12-000079PL Department Of Health, Board Of Medicine vs. Herbert R. Slavin, M.D. Status: Closed Recommended Order on Monday, January 7, 2013.

Summary: Petitioner failed to adduce clear and convincing evidence that Respondent's treatment of patient with desiccated thyroid medication constituted a departure from the standard of care. Recommend dismissal of Amended Administrative Complaint.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE , )

)

Petitioner, )

)

vs. ) Case No. 12 - 79 PL

)

HERBERT R. SLAVIN , M.D., )

)

Respondent. )

________________________________ )

RECOMMENDED ORDER

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

before Edward T. Bauer, an Administrative Law Judge of the

Division of Admini str ative Hearings, on June 22 and

September 14 , 2012 , by video teleconference a t sites in

Tall ahassee and Lauderdale Lakes , Florida.

APPEARANCES

For Pet itioner: Sharmin Hibbert , Esquire

Laura L. Glenn , Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

For Respondent: Andrea Wolfson, Esquire

Wolfson & Konigsburg, P.A.

4491 South State Road 7, Suite 314

Davie, Florida 33314

STATEMENT OF THE ISSUE S

The issues in this case are whether Respondent committ ed

the allegatio ns contained in the Amended Administrative

Complaint , and if so, the penalty that should be imposed.

PRELIMINARY STATEMENT

On October 31 , 2011, Petitioner, Department of Hea lth,

Board of Medicine, filed a two - count Administrative Complaint

( " Complaint " ) a gai nst Respondent, Dr. Herbert Slavin . In Count

I of the Complaint, Peti tioner alleged that Respondent violated

section 458.331(1)(t), Florida Statutes, in that his treatment

of patient L.V. fell below the appropriate standard of care in

one or more of th e following ways: (a) by incorrectly diagnosing

L.V. wit h hypothyroidism; (b) by prescribing a medication

(desiccated thyroid) that was not med ically indicated; (c) by

prescribing an in appropriate dosage of the medication (assuming

that desiccated thyroid was, in fact, medically indicated) ; (d)

by failing to manage the care his physician assistant provided

to L.V.; ( e) by failing to adequately supervise the activities

of his physician ' s assistant, as related to the t reatment of

L.V.; and (f) by failing to c orrectly interpret and/or respond

to L.V. ' s laboratory data. As an overlapping allegation,

Petition er further charged, in Count II of the Complaint, that

Respondent failed to adequately supervise the activities of his

physician assistant " as [they] relate d to the medical care and

treatment provided to . . . L.V., " contrary to section

458.331(1)(dd).

Respondent timely requested a formal hearing to contest the

allegations, a nd, on January 6 , 201 2 , the matter was referred to

the Division of A dministrative Hearings ( " DOAH " ) and assigned to

Administrative Law Judge John G . Van Laningham.

O n June 14, 2012, Petitioner moved to amend its Complaint

in order to clarify several of the underlying factual

assertions . (T he Amended Administrative Complaint , which wa s

attached to Petitioner ' s motion, did not include any additional

charges or theories of guilt.) Judge Van Laningham condu cted a

telephonic hearing on the motion on June 15 , 2012, during which

Petitioner represented that i t no longer intended to pursue an y

allegation that Respondent had failed to supervise his physician

assistant ÏÏ remarks that Judge Van Laningham and Respondent ' s

counsel reasonably interpret ed as an abandonment of Count II, as

well as theories (d) and (e) of Count I. An order granting

Pe titioner ' s motion was issued the same day, and, on June 21,

2012, Judge Van Laningham transferred the instant matter to the

undersigned for further proceedings.

As noted above, the final hearing in t his matter was held

on June 22, 2012 , during which th e undersigned ruled that

Petitioner would not be permitted to pursue Count II or theories

(d) or (e) of Count I. In support of the remaining allegations,

Petitioner presented the testimony of three witnesse s ( L.V.,

Dr. Elton Shapiro, and Dr. Vanessa Rodr iguez ) and introduced 1 7

exhibits, labeled 1 - 7 and 9 - 18 . 1 / Respondent tes tified on his

own behalf, presented the testimony of Shirley Jimen ez, and

introduced two exhibits, numbered 1 - 2 , which included the

deposition transcript of Respondent ' s expert witne ss, Dr. Edwin

Lee. A t the conclusion of the hearing, the undersigned granted

the request of Respondent ' s counsel for a deadline of 20 days

from the filing of the fi nal hearing transcript for the

submission of proposed recommended orders.

