16-005752PL Department Of Health, Board Of Medicine vs. Leib Singer, M.D. Status: Closed Recommended Order on Tuesday, March 28, 2017.

Summary: Medical malpractice was not proven where the standard of care was not clearly shown to require a liver biopsy prior to a colonoscopy under the particular circumstances of the patient involved.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF

MEDICINE,

Petitioner,

vs. Case No. 16 - 5752PL

LEIB SINGER, M.D.,

Respondent.

_______________________________/

RECOMMENDED ORDER

On January 23, 201 7, the final hearing was held by video

teleconference at sites in Lauderdale Lakes and Tallahassee,

Florida, before F. Scott Boyd, an Administrative Law Judge

assigned by the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Zachary Bell, E squire

Ross Daniel Vickers, Esquire

Department of Health

Prosecution Services Unit

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

For Respondent: Richa rd T. Woulfe, Esquire

Billing, Cochran, Lyles, Mauro

& Ramsey, P.A.

SunTrust Center, Sixth Floor

515 East Las Olas Boulevard

Fort Lauderdale, Florida 33301

STATEMENT OF THE ISSUE S

The issues in this case are whether Respondent violated

section 458.331(1)(t), Florida Statutes (2009), 1/ by committing

medical malpractice as alleged in the Amended Administrative

Complaint ; and, if so, what is the appropriate sanction.

PREL IMINARY STATEMENT

On December 2, 2014, the Department of Health (Petitioner

or Department) issued an Amended Administrative Complaint against

Leib Singer, M.D. (Respondent or Dr. Singer). The complaint

related to Dr. Singer ' s provision of medical care to

Patient J.R.R. Dr. Singer performed a colonoscopy and

esophagogastroduodenoscopy (EGD or upper endoscopy) on P atient

J.R.R. Dr. Singer disputed allegations of fact in the complaint

and requested a formal hearing. The case was forwarded to the

Division o f Administrative Hearings (DOAH) for assignment of an

administrative law judge on September 30, 2016.

The h earing was initially set for December 7 through 9,

2016, but after continuance upon Respondent ' s unopposed motion,

the final hearing took place on J anuary 23, 2017. The parties

stipulated to certain facts, which are accepted and included

among the Findings of Fact below. Petitioner offered Exhibits

P - 1 through P - 8, including depositions of Dr. Paul Goldberg and

Dr. Robert Goldberg, all of which were admitted into evidence

without objection. Respondent testified and offered the live

testimony of one other witness, Dr. Robert Goldberg. Five of

Respondent ' s exhibits were admitted: Exhibit R - 8, the transcript

and video deposition testimony of Dr. Robe rt Firpi; and Exhibits

R - 10 through R - 13, with the caveat that Exhibit

R - 10, an affidavit of Dr. Robert Goldberg, was hearsay and could

only be used to supplement or explain other evidence. Exhibit

R - 8 was admitted over the objection that Dr. Firpi was no t an

appropriate expert, as discussed in the Conclusions of Law below.

Respondent ' s Exhibits R - 1 through R - 3 and Respondent ' s Exhibits

R - 6 and R - 7 were duplicative of Petitioner ' s exhibits and so were

not separately admitted. Exhibits R - 4, R - 5, and R - 9 w ere

withdrawn by Respondent. Petitioner ' s objections to E xhibits

R - 14 and R - 15 were sustained, and they were not admitted.

Proposed recommended orders were timely filed by both

parties within ten days after February 24, 2017, when the one -

volume Transcri pt was received and posted to the docket. They

were considered in preparation of this Recommended Order.

FINDING S OF FACT

1. The Department is the state agency charged with

regulating the practice of medicine pursuant to section 20.43,

chapter 456, and c hapter 458, Florida Statutes (2016). The Board

of Medicine is charged with final agency action with respect to

physicians licensed pursuant to c hapter 458.

2. At all times material to the complaint, Dr. Singer was a

licensed physician in the state of Flo rida, having been issued

license number ME 34494.

3. Dr. Singer ' s address of record is 4800 North e ast 20th

Terrace, Suite 105, Fort Lauderdale, Florida 33308.

4. Dr. Singer is board - certified in internal medicine and

gastroenterology by the American Boar d of Internal Medicine.

5. An EGD uses a scope to look at the esophagus, stomach,

duodenum, and small bowel. A colonoscopy similarly looks at the

colon, using a slightly different scope.

