneurysm (AAA repair). After Patient H.H. was taken to the operating room and administration of anesthesia began, Respondent performed his routine preoperative check of femoral and pedal pulses. Checking for femoral and pedal pulses is the type of preoperative work-up Respondent routinely performs while he waits for the anesthesia to take its effect on the patient. The operative report indicates that the abdominal aneurysm was "very large" extending quite high within 1-2 cm from the renal vein and down to and involving the common and hypogastric arteries and noted to be "quite saccular" with "impending rupture in the near future at the neck." The common iliacs were noted to be "quite large and aneurysmatic." The external iliacs were soft but extremely small, "approximately 4-5 mm in size, certainly less than half, more like 1/4 the size of a normal iliac" but nevertheless usable vessels to make his anastomosis. As Respondent was bluntly dissecting (separating the tissues using the fingers) the aortic aneurysm from the venous plexus to position his proximal clamp when one of the lumbar veins was encountered and mass bleeding occurred. The venous plexus is a grouping of veins located under the aorta that can best be described as a wagon wheel. The system has a hub and all the veins in the grouping extend outward from the hub. If one of the veins in the grouping is injured, it will bleed heavily, but the bleeding is controllable. The lumbar veins are part of the venous plexus and a tear of the lumbar vein is a known risk during this type of surgery. Patient H.H. suffered the loss of three times the amount of blood as would have been routinely expected. The sudden blood loss caused the patient's condition to rapidly deteriorate. Dr. Wickstrom-Hill, Anesthesiologist, testified that had Respondent not controlled the blood loss, and had not maintained Patient H.H.'s vital signs, she would have died. Using sound medical judgment, Respondent elected to bypass the aneurysmatic common iliacs and make his anastomosis of the graft to the external iliacs in order to not disconnect or separate the aortic or common iliac aneurysms from the iliac vein. This is a very fragile vessel and could have resulted in further massive bleeding and possible death of the patient. A reasonable prudent physician faced with a similar circumstance and situation would not attempt to mobilize the aneurysm further if doing so would cause additional massive blood loss and possible death of the patient. The hypogastric arteries (a/k/a the internal iliacs) serve to provide the pelvic viscera (bladder, rectum, etc.) with blood. During the AAA repair, Respondent performed an embolectomy on both legs following manipulation of the aneurysm. The purpose of this procedure was to remove any debris which may have dislodged from the aneurysm and flowed distally to the legs. The procedure involves running a Fogarty catheter down the femoral arteries as far as the catheter will go, then inflating a balloon located at the end of the catheter. Once the balloon is inflated, the surgeon will extract the catheter, pulling the debris out of the artery. This process is repeated as necessary to remove all debris. Fresh clot was obtained from both legs, indicating a lack of debris. Prior to completing the anastomosis of the bifurcated graft to the aorta and external iliacs respectively, Respondent ran a Fogarty catheter down proximal (back into the graft itself), to remove any debris in the graft itself. Finally, he back-bled the graft (allowed blood to flow out of the graft, to, again, ensure that there existed no debris in the graft). On March 7, 1998, Patient H.H.'s medical condition stabilized such that Respondent felt it safe to return Patient H.H. to the operating room to undergo an additional embolectomy of the legs and an endarterectomy of the right femoral artery. The record demonstrates that Respondent believed he collected embolic debris from the femoral arteries. However, based upon the pathology report and the testimony of Dr. Zeller, the debris removed from Patient H.H. during this procedure was acute blood clots and atherosclerotic plaque. This finding is consistent with thrombotic material and not a result of debris coming from another location as it tends to demonstrate that Patient H.H. had a clotting disorder consistent with her medical history. The record also demonstrates that upon completion of the procedure, Patient H.H. was noted to have excellent pulses in the superficial and profunda femoral arteries distal to the anastomosis with good emptying and filing of the vessels. Before, during, and after the AAA repair, Respondent used Heparin (an anti-clotting drug) in an