16-004348PL Department Of Health, Board Of Medicine vs. Douglas M. Burks, M.D. Status: Closed Recommended Order on Thursday, March 16, 2017.

Summary: Department of Health proved by clear and convincing evidence that anesthesiologist did not give adequate information about experimental stem cell treatment but did not prove a standard of care violation.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF

MEDICINE,

Petitioner,

vs. Case No. 16 - 4348PL

DOUGLAS M. BURKS, M.D.,

Respondent.

_______________________________/

RECOMMENDED ORDER

On October 12 and 13, 2016, Administrative Law Judge J.

Lawrence Johnston held the final hearing in this case in Tampa.

APPEARANCES

For Petitioner: Chad Wayne Dunn, Esquire

Department of Health

Prosecution Services Unit

Bin C - 65

4052 Bald Cypress Way

Tallahassee, Florida 32399

For Respondent: Augustine Smythe Weekley, Esquire

Weekley Schulte Valdes, LLC

Suite 100

1635 North Tampa St reet

Tampa, Florida 33602

STATEMENT OF THE ISSUE

The issue in this case is whether the Board of Medicine

(Board) should revoke or otherwise discipline the RespondentÓs

medical license for violating section 458.331(1)(t) and (u),

Florida Statutes (2011), by using experimental stem cell therapy

that did not meet the standard of care and by not getting the

patientÓs informed consent.

PRELIMINARY STATEMENT

The Petitioner filed an Administrative Complaint charging

the violations in August 2015 . The Respondent disputed the

charges and asked for a hearing. The matter was referred to the

Division of Adminis trative Hearings in July 2016.

At the final hearing, the medical records of patient J.F.

were received as Joint Exhibit 1. The Petitioner ca lled

Marilyn Glassberg, M.D., as an expert witness, and the

PetitionerÓs Exhibits 1, 2, and 5 were received in evidence. The

Respondent testified and called Raghavendra Vijayanagar, M.D., as

an expert witness. The RespondentÓs Exhibits 1, 2, 5, and 11

w ere received in evidence; objections to the RespondentÓs other

exhibits were sustained.

The Transcript of the hearing was filed on October 31.

The parties agreed to file proposed recommended orders by

November 30. The proposed recommended orders have be en

considered.

FINDING S OF FACT

1. The Respondent is licensed to practice medicine in

Florida. He holds license ME 45186. He is a boa rd - certified

anesthesiologist.

2. In mid - 2011, the Respondent began working at Jouvence

Medical in Sarasota and was off ered the opportunity to take over

the stem cell medicine practice of Dr. Feinerman, who was

treating patients with lung disease using an intravenous

autologous stem cell procedure. The Respondent had no formal

training in stem cell medicine, which is not normally practiced

by anesthesiologists, but the Respondent observed Dr. Feinerman

perform his stem cell procedure and correctly concluded that he

was fully capable of performing it himself. In addition, the

Respondent had strong interest in stem cell med icine and gained

some knowledge of it from studying literature while seeking stem

cell therapy for his elderly father, who has chronic obstructive

pulmonary disease.

3. O n September 14, 2011, patient J.F. presented to the

Respondent at Jouvence with a num ber of medical issues, including

post - polio syndrome and end - stage idiopathic pulmonary fibrosis

(IPF). The standard of care for end - stage IPF is supportive

management, including oxygen, which was offered and being

provided by the patientÓs primary physic ian and pulmonologist,

who referred the patient to Jouvence for a stem cell treatment

that might provide additional health benefits and possibly extend

the pat ientÓs life, or even cure him.

4. On seeing the patient on September 14, 2011, the

Respondent ap propriately took his history, reviewed his medical

records and various test results, and offered the autologous stem

cell procedure he learned from Dr. Feinerman. The Respondent

adequately explained to the patient how the procedure would be

performed and how much it would cost. He told the patient that

results were not guaranteed, but that some patients reported

receiving benefits from the treatment. The patient signed a

consent form acknowledging and documenting what the Respondent

told him.

5. It cert ainly was true that the procedureÓs hoped - for

results were not guaranteed, but just saying that was ina dequate

to inform the patient.

6. The procedure proposed by the Respondent essentially

consisted of: a 60 cubic centimeter (cc) blood draw, and

intrave nous infusion of 150 micrograms (mcg) of Neupogen;

concentration of the drawn blood in a centrifuge; and, the next

day, peripheral intravenous infusion of 10 ccÓs of the patientÓs

concentrated blood, together wit h 100 ccÓs of saline solution.

