STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 01-0674

) DAVID LOWELL WILLIAMS, M.D., )

)

Respondent. )

________________________________)

RECOMMENDED ORDER

Pursuant to notice, this matter was heard on June 19, 2001, in Deland, Florida, before Donald R. Alexander, the assigned Administrative Law Judge of the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Kim M. Kluck, Esquire

Agency for Health Care Administration Post Office Box 4229

Tallahassee, Florida 32317-4229

For Respondent: Michael R. D'Lugo, Esquire

Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A.

Bank of America Center, Suite 1000

390 North Orange Avenue Orlando, Florida 32801-1646

STATEMENT OF THE ISSUE

The issue is whether Respondent's license as a medical doctor should be disciplined for the reasons given in the Administrative Complaint filed on October 25, 2000.

PRELIMINARY STATEMENT

On October 25, 2000, Petitioner, Department of Health, Board of Medicine, issued an Administrative Complaint alleging that while treating a patient in 1995, Respondent, David Lowell Williams, a licensed medical doctor, was guilty of failing to practice medicine with that level of skill, care, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions, and failing to keep written medical records justifying the course of treatment of the patient. Respondent denied the allegations and requested a formal hearing under Section 120.569, Florida Statutes, to contest the charges.

The matter was referred by Petitioner to the Division of Administrative Hearings on February 16, 2001, with a request that an Administrative Law Judge be assigned to conduct a formal hearing. By Notice of Hearing dated March 2, 2001, a final hearing was scheduled on April 23, 2001, in Daytona Beach, Florida. At the parties' request, the case was rescheduled to May 23, 2001, and then to June 19, 2001, in Deland, Florida. On June 15, 2001, the case was transferred

from Administrative Law Judge Charles C. Adams to the undersigned.

At the final hearing, Petitioner offered Petitioner's Exhibits 1 and 2, which are two depositions of Dr. John Dormois, a Tampa board-certified cardiologist and accepted as an expert in cardiology. The exhibits have been received in evidence. Respondent testified on his own behalf and offered Respondent's Exhibit's 1-4, which were received in evidence. Exhibit 1 is the deposition testimony of Dr. David A. Henderson, a Daytona Beach board-certified cardiologist and accepted as an expert in cardiology. The parties also offered Joint Exhibit No. 1, a copy of the medical records of the patient in question, which was received in evidence. Finally, the undersigned took official recognition of Rule 59R-8.001, Florida Administrative Code.

The Transcript of the hearing was filed on July 11, 2001.

By agreement of the parties, the time for filing proposed findings of fact and conclusions of law was extended to August 11, 2001. The same were timely filed, and they have been considered by the undersigned in the preparation of this Recommended Order.

FINDINGS OF FACT

Based upon all of the evidence, the following findings of fact are determined:

1. Background

   
   

   1. At all times material hereto, Respondent, David Lowell Williams (Respondent or Dr. Williams), was a licensed medical doctor having been issued license number ME 0035686 by Petitioner, Department of Health, Board of Medicine (Board). The Board is charged with the responsibility of regulating the practice of medicine in the State of Florida.

   2. Respondent is board-certified in cardiovascular disease and internal medicine and has practiced his specialty in Ormond Beach, Florida, since 1983. In 1990, Respondent accepted a position as a cardiologist with Florida Health Care Plan, Inc. Except for the charges raised in this proceeding, there is no evidence that Respondent has ever been involved in a prior disciplinary action.

   3. Based on a complaint filed with the Board by an attorney representing the family of a former patient, S.T., on October 25, 2000, the Department of Health, acting on behalf of the Board, filed an Administrative Complaint against Respondent generally alleging that in April 1995 he had failed to practice medicine with the level of skill and care required of a reasonably prudent physician, and that he failed to keep

      written medical records justifying the course of treatment of

      
      

      S.T. Respondent has denied the charges and contends that he practiced medicine within the standard of care and that the documentation related to the patient justified the course of treatment. In determining whether a deviation from the appropriate standard has occurred, the undersigned has considered the conflicting testimony presented by the witnesses and has accepted the more credible evidence, as reflected in the findings below. In doing so, the undersigned has discounted Petitioner's contention that Respondent's expert, Dr. Henderson, is a close friend of Respondent and therefore his testimony is clearly biased. Although the two once practiced together for a few years in the 1980's,

      Dr. Henderson acknowledged that they "don't get along very well right now."

