16-006149PL Department Of Health, Board Of Medicine vs. Ronald Evan Wheeler, M.D. Status: Closed Recommended Order on Friday, February 24, 2017.

Summary: Physician committed malpractice by diagnosing, recommending treatment, and treating prostate cancer without a tissue biopsy. Recommend license revocation and $30,000.00 fine.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF

MEDICINE,

Petitioner,

vs. Case Nos. 16 - 6136PL

16 - 6148PL

RONALD EVAN WHEELER, M.D., 16 - 6149PL

16 - 6150PL

Respondent.

_______________________________/

RECOMMENDED ORDER

Pursuant to notice, a formal administrative hearing was

conducted before Administrative Law Judge Mary Li Creasy by video

teleconference with locations in Sarasota and Tallahassee ,

Florida, on December 8 , 2016.

APPEARANCES

For Petitioner: Jack F. Wise, Esquire

Department of Health

Bin C - 65

4052 Bald Cypress Way

Tallahassee, Florida 32399

For Respondent: Christopher J. Schulte, Esquire

Weekley Schulte Valdes, LLC

Suite 100

1635 North Tampa Street

Tampa, Florida 33602

STATEMENT OF THE ISSUE S

Whether Respondent , a licensed physician, violated the

applicable standard of care by diagnosing prostate cancer in four

patients , and recommending and participating in a course of

treatment for these patients , without confirming prostate cancer

through tissue biopsy results ; and , if so, what is the

appropriate penalty?

PRELIMINARY STATEMENT

On March 21 , 2016, Petitioner, Department of Health, Board

of Medicine, referred the four above - captioned cases seeking

disciplinary sanction of the medical license of Respondent,

Ronald Evan Wheeler , M.D., to the Division of Administrative

Heari ngs (DOAH). On the next day, DOAH assigned Administrative

Law Judge J. Lawrence Johnston to conduct the proceeding. These

four cases were consolidated on March 23, 2016 , and the matter

was set for hearing for June 15 through 17, 2016.

This matter was con tinued until August 17 and 18, 2016 , and

was transferred to the undersigned on August 9 , 2016. On

August 12, 2016, the parties reached a proposed resolution and

filed a Joint Motion to Relinquish Jurisdiction Without

Prejudice , which was granted.

On Octo ber 14 , 2016, Petitioner filed a Motion to Re - Open

Proce e ding because a final agreement was not reached . The m otion

was granted and the matter was re - opened and re - set for

December 8 and 9, 2016.

The hearing was held as scheduled on December 8 , 2016 .

Joint Exhibits 1 through 8 were admitted into evidence. At the

hearing, Petitioner presented the testimony of Dennis Donahue,

M.D., its expert witness. Petitioner's Exhibits 1 through 14

were admitted into evidence.

Included in Petitioner 's exhibits were the deposition

transcripts of P atients G.P., J.W., K.S. , and V.P. , offered in

lieu of live testimony. Petitioner also provided the transcripts

of the Patients ' other physicians: Joel Gel man, M.D. (physician

for Patient G.P.); M. Eric Brewer, M.D. (ph ysician for

Patient J.W.); Jeffrey Jump, M.D. (physician for Patient K.S);

and Vip ul Patel, M.D. (physician for Pa tient V.P.). Also

i ncluded was the deposition transcript of Sarat Sabharwal, M.D.,

a board - certified urologist , who was identified as an exp ert by

Respondent.

Respondent testified on his own behalf and presented the

testimony of Stephen Leslie, M.D., as an expert witness.

Respondent's Exhibits 1 through 6 and 8 through 20 were admitted

into evidence.

A two - volume Transcript of the proceeding was filed on

January 9 , 2017 . Both parties filed timely proposed orders ,

which were given due consideration in the preparation of this

Recommended Order.

Unless otherwise indicated, citations to the Florida

Statutes or rules of the Florida Administrati ve Code refer to the

versions in effect at the time of the alleged violations.

FINDING S OF FACT

1. Petitioner is responsible for the investigation and

prosecution of complaints against medical doctors licensed in the

state of Florida, who are accused of v iolating chapters 456 and

458 of the Florida Statutes.

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

having been issued license number ME 46625 .

3. Respondent is not board - certified in any specialty

recognized by the Florida Board of Medicin e.

4. Respondent has never had disciplinary action against his

license to practice medicine.

Respondent's Practice

5. Since his residency concluded in 1985 , Respondent has

practiced urology. For more than 20 years, the focus of his

practice has been pro state disease , its diagnosis , and treatment .

6. In 2006, Respondent becam e the lead investigator for a

General El ectric study regarding its 3 - T esla magnetic resonance

spectroscopy imaging machine (3T MRI - s ) as part of an

Institutional Review Board measuri ng the heat generated by the

machine to ensure the safety of patients.

7. B etween 2006 and 2010 , 1 , 600 prostates were scanned with

a 3T MRI - s as part of the study . Respondent reviewed the results

of each radiology report associated with these scans and c ompared

them to the clinical data he had for each patient. Respondent

also completed a double - blind study of 200 of these patients who

had prostate biopsies during 2008 and 2009 , as well as the

3T MRI - s , correlated the results of the biopsies and the sca ns,

and became convinced that the 3T MRI - s technology alone is a

positive predictor of prostate cancer 95 percent of the time.

