06-000014PL Department Of Health, Board Of Medicine vs. Scott Geller, M.D. Status: Closed Recommended Order on Thursday, November 2, 2006.

Summary: Respondent failed to fully inform the patient of the experimental nature of the procedure and failed to determine in the record the postoperative endothelial cell count of the patient.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE , )

)

Petitioner , )

)

vs. ) Case No. 06 - 0014PL

)

SCOTT GELLER, M.D. , )

)

Respondent . )

)

RECOMMENDED ORDE R

Pursuant to notice, a final hearing was held in this case

on August 23, 2006, in Fort Myers, Florida, before Susan B.

Harrell, a designated Administrative Law Judge of the Division

of Administrative Hearings.

APPEARANCES

For Petitioner: Irving Levine, E squire

Department of Health

4052 Bald Cypress Way, Bin C65

Tallahassee, Florida 32399 - 3265

For Respondent: Bruce D. Lamb, Esquire

Ruden, McClosky, Smith, Schu ster

& Russell, P.A.

401 East Kennedy Boulevard, 27th Floor

Tampa, Florida 33602

STATEMENT OF THE ISSUES

The issues in this case are whether Respondent violated

Subsections 458.331(1)(m) , 458.331(1)(t), and 458.331(1)(u),

Florida Statutes (1997), 1 and, if so, what discipline should be

imposed.

PRELIMINARY STATEMENT

On April 19, 2005, Petitioner, Department of Health, Board

of Medicine (Department), filed a three - count Administ rative

Complaint against Respondent, Scott Lee Geller, M.D.

(Dr. Geller), alleging that he violated Subsections

458.331(1)(t), 458.331(1)(m), and 458.331(1)(u), Florida

Statutes (1997). On December 30, 2005, the Department filed

Amendments to the Adminis trative Complaint. Dr. Geller

requested an administrative hearing, and the case was forwarded

to the Division of Administrative Hearings on January 4, 2006,

for assignment to an a dministrative l aw j udge.

The final hearing was originally scheduled for Apri l 27

and 28, 2006. Dr. Geller filed a Motion to Continue, which was

granted, and the final hearing was rescheduled for June 28

and 29, 2006. Dr. Geller again requested the final hearing be

rescheduled, and his request was granted by an order

rescheduling the final hearing for August 22 and 23, 2006.

On August 8, 2006, Petitioner filed Petitioner's Motion for

Official Recognition, requesting that official recognition be

taken of Subsections 458.331(1)(m), 458.331(1)(t), and

458.331(1)(u), Florida Statutes (1997). Official recognition

was taken of those statutes by order dated August 9, 2006.

At the final hearing, the Department made an ore tenus

motion to amend the Administrative Complaint to correct a

scrivener's error. The motion was granted, and the

Ad ministrative Complaint was amended to reflect the correction

of the scrivener's error.

The parties entered into a Joint Pre - Hearing Stipulation

and stipulated to certain facts contained in Section E of the

Joint Pre - Hearing Stipulation. Those facts have b een

incorporated into this Recommended Order to the extent relevant.

At the final hearing, Joint Exhibit 1, the medical records

for patient P.K., was admitted in evidence. Petitioner's

Exhibits 1, 2, and 3 were admitted in evidence. The Department

submit ted the depositions of P.K. and Osama Hassan Mohamed Omar,

M.D., in lieu of live testimony. Dr. Geller testified in his

own behalf and called James Rowsey, M.D. , as his witness.

Respondent's Exhibits 1, 2, and 3 were admitted in evidence.

Respondent's E xhibit 2, the deposition of Herbert L. Gould,

M.D., was filed on September 13, 2006, as a late - filed exhibit.

The one - volume Transcript of the final hearing was filed on

September 7, 2006. The parties agreed to file their proposed

recommended orders withi n ten days of the filing of the

Transcript or the deposition of Dr. Gould, whichever was later.