2. The treatment of the patient

   
   

   1. Over a period of years, S.T. was treated by several doctors, including Respondent, who participated in the Florida Health Care Plan, Inc. network. The medical records for that treatment have been received in evidence as Joint Exhibit No.

   1. Because they are not in chronological order, contain matters relating to treatment by physicians other than Respondent, and include some partially illigible pages, the records are somewhat difficult for the reader to navigate.

      They do show, however, that S.T. occasionally cancelled appointments, would not always accept his doctor's advice, sometimes refused to take prescribed medications, and was perhaps not totally candid at all times with the treating physician regarding his symptoms.

      1. The records reflect that Respondent first began treating S.T. on March 29, 1989, on referral from his primary care doctor, Dr. Moussly, due to complaints of "burning in chest with exercise." S.T., then a sixty-year-old male, underwent a stress test on the treadmill which was terminated after three and one-half minutes due to fatigue and shortness of breath. The test revealed "significant ST segment depression" and was consistent with ischemia (inadequate blood flow to the heart). Respondent prescribed Lopressor (a beta- blocking agent used in the treatment of hypertension and angina) and a Nitro-patch (transdermal nitroglycerin delivery system). Dr. Williams also recommended that the patient have a cardiac catherization. Even though the records show that the patient was "reluctant to do this at this point in time," they indicate that a coronary angiogram was performed by Respondent on April 26, 1989, and that "a high-grade stenosis of approximately 90 [percent] . . . with deeply ulcerated plaque" was exhibited in the left anterior descending artery.

      2. S.T. was again referred by Dr. Moussly to Respondent on March 7, 1990, "on an urgent basis." However, S.T. cancelled his appointment and accepted another appointment on April 4, 1990. Despite the urgency of the referral, S.T. reported to Dr. Williams that he was doing well with no symptoms since his last visit one year earlier. His records reflect that his blood pressure was 136/86, his weight 258, his pulse was 60 and regular, his lungs were clear, and a cardiovascular examination was unremarkable. Dr. Williams concluded that S.T. was stable at that time with minimal chest discomfort, and he recommended that S.T. undergo a routine treadmill exercise test to further evaluate his coronary heart disease.

      3. A stress test was performed on May 11, 1990, but it was terminated after three minutes due to shortness of breath. Another stress test was conducted on July 5, 1990, the results of which were "significant for ischemia." Although a cardiac catherization was recommended, "[t]he patient again refuses at this point in time."

      4. On May 1, 1991, S.T. was again seen by Respondent (after cancelling an earlier appointment) at which time he indicated he was feeling well and was essentially asymptomatic. He specifically denied having any shortness of breath, light-headedness, dizziness, or chest pain, and he

         reported that he had skipped taking his prescribed Cardizem on numerous occasions without undergoing any significant change in his symptoms. On that date, his blood pressure was 150/90, his weight 259, his lungs were clear, and the cardiovascular examination revealed no murmur.

      5. Dr. Williams concluded that the patient "seems to be stable at this point in time," and allowed S.T. to discontinue Cardizem as a therapeutic trial, and if he had no further symptoms, he would continue on Lopressor only. Otherwise, he would need to start up on that medication again. Finally,

         Dr. Williams offered S.T. the opportunity to participate in a beta blocker angina trial for which he would be evaluated the following week. The patient apparently declined this offer.

      6. The patient did not return to Respondent's office until December 21, 1994, or more than three years later, after he was given a "[r]outine referral for a stress test" by

         Dr. Moussly. S.T. had seen Dr. Moussly on a "routine followup" on December 1, 1994, at which time he denied having chest pain or shortness of breath. On his visit with Respondent, S.T. underwent another treadmill test that was terminated after two minutes due to the development of ST- segment depression. S.T. also experienced tightness in his chest. The treadmill tests were positive for ischemia "at low exercise tolerance."