8. According to both parties' experts, as well as

Respondent, t he standard of care in Florida and throughout the

United States i s to use a needle tissue biopsy to identify

prostate cancer. As admitted by Respondent, medical schools

teach that needle biopsy is "the way" to diagnose prostate

cancer. Absent a biopsy showing malignant tissue, it is not

possible for a reasonably prude nt physician to diagnose or treat

prostate cancer. Biopsies are usually performed to diagnose

prostate cancer if a man has a combination of risk factors , such

as family history, an abnormal digital rectal exam , a nd/or

increasing levels of Prostate Specifi c Antigen (PSA) .

9. However, needle biopsies for prostate cancer carry a

fal se negative rate of 20 to 50 percent , which means that a

standard 12 - point needle biopsy (where 12 samples of tissue from

different locations in the prostate are sampled) often mi ss es

cancerous tissue. Prostate needle biopsies are sometimes painful

and carry a risk of complications , including common complications

such as bleeding and i nfection , and the unlikely complications of

septic shock and death.

10. Respondent is convinced that there is a significant

risk from a prostate needle biopsy to spread prostate cancer

cells outside the prostate capsule , which is referred to as

"seeding" or "needle tracking . " Respondent's belief is founded

upon a one - page 2002 article published in t he American Urological

Association , Inc.'s Journal of Urology (Journal) , which refers to

two cases in which a tumor was discovered in the rectal wall

after prostate biopsies and cryoblation. 1/ T he tumors were

suspected of being the result of needle tracki ng from prostate

cancer biopsies. Significantly, this article makes clear that

needle tracking resulting from prostate biopsies are rare and

" exceedingly uncommon. "

11. R espondent's concern , regarding prostate bi opsies

spreading prostate cancer, is also in part founded upon a

o ne - paragraph 1991 Journ al abstract reporting a John s Hopkins

University School of Medicine study of 350 patients in which

ne edle tracking was suspected in seven patients (two percent). 2/

According to Respondent, his belief that pr ostate biopsies spread

prostate cancer is "intuitive , " although he acknowledges this is

not the prevailing view in Florida. Respondent argues that

doctors do not want to believe needle tracking takes place with

prostate biopsies and suggests there is a fi nancial motivation

for doctors to require a positive bi o psy before definitively

diagnosing prostate cancer.

12. Respondent is so convinced of the dangers of needle

biopsies for prostate cancer that he published a book, Men at

Risk : the Dirty Little Secret Î Prostate Biopsie s Really Do

Spread P rostate Cancer Cells , in 2012 , which he provides to all

his patients. In his book, Respondent states:

For me, a 3T MRI scan is the best objective

marker to a diagnosis of prostate cancer .

To summarize, patients must answer one

question. Should I agree to a prostate

biopsy procedure where it has been proven to

spread prostate cancer cells or do I keep my

fingers and toes crossed, hoping for the

best? In two words, . . . "absolutely not."

To me, the decision is easy Î the literature

validates avoiding random biopsies and

supports imaging with a 3 T magnet.

There is no other organ in the human body

where diagnosis is dependent on sticking

needles randomly and blindly into a delicate

organ in an attempt to find cancer . This

practice is archaic, patently barbaric,

unacceptable and preferentially favored by

virtually all urologists.

Beyond the obvious benefit to being able to

see a cancer and its pattern of invasion with

the 3.0 Tesla MRI scan, there is no other

exam o r scan that competes in terms of

diagnostic accuracy or predictability.

The discerning patient will soon recognize

that guessing where cancer is located,

through random biopsies, is for the less

informed. [ 3 ]

13. Respondent refers to the use of 3T MRI - s as the "truth

serum" of prostate cancer diagnosis. During all times material

hereto, Respondent held himself out as a urologist who could

diagnose and treat prostate c ancer without a needle biopsy. In

fact , the four patients at issue in this case found Respond ent

through an I nternet search. Respondent defines his office, the

Diagnostic Center for Disease (DCD) as, "A comprehensive prostate

cancer diagnostic center in Sarasota, Florida specializing in

non - invasive diagnostics (MRI/MRIS) without bio psy as an integral

part of the diagnostic evaluation of prostate cancer. " 4/

14. R espondent also advertised himself as "a world expert

in High Intensity Focused Ultrasound (HIFU), having diagnosed and

treat ed more patients for prostate c a n cer from mor e countries

than any other treating doctor in the world." 5 / HIFU is a

treatment alternative to brachytherapy ( the insertion of

radioactive seeds into the prostate) , radiation, and

prostatectomy (the surgical removal of the prostate gland) for

prostate can cer and uses highly focused ultrasound waves i n a

small area to create intense heat , which destroys prostate cancer

tissue. HIFU was not an approved treatment for prostate cancer

in the United States until October 9, 2015 , at which time the

F ood and Drug Administration (FDA) approved the use of the

Sonablate machine for prostate tissue ablation. Prior to that

time, Respondent referred his patients to treatment facilities in

Mexico and the Caribbean where he performed HIFU treatments.

