14-003507PL Department Of Health, Board Of Medicine vs. Paul M. Goldberg, M.D. Status: Closed Recommended Order on Wednesday, March 4, 2015.

Summary: Petitioner established Respondent violated sections 458.331(1)(g) and (nn), Florida Statutes, as charged in Counts IV and V of the Administrative Complaint.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF

MEDICINE,

Petitioner,

vs. Case No. 14 - 3507PL

PAUL M. GOLDBERG, M.D.,

Respondent.

_______________________________/

RECOMMENDED ORDER

This case cam e before Administrative Law Judge Todd P.

Resavage for final hearing by video teleconference on

November 13, 2014, at sites in Tallahassee and Lauderdale Lakes,

Florida.

APPEARANCES

For Petitioner: Diane K. Kiesling, Esquire

Department o f Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

For Respondent: Paul M. Goldberg, M.D. , pro se

8180 Valhalla Drive

Delray Beach, Florida 33446

STATEMENT OF TH E ISSUE S

Whether Respondent, a medical doctor, in his treatment of

Patient M.A., failed to keep legible medical records in violation

of section 458.331 (1) (m), Florida Statutes (2007); prescribed or

administered inappropriate or excessive quantities of cont rolled

substances in violation of section 458.331(1)(q), Florida

Statutes (2007); committed medical malpractice by practicing

below the standard of care in violation of section 458.331(1)(t),

Florida Statu t es (2007); failed to perform a statutory or legal

obligation placed upon a licensed physician in violation of

section 458.331(1)(g), Florida Statutes (2007); and violated any

provision of chapter 458 or c hapter 456, or any rules adopted

pursuant thereto in violation of section 458.331(1)(nn), Florida

Stat utes (2007), as Petitioner alleges in the Third Amended

Administrative Complaint; if so, whether (and what) disciplinary

measures should be imposed.

PRELIMINARY STATEMENT

On July 23, 2012, Petiti oner, Department of Health, issued

an Amended Administrativ e Complaint against Respondent, Paul M.

Goldberg, M.D. Thereaft er, Respondent timely filed an E lection

of Rights disputing certain material facts alleged in the Amended

Administrative Complaint and requested an administrative hearing.

On September 21, 20 12, Petitioner referred the matter to the

Division of Administrative Hearings ( " DOAH " ) and the case w as

assigned DOAH Case number 12 - 3153PL. On March 22, 2013,

Petitioner filed a Motion to Relinquish Jurisdiction, and same

was granted.

On December 18, 2 013, the case was re - opened and assigned

DOAH Case Number 13 - 4894PL. On February 5, 2014, Petitioner

filed a Motion to Relinquish Jurisdiction. On February 6, 2014,

an order was issued closing the file and relinquishing

jurisdiction.

On July 25, 2014, t he case was re - opened and assigned

DOAH Case No. 14 - 3507PL. On August 1 , 2014, Petitioner filed an

unopposed motion to consolidate all pleadings and discovery taken

in the prior proceedings with the instant matter. On August 4,

2014, the motion to conso lidate was granted.

The final hearing was originally scheduled for September 30,

2014. On August 25, 2014, the final hearing was rescheduled for

November 13, 2014. On October 27, 2014, the case was transferred

to the undersigned for all further proceedi ngs.

The final hearing proceeded as scheduled. The final hearing

Transcript was filed on December 12, 2014. The identity of the

witnesses and exhibits and the rulings regarding each are as set

forth in the Transcript. On December 15, 2014, the parties filed

a Joint Motion for Extension of Time to F ile Proposed Recommended

O rders, and said motion was granted. Petitioner and Respondent

tim ely filed Proposed Recommended O rders, which were considered

in preparing this Recommended Order. Unless otherwise i ndicated,

all rule and statutory references are to the versions in effect

at the time of the alleged violation.

FINDING S OF FACT

INTRODUCTION

1. At all times relevant to this case, Respondent was

licensed to practice medicine in the State of Florida, ha ving

been issued license number ME 93957. Respondent was previously

licensed in New York and New Jersey; however, these licenses were

voluntarily surrendered upon relocation to Florida. Respondent

is not b oard certified in any specialty . R espondent ' s un refuted

testimony establishes that he has performed more than 10,000

cosmetic surgery procedures during his medical career.

2. Petitioner has regulatory jurisdiction over licensed

physicians such as Respondent. In particular, Petitioner is

auth orized t o file and prosecute an administrative complaint

against a physician, as it has done in this instance, when a

panel of the Board of Medicine has found that probable cause

exists to suspect that the physician has committed a

disciplinable offense.

3. On M ay 13, 2008, Patient M.A. ( " M.A. " ) presented to

Strax Rejuvenation & Aesthetics Institute ( " Strax " ), located at

4300 North University Drive, Suite A - 202, Lauderhill, Florida,

for a surgical consul t ation. At the time, Respondent practiced

cosmetic surgery at Strax.

4. On that date, M.A. consented to Respondent performing a

rhytidectomy , blepharoplasty , and liposuction . 1 / On May 13, 2008,

Respondent prescribed several medications for M.A. to bring to

the office on the date of surgery. Specifically, Resp ondent

prescribed Percocet 5/325 mg (quantity 30); Valium 10 mg

(quantity 10); Phenergan 25 mg (quantity 30); and Keflex 500 mg

(quantity 9).

5. On June 20, 2008, M.A. presented to Strax and Respondent

performed the above - noted procedures , as more fully discussed

below .

OFFICE SURGERY REGISTRATION

6 . Strax was not successfully registered with the

Department of Health to perform Level II surgical procedures in

Florida with a maximum planned duration of more than five (5)

minutes or any Level III of fice surgery, as fully defined in

Florida Administrative Code Rule 64B8 - 9.009, until September 23,

2008, over three months after the subject surgery.

