11-004240PL Department Of Health, Board Of Medicine vs. Zannos Grekos, M.D. Status: Closed Recommended Order on Monday, March 11, 2013.

Summary: DOH proved malpractice by physician who injected bone marrow into patient's brain and did not inform patient of grave risk.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE , )

)

Petitioner , )

)

vs. ) Case No. 11 - 4240PL

)

ZANNOS GREKOS, M.D. , )

)

Respondent . )

)

RECOMMENDED ORDER

On October 16 through 19, 2012, a final hearing was held in

this case in Naples, Florida, before J. Lawrence Johnston,

Administrative Law Judge, Division of Administrative Hearings

(DOAH).

APPEARANCES

For Petitioner: Robert A. Milne, Esquire

Ian Brow n, Esquire

Department of Health

Bin C - 65

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 3265

For Respondent: Richard G. Ozelie, Esquire

Law Offices of Richard G. Ozelie, LLC

750 South Dixie Highway

Boca Raton, Flo rida 33432 - 6108

STATEMENT OF THE ISSUE

The issue in this case is whether the Board of Medicine

should discipline Respondent, Zannos Grekos, M.D., on charges

arising out of a stem cell treatment performed on a patient on

March 24, 2010, and the subsequent death of the patient.

PRELIMINARY STATEMENT

Petitioner, Department of Health (DOH) , filed an

Administrative Complaint against Respondent charging that the

stem cell treatment he performed on the patient, D.F., on

March 24, 2010, fell below the standard of care; was not

justified by the medical records; was performed without the

patient ' s informed consent; was an exercise of influence over

the patient to exploit her for financial gain; and was the

" wrong " procedure in that it was not medically justified or

appropriate. Respondent disputed the charges and requested a

hearing, which was provided by DOAH.

At DOAH, the hearing was scheduled and continued three

times, discovery was conducted, the Administrative Complaint was

amended twice, and a pre - hearing st ipulation was filed. At the

final hearing, the third count, alleging exploitation for

financial gain, was dropped.

At the final hearing, DOH called the following witnesses:

Sara Norden, a DOH investigator; Jeffrey Colino, M.D., a

treating neurologist; J.F. , the patient ' s husband ; Ricardo

Parra, a certified vascular technician (CVT); Mark

Moscowitz, M.D., an oncologist; Richard Roland, M.D., a treating

critical care physician at Naples Community Hospital; Manfred

Borges, M.D., the Collier County Medical Examiner; Patrick

Mathias, M.D., a cardiologist; Respondent, both for limited

factual testimony at the hearing and by deposition; Roy

Armbinder, M.D., a hematologist and oncologist; and, by

deposition, Thomas Freeman, M.D., a professor at the University

of South Florida , College of Medicine. Petitioner ' s Exhibits 1

through 5 and 7 through 18 were received in evidence.

Respondent called the following witnesses: Todd

McAllister, Ph.D., a non - physician expert in stem cell

therapies; Mark May, an emergency m edical services (EMS)

technician; Mary Louise Fylstra, Respondent ' s office manager;

Raymond Lineas, a CVT expert; Jeffrey Colino, M.D.; Respondent ' s

mother, Effie Grekos; and several of Respondent ' s stem cell

patients. One Joint Exhibit (Dr. Colino ' s medi cal records for

D.F.) was received in evidence.

Transcripts of the final hearing , and of a hearing held on

October 31 , 2012, on Respondent ' s objections to the deposition

testimony of Dr. Freeman, have been filed. The parties filed

proposed recommended o rders, which have been considered.

FINDING S OF FACT

1. Respondent is licensed as a medical doctor in Florida,

holding license ME 61912. His medical practice is in Bonita

Springs, Florida. Respondent is board - certified in

cardiovascular disease and board - eligible in internal medicine.

Respondent also performs stem cell treatments.

2. D.F. was born February 10, 1941. She first began to

see Respondent in October 2007 for numerous medical complaints.

She had peripheral neuropathy , secondary to chemothe rapy for

cancer , and complained of a loss of feeling in her hands and

especially in her feet. She also complained of poor balance,

inability to walk with an appropriate gait, and diplopia. In

addition to Respondent, D.F. saw several other physicians,

inc luding a neurologist, but saw little or no improvements.