      7. Based on the above results, S.T. agreed to undergo cardiac catherization. On December 28, 1994, Respondent performed the cardiac catherization on S.T., which revealed that the main coronary artery was very short, but was essentially normal. The left anterior descending artery (one of the three main arteries to the heart) exhibited a proximal

         90 percent stenosis (stricture of a canal or narrowing of a cardiac valve). A second 75 percent stenosis was present in the distal portion of the artery. No other significant lesions were noted. The left circumflex artery was a large and dominant system. A stenosis in the distal portion of the parent circumflex of approximately 30 percent was present with no other significant lesions noted. The right coronary artery was a nondominant artery with no significant lesions noted.

      8. Based upon the results of the cardiac catherization, Dr. Williams concluded that P.T. demonstrated mild coronary artery disease in the left circumflex artery and "rather severe disease" in the left anterior descending artery. Respondent advised S.T. that he was a candidate for angioplasty (reconstitution or recanalization of a blood vessel) of the left anterior descending artery.

      9. On January 4, 1995, Respondent performed the angioplasty of S.T.'s left anterior descending artery, which contained two lesions. The proximal lesion was reduced from

         approximately 95 percent stenosis to around 10 percent, and the distal lesion was likewise reduced from approximately 75 percent stenosis to around 10 percent.

      10. On February 8, 1995, S.T. made a follow-up visit to Respondent's office. According to the patient notes, S.T.'s vital signs were normal, and he stated that he was "doing very well." Respondent's plan of treatment was to have him follow- up on an as-needed basis. In addition, Respondent discussed the "signs and symptoms of recurrence of chest discomfort" and the importance of stopping smoking as well as having good dietary practice and daily exercise.

      11. On March 7, 1995, Dr. Moussly again referred S.T. to Dr. Williams for a stress test due to the patient's "having very non[-]specific chest discomfort; non[-]exertional, non[-] radiating [pain that was] apparently . . . different than the pain he had prior to his angioplasty." Dr. Moussly also noted in his records that even though the patient had elevated cholesterol, he refused to take Pravachol, which had been prescribed by Dr. Moussly on December 1, 1994.

      12. Pursuant to the referral, on March 15, 1995, S.T. made a follow-up visit to Respondent complaining of "chest discomfort." He underwent another treadmill test which was terminated after three minutes due to chest discomfort and ST- segment depression. The test was positive for ischemia, which

          meant that restenosis of an artery had likely occurred. Respondent recommended repeat cardiac catheterization and angioplasty. Given S.T.'s age, progression of disease, and risk factors, which included "virtually every one known to man," restenosis was not particularly surprising since Respondent's expert established that "the restenosis rate for this [type of] patient was probably in excess of 50 percent."

      13. On March 17, 1995, Respondent performed a second angioplasty of S.T.'s left anterior descending artery and reduced the stenosis from 75 percent to 10 percent in both the proximal and distal lesions. There were no complications from this procedure, which S.T. tolerated well.

      14. On April 3, 1995, S.T. visited Respondent's office for a follow-up at which time he complained of chest discomfort. At that time, S.T. was "very vague about his discomfort" in terms of how often it occurred, how long it lasted, whether there were accompanying symptoms present, and whether the Nitroglycerin provided relief. S.T. did acknowledge, however, that the discomfort was "very infrequent." The records for that visit read as follows:

          Mr. T. since his last visit is having some chest discomfort, although, it has been better. He has taken some sublingual Nitroglycerin on a number of occasions, but is unable to recall exactly how often. His episodes are not exertionally related, different in type and severity than prior to his angioplasty. I feel he may be

          having coronary spasm, although, I cannot totally rule out restenosis. In any event, his symptoms are relatively mild. I have asked him to continue as we're doing. He wil [sic] return in two more weeks for follow-up examination. I have asked him to call should he get worse and he has, otherwise, been asked to keep a diary so that we can more objectively quantify his Nitroglycerin usage.