6. Patient J.R.R. underwent an EGD and colonoscopy on

January 11, 2007, under monitored anesthesia care (MAC). 2/ A two -

millimeter polyp was removed from the transverse colon.

Dr. Singer ' s notes indicate that Patient J.R.R. tolerated the

procedure well. The pathology report on the polyp concluded there

was no evidence of dysplasia or malignancy.

7. Patient J . R . R . suffered from chronic renal failure and

became dependent on dialysis in June of 2008. He was being

consid ered as a candidate for a kidney transplant.

8. Patient J.R.R. underwent an abdominal ultrasound on

A ugust 5, 2008.

9. The report for the August 5, 2008, ultrasound indicated

the study was interpreted by Michael Digiorgio, M.D., to show a

hyperechoic mass within the left lobe of the liver compatible with

hemangioma.

10. Patient J.R.R. underwent an abdo minal computerized

tomography ( CT ) scan without contrast on August 16, 2008.

11. The report for the August 16, 2008, CT scan without

contrast indicated the study was interpreted by Michael

Alboucrek, M.D., to reveal no significant abnormality.

12. On Sep tember 30, 2009, Patient J.R.R. had a pre -

transplant clinic visit at Jackson Health System with Linda J.

Chen, M.D., who assessed the patient as being clinically very

robust and having no absolute contraindications to rule him out

for organ transplant. Al so, Dr. Chen reported that Patient

J.R.R., among other things, would need a screening c olonoscopy and

upper endoscopy.

13. In her report, Dr. Chen described multiple medical

issues for Patient J.R.R. She noted that he was a 69 - year - old

male with more tha n a 35 Î year history of diabetes mellitus and

longstanding hypertension. He was in end - stage kidney disease and

was hemodialysis - dependent. He had a history of congestive heart

failure and coronary artery disease, as well as gastroesophageal

reflux diseas e. He suffered from ischemic cardiomyopathy,

underwent a three - vessel coronary artery bypass graft in August of

2008, and had a pacemaker since that time. His August 2009

echocardiogram showed a relatively good ejection fraction of

35 percent to 40 perce nt with akinesis in the apex and hypokinesis

in the lateral and inferior ventricle. As part of a full pre -

transplant workup, Dr. Chen recommended an abdominal ultrasound

and the screening colonoscopy, as well as the EGD because of his

chronic reflux.

14. It is not uncommon to request these endoscopic

procedures in anticipation of immunosupressants to be given after

a transplant.

15. Patient J.R.R. underwent an abdominal CT scan with

contrast on February 26, 2010.

16. The report for the February 26, 2010 , CT scan indicated

the study was interpreted by Michael Arch, M.D., to show mild

changes of cirrhosis with tiny bilateral pleural effusions.

Multiple hepatic lesions, some of which appeared to demonstrate

faint enhancement and to be new since the non - con trast CT on

August 16, 2008, were found suspicious for malignancy,

particularly metastases.

17. A CT scan conducted with contrast generally enhances the

image and permits more detail to be observed. The report for the

February 26, 2010, CT scan indicate d the possibility that some

abnormalities in the scan that appear to be new might actually

have been present earlier at the time the CT scan without contrast

was done.

18. Without specialized training, a gastroenterologist is

not independently qualified t o review and interpret radiological

imaging. Neither Dr. Singer, nor any of the experts who testified

at hearing, had this specialized training.

19. On March 2, 2010, Patient J.R.R. ' s referring physician,

Dr. Luis Cortez, requested an evaluation of Pati ent J.R.R. That

prescription referred to the recent CT scan showing possible

metastatic disease and ascites, stated that there had been a prior

colonoscopy in 2007 that was positive for a left - sided polyp, and

noted Patient J.R.R. had " congestive heart fa ilure and renal

failure. "

20. Ascites is an accumulation of fluid in the abdomen.

Ascites can make a liver biopsy more difficult and increase the

risk of bleeding, because the liver is displaced from the skin ,

and it can be difficult to apply pressure.

2 1. There was no indication of malignancy in Patient

J.R.R. ' s liver other than radiologic findings.

22. When advised of the possibility of cancer, without

confirmation, a gastroenterologist ' s responsibility is to attempt

to locate the cancer, determine it s primary source, and determine

how extensive it is.

23. The vast majority of cancers found within the liver do

not originate solely within the liver, but are metastases from a

different location, termed the primary source. The colon is the

single most c ommon site of primary tumors, but the primary could

also be in the lungs, stomach, or other organs.