3. In February 2010, D.F. consulted with Respondent to

determine whether stem cell therapy , which he advertised, could

help her. Respondent proposed an injection of stem cells from

her bone marro w, through a catheter, into the arterial

circulation of her brain. Respondent told the patient that the

treatment possibly could improve her neurological deficits and

that she would be no worse off if it did not achieve the desired

results.

4. Although D.F. had medical conditions that possibly

could respond to appropriate stem cell treatment, the evidence

was clear and convincing that her peripheral neuropathy would

not respond to an injection of stem cells into the brain or

central nervous system.

5. D.F. signed three " informed consent " forms in early

2010. DOH attempted to prove that there were serious

irregularities in some of the consent forms -- namely, that

patient and witness signatures were forged. DOH did not prove

this charge by clear and co nvincing evidence. The greater

weight of the evidence indicated that the signatures on the

forms were authentic and valid.

6. On February 17, 2010, the patient signed a Consent and

Acknowledgement Form for PRP and/or BMAC [bone marrow aspirate

concentr ate] Procedure. It confirmed the patient ' s election to

undergo " a state of the art treatment that involves using my own

adult stem cells . . . with full knowledge of the possible risks

and complications that may exist with the procedure. " She

acknowledge d " that though rare, serious risks may be associated

with this procedure and may include infection, stroke, heart

attack, kidney failure and death. "

7. On February 20, 2010, the patient signed a Cell Therapy

Product Supply Agreement with Regenocyte Worl dwide, Inc., a

corporation owned and controlled by Respondent and registered in

Panama. This agreement informed the patient that she was paying

Regenocyte for the cells to be used in her stem cell treatment,

as well as Respondent ' s " facility fees, " which would be paid to

Respondent by Regenocyte. It also informed the patient that her

stem cell treatment " has shown statistically significant

efficacy and safety in the clinical trial sponsored by the cell

producer and in patients treated outside the clinical trial. "

Regenocyte declined to warrant or guarantee the effect of the

therapy on the patient. The agreement informed the patient that

she was paying for a " product . . . made from your own cells. "

The agreement defines " Cell Therapy Product " as " a biol ogical

product containing Patient ' s own cells. " The patient was

cautioned that although the stem cell product would be made from

her own cells, it was possible that she could have adverse

effects from the procedure or the cells themselves, even though

" no adverse effects from the cells have been shown in any

patient treated so far with Regenocyte ' s cells, in or out of our

clinical trial . . . . " The form had the patient acknowledge

that her treatment was " innovative and novel " and that

Regenocyte was maki ng no guarantee or warranty as to its effect

or that it would cure the patient. Finally, the form had the

patient acknowledge her understanding " that though rare, serious

risks may be associated with this procedure and may include, but

certainly not limit ed to infection, stroke, heart attack, kidney

failure and death. " The agreement also had the patient alone

assume all risk after careful review of her medical condition.

It stated: " Although adverse effects have not been shown in

clinical trial with the se cells [,] adverse effects and danger

exists in all surgical procedures and unknown consequences

related to a new therapy, even autologous (your own cells)

therapy. " The form had the patient waive all liability , except

for negligence or willful misconduc t.

8. The procedure was scheduled for March 24, 2010, at

Respondent ' s facility. The patient arrived at Respondent ' s

facility before 9 a.m., accompanied by her husband and her

friend, Effie Grekos, who is Respondent ' s mother. There, s he

signed another form, this one consenting to a procedure

described as " bone marrow aspirate [BMA] and delivery of cells "

and an angiogram of the carotid arteries " [w]ith full knowledge

of the possible risks and complications of the procedure. " The

form had her also agree : " My doctor has discussed with me the

nature and purpose of this procedure, the risks involved, and

the possibility of complications with no guarantees or

assurance. "

9. Respondent was delayed and did not arrive at the

facility until after noon. At a pproximately 1 p.m., the patient

was taken to the cath lab , sedated, and anesthetized.

10. When the procedure began, Respondent used four

syringes to aspirate a total of approximately 240 cubic

centimeters (cc ' s) of bone marrow from the iliac crest of D .F. ' s

hip bone. The bone marrow was aspirated through a 170 to 260

micron - sized blood filter and stored in a standard blood

collection bag for later use.