7 . Respondent was not successfully registered with the

Department of Health to perform Level II s urgical procedures in

Florida with a maximum planned duration of more than five (5)

minutes or any Level III office surgery, as fully defined in

Florida Administrative Code Rule 64B8 - 9.009, until November 26,

2008, over four months after the subject surger y.

8 . The Agency for Health Care Administration did not issue

a license to Strax to operate as an ambulatory surgical center

for the period of May 13 through June 20, 2008, and Strax was not

licensed to operate as an ambulatory surgical center duri ng that

time period.

OFFICE SURGICAL LEVELS

9 . A brief discussion of office surgical " l evels " is a

necessary exercise to an understanding of the specific facts in

this ma tter. A Level I office surgery is defined , in Florida

Administrative Code Rul e 64B8 - 9.009(3)(a), as minor procedures

such as excision of skin lesions, moles, warts, cysts, lipomas ,

and repair of lacerations or surgery limited to the skin and

subcutaneous tissue. In a Level I office surgery, pre - operative

medications are not requir ed or used other than for minimal pre -

operative tranquilization and anesthesia is local, topical, or

none. In a Level I office surgery, no other personnel assistance

is required.

10. A Level II office surgery is defined in r ule 64B8 -

9.009(4)(a) to include any surgery in which the patient is placed

in a state which allows the patient to tolerate unpleasant

procedures while maintaining adequate cardiorespiratory function

and the ability to respond purposefully to verbal command and/or

tactile stimula tion. Such procedures incl ude, but are not

limited to, he morrhoidectomy, hernia repair, reduction of simple

fractures, breast biopsies, and certain liposuctions. A Level II

office surgery places other requirements on the physician such as

a transfer agre ement, specific training, necessary equipment and

supplies, and the assistance of other personnel.

JUNE 28, 2008 , SURGERY

1 1 . On June 28, 2008, M.A. presented to Strax for

Respondent to perform a face and neck lift and an upper and lower

blepharoplas ty. The Pre - Op Checklist provides that, at

10:20 a.m., M.A. was administered 18 mg of Dilaudid, 20 mg of

Percocet, 20 mg of Valium, and 25 mg of Phenergan. Respondent ' s

Operative Report documents that said medications and dosages were

given orally; howe ver, the Operative Report documents that 14 mg ,

not 18 mg, of Dilaudid was administered.

1 2 . Dilaudid is the brand name for hydromorphone, an

opioid. The intended purpose of Dialudid is analgesia, or relief

of pain. Percocet is the brand name for oxycodone/APAP, a

combination of oxycodone and acetaminophen. It is an opioid that

provides analgesic relief. Valium is the brand name for

diazepam, a benzodiazepine drug. Generally, it is used as a

sedative hypnotic and may be used as a pre - anesthetic drug.

Phenergan, a form of promethazine, is principally an

antihistamine - like drug, but often is prescribed to counteract

nausea.

1 3 . The Intra - Op Record documents that M.A. ' s surgical

procedures began at 11:00 a.m. and ended at 1:32 p.m.

Respon dent ' s Operative Report documents that M.A. tolerated the

procedure well and was returned to the recovery room in

satisfactory condition. The elective cosmetic procedures

performed by Respondent on M.A., which involved drug - induced

alteration of conscious ness, constitute a Level II office

surgery. During the surgical procedures, Respondent was not

a ssisted by an anesthesiologist, Cer tified Registered Nurse

Anesthet ist, or Physician Assistant qualified as set fo rth in

Florida Administrative Code Rule 64B8 - 30.012(2)(b)6 . Respondent

was ACLS certified and was assisted by a Registered Nurse;

however, the Registered Nurse was not functioning solely as an

assisting anesthesia provider.

14. At the time of the subject surgery, Respondent did not

have a tr ansfer agreement with a licensed hospital within

reasonable proximity to Strax. Respondent also did not have

staff privileges to perform the subject procedures at a licensed

hospital within reasonable proximity to Strax.

1 5 . The Intra - Op Record do cuments that 100 ml L.R. (lactate

ringers) IV fluids and 1 ampule of Narcan .4 mg were provided to

M.A. by the Registered Nurse. This record does not provide when

the fluid or the ampule were given. A document entitled

" Pre/Post - Operative - Recovery Room R ecord, " and dated June 21,

2008 (the day after surgery) , provides that Respondent was

notified of M.A. ' s oxygen saturation of 65 percent . Said record

f urther documents that an ampule of Narcan was administered at

2:10 p.m. M.A. ' s oxygen satur ation therea fter improved to

98 percent on room air. M.A. ' s oxygen saturation was thereafter

monitored until 3:20 p.m.

1 6 . Narcan is a narcotic antagonist that works by blocking

opiate receptor sites, thus reversing or preventing the toxic

effects of narcoti c analgesics.

1 7 . M.A. ' s daughter ( " L.F. " ) arrived at Strax at

approximately 4:00 p.m. When L.F. picked M.A. up at 4:45 p.m.,

M.A. could not walk without assistance. On the forty - f ive minute

drive home, M.A. slept in the vehicle despite loud cryi ng from

L.F. ' s young child. Once home, L.F. assisted M.A. in walking

from the vehicle to the home and assisted her into bed.

1 8 . L.F. credibly testified that thereafter she checked on

M.A. on an hourly basis. M.A. was typically asleep when L.F.

e ntered the room to change ice pads on her eyes. M.A. would

rouse from sleep during this exercise. When changing the pads,

M.A. r eported some pain in her legs.

1 9 . L.F. recalls that M.A. walked with assistance (from

L.F. and the wall) to use the r estroom. At approximately

7:30 p.m., L.F. spoke with an unknown Strax nurse. According to

L.F., the nurse advised that after M.A. ate dinner, she could

receive one Valium pill to help her sleep; however, she was not

to receive any additional pain medica tion.