24. When it is suspected that cancer may be present in the

liver, liver function tests may be ordered, which can indicate if

cancer may be blocking a bile duct or if there is damage to the

liver that might have been caused by cancer.

25. The April 14, 2010, history note by Dr. Singer indicated

that the liver function tests conducted for Patient J.R.R. were

normal.

26. Weight loss can be an indicator of c ancer. Patient

J.R.R. had not experienced weight loss.

27. Tumor markers from the blood may also be ordered to

assist in identifying possible cancers and helping to locate them.

Various markers are highly associated with certain specific organ

cancers and so can indicate where to focus attention. For

example, CA - 125 is highly suggestive of ovarian cancer, CA 19 - 9 is

highly suggestive of pancreatic or biliary cancer,

carcinoembryonic antigen (CEA) is highly suggestive of

gastrointestinal malignancies -- t hough it can be seen with other

malignancies as well -- and alpha - fetoprotein (AFP) is suggestive of

primary liver cancer.

28. Laboratory work for Patient J.R.R., dated March 8, 2010,

showed readings for the AFP tumor marker at less than 1.3 ng/mL,

CEA at l ess than .5 ng/mL, and CA 19 - 9 at 22 units/mL. The

April 14, 2010, history note by Dr. Singer indicated that CEA,

AFP , and CA 19 - 9 were normal. The normal AFP reading suggested

that if there was cancer in the liver, it was most likely

metastatic, and not primary, though not all patients with primary

liver cancer exhibit elevated AFP. The reading did not confirm

the presence of cancer.

29. Diagnostic imaging, such as CT scans and ultrasounds,

can help locate suspected cancer. Radiologists examine the

im aging and issue a report. Radiological imaging can tell a

radiologist if there is something abnormal in the body that could

be potentially malignant and can help to identify its location.

30. Dr. Singer ordered an abdominal ultrasound and a

liver/spleen scan for Patient J.R.R., which Patient J.R.R.

underwent on April 28, 2010.

31. The abdominal ultrasound report dated April 28, 2010,

indicated the study was interpreted by George Koshy, M.D., to show

multiple echogenic lesions throughout the liver suspici ous for

metastases as previously described by CT scan .

32. In a liver spleen scan, a radionuclide is injected into

the body, and is picked up by various cells. A liver spleen scan

has limited utility for evaluating nodules or lesions, but gives

informati on on how the liver is functioning.

33. Patient J.R.R. might also have been referred to an

interventional radiologist for a directed percutaneous biopsy of

the liver. In 2010, most interventional radiologists used

conscious sedation when they performed l iver biopsies, although

other forms of sedation might be used. Conscious sedation is a

state of sedation in which the patient is sleepy, but arousable,

comfortable for the procedure, and generally without loss of

protective reflexes, like the gag reflex, or withdrawing from

painful stimuli.

34. The tissue obtained from a liver biopsy would then have

been sent to a pathologist. A pathologist can usually tell if the

tissue obtained is malignant or not. If metastatic malignancy is

identified, the patholog ist can frequently narrow down the

location of the primary cancer through the use of immunoperoxidase

stains.

35. Interventional radiologists use radiologic imaging to

guide a percutaneous liver biopsy. This slightly decreases the

risk of perforation o f large blood vessels or bile ducts, and

allows a specific portion of the liver to be targeted for biopsy.

The primary risks associated with liver biopsy include perforation

and bleeding. There are also risks related to the anesthesia

used.

36. In con ducting a liver biopsy, tissue must come from the

mass or the filling defect, so the needle must get right into the

abnormal area to be successful. If the tissue sample taken is

from a part of the liver that is normal, it will fail to diagnose

the suspect ed cancer.

37. Dr. Singer did not order a liver biopsy for Patient

J.R.R., but decided to proceed with an EGD and colonoscopy.

38. Patient J.R.R. was scheduled to undergo a colonoscopy

and upper endoscopy on April 30, 2010, at Broward General Medical

Cen ter, and Dr. Singer was scheduled to perform the procedures.

39. Complications related to colonoscopies performed under

MAC include perforation and bleeding.

40. Complications related to upper endoscopies performed

under MAC include perforation and bleed ing.

41. Risks with MAC, usually used to perform an EGD or

colonoscopy, include respiratory and cardiac arrest and

respiratory insufficiency. Patients are breathing for themselves .

