09-005457PL Department Of Health, Board Of Medicine vs. Bernard J. Zaragoza, M.D. Status: Closed Recommended Order on Tuesday, April 6, 2010.

Summary: Respondent performed wrong procedure when he removed patient's kideny during gallbladder removal surgery.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 09-5457PL

)

BERNARD J. ZARAGOZA, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

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

before Larry J. Sartin, an Administrative Law Judge of the

Division of Administrative Hearings, on February 17, 2010, by

video teleconference between Lauderdale Lakes and Tallahassee,

Florida.

APPEARANCES

For Petitioner: Robert A. Milne

Assistant General Counsel

Diane K. Kiesling

Assistant General Counsel

Department of Health

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399-3265

For Respondent: Rolando A. Diaz, Esquire

Kubicki & Draper

25 West Flagler Street, Penthouse

Miami, Florida 33130

STATEMENT OF THE ISSUES

The issues for determination are whether Respondent Bernard

J. Zaragoza, M.D., violated Section 456.072(1)(bb), Florida

Statutes (2007), as alleged in an Administrative Complaint filed

by the Department of Health before the Board of Medicine on

June 30, 2008; and, if so, what disciplinary action should be

taken against his license to practice medicine in the State of

Florida.

PRELIMINARY STATEMENT

This case began with the filing by the Department of Health

before the Board of Medicine of an Administrative Complaint, DOH

Case Number 2007-38874, against Respondent Bernard J. Zaragoza,

M.D., an individual licensed to practice medicine in Florida.

On or about August 4, 2008, Respondent, through counsel, filed a

letter in which, among other things, the allegations of fact

contained in the Administrative Complaint were disputed and a

formal administrative hearing was requested.

On October 6, 2009, the matter was filed with the Division

of Administrative Hearings with a request that an administrative

law judge be assigned to conduct proceedings pursuant to Section

120.57(1), Florida Statutes (2009). The matter was designated

DOAH Case Number 09-5457PL and was assigned to the undersigned.

The final hearing was scheduled to be held on January 19

through 21, 2010, by video teleconference between sites in Miami

and Tallahassee, Florida, by Notice of Hearing by Video

Teleconference entered October 16, 2009. The hearing was

continued at the request of Respondent and re-scheduled for

February 17, 2010. The hearing was to be held in Miami. On

February 9, 2010, an Amended Notice of Hearing by Video

Teleconference was entered.

On February 16, 2010, the parties filed a Revised Joint

Pre-Hearing Stipulation. That pleading contains stipulated

findings of fact which have been included in this Recommended

Order.

On February 17, 2010, an Order Granting Motion for Official

Recognition filed by Petitioner was entered.

During the final hearing, Joint Exhibits 1 through 3 were

admitted. Petitioner presented the testimony of Respondent and

had Petitioner’s Exhibits 4 through 6, and 10 through 14

admitted. Petitioner also presented the rebuttal testimony of

Christian Birkedal, M.D. Respondent offered the deposition

testimony of Danny Sleeman, M.D. The transcript of the

deposition of Dr. Sleeman was admitted as Respondent’s

Exhibit 6.

The one-volume Transcript of the final hearing was filed on

March 4, 2010. By Notice of Filing Transcript entered the same

day, the parties were informed that the Transcript had been

filed and that their proposed recommended orders were to be

filed on or by March 15, 2010. Both parties timely filed

proposed orders. The post-hearing proposals of both parties

have been fully considered in rendering this Recommended Order.

All references to Florida Statutes in this Recommended

Order are to the 2007 version, unless otherwise indicated.

FINDINGS OF FACT

A. The Parties .

1. Petitioner, the Department of Health (hereinafter

referred to as the "Department"), is the agency of the State of

Florida charged with the responsibility for the investigation

and prosecution of complaints involving physicians licensed to

practice medicine in Florida. § 20.43 and Chs. 456 and 458,

Fla. Stat.

2. Respondent, Bernard J. Zaragoza, M.D., is, and was at

the times material to this matter, a physician licensed to

practice medicine in Florida, having been issued license number

ME 67920.

3. Dr. Zaragoza’s address of record is 3100 Coral Hills

Drive, Suite 207, Coral Springs, Florida 33065.

4. Dr. Zaragoza is certified in general surgery by the

American Board of Surgery.

5. Dr. Zaragoza has not been the subject of any

investigation, claim, or complaint relating to his professional

career other than this matter.

6. Dr. Zaragoza graduated, Summa Cum Laude, from the

University of Miami with a bachelors degree. He earned his

medical degree from Harvard Medical School.