11. Respondent then inserted a catheter into a blood

vessel in the patient ' s groin and advanced it up through her

circulatory system and , ultimately , to her carotid and vertebral

arteries. Via the catheter, he performed a cerebral angiogram

with contrast to visualize the carotid and vertebral arteries

prior to infusion of the patient ' s autologous BMA. The

angiogram confirmed that there was no blockage, but it revealed

that the patient ' s right vertebral artery was dominant, meaning

it was larger and supplied more blood to the brain than the left

vertebral artery, which was narrowed by plaque burden. Fo r that

reason, the left carotid and left vertebral arteries were not

aggressively pursued and were not cannulated for injection of

contrast during the angiogram.

12. A cerebral angiogram itself is an inherently risky

procedure. Even if performed flawles sly, there is a one percent

chance that a stroke will ensue. This is because the

vasculature in the brain and brain stem is the most delicate and

dangerous vasculature in the body. The carotid artery is about

seven millimeters (mm) in diameter, the verte bral arteries

narrow from about three mm in the neck to about 2.0 to 2.5 mm in

the brain, where they become the basilar arteries that supply

blood to the cerebellum and medulla via smaller and smaller

branches culminating in capillaries that are just 8 to 10

microns (thousandths of a mm) in diameter. Blood cells are

about the same size, meaning they must pass through the

capillaries single - file. Anything larger will clog the

capillaries and result in a stroke.

13. Due to the risks involved, great care m ust be taken in

performing a cerebral angiogram. The contrast used is not

thicker than blood and is clear so that it can be determined

before injection via syringe that it does not contain any

particulate matter, bubbles, blood clots, or anything that cou ld

cause a stroke. In addition, the minimum amount of contrast is

used -- usually not more than eight cc ' s.

14. After the cerebral angiogram, Respondent proceeded to

insert the patient ' s autologous BMA into the catheter in the

patient ' s groin and infused it into the patient ' s carotid and

vertebral arteries, where the BMA entered the cerebral

circulation of the patient ' s brain. The patient ' s autologous

BMA was not filtered again, concentrated, or processed in any

manner before infusion.

15. BMA is very d ifferent from the contrast used in a

cerebral angiogram. It is thick, aggregates, and contains not

only stem cells but also blood cells and other particulate

matter, including fat cells and bone spicules. In the treatment

attempted by Respondent, particu late matter naturally occurring

in BMA, up to the diameter of the filter used in obtaining the

BMA, was allowed to enter into the patient ' s cerebral

circulation. It was not possible to determine exactly what

particulate matter was in the BMA being infused . However, it is

clear from the evidence that due to the size of the filter, the

size of the blood vessels in the brain where the BMA was

infused, and the very large amount of BMA infused in this

fashion (at least 180 cc ' s and perhaps up to 240 cc ' s) , it was

virtually inevitable that the procedure would clog blood vessels

in the brain and cause a major and very possibly fatal stroke.

16. Respondent should have known the grave risk of the

procedure he performed on the patient. Instead, he denies the

grav ity of the risk. He testified that he did not know what

would happen as a result of the procedure.

17. The procedure ended at 5:15 p.m. Respondent left the

facility and had his CVT and medical office staff assist the

patient and her husband. About hal f an hour later, t he

patient ' s husband joined his wife in recovery. At the time, the

patient still was under the influence of her sedati on and

anesthesia . She was sleepy, groggy, uncommunicative, and unable

to walk.

18. The patient remained in recovery until about

6:45 p.m., when it was decided that the sedation and anesthesia

had worn off enough for Respondent ' s staff to help the patient ' s

husband and Effie Grekos get the patient into her husband ' s car

to be driven home. The patient still could not wa lk without

considerable assistance, was still somewhat sleepy and groggy,

and was not speaking normally although she was able to

communicate somewhat. They left the office about half an hour

later.

19. When they arrived home , it was close to 8 p.m. T he

patient ' s husband and Respondent ' s mother helped get the patient

into the house. Once there, against the instructions of

Respondent ' s staff, the patient ' s husband allowed his wife to

sit up in a reclining chair, instead of confining her to bed

rest. For the next hour or two, the patient remained in the

chair. She was able to communicate , but still was not speaking

normally.