effort to prevent the formation of clots throughout Patient H.H.'s vascular system. Intraoperatively, on March 3, 1998, Respondent administered 10,000 units of Heparin. Normally a patient will respond to 5,000 units. Despite giving Patient H.H. twice the normal amount of Heparin, Patient H.H. continued to have a lowered clotting time. It is noted in the medical record that Patient H.H. had an Antithrombin III deficiency. Antithrombin III is one of the factors that control how blood in the human body clots. Patient H.H.'s Antithrombin III deficiency is a hereditary defect that contributed significantly to her continued clotting despite the use of pharmacological intervention (substantial amount of Heparin). Respondent testified that in his medical training and experience, Patient H.H.'s Antithrombin III deficiency level was near fatal. Because Patient H.H. was hypercoagulative, thus causing the small vessels to clot off, on March 13, 1998, Patient H.H. underwent bilateral above the knee amputations. Hypercoagulopathy is a tendency to clot without anything being done - the blood just clots. This can be caused by a lower-than- normal blood pressure for a period of time and by having an Antithrombin III deficiency. Respondent observed during the surgery that this patient was hypercoagulative because he could see the blood clotting in the wound despite the fact that Patient H.H. was on twice the normal amount of Heparin. Respondent practiced within the standard of care at all times during the treatment of Patient H.H. Blood-flow going retrograde back into the common and iliac aneurismal sacs did not place Patient H.H. at a risk of rupture. The operative report clearly demonstrates that the aortic aneurysm involved the common iliacs and extended below the hypogastric arteries. The operative report also demonstrates that the external iliacs were extremely small, approximately one-quarter of the normal size. A reasonable and prudent surgeon, faced with a similarly situated patient with a massive sized aneurysm and the extremely small size of the distal external iliacs, would conclude that the pressure gradient now being carried to the graft rather than to the aneurysm would diminish flow to the aneurysms making the possibility of rupture unlikely. Moreover, the aneurysms were filled with calcified atherosclerotic plaque and other thrombotic (non-mobile) material. Dr. Begelman testified that calcified aneurysms do not tend to rupture as much. On direct examination, Dr. Begelman, Petitioner's expert, could not conclusively determine whether Respondent's surgical treatment of Patient H.H. fell below the standard of care and that distal clamping is an intra-operative decision to be made by the surgeon. Dr. Begelman who testified that he accepted Respondent's opinion that the iliacs were too large or too thin walled and could not distally clamp the aneurysm and that such decisions are those made by the surgeon on the case. Drs. Begelman and Seller and Respondent testified that it is usual and customary during this type of surgical procedure to distally clamp the aorta and that it is expected of a reasonable and prudent surgeon to make every attempt to do so. Nevertheless, all three doctors recognized that there are times when you cannot or should not distally clamp if to do so would cause further injury to the patient or death. Patient H.H. presented with very massive aneurysms of both the aorta and common iliacs making distal clamping impossible without sacrificing the hypogastric arteries thus placing Patient H.H. at risk for further injury or death. Petitioner's expert accepted Respondent's assessment of the condition of the iliacs and that Respondent did not want to dissect the iliacs off the iliac vein, which one needs to do in order to tie off distally. Dr. Begelman testified that he could not ascertain whether Respondent fell below the standard of care with respect to Respondent's treatment of Patient H.H. intraoperatively. Respondent acted within the standard of care and, therefore, did not violate Section 458.331(1)(t), Florida Statutes, when he did not clamp the distal arteries before manipulation of the aneurysm. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by sewing the bifurcated graft to the external iliacs and making no attempt to disconnect the aneurysm from the common and internal (a/k/a hypogastric) iliacs. The common and internal iliac tissues were also diseased because of their involvement with the aneurysms coupled with the fact that the aneurysm and surrounding tissue was inflamed. Inflammation causes the tissues of the surrounding viscera to become sticky and by that, stick together making separation difficult and more prone to bleeding on manipulation. Normally, the surgeon must bluntly dissect (lift up) the distal end of the aorta in order to place the distal clamps on the aorta below the aneurysm. However, the inflammation present in Patient H.H.'s aorta made it impossible to mobilize (lift up) the distal aorta for clamping because the tissue was stuck to the iliac vein which could have caused Patient H.H. to suffer a lethal blood loss. Normally, blood loss associated with this type of surgery amounts to 500 ccs for the total surgery. Patient H.H. lost 1500 ccs during the manipulation of the aortic aneurysm to place the proximal clamp and a total of 2400 ccs during the entire surgery which represented a blood loss of nearly 25-40 percent respectively of her estimated total blood volume. Respondent used sound medical judgment by making no attempt to dissect the common iliac from the subordinate tissue because, in his training and experience, the separation of tissues would have caused further, possible lethal bleeding. Drs. Begelman and Zeller, experts for Petitioner and Respondent respectively, testified that a reasonably prudent surgeon would not clamp below the common iliacs if to do so would sacrifice the hypogastric arteries and thereby cause irreparable harm or death to the patient. Dr. Zeller testified that the hypogastric arteries are of such importance that not clamping them, even at the risk of embolization, would nevertheless be within the standard of care. Respondent closely monitored Patient H.H. postoperatively. A reasonable and prudent surgeon is not expected to remain in the recovery room with his post-surgical patient until the patient becomes stable. Rather, the reasonable and prudent surgeon is expected to utilize the nursing staff who are charged with attending to the patient and to keep the physician updated on the patient's medical condition. Petitioner's witness, Doris Gutierrez, was the recovery room nurse on duty on March 6, 1998. Her duties included monitoring and reporting changes in Patient H.H.'s condition to Respondent. The record demonstrates that Respondent closely monitored Patient H.H. postoperatively by being in contact with the nursing staff and thereby giving orders for care and treatment to the nursing staff, either by telephone orders ("TO") or in person by verbal orders ("VO") to stabilize the patient. While in the recovery room, Patient H.H. was intubated, on a respirator. Petitioner's witnesses, Doris Gutierrez, confirmed Respondent's monitoring of Patient H.H. when she testified that she called Respondent several times to provide updates on Patient H.H.'s condition. The record demonstrates that postoperatively on March 6, 1998, Respondent wrote his initial order to the nursing staff at 12:30 p.m. while sitting in post-surgical recovery with Patient H.H. Thereafter, Respondent continued to monitor Patient H.H.'s condition and remained in communication with the nursing staff and wrote orders at 1:30 p.m., 2:30 p.m., 3:25 p.m., 5:00 p.m., 5:15 p.m., 8:15 p.m., and again on March 7, 1998 at 12:24 a.m. Following his TO on March 7, 1998, at 12:24 a.m., Respondent next saw Patient H.H. 7 1/2 hours later, at 8:00 a.m., prior to taking Patient H.H. to the surgery room to perform the endarterectomy and embolectomy. Ms. Gutierrez testified that she does not always note when the doctor comes back into the recovery room to give orders. She could not testify as to events that took place after Patient H.H. was transferred to the Surgical Intensive Care Unit ("SICU"). She also stated she did not know how many times Respondent went to SICU because she did not work in SICU when Patient H.H. was transferred out of the recovery room. Ms. Gutierrez was also unable to testify as to when the last time was that Respondent came to the recovery room. Respondent testified that there is a difference between a TO and a VO, the latter indicating that the physician was present in the room at the time he gave his order to the nurse. The evidence is not clear and convincing that Respondent did not provide appropriate postoperative monitoring of Patient H.H.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine: Enter a final order dismissing with prejudice the Administrative Complaint filed against Respondent in DOAH Case No. 01-4406PL, and DOH Case No. 1994-12341. Enter a final order dismissing with prejudice the Administrative Complaint filed against Respondent in DOAH Case No. 01-4407PL, and DOH Case No. 1999-57795. DONE AND ENTERED this 8th day of August, 2002, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 8th day of August, 2002. COPIES FURNISHED: William R. Huseman, Esquire Romualdo C. Marquinez, Esquire Huseman, Marquinez & Schlegal, P.A. 6320 St. Augustine Road, Building 12 Jacksonville, Florida 32217 Kim Kluck, Esquire Richard J. Shoop, Esquire Agency for Health Care Administration Post Office Box 14229, Mail Stop 39A Tallahassee, Florida 32317-4229 Dr. John O. Agwunobi, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue The issues in this case are whether Respondents performed a wrong procedure on patient C.C., as set forth in the second amended administrative complaints, and if so, what is the appropriate sanction.