7. Dr. Zaragoza performed a five-year surgical residency

program at New York Medical College’s Westchester County Medical

Center. During his residency, Dr. Zaragoza performed hundreds

of laparoscopic procedures, including laparoscopic

cholechstectomies (removal of the gallbladder).

8. A laparoscopic surgery is a technique in which the

abdomen is entered through small incisions rather than “opening

up” the abdomen. Normally, for abdominal laparoscopic surgery,

incisions are made at the belly button. This is the point which

is usually closest to the peritoneal cavity, thus reducing the

distance from the skin the surgeon must work through and the

surgeon has a broader view of the abdomen.

9. By October 2007, Dr. Zaragoza had performed in excess

of 2,000 laparoscopic cholecystectomy procedures.

B. Patient J.C.

10. On October 1, 2007, Patient J.C., a male, 83 years of

age, presented at Northwest Medical Center, located in Margate,

Florida, for treatment of abdominal pain and vomiting. Patient

J.C. had reported with the same symptoms a month earlier and had

been diagnosed with chronic cholecystitis, a chronic

inflammation of the gallbladder due to the blockage of the bile

ducts by gall stones. It is a life-threatening condition.

11. Patient J.C. was admitted by Rafael Rodriguez, M.D.,

who requested a consultation by Mark Shachner, M.D.,

Dr. Zaragoza’s partner. Dr. Shachner confirmed a diagnosis of

acute cholecystitis and, in light of the failed conservative

therapy which Patient J.C. had undergone since his first visit

and the potential threat to his life, Dr. Shachner recommended

surgery.

12. It was concluded that Patient J.C. would undergo an

attempted laparoscopic cholecystectomy. Dr. Zaragoza was to

perform the procedure.

13. It was concluded that a laparoscopic procedure was the

appropriate procedure for Patient J.C. due to his medical

history: atrial fibrillation, Alzheimer’s disease,

hypertension, and diabetes. He had also undergone prior

abdominal procedures. The parties did not dispute that a

laparoscopic procedure, because it was likely to reduce post-

operative complications, was the best type of surgical procedure

for Patient J.C.

14. Patient J.C., as a result of a prior gastrectomy, had

a long midline incision extending from the Xiphoid upper abdomen

to below the belly button. As a result of this surgery, Patient

J.C. had extensive adhesions of tissue up to the midline.

Patient J.C. had also undergone an appendectomy.

15. It was concluded that, due to Patient J.C.’s condition

and abdominal surgical history, rather than entering at the

belly button and risking injury to any structures that were

adhesed to the midline, a “right-sided” incision point would be

used. The Department does not dispute the appropriateness of

this decision.

16. Unfortunately, by using a right-sided incision point,

Dr. Zaragoza’s visualization of Patient J.C.’s abdominal cavity

was reduced.

17. Patient J.C. and his family were fully informed of the

nature of the proposed surgical procedure and the risks, after

which Patient J.C. signed a written consent for surgery. The

written consent included an authorization to “take whatever

action(s) and to perform whatever procedures(s) they deem

necessary and advisable, which may be in addition to or

different from those now planned” and an acknowledgement that

the surgery to be performed “may result in perforation or injury

to adjacent organs or structures.”

18. None of the witnesses convincingly testified that the

authorization included the authority to remove healthy organs or

that the acknowledgement included any suggestion that a healthy

organ might be completely removed.

19. Surgery was scheduled for October 2, 2007.

20. Dr. Zaragoza began the surgery with a right-sided

approach, freeing up the area and attempting to identify

important structures in the right upper quadrant of the abdomen.

In particular, the important structures Dr. Zaragoza attempted

to locate were the liver, colon, and the gallbladder.

21. Dr. Zaragoza encountered extremely heavy adhesions

(8 on a scale of 1 to 10) in Patient J.C.’s abdomen.

Dr. Zaragoza considered the risks of continuing or switching to

an open abdomen procedure and correctly concluded it was best to

proceed.

22. Dr. Zaragoza freed up extensive adhesions and was able

to correctly identify the liver. Unable to identify the

gallbladder and due to the extensive adhesions in the area of

the intestine, Dr. Zaragoza stopped the procedure in order to

retrieve a CT scan of the area and personally evaluate the

images. In order to expedite receipt of the CT study,

Dr. Zaragoza scrubbed out and personally walked to the radiology

suite.

23. After returning, Dr. Zaragoza read the CT scan and the

radiologist’s interpretation, which indicated that the

gallbladder was posterior to the transverse colon. Dr. Zaragoza

returned to Patient J.C., mobilized the colon to free it from

the liver and attempted to locate the gallbladder behind the

colon where he expected it to be.

