STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

AGENCY FOR HEALTH CARE )

ADMINISTRATION, )

)

Petitioner, )

)

vs. ) CASE NO. 95-3773

) JONATHAN MARC FRANTZ, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, Richard Hixson, held a formal hearing in this case on November 30, 1995 in Tampa, Florida.

APPEARANCES

For Petitioner: Joseph S. Garwood, Esquire

Agency for Health Care Administration Board of Medicine

1940 North Monroe Street Tallahassee, Florida 32399-0792

For Respondent: John Lauro, Esquire

Barnett Plaza, Suite 3950

101 East Kennedy Boulevard Tampa, Florida 33602

STATEMENT OF THE ISSUE

The issue for determination in this case is whether Respondent's license to practice medicine in the State of Florida should be disciplined for disseminating, or causing the dissemination of an advertisement that was false, deceptive or misleading in violation of Rule 59R-11.001, Florida Administrative Code, and Section 458.331(1)(x), Florida Statutes.

PRELIMINARY STATEMENT

On February 24, 1995, Petitioner, AGENCY FOR HEALTH ADMINISTRATION, in response to an anonymous complaint, filed a one count Administrative Complaint alleging that Respondent, JONATHAN M. FRANTZ, M.D., a medical doctor licensed in the State of Florida, violated Section 458.331(1)(x), Florida Statutes, in that Respondent disseminated or caused the dissemination of an advertisement that "...promoted the Excimer Laser and implied that patients could receive treatment for nearsightedness and astigmatism from the Excimer Laser though it was an investigational device not approved by the FDA for use, in violation of Rule

59R-11.001, Florida Statutes."

Respondent contested the allegations of the Administrative Complaint, and on July 28, 1995, the case was referred to the Division of Administrative Hearings. Pursuant to the Pre-Hearing Order entered in this case, the parties filed a Joint Prehearing Stipulation on November 27, 1995. The Formal Hearing was held on November 30, 1995.

At hearing, Petitioner presented the deposition testimony of two witnesses, Norman S. Levy, M.D., and Judith A. Lammert. Respondent raised numerous objections to the deposition testimony of Dr. Levy, and Ms. Lammert. Having reviewed the deposition testimony of both witnesses, it is clear that the witnesses were unavailable within the meaning of Rule 1.330(3), Florida Rules of Civil Procedure, and that Dr. Levy's review of the file prior to his rendering an opinion does not require the exclusion of his testimony. Any prejudice which is asserted by Respondent in this regard shall be considered in the weight given such opinion. Accordingly, Respondent's objections are denied.

Petitioner also presented the testimony of Frank Paoleloa, and Mary Briggs.

Petitioner presented five exhibits which were received into evidence. Respondent's objections as to relevance are denied. Respondent's objection to the letter to the agency from a prior counsel (A-7) is also denied because the letter does not specifically constitute a compromise or offer to compromise within the meaning of Section 90.408, Florida Statutes.

Respondent presented the testimony of John J. Rowsey, Jr., M.D., and Respondent testified in his own behalf. Respondent presented four exhibits which were received into evidence.

A transcript of the hearing was filed on December 15, 1995. The parties filed Proposed Recommended Orders on January 10, 1996. Specific rulings on the parties' proposed findings are set forth in the Appendix attached hereto.

FINDINGS OF FACT

1. Petitioner, AGENCY FOR HEALTH CARE ADMINISTRATION (AHCA), is the agency of the State of Florida vested with the statutory authority under Chapter 458, Florida Statutes, to regulate the practice of medicine.

   
   

2. Respondent, JONATHAN M. FRANTZ, M.D., is and at all material times has been, a licensed physician in the State of Florida, having been issued license number ME 0054884.

   
   

3. Respondent graduated from the University of Miami School of Medicine in 1983, and thereafter entered a residency program in Opthamology at the Louisiana State University Eye Center in New Orleans, Louisiana, where from 1987 to 1989 Respondent was a Fellow in Cornea, External Disease, and Refractive Surgery.

