STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF MEDICAL ) EXAMINERS, )

)

Petitioner, )

)

vs. ) CASE NO. 83-3378

)

CHARLES F. SHOOK, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, this cause came on for formal hearing before P. Michael Ruff, Hearing Officer, in Fort Myers, Florida on March 28, 1984. The appearances were as follows:

APPEARANCES

For Petitioner: Barbara K. Hobbs, Esquire

Staff Attorney

Department of Professional Regulation

130 North Monroe Street Tallahassee, Florida 32301

For Respondent: Patrick E. Geraghty, Esquire

HENDERSON, FRANKLIN, STARNES and HOLT

Post Office Box 280

Fort Myers, Florida 33902

This cause arose on an administrative complaint filed against the Respondent by the Petitioner named above wherein it is alleged, in effect, that the Respondent violated Section 458.331(1)(t), Florida Statutes, by committing gross or repeated malpractice or failure to practice according to standards accepted by reasonably prudent similar physicians in his community, with regard to treatment given patient Betty Fiore. Specifically, it is alleged that his surgical procedure and post- operative management of this patient's case, for whom he performed a "vein-stripping" procedure, departed from the above standard.

A formal proceeding was requested by Respondent and at the hearing Petitioner presented two expert witnesses. The Respondent presented three expert witnesses, as well as the testimony of other medical doctors who are familiar with the Respondent's character and his practice. The Respondent presented a total of thirteen witnesses and the petitioner three. Petitioner's exhibits 1, 2 and 3 were admitted into evidence as were Respondent's "A" and "E".

The parties ordered a transcript of the proceedings and elected to file proposed findings of fact and conclusions of law. All proposed findings of fact and conclusions of law and supporting arguments have been considered. To the extent that they are in accordance with the findings, conclusions and views stated herein, they are accepted. To the extent that the proposed findings, conclusions and arguments asserted are inconsistent herewith, they are rejected. Certain proposed findings and conclusions are omitted as not relevant nor as necessary to a proper determination of the material issues presented. To the extent that the testimony of various witnesses is not in accord with the findings herein, it is not credited. See, Sonny's Italian Restaurant v.

Department of Business Regulation, 414 So. 2d 1156, 1157 (Fla. 3d DCA 1982); Sierra Club v. Orlando Utilities Commission, 436 So. 2d 383 (Fla. 5th DCA 1983).

The issue to be resolved concerns whether the Respondent departed from the above-referenced standard of medical practice embodied in Section 458.331(1)(t), Florida Statutes and, if so, what, if any, penalty is warranted.

FINDINGS OF FACT

1. The Respondent, Charles P. Shook, M.D., is a medical doctor having been issued license number 0020414, pursuant to Chapter 458, Florida Statutes. He is board certified in the areas of general and peripheral vascular surgery and practices in those specialty areas in Fort Myers, Lee County, Florida. He has been practicing in Lee County since 1973. The Petitioner is an agency of the State of Florida, charged with enforcing the licensure and practice standards embodied in Chapter 458, Florida Statutes and related statutes and rules and imposing disciplinary measures for departure from those standards by physicians licensed in Florida when such are proven.

   
   

2. Mrs. Betty A. Fiore, at times pertinent hereto, was an obese, 47-year old female, with a history of thrombo-phlebitis and progressively enlarging and painful bilaterial varicosities of the veins in her right and left legs. She was admitted to Fort Myers Community Hospital on January 28, 1979, by the Respondent, for performance of a bilateral "vein-stripping" surgical procedure. Her medical history reflected that she had had a similar vein-stripping procedure performed over 20 years previously.

   
   

3. The patient was operated on by the Respondent on January 29, 1979, beginning at approximately 9:25 a.m. The procedure was quite lengthy due to certain complications and lasted until 1:25 p.m. that day.

   
   

4. After normal preparations, under general anesthesia, the Respondent began the operation by performing an oblique groin incision on the left leg just below the inquinal liagment, approximately ten centimeters in length. The incision penetrated the subcutaneous tissue and, as the "fossa-ovalis" was approached, the Respondent noted a significant amount of scar tissue, apparently related to the earlier surgical procedure, which obliterated and concealed much of the normal anatomy and structure in the area of surgery. It was of such a dense nature that only a faintly palpable pulse could be felt in the vessel.