The final hea ring Transcript was f iled with DOAH on

October 24 , 2012 . Thereafter, the undersigned granted the

parties ' joint request to extend the proposed recommended order

deadline to December 20, 2012. Both parties submitted proposed

recommended orders, which the undersigned has considered in the

preparation of this Recommended Order.

FINDINGS OF FACT

A. The Parties

1 . Petitioner Department of Health has regulatory

jurisdiction over licen sed physicians such as Respondent . In

particular, Petitioner is aut horized to file and prosecute an

administrative complaint, as it has done in this instance, when

a panel of the Board of Medicine has found probable cause exists

to suspect that the physician has committed one or more

disciplinable offenses.

2. At a ll times relevant to this proceeding, Respondent

was a physician licensed in the State of Florida , having been

issued license number ME 36889 , and hi s medical office was

located at 7200 West Commercial Boulevard, Suite 210, Fort

Lauderdale, Florida.

3. As mentioned previously , Petitioner alleges in this

cause that Respondent ' s treatment of patient L.V. fell below the

minimum standard of care in that: thyroid medication was

prescribed in the absence of medical necessity; or, even

assuming that some amou nt of thyroid medication was indicated,

L.V. was prescribed excessive doses of the drug. To facilitate

the reader ' s understanding of these issues, the factual

recitation will be preceded by a brief description of the

thyroid glan d and anterior pituitary , as well as the hormones

secreted b y these glands.

B. Relevant Glands and Hormones

4 . T he thyroid gland (or simply, " the thyroid " ) is one of

the human bo dy ' s primary endocrine glands. The thyroid secretes

several thyroid hormones ÏÏ Triiodoth y ronine ( " T3 " ) , the active

form of thyroid hormone; and Thyroxine ( " T4 " ), which is

inactive ÏÏ that control and regulate the body ' s metabolism ,

development, growth, and temperature.

5. The production of T3 and T4 is regulated by thyroid -

stimulating hormone ( " T SH " ), which is produced by the anterior

pituitary gland . Generally speaking, when thyroid hormone

levels are low, the production of TSH increases; conversely, TSH

production decreases when thyroid hormones concentrations are

high. Accordingly, a high TSH level is suggestive of an

underactive thyroid or hypothyroidi sm, while a depressed level

of TSH indicates an overactive thyroid or hyperthyroidism.

C . Treatment of L.V.

6 . On October 7, 2008, patient L.V., a 57 - year - old female,

p resented to Respondent ' s medical office to address, in the

patient ' s words, " hormonal problems . "

7 . As it was her first visit to Respondent ' s office, L.V.

was asked to complete a new patient intake form that solicited ,

among other information, her curr ent symptoms and previous

medical conditions. In the form, L.V. disclosed a variety of

complaints: dizziness, fati gue, insomnia, forgetfulness, a

rapid heartbeat, 2 / and post - menopausal symptoms.

8 . After completing the paperwork referenced above, L.V.

was seen by Shirley Jimenez, Respondent ' s physician assistant,

who conducted a physical examination 3 / a nd gathered a complete

history. During her visit with Ms. Jimenez , L.V. revealed, as

an additional complaint, that she occasionally experienced

intolera nce to cold.

9 . At the conclusion of the October 7, 2008, appointment,

Ms. Jimenez recommen ded , with Respondent ' s approval, that blood

work be conducted ÏÏ to determine, among other things , the levels

of T3, T4, and TSH ÏÏ and that L.V. return for a fol low - up

appointment in several weeks.

10 . O n or about October 21, 2008, the results of L.V. ' s

blood work were forwarded to Respondent for his review. With

respect to L.V. ' s levels of T3, T4, and TSH, the labora tory

report indicated the following values and reference ranges

(i.e., the levels deemed " normal " by the laboratory) :

