00-004413PL Department Of Health, Board Of Medicine vs. Robert A. Ross, M.D. Status: Closed Recommended Order on Wednesday, March 28, 2001.

Summary: Respondent performed within the standard of care when he encountered a serious vascular injury during a laparoscopic procedure; administrative complaint dismissed.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE , )

)

Petitioner , )

)

vs. ) Case No. 00-4413PL

)

ROBERT A. ROSS, M.D. , )

)

Respondent. )

___________________________________)

RECOMMENDED ORDER

Pursuant to Notice, this cause was heard by Linda M. Rigot,

the assigned Administrative Law Judge of the Division of

Administrative Hearings, on January 25, 2001, in Miami, Florida.

APPEARANCES

For Petitioner : Kim M. Kluck, Esquire

Agency for Health Care Administration

2727 Mahan Drive

Building Three, Suite 3431

Post Office Box 14229

Tallahassee, Florida 32317-4229

For Respondent : Mark A. Dresnick, Esquire

Sean M. Ellsworth, Esquire

Dresnick, Ellsworth & Felder, P.A.

SunTrust Plaza, Suite 701

201 Alhambra Circle

Coral Gables, Florida 33134

STATEMENT OF THE ISSUE

The issue presented is whether Respondent is guilty of the

allegations contained in the Administrative Complaint filed

against him, and, if so, what disciplinary action should be

taken against him, if any.

PRELIMINARY STATEMENT

On July 27, 2000, Petitioner issued an Administrative

Complaint alleging that Respondent had violated a statute

regulating his conduct as a physician licensed in the State of

Florida, and Respondent timely requested an evidentiary hearing

regarding the allegations in that Administrative Complaint.

Thereafter, this cause was transferred to the Division of

Administrative Hearings to conduct the evidentiary proceeding.

Petitioner presented the testimony of Harold Schulman,

M.D., by way of deposition, and Respondent presented the

testimony of Steven D. McCarus, M.D., by way of deposition.

Additionally, Joint Exhibits numbered 1 and 2, Petitioner’s

composite Exhibit numbered 1, and Respondent’s Exhibit numbered

1 were admitted in evidence.

Both parties submitted proposed recommended orders after

the conclusion of the final hearing. Those documents have been

considered in the entry of this Recommended Order.

FINDINGS OF FACT

1. At all times material hereto, Respondent has been a

physician licensed in the State of Florida and has been Board-

certified in obstetrics and gynecology.

2. On May 7, 1998, Patient A. J. underwent a laparoscopic

procedure due to a complex left ovarian cyst at Columbia

Surgical Park Center, an ambulatory care center located in

Miami, Florida. The operation consisted of a laparoscopy with

laparoscopic lysis of adhesions and a laparoscopic left ovarian

cystectomy. Respondent performed the surgical procedure under

general anesthesia. Gerald Kranis, M.D., was the

anesthesiologist during the procedure.

3. Respondent made a small vertical incision in the

umbilicus and insufflated the abdomen with carbon dioxide gas.

Respondent then entered the abdomen through a visiport with a

10-millimeter scope. He initially examined the upper abdomen.

The patient’s liver and gall bladder appeared normal.

Respondent next turned the laparoscope caudally.

4. Inspection of the pelvic organs revealed numerous

adhesions of the omentum and bowel to the anterior abdominal

wall and to the uterus. Respondent took down the adhesions with

sharp dissection with no bleeding. Respondent noted that there

was adherence of the bowel to the anterior uterus. This was

dissected away with sharp dissection.

5. Inspection of the right adnexa showed a hemmoraghic

cyst of the left ovary, and this was dissected by sharp

dissection. In the process, the cyst ruptured extruding

chocolate-appearing material. The cyst wall was grasped with an

atraumatic grasper and teased out. Hemostasis was secure, and

the cyst was retained to be sent to pathology. Inspection of

the cul-de-sac revealed numerous adhesions of the bowel to the

posterior uterus, and these were lysed with sharp dissection.

6. At the end of the procedure, just before Respondent

exited the abdomen, the patient’s blood pressure dropped.

Inspection of the abdomen revealed no increased bleeding, but

there was one area when viewed through the laparoscope that was

suspicious of a hematoma. Respondent removed the laparoscope

and placed a Foley catheter in the bladder.