20 . L.F. assisted M.A. from the bedroom to the living room

couch to eat. L.F. served M.A. some chicken soup and crackers

around 8:00 p.m. L.F. recalls that M.A. ate a few of the

crackers, and a small amount of the soup. L.F. made M.A. drin k

the soup broth. At approximately 8:15 p.m., L.F. assisted M.A.

in returning to the bed. At approximately 8:30 p.m., L.F. gave

M.A. one tablet of Valium.

21 . Thereafter, L.F. continued to check on M.A. hourly

until 11:00 p.m . At 11:00 p.m. , M.A . did not wake up when L.F.

checked on her, a nd L.F. witnessed heavy breathing Ï Ï like a snore.

After this occasion, L.F. went to sleep. When L.F. checked on

M.A. at 1:00 a.m., she took off M.A. ' s eye pads, and M.A. felt

stiff. L.F. alerted her husband, w ho called 911. M.A. was

subsequently transported to North Broward Medical Center where

she was pronounced dead on June 21, 2008, at 2:07 a.m.

POST - MORTEM

22 . On June 21, 2008, at 8:20 a.m., M.A. ' s body was

released to the Broward County Medical E xaminer ' s Office

( " BCME " ) . The body was refrigerated at 10:03 a.m. At

11:41 a.m., the Florida Lions Eye Bank harvested M.A. ' s corneas

and ocular fluid at BCME. At 10:31 p.m., M.A. ' s body was

received at the Dade County Medical Examiner ' s Office ( " DCME " )

for tissue recovery by the University of Miami Tissue Bank.

2 3 . On June 22, 2008, at 3:02 a.m., M.A. ' s body was

returned to the BCME. There is no evidence that M.A. ' s body was

not properly handled or refrigerated.

2 4 . The following day, June 23, 2008, at 8:3 0 a.m.,

Associate Medical Examiner Iouri Boiko, M.D., performed an

autopsy on M.A. ' s body. In the process of conducting the

autopsy, Dr. Boiko collected M.A. ' s central blood and urine for

analysis. The samples were taken to the secur e toxicology lab.

Said specimens were stored in a toxicology lab refrigerator.

2 5 . On October 1, 2008, forensic toxicologist Michael

Wagner performed an ABN procedure (acid, basic and neutral drugs)

on M.A. ' s collected blood. The procedure was pe rformed on the

gas chromatography - mass spectrometer. This testing revealed the

presence of acetaminophen, caffeine, MGEX - the metabolite of

Lidocaine, Atropine, Promethazine .40 mg/L, Diazepam .27 mg/L ,

and Oxycodone .25 mg /L.

2 6 . On October 6, 200 8, Mr. Wagner performed a propryl

derivation to detect the presence or absence of any opiates.

This testing revealed H ydromorphone .11 mg/L. Based on these

results, Mr. Wagner prepared a Final Toxicology Report on

October 10, 2008. On October 28, 2008, Dr. Boiko issued his

final anatomical diagnoses and opined that M.A. died as a result

of combined drug toxicity and that coronary artery

atherosclerosis was a factor contributory to death. Dr. Boiko

did not offer any expert testimony concerning whether R espondent

met the prevailing professional standard of care.

EXPERT WITNESS TESTIMONY

2 7 . The record evidence in the instant matter reveals very

little concerning Respondent ' s practice. From the record, the

undersigned can conclude that Respondent was issued a license to

practice medi cine in the State of Florida on or about August 2,

2005. From Respondent ' s unrefuted testimony, he has performed

more than 10,000 cosmetic surgery procedures during his medical

career (which ostensibly includes his ten ure in New York and New

Jersey). Petitioner ' s Third Amended Administrative Complaint

alleges that Respondent " is not board certified in any particular

specialty area of medical practice. "

2 8 . In support of the allegations contained in Count III,

t hat Respondent committed medical malpractice by practicing below

the standard of care in violation of section 458.331(1)(t),

Florida Statutes, Petitioner presented the testimony, via

deposition, of Scott Berger, M.D. Dr. Berger is Board Certified

by the A merican Board of Anesthesiology and the American Academy

of Pain Management. On multiple occasions, Dr. Berger opined

that various acts or omissions of Respondent did not meet the

standard of care; however, Dr. Berger never articulated the

applicable stan dard of care owed by Respondent. Accordingly, the

undersigned is precluded from considering Dr. Berger ' s testimony

in making any findings of fact concerning whether Respondent ' s

conduct fell below the standard of care, as alleged in Count III.

2 9 . Petitioner also presented the testimony of forensic

toxicologist Bruce A. Goldberger, Ph.D., DABFT. He holds both a

Master ' s degree and a Ph.D in forensic toxicology and is trained

in pathology. Dr. Goldberger, despite his qualifications, is not

qualifi ed to give expert testimony concerning the prevailing

standard of care. 2 /

CONCLUSIONS OF LAW

3 0 . The Division of Administrative Hearings has

jurisdiction over the parties and subject matter of this cause,

pursuant to section 120.57(1), Florida Stat utes.

31. T his is a disciplinary proceeding in which the

Department seeks to discipline Respondent ' s license to practice

medicine. Accordingly, the Department must prove the allegations

contained in the 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).

32 . Regarding the standard of proof, in Slomowitz v.

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

developed a " workable definition of clear and convincing

evidence " and found that of necessity such a definition would

need to contain " both qualitative and quantitative standards. "

The Court held that:

[C]lear and convincing evidence requires that

the evidence must be found to be credible;

the facts to which the witnesses testify must

be distinctly remembered; the testimony must

be precise and explicit and the witnesses

must be lacking 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

hesitancy, as to the truth of the allegations

sought to be established.

