07-003511PL Department Of Health, Board Of Medicine vs. Anthony Brignoni, M.D. Status: Closed Recommended Order on Wednesday, April 23, 2008.

Summary: Respondent did not violate standard-of-care when he did not specify the strength of acetic acid to be used in surgery.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 07-3511PL

)

ANTHONY BRIGNONI, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

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

on January 30, 2008, in Port Charlotte, Florida, before Susan B.

Harrell, a designated Administrative Law Judge of the Division

of Administrative Hearings.

APPEARANCES

For Petitioner: Staci Braswell, Esquire

Ephraim Livingston, Esquire

Department of Health

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399-3265

For Respondent: Sean M. Ellsworth, Esquire

Ellsworth Law Firm, P.A.

404 Washington Avenue, Suite 750

Miami Beach, Florida 33139

STATEMENT OF THE ISSUES

The issues in this case are whether Respondent violated

Subsection 458.331(1)(t), Florida Statutes (2002), 1 and, if so,

what discipline should be imposed.

PRELIMINARY STATEMENT

On March 13, 2007, the Department of Health (Department)

filed an Administrative Complaint before the Board of Medicine

(Board), alleging that Respondent, Anthony Brignoni, M.D.

(Dr. Brignoni), violated Subsection 458.331(1)(t), Florida

Statutes. Dr. Brignoni requested an administrative hearing, and

the case was forwarded to the Division of Administrative

Hearings on July 30, 2007, for assignment of an Administrative

Law Judge to conduct the final hearing.

The final hearing was originally scheduled for October 5,

2007. The final hearing was rescheduled two times. On

January 16, 2008, Petitioner filed a Motion to Amend

Administrative Complaint. The motion was granted by Order dated

January 28, 2008.

On January 28, 2008, Petitioner filed Petitioner’s Motion

for Official Recognition. The motion was granted at the final

hearing, and official recognition was taken of Subsection

458.331(1)(t), Florida Statutes, and Florida Administrative Code

Rule 64B8-8.001.

The parties filed a Joint Pre-hearing Stipulation and

agreed to certain facts contained in paragraph 5 of the Joint

Pre-hearing Stipulation. To the extent relevant, those facts

are incorporated in this Recommended Order.

At the final hearing, Petitioner called Lynne Greenockle

and Edward J. Zelnick, M.D., as its witnesses. Joint Exhibits 1

and 2 were admitted in evidence. Petitioner’s Exhibit 1 was

admitted in evidence. At the final hearing, Dr. Brignoni

testified in his own behalf and called James W. Orr, Jr., M.D.,

as his witness. Respondent’s Exhibit 1 was admitted in

evidence.

The parties agreed to file their proposed recommended

orders within ten days of the filing of the transcript of the

final hearing. The Transcript was filed on February 25, 2008.

The parties timely filed their Proposed Recommended Orders,

which have been considered in the rendering of this Recommended

Order.

FINDINGS OF FACT

1. Petitioner is the state department charged with

regulating the practice of medicine pursuant to Section 20.43

and Chapters 456 and 458, Florida Statutes (2007).

2. At all times material to the Amended Administrative

Complaint, Dr. Brignoni was licensed to practice medicine in the

State of Florida pursuant to Chapter 458, Florida Statutes,

having been issued license number ME 59140. Dr. Brignoni is

board-certified in obstetrics and gynecology.

3. On September 5, 2002, patient C.W. presented to

Dr. Brignoni, who diagnosed her with severe dysplasia, vulvar

intraepithelial neoplasia. Dr. Brignoni recommended that C.W.

undergo a wide local excision of vulva/vaginal lesion.

4. On September 12, 2002, C.W. went to Charlotte Regional

Medical Center for Dr. Brignoni to perform the wide local

excision of vulvar intraepithelial neoplasia. Prior to the

surgery, Dr. Brignoni had issued a card which indicated the

supplies and instruments that he would need for a procedure such

as the one that he was going to perform on C.W. The card is

kept at Charlotte Regional Medical Center so that the supplies

and instruments can be prepared and available at the time the

procedure is scheduled to be performed. The card called for

acetic acid to be supplied for the procedure, but no strength

was specified.