Hormone Result Reference Range s

T3, Free: 264 pg/dL 230 - 420 pg/dL

T4, Free: 1.1 ng/dL 0 .8 - 1.8 ng/dL

TSH: 2.94 mIU/L 0.40 - 4.50 mIU/L

11. L.V. ' s next office a ppointment was on October 23,

2008, during which she met Respondent for the first time. On

that date, Respon dent determined, based upon a review of L.V. ' s

complaints and symptoms ( fatigue, dizziness, cold intolera nce,

forgetfulness, and low basa l body tem perature) and an

examination of the labora tory results ÏÏ as enumerated above, a T3

leve l at the low end of the reference range and a TSH value

greater than 2.50 mIU/L, considered by Respondent to be high in

light of L.V. ' s symptoms ÏÏ that the patient suffere d from thyroid

dysfunction. Notably, and contrary to Petitioner ' s allegations,

Respondent did not diagnose L.V. with hypothyroidism. 4 /

12. Believing that L.V. ' s symptoms could be allev iated by

increasing her T3 level into the upper half of the typic al r ange

(i.e., 350 pg/dL) , Respondent prescribed a low dosage of

desiccated thy roid ÏÏ a medication prepared from pig thyroids,

which contains both T3 and T4 ÏÏ in the amount of .25 grain, which

L.V. was instructed to take twice daily. 5 / By all accounts, L.V.

be gan taking the desiccated thyroid medicati on on or about

October 23, 2008, and cont inued to do so until April 19, 2009.

13. L.V. app eared for her third appointment on

November 12, 2008 , during which the patient made no indication

of adverse side eff ects from the desiccated thyroid. At the

conclusion of the office visit, Respondent refilled L.V. ' s

prescription at the same dosage.

14. One month later, on December 12, 2008, a second blood

sample was collected from L.V. The results, which were repo rted

to Respondent on Decembe r 22, 2008, 6 / indicated little to no

change in L.V. ' s levels of T3, T4, and TSH :

Hormone Result Reference Ranges

T3, Free: 255 pg/dL 230 - 420 pg/dL

T4, Free: 1.0 ng/dL 0.8 - 1.8 ng/dL

TSH: 3.00 mIU/L 0.40 - 4.50 mIU/L

15. During her next office appointment , which occurred on

December 29, 2008, L.V. once again reported no adverse side

effects from the medica tion. L.V. did, however, state that she

continued to suffer from vertigo, fatigue, and forgetfulness .

In li ght of these persistent symptoms , as well as the laboratory

results that revealed no meaningful change in the levels of T3,

T4, and TSH (indeed, the T3 value had decreased slightly),

Respondent increased the dosage of desiccated thyroid to .5

grain twice daily .

16. L.V. appeared for her fifth office visit on

January 13, 2009, at which time she reported, once again, that

she continued to experience vertigo and fatigue. Respondent

concluded, reasonably, that L.V. should be continued on

desicc ated thyroid at the current dosage due to the relatively

short a mount of time that had elapsed (15 days) since the

medication ' s increase to .5 grain twice daily ; in other words,

Respondent believed that the additi onal time was needed for the

higher dosage to produce results.

17. O n February 10, 2009, L.V. provided a third blood

sample, the results of which were reported to Respondent 14 days

l ater. In contrast to the previous sample, which demonstrated

little or no change in L.V. ' s hormone levels , the February 10

laboratory report showed th at the medication was beginning to

achieve the desired effect ÏÏ i.e., increases in the T3 and T4

hormones, as well as a corresponding decrease in TSH:

Hormone Result Previous Result Reference Ranges

T3, Fre e: 293 pg/dL 255 pg/dL 230 - 420 pg/dL

T4, Free: 1.1 ng/dL 1.0 ng/dL 0.8 - 1.8 ng/dL

TSH: 1.78 mIU/L 3.00 mIU/L 0.40 - 4.50 mIU/L

18. L .V. ' s final office appointment, at least as an active

patient of Respondent ' s, was on February 24, 2009. During the

visit, L.V. reported some improvement with her ver tigo and

fatigue , and, a s was the case during each of the prior

appointments, L.V. neither disclosed, nor did Respondent or his

staff detect, any adverse side effects from the thyroid

medication. In light of L.V. ' s continued symptoms ; her T3

level , which was still significantly below Respondent ' s target

of 350 pg/dL; and demonstrated ability to tolerate the

medication, Respondent determined that an increase of the

desiccated thyroi d to .5 grain three times daily would prove

helpful.