   The Respondent dissected out the various venous branches in the area and individually ligated them. During his dissection process, the distal common femoral artery was injured by being slightly nicked with the surgical instrument. Repair procedures for the injury to the artery were carried out as will be described below. In any event, the "codman stripper" was employed in carrying out the stripping operation on the vein in question and additionally, several incisions were made around the calf of the leg to alleviate smaller varicosities. One large perforating vein in the malleolar area had to be

   ligated after the superficial portion had been stripped away. The Respondent then began to perform a similar procedure on the right leg, in spite of the initial difficulties he had had on the left leg, because he did not expect such severe scar tissue involvement with the anatomical structures in the area of incision on both legs. When he carried out the incision on the right leg however, he found that the anatomy of the right leg was essentially the same as that of the left and that substantial scar tissue reaction had occurred, related to prior surgery, with obliteration of much of the normal anatomy, including concealment of the femoral artery. Due in large part to these anatomical changes and complications involved in dissecting out the various venous branches involved in the stripping procedure, the right femoral artery was also slightly nicked by the scalpel.

   
   

5. The Respondent attempted to suture the femoral arteries nicked in both legs at the time these injuries occurred, but the sutures would not hold in the arteries due to some then unknown, medical condition. After the same failure to hold sutures was encountered with regard to both femoral arteries, the Respondent sent samples of the arteries to the pathologist for evaluation. The pathologist report indicated that the arteries were "normal." Parenthetically it should he noted that the "complaining witness," Mrs. Fiore, has been found to exhibit symptoms of diabetes mellitus. Her testimony was somewhat evasive concerning the degree to which she may suffer from this malady, which can have a detrimental effect on the vascular system. In any event, when working first on the left leg, the Respondent elected to resect back along the artery for approximately a half-inch on each side of the wound and after that resection, to repair the femoral artery with the insertion of a 6 millimeter gortex graft. Likewise, with regard to the right leg, the Respondent found the sutures would not hold in the damaged artery (which was of a "cheese-like" consistency). He therefore performed a similar resection and insertion of a 6 millimeter gortex graft to repair the injury. The surgical procedure was then successfully concluded.

   
   

6. Post-operatively the patient encountered some complications involving infection in the groin area, requiring two additional admissions to Fort Myers Community Hospital. Subsequently, she was transferred to Methodist Hospital in Houston, Texas, where she underwent two additional surgical procedures.

   
   

7. The Petitioner presented the opinions of two expert witnesses, Dr. Alexander Braze and Dr. E. William Reiber. Dr. Braze's expert opinion is predicated on the review of Mrs. Fiore's office records from the Respondent's office, the hospital charts for her three admissions to Fort Myers Community Hospital, and summaries of her two admissions to the Methodist Hospital in Houston, Texas. His opinion is not based on any examination of the patient involved. Dr. Braze thus opined that because of the previous surgery on the greater saphenous vein, bilaterally, there would be obvious and considerable scarring and scar tissue in the subcutaneous area which would distort and conceal the individual anatomical structures. He himself has never nicked a femoral artery while doing a vein-stripping operation but, although he acknowledges it is an "uncommon complication, he has heard of it occurring. He was unable to render an opinion concerning whether or not the operation was performed properly because this was not a typical vein ligation and stripping procedure, due to the presence of extensive scar tissue, and resulting difficulty involved. The dense scar tissue precluded identification of the structures in the area of the surgical incision and meant that the Respondent had to proceed slowly and very meticulously with a careful dissection, deviation from which careful procedure could cause difficulty. The doctor's procedure was

   slow and meticulous. The procedure (for both legs) took approximately four hours.

   
   

8. Although the Respondent proceeded with care, he nicked the arteries anyway. Dr. Braze could not state that such a complication, albeit uncommon, constituted a departure from standards normally recognized in the medical community. With regard to the doctor's judgmental decision to proceed to the right leg after nicking and repairing the artery in the left leg and completing the vein stripping procedure in the left leg. Dr. Braze opined that he was acting as a reasonable physician in proceeding to the other leg since he had already corrected the initial injury, especially since it was the leg in which she was having her chief complaints. In any event, Dr. Braze was unable to render an opinion as to whether or not the procedure up to the point of nicking the artery was properly or improperly done, although he acknowledged that the lengthy time taken to perform the total procedure indicates that the doctor was proceeding slowly and with greater than normal difficulties. In any event, after the arteries were nicked, the procedure followed by the Respondent was excellent and the repair work was competently and efficiently performed.

   
   

9. Dr. Reiber, Petitioner's other expert witness, testified by deposition, which was stipulated into evidence. His expert opinion was based on a review of the deposition of the Respondent, the Fort Myers Community Hospital records of the patient, and the depositions of the patient, Betty Fiore, Arnold Flare and Quillen Jones. Additionally, he reviewed the records dealing with Mrs. Flare's treatment in Houston, Texas. He thus opined that the Respondent made two technical errors when he injured the arteries in each leg and he felt that it was an error in judgment to have performed the procedure on the right leg after having encountered difficulty in the initial procedure on the left leg. He was unable to opine however, that the treatment rendered the patient by Respondent fell below the appropriate standard of care accepted by similar physicians in the community. Moreover, he also opined that the Respondent's treatment after nicking the arteries affirmatively met the standard of care for reasonably prudent physicians in such circumstances.