The parties timely filed their proposed recommended orders.

FINDINGS OF FACT

1. The Department is the state department charged with

regulating the practice o f medicine pursuant to Section 20.43,

and Chapters 456 and 458, Florida Statutes (2006).

2. At all times material to this proceeding, Dr. Geller

was a licensed physician within the State of Florida, having

been issued license number 35800 on December 18, 1979.

Dr. Geller is board - certified in Ophthalmology.

3. Patient P.K. first presented to Dr. Geller's office on

February 17, 1998, for evaluation for refractive surgery. At

the time of her first visit, P.K. was 56 years old. She had

been experiencing d ifficulty tolerating contact lenses due to

dry eyes, seasonal allergies, and some night vision problems,

and did not want to wear glasses.

4. Prior to P.K.'s first visit to Dr. Geller, P.K. had

been evaluated by Dr. Jonathan Frantz to determine if she was a

good candidate for laser refractive surgery. Dr. Frantz

informed P.K. that she was not a candidate for laser refractive

surgery.

5. Dr. Geller examined P.K.'s eyes on February 17, 1998,

at which time he recorded P.K.'s visual acuity with corrective

l enses for both eyes. He did not record her uncorrected visual

acuity. The evidence did not establish that the failure to

determine and record P.K.'s uncorrected visual acuity prior to

surgery was below the level of care, skill, and treatment which

is rec ognized by a reasonably prudent similar physician as being

acceptable under similar conditions and circumstances.

6. During the examination on February 17, 1998, Dr. Geller

determined P.K.'s anterior chamber depth to be 2.78 by using an

optical device and 2.76 - 2.8 by using a sonogram. Dr. Herbert

Gould testified as an expert witness for Dr. Geller. It was

Dr. Gould's opinion that at least 2.8 millimeters of depth was

needed in the anterior chamber for the insertion of a phakic

lens. Dr. Osama Omar tes tified as an expert for the Department.

Dr. Omar was of the opinion that an anterior chamber depth of

three millimeters was needed for the insertion of a phakic

intraocular lens; however, Dr. Omar's opinion was based on a

course that he had taken involvin g an Artisan lens , not a Phakic

6 intraocular lens, which was used in P.K.'s surgery.

Dr. Gould's testimony concerning the anterior chamber depth

needed for the insertion of a phakic lens is more credible.

7. Dr. Geller measured P.K.'s preoperative endot helial

cell count for both eyes by specular microscopy. The reading

was more than 2400. Based on his examination of February 17,

1998, Dr. Geller diagnosed P.K. with hyperopia (farsightedness)

in both eyes.

8. Dr. Geller told P.K. that he could implan t a phakic

intraocular lens in each eye that could correct the refractive

errors. When a phakic intraocular lens is used, the patient's

natural, crystalline lens is left in place, and the intraocular

lens is placed either right in front of the iris or in the pupil

area plane right behind the iris.

9. Dr. Geller discussed the risks and benefits associated

with the insertion of a phakic intraocular lens with P.K. and

made a notation of the discussion on P.K.'s medical records for

February 17, 1998. His not es established that he had discussed

over and under correction, fluctuating vision, corneal disease,

and future surgery with her.

10. P.K. was scheduled for the insertion of a phakic

intraocular lens in her left eye on March 10, 1998, and in her

right eye on March 31, 1998. P.K. signed a consent form for

each surgery scheduled to be performed. The consent forms

provided:

INFORMED CONSENT FOR LENS IMPLANTATION

CORRECTION OF REFRACTIVE ERRORS

Dear Patient,

The South Florida Eye Clinic and Dr. Scott

L. Ge ller have prepared this "informed

consent" so that you may understand some of

the major details of 'permanent contact

lens' intraocular lens implantation. This

informed consent naturally is limited in

scope and we will just address some major

issues relat ed to all ophthalmic surgery.

Your discussion with Dr. Geller can

elaborate on any of these issues and can

touch on other considerations that you may

have.