   
   

4. During his Fellowship at the Louisiana State University Eye Center, Respondent participated in the initial research projects involving the Excimer Laser Procedure, which at that time was exclusively an investigational device.

   
   

5. The term "investigational device" is a technical term used by the Food and Drug Administration (FDA) and medical researchers. The term means that a device has yet to be approved for treatment of human patients by the FDA and that its use is limited by the FDA to research investigations.

   
   

6. The Excimer Laser is a device that projects a wavelength of light over the surface of the cornea to treat nearsightedness and astigmatism. The

   wavelength of light removes irregularities on the surface of the cornea or anterior corneal tissue in order to change the refraction of the eye and improve the patient's eyesight. At all material times, the Excimer Laser was an investigational device.

   
   

7. Radial Keratotomy is, and at all material times was an FDA approved procedure for the treatment of nearsightedness and astigmatism. The Excimer Laser procedure differs from Radial Keratotomy in that Radial Keratotomy is a procedure in which incisions are made to the corneal tissue itself. The incisions allow for the flattening of the center of the cornea, and thus, unlike the Excimer Laser, actually change the structure of the cornea.

   
   

8. During his Fellowship, Respondent participated in primate and human research involving the Excimer Laser, and assisted in the development of protocols for use in the first treatment of human patients with the device. Respondent received a research award from the National Eye Institute for his investigative work with the Excimer Laser. Respondent has published several articles in medical literature relating to the Excimer Laser.

   
   

9. Respondent is certified by the American Board of Opthamology, and is a member of the American Academy of Opthamology.

   
   

10. After completion of his Fellowship, Respondent entered private practice in Ft. Myers, Florida. While in private practice, Respondent continued his research work with the Excimer Laser. In 1990, Respondent was selected as one of a small group of physicians to conduct Excimer Laser investigational treatments on patients. As a principal investigator, Respondent treated patients with all degrees of nearsightedness and astigmatism.

    
    

11. In May of 1993 Respondent was employed by Eye Centers of Florida located in Ft. Myers, Florida. Respondent performed Excimer Laser investigational procedures while so employed.

    
    

12. At this time, the Excimer Laser procedure was also being performed by Dr. James J. Rowsey, Jr., Chairman of the Department of Opthamology at the University of South Florida in Tampa, Florida. The Excimer Laser procedure performed at the University of South Florida offered a different protocol than that offered by Respondent at the Eye Centers of Florida.

    
    

13. Respondent was the only Opthamologist in Florida offering Excimer Laser procedures for patients with all degrees of nearsightedness and astigmatism, as well as offering Radial Keratotomy.

    
    

14. In addition to his expertise in Opthamology, Dr. Rowsey has extensive expertise in the area of ethical medical advertising.

    
    

15. On May 23, 1993, the following advertisement was published in the Charlotte Sun Herald, a Florida newspaper:

    
    

    Jonathan M. Frantz, M.D., corneal specialist with the Eye Centers of Florida, invites you to join him for an exciting lecture on the newest breakthroughs in eye surgery - the Excimer laser and Radial Keratotomy (RK). Eye Care Centers of Florida is the only eye care center in Florida that offers both options. Come to our free seminar and find out how you can reduce your need for glasses or contact lenses.

    EXCIMER LASER RADIAL KERATOTOMY

    THE CORRECTION OF NEARSIGHTEDNESS AND ASTIGMATISM

    
    

    FREE ADMISSION AND SCREENING FOR EXCIMER LASER AVAILABLE

    
    

    PLEASE BRING GLASSES AND/OR CURRENT EYE GLASS PRESCRIPTION WEDNESDAY, MAY 26 7:00 PM

    
    

    FIRST FEDERAL BANK BUILDING

    
    

    3524 D TAMIAMI TRAIL (SECOND FLOOR) PORT CHARLOTTE

    RESERVATIONS 1-800-226-3377

    
    

    OR 1-813-939-3456

    
    

    EYE CENTERS OF FLORIDA

    
    

    Helping You See Your Best

    
    

    4101 Evans Avenue Fort Myers, Florida

    
    

    (Caution: The Excimer Laser is an Investigational Device. Limited by Federal Law to Investigational Use.)