I f their breathing is suppressed or they are obstructing their

airway -- w ith their tongue, for example -- their oxygen saturation

drops. Propofol, the most commonly used anesthetic, is cardio -

reactive and can cause a drop in blood pressure. These are

reasons why sedation is monitored by an anesthesiologist or nurse

anesthetist. The anesthesiologist determines what form of

sedation is best for a particular patient. A gastroenterologist

must consider anesthesia along with all of the risks of a

procedure. The anesthesiologist is the " final gatekeeper " with

respect to risks of an esthesia.

42. Conscious sedation is usually considered less risky than

MAC, but with some patients, the anesthesia risks of conscious

sedation can be even higher than those with MAC. As Dr. Paul

Goldberg testified, sometimes an anesthesiologist might dec line to

do MAC:

Or they ' ll say to you, they won ' t Ï they ' ll say

I ' m not doing it. You can do it on your own,

but that ' s called insanity. If the

anesthesiologist think ' s it ' s too risky to do

the case then the Ï only the fool goes ahead

under most circumstance s and does it without

them because the risk of doing conscious

sedation to that patient is higher than the

risk of doing managed care.

43. Prior to performing the colonoscopy and upper endoscopy,

Dr. Singer was aware that Patient J.R.R. had multiple docu mented

comorbidities.

44. The comorbidities of primary concern with endoscopic

procedures relate to the need for MAC sedation, and include

respiratory issues, cardiac issues, and metabolic issues.

45. Patients with significant comorbidities have a highe r

chance of complication during surgery compared to those without

comorbidities.

46. Patient J.R.R. ' s April 30, 2010, colonoscopy and upper

endoscopy procedures were performed under MAC using Propofol.

47. Dr. Singer has the authority to forego proceedi ng with a

surgery, or cancel a surgery, if he believes the surgery is not in

the best interests of the patient.

48. Statistically speaking, the risks for a liver biopsy are

lower than the risks for a colonoscopy. While the risks for

either procedure are low, in general the risks in a colonoscopy

are approximately five times the risks of a liver biopsy.

49. A gastroenterologist attempts to minimize risks to the

patient and so attempts to diagnose as noninvasively as possible.

A gastroenterologist must c arefully consider the individual

patient and his comorbidities when weighing how safe it is to

undertake a given procedure. What is safe for one patient may not

be safe for another. Especially with elderly patients who exhibit

numerous comorbidities, it is necessary to look at the risk of a

procedure versus the benefit to be gained from it. All of the

experts agreed that each patient must be considered individually .

50. Despite knowing of the possible liver malignancy,

Dr. Singer elected to continue wit h the colonoscopy and upper

endoscopy.

51. Patient J.R.R. expired in the operating room immediately

following the completion of the April 30, 2010, colonoscopy and

upper endoscopy, while still under the effects of anesthesia.

Experts and Standard of Care

52. Dr. Paul Goldberg is licensed to practice medicine in

the state of Florida. He is board - certified in the specialty of

internal medicine and in the subspecialty of gastroenterology. He

is a fellow of the American College of Gastroenterology and the

American Gastroenterological Association. He is a member of the

American Society for Gastrointestinal Endoscopy and of ASPEN, the

American Society for Parenteral and Enteral Nutrition.

53. Dr. Paul Goldberg has active privileges at the Villages

Regiona l Hospital, Florida Hospital Waterman in Tavares, and

Leesburg Regional Medical Center in Leesburg. He also has

affiliate staff privileges at Halifax Health in Daytona Beach and

at Memorial Hospital Daytona Beach. He was in the active practice

of gastroe nterology in the three years before April 2010.

54. Dr. Paul Goldberg conducted a review of Patient J.R.R. ' s

pertinent medical records, including records created by

Dr. Singer. He did not review the March 2, 2010, request of

Dr. Luis Cortez for an evalu ation of Patient J.R.R. or the

references there to the CT scan showing possible metastatic

disease and ascites, and noting Patient J.R.R. ' s " congestive heart

failure and renal failure. "

55. Dr. Robert Goldberg is a licensed Florida medical doctor

who spec ializes in internal medicine and has a subspecialty in

gastroenterology. He has been board - certified in both for more

than 25 years. He is a full - time faculty member of the University

of Miami. He teaches medical students from that school -- as well

as st udents from Florida International University and Nova

Southeastern -- how to conduct histories primarily related to

gastroenterology and provides opportunities for them to observe

endoscopic procedures. He gives lectures to residents on

gastrointestinal phy siology and teaches sedation and monitoring

during endoscopic procedures.