15. The standar d of care in Florida precludes treating

prostate cancer with HIFU in the absence of a tissue biopsy

confirming the presence of cancer. In order to be eligible for

HIFU treatment, in addition to a positive diagnosis, the

patient's prostate gland must be le ss than 40 grams. HIFU is not

appropriate on patients with multiple calcifications in their

prostate because they interfere with the treatment.

16. Because a smaller prostate gland is easier to work

with, p rior to undergoing HIFU treatment, patients are often

prescribed Bicalutamide (also known by its brand name , Casodex)

and Trelstar. Bicalutamide suppresses the uptake of testosterone

and Trelstar suppresses the production of testosterone, with both

drugs having the effect of shrinking the prostate gland. Side

effects of these drugs include hot flashes, weakness, and a sense

of a loss of well - being.

Facts Related to Patient G.P.

17. Patient G.P. , a 69 year - old retir ee , had a prostate

biopsy performed in December 2005 after a rise in his PSA l evel.

This biopsy was negative for prostate cancer , but Patient G.P.

was diagnosed with an enlarged prostate and benign prostate

hyperplasty (BPH).

18. In M ay 2008, Patient G. P. learned through a physical

exam for a life insurance policy that his PS A level was elevated.

After anoth er check of his PSA level in November 2008, Patient

G.P. was advised to undergo another prostate biopsy. Because his

fi r st prostate biopsy was painful , Patient G.P. searched t he

Internet for alternatives to biopsy and lea rned of Respondent and

his use of the 3T MRI - s at the DCD in Sarasota for diagnosing

prost at e cancer.

19. Patient G.P. traveled to Florida from Michigan to meet

with Respo nd e n t on January 5, 2009 . Patient G.P. underwent a 3T

MRI - s scan at Respondent 's office. Respondent told Patient G.P.

that he was unsure of the results because they were consistent

with BPH and not prostate cancer. However, Respondent advised

Patient G.P. was considered "high risk" because his father died

from prostate cancer in 2 002. Rather than undergoing any

treatment at that time, Patient G.P. was prescribed Avodart for

his BPH and agreed to active surveillance (A.S.) whereby he would

receive regular PSA screening .

20. When Patient G.P.'s December 2009 PSA level went up

after being on Avodart for most of the year, he was concerned and

telephone d Responde n t's office. Respondent prescribed Casodex

based upon his telephone call with Patient G.P. on January 15,

2010.

21. By February 2010, G.P.'s PSA level decreased

sig nificantly , but not as much as he believed it should have

after taking Casodex for several weeks. Patient G.P. also

experienc ed urinary frequency problems and pain. He returned to

R e sp o ndent's office where Responde n t performed a n ultrasound and

digital r ectal exam . R e sponde n t told Patient G.P. it was likely

he had prostate cancer , b ut that he could not be sure wi t h ou t a

biopsy . However , Respondent's medical records reflect that

Respondent diagnosed Patient G.P. as having prostate cancer

without a tissue biopsy . 6/ Respondent offered to do a targeted

biopsy based on an MRI scan. Respondent also discusse d his

concerns regarding needle tracking from biopsies with

Patient G.P.

22. Patient G.P. made it clear he did not want a biopsy ,

and he wanted t o proceed to HIFU . Respondent advised Patient

G.P. of the risk of erectile dysfunction following HIFU , but did

not discuss the possibility of urinary stricture problems.

23 . In April 2010, Patient G.P. traveled to Mexico where

the HIFU procedure was performed by Respondent. In March 2011,

Patient G.P. saw a urologist in Michigan about his diminished

urinary stream and pain. The urologist used a reamer to open

Patient G.P's urethra , but on April 15, 2011, he went to the

emergency room because he was completely unable to urinate.

Patient G.P. was cath eterized and subsequently underwent

electro - vaporization on April 25, 2011, to relieve the urinary

stricture. In August 2011, Patient G . P . also underwent hydro -

dilating in an attempt to relieve the sym ptoms of his urinary

stricture.

24 . In September 2011, Patient G.P. saw board - certified

urologist Dr. Joel Gelman , who specializes in urethral

reconstruction . At that time, Patient G.P. was advised that his

urinary stricture , caused by the HIFU trea tment , was a

significant problem because his urethra was closed off a l m ost to

the bladder neck. Dr. Gelman performed a trans urethral resection

of the prost ate (TURP) .

25. As part of the TURP procedure, Dr. Gelman took samples

of Patient G.P.'s prost ate tissue and no evidence was found of

prostate cancer. Although Patient G.P. had no complaints

regarding his course of treatment from Respondent, Dr. Gelman

filed a complaint against Respondent because he was concerned

that Respondent prescribed medicat ions and performed HIFU on

Patient G.P. for prostate cancer without a tissue biopsy.

Facts Related to Patient J.W .

2 6 . Patient J.W. , a 74 year - old retired dentist, had two

biopsies performed in 2005 and 2007 ordered by his urologist in

Alabama in res ponse to elevated PSA levels. No evidence of

malignancy was found.

27. Patient J.W.'s PSA level was again elevated when tested

in March 2012. He was reluctant to have another biopsy because

the first two were painful. Patient J.W. was told about

R espondent by a friend , and he viewed Respondent's web site.

Patient J.W. was interested in consulting with Respondent because

Respondent advertised he had an MRI machine that could detect

cancer cells , and Respondent believed prostate biopsies spread

cance r.

