STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF BUSINESS AND ) PROFESSIONAL REGULATION, )

BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) CASE NO. 94-2116

) JOHN AUGUST ORTOLANI, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, Don W. Davis, held a formal hearing in the above- styled case on December 12-13, 1995, in Daytona Beach, Florida.

APPEARANCES

For Petitioner: Albert Peacock, Esquire

Edward H. Lerner, Esquire

Agency for Health Care Administration 1940 North Monroe Street, Suite 60

Tallahassee, Florida 32399-0792

For Respondent: Donald W. Weidner, Esquire

Donna J. Torsney, Esquire

10161 Centurion Parkway North, Suite 190

Jacksonville, Florida 32256 STATEMENT OF ISSUE

The issue for determination is whether Respondent, a licensed physician, committed violations of Chapter 458, Florida Statutes, sufficient to justify the imposition of disciplinary sanctions against his license.

PRELIMINARY STATEMENT

On May 15, 1992, Petitioner issued an Administrative Complaint alleging that Respondent failed to practice medicine with the level of care, skill and treatment recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances in violation of Section 458.331(1)(t), Florida Statutes; that Respondent had failed to keep medical records justifying the course of treatment accorded a patient in violation of Section 458.331(1)(m), Florida Statutes; and that Respondent inappropriately prescribed, dispensed, or administered a legend drug inappropriately and not in a patient's best interest in violation of Section 458.331(1)(q), Florida Statutes.

Respondent requested a formal administrative hearing on the charges set forth in the Administrative Complaint. Subsequently, the matter was transferred to the Division of Administrative Hearings for conduct of a formal hearing pursuant to Section 120.57(1), Florida Statutes.

During the hearing, Petitioner presented testimony of four (4) witnesses and eleven (11) exhibits. Respondent presented testimony of three (3) witnesses and (5) five exhibits.

The transcript of the final hearing was filed with the Division of Administrative Hearings on January 5, 1996. The parties requested and were granted leave to file posthearing submissions more than 10 days after the filing of the transcript, and in accordance with Rule 60Q-2.031, Florida Administrative Code, waived provisions of Rule 28-5.402, Florida Administrative Code.

Proposed findings of fact submitted by the parties are addressed in the appendix to this recommended order.

FINDINGS OF FACT

1. The Respondent is a licensed physician in the state of Florida, and holds license number ME 0034710. Respondent's last known address is 1430 Mason Avenue, Daytona Beach, Florida, 32117-4551.

   
   

2. At all times material to these proceedings, Respondent, who is both a neurologist and a psychiatrist, specialized in the diagnosis and treatment of headaches in his medical practice with Daytona Neurological Associates in Daytona Beach, Florida.

   
   

3. At various times from approximately May 18, 1984, through December 23, 1988, Respondent rendered neurological care to Patient C.R., a female born on November 14, 1963.

   
   

4. On May 18, 1984, when C.R. initially came to Respondent's office complaining of severe headaches, Respondent noted in his medical records that the patient had been on birth control pills for three years and had ceased taking them two months prior to this visit. C.R. was also a cigarette smoker.

   
   

5. From approximately May 18, 1984, until September 12, 1986, C.R. was prescribed a variety of medications at various times by Respondent for the patient's headaches. The medications included Asendin, Phrenilin Forte, Norpramin, and Tylenol #3.

   
   

6. Medrol, Prednisone, and Decadron are legend drugs as defined in Section 465.003, Florida Statutes, and contain both natural and synthetic adrenocortical steroids (glucocorticoids).

   
   

7. On September l2, 1986, Respondent prescribed a Medrol Dosepak unit to

   C.R. A Medrol Dosepak is a corticosteroid specific package that is tapered over six days from the first dose down to the last dose and contains a total of 84 mg of methylprednisolone (105 mg Prednisone equivalent). The medication was concluded on or about September 17, 1986.

   
   

8. On October 30, 1986, Respondent prescribed another Medrol Dosepak unit to C.R. The patient took the Medrol tablets beginning on this date, in decreasing dosages, starting at 24 mg and ending at 4 mg six days later, for a total of another 84 mg of methylprednisolone (105 mg Prednisone equivalent).

9. Both prescriptions of Medrol (September 12, 1986 and October 30, 1986) were short courses and treatment was not inappropriate.

   
   

10. On November 7, 1986, C.R. went to a hospital emergency room where she was prescribed Prednisone 40 mg for three days and 20 mg for four days and referred back to the Respondent for follow-up care. During this hospitalization, C.R. received approximately 200 mg of Prednisone.