56. Dr. Robert Goldberg has hospital privileges at Mount

Sinai Medical Center and concentrates about 90 percent of his

practice in the subspecialty of gastroenterology. He was in

active clinical practice of gastroenterology and routinely

performed EGDs, colonoscopies, and dilations in the three years

before April 2010. He used to perform liver biopsies, but n o

longer does so.

57. Dr. Robert Goldberg conducted a complete review o f

Patient J.R.R. ' s pertinent medical records.

58. Dr. Roberto Firpi is a licensed Florida medical doctor

who specializes in internal medicine and has subspecialties in

gastroenterology and transplant hepatology. He is a fellow of the

American College of Gastroenterology and a fellow of the American

Gastroenterological Association. He is also a member of the

American Association of the Study of Liver Disease and the

European Association of the Study of Liver Disease. He has

hospital privileges at the Uni versity of Florida and the Veterans

Administration Hospital in Gainesville. He had an active clinical

practice for at least three years prior to April 2010, in which he

practiced in gastroenterology and liver diseases.

59. Dr. Firpi is also an associate professor of medicine at

University of Florida , Department of Medicine, Division of

Gastroenterology and Hepatology. During the three years prior to

April 2010, he taught medical students liver disease and

instructed fellows on procedures such as colonosc opies,

endoscopies, and liver biopsies. He also gave lectures to

residents on gastrointestinal physiology and taught sedation and

monitoring during endoscopic procedures.

60. Dr. Firpi conducted a complete review of Patient

J.R.R. ' s pertinent medical r ecords.

61. Dr. Paul Goldberg, Dr. Robert Goldberg, and Dr. Firpi

are all experts in gastroenterology and have knowledge, skill,

experience, training, and education in the prevailing professional

standard of care recognized as acceptable and appropriate b y

reasonably prudent gastroenterologists.

62. There was considerable divergence in their testimony and

opinions as to the applicable standard of care for a

gastroenterologist treating a patient similar to Patient J.R.R.

63. Dr. Paul Goldberg indicated th at a liver biopsy should

be done before a colonoscopy unless there was a strong indication

that the metastases was originating in the colon, testifying:

Q: If you suspected that the cancer Ï the

origin source of the cancer Ï was in the colon,

would the colono scopy help you determine that?

A: Based upon Ï I mean it depends upon how

strongly I suspect it and what I ' m seeing. If

I had a CT scan that showed a mass in the

colon, yeah, absolutely I would look with a

colonoscope. If I had a mildly elevated CEA,

no, that wouldn ' t be Ï and holes in liver, no,

that wouldn ' t be my first choice because it ' s,

you know, I would get the liver biopsy first

because it tends Ï it would be more useful to

get that information because I ' m not Ï I really

don ' t have a good indication it ' s coming from

the colon.

64. Dr. Paul Goldberg testified that due to the risks of

sedation, the risk of a liver biopsy is less than the risk of a

colonoscopy in a patient with heart disease, congestive heart

failure, diabetes, respiratory issues, and sle ep apnea.

65. It was Dr. Paul Goldberg ' s opinion that scheduling and

performing the EGD and colonoscopy procedures, which required

Patient J.R.R. to be placed under MAC, before more thoroughly

evaluating the abnormalities identified in the radiologic find ings

by conducting a liver biopsy, fell below the standard of care

applicable to a prudent gastroenterologist with training similar

to that of Dr. Singer.

66. Dr. Robert Goldberg concurred that if metastases in the

liver w ere strongly shown, a liver biops y would be appropriate,

but concluded that it was not strongly shown in Patient J.R.R.,

testifying:

Q: And if those imaging studies indicated

that the nodules in the liver were potentially

metastatic, and the blood tests did not

indicate any particular ca ncer, would you go

to a colonoscopy as your next diagnostic tool?

A: Yeah. You are creating a hypothetical. I

would look at the case and, you know,

specifically, what are their blood tests? Has

the patient lost weight? Is the patient

having abdominal pain? Is the patient anemic?

Are the liver function tests abnormal? Is Î

am I strongly thinking that this is metastatic

cancer, or am I thinking these are benign

nodules Î regenerating nodules? For example,

in the context of cirrhosis, hemangioma, et

cetera. So it all depends on the specifics of

the case.

Q: What if the report from the CT scan said

the nodules were suspicious for metastases,

and then an ultrasound confirmed the same

report?

A: Were they present before?

Q: What if that was unclea r?

A: Well, I - Î I would have to, again, review

the reports and see what is being said, and if

the information strongly supported that this

was metastatic liver disease, I would consider

doing a liver biopsy.