28. Patient J.W. traveled from Alabama to meet with

Respondent at the DCD on May 14 and 15, 2012. After a sonogram

and MRI, Respondent diagnosed Patient J.W. with prostate cancer.

Respondent discussed a trea tme nt plan which included what

Responde nt called "chemical castration" for a period of six

months , to be followed with a trip to Mexico for HIFU treatment

at the cost of $32,000.00 . Responde n t did not suggest any other

treatment options to Patient J.W. or recommend a tissue biopsy.

29. T he idea of "chemical castration" scared Pat i e nt J.W. ,

who sought a second opinion in June 2012 from another urologist ,

Dr. M. Eric Brewer . Dr. Brewer told J.W. that HIFU was not an

accepted treatment in the United States for prostate can c er .

Patient J.W. declined to go forward with treatment by Respondent.

Dr. Brewer recommended A . S . and , as recommended by Dr. Brewer,

Patient J.W. ha s his PSA level checked every six months. Patient

J.W.'s PSA levels have decreased without any treatment.

30. Dr. Br e wer discussed Patient J.W.'s case with his

partners , the tumor board, the president of the Southeastern

Urological Association , and the president of the American Board

of Urology , who unanimously advised Dr. Brewe r to file a

complaint with Petitioner agai nst Re sponde n t for cancer diagnosis

and recommending treatment in the absence of a pathologic

specimen.

Facts Related to Patient K . S.

31. Patient K.S. is a 62 - year - old video producer and editor

from Tennessee. He has no family history of prostate ca ncer.

Patient K.S. had his PSA level tested in 2005 and 2009 , at which

time it was considered elevated.

32. Patient K.S. was referred to a urologist by his primary

care physician. After again showing elevated PSA levels,

Patient K.S. underwent a p rostate biopsy in 2011 and 2012.

Neither biopsy was positive for prostate cancer. However,

Patient K.S. and his wife were concerned about his rising PSA

level and sought a second opinion.

33. Patient K.S.' wife was concerned that if her husband

had prostate cancer, his local urologist would recommend removal

of the prostate. She researched alternative treatments on th e

Internet and found Responde n t's website.

34. On Octobe r 15, 2012, Patient K.S. and his wif e traveled

to the DCD in Sarasota t o meet with Respondent. Respondent

initially performed an ultrasound on Patient K.S. and then told

Patient K.S. he was "concerned" Patient K.S. had prostate cancer.

He recommended HIFU treatment to Patient K.S.

35. Respondent made it clear to Patie nt K.S. that

Responde n t would not perform a needle biopsy because it push es

cancer further into the prostate . Respondent told Patient K.S.

that the MRI would make it clear whether Patient K.S. had

prostate cancer. Later that same day, Patient K.S . had an MRI

performed at the D C D .

36. Approximately a week later, Patient K.S. r eceived a

telephone call from Re sponde n t with the MRI results who told

Patient K.S. that based on the MRI, he had Gleason 7 prostate

cancer, a fairly aggressive form of prostate cancer that c ould be

treated with HIFU in Mexico the following month. This was

followed up with an e - mail from the DCD to Patient K.S. demanding

a payment of $32,000.00 within three days to schedule the HIFU

procedure in Mexico . Patient K.S.' wife immed iately secured a

bank loan for the $32,000.00

37. Due to the seriousness of the diagnosis and the rush

for payment for HIFU, Patient K.S. visited his primary care

doctor for another opinion. Patient K.S' prima r y care doctor ,

Dr. Jeffrey Jump, told h im that no one can diagnose prostate

cancer as a Gleason 7 without a tissue biopsy. Further, it was a

" red flag " to Dr. Jump that a cash payment of $32,000.00 was

expected in such a short time frame to schedule treatment.

38. After speaking to Dr. Ju mp, Patient K.S. decided not to

have HIFU and instead opted for A . S. Subsequent PSA level tests

for Patient K.S. have shown a decrease in his PSA level . Patient

K.S.' wife filed a complaint with the Petitioner against

Respondent .

Facts Related to Patient V.P.

39. Patient V.P. is a 63 - year - old construction worker and

guide from Alaska. He has no family history of prostate cancer.

40. In August 2013, at age 60, Patient V.P. had his first

physical examination. As part of the exam, he took a PSA test ,

which showed an elevated PSA level of 6.3. As a result,

Patient V.P. was referred to a urologist who recommended a

biopsy .

41. Patient V.P. heard from friends that prostate biopsies

are painful , so he looked on the I nternet for alternatives .

Patient V.P. found Respondent's website , which claimed Respondent

could diagnose prostate cancer without a biopsy by using new MRI

technology.

42. Patient V.P. traveled to Sarasota to meet Respondent on

September 11, 2013. Respondent performed a d igital rectal exam

and told Patient V.P. that his prostate was much enlarged.

43. Respondent next performed a prostate ultrasound on

Patient V.P. Immediately after the ultrasound, Responde n t told

Patient V.P., "I'm telling you right now you have pro state

cancer." Respondent provided Patient V.P. with a prescription

for Bicalutamide and T relstar , which Respondent said would wipe

out Patient V.P.'s testosterone and slow the growth of the

cancer.