Id. The Florida Supreme Court later adopted the Sl omowitz

court ' s description of clear and convincing evidence. See In re

Davey , 645 So. 2d 398, 404 (Fla. 1994). The First District Court

of Appeal also has followed the Slomowitz test, adding the

interpretive comment that " [a]lthough this standard of pro of may

be met where the evidence is in conflict . . . it seems to

preclude evidence that is ambiguous. " Westinghouse Elec. Corp.

v. Shuler Bros., Inc. , 590 So. 2d 986, 988 (Fla. 1st DCA 1991);

rev. denied , 599 So. 2d 1279 (Fla. 1992)(citations omitted).

33 . Section 458.331(1), Florida Statutes, authorizes the

Board of Medicine to impose penalties ranging from the issuance

of a letter of concern to revocation of a physician ' s license t o

practice medicine in Florida i f a physician commits one or more

act s specified therein.

34 . In its Complaint, the Department alleges that

Respondent is guilty of: failing to keep legible medical records

(Count I); administering legend drugs other than in the course of

his professional practice (Count II); committing me dical

malpractice (Count III); failing to perform statutory or legal

obligations placed upon a licensed physician (Count IV ); and

violating provisions of chapter 458 or c hapter 456, or any rules

adopted pursuant thereto (Count V).

35 . P etitioner contends , in Count I of the Complaint , that

Petitioner has violated s ection 458.331(1)(m) which provides:

(1) The following acts constitute grounds

for denial of a license or disciplinary

action, as specified in s. 456.072(2):

* * *

(m) Failing to keep legib le, as defined by

department rule in consultation with the

board, medical records that identify the

licensed physician or the physician extender

and supervising physician by name and

professional title who is or are responsible

for rendering, ordering, sup ervising, or

billing for each diagnostic or treatment

procedure and that justify the course of

treatment of the patient, including, but not

limited to, patient histories; examination

results; test results; records of drugs

prescribed, dispensed, or adminis tered; and

reports of consultations and

hospitalizations.

36. As noted in section 458.331(1)(m), legibility of

medical records is to be determined in reference to a defined

(Department of Health) rule. Here, Petitioner ' s Complaint

sufficiently sets for th the factual allegations underpinning a

violation of section 458.331(1)(m); however, it fails to

reference the specific applicable board rule . Accordingly, the

undersigned is constrained to reviewing the allegations of

Count I solely by the plain text of section 458.331(1)(m).

37. Petitioner alleges Respondent violated section

458.331(1)(m) in several aspects. First, Petitioner alleges that

Respondent failed to accurately record how much Dilaudid was

administered to patient M.A. The amount of Dilaudid administered

varies between the Operative Report authored by Respondent

(14 mg) and the Pre - Opertive Checklist (18 mg) authored by a

nurse. Respondent maintains that 14 mg is the correct amount

administered and Petitioner has failed to present e vidence to the

contrary. Petitioner failed to present clear and convincing

evidence that this discrepancy is a violation of section

458.331(1)(m).

38. Next, Petitioner alleges that, with respect to Narcan,

Respondent failed to document the quantit y, time, and personnel

associated with its administration. Here the Intra - Op Record

dated June 20, 2008, and signed by Respondent, documents that one

ampule of Narcan was given by the nurse. This medical record

fails, however, to document when the ampule was administered or

who administered the same. The Pre/Post - Operative - Recovery Room

Record, dated either incorrectly as June 21, 2008, or

alternatively a late entry, documents that one .4 mg ampule of

Narcan was administered at 2:10 p.m. Construing the records

together, the undersigned concludes that Petitioner failed to

present clear and convincing evidence that this discrepancy is a

violation of section 458.331(1)(m).

39. Finally, Petitioner alleges that Respondent failed to

document the result s of the continuous evaluation of the

patient ' s oxygenation, venti lation, circulation , and temperature.

While Respondent may have had an obligation to continually

ev a l u a te M.A. ' s oxygenation, ventilation, circulation , and

temperature while performing offi ce surgery, the undersigned is

unaware of, and Petitioner has nei ther pled nor cited to any

authority for , the proposition that Respondent was required to

document the same. The undersigned concludes that Petitioner

failed to present clear and convincing evidence that this

discrepancy is a vioaltion of section 458.331(1)(m).

40. In Count II of the Complaint, Petitioner alleges

Respondent violated section 458.331(1)(q) by prescribing or

administering excessive or inappropriate quantities or

combinations o f Dilaudid, Percocet, or Valium to M.A. on June 20,

2008. Section 458.331(1)(q) provides

(1) The following acts constitute grounds

for denial of a license or disciplinary

action, as specified in s. 456.072 (2):

* * *

( q) Prescribing, dispensing, admin istering,

mixing, or otherwise preparing a legend drug,

including any controlled substance, other

than in the course of the physician ' s

professional practice. For the purposes of

this paragraph, it shall be legally presumed

that prescribing, dispensing, a dministering,

mixing, or otherwise preparing legend drugs,

including all controlled substances,

inappropriately or in excessive or

inappropriate quantities is not in the best

interest of the patient and is not in the

course of the physician ' s professional

practice, without regard to his or her

intent.

41. Assuming arguendo that Petitioner established by clear

and convincing evidence that Respondent prescribed or

administered excessive or inappropriate quantities or

combinations of Dilaudid, Percocet, or Valium to M.A. on June 20,

2008 , it would be legally presumed that it was not in the best

interest of M.A. and not in the course of Res po ndent ' s

professional practice, without regard to his intent. The

undersigned finds, however, that the clear and co nvincing

evidence establishes that Respondent was, in fact, practicing

medicine in his treatment of M.A. on June 20, 2008 , and,

therefore, the legal presumption was rebutted. Accordingly,

Petitioner failed to prove a violation of section 458.331(1)(q).