Implants performed for correction of

refractive error (to get you minimal

eyeglass correction, or no eyeglass

correction at all) have been performed since

the early 1950's. However, in the last ten

years, they have been widely performed

throughout the world especially in Europe

and South America. Lens implants for

correction of refractive errors are

performed by individual doctors in the

United States under 'the scope of medical

practice.' At this juncture no FDA approved

lenses are available. The lenses being used

in our practice have been obtained by

Dr. Geller for use in our ongoing clinical

stud ies for correction of errors of

refraction.

Lens implants have been performed by our

office during and after cataract surgery for

the past 15 years and Dr. Geller has

extensive experience in all lens implant

operations. The lens implant operation for

the correction of refractive error is very

similar to the operation performed for

correction of aphakia that has been done by

ophthalmologist [ sic ] worldwide for well

over 20 years. Lens implant for refractive

error however have [ sic ] only been performed

wid ely for about the past eight years. We

can only predict based on our experience

with this and similar surgeries that the

operation is safe and effective. However we

cannot predict the future and we want you to

understand this.

The problems that can be a ssociated with any

kind of intraocular surgery include [ sic ]

intraocular lens implantations are

hemorrhage, infection, cataract, glaucoma,

and the necessity for future corneal

surgery. We will remind you that these are

potential problems that can occur wi th any

similar surgery, and are rarely seen during

the career of any ophthalmologist.

There have been reported optical aberrations

rarely after lens implantation surgery,

notably glare or a refractive error that is

not exactly as predicted. This may

nece ssitate a change of the lens or a

revision of the wound. These problems are

extremely rare.

Dr. Geller wants to assure you that he is

totally confident that this procedure is the

most effective for you at this time. In

studying this procedure under a wor ld

renowned ophthalmologist and has seen

patients who have had several years or

internal contact lens use. If you should

have any further questions, please don't

hesitate to ask Dr. Geller directly.

11. Dr. Geller told P.K. that he had done many lens

i mplants. Dr. Geller's assistant also told P.K. that Dr. Geller

had been doing lens implants for a long time with good results.

Based on the representations from Dr. Geller and his assistant

and the information contained in the consent form, P.K.

understa ndably was left with the impression that Dr. Geller had

been doing the implantations of Phakic 6 intraocular lenses in

his office on a regular basis and that he had done many of the

implantations without problems.

12. On March 10, 1998, when Dr. Geller pe rformed the

scheduled lens implantation surgery on P.K.'s left eye, he noted

her corrected visual acuity, but did not record her uncorrected

visual acuity. During the surgery, Dr. Geller inserted a

Phakic 6 intraocular lens manufactured by Ophthalmic Inno vations

into P.K.'s left eye.

13. On March 31, 1998, P.K. presented at Dr. Geller's

office for lens implantation in her right eye. Prior to the

surgery, Dr. Geller checked the uncorrected visual acuity of

P.K.'s right eye, which was 20/150. During the surgery,

Dr. Geller inserted a Phakic 6 intraocular lens manufactured by

Ophthalmic Innovations into P.K.'s right eye.

14. In March of 1998, the lenses which were inserted in

P.K.'s eyes were not approved by the Food and Drug

Administration (FDA). The P hakic 6 intraocular lens had been

approved for use in Canada and some countries in Europe, Asia,

and South America. At the time of P.K.'s surgery, the phakic

lenses were not available through standard, mainstream

commercial sources within the United State s.

15. Dr. Omar opined that the use of a lens which has not

been approved by the FDA falls below the standard of care which

should be used by a reasonably prudent similar physician.

