STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 00-0245

)

JAMES ANASTASIO HALIKAS, M.D. )

)

Respondent. )

)

RECOMMENDED ORDER

On April 17, 2000, a formal administrative hearing in this case was held in Naples, Florida, before William F. Quattlebaum, Administrative Law Judge, Division of Administrative Hearings.

APPEARANCES

For Petitioner: Kristy M. Johnson, Esquire

Agency for Health Care Administration 2727 Mahan Drive

Post Office Box 14229 Tallahassee, Florida 32317-4229

For Respondent: Donald W. Weidner, Esquire

G. Thomas Bowden, II, Esquire Donald W. Weidner, P.A. 11265 Alumni Way, Suite 201 Jacksonville, Florida 32246

STATEMENT OF THE ISSUE

The issue in the case is whether the allegations of the Administrative Complaint filed by the Petitioner are correct and, if so, what penalty should be imposed against the Respondent.

PRELIMINARY STATEMENT

By Administrative Complaint dated August 24, 1999, the Department of Health, Board of Medicine (Petitioner), alleged that James Anastasio Halikas, M.D. (Respondent) violated Section 458.331(1)(b), Florida Statutes. The Respondent requested a formal hearing. The Department forwarded the request for hearing to the Division of Administrative Hearings, which scheduled and conducted the proceeding.

At the hearing, the Petitioner had Exhibits numbered 1-2 admitted into evidence. The Respondent testified on his own behalf and had Exhibit numbered 1 admitted into evidence.

Subsequent to the hearing, the Respondent was granted leave to file an additional exhibit. The late-filed exhibit was not properly authenticated and is hereby rejected. A Transcript of the hearing was filed on April 25, 2000. Both parties filed Proposed Recommended Orders.

FINDINGS OF FACT

1. Beginning on October 3, 1995, and at all times material to this case, the Respondent has been licensed as a medical doctor in the State of Florida, holding license number ME 69324.

2. At all times material to this case, the Respondent was also a licensed medical doctor in Minnesota.

3. From 1984 to 1998, the Respondent was employed as a professor at the University of Minnesota (University).

4. As a University professor, the Respondent was involved in chemical dependency research and participated in human research projects intended to treat drug addictions.

5. Beginning in June 1993, the Respondent conducted a study wherein Gamma-Hydroxybutrate (GHB) was provided to human test participants.

6. The Respondent was the principal investigator in the study. He personally applied to and received permission from the

   U.S. Food and Drug Administration (FDA) to conduct the study.

   
   

7. The human participants in the 1993 GHB study were primarily a group of Southeast Asians known as "Nmong" who exhibit high rates of opium addiction. The purpose of the study was to determine whether GHB could be beneficial in detoxification from opium addiction.

8. As the principal investigator, the Respondent was responsible for planning and implementation of the study.

9. Obtaining the "informed consent" of study participants was a requirement of the University's standard protocol, and is a standard requirement for any human research project

10. The informed consent documentation used in the Respondent's GHB study consisted of five English-text pages.

11. The participants in the GHB study were essentially unable to speak or read English.

12. The Respondent assumed that the University hospital, where the study was conducted, would obtain the appropriate informed consent from participants.

13. By the time the GHB study began, informed consent had not been obtained from all the human test subjects.

14. The University apparently became aware of the informed consent issue, and asked the Respondent on August 4, 1993 to discontinue the test.

15. The Respondent terminated the test on August 5, 1993.

    
    

16. After the test was terminated, the University reviewed the test's procedures and determined that in addition to the informed consent issue, test administrators had failed in some cases to follow dosing protocol limits, and had also failed to provide a substitute drug (methadone) to study participants who sought the substitution.

17. Based on the improper implementation of the study, the University took disciplinary action against the Respondent including a reprimand, restrictions against conducting research involving university hospital patients, and imposition of a two- year monitoring period of the Respondent's clinical performance.

18. Based on the University action, the Minnesota Board of Medical Practice reviewed the situation. The Board is the licensing authority for physicians in the State of Minnesota.

19. By Order dated May 9, 1998, the Respondent entered into a stipulation and order with the Minnesota Board of Medical Practice. The stipulation and order required as follows:

    1. provide proof of compliance with requirements imposed by the University of Minnesota;

    2. notify the Minnesota Board of Medical Practice if Respondent participated in human research studies for a period of two (2) years;

       c. obtain a supervising physician, meet with the supervising physician monthly, and provide the supervising physician with information pertaining to Respondent's clinical practice outside the scope of his teaching responsibilities;

       d) meet with a designated member of the Minnesota Board of Medical Practice quarterly to review Respondent's progress under the terms of the order; and

       c) pay a civil penalty in the amount of

       $3,500.

20. Although the Respondent did not have a private clinical practice in Minnesota, he had a limited number of clinical patients at a VA hospital in Minnesota who were outside his teaching responsibilities. In accordance with the terms of the settlement and order, the Respondent obtained a supervising physician who apparently oversaw the clinical practice.