    
    

16. The advertisement also contained Respondent's picture, and the logo for the Eye Centers of Florida.

    
    

17. The advertisement was composed by a marketing agency retained by the Eye Centers of Florida. Respondent was generally aware of the contents of the advertisement, but did not give specific approval for the placement of the advertisement.

    
    

18. Respondent was aware that the advertisement of the Excimer Laser required cautionary language stating that the procedure was an investigational device limited by the FDA.

    
    

19. The advertisement clearly states that the Excimer Laser is an investigational device limited by the FDA.

    
    

20. The advertisement is a public invitation to attend a lecture given by Respondent concerning the Excimer Laser and Radial Keratotomy. At the lecture, Respondent explained that the Excimer Laser was an investigational device. Thereafter a person seeking Excimer Laser treatment was given a consent form that explained in detail the investigatory nature of the procedure.

21. As a principal investigator Respondent was limited in the number of patients he could treat with the Excimer Laser.

    
    

22. Respondent received an economic benefit from the treatment of patients with the Excimer Laser.

    
    

23. As a result of the investigational efforts of Respondent and other medical researchers, the Excimer Laser was proved to have beneficial results in the treatment of nearsightedness and astigmatism. Subsequent to the publication of the advertisement, the Excimer Laser received FDA approval.

    
    

24. The advertisement was reviewed by Norman S. Levy, M.D., Ph.D., an Opthamologist, and Director of the Florida Opthamologic Institute in Gainesville, Florida. As an expert in Opthamology, Dr. Levy opined that the advertisement published in this case was deceptive in that the advertisement implied that the Excimer Laser and Radial Keratotomy procedures were equally available, and the experimental nature of the Excimer Laser procedure was not clear from the advertisement.

    
    

25. The advertisement was also reviewed by Dr. Rowsey, who opined that the advertisement was not misleading or deceptive, that the advertisement clearly contained cautionary language stating that the Excimer Laser was at that time an investigational device, and that the advertisement was merely a public invitation to a lecture to obtain more information regarding these procedures. In this respect, Dr. Rowsey has specific and extensive experience with the Excimer Laser, as well as in medical ethics, and his opinion on this issue is deemed more credible.

    
    

26. There is no evidence that a patient of the Respondent's was deceived or mislead by the advertisement.

    
    

    CONCLUSIONS OF LAW

    
    

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

    
    

28. In a licensure disciplinary proceeding the Agency has the burden of proving the allegations of the Administrative Complaint by clear and convincing evidence. Ferris v. Turlington, 510 So.2d 292 (Fla. 1st DCA 1987); Pic N' Save

    v. Department of Business and Professional Regulation, 601 So.2d 245 (1st DCA 1992); Engel v. Department of Professional Regulation, 477 So.2d 10 (Fla. 4th DCA 1984).

    
    

29. "Clear and convincing" evidence has been defined as follows:

    
    

    We therefore hold that clear and convincing evidence requires that the evidence must be found to be credible; the facts to which the witnesses testify must be distinctly remembered; the testimony must be precise and explicit and the witnesses must be lacking in confusion as to the facts in issue. The evidence must be of such weight that it produces in the mind of the trier of the fact a firm belief of conviction, without hesitancy, as to the truth of the allegations sought to be established.

    Slomowitz v. Walker, 429 So.2d 797, 800 (Fla. 4th DCA 1983).

    
    

30. In this case, the Administrative Complaint charges Respondent with a violation of Section 458.331(1)(x), Florida Statutes, which provides in pertinent part that disciplinary action may be imposed against a physician for "(v)iolating any provision of this chapter (or) a rule of the board or department..."