42. In Count III of the Complaint , Petitioner alleges that

Respondent ' s conduct v iolated section 458.331(1)(t)1 . , Florida

Statutes, which provides:

(1) The following acts constitute grounds

for denial of a license or disciplinary

action, as specifi ed in s. 456.072 (2):

* * *

(t) Notwithstanding s. 456.072 (2) but as

specified in s. 456.50 (2):

1. Committing medical malpractice as de fined

in s. 456.50. The board shall give great

weight to the provisions of s. 766.102 when

enforcing this paragraph. Medical

malpractice shall not be construed to require

more th an one instance, event, or act.

43. Section 456.50 (1) (g), in turn, defines " me dical

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. "

44. Section 766.102 (1 ) provides , in pertinent part , as

follows:

The pr evailing professional standard of care

for a given health care provider shall be

that level of care, skill, and treatment

which, in light of all relevant surrounding

circumstances, is recognized as acceptable

and appropriate by reasonably prudent similar

h ealth care providers.

45. Section 766.102(5) governs the requisite qualifications

of expert witness testimony regarding the prevailing professional

standard of care . Section 766.102(5) provides as follows:

(5) A person may not give expert testimo ny

concerning the prevailing professional

standard of care unless that person is a

licensed health care provider and meets the

following criteria:

(a) If the health care provider against whom

or on whose behalf the testimony is offered

is a specialist, the expert witness must:

1. Specialize in the same specialty as the

health care provider against whom or on whose

behalf the testimony is offered; or

specialize in a similar specialty that

includes the evaluation, diagnosis, or

treatment of the medical c ondition that is

the subject of the claim and have prior

experience treating similar patients; and

2. Have devoted professional time during the

3 years immediately preceding the date of the

occurrence that is the basis for the action

to:

a. The activ e clinical practice of, or

consulting with respect to, the same or

similar specialty that includes the

evaluation, diagnosis, or treatment of the

medical condition that is the subject of the

claim and have prior experience treating

similar patients;

b. Instruction of students in an accredited

health professional school or accredited

residency or clinical research program in the

same or similar specialty; or

c. A clinical research program that is

affiliated with an accredited health

professional school or accredited residency

or clinical research program in the same or

similar specialty.

(b) If the health care provider against whom

or on whose behalf the testimony is offered

is a general practitioner, the expert witness

must have devoted professional time during

the 5 years immediately preceding the date of

the occurrence that is the basis for the

action to:

1. The active clinical practice or

consultation as a general practitioner;

2. The instruction of students in an

accredited health professio nal school or

accredited residency program in the general

practice of medicine; or

3. A clinical research program that is

affiliated with an accredited medical school

or teaching hospital and that is in the

general practice of medicine.

(c) If the he alth care provider against whom

or on whose behalf the testimony is offered

is a health care provider other than a

specialist or a general practitioner, the

expert witness must have devoted professional

time during the 3 years immediately preceding

the dat e of the occurrence that is the basis

for the action to:

1. The active clinical practice of, or

consulting with respect to, the same or

similar health profession as the health care

provider against whom or on whose behalf the

testimony is offered;

2. The instruction of students in an

accredited health professional school or

accredited residency program in the same or

similar health profession in which the health

care provider against whom or on whose behalf

the testimony is offered; or

3. A clinica l research program that is

affiliated with an accredited medical school

or teaching hospital and that is in the same

or similar health profession as the health

care provider against whom or on whose behalf

the testimony is offered.

46. Petitioner p resented the testimony, via deposition, of

Scott Berger, M.D., who is Board Certified by the American Board

of Anesthesiology and the American Academy of Pain Management .

Respondent did not object to Dr. Berger ' s testimony on the

grounds that Dr. Berger f ailed to satisfy the criteria of section

766.102. 3 /

47. To prevail on its medical malpractice claim, Petitioner

must first establish the standard of care owed by Respondent.

Gooding v. Univ. Hosp. Bldg., Inc . , 445 So. 2d 1015, 1018 (Fla.

1984); Ho llywood Med. Ctr. v. Reed , 82 So. 3d 122, 125 (Fla. 4th

DCA 2012). " [W]hat the standard of care requires is a question

of fact, not a question of law. " Torres v. Sullivan , 903 So. 2d

1064, 1067 (Fla. 2d DCA 2005). On multiple occasions, Dr. Berger

opine d that various acts or omissions of Respondent did not meet

the standard of care; however, Dr. Berger never articulated the

applicable standard of care owed by Respondent.

48. In T orres , the court properly noted that , " [t]he

standard of practice an d treatment within a particular medical

specialty when physicians in that field are presented with a

particular set of circumstances is a subject well beyond the

[factfinder ' s] expertise, not a matter within the comprehension

of laymen. " Torres , 903 So. 2 d at 1067 (internal citations

omitted ) . " As a result, expert testimony is generally required

to establish the standard of care prevalent in a particular

medical field. " Id . ; see also Pervis v. Dept . of Prof . Reg . , B d.

of Veterinary Medicine , 461 So. 2d 1 34 (Fla. 1st DCA 1984)

(holding that in disciplinary proceedings, the board has the

burden of proving the applicable standard by competent

substantial evidence).

49. Petitioner failed to present sufficient evidence to

establish the standard of care owed by Respondent. Accordingly,

Petitioner failed to establish Respondent violated section

458.331(1)(t)1.

50. In Count IV of the Complaint, Petitioner alleges

Respondent violated section 458.331(1)(g) by failing to perform

any statutory or lega l obligation upon a licensed physician.

Petitioner alleges Respondent committed eight separate failures.

First, Petitioner alleges Respondent failed " to ensure that St rax

was registered as an OSR on June 20, 2008, when he performed

Level II surgery on MA . " If proved, such a failure would be a

violation of Florida Administrative Code Rule 64B 8 - 9.0091(1)(a).