5. Acetic acid is commonly used during gynecological

procedures to highlight abnormal areas. In the instant case, it

would be used to highlight the lesion that was to be excised.

When acetic acid is used for such a purpose, the acceptable

concentration is approximately three-to-five-percent.

6. Typically, when Dr. Brignoni arrives in the operating

room to perform a procedure, all liquids and instruments

required for the procedure are prepared and ready for use. A

surgical technician is responsible for assembling the liquids

and instruments needed for the procedure.

7. When Dr. Brignoni began the excision on September 12,

2002, the surgical technician had not placed any acetic acid on

the cart which housed the supplies and instruments needed for

the procedure. Dr. Brignoni requested that acetic acid be

obtained, and the circulating nurse went to the pharmacy to

procure the acid. Dr. Brignoni did not request any specific

concentration of acetic acid. The circulating nurse came back

with a bottle of 100 percent acetic acid and decanted the acid

into a container which she gave to the surgical technician.

8. Dr. Brignoni took a piece of gauze saturated with the

100 percent acetic acid and swabbed the vulva area. He

immediately noticed that area was peeling. This was not the

reaction that would have occurred using a three-to-five-percent

solution. Dr. Brignoni asked the surgical staff what solution

did they give him, and he was shown the bottle containing a

100 percent concentration of acetic acid.

9. Upon learning that he had applied 100 percent acetic

acid to C.W.’s vulva area, Dr. Brignoni irrigated the area with

over a liter of sterile water. He determined that he could

proceed with the procedure, which he did. Prior to proceeding

with the procedure, he did not consult with a physician familiar

with chemical burns in determining whether it was appropriate to

continue with the procedure. Dr. Brignoni did check with an

emergency room physician after the procedure to confirm that he

treated the burn correctly by irrigating with sterile water.

10. As a result of the use of 100 percent acetic acid

rather than a three-to-five-percent solution, C.W. experienced

second degree burns in the area of her vulva and buttock. The

normal time for the healing of a wide local excision of the

vulva area is four to six weeks. C.W. healed in approximately

eight weeks.

11. Edward J. Zelnick, M.D., testified as an expert for

the Department. Dr. Zelnick was licensed to practice medicine

in Florida in 1975 and is board-certified by the American Board

of Obstetrics and Gynecology. Currently, Dr. Zelnick is the

chief executive officer and clinical researcher at Horizon

Institute for Clinical Research. The last time that Dr. Zelnick

performed a surgical procedure was in 1998.

12. James Orr, M.D., testified as an expert for

Dr. Brignoni. Dr. Orr has been board-certified in obstetrics

and gynecology and gynecologic oncology since 1984. Currently,

he is the medical director of Lee Cancer Center at Lee Memorial

Hospital in Fort Myers, Florida, and is the director of

Gynecologic Oncology and Gynecologic Oncology Research at Lee

Cancer Center. He is a former associate professor of Obstetrics

and Gynecology at the University of Alabama Birmingham School of

Medicine and a clinical professor in the Department of

Obstetrics and Gynecology at the University of South Florida.

13. Dr. Orr has performed wide local excisions of the

vulva area hundreds of times, and teaches this procedure to

residents and medical students. It is Dr. Orr’s opinion that it

is not standard procedure for a surgeon to specify the

concentration of acetic acid for such a procedure. The normal

strength of acetic acid used in a wide local excision of the

vulva area is understood to be three-to-five-percent, and the

standard-of-care requires a physician to simply ask for acetic

acid without specifying the concentration. Dr. Orr’s opinion is

credited.

14. It was Dr. Orr’s opinion that Dr. Brignoni correctly

irrigated the area after the application of the acetic acid and

that there was no reason for Dr. Brignoni to stop the procedure

after the irrigation. The biggest risk to the patient would

have been stopping the procedure and putting the patient under

anesthesia for a second time. Dr. Orr’s opinion is credited.