          
          

          Although S.T.'s vital signs are not recorded in the above note, Dr. Williams performed a physical examination of the patient that day, and he recorded the vital signs on a separate office record entitled "Vital Sign Sheet." He also maintained a separate patient medication chart, which reflected the various medications taken by all his patients; however, due to its age, that chart has been purged in the normal course of business.

      15. A stress test was not ordered by Respondent since he considered the patient's chest discomfort to be "very mild," and the patient described the pain as "completely different" than his previous angina. Also, the pain was not exertionally related, and restenosis was unlikely "at this early date following an angioplasty." Dr. Williams concluded that more than likely the pain was a coronary spasm (a muscular contraction of the wall of the artery), which typically occurs up to 30 to 60 days after the procedure, and he would wait "to see if [the symptoms are going] to go away . . . [w]hich they frequently do after an angioplasty." Finally, Respondent

          noted that the cardinal indicators of ischemic heart disease (a blockage) were not present - - exertional pain, relief from Nitroglycerin, and a similarity with pain experienced before the angioplasty was performed. He accordingly advised S.T. to continue his present course of treatment and to follow-up in two weeks, or if his condition worsened, to return sooner or go to an emergency room.

      16. On Friday, April 7, 1995, S.T. went to the Halifax Hospital Emergency Room in Daytona Beach, Florida, complaining of chest pressure, accompanied by an episode of dizziness, weakness, diaphoresis, and nausea. He also advised that he had been taking several Nitroglycerines on a regular basis.

          Respondent was not present at the facility, and was not the on-call cardiologist on this date. S.T. was seen by

          Dr. David E. Stibbins, who observed that S.T. was bradycardic and had low blood pressure. Like the information given to Dr. Williams on April 3, here the patient gave vague information regarding his chest discomfort. The records

          suggest that Dr. Stibbins opined that the patient's discomfort was not cardiac related and was probably due to anxiety. A cardiac consultation was requested, but not conducted, and

          S.T. was kept in the hospital overnight for observation.

          
          

          Around 1:15 a.m., S.T. reported a few "twinges" in his chest

          to the nurse, but he told her the pain was not serious enough to wake up his doctor.

      17. After denying that he had experienced any chest pain other than the few twinges described above, on the afternoon of April 8, 1995, S.T. was discharged from the hospital in stable condition (without ever being seen by a cardiologist) and advised to follow-up with Respondent in two days (the following Monday). On Sunday, April 9, 1995, the patient suffered a cardiac event and expired. The cause of death on his certificate of death is probable sudden death as a result of coronary artery disease, but neither expert in this case could give a precise reason for S.T.'s demise.

3. The standard of care

1. In the aftermath of an angioplasty, a variety of things can occur causing chest discomfort in the patient. While the beneficial effects of an angioplasty "can last . . . [up] to 20 years," three to five percent of patients experience an acute closure within a matter of minutes or hours, which is the sudden and complete obstruction of the artery. Because of this risk, after a procedure is performed, patients are kept in the hospital at least over night for observation. An acute closure often occurs in patients with a

   70 to 80 percent narrowing of the artery.

2. During the first few weeks after a procedure, acute thrombosis to the vessel at the site of the injury sometimes occurs, but a patient with that condition would experience "intense discomfort that's exactly the same as the patient's pre-intervention discomfort." Without such symptoms, that diagnosis would be "down [on] the list of considerations" by the treating physician.

3. Between six and eight weeks and four months after the procedure, up to a third of balloon angioplasty patients experience a subacute closure (or restenosis) of the artery. Typically, these patients return to the physician's office with clinical symptoms of angina chest pain (similar to that experienced before the procedure) and require a repeat procedure. If restenosis has occurred, the patient is at risk for additional cardiac complications, such as myocardial infarction (heart attack).

4. In some cases, within 30 to 60 days after a procedure, a patient will experience a "different type of sensation" in the chest due to the mechanical stretching of the vessel wall during the procedure. Other patients experience an artery spasm (cramping of the vessel wall), which occurs when the muscle cells go into spasm and constrict the artery. In both of these situations, the discomfort is dissimilar to that experienced before the procedure.