Dr. Herbert Gould and Dr. James Rowsey, who also testified as

expert w itness for Dr. Geller, opined that the use of a lens

which has not been approved by the FDA, by itself, does not

equate to a failure to practice 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. The testimony of Drs. Gould and Rowsey are

more credible. It should be noted that the FDA did not ban the

use of the Phakic 6 lens, but that the lens had not been

investigated and approved by the FDA. There have been other

products which have not been approved by the FDA, but which

physicians use without falling below the standard of care

required of the physicians. One such product is glue which was

used by physicians in eye surgery.

16. P.K. returned to Dr. Geller's office for

postoperative care in March and April 1998. She was in Canada

during the summer of 1998 and did not see Dr. Geller from April

to October 1998. On October 15, 1998, P.K. presented to

Dr. Geller complaining of sen sitivity to light and poor visual

acuity. Dr. Geller diagnosed P.K. as having iritis.

17. On October 21, 1998, Dr. Geller indicated in P.K.'s

medical notes to "get spec micros ou," which indicates a

specular microscopy for both eyes. Such a test would i ndicate

P.K.'s endothelial cell count. Dr. Geller's notes indicate a

similar entry on November 2, 1998. Dr. Geller's medical notes

for P.K.'s visit on November 17, 1998, indicate "spec done ou,"

but reveal a pachymetry reading of 56/48 and do not indicat e an

endothelial cell count. Pachymetry is a test which is used to

determine the health of a cornea by measuring the thickness of

the cornea. The specular microscopy measures the endothelial

cell density of the cornea. The testimony of Dr. Omar is

credi ted that a postoperative specular microscopy was required

to be done in order to compare the preoperative and

postoperative endothelial cell counts.

18. On November 17, 1998, Dr. Geller identified a corneal

edema in P.K.'s right eye. He did not refer P.K . to a corneal

specialist. Dr. Geller had experience in treating corneal

problems, including performing corneal transplants. His

experience and training was sufficient to treat P.K.'s corneal

edema without having to refer her to a corneal specialist.

Dr . Geller treated the edema with anti - inflammatory drugs. The

edema continued to be present on subsequent visits on

December 1, 3, and 9, 1998. On December 9, 1998, Dr. Geller

recommended the removal of the phakic intraocular lens from

P.K.'s right eye. He removed the lens on December 15, 1998.

Dr. Geller provided postoperative care for P.K. through

March 1999. P.K. did not return to see Dr. Geller after

March 1999.

19. P.K. returned to Canada and in June 1999 saw Dr. Peter

J. Agapitos, who diagnosed h er with corneal edema in both eyes

and recommended that P.K. return to Florida to have Dr. Geller

remove the intraocular lens in the left eye. On June 21, 1999,

P.K. called Dr. Geller's office complaining that her left eye

was very sensitive to light, cru sty, and irritated. Dr.

Geller's office referred P.K. to a physician in Canada.

20. P.K. had the intraocular lens in her left eye removed.

Additionally, she has required cataract surgery and more than

one corneal transplant since Dr. Geller performed th e phakic

intraocular lens implantations.

21. Dr. Omar was of the opinion that the implantation of a

phakic intraocular lens to treat refractive error was

experimental in 1998. He defined "experimental" as "a treatment

that's currently untested, not devel oped to the point which can

be offered in a mainstream fashion, has not demonstrated safety,

ethicacy [sic] in the correction of the problem that the patient

may need." Drs. Gould and Rowsey did not feel that the

procedure was experimental by 1998. Dr. R owsey did opine that

the procedure was "uncommon" in the United States.

22. Physicians in Europe, Asia, and South America were

doing phakic intraocular implants during the 1980's. By 1998,

there were peer reviewed literature published concerning phakic

i ntraocular implants and a considerable amount of presentations

given concerning the use of phakic intraocular lenses. The

production of the Phakic 6 intraocular lens began in 1992, and

by the time of P.K.'s surgery, approximately 4,000 to 5,000

implants o f the Phakic 6 intraocular lens had been done

successfully worldwide. However, few physicians in the United

States were performing phakic intraocular lens implantations by

1998, and only a couple of dozen phakic intraocular lens

implants had been done in the United States by 1998,

representing less than one percent of the total intraocular lens

implantations. In 1998, there was no doctor in the United

States who was routinely implanting these lenses except as part

of a study.