D. L.V. ' s Hospitalization

19. Nearly two months later, o n April 19, 2009, L.V.

presented to the emergency room at Coral Springs Medical Center

( " Coral Springs " ) and reported that she was experiencing " chest

pains " ; she also informed the medical staff that she had been

suffering , for approximately three weeks, from persistent

diarr hea ÏÏ a condition that L.V. had experienced on mult iple

occasions over the years, long before she began taking the

desiccated thyroid medication prescribed by Respondent. Based

upon the nature of the complaints, L.V. was promptly admitted to

the hospital for evaluation and treatment.

20 . L.V. remained hospitalized at Coral Springs for the

next several days, during which time no evidence of a cardiac

event was discovered. Indeed, the treatin g cardiologist summed

up L.V. ' s symptoms as follows: " Non - cardiac chest pain. The

less said about this the better. No further investigation

needed. "

21 . With respect to L.V. ' s diarrhea, the treating

endocrinologist, Dr. Vanessa Rodriguez, attributed the symptom

to iatrogenic hyperthyroidism ( i.e., physician - induced

overactive thyroid ) . Dr. Rodriguez reached this conclusion

based upon L.V. ' s low TSH level ( .02 and .03 mIU/L on April 19

and 21, respectively), notwi thstanding L.V. ' s normal thyroid

values 7 / and the absence of symptoms frequently associated with

hyperthyroidism, such as rapid heartbe at, 8 / trem ors, and

hyperreflexia. Based upon her diagnosis ÏÏ which, as di scussed

lat er in this Recommended Order , is rebutted by the credible

testimony of Respondent ' s expert ÏÏ Dr. Rodriguez instructed L.V.

to disconti nue the desiccated thyroid medication.

E. Expert Testimony

22 . During the final hearing in this cause, Petitioner

pre sented the testimony of Dr. Elton Shapiro, a board - certified

endocrinologi st, in support of its contention that Respondent ' s

treatment of L.V. departed from the standard of care.

23 . During his direct examination, Dr. Shapiro opined,

first, that Respon dent violated the standard of care by

initiating treatment with desiccated thyroi d medication where

the patient ' s TSH did not fall outside the testing laboratory ' s

reference range . In Dr. Shapiro ' s vie w, once it is determined

that a patient ' s TS H level is within the upper limit of the

reference range established by the laboratory (typically 4.5

mIU/L) , 9 / it is improper for a physician to begin thyroid

supplement ation ÏÏ irrespective of the patient ' s symptoms , 10 /

thyroid hormone levels (i.e., T3 and T4), or th e proximity of

the TSH value to the upper end of the range. Thus, per

Dr. Shapiro ' s conception of the standard of care, a physician

would commit misconduct by prescribing , ab initio, thyroi d

medication to a patient with a TSH of 4.4 mIU/L ( a value b arely

within the upper limit ), even if the levels of T3 and T4 are low

and the patient exhib its symptoms consistent with thyroid

dysfunction.

24 . Dr. Shapiro further opined that once thyroid

medication is prescribed ÏÏ which, per the witness, may only oc cur

if the TSH is greater than 4.5 mIU/L ÏÏ a physician should

endeavor to decrease the patient ' s TSH to a range of .3 - 3.0

mIU/L, with an optimum level of 2.0 mIU/L . Thus, Dr. Shapiro

accepts as " normal, " for initial diagnostic purposes, a TSH

level that do es not exceed the upper reference range of 4.5

mIU/L ; upon the initiation of therapy , however, a TSH level

previously regarded during the diagnostic phase as acceptable

(e.g., 4.0 mIU/L) is less than ideal a nd worthy of downward

movement . In other words, what is considered " normal " or

optimal depends, in Dr. Shapiro ' s view , on whether the patient

has already been placed on thyroid medication or has yet to

begin such therapy. 11 /

25. With respect to Respondent ' s treatment of L.V. during

the period of Nov ember 2008 through February 2009 (i.e., after

the patient began taking thyroid medication), Dr. Shapiro

testified that Respondent deviated from the standard of care by:

ordering a refill of the thyroid medication in November 2008;

increasing the dosage of thyroid medication in December 2008;

continuing L.V. on the medication in January 2009; and

increasing the dosage a second time in February 2009. A s the

sole basis for his opinion that continued treatment was not

warranted, Dr. Shapiro noted that L.V. ' s TSH levels in December

2008 and February 2009 (3.00 mIU/L and 1.78 mIU/L, respectively)

did not exceed the upper end of the laboratory reference range

( 4.5 mIU/L ) and were therefore " normal. " This testimony

appears , however, to be inconsistent with the wi tness ' own

standard, as described in the previous paragraph of this

Recommend Order : i.e., once thyroid supplementation has begun,

the laboratory refer ence ranges are supplanted by a permissible

range of .3 - 3.0 mIU/L and a target of 2.0 mIU/L. 12 /

26 . F inally, Dr. Shapiro opined, based solely upon L.V. ' s

extremely low TSH levels upon her admission to the hospital,

that Respondent ' s treatment resulted in the patient ' s

development of iatrogenic hyperthyroidism.