44. Respondent told P atient V.P. that prostate bio psies are

dangerous and metas t asize cancer c ells. Respondent said that

even though he knew Patient V.P. had cancer, he wanted an MRI to

see the amount of cancer. Respondent also offered Patient V.P.

the opportunity to participate in a private placement o ffering

for a HIFU company he was forming for a minimum investment of

$50,000.00.

45. The following day, Patient V.P. had an MRI and then met

with Respondent to review the results. Respondent showed Patient

V.P. his MRI images and pointed to areas o f concern. Respondent

told Patient V.P. he had extensive prostate cancer and that

Patient V.P. did not have much time to decide whether to have

HIFU because the cancer was about to metastasize.

46. Re sponde n t told Patient V.P. to take the B icalutami de

for ten days and then return for an injection of Trelstar to

atrophy his prostate and make him ready for HIFU in 90 days.

47. At Respondent's direction, Patient V.P. began the

Bical utamide and then returned to the DCD on September 20 , 2013,

for a three - month injection of Trelstar. During this visit,

Patient V.P. questioned the cost if the HIFU was not successful

in getting all the cancer and he needed further treatment.

Respondent told Patient V.P. that he "doesn't miss , " but an

additional treatm ent of HIFU would cost another $10,000.00 to

$12,000.00, in addition to the $32,000.00 for the initial

treatment.

48. C oncerned about these costs, Patient V.P. asked about

going to Loma Linda , California , for proton therapy as an

alternative. Respon dent told Patient V.P. that proton therapy

would cause bladder cancer and any alternative to HIFU would

require a needle biopsy first. Respondent actively discouraged

Patient V.P . from any non - HIFU treatment for prostate cancer.

49. As soon as Patie nt V.P. questioned Respondent about

alternatives to HIFU, he was suddenly fast - tracked for HIFU

scheduled October 24 through 26, 2013. He was told he needed to

make a $10,000.00 deposit to hold the date and the total cost was

$32,000.00.

50. Despite his concerns regarding the expedited scheduling

of his procedure and the cost of the HIFU treatment, Patient V.P.

returned to the office with a check for $10,000.00 to cover the

cost of the deposit to hold the October treatment d ate. While

w aiting to han d the check to Respondent's receptionist,

Patient V.P. overheard Respondent on a speakerphone arguing with

a radiologist concerning an MRI report. Respondent was insisting

the radiologist include the word "cancer" on MRI report s and the

radiologist insis ted it was not possible for him to make such a

diagnosis. After hearing this conversation, Patient V.P.

immediately left Respondent's office with his check.

51. Patient V.P. subsequently discussed his experience with

a trusted friend who practiced a s a nurse in a cancer clinic.

She , too , expressed concerns about diagnosing and treating

prostate cancer without a biopsy. Patient V.P. was referred by

this friend to Dr. Vipul Patel, a physician specializing in

urologic cancer in Orlando.

52. Pati ent V.P. met with Dr. Patel on October 18, 2013.

Dr. Patel advised Patient V.P. that it was not possible to

diagnose prostate cancer without a biopsy. Dr. Patel also

disputed that prostate biopsies can spread prostate cancer.

53. Dr. Patel perfor med a digital rectal exam and found

Patient V.P.'s prostate to be slightly enlarged ( which is not

abnormal for a man of Patient V.P.'s age ) , normal , and smooth.

Dr. Patel told Patient V.P. that he doubted he had prostate

cancer. Patient V.P. then underw ent a prostate biopsy by

Dr. Patel , which was negative for prostate cancer. This was

surprising to Patient V.P. because Respondent led him to believe,

based on the MRI, that his prostate was full of cancer.

54. Patient V.P. experienced significant side effects as a

result of taking the medications ordered by Respondent. The

Bicalutamide caused Patient V.P. to experience overwhelming

depression, shakes, hot flashes, tunnel vision , and headaches.

The Trelstar cause d erectile dy sfunction, increased f requency o f

hot flashes, night sweats , and made Patient V.P. so weak he was

unable to work for eight months.

Standard of Care

55. As discussed above, t he experts who provided

deposition s o r live testimony in this case were unanimous in

their conclusi ons that the standard of care in Florida from 2008

through 2013 precluded diagnosis or treatment of prostate cancer

in the absence of a tissue biopsy. A reasonably prudent

physician would not tell a patient he had prostate cancer based

upon an ultrasound and/ or MRI. A reasonably prudent physician

would not prescribe medication, suggest treatment, or participate

in treating a patient for prostate cancer , based upon an

ultrasound or MRI.

56. Respondent claims that in each of these cases, he

advised th e patient that a needle biopsy was the definitive test

for prostate cancer , but it was a method he did not favor due to

the pos sibility of needle tracking. Respondent's testimony in

this regard is not credible in light of the credible testimony of

the thr ee patients that Respondent made clear he would not

perform a needle biopsy and actively discouraged them from

anything other than diagnosis by MRI and subsequent HIFU

treatment. Respondent's suggestion, that he offered needle

biopsy as an option, is whol ly inconsistent with the title,

theme , and contents of his own book , an d the manner in which he

defined his method of diagnosing prostate cancer at the DCD in

his book and on his website .

