STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) CASE NO. 90-0068

)

)

MANUEL LUNA, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to written Notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, Daniel Manry, held a formal hearing in the above styled case on March 14, 1991, in Fort Lauderdale, Florida.

APPEARANCES

For Petitioner: Francesca Small

Senior Medical Attorney

Department of Professional Regulation Northwood Centre

1940 North Monroe Street, Suite 60

Tallahassee, Florida 32399-0792

For Respondent: Neil Garfield, Esquire

3500 North State Road 7, Suite 333 Fort Lauderdale, Florida 33319

STATEMENT OF ISSUES

The issues for determination in this proceeding are whether Respondent committed the acts alleged in the Administrative Complaint and, if so, what disciplinary action, if any, should be taken against Respondent's license.

PRELIMINARY STATEMENT

Petitioner filed an Administrative Complaint against Respondent on October 6, 1989. Respondent was charged with violating Sections 458.331(1)(t), (m), and (q), Florida Statutes, by: committing gross or repeated malpractice or 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 circumstances; failing to keep written medical records justifying the course of treatment; and prescribing, dispensing, administering, mixing, or otherwise preparing legend drugs, inappropriately or in excessive or inappropriate quantities not in the best interest of the patient.

Respondent requested a formal hearing on October 25, 1989. The matter was referred to the Division of Administrative Hearings for assignment of a hearing officer on January 4, 1990, and assigned to Hearing Officer Michael M. Parrish on January 12, 1990. A formal hearing was scheduled for May 9, 1990, pursuant to a Notice of Hearing issued on February 27, 1990. The formal hearing was continued and rescheduled several times and finally set for March 14, 1991, pursuant to the Order Granting Continuance entered on January 9, 1991. The matter was transferred to the undersigned on March 12, 1991.

At the formal hearing, Petitioner offered five exhibits for admission in evidence. Three of Petitioner's exhibits consisted of the deposition testimony of Petitioner's experts, Robert Derhagopian, M.D.; Lee Fischer, M.D.; and Reynold Stein, M.D. Petitioner's Exhibits 1-5 were admitted in evidence pursuant to the stipulation of the parties. 1/ Petitioner also presented the live testimony of the Patient L.M.A.

Respondent offered two exhibits for admission in evidence. Respondent's Exhibit 2 was offered as a late filed exhibit and was timely filed on May 30, 1991. Respondent's Exhibits 1 and 2 were admitted in evidence without objection. In addition, Respondent testified in his own behalf.

The time for filing proposed findings of fact and conclusions of law was extended pursuant to the Order Granting Enlargement of Time entered on May 10, 1991. Petitioner timely filed its Proposed Recommended Order on May 3, 1991. Respondent's Proposed Recommended Order was timely filed on May 30, 1991. The parties' proposed findings of fact are addressed in the Appendix to this Recommended Order.

FINDINGS OF FACT

1. Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.30, Florida Statutes, and Chapters 455 and 459, Florida Statutes. Respondent is licensed as a physician in the State of Florida pursuant to license number ME 0032342. Respondent's address is 4100 South Hospital Drive, Suite 202, Plantation, Florida 33317.

   
   

2. Patient L.M.A. (the "Patient") was seen by Dr. Burkhart in September, 1985, prior to the Patient's initial examination by Respondent. Dr. Burkhart examined the Patient's throat and found an unidentified mass in the Patient's throat. Dr. Burkhart advised the Patient that a throat scan should be performed.

   
   

3. The Patient consulted Respondent on September 28, 1985. The Patient complained of a sore throat, hypertension, excessive weight, and marginal diabetes. Physical findings included some redness of the throat and slight edema on the soft palate. The Patient informed Respondent of her history of cancer of the uvula and of what Dr. Burkhart had said to her regarding the mass in her throat and the need for a throat scan. Respondent told the Patient that there was no need for a throat scan.

   
   

4. Respondent provided medical care and treatment for the Patient from September 28, 1985, until March 28, 1988. During the time Respondent provided medical care and treatment to the Patient, Respondent knew that the Patient had cancer of the uvula in 1974.