27. On cross - examination, Dr. Shapiro was asked, on a

number of occasions , to enumerate the sources upon which he

relied in his articulation of the standard of care. In

response, Dr. Shapiro repeatedly t estified that his opinions

were derived from guidelines promulgated by the Ame rican College

o f Endocrinology ( " ACE guidelines " ) , 13 / which contemplate that

thyroid supplementation is properly initiated only where a

patient ' s TSH level is greater than the testing laboratory ' s

reference range 14 / ; once treatment is initiated, the guidelines

call for a T SH range of .3 - 3.0 mIU/L and a target of 2.0

mIU/L. 15 /

28. Critically, h owever, Dr. Shapiro never testified that

the ACE guidelines were intended by its drafters to establish a

standard of care, nor , more importantly, di d he testify tha t

Florida physici ans adhere to these guidelines with such

uniformity that they mark the standard of a minimally competent

practitioner . Instead, Dr. Shapiro ' s testimony simply reflects

that he regards the ACE guidelines as absolute and binding ,

which, as discussed later i n this Recommended Order , is

insufficient to establish the standard of care by clear and

convincing evidence.

29 . Even assuming that Dr. Shapiro ' exclusive reliance on

the ACE guidelines is a deficiency that can be brushed aside ,

the undersigned woul d nevertheless reject his opinion s in favor

of those articulated by Respondent ' s expert witness, Dr. Edwin

Lee . 16 / Dr. Lee, a board - certifi ed endocrinologist , credibly

opined, first, that Respondent ' s initiation of treatment was

consistent with the standar d of care in light of L.V. ' s

symptoms, initial TSH value (which exceeded 2.5 mIU/L) , as well

as L.V. ' s level of T3 , Free , which was measured at the low end

of the reference range . (Dr. Lee explained that 95% of normal

patients ha ve a TSH level of 2.5 mIU/ L or less , and that a value

in e xcess of 2.5 mIU/L is an indication of mild underactive

thyroid.) Further, Dr. Lee testified, again credibly, that

Respondent ' s continued treatment of L.V. with increasing

levels 17 / of desiccated thyroid supplementation comp orted with

the standard of care where the patient, who had demonstrated no

adverse reactions to the medication, continued to present with

symptoms and sub - optimal laboratory values (i.e., levels of T 3

below an ideal range of 300 - 350 pg/dL , and TSH values o utside a

target range of .3 - 1.0 mIU/L) .

30. Finally, Dr. Lee credibly opined that that

Respondent ' s treatment of L.V. with desiccated thyroid

medication did not result in iatrogenic hyperthyroidism. In

suppor t of this opinion, Dr. Lee emphasized, am ong other

factors, that L.V. ' s T3 and T4 levels, as well as heart rat e,

were entirely normal upon the patient ' s admission to the

hospital. 18 / Dr. Lee further observed, correctly in the

undersigned ' s view , that L.V. ' s persistent diarrhea ÏÏ a condition

from w hich the patient had suffered on multiple occasions over

the years, long before she began treatment with Respondent ÏÏ was

more like ly caused by medications ( Flagyl and Levaquin)

prescribed by another physician.

CONCLUSIONS OF LAW

A. Jurisdiction

31 . DOAH has jurisdiction over the parties and subject

matter of this cause, pursuant to section 120.57(1), Florida

Statutes .

B. The Burden and Standard of Proof

32 . This is a disciplinary proceeding in which Petitioner

seeks to discipline Respondent ' s lic en se to practice medicine .

Accordingly, Petitioner m ust prove the allegations contained in

the Amended Administrative Complaint by clear and convincing

evidence. Dep ' t of Banking & Fin., Div. of Secs. & Investor

Prot. v. Osborne Sterne, Inc. , 670 So. 2d 932, 935 (Fla. 1996);

Ferris v. Turlington , 510 So. 2d 292 , 294 (Fla. 1987).