Rule 64B8 - 9.0091(1)(a) provides, in pertinent part, as follows:

(1) Registration.

(a) Every licensed physician who holds an

active Florida licens e and performs Level II

surgical procedures in Florida with a maximum

planned duration of more than five (5)

minutes or any Level III office surgery, as

fully defined in Rule 64B8 - 9.009, F.A.C.,

shall register the office with the Department

of Health. It is the physician ' s

responsibility to ensure that every office in

which he or she performs Levels II or III

surgical procedures as described above is

registered, regardless of whether other

physicians are practicing in the same office

or whether the office is non - physician owned.

51. Petitioner proved by clear and convincing evidence that

Respondent failed to ensure that Strax was properly registered as

set forth above.

52. Petitioner next alleges that Respondent failed to

e nsure that Strax wa s inspected as required by Florida

Administrative Code Rule 64B8 - 9.0091, prior to performing

Level II surgery on M.A. on June 20, 2008. Rule 64B8 - 9.0091(2)

provides as follows:

(2) Inspection.

(a) Unless the physician has previously

provide d written notification of current

accreditation by a nationally recognized

accrediting agency or an accrediting

organization approved by the Board the

physician shall submit to an annual

inspection by the Department. Nationally

recognized accrediting agen cies are the

American Association for Accreditation of

Ambulatory Surgery Facilities (AAAASF),

Accreditation Association for Ambulatory

Health Care (AAAHC) and Joint Commission on

Accreditation of Healthcare Organizations

(JCAHO). All nationally recognize d and

Board - approved accrediting organizations

shall be held to the same Board - determined

surgery and anesthesia standards for

accrediting Florida office surgery sites.

(b) The office surgery inspection fee set

forth in the Department ' s Rule 64B - 4.002,

F .A.C., shall be remitted for each practice

location.

(c) The inspection conducted pursuant to

this rule shall be announced at least one

week in advance of the arrival of the

inspector(s).

(d) The Department shall determine

compliance with the requireme nts of Rule

64B8 - 9.009, F.A.C.

(e) If the office is determined to be in

noncompliance, the physician shall be

notified and shall be given a written

statement at the time of inspection. Such

written notice shall specify the

deficiencies. Unless the defi ciencies

constitute an immediate and imminent danger

to the public, the physician shall be given

30 days from the date of inspection to

correct any documented deficiencies and

notify the Department of corrective action.

Upon written notification from the physician

that all deficiencies have been corrected,

the Department is authorized to re - inspect

for compliance. If the physician fails to

submit a corrective action plan within 30

days of the inspection, the Department is

authorized to re - inspect the offi ce to ensure

that the deficiencies have been corrected.

(f) The deficiency notice and any subsequent

documentation shall be reviewed for

consideration of disciplinary action under

any of the following circumstances:

1. When the initial notice of defici encies

contain deficiencies that constitute

immediate and imminent danger to the public;

2. The physician fails to provide the

Department with documentation of correction

of all deficiencies within thirty (30) days

from the date of inspection;

3. Upon a finding of noncompliance after a

reinspection has been conducted pursuant to

paragraph (2)(e) of this rule.

(g) Documentation of corrective action shall

be considered in mitigation of any offense.

(h) Nothing herein shall limit the authority

of the Department to investigate a complaint

without prior notice.

53. Petitioner proved by clear and convincing evidence that

Respondent did not ensure that Stra x was inspected as required by

r ule 64B9 - 9.0091(2).

54. Petit i oner next alleges that Respondent failed to

comply with Florida Administrative Code Rule 64B8 - 9.009, Standard

of Care for Office Surgery. This general allegation fails to set

forth with requisite specificity how Respondent failed to comply

with said standard of care. Specific standard of care violations

regarding said rule are subsequently alleged and will be

addressed below.

55. Petitioner next alleges that Respondent failed to

perform a statutory or legal obligation by performing Level II

surgery on M.A., at Strax, whe n it had not been registered or

inspected for the performance of office surgery. This allegation

is simply a combination of two allegations addressed above. As

previou sly addressed, Petitioner prov ed said allegations by clear

and convincing evidence.

56. Petit ioner further alleges that Resp o n dent failed to

comply with the requirements of Florida Administrative Code Rule

64B8 - 9.009(2) (g) . Rule 64B8 - 9.009(2)(g), provides:

(2) General Requirements for Office Surgery.

* * *

(g) The Board of Medic ine adopts the

" Standards of the American Society of

Anesthesiologists for Basic Anesthetic

Monitoring, " approved by House Delegates on

October 21, 1986, and last amended on

October 21, 1998, as the standards for

anesthetic monitoring by any qualified

ane sthesia provider.

1. These standards apply to general

anesthetics, regional anesthetics, and

monitored anesthesia care (Level II and III

as defined by this rule) although, in

emergency circumstances, appropriate life

support measures take precedence. Th ese

standards may be exceeded at any time based

on the judgment of the responsible

supervising physician or anesthesiologist.

They are intended to encourage quality

patient care, but observing them cannot

guarantee any specific patient outcome. They

are subject to revision from time to time, as

warranted by the evolution of technology and

practice. This set of standards address only

the issue of basic anesthesia monitoring,

which is one component of anesthesia care.

2. In certain rare or unusual circu mstances

some of these methods of monitoring may be

clinically impractical, and appropriate use

of the described monitoring methods may fail

to detect untoward clinical developments.