7. Accordin g to the Respondent, the treatment would confer

maximum benefits by delivering mesenchymal stem cells directly

into the patientÓs fibrotic lungs and also by stimulating the

patientÓs bone marrow to produce additional mesenchymal stem

cells that would migra te to and concentrate in the lungs. Once

in the lungs, the mesenchymal stem cells theoretically would

differentiate and regenerate healthy, non - fibrotic lung tiss ue to

replace fibrotic tissue.

8. Mesenchymal stem cell treatments to regenerate heart

tissu e have been successful, and it is hoped that these

treatments increasingly will replace heart transplants and

surgeries. The similar use of mesenchymal stem cells for lung

disease is being studied in vigorously regulated and controlled

FDA - approved trials , which are experiments on human subjects.

Safety trials were held in 2015 and 2016. So far, the trials

have not progressed beyond safety trials; trials to dete rmine

efficacy have not begun.

9. The FDA - approved trials of stem cell treatments for lung

d isease are much different from the procedure performed by the

Respondent. They involve the extraction, concentration, and

characterization of tens or hundreds of millions of mesenchymal

stem cells from human donors and the use of those stem cells to

treat human subjects. The RespondentÓs treatment was so

different from these trials that it did not even require FDA

approval.

10. It was unrealistic for the Respondent to think it

likely that the procedure he performed on J.F. would result in

regeneration of lung tissue. Blood contains a minimal number of

mesenchymal stem cells. Neupogen is a granulocyte colony -

stimulating factor that is administered (usually in multiple

doses over a relatively long period of time, especially when

administered through the p eripheral veins, as done in the

RespondentÓs procedure) to chemotherapy patients to amplify the

development of white blood cells called neutrophils. Neutrophils

are hematopoietic stem cells, which do not differentiate as

mesenchymal stem cells do. The tw o injections of Neupogen

administered in the RespondentÓs procedure would not be expected

to increase the production of mesenchymal stem cells

significantly. There was no reasonable expectation that the

procedure performed by the Respondent would introduc e a

significant amount of mesenchymal stem cells into the patientÓs

lungs so as to achieve the maximum hoped - for benefi t of

regenerating lung tissue.

11. T here had been anecdotal reports that patients have

benefited from the treatment offered to J.F. by t he Respondent.

Since the functioning of stem cells in the body was not well

known at the time, it was possible that some of the reported

benefits are real. It is possible that the introduction of even

a small number of stem cells, either mesenchymal or h ematopoetic,

could reduce inflammation in the lungs and stimulate the

production of additional stem cells in the bone marrow.

(There also could have been benefits from a placebo effect, even

if no t intended by the Respondent.)

12. The procedure performe d by the Respondent was fairly

benign. Since the patientÓs own blood was being used, there was

little or no risk of rejection. There is a risk of infection

from any blood draw and infusion. While the risk of infection

was relatively small, the harm to a patient in J.F.Ós condition

from any infection would be significant and could result in the

loss of lung tissue. Loss of consciousness was another risk from

the procedure that was small but serious for a patient in J.F.Ós

condition. There also was some risk of p ulmonary emboli, albeit

small.

13. The patient survived the proc edure performed on

September 14 and 15, 2011. The evidence was not clear, but it

suggested that the patient was neither harmed nor benefited.

About a month later, the patientÓs con dition worsened and he

died, which was not unexpected giv en his dire medical condition.

14. After J.F. died, his life partner R.C. asked the

Respondent to return the $5,000 he had paid for J.F.Ós procedure.

The Respondent referred him to Jouvence, which declined to return

the money. R.C. filed a complaint with the Department of Health,

which investigated and filed the pen ding Administrative

Complaint.

15. Shortly after J.F. died, the Respondent decided to

discontinue offering the procedure to similar pa tients because

the small chance of benefits did not o utweigh the risk of

infection.

16. As to the charge that the Respondent practiced below

the standard of care, the standard of care for the patient J.F.

was supportive management, which the patientÓs ot her doctors

already were providing. The Respondent offered the patient the

possibility of a health benefit beyond the standard of care.