21. In September 1998, the Respondent moved to Florida and began a private clinical practice.

    CONCLUSIONS OF LAW

    
    

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

23. The Department of Health, Board of Medicine, is responsible for disciplinary proceedings against licensed physicians in Florida. Chapter 458, Florida Statutes.

24. The Department has the burden of proving the allegations against the Respondent by clear and convincing evidence. Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987). In this case, the burden has been met.

25. Section 458.331, Florida Statutes, sets forth grounds for disciplinary action against licensed physicians in Florida. Section 458.331(1)(b), Florida Statutes, provides that the Board of Medicine may discipline the license of a physician for the following reason:

    Having a license or the authority to practice medicine revoked, suspended, or otherwise acted against, including the denial of licensure, by the licensing authority of any jurisdiction, including its agencies or subdivisions. The licensing authority's acceptance of a physician's relinquishment of a license, stipulation, consent order, or other settlement, offered in response to or in anticipation of the filing of administrative charges against the physician's license, shall be construed as action against the physician's license.

26. In this case, the evidence establishes that action was taken against the Respondent's licensure as a physician in Minnesota by the state's Board of Medical Practice.

27. Section 458.331 (2), Florida Statutes, provides as follows:

    (2) When the board finds any person guilty of any of the grounds set forth in subsection

    (1), including conduct that would constitute a substantial violation of subsection (1) which occurred prior to licensure, it may enter an order imposing one or more of the following penalties:

    1. Refusal to certify, or certification with restrictions, to the department an application for licensure, certification, or registration.

    2. Revocation or suspension of a license.

    3. Restriction of practice.

    4. Imposition of an administrative fine not to exceed $10,000 for each count or separate offense.

    5. Issuance of a reprimand.

    6. Placement of the physician on probation for a period of time and subject to such conditions as the board may specify, including, but not limited to, requiring the physician to submit to treatment, to attend continuing education courses, to submit to reexamination, or to work under the supervision of another physician.

    7. Issuance of a letter of concern.

    8. Corrective action.

    9. Refund of fees billed to and collected from the patient.

    10. Imposition of an administrative fine in accordance with s. 381.0261 for violations regarding patient rights. In determining what action is appropriate, the board must first consider what sanctions are necessary to protect the public or to compensate the patient. Only after those sanctions have been imposed may the disciplining authority consider and include in the order requirements designed to rehabilitate the physician. All costs associated with compliance with orders issued under this subsection are the obligation of the physician.

28. Rule 64B8-8.001, Florida Administrative Code, provides a range of disciplinary guidelines for use by the Board of Medicine in imposing discipline for various statutory violations. Rule 64B8-8.001(2)(b), Florida Administrative Code, states that

    violation of Section 348.331(1)(b), Florida Statutes, can result in "imposition of discipline comparable to the discipline which would have been imposed if the substantive violation had occurred in Florida to suspension or denial of the license until the license is unencumbered in the jurisdiction in which disciplinary action was originally taken, and an administrative fine ranging from $1,000.00 to $5,000.00."

29. Subsequent to the hearing, the Respondent was granted leave to file an exhibit which appears to be a document from the Minnesota Board of Medical Practice that removes the restrictions against the Respondent's practice. The exhibit filed by the Respondent is not properly authenticated, is hearsay, and has not been relied upon in the preparation of this Recommended Order.

30. The Petitioner asserts that the purpose of the Respondent's move to Florida was to escape from restrictions placed on his clinical practice in Minnesota. The Respondent asserts that the purpose of the move was to follow his wife, who moved to Florida to escape the Minnesota winters. There is no credible evidence that the Respondent's move impacted any restrictions placed against his licensure in Minnesota.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Petitioner enter a final order imposing a suspension of the Respondent's Florida licensure until the Respondent's Minnesota license is unencumbered.

DONE AND ENTERED this 20th day of July, 2000, in Tallahassee, Leon County, Florida.

WILLIAM F. QUATTLEBAUM

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 20th day of July, 2000.

COPIES FURNISHED:

Angela T. Hall, Agency Clerk Department of Health

4052 Bald Cypress Way Bin A02

Tallahassee, Florida 32399-1701

William W. Large, General Counsel Department of Health

4052 Bald Cypress Way Bin A02

Tallahassee, Florida 32399-1701

Tanya Williams, Executive Director Board of Medicine

Department of Health 4052 Bald Cypress Way BIN C01

Tallahassee, Florida 32399-3251

Kristy M. Johnson, Esquire

Agency for Health Care Administration 2727 Mahan Drive

Post Office Box 14229 Tallahassee, Florida 32317-4229

Donald W. Weidner, Esquire

G. Thomas Bowden, II, Esquire Donald W. Weidner, P.A.

11265 Alumni Way, Suite 201

Jacksonville, Florida 32246

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 must be filed with the agency that will issue the final order in this case.

Docket for Case No: 00-000245

Orders for Case No: 00-000245