33 . Clear and convincing evidence:

[R]e quires that the evidence must be found

to be credible; the facts to which the

witnesses testify must be distinctly

remembered; the testim ony must be precise

and lacking in confusion as to the facts in

issue. The evidence must be of such a

weight that it produces in the mind of the

trier of fact a firm belief or conviction,

without hesitancy, as to the truth of the

allegations sought to be established.

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

C. Petitioner ' s Authority to Impose Discipline;

The Charge Against Respondent

34 . Sectio n 458.331(1 ), Florida Statutes, authorizes the

Board of Medicine to impose pena lties ranging from the issuance

of a letter of concern to revocation of a physician ' s license to

practice medicine in Florida if a physician commits one or more

acts specified therein.

35 . In Count I of the Amended Administrative Complaint,

Petitioner charges Respondent with a violation of section

458.331(1)(t ), which provides three grounds for disciplinary

action :

1. Committing medical malpractice as

defined in s. 456.50 . The board shall give

great weight to the provisions of s. 766.102

when enforcing this paragraph. Medical

malpractic e shall not be construed to

require more than one instance, event, or

act.

2. Committing gross medical malpractice.

3. Committing repeated medical malpractice

as defined in s. 456.50 . A person found by

the board to have committed repeated medical

malpractice based on s. 456.50 may not be

licensed or continue to be licensed by this

state to provide health care services as a

medical doctor in this state.

(e mphasis added).

36 . Of the three forms of malpractice detailed above,

Petitioner asserts only that Respondent is guilty of " medical

m alpractice, " which is defined , in relevant part, 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. " § 456.50(1)(g), Fla. Stat. In turn,

s ection 766.1 02 (1), Florida Statutes, provides:

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 ap propriate by reasonably prudent

s imilar health care providers .

(emphasis added).

37 . In paragraph 33 of the Amended Administrative

Complaint, Petitioner contends that Respondent failed to meet

the standard of care in one or more of the following wa ys:

a. by incorrectly diagnosing Patient L.V.

with hypothyroidism ;

b. by prescribing a medication, desiccated

thyroid, either Armour or Nature - throid,

which was not medically indicated in Patient

L.V. ;

c. by failing to prescribe an appropriate

and/or correct dosage of desiccated thyroid,

Armour or Nature - throid, if it was medically

indicated in Patient L.V. ;

* * *

f. by failing to correctly interpret and/or

respond to Patient L.V. ' s laboratory data

results while continually treating her for

hypothyr oidism .

38 . In light of the undersigned ' s finding that Respondent

never diagnosed L.V. with hypothyroidism, Petitioner ' s first

theory of guilt is rejected without further discussion.

39 . With respect to the remaining theories , Petitioner

attempts to prove Respondent ' s guilt through the testimony of

its expert, Dr. Shapiro , that the treatment of L.V. d eviated

from the ACE guidelines ÏÏ the provisions of which , in Dr.

Shapiro ' s opinion , constitute the standard of care because he

agrees with their cont ent and believes t hat physicians are bound

to follow them. As alluded to previously, however, and as

discussed in greater detail below, such testimony lacks

probative force and is substantively deficient.

40 . First, it is well - settled that although an e xpert may

rely upon information that has not been admitted into evidence

in forming an opinion , e.g. , the ACE guidelines, it is improper

for an expert to base an opinion entirely on hearsay. Linn v.

Fossum , 946 So . 2d 1032, 1037 - 38 (Fla. 2006) ; Gerber v . Iyengar ,

725 So. 2d 1181, 1185 (Fla. 3d DCA 1998 ).

41 . Further, and on a more fundamental level, Dr.

Shapiro ' s testimony is unpersuasive because it betra ys a

misunderstanding of the means by which a standard o f care is

properly formulated . In lieu o f testimony that " a physician

must do X , Y, and Z because certain guidelines require it, "

Peti tioner must instead demonstrate through its expert that " X ,

Y, and Z represent the prevailing practice s in the community

because X , Y, and Z are what physicians a ctually do . " See Sweet

v. Sheehan , 932 So. 2d 365, 368 (Fla. 2d DCA 2006)(observing

that a physician owes a duty to " use the ordinary skills, means

and methods that are recognized as necessary and which are

customarily followed in the particular type of c ase to the

standard of those who are qualified by training and experience

to perform similar services in the community or in a similar

community " )(emphasis added) (quoting Brooks v. Serrano , 209 So.