   
   

10. The expert witnesses presented on behalf of the Respondent were Drs. Peter M. Sidell and Luis A. Ruilova. Both witnesses opined, in effect, that, given the obesity of the patient and the difficult surgical process that alone entailed, coupled with the significant involvement of scar tissue in the area of the incision, that the complications associated with this procedure could occur in the hands of even the most renowned surgeon. The fact that the Respondent experienced these complications does not render his practice in this regard to be below the standard of care for vascular surgeons in that community or area of practice. They further opined that it is a matter of personal judgment on whether to proceed to the other leg after encountering these difficulties. A reasonable judgment would have been to explore the groin area on the other side, after accomplishing repair of the first injured artery, which was done. The initial arterial injury having been repaired in a successful manner, both of the Respondent's experts opined that, the patient then being stabilized, the Respondent was justified in proceeding to the other leg and performing the procedure on that side. The main purpose of the operation was to remove the veins of the patient since the patient was symptomatic with varicosities. It therefore would be poor judgment to simply repair the nicked artery and proceed no further, since the symptomatic vein would remain uncorrected. In short, both experts for Respondent opined that neither the vein-stripping procedure, the repair of the damaged arteries nor post-operative management for which Respondent was responsible were performed in a manner below the appropriate standard of care of reasonably prudent physicians in the community.

11. Thus, although the patient unfortunately experienced difficulties during a procedure involving the accidental nicking of her femoral arteries and, after the grafts repairing those injured arteries were performed, later suffered an infection at the operative site necessitating further hospitalization, no expert witness could describe the treatment and care afforded this patient as being below the appropriate standard of care exercised by a reasonably prudent physician performing such vascular surgical practice in the Fort Myers community or area. The Respondent has never encountered this difficulty either before or since this occasion in his practice, which is characterized by frequent vascular surgical procedures. Additionally, Dr. Ruilova established that the nicking of the femoral arteries during such a procedure, although not a common occurrence, is well documented in the literature and not at all unheard of. Indeed, Dr. Ruilova, when assisting a distinguished surgeon who was chief of surgery at the Mayo Clinic at the time, observed that expert surgeon nick a femoral artery in a vein- stripping procedure on two occasions. Finally, it is noted that the Respondent's practice has been characterized by a high level of professional expertise, competence and compassion in caring for his patients, both before and since the occasion in question. He has never before been subjected to disciplinary action.

    
    

    CONCLUSIONS OF LAW

    
    

12. The Division of Administrative Hearings has jurisdiction of the subject matter of the parties to this proceeding. Section 120.57(1), Florida Statutes.

    
    

13. The Administrative Complaint filed herein charges that the Respondent violated Section 453.331(1)(t), Florida Statutes, by committing 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. That section additionally requires the board to accord great weight to the provisions of Section 768.45, Florida Statutes, which establishes the standards for recovery for medical negligence in civil cases. That section provides as follows:

    
    

    (3)(a) If the injury is claimed to have resulted from the negligent affirmative medical intervention of the healthcare provider, the claimant must, in order to prove a breach of an accepted standard of care, show that the injury was not within the necessary or reasonably foreseeable results of the surgical, medicinal, or diagnostic procedure constituting the medical intervention, if the intervention from which the injury is alleged to have resulted was carried out in accordance with an acceptable standard of care by a reasonably prudent similar healthcare provider.

    
    

14. Further, Section 768.45(4), provides that the existence of a medical injury shall not create an inference or presumption of negligence. Florida Case Law in following this statutory scheme establishes the principle that physicians are not guarantors of diagnoses or treatments and are not necessarily liable even when desired results do not ensue. A physician is not liable in negligence

    for honest errors of judgment under prevail inn case law, since physicians are allowed a considerable range in the exercise of their medical judgment and discretion. Thus, in order to hold a physician liable, it must be shown that the course of treatment which he pursued or failed to pursue, was clearly against the course of treatment or practice recognized as correct by his peers. Dillman v. Helman, M.D., 283 So. 2d 388 (Fla. 2d DCA 1973); Potock v. Turek, M.D., 227 So. 2d 724 (Fla. 3d DCA 1969): Blackwell v. Southern Florida Sanitorium and Hospital Corporation, 174 So. 2d 45 (Fla. 3d DCA 1965); Atkins v. Humes, 107 So. 2d 253 (Fla. 2d DCA 1958); Hill v. Boughten, 1 So. 2d 610 (Fla.