57 . It is self - evident that a patient ' s perceptions

regarding the safety and efficacy of needle biopsies for prostate

cancer detection are at least , in part , influenced by the

discussion with the physician. Respondent's active efforts to

dissuade these patients from having the one definitive test for

prostate cancer , by dramatically over - inflating the

infinitesimally small possibility of needle tracking, were wholly

inconsistent with the standard of care.

58 . Respondent claims that these four patients insiste d

they did not want a needle biopsy, theref or e , it wa s appropriate

to diagnos e them on the basis of " a preponderance of the evidence

a nd concordance of data " and move forward with a treatment plan ,

including medications and HIFU.

59 . The standard of care in Florida during 2008 through

2013 , for a situa tion in which a patient suspected of having

prostate cancer refused a needle biopsy , was to prescribe a

course of A . S . , including regular and frequent PSA testing, and

to offer no other treatment. 7/

Ultimate Factual Determinations

60. Petitioner esta blished by clear and convincing evidence

that Respondent commit t ed medical malpractice in his treatment of

Patients G.P., J.W., K.S., and V.P. by the following violations

of the standard of care:

a. f ailing to obtain and review prostate

biopsy results bef ore confirming the patient

had, or diagnosing the patient with , prostate

cancer ( Patients G.P., J.W., K.S., and V.P. );

b. p rescribing Bicalutamide/Casodex to a

patient without first confirming through a

prostate tissue biopsy that the patient has

prostat e cancer ( Pat i e nts G.P. and V.P);

c. p rescri b ing, injecting, or authorizing

the in j ection of Trelstar to a patient

without first confirming through biops y

results that the patient has pr ostate cancer

(Patient V.P);

d. r ecommending and/or attempting to

facilitate HIFU treatment without first

confirming through biops y results that the

patient has prostate cancer (Patients G.P.,

J.W., K.S., and V.P.); and

e. p articipating in, and/or assi s ting with

the performance of HIFU treatment for a

patient without f irst confirming through

biopsy results that the patient has prostate

cancer (Patient G.P.).

Accordingly, Respondent is guilty of the offense d efined in

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

CONCLUSIONS OF LAW

61 . DOAH has personal and subject matter j urisdiction in

this proceeding pursuant to sections 120.569 and 120.57(1),

Florida Statutes .

62. A proceeding to suspend, revoke, or impose other

discipline upon a license is penal in nature. State ex rel.

Vining v. Fla. Real Estate Comm'n , 281 So. 2d 487, 491 (Fla.

1973). Petitioner must theref ore prove the charges against

Respondent by clear and convincing evidence. Fox v. Dep't of

Health , 994 So. 2d 416, 418 (Fla. 1st DCA 2008)(citing Dep't of

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

1996)).

63. The clear and convincing standard of proof has been

described by the Florida Supreme Court:

Clear and convincing evidence requires that

the evidence must be found to be credible;

the facts to which the witnesses testify must

be distinctl y 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 fact a firm belief or conviction,

without he sitancy, as to the truth of the

allegations sought to be established.

In re Davey , 645 So. 2d 398, 404 (Fla. 1994)(quoting Slomowitz v.

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

64. Disciplinary statutes and rules "must always be

construed s trictly in favor of the one against whom the penalty

would be imposed and are never to be extended by construction."

Griffis v. Fish & Wildlife Conserv. Comm'n , 57 So. 3d 929, 931

(Fla. 1st DCA 2011); Munch v. Dep't of Prof'l Reg., Div. of Real

Estate, 592 So. 2d 1136 (Fla. 1st DCA 1992).

65. The grounds proving Petitioner's assertion that

Respondent's license should be disciplined must be those

spe cifically alleged in the Amended Administrative Complaint.

See e.g. , Trevisani v. Dep't of Health , 908 So. 2d 1108 (Fla. 1st

DCA 2005); Kinney v. Dep't of State , 501 So. 2d 129 (Fla. 5th DCA

1987); and Hunter v. Dep't of Prof'l Reg. , 458 So. 2d 842 (Fla.

2d DCA 1984).

Medical Malpractice

66. Section 458.331(1)(t) provides that it is a violation

for a medical doctor to commit medical malpractice, as defined in

section 456.50. Section 456.50(1)(g) defines "medical

malpractice" as the failure to practice medicine in accordance

with the level of care, skill, and treatment recognized in

general law related to health care licensure.

67. Petitioner proved by clear and convincing evidence that

Respondent violated section 458.331(1)(t) by falling below the

standard of care for doctors in the state of Florida and by

failing to obtain a tissue biopsy positi ve for prostate cancer

before : diagnosing prostate cancer; recommending treatment for

prostate cancer; commencing treatment to shrink prostates with

medications; recommending HIFU ; and performing HIFU.

68. Respondent does not dispute that the existin g standard

of care is a tissue biopsy for the diagnosis and treatment of

prostate cancer. 8/ However, Respondent asserts that he is on the

cutting edge of medicine by diagnosi ng prostate can cer using

3T MRI - s and treating prostate cancer with HIFU , and it is time

that the standard of care be modified in accordance with his

practice .

69. In support of this contention, Respondent points to

several recent articles which support the efficacy of this

diagnosis and treatment protocol . 9 / Respondent also cites to

section 456.41 which permits physicians to offer complementary

and alternative health care treatments to patients .