20. Respondent ' s mother left and returned to her home at

approximately 9 p .m. The patient ' s husband went to sleep in his

bedroom , leaving his wife in the reclining chair. A few hours

later, the patient fell onto the floor, hit her face and mouth

on the couch, and began to vomit uncontrollably. When the

patient ' s husband found her on the floor, he tried to help her

up, cleaned up the vomit, and called 911.

21. The North Naples Fire Department arrived at the scene

first, followed some time later by the EMS technicians. The EMS

technicians had no present recollection of the patient and

relied on their written report, which was amb iguous in some

respects. It states the patient was found on the floor in the

bedroom but does not clearly state who found her or how she got

there. It states the patient ' s skin color was pale, meaning

abnormal, and that she was lethargic but that she res ponded to

verbal contact. However, a computer - generated entry on the

report form states the patient was " alert. " That entry was

triggered by a score of 14 out of 15 on the Glasgow Coma scale,

which meant she was not " unresponsive " or " lethargic " but

" res ponded to verbal contact, " although she did not speak

spontaneously and did not look at anyone until they spoke to

her. It reports that the patient said she got up to go to the

bathroom and fell forward to the carpeted floor, striking her

head on the couc h. The patient was not considered to be

incoherent or immobile, but her husband had to sign her name for

her on the report form. The report states that the patient had

a cervical injury and pain, but also states that the fall was

mild in severity.

22. The patient was taken by ambulance to North Collier

Community Hospital at approximately 2 a.m. Although the

patient ' s husband had been unable to contact Respondent by

calling his office telephone, Respondent was contacted by the

hospital staff and, at app roximately 5:30 a.m., had the patient

transferred and admitted to Naples Community Hospital. There,

she was diagnosed as having had a stroke that caused

debilitating and irreparable damage to the cerebellum and

medulla of her brain. The patient never rec overed or improved,

and she died on April 4, 2010.

23. There was conflicting testimony and evidence as to the

cause of the stroke and how quickly the stroke progressed after

the procedure. The patient ' s husband testified that his wife

showed symptoms th at, if factual, would have signified an

immediate, massive stroke early in the evening, soon after the

procedure ended. The testimony of Respondent ' s mother , and to a

lesser extent, Respondent ' s staff and the EMS technicians ,

contradict the husband. Howe ver, the expert testimony was that

the symptoms of a cerebellar infarct, which is the kind of

stroke suffered by the patient, can vary depending on a number

of factors. Respondent ' s medical staff, his mother, and the EMS

technicians could have confused th e patient ' s stroke symptoms

with the symptoms of her pre - existing medical conditions, which

included poor balance and an unnatural gait, as well as the

effects of anesthesia -- especially since they did not have

knowledge of the details of the procedure perf ormed by

Respondent or the medical significance of those details.

24. Based on all the evidence, it appears that the patient

suffered a cerebellar infarct early in the evening, during or

shortly after the procedure , and that the stroke progressed in

wave s over time. In this scenario, a blockage in small blood

vessels of the brain initially deprives the tissues directly

served by those vessels of oxygen. In no more than six hours of

being deprived of oxygen, the brain tissue dies. As tissues die

from ox ygen deprivation, they swell, which compresses and closes

off nearby blood vessels, depriving additional tissue of oxygen,

and the process continues in waves. As the stroke progresses,

it becomes more and more debilitating.

25. Respondent argues that th e evidence is consistent with

either a stroke caused by the cerebral angiogram, with no

contribution from the infusion of BMA, or an immediate, massive

stroke caused by the patient ' s fall at her house.

26. As to the latter argument by Respondent, there w as a

contusion on the patient ' s face as a result of her fall, but it

was minor, and it is unlikely to have caused an immediate,

massive stroke. It is much more likely that the patient ' s

stroke was caused by the procedure. As to the former argument,

there is a one percent chance that a cerebral angiogram will

produce a stroke , even if performed flawlessly. However, in

this case, the chances are much greater that the patient ' s

stroke was caused by the infusion of BMA. (The absence of

evidence of BMA in th e brain on autopsy is explained by the

action of naturally - occurring macrophages that clean up the dead

tissue and other foreign matter, which would have decomposed and

eliminated evidence of the BMA.)