5. Respondent examined the Patient approximately 19 times over a period of

   11 months during 1986. The Patient's chief complaints involved upper respiratory symptoms and throat problems. On January 13 and 27, 1986, and on March 26, 1986, Respondent prescribed throat lozenges for the Patient. The medical records disclose that the Patient complained of upper respiratory symptoms including coughing, a runny nose, and watery eyes. Throat lozenges, however, are customarily prescribed for a sore throat.

   
   

6. On April 7, 1986, Respondent found that the Patient had a sore, reddened throat and coughing. Respondent prescribed antibiotics in the form of intramuscular Penicillin and 500 mg. of Penicillin four times a day for ten days. Dr. Burkhart's office called the Patient sometime in April, 1986, and reminded her that it was important for her to have a throat scan performed. The Patient told Respondent, and Respondent told the Patient that she did not need a throat scan.

   
   

7. The Patient saw Respondent on May 1, 1986, complaining of a sore throat, coughing, and difficulty swallowing. Respondent prescribed Penicillin parenterally and 500 mg. orally for 10 days. When the Patient returned to Respondent on May 13, 1986, complaining of a sore throat and a lump in her throat, Respondent prescribed antibiotics in the form of 400 mg. of Erythromycin orally for ten days, Septa (a sulfa drug), and Chloraseptic.

   
   

8. The Patient saw Respondent on June 19 and 25, 1986. The medical records indicate that the Patient had no complaints but that the Respondent again told the Patient to take Chloraseptic lozenges.

   
   

9. The Patient saw Respondent on August 4, 1986, complaining that she could feel something in her throat. The Respondent prescribed more antibiotics in the form of Penicillin and Ampicillin, Probenecid, and more Chloraseptic. 2/ Respondent advised the patient to see a throat specialist but did not arrange a consultation or a referral.

   
   

10. The Patient saw Respondent on August 8, 1986, complaining of a sore, reddened throat, infected tonsils, and a cough. Respondent prescribed ten more days of Penicillin 500 mg. The Patient saw Respondent again on August 21, 1986. The Patient's throat was red and Respondent prescribed Chloraseptic lozenges.

    
    

11. In September, 1986, the Patient had difficulty swallowing. Her throat was raw and sore. Upon self-examination, she saw that her uvula was raw.

    
    

12. On October 16, 1986, the Patient complained of vague throat symptoms including a "sensation" in her throat. The Respondent prescribed antibiotics in the form of 250 mg. of Erythromycin three times a day and Chloraseptic lozenges.

    
    

13. On November 19, 1986, the Patient's throat was sore and reddened. The Respondent prescribed antibiotics in the form of intramuscular Penicillin and oral Penicillin.

    
    

14. On December 6, 1986, the Patient's throat remained sore and reddened. Respondent prescribed antibiotics in the form of Erythromycin and also prescribed Chloraseptic. Respondent's medical records indicate that a referral to Dr. Ramos, an otolaryngologist, was considered by Respondent.

    
    

15. On December 16, 1986, the Patient told Respondent that she felt that she had cancer again and that she would not take any more antibiotics. Respondent made an appointment for the Patient to see Dr. Ramos.

16. Dr. Ramos performed a biopsy on the Patient in December, 1986. The Patient was found to have a schema-cell carcinoma of the soft palate. The Patient was diagnosed as having cancer of the uvula and treated with radiation therapy. The radiation therapy dried up the Patient's saliva glands.

    
    

17. Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent physician as being acceptable under similar circumstances. The Patient's complaints of sore throat were related to her underlying cancer. Respondent was under the impression that an infectious process was involved and prescribed antibiotics. Respondent failed to document the existence of an infectious process either by the presence of a fever or by a culture of the throat. 3/ Respondent's examination of the Patient's head and neck was incomplete. Respondent failed to document that a mirror examination was performed on the soft palate, including the back of the Patient's uvula, hypopharynx, and larynx. 4/

    
    

18. The Patient had a higher than average chance of getting cancer in the throat area due to the fact that she had cancer of the uvula in the past and had been a smoker. Appropriate medical treatment requires that cancer be ruled out as a cause of repeated sore throats, even in patients without prior histories of cancer, before concluding that an infectious process is the cause of the sore throats. The Patient either had cancer or Erythroplasia of Queyrat when she first visited Respondent on September 28, 1985, which Respondent improperly interpreted as an infectious process. 5/

    
    

19. Respondent failed to keep written medical records justifying the course of treatment in three respects. First, the records failed to justify the initial use of antibiotics. Second, the records failed to justify the continued use of antibiotics when they did not resolve the condition. Third, the records failed to justify the failure to consult with or refer the patient to a specialist in a timely manner.

