09-001577PL Department Of Health, Board Of Medicine vs. Joseph Daniel Labs, M.D. Status: Closed Recommended Order on Wednesday, October 14, 2009.

Summary: Respondent placed breast implants subpectorally as requested by the patient. There is no violation of Section 458.331, Florida Statutes.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 09-1577PL

)

JOSEPH DANIEL LABS, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

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

on June 23 and 24, 2009, in Naples, Florida, before Susan B.

Harrell, a designated Administrative Law Judge of the Division

of Administrative Hearings.

APPEARANCES

For Petitioner: Shirley L. Bates, Esquire

Diane K. Kiesling, Esquire

Department of Health

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399-3265

For Respondent: Louis J. La Cava, Esquire

Stephens, Lynn, Klein, La Cava,

Hoffman & Puya, P.A.

101 East Kennedy Boulevard, Suite 2500

Tampa, Florida 33602

STATEMENT OF THE ISSUES

The issues in this case are whether Respondent violated

Florida Statutes (2005), 1 and, if so, what discipline should be

imposed.

PRELIMINARY STATEMENT

On November 24, 2008, the Department of Health (Department)

filed an Administrative Complaint with the Board of Medicine

against Respondent, Joseph Daniel Labs, M.D. (Dr. Labs),

alleging that Dr. Labs violated Subsections 458.331(1)(m),

458.331(1)(t), and 456.331(1)(bb), Florida Statutes. Dr. Labs

requested an administrative hearing, and the case was forwarded

to the Division of Administrative Hearings on March 26, 2009,

for assignment of an Administrative Law Judge to conduct the

final hearing.

On June 16, 2009, the parties filed a Joint Pre-hearing

Stipulation in which they stipulated to certain facts contained

in Section E of the Joint Pre-hearing Stipulation. To the

extent relevant, those facts have been incorporated in this

Recommended Order.

At the final hearing, the Department called the following

witnesses: W.S.; Alexia Marciano, M.D.; and Frank Lomagistro,

M.D. Petitioner’s Exhibits 1 through 6 and 11 were admitted in

evidence. The Department was given leave to file Petitioner’s

Exhibit 12 as a late-filed exhibit. The Department filed

Petitioner’s Exhibit 12 on June 26, 2009, and it is admitted.

Additionally, the Department proffered Petitioner’s Exhibit 13.

At the final hearing, Dr. Labs testified on his own behalf and

called Francis W. Reiger, M.D., as a witness. Respondent’s

Exhibits 1 through 5 were admitted in evidence.

The two-volume Transcript was filed on August 3, 2009. At

the final hearing, the parties agreed to file their proposed

recommended orders within ten days of the filing of the

Transcript. On August 5, 2009, the Department filed an

unopposed Motion for Extension of Time to File Proposed Orders.

The motion was granted by Order entered August 6, 2009,

extending the time for filing proposed recommended orders to

August 28, 2009. The parties timely filed their Proposed

Recommended Orders, which have been considered in rendering this

Recommended Order.

FINDINGS OF FACT

1. The Department is the State of Florida agency charged

with regulating the practice of medicine in Florida pursuant to

Section 20.43 and Chapters 456 and 458, Florida Statutes.

2. At all times material to the Administrative Complaint,

Dr. Labs was a licensed medical doctor within the State of

Florida, having been issued license number ME 61579.

3. Dr. Labs is certified by the American Board of Surgery

and the American Board of Plastic Surgery.

4. In April 2006, W.S. went to see Dr. Labs for a

consultation. In the late 1980’s, W.S. had had breast implants

placed by a physician in Texas. In 1995, another physician did

a mastopexy to lift her breasts. W.S. wanted Dr. Labs to

replace the breast implants that had been in place since the

late 1980’s with smaller implants, to reduce the size of her

breasts by excising tissue, and to lift the breasts with a

mastopexy. She was under the impression that the implants which

she currently had had been placed underneath the pectoral

muscle, and she told Dr. Labs that she wanted to have the new,

smaller implants also placed underneath the muscle, meaning

subpectoral placement.

5. Dr. Labs agreed to place the implants subpectorally.

There are two ways that implants can be placed subpectorally.