24. What Dr. Zaragoza found behind the transverse colon

was a dark, thickened, and solid structure in the anatomical

position which the CT scan and radiologist report suggested the

gallbladder would be located.

25. While the gallbladder, which consists of a water sac,

is normally soft, pink, and pliable, this is not the case with

an inflamed and infected one. Given Patient J.C.’s history of

chronic cholecystitis with an acute cholecystitis secondary to

the blockage of bile ducts by gallstones, Dr. Zaragoza was

expecting to find a dark, thickened, and solid gallbladder in

Patient J.C.

26. Concluding that the structure he had located was the

gallbladder, Dr. Zaragoza freed the organ of surrounding tissue,

freeing away without incision adhesions to the organ, bringing

the organ into position for removal. As Dr. Zaragoza began to

free up the fat tissue around what he believed were the bile

duct and blood vessels of the gallbladder, the organ ruptured,

revealing a solid mass. Dr. Zaragoza believed that the mass was

a tumor, which Dr. Zaragoza had encountered in other gallbladder

surgeries.

27. Dr. Zaragoza continued the procedure, separating the

gallbladder for removal. While dividing what he believed was a

cystic duct, Dr. Zaragoza encountered a bifurcation that did not

correspond to the anatomy of the gallbladder. At this point,

Dr. Zaragoza decided that surgery needed to be converted from

laparoscopic to an open procedure. After doing so, a frozen

section of the organ was sent to pathology for evaluation, in

order to obtain a rapid evaluation of the tissue.

28. The pathology report revealed that the organ that

Dr. Zaragoza had removed from Patient J.C. was a healthy kidney.

29. Dr. Zaragoza thereupon located the gallbladder by

examining the dense adhesions around the colon, a risky

procedure. Ultimately Dr. Zaragoza was required to cut into the

transverse colon where he located the gallbladder, which had

eroded into the transverse colon.

30. Dr. Zaragoza then completed the surgical procedure,

removing the gallbladder.

31. Patient J.C.’s family was immediately advised of what

had taken place; that Dr. Zaragoza had removed a kidney, in

addition to successfully removing the gallbladder.

32. The removal of a healthy kidney involves a medical

procedure totally unrelated to removal of an unhealthy

gallbladder. Removal of a healthy kidney is not a known or

expected complication of gallbladder removal. Dr. Zaragoza’s

removal of Patient J.C.’s kidney during gallbladder surgery

constituted a “a wrong-site procedure, wrong procedure, or an

unauthorized procedure, or a procedure that is medically

unnecessary or otherwise unrelated to the patient’s diagnosis or

medical condition.” The Department’s proposed findings of fact

12 through 20 contained in the Department’s Proposed Recommended

Order, are accurate, support the ultimate findings of fact made

in this paragraph and are subordinate thereto.

33. Proposed findings of fact 36 through 38 of

Respondent’s Proposed Order in large part accurately reflect the

difficulty of the surgery performed on Patient J.C. Even the

Department’s own expert noted that he thanked God Patient J.C.

had not been his patient. The suggestion in paragraph 26 that

the removal of the kidney was “simply an unwanted complication

associated with this cholecystectomy procedure” is, however, not

supported by the weight of the evidence.

CONCLUSIONS OF LAW

A. Jurisdiction .

34. The Division of Administrative Hearings has

jurisdiction over the subject matter of this proceeding and of

the parties thereto pursuant to Sections 120.569 and 120.57(1),

Florida Statutes (2009.

B. The Burden and Standard of Proof .

35. The Department seeks to have penalties imposed against

Dr. Zaragoza’s license through the Administrative Complaint that

include suspension or revocation of his license and/or the

imposition of an administrative fine. Therefore, the Department

has the burden of proving the specific allegations of fact that

support its charge that Dr. Zaragoza violated the statutory

provision alleged in the Administrative Complaint by clear and

convincing evidence. Department of Banking and Finance,

Division of Securities and Investor Protection v. Osborne Stern

and Co. , 670 So. 2d 932 (Fla. 1996); Ferris v. Turlington , 510

So. 2d 292 (Fla. 1987); Pou v. Department of Insurance and

Treasurer , 707 So. 2d 941 (Fla. 3d DCA 1998); Nair v. Department

of Business and Professional Regulation , 654 So. 2d 205 (Fla.

of fact shall be based on a preponderance of the evidence,

except in penal or licensure disciplinary proceedings or except

as otherwise provided by statute.").