    
    

20. Respondent prescribed, dispensed, and administered, legend drugs inappropriately and not in the best interest of the Patient. Respondent treated the Patient with antibiotics when such treatment was not justified.

    
    

    CONCLUSIONS OF LAW

    
    

21. The Division of Administrative Hearings has jurisdiction over the parties and subject matter of this proceeding. Section 120.57, Florida Statutes. The parties were duly noticed for the formal hearing.

    
    

22. Petitioner has the burden of proof in this proceeding, and must show by clear and convincing evidence that Respondent committed the acts alleged in the Administrative Complaint and what discipline should be imposed. Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987). Here, petitioner has met its burden of proof.

    
    

23. Ruling on certain objections made by Respondent during the deposition of Dr. Gary Stone were reserved for disposition in this Recommended Order. Respondent's objections are sustained with respect to the objections on: page 19, lines 13-25; page 20, lines 1 and 2; page 20, lines 11-25; page 21, line 1; and page 23, lines 3-16. Respondent's motions to strike with respect to the foregoing objections are denied.

24. Respondent violated 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. Respondent failed to adequately diagnose and assess Patient L.M.A. (the "Patient"). Respondent noted redness and edema of the pharynx on numerous occasions but did not determine the cause of the recurrent condition before concluding that the cause was an infectious process and treating the Patient with antibiotics. Respondent failed to timely consult with or refer the Patient to an appropriate specialist. Respondent continued aggressive antibiotic therapy which was insufficiently monitored and which failed to resolve the patient's condition.

    
    

25. Respondent violated Section 458.331(1)(m), Florida Statutes, by failing to keep written medical records justifying the course of treatment followed for the Patient. Respondent's medical records failed to justify the aggressive antibiotic treatment administered to the Patient. Respondent's medical records failed to justify continued antibiotic therapy without consultation with a specialist in view of the Patient's history of oral cavity cancer. Respondent's medical records failed to justify the delay from August 4, 1986, when Respondent first considered referring the Patient to a specialist and the actual referral on December 16, 1986.

    
    

26. Respondent violated Section 458.331(1)(q), Florida Statutes, by prescribing, dispensing and administering, legend drugs, inappropriately and in a manner that was not in the best interest of the Patient. Respondent treated the Patient with aggressive antibiotic therapy which was insufficiently monitored and which failed to resolve the Patient's condition.

    
    

27. Petitioner is empowered under the provisions of Section 458.331(2), Florida Statutes, to revoke, suspend or otherwise discipline the license of a physician who violates one or more of the following provisions in Section 458.331(1):

    
    

    (m) Failing to keep written medical records justifying the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations.

    * * *

    (q) Prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's professional practice. For the purposes of this paragraph, it shall be legally presumed that prescribing . . . legend drugs . . . inappropriately . . . is not in the best interest of the patient

    and is not in the course of the physician's professional practice, without regard to his intent.

    * * *

    (t) Gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. . . .