Q: Okay. And what evidence would you be

lo oking at to strongly support that?

A: Weight loss, abnormal liver function

tests, lesions which radiologically are

suggestive of metastatic liver disease,

lesions which have clearly changed over a

period of time. It would have to be a

clinical suspiciou s Î suspicion of metastatic

liver disease.

67. Dr. Robert Goldberg further testified:

Q: Finally, doctor, do you -- is it your

opinion that Dr. Singer acted appropriately

and within the standard of care for physicians

like him -- as a gastroenterologist -- i n his

care, treatment, assessment and evaluation of

this patient and going forward with the

colonoscopy when he did?

A: It is. I believe that Dr. Singer acted

appropriately, prudently, thoughtfully, and as

I go over the records, even in retrospect, I

su spect I would have acted very similarly.

68. Dr. Robert Goldberg found it significant that the report

of the later scan, with contrast, also seemed to indicate that

there were several lesions that had n o t changed at all. He

thought it unlikely that if t hese were cancerous lesions present a

year and a half before, that there would have been no weight loss,

no evidence of impaired liver function, and no direct symptoms

accompanying metastatic liver disease. He also noted that if

Patient J.R.R. had regener ative nodules and hemangioma, there was

an increased risk of bleeding with a liver biopsy that could be

significant.

69. It was Dr. Fir pi ' s opinion that even if metastatic

disease was clearly shown, that a liver biopsy would not be

necessary for a p atient similar to Patient J.R.R., testifying:

Q: Would you order a colonoscopy?

A: Yes, I would.

Q: And what would you be looking for? How

would that help you?

A: It will help me find out if the primary is

colon cancer. You need to know is the primary

f rom there and do staging.

Q: Would you order the colonoscopy regardless

of the results of the liver function tests and

cancer markers?

A: If they ' re telling me in radiology that

this is metastatic disease or it looks like

metastatic disease, I would ha ve ordered the

colonoscopy.

Q: So for every patient that ' s referred to

you for a liver evaluation you do a

colonoscopy?

A: Not for a liver evaluation. For liver

metastasis.

Q: So for every patient that ' s referred to

you for lesions in the liver susp icious for

metastases you do a colonoscopy?

A: They should have a colonoscopy.

Q: Even patients with significant

comorbidities?

A: Yes.

Q: Would you include a liver biopsy?

A: I ' m not sure why. I don ' t think so. I

would say no.

70. Dr. Firpi testified that the standard of care for a

patient with all of the conditions and circumstances of Patient

J.R.R. required that a colonoscopy and endoscopy be conducted if a

CT scan determined that there was metastatic disease in the liver.

He testified th at he would not have done anything differently than

Dr. Singer did.

71. Dr. Singer testified that in the particular case of

Patient J.R.R., he concluded that the risks of a liver biopsy were

in fact greater than the risks of an EGD and colonoscopy, due to

the greater ability to control complications in endoscopic

procedures, possible liver hemangioma, coagulation problems,

ascites, and renal failure. Dr. Singer testified that there were

multiple reasons to conduct a colonoscopy: elapsed time since the

pr evious colonoscopy; the possibility of metastatic liver cancer;

and the transplant clearance. Given increased risk for a liver

biopsy and the fact that the colon was the most likely spot for a

primary tumor, he testified that he decided to perform the EGD and

colonoscopy before a liver biopsy.

72. It was not clearly shown that, in scheduling and

performing the EGD and colonoscopy on Patient J.R.R. prior to

further evaluation of the abnormal radiologic evaluations of

possible metastatic lesions or cirrhos is of the liver, Dr. Singer

deviated from the standard of care recognized as acceptable and

appropriate by reasonably prudent similar health care providers.

73. It was stipulated that Dr. Singer did not deviate from

the standard of care in his actual perf ormance of Patient J.R.R. ' s

April 30, 2010, colonoscopy and upper endoscopy procedures.

74. No evidence was introduced to show that Dr. Singer has

had any prior discipline imposed upon his license.

75. Dr. Singer was not under any legal restraints on

Apr il 30, 2010.

76. It was not shown that Dr. Singer received any special

pecuniary benefit or self - gain from his actions on April 30, 2010.

77. It was not shown that the actions of Dr. Singer on

April 30, 2010, involved any trade or sale of controlled

subs tances.

CONCLUSIONS OF LAW

78. The Division of Administrative Hearings has jurisdiction

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

Florida Statutes (2016).