Brief interruptions of continual monitoring

may be unavoidable. For pur pose of this

rule, " continual " is defined as " repeated

regularly and frequently in steady rapid

succession " whereas " continuous " means

" prolonged without any interruption at any

time. "

3. Under extenuating circumstances, the

responsible supervising physi cian or

anesthesiologist may waive the requirements

marked with an asterisk (*); it is

recommended that when this is done, it should

be so stated (including the reasons) in a

note in the patient ' s medical record. These

standards are not intended for the

a pplication to the care of the obstetrical

patient in labor or in the conduct of pain

management.

a. Standard I.

I. Qualified anesthesia personnel shall be

present in the room throughout the conduct of

all general anesthetics, regional a nesthetics

and monitored anesthesia care.

II. OBJECTIVE. Because of the rapid changes

in patient status during anesthesia,

qualified anesthesia personnel shall be

continuously present to monitor the patient

and provide anesthesia care. In the event

the re is a direct known hazard, e.g.,

radiation, to the anesthesia personnel which

might require intermittent remote observation

of the patient, some provision for monitoring

the patient must be made. In the event that

an emergency requires the temporary abs ence

of the person primarily responsible for the

anesthetic, the best judgment of the

supervising physician or anesthesiologist

will be exercised in comparing the emergency

with the anesthetized patient ' s condition and

in the selection of the person left

r esponsible for the anesthetic during the

temporary absence.

b. Standard II.

I. During all anesthetics, the patient ' s

oxygenation, ventilation, circulation and

temperature shall be continually evaluated.

II. OXYGENATION.

(A) OBJECTIVE. To ensure ad equate oxygen

concentration in the inspired gas and the

blood during all anesthetics.

(B) METHODS.

(I) Inspired gas: During every

administration of general anesthesia using an

anesthesia machine, the concentration of

oxygen in the patient breathing s ystem shall

be measured by an oxygen analyzer with a low

oxygen concentration limit alarm in use.*

(II) Blood oxygenation: During all

anesthetics, a quantitative method of

assessing oxygenation such as a pulse

oximetry shall be employed.* Adequate

illu mination and exposure of the patient are

necessary to assess color.*

III. VENTILATION.

(A) OBJECTIVE. To ensure adequate

ventilation of the patient during all

anesthetics.

(B) METHODS.

(I) Every patient receiving general

anesthesia shall have the adequacy of

ventilation continually evaluated.

Qualitative clinical signs such as chest

excursion, observation of the reservoir

breathing bag and auscultation of breath

sounds are useful. Continual monitoring for

the presence of expired carbon dioxide sh all

be performed unless invalidated by the nature

of the patient, procedure or equipment.

Quantitative monitoring of the volume of

expired gas is strongly encouraged.*

(II) When an endotracheal tube or laryngeal

mask is inserted, its correct positioning

must be verified by clinical assessment and

by identification of carbon dioxide analysis,

in use from the time of endotracheal

tube/laryngeal ma sk placement, until

extubation/ removal or initiating transfer to

a postoperative care location, shall be

perfor med using a quantitative method such as

capnography, capnometry or mass

spectroscopy.*

(III) When ventilation is controlled by a

mechanical ventilator, there shall be in

continuous use a device that is capable of

detecting disconnection of components of the

breathing system. The device must give an

audible signal when its alarm threshold is

exceeded.

(IV) During regional anesthesia and

monitored anesthesia care, the adequacy of

ventilation shall be evaluated, at least, by

continual observation of quali tative clinical

signs.

IV. CIRCULATION.

(A) OBJECTIVE. To ensure the adequacy of

the patient ' s circulatory function during all

anesthetics.

(B) METHODS.

(I) Every patient receiving anesthesia shall

have the electrocardiogram continuously

displayed from the beginning of anesthesia

until preparing to leave the anesthetizing

location.*

(II) Every patient receiving anesthesia

shall have arterial blood pressure and heart

rate determined and evaluated at least every

five minutes.*

(III) Every patient receiving general

anesthesia shall have, in addition to the

above, circulatory function continually

evaluated by at least one of the following:

palpation of a pulse, auscultation of heart

sounds, monitoring of a tracing of intra -

arterial pressure, ultraso und peripheral

pulse monitoring, or pulse plethysmography or

oximetry.

V. BODY TEMPERATURE.

(A) OBJECTIVE. To aid in the maintenance of

appropriate body temperature during all

anesthetics.

(B) METHODS. Every patient receiving

anesthesia shall have temperature monitored

when clinically significant changes in body

temperature are intended, anticipated or

suspected.

57. Petitioner provided by clear and convincing evidence

that Respondent did not continually evaluate M.A. ' s oxygenation,

ventilat ion, circulation , and temperature, as required (and as

applicable to the subject procedures) by r ule 64B8 - 9.009(2)(g).

58. Petitioner further alleges Respondent failed to comply

with the requirements of Florida Administrative Code Rule 64B8 -

9.009(4) (b)1., by failing to have an appropriate transfer

agre ement. Rule 64B8 - 9.009(4)(b)1. provides

(4) Level II Office Surgery.

* * *

(b) Standards for Level II Office Surgery.

1. Transfer Agreement Required. The

physician must have a transfer agreeme nt with

a licensed hospital within reasonable

proximity if the physician does not have

staff privileges to perform the same

procedure as that being performed in the out -

patient setting at a licensed hospital within

reasonable proximity. " Reasonable proxim ity "

is defined as not to exceed thirty (30)

minutes transport time to the hospital.

59. Petitioner proved by clear and convincing evidence that

Respondent did not have a transfer agr eement as required by r ule

64B8 - 9.009(4)(b)1.

60. Finally , Petitioner alleges that Respondent committed

violations that, if proven , would violate r ule 64B8 - 9.009(4)(b)4.

Rule 64B8 - 9.009(4)(b)4 . provides:

Assistance of Other Personnel Required. The

surgeon must be assisted by a qualified

anesthesia provider as follows: An

Anesthesiologist, Certified Registered Nurse

Anesthesist [sic] , or Physician Assistant

qualified as set forth in subparagraph 64B8 -

30.012(2)(b)6., F.A.C., or a registered nurse

may be utilized to assist with the

anesthesia, if the surgeon is ACLS certified.