Although the chances of complete success were extremely small to

nonexistent, there was a chance of some health benefi ts, and the

concomitant risks were not clearly unreasonable. The procedure

was performed in an appropriate manner in all other respects.

17. As to the charge of experimentation without giving

informed consent, the Respondent should have been more forthri ght

in disclosing to the patient that his chances of receiving a

medical benefit were very small and that the chances of a cure or

an appreciable lengthening of his life were extremely small. It

was not enough to say Ðresults are not guaranteed.Ñ

CONCLUSI ONS OF LAW

18. Section 458.331(1)(u), Florida Statutes (2011),

provided that performing 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 is

ground s for discipline by the Board.

19. Section 458.331(1)(t) provided that committing medical

malpractice as defined in section 456.50 is grounds for

discipline by the Board of Medicine. Th e Board was required to

give great weight to th e provisions of section 766.102, Florida

Statutes, when enforcing section 458.331 (1)(t). Medical

malpractice is defined in section 456.50 as the failure to

practice medicine in accordance with the level of ca re, skill,

and treatment recognized in general law related to health care

licensure. Section 766.102 provided that the prevailing

professional standard of care for a given health care provider

shall be that level of care, skill, and treatment which, in li ght

of all relevant surrounding circumstances, is recognized as

acceptable and appropriate by reasonably prudent similar health

care providers.

20. In a penal proceeding, the prosecutor must prove the

allegations and charges by clear and convincing eviden ce. Dep't

of Banking & Fin. v. Osborne Stern & Co. , 670 So. 2d 932 (Fla.

1996); Ferris v. Turlingto n , 510 So. 2d 292 (Fla. 1987).

21. Clear and convincing evidence "requires more proof than

a 'preponderance of the evidence' but less than 'beyond and to

the exclusion of a reasonable doubt.'" In re Graziano , 696

So. 2d 744, 753 (Fla. 1997). As stated by the Florida Supreme

Court, the standard:

[E]ntails both a qualitative and quantitative

standard. The evidence must be credible; the

memories of the wi tnesses must be clear and

without confusion; and the sum total of the

evidence must be of sufficient weight to

convince the trier of fact without hesitancy.

In re Davey , 645 So. 2d 398, 404 (Fla. 1994) (citing, with

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

1983)); see also In re Henson , 913 So. 2d 579, 590 (Fla. 2005).

"Although this standard of proof may be met where the evidence is

in conflict, it seems to preclude evidence that is ambiguous."

Westinghouse Elec tric Corp. v. Shul er Bros. , 590 So. 2d 986, 989

(Fla. 1991) .

22. Section 456.41 , Florida Statutes (2011) , authorized the

Respondent to offer and provide complementary or alternative

health care treatments. This was defined by statute as Ðany

treatment that is designed to provide patients with an effective

option to the prevailing or conventional treatment methods

associated with the services provided by a health care

practitioner.Ñ £ 456.41(2)(a) , Fla. Stat . ÐA health care

practitioner who offers to provide a patient wit h a complementary

or alternative health care treatment 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 deci sion regarding

such treatment option.Ñ £ 456.41(3) , Fla. Stat . The information

communicated can be communicated to the patient orally or in

written form, either directly to the patient or to the patientÓs

legal re presentative. § 456.41(3)(b) , Fla. Stat .