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

discipline upon a licens e is penal in nature. State ex rel.

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

1973). Petitioner must therefore prove the charges against

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

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

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

1996)).

80. The clear and convincing standard of proof has been

described by the Florida Supreme Court:

Clear and convincing evidence requires that

the evidence must b e 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 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 hesitancy,

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. 4 th DCA 1983)).

81. D isciplinary statutes and rules " must always be

construed strictly 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).

82. Before consideration of the charges of the Amended

Administrative Complaint, two evidentiary issues merit

discussion. First, Responde nt objected during deposition, on

grounds of hearsay and bolstering, to portions of Dr. Paul

Goldberg ' s testimony in which he indicated that he had relied

upon literature in forming his opinion. The general rule is that

an expert may not bolster his testi mony by testifying that a

particular treatise supports his opinion. The evidence code

specifically addresses this issue. Under section 90.704, Florida

Statutes, data that is of a type reasonably relied upon by

similar experts may form a basis of an exper t opinion, but data

that is not otherwise admissible may be disclosed to a jury only

if its probative value substantially outweighs its prejudicial

effect. See also Linn v. Fossum , 946 So. 2d 1032, 1036 (Fla.

2006).

83. The rules of evidence in administr ative proceedings are

less strict than those applicable to civil proceedings, and

hearsay is admissible to supplement or explain other competent

evidence. § 120.57(1)(c), Fla. Stat. Here, where Dr. Paul

Goldberg did not mention any particular literature or treatise by

name, but only mentioned that he had reviewed some literature

along with the medical records, there was no inappropriate

bolstering or prejudice to Respondent. Further, the hearsay

information he referenced may properly be considered becaus e it

supplements and explains his opinion that the risks of the EGD and

colonoscopy under sedation were greater than the risks of a

percutaneous liver biopsy. Orasan v. Ag. for Health Care Admin. ,

668 So. 2d 1062, 1063 (Fla. 1st DCA 1996)(error for hearin g

officer to sustain objection that hearsay evidence was

inadmissible as bolstering appellant ' s testimony).

84. Second, Petitioner objected, through its Motion in

Limine, to the admission of the deposition testimony of Dr. Firpi

on the grounds that while he is board - certified in the specialty

of internal medicine with a subspecialty in gastroenterology, he

also holds certification in another subspecialty, that of

transplant hepatology, while Respondent is only board - certified in

internal medicine with a su bspecialty in gastroenterology.

85. Section 458.331(1)(t)1. provided that the Board of

Medicine shall give great weight to the provisions of section

766.102, Florida Statutes, in proceedings involving allegations of

medical malpractice as grounds for di sciplinary action.

86. Section 766.102(5)(a) provided in relevant part that an

expert must:

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 in cludes the

evaluation, diagnosis, or treatment of the

medical condition that is the subject of the

claim and have prior experience treating

similar patients [.]

87. Even were the subspecialty of transplant hepatology not

sufficiently similar to the subspe cialty of gastroenterology under

this provision, this is not a situation in which the testimony of

a specialist is being offered against a generalist, or conversely

where the testimony of a generalist is being offered against a

specialist, both clearly for bidden. Instead, the proffered expert

here is certified in the same specialty, as well as the same

subspecialty, in which Respondent is certified. Dr. Firpi also

had both an active clinical practice, and instructed students and

residents, in gastroentero logy within the three years immediately

preceding April 2010. Dr. Firpi is qualified by his education,

training, and experience to testify as to the prevailing

professional standard of care applicable to an internal medicine

specialist with a subspecialty in gastroenterology, such as

Respondent. § 766.102(5)(a)2.a., b. , Fla. Stat. To the extent

that Dr. Firpi is also a subspecialist in another area, this does

not disqualify him as an expert in the same subspecialty as

Respondent, but rather places respon sibility on all parties to

ensure that offered testimony is relevant as to the standard of

care governing Respondent. After argument on the Motion in Limine

at hearing, 3/ Respondent ' s Exhibit R - 8 was admitted over

Petitioner ' s objection (subject to object ions made within the

deposition).

88. The Amended Administrative Complaint alleged that

Respondent committed medical malpractice in violation of section

458.331, which provided, in relevant part:

(1) The following acts constitute grounds for

. . . disci plinary action . . . .

* * *

(t)1. Committing medical malpractice as

defined in s. 456.50.

89. Section 456.50(1)(g), Florida Statutes, defined " medical

malpractice " in relevant part as the failure to practice medicine

in accordance with the l evel of care, skill, and treatment

recognized in general law related to health care licensure.