    
    

11. On November 14, 1986, Respondent saw C.R. in his office and indicated in his records that the patient seemed to be doing better on Prednisone and "[w]e will keep her on this medication and re-evaluate her in one month. She is to . . . decrease the Prednisone and come off this in about a week or two."

    
    

12. On November 25, 1986, Respondent saw C.R. in his office. Respondent indicated in his records that he would keep C.R. on Prednisone l0 mg daily for "another week or so."

    
    

13. From November 7, 1986 until November 30, 1986, C.R. received a total of 465 mg of Prednisone.

    
    

14. Appropriateness of corticosteroid use varies with both amount and duration. The amount initiated in the Emergency Room on November 7, 1986, was not excessive, but Respondent's rationale for continuation of the drug, or whether the November 14, 1986 dosage was tapered or less than that previously prescribed for C.R. in the emergency room, is not documented in Respondent's patient records.

    
    

15. On January 20, 1987, Respondent saw C.R. in his office and documented that he was going to give the patient another "short course" of Prednisone.

    
    

16. Respondent saw C.R. again in his office on January 30, 1987, and documented further prescription of Prednisone.

    
    

17. The documentation for the above two visits does not indicate the dosage details nor suggest what circumstances of the patient's condition justify again prescribing prednisone other than the remark dated January 20, 1987, that "[p]atient is having some headaches again."

    
    

18. For the period of January 20, 1987 through February 9, 1987, C.R. was prescribed a total of 510 mg of Prednisone.

    
    

19. Petitioner's Exhibit 5 is a calendar prepared by C.R. which allegedly documents the patient's receipts for prescriptions which she purchased upon Respondent's authorization. C.R. has no independent recollection of amounts or times when she took the medications. On the basis of information reflected on the calendar, Petitioner seeks to establish that Respondent prescribed corticosteroids for C.R. in excess of that otherwise established by the evidence in this case. In view of the lack of C.R.'s independent recollection of when she took the medications, the lack of corroborating original receipts, C.R.'s lack of detail recall concerning her treatment by Respondent, her inability to remember when she prepared the calendar other than in preparation for civil litigation against Respondent following her treatment, and lack of other direct evidence corroborating the document's veracity, the calendar standing alone is not credited for the purpose of establishing amounts and times of medication prescribed for C.R. by Respondent.

20. C.R. had an office visit on March 18, 1988 but there is no reference to any Prednisone prescription in the medical record. A handwritten note for the date of April 6, 1988 in the Respondent's medical record states that the patient was "told to stay on Prednisone." Respondent conceded in testimony that he apparently failed to document prescribing 60 mg Prednisone in April of 1988.

    
    

21. From April 27, 1988 through May 8, 1988, Respondent had C.R. admitted to Halifax Medical Center in Daytona Beach, Florida. During that period, she received 909 mg. Prednisone equivalent (Decadron). Respondent discharged the patient with a diagnosis of severe vascular migraine headaches under control with a combination of Mellaril and Procardia.

    
    

22. At the time of the April, 1988 admission, C.R. was suffering from crescendo migraine with numbness, blurring, and an episode of loss of consciousness.

    
    

23. As established by testimony of Thomas M. Zizic, M.D., Respondent's expert in avascular necrosis, corticosteroid use, and treatment of headache, patients with the symptoms displayed by C.R., when she was hospitalized in April of 1988, are at risk for transient ischemic attacks and strokes. As opined by Dr. Zizic, and corroborated by testimony of Victor B. Robert, M.D., the short course of less than two weeks of high dose steroids in the course of the April, 1988 hospitalization was not inappropriate.

    
    

24. Zizic also opined that the other courses of steroids prescribed previously for C.R. were not inappropriate. As established by Zizic, steroid medications in the amounts and duration prescribed for C.R. are not causative of avascular or aseptic necrosis. Dosage amounts of these drugs have to be much greater and for longer periods of time to occasion such side effects. Even assuming C.R.'s calendar of medications and the resultant supposition that she ingested more steroid medication than is established by the credible evidence, Zizic opined that the likelihood that such medication amounts and duration resulted in C.R.'s development of aseptic necrosis is less than five percent. Zizic also testified that he would not have felt it necessary to warn C.R. of the potential for avascular or aseptic necrosis in view of the remoteness of such a possibility at dosages prescribed for her.

    
    

25. Dr. Jacob Green, an expert witness presented by Respondent, is a neurologist who provided insight into the clinical management of the difficult headache patient, noting that there is no standard treatment for such patients, "[y]ou just have to use what works . . . Its a matter of trial and error in a lot of cases."