70. Significantly, the articles relied upon by Respondent

were published after the diagnosis and treatment of the patients

at issue in this action. Further, these articles do not advocate

for the use of MRI technology to diagnos e prostate cancer.

Rather, they suggest MRI has a developing role in guided prostate

biopsy procedures for diagnosis and treatment of prostate cancer

a nd emphasize that further study is needed. 10 /

71. While section 456.41 a uthorizes a health care

practitioner to "recommend any mode of treatment that is, in his

or her judgment, in the best interests of the patient, including

complimentary or alterna tive health care treatments, in

accordance with the p rovisions of his or her license, " the

practitioner must inform the patient of the benefits and risks

associated with the treatment for the patient to make an informed

and prudent decision rega rding the t reatment option.

§ 456.41(3)(c) , Fla. Stat . This section does not " alter, in any

way the provis i ons of the individual practice acts for those

licensees, which require licensees to practice within their

respective standards of care. " § 456.41(5), Fla. S tat.

72. Respondent gross ly exaggerated the risks of prostate

biopsy while shamelessly promoting MRI technology as the premier

diagnostic tool for prostate cancer. Respondent lured patients

from around the country to Florida with the false promise o f a

pain - free , accurate diagnostic procedure , and promoted an

unapproved, expensive treatment outside the United States.

73. Respondent built his entire business model and

advertised his services of prostate cancer diagnosis and

treatment without a n eedle biopsy knowing this violated the

standard of care. At a minimum, the conversation between the

radiologi st and Respondent overheard by P atient V.P. demonstrates

that Respondent knew or should have known that prostate cancer

diagnosis is not possible w ith a 3T MRI - s. Respondent is well

aware that no other licensed physician in the United States is

purporting to diagnose and treat prostate cancer without a tissue

biopsy, other than in exceptional circumstances, which did not

exist for these four patien ts.

74 . Whether Respondent was motivated by his sincere, but

misguided , belief that prostate biopsies spread cancer, or by

greed, is irrelevant to the determination of a violation .

Respondent violated the standard of care by telling patients they

ha d prostate cancer without a confirmatory prostate tissue

biopsy. Respondent not only failed to disclose to these patients

that 3T MRI - s technology cannot defini tively diagnose prostate

cancer but actively discouraged these patients from obtaining

biopsies that we now know would likely show no cancer.

Recommending a course of "chemical castration" and HIFU in the

absence of a positive tissue biopsy violates the standard of

care, constitutes malpractice , and is nothing less than barbaric .

Penalty Assessment

75 . Respondent has no prior discipline against his medical

license.

76 . Petitioner imposes penalties upon licensees consistent

with disciplinary guidelines prescribed by rule. See Parrot

Heads, Inc. v. Dep't of Bus. & Prof'l Reg. , 741 So. 2d 1231,

1233 - 34 (Fla. 5th DCA 1999).

77 . Penalties in a licensure discipline case may not exceed

those in effect at the time the violations were committed.

Willner v. Dep't of Prof'l Reg., Bd. of Med. , 563 So. 2d 805, 806

(Fla. 1st DCA 1990), rev. deni ed , 576 So. 2d 295 (Fla. 1991).

Id.

78 . At the time of the incidents, Florida Administrative

Code Rule 64B8 - 8.001(2)(t) provided that for a first - time

offender committing medical malpractice, as described in section

458.331(1)(t), the prescribed pen alty range was from one year

probation to revocation or denial and an administrative fine from

$1,000.00 to $10,000.00. The recommended penalty for a second

violation of section 458.331(1)(t) ranged from two years of

probation to revocation and an adminis trative fine from $5,000.00

to $10,000.00.

79 . Rule 64B8 - 8.001(3) provided that, in applying the

penalty guidelines, the following aggravating and mitigating

circumstances should also be taken into account:

(3) Aggravating and Mitigating

Circumstan ces. Based upon consideration of

aggravating and mitigating factors present in

an individual case, the Board may deviate

from the penalties recommended above. The

Board shall consider as aggravating or

mitigating factors the following:

(a) Exposure of patient or public to injury

or potential injury, physical or otherwise:

none, slight, severe, or death;

(b) Legal status at the time of the offense:

no restraints, or legal constraints;

(c) The number of counts or separate

offenses established;

(d ) The number of times the same offense or

offenses have previously been committed by

the licensee or applicant;

(e) The disciplinary history of the

applicant or licensee in any jurisdiction and

the length of practice;

(f) Pecuniary benefit or self - g ain inuring

to the applicant or licensee;

(g) The involvement in any violation of

Section 458.331, F.S., of the provision of

controlled substances for trade, barter or

sale, by a licensee. In such cases, the

Board will deviate from the penalties

recomm ended above and impose suspension or

revocation of licensure.

(h) Where a licensee has been charged with

violating the standard of care pursuant to

Section 458.331(1)(t), F.S., but the

licensee, who is also the records owner

pursuant to Section 456.057( 1), F.S., fails

to keep and/or produce the medical records.

(i) Any other relevant mitigating factors.