90. Section 766.102(1) further provided in part that " the

prevailing professional standard of care for a given health care

provider shall be that level of care , skill, and treatment which,

in light of all relevant surrounding circumstances, is recognized

as acceptable and appropriate by reasonably prudent similar

health care providers. "

91. Petitioner alleged that Respondent committed medical

malpractice in:

a. failing to cancel or postpone J.R.R. ' s

April 30, 2010, surgical procedures, pending

an evaluation of J.R.R. ' s potential liver

malignancies; and/or

b. failing to pursue the abnormal findings of

the multiple radiologic evaluations of

possible metastatic lesions, and/or cirrhosis

of J.R.R. ' s liver prior to performing the

April 30, 2010, procedure on Respondent.

92. The essence of Dr. Paul Goldberg ' s analysis in support

of the complaint was that the least invasive diagnostic procedure

should be utilized a nd that, primarily due to the type of

anesthesia necessary, a liver biopsy entailed less risk than an

EGD and colonoscopy.

93. While Petitioner presented convincing evidence that,

statistically, an EGD and colonoscopy does involve more risk than

a liver biopsy for patients generally, due in large part to the

anesthesia used, this showing alone was insufficient to clearly

and convincingly demonstrate malpractice. Under appropriate

" risk - benefit " evaluation, the relative benefits of the two

approaches in a patient similar to Patient J.R.R. must also be

considered. The evidence that the liver biopsy would have

provided sufficient benefits in light of its risks as compared to

the overall risks and benefits of the EGD and colonoscopy for

Patient J.R.R. was st rongly contested, and not clearly and

convincingly shown.

94. Petitioner failed to establish by clear and convincing

evidence that Respondent committed medical malpractice i n

violation of section 458.331(1)(t)1., as charged in the Amended

Administrative C omplaint.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is

RECOMMENDED that a final order be entered by the Department

of Health, Board of Medicine, dismissing the Amended

Administrative Complaint against Dr. Leib Singe r.

DONE AND ENTERED this 28th day of March , 2017 , in

Tallahassee, Leon County, Florida.

S

F. SCOTT BOYD

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 28th day of March , 2017 .

ENDNOTE S

1/ Citations to statutes are to those versions in effect during

t he time of Respondent ' s treatment of J.R.R. in April 2010, except

as otherwise indicated.

2/ EGDs and colonoscopies are usually performed under monitored

anesthesia care (MAC). Patients receive a sedative, in most cases

Propofol, and they are unconsciou s during the procedure. Patients

are monitored by a nurse anesthetist or anesthesiologist.

3/ Although ruling on the Motion in Limine was deferred to the

hearing, neither party offered evidence, instead agreeing that the

specialties and subspecialties w ere identical on their face, and

focusing argument upon the effect of the additional subspecialty

certification held by Dr. Firpi. Section 766.102 by its terms

governs the qualifications of an expert at hearing. That statute

has been applied by Florida c ourts in the version that exists at

the time of the incident. See, e.g. , Williams v. Oken , 62 So. 3d

1129, 1131 (Fla. 2011) (referencing the 2005 version of presuit

requirements, not the version later in effect). The Florida

Supreme Court declined to ado pt the " same specialty " amendment

made by chapter 2013 - 108, § 2, Laws of Florida. See In re

Amendments to the Fla. Evidence Code , No. SC16 - 181, 2017 Fla.

LEXIS 338, at *21 (Feb. 16, 2017). Whether or not the " same or

similar specialty " or " same specialty " language is applied, the

result would be the same in this case, as discussed above.

COPIES FURNISHED:

Zachary Bell, Esquire

Ross Daniel Vickers, Esquire

Department of Health

Prosecution Services Unit

4052 Bald Cypress Way , Bin C - 65

Tallahassee, Florid a 32399 - 3265

(eServed)

Richard T. Woulfe, Esquire

Billing, Cochran, Lyles, Mauro

& Ramsey, P.A.

SunTrust Center, Sixth Floor

515 East Las Olas Boulevard

Fort Lauderdale, Florida 33301

(eServed)

Nichole C. Geary, General Counsel

Department of Heal th

4052 Bald Cypress Way, Bin A - 02

Tallahassee, Florida 32399 - 1701

(eServed)

Claudia Kemp, J.D., Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way, Bin C - 03

Tallahassee, Florida 32399 - 3253

(eServed)

NOTICE OF RIGHT TO SUB MIT 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.