    
    

31. Rule 59R-11.001(2), Florida Administrative Code, [formerly Rule 61F- 24.001(2)], provides:

    
    

    1. The Board permits the dissemination to the public of legitimate information, in accordance with the Board's rules, regarding the practice of medicine and where and from whom medical services may be obtained, so long as such information is in no way false, deceptive or misleading

    2. No physician shall disseminate or cause the dissemination of any advertisement or any adver- tising which is in any way false, deceptive or misleading. Any advertisement or advertising shall be deemed by the Board to false, deceptive or misleading if it:

       1. Contains any misrepresentation of facts; or

       2. Makes only a partial disclosure of relevant facts; or

       3. Creates false or unjustified expectations of beneficial assistance; or

       4. Contains any representation or claims, as to which the physician, referred to in the adver- tising, does not expect to perform; or

       5. Contains any other representation, statement, or claim which misleads or deceives; . . .

       
       

32. In this case, the evidence is not clear and convincing that the advertisement published on May 23, 1993, was false, deceptive, or misleading. The advertisement does not contain false representations. While an Excimer Laser protocol was offered by Dr. Rowsey at the University of South Florida, Dr. Rowsey's own testimony established that Respondent was the only Opthamologist in Florida offering all aspects of the Excimer Laser protocols at the time of the advertisement.

    
    

33. Additionally, the advertisement clearly states on its face in cautionary language that the Excimer Laser is an investigational device subject to FDA limitations. The advertisement does not create false or unjustified expectations because the Excimer Laser proved to have beneficial effects in treating nearsightedness and astigmatism.

    
    

34. Moreover, the advertisement, in the context in which it was published, is merely a public invitation to attend a lecture to obtain further information relating to procedures for the treatment of nearsightedness and astigmatism.

    [In this respect, compare Sherman v. Department of Professional Regulation, 452 So.2d 1128 (Fla. 4th DCA 1984) holding that an advertisement containing a public invitation to attend a holistic fair did not constitute a misleading or deceptive advertisement on the part of a chiropractic physician.]

35. The information regarding Excimer Laser and Radial Keratotomy as represented in the advertisement was subsequently provided by Respondent to any prospective patient at the lecture and again in the consent form. There is no evidence that a prospective patient was misled or otherwise deceived by the advertisement, and a fair reading of the advertisement does not lead to the conclusion that a lay person would be deceived or misled.

RECOMMENDATION

Based on the foregoing findings of fact and conclusions of law, it is recommended that Petitioner, the AGENCY FOR HEALTH CARE ADMINISTRATION, enter a final order dismissing the Administrative Complaint filed against Respondent JONATHAN M. FRANTZ, M.D., in the above-styled case.

RECOMMENDED in Tallahassee, Leon County, Florida, this 24th day of January, 1996.

RICHARD HIXSON, 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 24th day of January, 1996.

APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-3773

Petitioner's Proposed Findings of Fact. 1.-6 Accepted and incorporated.

1. Rejected to the extent that Respondent personally approved the advertisement.

2. Rejected to the extent that a lay person could be misled.

3. Rejected as not supported by the weight of evidence.

Respondent's Proposed Findings of Fact. 1.&2. Accepted and incorporated.

3. Rejected as irrelevant.

4.-.7. Accepted and incorporated. 8.&9. Rejected as not necessary. 10.-12. Accepted and incorporated.

13. Rejected as not necessary. 14.-16. Accepted and incorporated.

17. Rejected as not necessary.

18.-26. Accepted and incorporated.

COPIES FURNISHED:

Joseph S. Garwood, Esquire AHCA - Board of Medicine 1940 North Monroe Street

Tallahassee, Florida 32399-0792

John Lauro, Esquire Barnett Plaza, Suite 3950

101 East Kennedy Boulevard Tampa, Florida 33602

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

ALL PARTIES HAVE THE RIGHT TO SUBMIT WRITTEN EXCEPTIONS TO THE RECOMMENDED ORDER. ALL AGENCIES ALLOW EACH PARTY AT LEAST TEN (10) DAYS IN WHICH TO SUBMIT WRITTEN EXCEPTIONS. SOME AGENCIES ALLOW A LARGER PERIOD WITHIN WHICH TO SUBMIT WRITTEN EXCEPTIONS. YOU SHOULD CONSULT WITH THE AGENCY THAT WILL ISSUE THE FINAL ORDER IN THIS CASE CONCERNING THEIR 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: 95-003773

Orders for Case No: 95-003773