    
    

26. Green also noted that once a patient is treated with corticosteroids, the dosages must be tapered gradually, not stopped suddenly. Green concluded C.R.`s dosages were decreased appropriately, that duration of Medrol and Prednisone prescribed for the patient was appropriate, and that use and duration of Decadron during C.R.`s hospitalization in April, 1988, was also appropriate.

    
    

27. While Green acknowledged that avascular necrosis of the hips is a known complication of steroid use, he testified that in 1986 or 1987 he would not have felt that failure to warn a patient about the potential for such a remote side effect constituted a breach of the standard of care and would not have warned the patient.

    
    

28. In Green's opinion, Respondent did not prescribe Medrol, Prednisone or Decadron contrary to the best interests of C.R.

29. In 1989, C.R. was diagnosed with aseptic necrosis of the femoral head of both her hips and underwent surgery in 1989 and 1990 resulting in total hip replacements. She has undergone surgery for "a revision on the left side" and continues to have problems.

    
    

30. While differing expert testimony presented in this proceeding fails to clearly and convincingly establish a causal connection between the steroid medications given to C.R. and her resultant physical problems, the common consensus of those experts is that avascular necrosis is a complication that can arise from the use of steroids, given sufficient dosages and duration of such medication.

    
    

31. Although Respondent did not inform C.R. of the potential of avascular necrosis from corticosteroid dosing by the prescribed medications and did not at any time during the course of his treatment discuss with CR the potential for such harmful side effects, the evidence fails to establish that the patient should have been informed in 1986 regarding the remote potential for harmful side effects of such medications.

    
    

32. However, Respondent's medical records on the patient C.R. were inadequate. The records did not serve as an effective basis for planning patient care and providing for continuity in the evaluation of the patient's condition and treatment. The records did not furnish documentary evidence of the course of the patient's medical evaluation, treatment, and change in condition. Detail of the records was not sufficient to clearly demonstrate why one course of treatment was undertaken in preference to another course and would not have communicated sufficient information for any other practitioner who would have assumed the patient's care.

    
    

    CONCLUSIONS OF LAW

    
    

33. The Division of Administrative Hearings has jurisdiction over the parties and the subject matter. Section 120.57(1), Florida Statutes.

    
    

34. Petitioner bears the burden of proof of the charges set forth in the Administrative Complaint. Since a final determination of Respondent's culpability could result in the revocation of Respondent's license, the proof that Respondent has committed those violations must be clear and convincing. Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987).

    
    

35. Respondent is alleged in count one of the Administrative Complaint to have violated Section 458.331(1)(t), Florida Statutes, through gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The basis upon which Petitioner relies to prove this charge is that Respondent prescribed excessive amounts of corticosteroids to C.R. for extended periods of time and failed to warn her of the potential side effects, inclusive of aseptic necrosis of the femoral heads.

    
    

36. Petitioner has not proven clearly and convincingly that the dosages were excessive or were prescribed for extended periods of time. Respondent's failure to apprise C.R. of an extremely remote possibility of aseptic necrosis of the femoral heads is, in view of prevailing medical standards in 1986, insufficient to establish guilt of this count of the Administrative Complaint.

37. Count two of the Administrative Complaint alleges that Respondent's records did not include all times that he prescribed Prednisone to C.R.; the dosages of corticosteroids prescribed; instructions given by him to the patient; justification for the prescription of corticosteroids over a period of six months; or documentation that Respondent had informed the patient that she was ingesting steroids and had been warned of side effects. Consequently, Petitioner alleges that Respondent has violated Section 458.331(1)(m), Florida Statutes, which reads as follows:

    
    

    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.

    
    

38. Respondent did not prescribe corticosteroids steadily for an entire period of six months, but these drugs were prescribed at intervals over time that exceeded that period without adequate record explanation. Further, Respondent's records do not reflect all prescriptions issued by him for C.R., all instructions given by Respondent to C.R., or that Respondent had informed

    C.R. of the medication she was taking and potential side effects of that medication. Respondent is guilty of count two of the Administrative Complaint.

    
    

39. Count three of the Administrative Complaint alleges that Respondent prescribed Medrol Dosepak and Prednisone to C.R. for a period of approximately six months, along with the prescription of 4 mg of Decadron (equal to four times the amount of Prednisone) during a 12-day hospitalization of the patient, and consequently violated Section 458.331(1)(q), Florida Statutes, which reads as follows:

    
    

    Being guilty of prescribing, 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, dispensing, administering, mixing, or otherwise preparing legend drugs, including all controlled substances,

    inappropriately or inexcessive or inappropriate quantities 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.