36. What constitutes "clear and convincing" evidence was

described by the court in Evans Packing Co. v. Department of

Agriculture and Consumer Services , 550 So. 2d 112, 116, n. 5

(Fla. 1st DCA 1989), as follows:

. . . [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 evidence 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

the firm belief or conviction, without

hesitancy, as to the truth of the

allegations sought to be established.

Slomowitz v. Walker , 429 So. 2d 797, 800

(Fla. 4th DCA 1983).

See also In re Graziano , 696 So. 2d 744 (Fla. 1997); In re

Davey , 645 So. 2d 398 (Fla. 1994); and Walker v. Florida

Department of Business and Professional Regulation , 705 So. 2d

652 (Fla. 5th DCA 1998)(Sharp, J., dissenting).

C. The Charges of the Administrative Complaint .

37. Section 456.072(1), Florida Statutes, authorizes the

Board of Medicine (hereinafter referred to as the “Board”) to

impose penalties against Florida physicians ranging from the

issuance of a letter of concern to revocation of the physician's

license to practice medicine in Florida if the physician commits

one or more acts specified therein.

38. The Administrative Complaint in this case alleges that

Dr. Zaragoza violated the following provision of Section

456.072(1), Florida Statutes:

(bb) Performing or attempting to perform

health care services on the wrong patient, a

wrong-site procedure, a wrong procedure, or

an unauthorized procedure or a procedure

that is medically unnecessary or otherwise

unrelated to the patient's diagnosis or

medical condition. For the purposes of this

paragraph, performing or attempting to

perform health care services includes the

preparation of the patient.

39. In determining whether Dr. Zaragoza committed the

alleged statutory violation, only those specific factual grounds

alleged by the Department in the Administrative Complaint may

form the basis of a finding of violation. See Trevisani v.

Department of Health , 908 So. 2d 1108 (Fla. 1st DCA 2005);

Cottrill v. Department of Insurance , 685 So. 2d 1371 (Fla. 1st

DCA 1996). Due process prohibits the Department from taking

disciplinary action against a licensee based on matters not

specifically alleged in the charging instrument, unless those

matters have been tried by consent. See Shore Village Property

Owners’ Association, Inc . v. Department of Environmental

Protection , 824 So. 2d 208, 210 (Fla. 4th DCA 2002); and Delk v.

Department of Professional Regulation , 595 So. 2d 966,967 (Fla.

5th DCA 1992).”

40. In addressing the charges against Dr. Zaragoza, it is

recognized that the Board is the agency which has been charged

with responsibility for administering the Medical Practice Act,

Chapter 458, Florida Statutes, and the rules relevant to this

matter adopted by the Board. The Board’s interpretation of

those provisions of law that it has been charged by the

legislature to administer must be given great weight. See

Phillips v. Board of Dentistry , 884 So. 2d 78 (Fla. 4th DCA

2004).

41. It is also recognized, however, that "the conduct

proved must legally fall within the statute or rule claimed [in

the charging instrument] to have been violated." Delk v.

Department of Professional Regulation , 595 So. 2d 966, 967 (Fla.

5th DCA 1992). In deciding whether "the statute or rule claimed

to have been violated" was in fact violated, as alleged, if

there is any reasonable doubt, that doubt must be resolved in

favor of the licensee. See Whitaker v. Department of Insurance

and Treasurer , 680 So. 2d 528, 531 (Fla. 1st DCA 1996); Elmariah

v. Department of Professional Regulation, Board of Medicine , 574

So. 2d 164, 165 (Fla. 1st DCA 1990); and Lester v. Department of

Professional and Occupational Regulations , 348 So. 2d 923, 925

(Fla. 1st DCA 1977).

42. There is little, if any, dispute about what took place

on October 2, 2007, during the surgical procedure preformed by

Dr. Zaragoza on Patient J.C. The evidence clearly and

convincingly proved that the procedure was extremely difficult

and, once fully understood, less shocking than at first blush.

Ultimately, despite the difficulties encountered by Dr. Zaragoza

and the unusual set of circumstances surrounding the surgery,

the evidence proved clearly and convincingly that the removal of

Patient J.C.’s kidney constituted “a wrong-site procedure, a

wrong procedure, or an unauthorized procedure or a procedure

that is medically unnecessary or otherwise unrelated to the

patient's diagnosis or medical condition.”

43. Therefore, it is concluded that the Department has

proved clearly and convincingly that Dr. Zaragoza has violated

Section 456.072(1)(bb), Florida Statutes, as alleged in the

Administrative Complaint.