23. In 1997, Dr. Geller went to New York City to the

surgery center of Dr. Miles Galin, who was performing

implantations of phakic intraocular lenses. Dr. Geller observed

several preoperative and postoperative cases on the day he

visited Dr. Galin. Dr. Geller also "scrubbed in" and observed

at least one implantation being performed by Dr. Galin. Prior

to performing surgery on P.K., Dr. Geller had performed less

than five implantations of phakic intraocular lenses and had

reviewed literature in American and European journals concern ing

phakic intraocular lenses.

24. The procedures and skills used to insert an

intraocular lens implant are substantially similar to those

procedures and skills necessary to place an anterior chamber

lens after a cataract removal. Dr. Geller's practice i nvolves

anterior segment surgery, including cataract surgery. The

evidence established that Dr. Geller had adequate education and

training to be able to insert phakic intraocular lenses.

CONCLUSIONS OF LAW

25. The Division of Administrative Hearings has

jurisdiction over the parties to and the subject matter of this

proceeding. §§ 120.569 and 120.57, Fla. Stat. (2006).

26. The Department has the burden to establish the

allegations in the Administrative Complaint by clear and

convincing evidence. Depar tment of Banking and Finance v.

Osborne Stern and Co. , 670 So. 2d 932 (Fla. 1996) . The

Department has alleged that Dr. Geller violated Subsections

458.331(1)(m), 458.331(1)(t) , and 458.331(1)(u), Florida

Statutes, which provide:

(1) The following acts sh all constitute

grounds for which disciplinary action

specified in subsection (2) may be taken:

* * *

(m) Failing to keep legible, as defined by

department rule in consultation with the

board, medical records that identify the

licensed physician or t he physician extender

and supervising physician by name and

professional title who is or are responsible

for rendering, ordering, supervising, or

billing for each diagnostic or treatment

procedure and that justify the course of

treatment of the patient, in cluding, but not

limited to patient histories; examination

results; test results; records of drugs

prescribed, dispensed, or administered; and

reports of consultations and

hospitalizations.

* * *

(t) Gross or repeated malpractice or the

failure to p ractice 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. The

board shall give great weight to the

provision of s. 766.102 when enforcing this

paragraph. . . . As used in this paragraph,

"gross 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," shall not be construed

to require that a physician be incompetent

to practice medicine in order to be

disciplined pursuant to this paragraph.

(u) Performing any procedure or prescribing

any therapy which, by the pr evailing

standards of medical practice in the

community, would constitute experimentation

on a human subject, without first obtaining

full, informed, and written consent.

27. The Department alleged in the Administrative Complaint

that Dr. Geller violated Subsection 458.331(1)(m), Florida

Statutes, by failing to record P.K.'s preoperative corrected and

uncorrected visual acuity; P.K.'s endothelial cell count; and

P.K.'s anterior chamber depth. The evidence established that

Dr. Geller did determine and rec ord the preoperative corrected

visual acuity for both of P.K.'s eyes, did determine and record

the preoperative uncorrected visual acuity for P.K.'s right eye,

but did not determine and record the preoperative uncorrected

visual acuity for P.K.'s left eye. However, the Department did

not clearly and convincingly establish that the preoperative

uncorrected visual acuity of P.K. was required to be determined.

28. The evidence established that Dr. Geller did determine

and record the anterior chamber depth fo r both of P.K.'s eyes.

29. The evidence established that Dr. Geller did determine

and record P.K.'s preoperative endothelial cell count , but did

not determine and record her postoperative endothelial cell

count. Although Dr. Geller's records appear to indicate that a

specular microscopy was done postoperatively, the results of

such a test were not recorded. The Department has established

by clear and convincing evidence that Dr. Geller violated

Subsection 458.331(1)(m), Florida Statutes, by failing to record

P.K.'s post operative endothelial cell count.