Count I - Standard of Care

27. The evidence was clea r and convincing that

Respondent ' s stem cell treatment provided to D.F. on March 24,

2010, fell below that level of care, skill, and treatment which,

in light of all relevant surrounding circumstances, is

recognized as acceptable and appropriate by reasona bly prudent

similar health care providers. No such health care provider

would have provided the treatment, which almost certainly would

result in a serious stroke.

28. The evidence was clear and convincing that

Respondent ' s care after the stem cell trea tment provided to

D.F., on March 24, 2010, fell below that level of care, skill,

and treatment which, in light of all relevant surrounding

circumstances, is recognized as acceptable and appropriate by

reasonably prudent similar health care providers. Any such

health care provider would have recognized the likelihood of a

serious stroke and, if the procedure was attempted contrary to

the standard of care, would not have then left the patient w ith

his CVT and medical staff; rather, emergency transfer to an

a ppropriate hospital setting would have been required.

Count II - Adequate Medical Records

29. DOH attempted to prove that Respondent ' s medical

records were inadequate because they did not substantiate that

he was attempting to treat conditions capable of responding to

intra - cranial infusion of stem cells. That allegation was not

proven by clear and convincing evidence. Respondent ' s medical

records indicated that he also was attempting to treat

neurological deficits other than peripheral neuropathy that

could be treated with appropriate intra - cranial infusion of stem

cell (assuming informed consent ) . No medical records could

justify the procedure Respondent attempted on D.F. on March 24,

2010.

Count III - Informed Consent

30. DOH contends that the pati ent did not give informed

consent , in part , because Respondent did not test to ensure that

the autologous BMA to be infused actually contained stem cells.

However, Respondent has conducted a trial to confirm the

efficacy of BMA as a source of stem cells. There is medical and

scientific literature documenting this, and Respondent ' s

non - physician stem cell expert testified that BMA is an

efficacious source of stem cells. DOH did not prove that the

autologous BMA infused in the patient was devoid of ste m cells ,

or that it did not contain enough to be efficacious.

31. DOH also contends that the patient did not give

informed consent , in part , because Respondent infused BMA, not a

processed BMAC product . The signed consent forms themselves

proved this al legation clearly and convincingly.

32. The evidence also was clear and convincing that, taken

together, the written consents did not adequately inform the

patient of the true risk of the treatment Respondent proposed.

They informed the patient regarding the risks of aspiration of

bone marrow from the iliac crest, a cerebral angiogram using

contrast, and the infusion of a processed BMAC product ; they

implied that the procedure Respondent proposed would not entail

any greater risks.

33. The evidence was clear and convincing that Respondent

did not give the patient unwritten information regarding the

proposed treatment or its risks. To the contrary, in defending

against the allegations in this case, Respondent has denied that

there was any additional risk .

Count V - " Wrong Procedure "

34. DOH attempted to prove that the procedure performed by

Respondent had no basis in medicine or science and was a wrong

procedure, in part , because he performed it to treat peripheral

neuropathy, which would not respond to intra - cranial infusion of

stem cells. However, taken together, the evidence was that

Respondent proposed the procedure to treat neurological

deficits, other than peripheral neuropathy, that could be

treated with appropriate intra - cranial infusion of stem cells

(assuming informed consent ) .

35. Respondent presented the testimony of its non -

physici an stem cell therapy expert, evidence concerning medical

and scientific literature about stem cell treatment, and

evidence of a trial conducted by Respondent on the efficacy of

BMA as a source of stem cells. This evidence proved that intra -

cranial infusion of stem cells to treat neurological deficits in

the brain and central nervous system , while innovative and

perhaps investigational, has a medical and scientifi c basis and

can be appropriate under certain circumstances, including

informed consent. Respondent ' s evidence also proved that BMA is

an efficacious source of stem cells and sometimes achieves

results as good or better than processed BMAC products.

Howev er, Respondent ' s evidence did not address or refute DOH ' s

clear and convincing evidence that there is no medical and

scientific basis for the treatment Respondent attempted to

perform on D.F. on March 24, 2010, which clearly was a " wrong "

procedure.