2d 279, 280 (Fla. 4th DCA 1968)) ; Dep ' t of Health v. Gaeta , Case

No. 11 - 5793, 2012 Fla. Div. Adm. Hear. LEXIS 301, *17 - 18 (Fla.

DOAH June 12, 2012 ; DOH Sept. 5, 2012 )(emphasizing that the

standard of care " must be based on generally prevailing peer

performance, that is, be recognized as necessary and customarily

followed in the community. " )

42 . Dr. Shapiro ' s testimony that he considers the

guideli nes to be binding on himself (and others) falls well

short of persuading the undersigned, by clear and convincing

evidence, that the guidelines are customarily follow ed by

Florida physicians and , therefore , represent the standard of

care. See Diaz v. New York Downtown Hosp. , 784 N.E.2d 68, 70

(N.Y. 2002)(holding expert testimony failed to create a triable

issue of negligence in the absence evidence that guidelines of

the American College of Radiology, upon which the expert relied,

had been generally accepted and implemented by hospitals); see

also LaFarge v. Kyker , 201 1 U.S. Dist. LEXIS 143015 , *11 - 12

(N.D. Miss. Dec. 12, 2011) (observing, in the context of a

medical ma lpractice action, that guidelines published by

American College of Cardiology and the American Heart

Association " are indeed just ' guidelines '" and do not set forth

the standard of care); Bettis v. Wade , 2011 Ill. App. Unpub.

LEXIS 1337 , *15 (Ill. App. Ct. May 6, 2011)( " Since there was no

showing that the guidelines were observed by others in the

relevant chiropractic community, it was improper for Dr. Sash to

rely on them to establish the standard of care applicable to

defendant " ); Dowling v. Deakins , 2009 Minn. Dist. LEXIS 27, *8

(Minn. Dist. Ct. Sept. 1, 2009)( " Policies and guidelines do not

set the standard of care. Rather, in a medical negligence case

. . . the standard of care is established through expert

testimony regarding the prevailing standard o f care in the

community. " ).

43 . Even assuming, arguendo, that Dr. Shapiro ' s testimony

did not suffer f rom the defects outlined above, his views

concerning the propriety of L.V. ' s treatment are less persuasive

than those of Dr. Lee ' s. This is so because Dr. Shapiro never

cogently articulated, other than by reference to the ACE

guidelines, why a TSH value, albeit the most sensitive means of

evaluating thyroid function, should be relied upon exclusively

in determining whether thyroid supplementatio n should be

initiated or continued. In other words, Dr. Shapiro failed to

explain why a physician, once in possession of a patient ' s

l aboratory results, must completely exclude the patient ' s

physical symptom s and levels of T3 and T4 ÏÏ the hormones actually

produced by the thyroid ÏÏ from the decision - making process .

44. Dr. Lee ' s articulation of the standard of care , on the

other hand, is far less mechanical in that it takes into account

the patient ' s T3 and T4 levels, 19 / symptoms, as well as the TSH

level s in the management of a patient ' s treatment. Dr. Lee ' s

approach, in short, is more appealing in that it leaves greater

room for the application of judgment and discretion ÏÏ elements

that must be at a physician ' s disposal if medicine is to be both

a scienc e and an art . See Chandler v. Greenstone Ltd. , 2011

U.S. Dist. LEXIS 90122 (W.D. Wash. Aug. 12, 2011)( " [T]he

e videntiary . . . reliability of a physician ' s testimony must be

evaluated with an awareness that medicine is both an art and a

science " ); Nat ' l U nion of Hosp. & Health Care Emps. v. Cnty. of

Cook , 692 N.E.2d 1253, 1263 (Ill. App. Ct. 1998)(distinguishing

the practice of medicine from " mechanical and routinized " tasks

and observing that modern medicine is both a science and an

art).

45 . For th e reasons elucidated above , Petitioner has

failed to adduce clear and convincing evidence that Respondent

violated section 458.331(1)(t) in the manner alleged in the

Amended Administrative Complaint .