80 . A significant aggravating factor is that Respondent's

actions exposed the public , and Pa tients J.W. and K.S. , to

potential severe physical injury , and treated Patients G.P. and

V.P. resulting in severe injury . Aggravating factor (c) applies

because Petitioner established four separate offenses commi tted

by Respondent.

81. T his is mitigated by Respondent's prior discipline - free

history.

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 that Respondent violated section 458.331(1)(t),

Florida Statutes, as charged in Amended Administrativ e

Complaint s ; imposing a fine of $ 30,000.00 ; revoking Respondent's

medical license ; and imposing costs of the investigation and

prosecution of this case.

DONE AND ENTERED this 2 4th day of February , 2017 , in

Tallahassee, Leon County, Florida.

S

MARY LI CREASY

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 C lerk of the

Division of Administrative Hearings

this 24th day of February , 2017 .

ENDNOTE S

1/ Responde n t's Exhibit 18, Theresa M. Koppie, Brian P. Grady,

and Katsuto Shinohara, Rectal Wall Recurrence of Prostate

Adenocarcinoma , 168 J. of Urology 2120 (N ov. 2002).

2/ Respondent's Exhibit 19, S.S. Bastacky, P.C. Walsh, and

J.I. Epstein , Needle Biopsy Associated Tumor Tracking of

Adenocarcinoma of the Prostate , 145 J. of Urology 1003 ( May

1991).

3/ Ronald E. Wheeler, Men at Risk: the Dirty Little Secre t Î

Prostate Bio psies Really Do Spread P rostate Cancer Cells ,

pp. 50, 128, 145, 148, 149 (2012).

4/ Id. at 269.

5/ Id. at back cover.

6/ Joint Exhibit 1, page 51, "HIFU Î Procedure Report f o r

Prostate Cancer."

7/ Respondent's expert, Sarat Sabharw al, M.D., suggested that if

a patient has a particularly unique medical basis for refusing a

needle biopsy, it might be appropriate to trea t for suspected

prostate cancer. H owever, Dr. Sabharwal admitted that based upon

his review of the medical records o f each of these patients, none

of them had such a condition that would warrant treatment in the

absence of a confirmatory tissue biopsy . Further, Dr. Sabharwal

confirmed that "in the time period between 2008 and 2013, any

patient that he [Respondent] atte mpted to treat for prostate

cancer without a confirmatory biopsy would have resulted in a

deviation from the standard of care." Petitioner's Exhibit 10,

54/25 - 55/9.

8/ See Transcript of the final hearing, Vol. 2, 233/12 - 15 ;

241/6 - 22 ; 248/9 - 249/8 .

9 / Respondent's Ex. 8, Thomas P, Frye, Amichai Kilchevsky, Arvin

K. George, and Peter Pinto, Multiparametric Magnetic Resonance

Imaging for Prostate Cancer , 35 AUA Update Series Lesson 14,

pp. 137 - 152 ( 2016); Respondent's Ex. 9, Baris Turkbey, Anna M.

Brown , Sandeep Sankineni, Bradford J. Wood, Peter Pinto, and

Peter Choyke, Mul t iparametric Prostate Magnetic Resonance Imaging

in the Evaluation of Prostate Cancer , 66 CA: A Cancer Journal for

Clinicians Issue 4, pp, 326 - 336 (July/Au g. 2016); Respondent's

Ex. 1 0, Robert K. Nam, Christopher J.D. Wallis, Jessica Stojcic -

Bendavid, Laurent Millot, Christopher Sherman, Linda Sugar, and

Ma so om A. Haider , A Pilot Study to Evaluate the Role of Magnetic

Resonance Imaging for Prostate Cancer Screening in the General

Popul ation , 196 J. of Urology Issue 2, pp. 361 - 366 (Aug. 2016).

10 / Frye et al., supra note 9 , at 147 ( " The potential future use

of mpMRI is as a screening test in conjunction with PSA or novel

biomarkers to provide a filter to identify patients who may

benef it most from undergoing prostate biopsy. Of course,

determining the appropriate screening population will require

careful investigation until widespread adoption of this approach

can be implemented . ") ; Turkeby et al., supra note 9 , at 336

( " There are seve ral challenges facing prostate mpMRI. First, the

existing clinical data, although very compelling, cannot be

categorized as "Level 1" evidence, as it is largely derived from

single - institution studies. Larger, multi - ins t itutional studies

are needed befor e mpMRI becomes the standard of care. " ) ; Nam et

al., supra note 9 , at 364 (" This preliminary study suggests that

it may be reasonable to consider prostate MRI for prostate cancer

screening, although larger studies are required before

implementation . . . In this pilot study, we found that prostate

cancer screening using multiparametric prostate MRI is feasible

for use in the general population. We propose that prostate MRI

should be further evaluated in a prostate screening study . ").

COPIES FURNISHED:

Christopher J. Schulte, Esquire

Weekley Schulte Valdes, LLC

Suite 100

1635 North Tampa Street

Tampa, Florida 33602

(eServed)

Jack F. Wise, Esquire

Department of Health

Bin C - 65

4052 Bald Cypress Way

Tallahassee, Florida 32399

(eServed)

Nichole C. Gear y, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

(eServed)

Claudia Kemp, JD, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way, Bin C03

Tallahassee, Florida 32399 - 3253

( eServed)

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 issue the F inal Order in this case.