CONC LUSIONS OF LAW

36. Because it seeks to impose license discipline, DOH has

the burden to prove its allegations by clear and convincing

evidence. See Dep ' t of Banking & Fin . v. Osborne Stern & Co.,

Inc. , 670 So. 2d 932 (Fla. 1996); Ferris v. Turlington , 510

So. 2d 292 (Fla. 1987). This " entails both a qualitative and

quantitative standard. The evidence must be credible; the

memories of the witnesses must be clear and without confusion;

and the sum total of the evidence must be of sufficient weight

to convi nce the trier of fact without hesitancy. " In re Henson ,

913 So. 2d 579, 590 (Fla. 2005)(quoting Slomowitz v. Walker , 429

So. 2d 797, 800 (Fla. 4th DCA 1983) ) . " Although this standard

of proof may be met where the evidence is in conflict, . . . it

seems t o preclude evidence that is ambiguous. " Westinghouse

Electric Corp., Inc. v. Shuler Bros. , 590 So. 2d 986, 988 (Fla.

1st DCA 1991).

37. Count I of the amended Administrative Complaint

charges Respondent with medical malpractice as defined in

section 456 .50 , Florida Statutes (2009 ), 1/ regarding the

treatment he performed on D.F. on March 24, 2010, in violation

of section 458.331(1)(t) , Florida Statutes . Section

456.50(1)(g) defines medical malpractice as " the failure to

practice medicine in accordance wi th the level of care, skill,

and treatment recognized in general law related to health care

licensure. " According to section 766.102(1), Florida Statutes,

such a failure occurs upon :

a breach of the prevailing professional

standard of care for that healt h care

provider. The prevailing professional

standard of care for a given health care

provider shall be that level of care, skill,

and treatment which, in light of all

relevant surrounding circumstances, is

recognized as acceptable and appropriate by

reas onably prudent similar health care

providers.

38. In this case, DOH proved by clear and convincing

evidence that Respondent committed medical malpractice as

defined in section 456.50 regarding the stem cell treatment he

performed on D.F. on March 24, 2010 , and thus violated section

458.331(1)(t). The infusion of approximately 240 cc ' s of

unconcentrated, grossly filtered BMA into the cerebral

circulation of the patient via the vertebral arteries had

virtually no hope of success because of the very high

pro bability that it would cause the patient to have a serious

stroke. Respondent should have known this and should not have

attempted the procedure.

39. Count II of the amended Administrative Complaint

charges Respondent with failure to keep medical record s that

justified the treatment he performed on D.F., on March 24, 2010,

in violation of section 458.331(1)(m). This charge was proven

only in the sense that no medical records could have justified

the procedure performed in this case.

40. Count IV of th e amended Administrative Complaint

charges Respondent with performing professional services not

duly authorized by the patient, in violation of section

458.331(1)(p). This charge was proven by clear and convincing

evidence. In order for the patient to ha ve given informed

consent, she would have had to know that Respondent intended to

infuse BMA, not a BMAC product, and that the treatment

Respondent was attempting had virtually no hope of success and

probably would result in the patient having a serious st roke.

Respondent did not so inform the patient.

41. Count V of the amended Administrative Complaint charges

Respondent with performing a wrong procedure that was medically

unnecessary or otherwise unrelated to the patient ' s diagnosis or

medical conditio n, in violation of section 456.072(1 )( bb). This

charge was proven by clear and convincing evidence, not because

it was performed solely to cure peripheral neuropathy (which was

not proven) , and not because there is no medical or scientific

basis for the a ppropriate use of stem cells to treat neurological

deficits other than peripheral neuropathy (which there is), but

because the infusion of approximately 240 cc ' s of unconcentrated,

grossly filtered BMA into the patient ' s cerebral circulation had

virtually no hope of success and had a very high probability that

it would cause the patient to have a serious stroke. In that

sense, it was a " wrong " procedure.