CONCLUSIONS OF LAW

15. The Division of Administrative Hearings has

jurisdiction over the parties to and the subject matter of this

proceeding. §§ 120.569 and 120.57, Fla. Stat. (2007).

16. The Department has the burden to establish the

allegations in the Amended Administrative Complaint by clear and

convincing evidence. Department of Banking and Finance v.

Osborne Stern and Co. , 670 So. 2d 932 (Fla. 1996). The

Department has alleged in the Amended Administrative Complaint

that Dr. Brignoni violated Subsection 458.331(1)(t), Florida

Statutes, which provides that the following acts constitute

grounds for disciplinary action:

Gross or repeated malpractice or the failure

to practice medicine with that level of

care, skill, and treatment which is

recognized by a reasonably prudent similar

physician as being acceptable under similar

conditions and circumstances. The board

shall give great weight to the provisions of

s. 766.102 when enforcing this paragraph.

As used in this paragraph, “repeated

malpractice” includes, but is not limited

to, three or more claims for medical

malpractice within the previous 5-year

period resulting in indemnities being paid

in excess of $25,000 each to the claimant in

a judgment or settlement and which incidents

involved negligent conduct by the physician.

As used in this paragraph, “gross

malpractice” or “the failure to practice

medicine with that level of care, skill, and

treatment which is recognized by a

reasonably prudent similar physician as

being acceptable under similar conditions

and circumstances,” shall not be construed

to require that a physician be incompetent

to practice medicine in order to be

disciplined pursuant to this paragraph.

17. The Department alleged in the Amended Administrative

Complaint that Dr. Brignoni violated Subsection 458.331(1)(t),

Florida Statutes, in the following ways:

a. by failing to confirm the concentration

of acetic acid prior to applying the acetic

acid to Patient C.W.;

b. by failing to use an acceptable

concentration of acetic acid during the

preparation of Patient C.W.; and/or

c. by continuing with the lesion excision

without fully assessing the extent of

Patient C.W.’s injury and/or allowing

sufficient time for the injury to heal

before doing the operation.

18. The Department has failed to establish by clear and

convincing evidence that Dr. Brignoni fell below the standard-

of-care in his care and treatment of C.W. The standard-of-care

does not require a surgeon to specify the concentration of

acetic acid when performing a wide local excision of the vulva

area. Dr. Brignoni expected that the staff would provide him

with a three-to-five-percent concentration of acetic acid and

had no reason to believe that he had been given a greater

concentration of acetic acid when the scrub technician gave him

the acetic acid that was used in the procedure on C.W. The

standard-of-care does not require a physician to specify a

three-to-five-percent concentration of acetic acid when

requesting acetic acid, and the standard-of-care does not

require that a physician confirm the strength of acetic acid

when he is handed the solution during a surgical procedure. Dr.

Brignoni appropriately irrigated the area where the acetic acid

had been applied and did not violate the standard-of-care when

he continued with the procedure after the irrigation was

complete. Thus, the Department has failed to establish that Dr.

Brignoni violated Subsection 458.331(1)(t), Florida Statutes.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is RECOMMENDED that a final order be entered finding

that Dr. Brignoni did not violate Subsection 458.331(1)(t),

Florida Statutes, and dismissing the Amended Administrative

Complaint against Dr. Brignoni.

DONE AND ENTERED this 23rd day of April, 2008, in

Tallahassee, Leon County, Florida.

S

SUSAN B. HARRELL

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 23rd day of April, 2008.

ENDNOTE

1/ Unless otherwise indicated, all references to the Florida

Statutes are to the 2002 codification.

COPIES FURNISHED :

Sean M. Ellsworth, Esquire

Ellsworth Law Firm, P.A.

404 Washington Avenue, Suite 750

Miami Beach, Florida 33139

Staci Braswell, Esquire

Ephraim Livingston, Esquire

Department of Health

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399-3265

Josefina M. Tamayo, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A-02

Tallahassee, Florida 32399-1701

Larry McPherson, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399-1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this Recommended Order. Any exceptions

to this Recommended Order should be filed with the agency that

will issue the Final Order in this case.