RECOMMENDATION

Based on the foregoing Findings o f Fact and Conclusions of

Law, it is RECOMMENDED that a final order be entered by th e

Board of Medicine dismissing Counts I and II of the Amended

Administrative Complaint.

DONE AND ENTERED this 7 th day of January, 2013 , in

Tallahassee, Leon County , Florida.

S

___________________________________

EDWARD T. BAUER

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 Administrative Hearings

this 7 th day of January, 2013 .

ENDNOTES

1 / The deposition transcript of Dr. Guy Zingaro (identified as

Petitioner 's Exhibit 10) has been received in lieu of the

witness' live testimony.

2 / Ms. Jimenez testified credibly that L.V. did not present with

a rapid heartbeat during any offi ce visit. The undersigned's

finding in this regard does not conflict with the Joint

Prehearing Stipulation, wherein the parties simply agreed that

L.V. " complained " of heart palpitations.

3 / The physical examination also included an EKG, which yielded

unremarkable results.

4 / See transcript of September 14, 2012, proceedings at p. 81,

lines 23 - 25.

5 / Although not relevant to the issues raised in the Amended

Complaint, Respondent also prescribed Vitamin D and

progesterone.

6 / See P etitioner's Exhibit 12, p. 595 (Petitioner's exhibits

are marked with two sets of page numbers; the undersigned's

references are to the "Bates numbering"); see also transcript of

September 14, 2012, proceedings at pp. 85 - 86.

7 / The April 21 testin g revealed a T3 of 390 pg/dL, which was

within the upper limit of 420 pg/dL, and a T4 level of 1.00,

which likewise fell within the reference ranges.

8 / L.V.'s hospital re cords reflect a normal heart rate upon her

arrival at the emergency room (72 beats per minute) and during

her subsequent period of hospitalization. See Pet Ex. 15, pp.

133 - 136 (references are to the "Bates numbering.")

9 / See transcript of June 22, 2012, proceedings at p. 188, lines

9 - 11.

10 / See transcript of September 14, 2012, proceedings at p. 8,

lines 5 - 17.

11 / See transcript of June 22, 2012, proceedings at p. 191,

lines 24 - 25; p. 192, lines 1 - 3.

12 / This discrepancy is likely explained by Dr. Shapiro's view

that treatment should not have been initiated in the first

i nstance.

13 / See transcript of September 14, 2012, proceedings at p. 9,

lines 12 - 14.

14 / See transcript of September 14, 2012, proceedings at p. 8,

lines 14 - 22; p. 9, lines 8 - 14.

15 / See transcript of June 22, 2012, proceedings at p. 191,

lines 2 4 - 25; transcript of September 14, 2012, proceedings at p.

58, lines 1 - 3.

16 / The undersigned hereby accepts Dr. Lee (whose deposition has

been received in lieu of live testimony) as an expert in the

specialty of endocrinology.

17 / In its Proposed Re commended Order, Petitioner highlights Dr.

Lee's concession that a physician would violate the standard of

care if the level of thyroid medication were increased in the

absence of current laboratory values. That is true as far as it

goes ÏÏ but it does not advance Petitioner's cause. As detailed

elsewhere in this order, Respondent ordered (and reviewed) blood

tests prior to each dosage increase. See Petitioner's Exhibit

12, pp. 595 and 605 (references are to the "Bates numbering");

see also transcript of S eptember 14, 2012, proceedings at p. 85,

lines 11 - 25; p. 86, lines 1 - 17; p. 92, lines 1 - 11.

18 / Al though L.V.'s TSH was indeed low, the undersigned credits

Dr. Lee's testimony that iatrogenic hyperthyroidism does not

occur in the absence of abn ormal T3 or T4 levels.

19 / See Respondent's Exhibit 2, pp. 10; 17; 22; 70, lines 21 - 25;

71, line 1.

COPIES FURNISHED :

Andrea Wolfson, Esquire

Wolfson & Konigsburg, P.A.

4491 South State Road 7, Suite 314

Davie, Florida 33314

Sharmin R. Hibbert, Esquire

Laura L. Glenn, Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

Jennifer A. Tschetter, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A - 02

Tallahassee, Florida 32399 - 1701

Allison Du dley, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions

within 15 days from the date of this rec ommended order. Any

exceptions to this recommended order must be filed with the

agency that will issue the final order in this case.