7. Respondent then performed a laparotomy, entering the

abdomen through a Pfannenstiel incision. There were numerous

adhesions of the bowel to the anterior abdominal wall, and

Respondent lysed them with sharp dissection.

8. Respondent then discovered a retroperitoneal hematoma.

Respondent applied pressure on this area, and a vascular surgeon

was summoned. Although the medical records do not specify that

pressure was applied with a wet pad, the Department’s expert and

Respondent’s expert interpret the description in the medical

records to show that Respondent applied direct pressure with a

wet pad.

9. Upon his arrival, Manuel Torres-Salich, M.D., a

vascular surgeon, assumed responsibility for managing the

patient. He noted that the systolic pressure was 60 MMHG, and

he extended the Pfannenstiel incision to a long midline vertical

incision. Upon entering the abdominal cavity, he noticed a

massive amount of blood throughout the abdominal cavity.

However, he did not quantify the amount of blood he observed.

10. Dr. Torres-Salich attempted the surgical repair of the

patient’s vascular injuries. He discovered a large anterior

laceration of the right proximal common iliac artery at the

bifurcation of the aorta and a laceration of the anterior wall

of the iliac vein.

11. During the course of the surgical repairs, the patient

experienced cardiac arrest, and CPR was administered while the

vascular surgical repairs continued. As Dr. Torres-Salich

continued to repair the vascular injuries, the patient

experienced further cardiac complications. Cardiac massage and

CPR were performed. The patient did not respond and expired.

12. No evidence was offered as to the medical equipment

available at Columbia Surgical Park Center. Specifically, no

evidence was offered as to whether vascular clamps were

available for use by Respondent, and, if available, whether

these were the type of clamps appropriate for controlling a

vascular injury of the iliac artery or iliac vein by a

gynecologist. Further, no evidence was offered as to the types

of medical personnel available at Columbia Surgical Park Center

to assist Respondent other than anesthesia personnel.

13. The record in this cause is clear, however, that a

vascular surgeon was not in attendance at Columbia Surgical Park

Center during patient A. J.’s procedure but was summoned on an

emergency basis. The vascular surgeon arrived within about 20

to 25 minutes after the vascular emergency was discovered.

14. The vascu lar lacerations that occurred to the iliac

artery and iliac vein were lacerations to two of the largest

blood vessels in the body. There is no evidence that any

improper technique by Respondent during the laparoscopic

procedure caused the lacerations of the iliac artery and iliac

vein. The exact cause of these lacerations is not known.

However, there are three possible causes : from insertion of the

Voorhees needle, from insertion of the trocar, or from

dissection of adhesions.

15. A gynecologist who e xperiences a significant vascular

injury, such as a laceration of an iliac artery, is trained to

abandon the laparoscopic approach immediately, make an incision

via laparotomy, and place direct pressure right on the area with

a hand or pack. Respondent handled the laparoscopic

complication appropriately by performing a laparotomy and

applying direct pressure to the retroperitoneal hematoma.

Respondent also handled the laparoscopic complication

appropriately by calling for the emergency assistance of a

vascular surgeon.

16. General gynecologists are not trained to repair

vascular injuries, and the immediate objective of a gynecologist

once a vascular injury is identified is to do one of two things :

apply direct pressure to the area of the bleed or try to clamp

the vessel. Visualization of the specific vessel causing the

bleed is required to properly use a clamp.

17. Visualization of the specific blood vessels causing

this patient’s retroperitoneal hematoma would require Respondent

to perform a retroperitoneal dissection, which general

gynecologists are not trained to perform. The standard of care

in such a situation is for the gynecologist to summon a vascular

surgeon. Further, if a gynecologist is not able to identify the

exact point of injury, then direct pressure to the hematoma is

sufficient and within the standard of care.

18. There is no evidence that Respondent ever attended a

gynecologic oncology fellowship where a general gynecologist

would get additional training to be able to perform a

retroperitoneal dissection. Respondent did not deviate from the

standard of care by failing to perform a retroperitoneal

dissection to visualize the specific blood vessels causing the

hematoma.

19. Respondent did not deviate from the prevailing

standard of care by failing to apply pressure above the injury

to stop the bleeding. Respondent’s application of pressure at

the site of the hematoma was proper.

20. Respondent did not fail to adequately prepare for and

deal with a known complication of laparoscopy. He complied with

the standard of care by stopping the laparoscopic approach,

performing a laparotomy, applying pressure to the bleeding site,

and immediately calling a vascular surgeon.