Findings Of Fact The Department of Health, Board of Medicine, is the state agency charged with regulating the practice of medicine in the state of Florida, pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to this proceeding, Respondents were licensed physicians within the state, with Dr. Kenneth D. Stahl having been issued license number ME79521 and Dr. Eddie Ward Manning having been issued license number ME110105. Dr. Stahl has been licensed to practice medicine in Florida since 1999 and in California since 1987. He has never had disciplinary action taken against either license. Dr. Stahl is board certified by the American College of Surgeons in general surgery, cardiac and thoracic surgery, and trauma and critical care surgery. Dr. Stahl's address of record is 3040 Paddock Road, Fort Lauderdale, Florida 33141. Dr. Manning has been licensed to practice medicine in Florida since May 31, 2011. He has never had disciplinary action taken against his license. On June 23, 2011, Dr. Manning was a resident in general surgery. Dr. Manning's address of record is 1900 South Treasure Drive, Apartment 6R, North Bay Village, Florida 33141. In February 2011, patient C.C., a 52-year-old female, was admitted to Jackson Memorial Hospital (JMH) with a diagnosis of perforated appendicitis. She also had a perirectal abscess. Her records indicate that she was treated with percutaneous drainage and a course of intravenous (IV) antibiotics. She was discharged on March 4, 2011. On June 22, 2011, patient C.C. presented to the JMH Emergency Department complaining of 12 hours of abdominal pain in her right lower quadrant with associated nausea and vomiting. Shortly after her arrival she described her pain to a nurse as "10" on a scale of one to ten. A computed tomography (CT) scan of patient C.C.'s abdomen was conducted. The CT report noted that the "the uterus is surgically absent," and "the ovaries are not identified." It noted that "the perirectal abscess that was drained previously is no longer visualized" and that the "appendix appears inflamed and dilated." No other inflamed organs were noted. The radiologist's impression was that the findings of the CT scan were consistent with non-perforated appendicitis. Patient C.C.'s pre-operative history listed a "total abdominal hysterectomy" on May 4, 2005. Patient C.C.'s prior surgeries and earlier infections had resulted in extensive scar tissue in her abdomen. Dr. Stahl later described her anatomy as "very distorted." Patient C.C. was scheduled for an emergency appendectomy, and patient C.C. signed a "Consent to Operations or Procedures" form for performance of a laparoscopic appendectomy, possible open appendectomy, and other indicated procedures. Patient C.C. was taken to surgery at approximately 1:00 a.m. on June 23, 2011. Dr. Stahl was the attending physician, Dr. Manning was the chief or senior resident, and Dr. Castillo was the junior resident. Notes indicate that Dr. Stahl was present throughout the critical steps of the procedure. Dr. Stahl had little recollection of the procedure, but did testify that he recalled: looking at the video image and seeing a tremendous amount of infection and inflammation and I pulled-–I recall that I myself went into the computer program and pulled up the CT scan and put that on the screen right next to the video screen that's being transmitted from the laparoscope and put them side-to-side and compared what the radiologists were pointing to as the cause of this acute infection and seeing on the laparoscopic video image that that indeed matched what I saw in the CT scan and I said, well, let's dissect this out and get it out of her so we can fix the problem. Dr. Stahl further testified that the infected, hollow organ that was dissected and removed was adherent laterally in the abdomen and was located where the appendix would normally be. He recalled that an abscess cavity was broken into and the infected, "pus-containing" organ that was removed was right in the middle of this abscess cavity. Dr. Stahl also recalled the residents stapling across the base of the infected organ and above the terminal ileum and the cecum and removing it. The Operative Report was