23. In 2015 , Florida enacted the ÐRight to Try ActÑ

for eligible patients with a terminal condition. § 499.0295 ,

Fla. Stat . This law specifies the use of medical cannabis but

also authorizes the use of any Ðdrug, biological product, or

device that has successfully completed phase 1 of a clinical

trial , Ñ even if it Ðhas not been approved for general use by the

United States Food and Drug Administration and remains under

investigation in a clinical trial approved by the United States

Food and Drug Admini stration.Ñ £ 499.0295(2)(c)1. , Fla. Stat

Written informed consent is required, to include : an explanation

of currently a pproved products and treatments; attestation that

the patient concurs with the physician in believing that all

currently approved pro ducts and treatments are unlikely to

prolong the patientÓs life ; identification of the specific

investigational drug, biological product, or device that the

patient is seeking to use ; a realistic description of the most

likely outcomes of using the investi gational drug , biological

product, or device; a statement that the patientÓs health plan or

third - party administrator and physician are not obligated to pay

for care or treatment consequent to the use of the

investigational drug, biological product, or dev ice unless

required to do so by law or contract ; a statement that the

patientÓs eligibility for hospice care may be withdrawn if the

patient begins treatment with the investigational drug,

biological product, or device and that hospice care may be

reinstat ed if the treatment ends and the patient meets h ospice

eligibility requirements; and a statement that the patient

understands he or she is liable for all expenses consequent to

the use of the investigational drug, biological product, or

device and that lia bility extends to the patientÓs estate, unless

a contract between the patient and the manufacturer of the

investigational drug, biological product, or device states

otherwise. § 499.0295(2)(e) , Fla. Stat . ÐIf an eligible patient

dies while using an inves tigational drug, biological product, or

device pursuant to this section, the patientÓs heirs are not

liable for any outstanding debt related to the patientÓs use of

the investigational drug, biological product, or de vice.Ñ

§ 499.0295(6) , Fla. Stat .

24. Section 499.0295 , Florida Statutes, does not apply to

this case because it was not enacted until 2015. If it did

apply, the Respondent would not have met its requirements.

25. The Petitioner did not prove by clear and convincing

evidence that the Respond ent violated section 458.331(1)(t) by

practicing medicine below the applicable standard of care. The

procedure performed by the Respondent for the patient J.F. was a

complementary or alternative health care treatment authorized by

section 456.41. However , the Respondent did not meet the

requirements of that statute because he did not explain the

benefits and risks associated with the treatment to the extent

necessary for the patient to make an informed and prudent

decision regarding the treatme nt option.

26. The Petitioner proved by clear and convincing evidence

that the Respondent violated section 458.331(1)(u) by performing

a procedure or prescribing a therapy that would constitute

experimentation on a human subject, without first obtaining full,

infor med, and written consent.

27. The Respondent contends that the decision in State

Board of Medical Examiners of Florida v. Robert J. Rogers, M.D. ,

387 So. 2d 937 (Fla. 1980), requires his complete exoneration on

all charges. In Rogers , the board reprimand ed the physician for

performing chelation therapy for arteriosclerosis and ordered him

to discontinue the practice, notwithstanding that a definite

minority of physicians used chelation therapy, there was no

proven risk to patients, and the patients were n ot being misled

about the benefits of the procedure. That made the boardÓs

disciplinary action an unreasonable exercise of police power. At

least insofar as discipline against the Respondent for not

providing J.F. with enough information to give his info rmed

conse nt, Rogers is distinguishable.

28. Florida Administrative Code Rule 64B8 - 8.001(2)(a)

(Rev. June 21, 2011) provided the range of disciplinary penalties

typically imposed for violations of section 458.331(1)(u).

Section (3) of the rule provided aggravating and mitigating

factors to consider for a deviation f rom the typical penalty

range.

29. Under the rule, the penalties for a violation of

section 458.331(1)(u) ranged from a one - year suspension, followed

by probation, and 100 to 200 hours of com munity service, to

revocation or denial and an administrative fine of $1,000 to

$10,000. Consideration of the aggravating and mitigating factors

in the rule warrant a penalty below the guidelines. In this

case, probation and a $1,000 fine is all that is warranted.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

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

order: finding the Respondent guilty of a violation of

section 458.331(1)(u); placing him on probation fo r one year; and

fining him $1,000.

DONE AND ENTERED this 20 th day of December , 2016 , in

Tallahassee, Leon County, Florida.

S

J. LAWRENCE JOHNSTON

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Bu ilding

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 Administrative Hearings

this 20 th day of December , 2016 .

COPIES FURNISHED:

Chad Wayne D unn, Esquire

Department of Health

Prosecution Services Unit

Bin C - 65

4052 Bald Cypress Way

Tallahassee, Florida 32399

(eServed)

Augustine Smythe Weekley, Esquire

Weekley Schulte Valdes, LLC

Suite 100

1635 North Tampa Street

Tampa, Florida 33602

(eServed )

Sarah E. Corrigan, Esquire

Department of Health

Prosecution Services Unit , Bin C - 65

4052 Bald Cypress Way

Tallahassee, Florida 23299

(eServed)

Claudia Kemp, JD, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way, Bin C - 0 3

Tallahassee, Florida 32399 - 3253

(eServed)

Nichole C. Geary, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A - 02

Tallahassee, Florida 32399 - 1701

(eServed)

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit wri tten 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 issue the Final Order in this case.