30. The Department alleged in the Administrative Complaint

that Dr. Geller violated Subsection 458.331(1)(t), Florida

Statutes, by the following acts:

a. Inserting a non - FDA approved phakic

intraocular lenses into Patient P.K.'s

[eyes] without adequate education and

training.

b. Failing to keep legible medical records

that justified the course of treatment of

Patient P.K.

c. Failing to determine and/or record the

preoperative visual acuity, with or wit hout

glasses, of Patient P.K.

d. Failing to determine the Endothelial

Cell Count and Anterior Chamber Depth of

Patient P.K.

e. Failing to properly emphasize to Patient

P.K. in the informed consent the extent of

the experimental nature and unpredictable

o utcome of the surgery.

f. Failing to discuss the risks and

benefits of the surgery to Patient P.K.

g. Failing to timely refer Patient P.K. to

specialized consultations.

h. Failing to make an adequate assessment

of Patient P.K.'s complaints and symptoms.

31. The Department failed to establish by clear and

convincing evidence that Dr. Geller inserted that the phakic

intraocular lenses without adequate education and training. The

evidence established that Dr. Geller was board - certified and had

many years of experience in inserting anterior chamber lenses.

The skills and procedures necessary for inserting anterior

chamber lenses are similar to those needed for inserting phakic

intraocular lenses. He had reviewed literature that was

available concerning i mplantation of phakic intraocular lenses

and had gone to New York City to observe Dr. Miles Galin perform

the surgery.

32. It is undisputed that the Phakic 6 intraocular lenses

that were inserted were not approved by the FDA in 1998.

However, the Depart ment has failed to establish that the use of

a lens not approved by the FDA equates to a 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 simi lar conditions and circumstances .

33. The Department did establish that Dr. Geller failed to

obtain the preoperative uncorrected visual acuity of P.K.'s left

eye. The Department failed to establish by clear and convincing

evidence that the level of care, skill, and treatment which is

recognized by a reasonably prudent similar physician as being

acceptable under similar conditions and circumstances required

that P.K.'s preoperative uncorrected visual acuity be determined

as part of her evaluation.

34. T he Department argued in its proposed recommended

order that Dr. Geller failed to keep medical records that

justified the course of treatment of P.K. "in that preoperative

uncorrected visual acuity for one or both eyes was absent

thereby failing to establis h a baseline for postoperative care

and further treatment." Because the Department failed to

establish that it was necessary for Dr. Geller to get a

preoperative and postoperative uncorrected visual acuity, it has

failed to establish that Dr. Geller faile d to keep medical

records that justified the course of treatment for P.K.

35. The Department failed to establish by clear and

convincing evidence that Dr. Geller should have referred P.K. to

a corneal specialist after she began experiencing corneal edema.

The evidence demonstrated that Dr. Geller had sufficient

training and experience to treat the corneal problems that P.K.

experienced when she presented to him with corneal edema.

36. The Department failed to establish by clear and

convincing evidence th at Dr. Geller did not make an adequate

assessment of P.K.'s complaints and symptoms , in that Dr. Geller

failed to properly evaluate P.K.'s candidacy for implanting a

phakic intraocular lens because the anterior chamber depth was

less than the minimum anter ior chamber depth needed for

insertion of a phakic intraocular lens. There was a t least one

reading from the sonogram that showed the anterior chamber depth

at 2.8. P.K.'s anterior chamber depth was marginal , but within

the minimum depth needed of 2.8.

37. The Department did establish that Dr. Geller violated

Subsection 458.331(1)(t), Florida Statutes, by failing to get a

postoperative endothelial cell count. Dr. Geller got a

preoperative endothelial cell count , but did not get a

postoperative endothe lial cell count with which to compare to

the preoperative baseline. Thus, he failed 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 conditio ns and circumstances.