dictated by Dr. Manning after the surgery and electronically signed by Dr. Stahl on June 23, 2011. The report documents the postoperative diagnosis as "acute on chronic appendicitis" and describes the dissected and removed organ as the appendix. Progress notes completed by the nursing staff record that on June 23, 2011, at 8:00 a.m., patient C.C. "denies pain," and that the laparoscopic incision is intact. Similar notes indicate that at 5:00 p.m. on June 23, 2011, patient C.C. "tolerated well reg diet" and was waiting for approval for discharge. Patient C.C. was discharged on June 24, 2011, a little after noon, in stable condition. On June 24, 2011, the Surgical Pathology Report indicated that the specimen removed from patient C.C. was not an appendix, but instead was an ovary and a portion of a fallopian tube. The report noted that inflammatory cells were seen. Surgery to remove an ovary is an oophorectomy and surgery to remove a fallopian tube is a salpingectomy. On Friday, June 24, 2011, Dr. Namias, chief of the Division of Acute Care Surgery, Trauma, and Critical Care, was notified by the pathologist of the results of the pathology report, because Dr. Stahl had left on vacation. Dr. Namias arranged a meeting with patient C.C. in the clinic the following Monday. At the meeting, patient C.C. made statements to Dr. Namias regarding her then-existing physical condition, including that she was not in pain, was tolerating her diet, and had no complaints. Dr. Namias explained to patient C.C. that her pain may have been caused by the inflamed ovary and fallopian tube or may have been caused by appendicitis that resolved medically, and she might have appendicitis again. He explained that her options were to undergo a second operation at that time and search for the appendix or wait and see if appendicitis recurred. He advised against the immediate surgery option because she was "asymptomatic." The second amended administrative complaints allege that Dr. Stahl and Dr. Manning performed a wrong procedure when they performed an appendectomy which resulted in the removal of her ovary and a portion of her fallopian tube. It is clear that Dr. Stahl and Dr. Manning did not perform an appendectomy on patient C.C. on June 23, 2011. Dr. Stahl and Dr. Manning instead performed an oophorectomy and salpingectomy. It was not clearly shown that an appendectomy was the right procedure to treat patient C.C. on June 23, 2011. The Department did convincingly show that patient C.C. had a history of medical problems and that she had earlier been diagnosed with appendicitis, had been suffering severe pain for 12 hours with associated nausea and vomiting, that she suffered from an infection in her right lower quadrant, that the initial diagnosis was acute appendicitis, and that the treatment that was recommended was an appendectomy. However, substantial evidence after the operation suggests that an appendectomy was not the right procedure. The infected and inflamed organ that was removed from the site of a prior abscess was not an appendix. After the procedure, patient C.C. no longer felt severe pain in her lower right quadrant, with associated nausea and vomiting. She was discharged the following day and was asymptomatic. It is, in short, likely that the original diagnosis on June 22, 2011, was incorrect to the extent that it identified the infected organ as the appendix. The pre-operative diagnosis that patient C.C.'s severe pain and vomiting were caused by a severe infection in an organ in her lower right quadrant was correct. Surgical removal of that infected organ was the right procedure for patient C.C. If that inflamed organ was misidentified as the appendix before and during the operation, that would not fundamentally change the correctness of the surgical procedure that was performed. The evidence did not clearly show that the wrong procedure was performed. It is more likely that exactly the right procedure was performed on patient C.C. That is, it is likely that an oophorectomy and salpingectomy were the right procedures to address the abdominal pain that caused patient C.C. to present at the JMH emergency room, but that the right procedure was incorrectly initially denominated as an "appendectomy," as a result of patient history and interpretation of the CT scan.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Medicine, enter a final order dismissing the second amended administrative complaints against the professional licenses of Dr. Kenneth D. Stahl and Dr. Eddie Ward Manning. DONE AND ENTERED this 15th day of July, 2015, in Tallahassee, Leon County, Florida. S F. SCOTT BOYD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of July, 2015.