    1941). The Department of Professional Regulation and Board of Medical Examiners, in seeking to impose restrictions on the Respondent's right to practice his livelihood in the medical profession, must prove that the Respondent's performance of treatment on the subject patient fell below standards of medical practice acceptable to his professional peers. This proof must be of a clear and convincing nature according to the opinions in Walker v. State, 322 So. 2d 612 (Fla. 3d DCA 1976); Reid v. Florida Real Estate Commission, 188 So. 2d 846 (Fla. 2d DCA 1966) and, since the Respondent is charged to have breached a standard of conduct which is not explicitly delineated in statute or rule, "the critical matters in issue must be shown by evidence which is indubitably as `substantial' as the consequences." Bowling v. Department of Insurance, 394 So. 2d 165, 172 (Fla. 1st DCA 1981).

    
    

15. The Petitioner has clearly failed to sustain its burden of proving that the Respondent failed to practice medicine with that level of care, skill and treatment recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances. The allegations in Counts 5, 6, 7 and 8 concern the ligation of the left femoral artery allegedly resulting in surgical complications and injury to the right femoral artery resulting in additional surgical complications and in this regard the Respondent has clearly not been proven to fall below the level of care, skill and treatment recognized by reasonably prudent similar physicians under these conditions and circumstances. The injuries suffered by this patient were caused by a known, albeit rare, complication for this type of surgical procedure which was directly related to the large amount of scar tissue in the area of surgical incision which concealed certain of the anatomical structures, i.e. veins, arteries and nerves in the left and right groin regions, which concealment was a direct causative factor in the Respondent's accidently nicking the arteries involved. This scar tissue accumulation and its complicating effect on the surgery was attributable to an earlier surgical intervention many years before and was a definite contributing factor in the complications suffered by the patient.

    
    

16. Concerning paragraph 9 of the Administrative Complaint, it is alleged generally that a reasonably prudent similar physician would have delayed performing the surgical procedure on the right leg after erring in the procedure on the left. This proposition was not at all supported by even Petitioner's expert testimony. Both Petitioner's experts, as well as those supportive of the Respondent, felt that the Respondent's decision to proceed to the other leg and perform the procedure thereon was within the proper exercise of his professional judgment and they could not state that they would have done otherwise under the circumstances, especially the circumstances that the patient's worst complaints came from the area where the surgical procedure was performed on the right leg.

    
    

17. Concerning paragraphs 10, 11 and 12 of the Administrative Complaint, it is alleged generally that Respondent inserted a gortex graft which became infected post-operatively, that a reasonably prudent physician under similar circumstances would have identified the infection and treated it promptly, and that Respondent's alleged failure to do so caused the necessary arterial by-pass

    and continuing medical treatment. This assertion is not supported by the evidence in this cause either. The Petitioner's experts as well as those testifying on behalf of the Respondent, agreed in their opinions that all actions taken by the Respondent after nicking the femoral arteries met all appropriate standards of care. No testimony or evidence other than expert opinion was adduced in this regard.

    
    

18. Thus, the actions of the Respondent have not been proven to constitute gross or repeated malpractice. The actions of the Respondent in treating the subject patient have also not been proven to constitute a failure to practice medicine with the level of care, skill and treatment recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances. Accordingly, the allegations of the Administrative Complaint have not been proven and the complaint should be dismissed.

RECOMMENDATION

Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, it is, therefore

RECOMMENDED that a Final Order be entered by the Board of Medical Examiners dismissing the complaint in its entirety.

DONE and ENTERED this 11th day of October, 1984, in Tallahassee, Florida.

P. MICHAEL RUFF Hearing Officer

Division of Administrative Hearings The Oakland Building

2009 Apalachee Parkway

Tallahassee, Florida 32301

(904)488-9675

FILED with the Clerk of the Division of Administrative Hearings this 11th day of October, 1984.

COPIES FURNISHED:

Barbara K. Hobbs, Esquire

Department of Professional Regulation

130 North Monroe Street Tallahassee, Florida 32301

Dorothy Faircloth, Executive Director Board of Medical Examiners

130 North Monroe Street Tallahassee, Florida 32301

Patrick Geraghty, Esquire HENDERSON, FRANKLIN, STARNES & HOLT

Post Office Box 280

Fort Myers, Florida 33902

Fred M. Roche, Secretary

Department of Professional Regulation

130 North Monroe Street Tallahassee, Florida 32301

Docket for Case No: 83-003378

Orders for Case No: 83-003378