    
    

28. Disciplinary guidelines for violations of Section 458.331(1), Florida Statutes, are provided in Florida Administrative Code Rule 21M-20.001. Rule 21M-20.001(2) requires Petitioner to impose penalties within the stated range for each statutory violation. For a violation of Section 458.331(1)(m), Rule 21M-20.001(2)(m) requires a minimum penalty of a reprimand and administrative fine in the amount of $250 and authorizes a maximum penalty of two years suspension followed by probation, and an administrative fine of $5,000. For a violation of Section 458.331(1)(q), Rule 21M-20.001(2)(q) requires a minimum penalty of one year probation and an administrative fine of $250 and authorizes a maximum penalty of revocation and an administrative fine of $5,000. For a violation of Section 458.331(1)(t), Rule 21M-20.001(2)(t) requires a minimum

penalty of two years probation and an administrative fine of $250 and authorizes a maximum penalty of revocation and an administrative fine of $5,000.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order finding the Respondent

guilty of violating Sections 458.331(1)(m), (q), and (t), Florida Statutes, and imposing the following disciplinary action: a reprimand; an administrative fine in the amount of $5,000; and three years of probation in accordance with terms to be determined by Petitioner.

DONE AND ORDERED in Tallahassee, Leon County, Florida, this 20th day of August 1991.

DANIEL MANRY

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 20th day of August 1991.

ENDNOTES

1/ Petitioner's Exhibit 1 is a statement of stipulated facts. Petitioner's Exhibit 2 is a composite exhibit of Respondent's office records and physician's notes. Petitioner's Exhibit 3 is the deposition of Dr. Robert Derhagopian.

Petitioner's Exhibit 4 is the deposition of Dr. Lee Fischer. Petitioner's Exhibit 5 is the deposition of Dr. Reynold Stein.

2/ Probenecid intensifies the effect of Penicillin.

3/ A throat culture is a lab test used by physicians to determine if antibiotics are needed, and if so, what type. It is also used to determine if the patient is responding to antibiotics.

4/ The physical examination performed by Respondent included a visual examination of the head and neck structures by looking in the throat. Respondent felt the soft palate and examined the neck for lymph nodes. Notations made by the nurse regarding the Patient's vital signs indicate the Patient was always afebrile, i.e., had no temperature or fever. The medical records indicate that gram stains were ordered but fail to indicate the results of such tests, if any.

5/ Erythroplasia of Queyrat is a pre-cancer condition that includes redness of the throat. It is an indication that cancer is brewing.

APPENDIX

Petitioner has submitted proposed findings of fact. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they have been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted. Although most of Petitioner's proposed findings were cast in the form of "fact", they were in substance argument and rejected accordingly.

The Petitioner's Proposed Findings of Fact

Proposed Finding Paragraph Number in Recommended Order of Fact Number of Acceptance or Reason for Rejection

32-35 Rejected as either conclusions of law or as invading the province of the trier of fact

36, 37 Rejected as recited testimony

Respondent has submitted proposed findings of fact in paragraph numbers 4.1-27. Paragraph numbers 1-3 are considered as a preliminary statement. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they have

been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted.

Respondent Proposed Findings of Fact

Proposed Finding Paragraph Number in Recommended Order of Fact Number of Acceptance or Reason for Rejection

15-16 Rejected as irrelevant and immaterial

1. Rejected in Finding 17

2. Accepted in Finding 19

3. Rejected as argument

4. Rejected as recited testimony

5. Rejected as irrelevant and immaterial

6. Rejected as speculation

7. Rejected as invading the province of the trier of fact

8. Rejected in Finding 17

9. Rejected as recited testimony

10. Rejected as recited testimony

11. Rejected as conclusion of law

COPIES FURNISHED:

Dorothy Faircloth Executive Director Department of Professional

Regulation Board of Medicine Northwood Centre

1940 North Monroe Street, Suite 60

Tallahassee, Florida 32399-0792

Jack McRay General Counsel

Department of Professional Regulation

Northwood Centre

1940 North Monroe Street, Suite 60

Tallahassee, Florida 32399-0792

Francesca Small, Esquire Department of Professional

Regulation Northwood Centre

1940 North Monroe Street, Suite 60

Tallahassee, Florida 32399-0792

Neil Garfield, Esquire

500 North State Road 7 Suite 333

Fort Lauderdale, Florida 33319

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions to this Recommended Order. All agencies allow each party at least 10 days in which to submit written exceptions. Some agencies allow a larger period within which to submit written exceptions. You should contact the agency that will issue the final order in this case concerning agency rules on the deadline for filing exceptions to this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the final order in this case.

Docket for Case No: 90-000068

Orders for Case No: 90-000068