38. The Department failed to establish by clear and

convincing evidence that Dr. Geller failed to discuss the risks

and benefits of the surgery with P.K. Dr. Geller's notes

indicate that he had discussed the risks with P.K., and the

informed consent form which P.K. read and signed specifically

set forth the potential risks involved with the surgery.

39. The Department failed to establish by clear and

convincing evidence that Dr. Geller failed to timely refer the

patient for speciali zed consultations.

40. The Department alleged in the Administrative Complaint

that Dr. Geller violated Subsection 458.331(1)(u), Florida

Statutes, by "experiment[ing] on a human subject without

obtaining full, informed, and written consent when he place d

phakic intraocular lenses in Patient P.K.'s eyes without fully

detailing the known risks of the procedure." In Rush v. Parham ,

625 F.2d 1150 (5th Cir 1980), the Fifth Circuit considered the

experimental nature of treatment for purposes of Medicaid

cover age, stating that in making a determination of whether a

service is experimental "a basic consideration is whether the

service has come to be generally accepted by the professional

community as an effective and proven treatment for the condition

for which it is being used." Id. at 1156 n.11. Experimental

treatment was equated to treatment that "is not generally

accepted, is rarely used, novel, or relatively unknown." Id.

Based on the definition of experimental set forth in Rush and as

stated by Dr. Omar , the use of a phakic intraocular lens for

refraction correction was experimental. In 1998, it was

uncommon for the phakic intraocular lenses to be used to treat

refractory error in the United States. By 1998, only a couple

of dozen such implantations ha d been done in the United States,

and no doctor was doing it on a routine basis , except as part of

a study.

41. The informed consent form, which P.K. signed ,

discussed the use of the procedure outside the United States,

but did not adequately inform her of the extent that the

procedure was being done in the United States. Additionally,

the consent form stated that Dr. Geller had "extensive

experience in all lens implant operations." He did not have

extensive experience in using phakic intraocular lense s to

corrective refractory errors. P.K. was not fully informed of

the experimental nature of the procedure nor was she informed of

the lack of experience that Dr. Geller had in implanting these

types of lenses for refractive correction.

42. The Departmen t has established by clear and convincing

evidence that Dr. Geller violated Subsection 458.331(1)(u),

Florida Statutes, by failing to obtain full and informed consent

from P.K. prior to performing the implantation of the Phakic 6

intraocular lenses. Addit ionally, the Department established by

clear and convincing evidence that Dr. Geller violated

Subsection 458.331(1)(t), Florida Statutes, by failing to

properly emphasize to P.K. the experimental nature of the

procedure. Thus, Dr. Geller failed to practic e 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.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is

RECOMMENDED that a final order be entered finding that

Dr. Geller violated Subsections 458.331(1)(m), 458.331(1)(t) and

458.331(1)(u), Florida Statutes; imposing a reprimand; imposing

an administrative fine of $1,000 for each violation for a t otal

of $3,000; placing Dr. Geller on probation for one year on the

terms to be set by the Board of Medicine; and requiring

Dr. Geller to attend continuing medical education courses to be

specified by the Board of Medicine.

DONE AND ENTER ED this 2nd day of November , 2006 , in

Tallahassee, Leon County, Florida.

S

SUSAN B. HARRELL

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 2nd of November , 2006 .

ENDNOTE

1/ Unless otherwise indicated, all references to the Florida

Statutes are to the 1997 version.

COPIES FURNISHED :

Bruce D. Lamb, Esquire

Ruden, McClosky, Smith, Schuster

& Russell, P.A.

401 East Jackson Street, 27th Floor

Tampa, Florida 33602

Irving Levine, Esquire

Department of Health

4052 Bald Cypress Way , Bin C65

Tallahassee, Florida 32399 - 3265

Larry McPherson, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1701

Timothy M. Cerio, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Flor ida 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 agency that

will issu e the Final Order in this case.