An assisting anesthesia provider cannot

function in any other capacity during the

procedure. If additional assistance is

required by the specific procedure or patient

circumstances, such assistance must be

provided by a physician, osteopa thic

physician, registered nurse, licensed

practical nurse, or operating room

technician. A physician licensed under

Chapter 458 or 459, F.S., a licensed

physician assistant, a licensed registered

nurse with post - anesthesia care unit

experience or the equ ivalent, credentialed in

Advanced Cardiac Life Support or, in the case

of pediatric patients, Pediatric Advanced

Life Support, must be available to monitor

the patient in the recovery room until the

patient is recovered from anesthesia.

61. Petition er proved by clear and convincing evidence

that, during the subject surgery, Respondent was not assisted by

a n a nesthesiologist, Cer tified Registered Nurse Anesthet ist, or

Physician Assistant qualified as set forth in subparagraph

64B8 - 30.012(2)(b)6., F.A .C. The evidence established that

Respondent was ACLS certified and that a Registered Nurse was

present during the surgical procedures; however, the evidence

further established that the nurse was not functioning solely as

an assisting anesthesia provider . Accordingly, Petitioner

established by clear and conv incing evidence a violation of r ule

64B8 - 9.009(4)(b)4.

62. Based on the above - noted violations of Florida

Administrative Code Rules 64B8 - 9.009 and 64B8 - 9. 0091, Petitioner

established that Resp ondent violated section 458.331(1)(g),

Florida Statutes.

63. In Count V of the Complaint, Petitioner sets forth t he

exact factual allegations contained in Count IV. In Count V,

however, Petitioner alleges that the same allegations contained

in Coun t IV support a violation of section 458.331(1)(nn).

Section 458.331(1)(nn) provides that violating any provision of

[chapter 458] or chapter 456, or any rules adopted pursuant

thereto , is grounds for disciplinary action. Consistent with the

anaylsis rega rding Count IV, Petitioner has established by clear

and convincing evidence that Respondent violated section

458.331(1)(nn), Florida Statutes.

64. The Board of Medicine imposes penalties upon licensees

in accordance with the disciplinary guidelines prescribed in

Florida Administrative Code Rule 64B8 - 8.001. As it relates to

Respondent ' s viol ation of section 458.331(1) ( g), r ule 64B8 -

8.001(2)(g) provides a range ( for a first offense ) from a letter

of concern to revocation or denial and an a dministrativ e fine

from $1,000 to $10,000. As it relates to Respondent ' s violat ion

of section 458.331(1)(nn), r ule 64B8 - 8.001(2)(x)1. provides a

range ( for a first offense ) from a reprimand to revocation or

denial and an administrative fine from $1,000 to $10,000.

65. Rule 64B8 - 8.001(3) provides that, in applying the

penalty guidelines, the following aggravating and mitigating

circumstances shall be considered:

(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

th e 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 - gain inuring

to the applicant or licensee;

(g) The involvement in any violation of

Sectio n 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

recommended 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 mitig ating factors.

66. Having considered the potential aggravating and

mitigating factors, the undersigned does not find compelling

reasons to deviate from the guidelines and, therefore, recommends

that the Board of Medicine impose a penalty that falls within the

recommended range.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

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

order:

1. Finding that Paul M. Goldberg, M.D., violated sections

458.331(1)(g) and (n n), Florida Statutes, as charged in Counts IV

and V of the Complaint;

2. Dismissing Counts I - III of the Complaint;

3. Imposing $20,000 in administrative fines; issuing a

reprimand against Dr. Goldberg ' s medical license; requiring

Dr. Goldberg to compl ete the " Laws and Rules " Course; suspending

Dr. Goldberg ' s medical license until such time as Dr. Goldberg

undergoes a " UF CARES " evaluation; and placing Dr. Goldberg ' s

license on probation for three years under indirect supervision

with 100 percent chart review of c osmetic surgery patients and

25 percent chart review of all other patients.

DONE AND ENTERED this 4th day of March , 2015 , in

Tallahassee, Leon County, Florida.

S

TODD P. RESAVAGE

Administrative Law Judge

Div ision 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 4th day of Marc h , 2015 .

ENDNOTE S

1 / R h ytidectomy is the technical term for what is commonly

referred to as a face lift. Blepharoplasty is the surgical

modification of the eyelid.

2 / The deposition testimony of Michel Samson, M.D., who was

retained as an expert by Respondent, was admitted without

objection by either party. Dr. Samson is certified by the

American Board of Plastic Surgery. Dr. Samson opined that the

type and dosages of drugs administered to M.A. were within the

standard of care; however, Dr. Samson also failed to properly

articulate the appropriate standard of care owed by Respondent.

Respondent also presented the testimony of toxicologist Ralph

Harbison, Ph.D. Dr. Harbison, despite his qualifications, is not

qualified to give expert testimony con cerning the prevailing

standard of care.

3 / Respondent ' s objection, which was overruled, was based solely

on the ground that Respondent did not feel Dr. Berger was

qualified to comment o n anesthesia because Dr. Berger " really

doesn ' t deliver anesthesia in an operative setting. He does pain

management. "

COPIES FURNISHED:

Diane K. Kiesling, Esquire

Department of Health

4052 Bald Cypress Way , Bin C - 65

Tallahassee, Florida 32399

(eServed)

Paul M. Goldberg, M.D.

8180 Valhalla Drive

Delray Beach, Flor ida 33446

Jennifer A. Tschetter, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

(eServed)

Andre Ourso, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way, Bin C03

Tallah assee, 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 Final Order in this case.