    
    

40. The evidence fails to clearly and convincingly show that Respondent's prescription of the subject drugs was inappropriate, inexcessive or inappropriate in quantities. Respondent is not guilty of count three of the Administrative Complaint.

RECOMMENDATION

ACCORDINGLY, it is recommended that a final order be entered finding the Respondent guilty of count two of the Administrative Complaint, violation of Section 458.331(l)(m), Florida Statutes; requiring as a penalty that

Respondent's license to practice as a physician in the State of Florida be placed on probation for a period of one year upon conditions prescribed by the Board of Medicine; and further requiring that Respondent pay a fine in the amount of $5,000.

DONE and ENTERED this 26th day of February, 1996, in Tallahassee, Leon County, Florida.

DON W. DAVIS, 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 26th day of February, 1996.

APPENDIX CASE NO. 94-2116

In accordance with requirements of Section 120.59, Florida Statutes, the following constitute my rulings with regard to proposed findings of fact submitted by the parties.

Respondent's Proposed Findings.

1.-2. Accepted.

1. Rejected, unnecessary.

2. Rejected, subordinate to HO findings.

3. Accepted, but not verbatim. While the calendar was admitted, it may only be used to corroborate direct testimony. C.R. had no independent recollections which could be corroborated by the calendar. Respondent took issue with the calendar, consequently the calendar is not credited as a basis for fact finding with the exception of Dr. Zizic's opinion regarding dosage levels.

4. Incorporated by reference.

7.-10. Rejected, subordinate to HO findings.

11. Accepted, not verbatim.

12.-15. Incorporated by reference. 16.-18. Accepted.

19.-22. Rejected, subordinate to HO findings.

Petitioner's Proposed Findings.

1-4. Accepted.

5. Rejected, unnecessary. 6.-9. Accepted, not verbatim.

10. Accepted in part, remainder rejected as subordinate. 11.-12. Accepted.

13.-19. Rejected, subordinate to HO findings. 20.-22. Accepted.

23.-25. Rejected, subordinate to HO findings.

COPIES FURNISHED:

Albert Peacock, Esquire Department of Business and

Professional Regulation 1940 North Monroe Street Suite 60

Tallahassee, Florida 32399-0792

Donna J. Torsney, Esquire Donald W. Weidner, P.A.

10161 Centurion Parkway North Suite 190

Jacksonville, Florida 32256

Jerome W. Hoffman, General Counsel Agency for Health Care

Administration 2727 Mahan Drive

Tallahassee, Florida 32308-5403

Dr. Marm Harris, Executive Director Agency for Health Care

Administration

Division of Medical Quality Assurance 1940 North Monroe Street

Tallahassee, Florida 32399-0792

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.

================================================================= AGENCY FINAL ORDER

=================================================================

STATE OF FLORIDA

AGENCY FOR HEALTH CARE ADMINISTRATION BOARD OF MEDICINE

AGENCY FOR HEALTH CARE ADMINISTRATION, BOARD OF MEDICINE,

Petitioner,

AHCA NO: 89-09022

1. DOAH CASE NO: 94-2116

   LICENSE NO: ME 0034710

   JOHN AUGUST ORTOLANI, M.D.,

   
   

   Respondent.

   /

   
   

   FINAL ORDER

   
   

   THIS MATTER was heard by the Board of Medicine (hereinafter Board) pursuant to Section 120.57(1)(b)10., Florida Statutes, on June 7, 1996, in Miami Beach, Florida, for consideration of the Hearing Officer's Recommended Order (Attached as App. A) Respondent's written Exceptions to the Recommended Order (Attached as App. B) and Petitioner's written Response thereto (Attached as App. C) in the case of Agency for Health Care Administration, Board of Medicine v. John August Ortolani, M.D. At the hearing before the Board, Petitioner was represented by Larry G. McPherson, Jr., Chief Medical Attorney. Respondent was present and was represented by Donald W. Weidner, Esquire and Donna J. Torsney, Esquire. Upon consideration of the Hearing Officer's Recommended Order, the exceptions and responses thereto of the parties, after review of the complete record and having been otherwise fully advised in its premises, the Board makes the following findings and conclusions:

   
   

   RULING ON RESPONDENT'S EXCEPTION TO FINDINGS OF FACT

   
   

   The Respondent's Exception to paragraph 32 of the Recommended Order of the Hearing Officer which found that Respondent's medical records were inadequate, is REJECTED. The finding of the Hearing Officer was supported by competent, substantial evidence of record.