D. The Appropriate Penalty .

44. In determining the appropriate punitive action to

recommend to the Board in this case, it is necessary to consult

the Board's "disciplinary guidelines," which impose restrictions

and limitations on the exercise of the Board's disciplinary

authority under Section 456.072, Florida Statutes. See Parrot

Heads, Inc. v. Department of Business and Professional

Regulation , 741 So. 2d 1231 (Fla. 5th DCA 1999).

45. The Board's guidelines are set out in Florida

Administrative Code Rule 64B8-8.001. Pertinent to this matter,

Florida Administrative Code Rule 64B8-8.001(2)(ss), effective

January 30, 2007, provides the following recommended range of

penalties for a first time offence:

From a $1,000.00 fine, a letter of concern,

a minimum of five (5) hours of risk

management education, and one (1) hour

lecture on wrong-site surgery in the State

of Florida to a $10,000.00 fine, a letter of

concern, a minimum of five (5) hours of risk

management education, 50 to 100 hours of

community service, undergo a risk management

assessment, a one (1) hour lecture on wrong-

site surgery, and suspension to be followed

by a term of probation.

46. Florida Administrative Code Rule 64B8-8.001(3),

effective January 30, 2007, provides that, in applying the

penalty guidelines, the following aggravating and mitigating

circumstances are to be taken into account:

(3) Aggravating and Mitigating

Circumstances. Based upon consideration of

aggravating and mitigating factors present

in an individual case, the Board may deviate

from the penalties recommended above. The

Board shall consider as aggravating or

mitigating factors the following:

(a) Exposure of patient or public to

injury or potential injury, physical or

otherwise: none, slight, severe, or death;

(b) Legal status at the time of the

offense: no restraints, or legal

constraints;

(c) The number of counts or separate

offenses established;

(d) The number of times the same offense

or offenses have previously been committed

by the licensee or applicant;

(e) The disciplinary history of the

applicant or licensee in any jurisdiction

and the length of practice;

(f) Pecuniary benefit or self-gain inuring

to the applicant or licensee;

(g) The involvement in any violation of

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

controlled substances for trade, barter or

sale, by a licensee. In such cases, the

Board will deviate from the penalties

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 mitigating factors.

47. In its Proposed Recommended Order, the Department has

recognized that the “level of aggravating factors is not high

given the circumstances and the extensive mitigating factors”

which include the facts that: Dr. Zaragoza has had no previous

discipline taken against his license; he has been practicing for

12 years without incident; his medical license was clear and

active and had no restraints, or legal constraints; all the

experts who testified in this matter were in agreement about the

medical complications encountered and that the error was not

caused by negligence or want of skill in Dr. Zaragoza’s

technique; and Dr. Zaragoza has been candid throughout this

proceeding, before the Board and at hearing.

48. The Department has requested that it be recommended

that Dr. Zaragoza be subjected to a fine of $10,000.00, receive

a letter of concern, undergo five hours of risk management

education, and be required to perform 50 hours of community

service.

49. The penalty requested by the Department, other than

the absence of a suspension, followed by probation, and an hour

lecture on wrong-site surgery are on the higher side of the

range of penalties. Therefore, it will be recommended that the

amount of the fine requested by the Department be reduced.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is

RECOMMENDED that a final order be entered by the Board of

Medicine finding that Bernard J. Zaragoza, M.D., has violated

Section 456.072(1)(bb), Florida Statutes, as alleged in the

Administrative Complaint; imposing a fine of $5,000.00; issuing

a letter of concern; requiring the completion of five hours of

risk management education; and requiring that he perform 50

hours of community service.

DONE AND ENTERED this 6th day of April, 2010, in

Tallahassee, Leon County, Florida.

___________________________________

LARRY J. SARTIN

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

[phone] SUNCOM 278-9675

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

This 6th day of April, 2010.

COPIES FURNISHED:

Rolando A. Diaz, Esquire

Kubicki & Draper

25 West Flagler Street, Penthouse

Miami, Florida 33130

Robert A. Milne, Esquire

Department of Health

Prosecution Services Unit

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399

Diane K. Kiesling, Esquire

Department of Health

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399

Larry McPherson, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399-3265

Dr. Ana M. Viamonte Ros, Secretary

Department of Health

4052 Bald Cypress Way, Bin A00

Tallahassee, Florida 32399-1701

Josefina M. Tamayo, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399-1701

R. S. Power, Agency Clerk

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399-1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this recommended order. Any exceptions

to this recommended order should be filed with the agency that

will issue the final order in these cases.