5. Given the foregoing, if a patient presents himself to the doctor within a matter of weeks after an angioplasty with vague, non-ischemic related chest discomfort, it is not a deviation from the standard of care for the physician to choose a course of treatment consisting of "medical management" of the patient, that is, the close monitoring of the patient in the following days and weeks, and treating the patient with beta blockers, nitrates, and aspirin to ameliorate his symptoms. Conversely, if a patient presents himself to the physician with chest discomfort which is ischemic in nature, the ordering of further tests, including an exercise EKG, would be appropriate, with possible referral to a hospital for another cardiac catherization.

6. Other considerations in determining the appropriate course of treatment of a patient include the cardiologist's familiarity with the patient's prior symptoms and history and the symptoms presented at the current time. In addition, the physician must rely upon his experience, knowledge, and education in the field. Taking into account all of these circumstances and considerations, the more convincing evidence establishes that Respondent did not deviate from the standard of care.

   c. The adequacy of the patient's records

   
   

7. The Board has also alleged that Respondent failed to keep adequate medical records on the April 3, 1995, office visit in that he failed to document a physical examination or the results of any ancillary tests, and that the records as a whole fail to justify the course of treatment of the patient.

8. The criticisms of Dr. Williams are based upon the testimony of the Board's expert, Dr. Dormois, who presented deposition testimony in this matter. In his deposition, however, Dr. Dormois withdrew his earlier criticisms of the records, and he indicated that the records provided by

   Dr. Williams "are generally adequate." He also concluded that this case "is not an issue of a medical record deficiency," but rather is "a deficiency of [a] failure to make clinical decisions." When these admissions are coupled with the testimony of Dr. Henderson, who concluded that the records were adequate, it is found that the Respondent kept written medical records justifying the course of treatment of the patient.

   CONCLUSIONS OF LAW

   
   

9. The Division of Administrative Hearings has jurisdiction over the subject matter and the parties hereto pursuant to Sections 120.569 and 120.57(1), Florida Statutes.

10. Because Respondent is subject to the imposition of an administrative fine, as well as the suspension or revocation of his professional license, Petitioner bears the burden of proving by clear and convincing evidence that the allegations in the complaint are true. See, e.g., Nair v. Dep't of Bus. and Prof. Reg., 654 So. 2d 205 (Fla. 1st DCA 1995).

11. The charging document alleges that on April 3, 1995, Respondent violated Section 458.331(1)(m), Florida Statutes (1993), by "fail[ing] to keep written medical records justifying the course of treatment of the patient, in that [he] failed to adequately document the physical findings of Patient S.T.'s condition," and that he violated Section 458.331(1)(t), Florida Statutes (1993), 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. by "failing to conduct a physical examination or further diagnostic procedures, such as an EKG or a stress test, after Patient

    S.T. complained of chest pain," and by failing "to make a proper diagnosis."

12. Because there is less than clear and convincing evidence to establish the foregoing violations, the Administrative Complaint should be dismissed, with prejudice.

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.

DONE AND ENTERED this 30th day of August, 2001, in Tallahassee, Leon County, Florida.

___________________________________ DONALD R. ALEXANDER

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 30th day of August, 2001.

COPIES FURNISHED:

Kim M. Kluck, Esquire

Agency for Health Care Administration Post Office Box 4229

Tallahassee, Florida 32317-4229

Michael R. D'Lugo, Esquire Wicker, Smith, Tutan, O'Hara,

McCoy, Graham & Ford, P.A.

Bank of America Center, Suite 1000

390 North Orange Avenue Orlando, Florida 32802-1646

Tanya Williams, Executive Director Board of Medicine

Department of Health 1940 North Monroe Street

Tallahassee, Florida 32399-0750

William W. Large, General Counsel Department of Health

4052 Bald Cypress Way Bin A02

Tallahassee, Florida 32399-1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the Board of Medicine.

Docket for Case No: 01-000674PL

Orders for Case No: 01-000674PL