42. Respondent attempts to escape discipline by resort ing

to section 458.331(1)(u), which prohibits " [p]erforming any

procedure or prescribing any therapy which, by the prevailing

standards of medical practice in the community, would constitute

experimentation on a human subject, without first obtaining

full, informed, and written consent. " The stem c ell treatment

attempted on D.F. on March 24, 2010, could be characterized as

" experimentation on a human subject. " It was not performed

after " first obtaining full, informed, and written consent. "

43. Respondent also attempts to escape discipline by

resort ing to section 456.41, which authorizes " complementary or

alternative health care treatments. " However, this statute only

authorizes effective options and requires that the licensee

" must inform the patient of the nature of the treatment and must

explain the benefits and risks associated with the treatment to

the extent necessary for the patient to make an informed and

prudent decision regarding such treatment option. " § 456.41(1)

& (2)(a). In this case, the stem c ell treatment performed on

D.F. on March 24, 2010, was not an effective option, and the

patient was not given the information needed to give informed

consent. In addition, this statute " does not modify or change

the scope of practice of any licensees of the department, nor

does it alter in any way the provisions of the individual

practice acts for those licensees, which require licensees to

practice within their respective standards of care and which

prohibit fraud and exploitation of patients. " § 456.41(5).

44. Florida Administrative Code Ru le 64B8 - 8.001 ( r evised

February 2009) provides disciplinary guidelines for proven

violations. Subparagraph (1)(t) of the rule states that the

recommended ranges of penalties for the proven offense of gross

malpractice alleged in Count I are from a year su spension ,

followed by three years probation, and 50 to 100 hours of

community service, to revocation and an administrative fine from

$1,000 to $10,000 (with licensee subject to reexamination).

Subparagraph (1)(m) of the rule states the recommended ranges of

penalties for the violation alleged in Count II, but penalties

for Count II should not be added to the penalties for Count I

since Count II was proven only in the sense that there are no

medical records that could justify the procedure performed in

this case. Paragraph (1)(p) of the rule states that the

recommended ranges of penalties for the proven violation alleged

in Count IV are from a reprimand and $250 fine to a suspension

for two years, to be followed a period of probation, 50 to 100

hours of com munity service, and an administrative fine from

$1,000 to $10,000. Although they arise out of the same

procedure, the penalties for Count IV should be added to the

penalties for Count I because they are different violations.

Subparagraph (1)(qq) of the r ule states the recommended ranges

of penalties for the proven violation alleged in Count V, but

penalties for Count V should not be added to the penalties for

Counts I and II since Respondent performed the " wrong " procedure

in the sense that it constituted medical malpractice, not in the

sense that it was a " wrong - site surgery. "

45. Consideration of the totality of circumstances

surrounding this case, most especially Respondent ' s continuing

failure to recognize the complete inappropriateness of the

proced ure he performed on the patient and the inadequacy of the

information he provided to obtain the patient ' s consent, together

with the aggravating and mitigating factors under rule 64B8 -

8.001(3) (which are utilized to justify a departure from the

disciplinar y guidelines), supports the imposition of a penalty at

the top of the ranges -- namely, revocation and a $20,000 fine.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is RECOMMENDED that the Board of Medicine enter a final

order adopting the Findings of Fact and Conclusions of Law,

revoking Respondent ' s license, and imposing a $20,000 fine.

DONE AND ENTERED this 11th day of March , 2013 , in

Tallahassee, Leon County, Florida.

S

J. LAWRENCE J OHNSTON

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Adminis trative Hearings

this 11th day of March , 2013 .

ENDNOTE

1/ All statutory references are to the 2009 version of the

Florida Statutes.

COPIES FURNISHED:

Allison M. Dudley, Executive Director

Board of Medicine

Department of Health

Bin C - 03

4052 Bald Cyp ress Way

Tallahassee, Florida 32399

Jennifer A. Tschetter, General Counsel

Department of Health

Bin A - 02

4052 Bald Cypress Way

Tallahassee, Florida 32399

Richard G. Ozelie, Esquire

Law Offices of Richard G. Ozelie, LLC

750 South Dixie Highway

Boca R aton, Florida 33432 - 6108

Robert A. Milne, Esquire

Ian Brown, Esquire

Department of Health

Bin C - 65

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 3265

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions wit hin

15 days from the date of this Recommended Order. Any exceptions

to this Recommended Order should be filed with the agency that

will issue the Final Order in this case.