CONCLUSIONS OF LAW

21. The Division of Administrative Hearings has

jurisdiction over the subject matter and the parties hereto.

Sections 120.569 and 120.57(1), Florida Statutes.

22. The Administrative Complaint filed in this cause

alleges that Respondent failed to practice medicine with that

level of care, skill, and treatment which is recognized by a

reasonably prudent physician as being acceptable under similar

conditions and circumstances in that Respondent: (1) failed to

recognize that the right iliac artery had been lacerated, (2)

failed to visualize the site of injury, (3) failed to use

pressure above the injury to stop the bleeding, and (4) in,

general, failed to adequately prepare and deal with a known

complication of laparoscopy. The Administrative Complaint

alleges, therefore, that Respondent violated Section

458.331(1)(t), Florida Statutes. The Department has failed to

meet its burden of proof in this proceeding.

23. The Department presented only the deposition testimony

of one expert witness, and the Respondent presented only the

deposition testimony of one expert witness. Both of those

experts agree that there is no factual basis for the first

allegation, i.e . , that Respondent failed to recognize that the

right iliac artery had been lacerated. Accordingly, Respondent

cannot be found guilty of that allegation.

24. As to the other three allegations, the two experts

disagree. It is necessary, therefore, to evaluate the weight to

be given to each expert’s testimony. The Department’s expert is

Board-certified in obstetrics and gynecology and is semi-

retired. He has never taught laparoscopy, and laparoscopic

procedures are not one of his primary interests.

25. On the other hand, Respondent’s expert is also Board-

certified in obstetrics and gynecology and has a special

interest in laparoscopic procedures. He has taught laparoscopic

surgery since 1986 and has published several articles on the

subject. He limits his practice to gynecological surgery, and

approximately ninety percent of his gynecological surgery is

laparoscopic surgery. He has performed approximately ten times

the number of laparoscopic procedures as the Department’s expert

and focuses on the most difficult ones.

26. Respondent’s expert is, therefore, more qualified than

the Department’s to render an opinion in this case and his

opinion is afforded more weight. Respondent’s expert testified

that Respondent did not deviate from the prevailing standard of

care by failing to visualize the site of the injury because the

site of the injury cannot be visualized, and Respondent applied

direct pressure at the site of the hematoma, which was the site

of the injury. Respondent’s expert testified that Respondent

did not deviate from the prevailing standard of care by failing

to use pressure above the injury to stop the bleeding because

Respondent applied pressure in the proper location.

Respondent’s expert further testified that Respondent did not

fail to adequately prepare for and deal with a known

complication of laparoscopy. Since Respondent did exactly what

the prevailing standard of care calls for , he obviously knew how

to deal with that known complication.

27. Respondent’s expert testified, and it has been found,

that Respondent performed in accordance with the prevailing

standard of care for gynecologists in all respects during the

procedure he performed on patient A. J.

28. Interestingly, both experts recognized as an expert in

the field a Dr. Nezhat, who authored an article entitled

“Delayed Recognition of Iliac Artery Injury During Laparoscopic

Surgery.” In that article Dr. Nezhat advises physicians

performing laparoscopic procedures who notice an injury to a

major vessel such as the iliac artery or vein to immediately do

a laparotomy, put a wet pad over the area, apply heavy pressure

or vascular clamps, and call for help. That is precisely what

Respondent did, according to the medical records admitted in

evidence in this cause.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is

RECOMMENDED that a final order be entered finding

Respondent not guilty of the allegations contained in the

Administrative Complaint and dismissing the Administrative

Complaint filed against him in this cause.

DONE AND ENTERED this 28th day of March, 2001, in

Tallahassee, Leon County, Florida.

___________________________________

LINDA M. RIGOT

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488- 9675 SUNCOM 278-9675

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 28th day of March, 2001.

COPIES FURNISHED:

Kim M. Kluck, Esquire

Agency for Health Care Administration

2727 Mahan Drive

Building Three, Suite 3431

Post Office Box 14229

Tallahassee, Florida 32317-4229

Mark A. Dresnick, Esquire

Sean M. Ellsworth, Esquire

Dresnick, Ellsworth & Felder, P.A.

SunTrust Plaza, Suite 701

201 Alhambra Circle

Coral Gables, Florida 33134

Tanya Williams, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Bin A02

Tallahassee, Florida 32399-1701

Theodore M. Henderson, 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 this case.