   
   

   FINDINGS OF FACT

   
   

   1. The Hearing Officer's Recommended Findings of Fact are approved and adopted and are incorporated herein by reference as the Findings of Fact of the Board in this cause.

      
      

   2. There is competent, substantial evidence to support the Board's findings herein.

RULING ON RESPONDENT'S EXCEPTION TO CONCLUSIONS OF LAW

The Petitioner's Exception to paragraphs 37 and 38 of the Conclusions of Law of the Recommended Order of the Hearing Officer that the Respondent violated Section 458.331(1)(m), Florida Statutes, is REJECTED. The conclusion of the Hearing Officer was supported by competent, substantial evidence and the omissions of the Respondent in maintaining adequate medical records during the period in question were fairly encompassed by the statute in force at the time of the violation.

CONCLUSIONS OF LAW

1. The Board has jurisdiction over the parties and subject matter of this case pursuant to Section 120.57 and Chapter 458, Florida Statutes.

   
   

2. The findings of fact set forth above do not establish that Respondent has violated Section 458.331(1)(t) and (q), Florida Statutes as charged in the Administrative Complaint and these two allegations are DISMISSED.

   
   

3. The findings of fact set forth above do establish that Respondent has violated Section 458.331(1)(m), Florida Statutes, as charged in the Administrative Complaint.

3. The Conclusions of Law of the Recommended Order are approved and adopted and incorporated herein.

RULING ON RESPONDENT'S EXCEPTION TO THE RECOMMENDED PENALTY

1. The Respondent's exception to the recommended penalty of the Hearing Officer, is ACCEPTED. The Board finds that although the recommended penalty of the Hearing Officer was within the disciplinary guidelines provided for the violation, under the circumstances of this case, a lesser penalty is appropriate.

DISPOSITION

WHEREFORE, it is hereby ORDERED and ADJUDGED that Respondent has not violated Sections 458.331(1)(q) and (t), Florida Statutes, as alleged in the Administrative Complaint and these two allegations are DISMISSED, however, Respondent has violated Section 458.331(1)(m), Florida Statutes and the following penalty is imposed:

1. Respondent shall pay an administrative fine of five thousand dollars ($5,000) to the Board within thirty (30) days of the filing of the Final Order in this case.

   
   

2. Within one (1) year of the filing of the Final Order in this case, the Respondent shall complete the course " Medical Record Keeping" sponsored by the Florida Medical Association.

   
   

3. Within one (1) year of the filing of the Final Order in this case, the Respondent shall have an independent, certified health care risk manager review the adequacy of Respondent's office practice. This independent consultant shall prepare a report specifically addressing the Respondent's office practice. Such report will include, if necessary, suggested improvements of the quality assurance of Respondent's practice. The Respondent will submit to the Board of Medicine and the Office of the General Counsel, Medical Section, this report and documentation that demonstrates his compliance with the suggestions enumerated in the consultant' s report.

NOTICE

The parties are hereby notified pursuant to Section 120.59(4), Florida Statutes, that an appeal of this Final Order may be taken pursuant to Section 120.68, Florida Statutes, by filing one copy of a Notice of Appeal with the Clerk of the Agency for Health Care Administration and one copy of a Notice of

Appeal with the required filing fee with the District Court of Appeal within thirty (30) days of the date this Final Order is filed.

DONE and ORDERED this 8th DAY OF July, 1996.

BOARD OF MEDICINE

MARY KATHRYN GARRETT, M.D. CHAIRMAN

CERTIFICATE OF SERVICE

I HEREBY CERTIFY that a true and correct copy of the foregoing Final Order and its attachments have been forwarded by U.S. Mail to John A. Ortolani, 1430 Mason Avenue, Daytona Beach, Florida 32117-4551, Donald W. Weidner, Esquire, and Donna J. Torsney, Esquire, 10161 Centurion Parkway North, Suite 190, Jacksonville, Florida 32256, Don W. Davis, Hearing Officer, Division of Administrative Hearings, The DeSoto Building, 1230 Apalachee Parkway, Tallahassee, Florida 32399-1550 and by hand delivery to Larry G. McPherson, Jr., Chief Medical Attorney, Agency for Health Care Administration, 1940 North Monroe Street, Tallahassee, Florida 32399-0792 on this 15th day of July, 1996.

Marm Harris, Ed.D. Executive Director

Docket for Case No: 94-002116

Orders for Case No: 94-002116