The first method involves placing the implant entirely under the

muscle and then suturing the implant in place. There is very

little migration of the implant with this method because the

implant is tightly held by the muscle. The second method is

called a dual-plane technique. In this method, a portion of the

implant is placed under the pectoral muscle and a portion of the

implant is covered by the glandular or lower part of the breast.

6. Dr. Labs performed a bilateral reduction, mastopexy,

and implant exchange on W.S. on April 25, 2006. His operative

report described the procedure as follows:

The patient was taken to the operating room

after being marked in the standing position.

She was placed in the supine position for

smooth induction of anesthesia. Sequential

compression boots were placed for DVT

prophylaxis. The procedure began with de-

epithelization of skin above each nipple for

reinset. Scars were then excised around the

nipple and from the vertical incision

beneath the nipple to inframammary fold.

Skin flaps were elevated and, then the

central nipple pedicle preserved. Implants

were removed, and breast tissue was excised

laterally. The implants were then replaced

with silicone implants after Betadine

irrigation and surgical glove change. The

removed implants were 220cc. The replaced

implants were 175cc, and each breast was

subjected to a 75 gram reduction. Towel

clips were placed, and the patient was

placed in the sitting position. Symmetry

was excellent at the conclusion of the

procedure. Multiplayer inset was then

performed. The patient was placed in a

sterile bulky dressing and Ace wrap. She

returned to the recovery room in

satisfactory condition, having tolerated the

procedure well. Final sponge, needle and

instrument counts were correct at the

conclusion of the procedure. The patient

was given explicit postoperative

instructions for the care and maintenance of

her wound and will be seen again in followup

at the plastic surgery office.

7. Dr. Labs took out the 220cc implants and placed

175cc implants in the same pocket where the 220cc implants had

been placed. The 220cc implants which Dr. Labs removed had a

small rim of the superior portion of the implants placed

underneath the muscle. The remaining portion of the implants

were subglandular.

8. Dr. Labs placed the superior medial portion of

the 175cc implants between .5 and 2.5 centimeters under the

muscle, meaning that about ten percent of the implants were

placed under the muscle. The remainder of the implants was

subglandular. The method used by Dr. Labs was the dual-plane

method and is considered to be a subpectoral placement.

9. W.S. signed a consent form, which included an

explanation of risks associated with open capsulectomy with

breast implant exchange surgery. The risk of implant

displacement was explained as follows:

Displacement or migration of a breast

implant may occur from its initial placement

and can be accompanied by discomfort and/or

distortion in breast shape. Difficult

techniques of implant placement may increase

the risk of displacement or migration.

Additional surgery may be necessary to

correct this problem.

10. Subsequent to the surgery by Dr. Labs, W.S. began to

experience problems with her breasts. The breasts were

distorted, became an odd shape and stuck out more than her

breasts had done with the implants placed by the Texas

physician. Her breasts were bulging in the front and middle.

W.S.’s breasts became uncomfortable, and W.S. was unable to lie

on her stomach. The breasts did not look or feel natural; they

were stiff, hard, and tight. The problems began to occur not

long after the surgery; however, the distortion was not present

until a month after the surgery.

11. On December 6, 2006, W.S. visited Alexia Marciano,

M.D., a board-certified plastic surgeon, for a consultation

concerning the problems she was having with her breasts. On

examination, Dr. Marciano noted that W.S. had pseudoptosis,

which means there was some loose skin, but the nipple was still

above the inframammary fold. Dr. Marciano observed that W.S.’s

breasts were distorted, irregular in shape and position. There

were capsular contractures, which are scar tissue that forms

around the implants. The capsular contractures were a grade IV, 2

which means that one could look at the breast and visually see

the tightening. To Dr. Marciano, the implants appeared to be on

top of the muscle, based on “the superficiality and the position

of the implants in relation to the skin above and to the

pectoralis muscle on the upper portion of the chest and on

palpation.” 3 W.S. advised Dr. Marciano that she wanted to have

surgery to correct the problems she was having with her breasts

and that she wanted to have smaller implants placed under the

muscle.

12. On January 19, 2007, Dr. Marciano performed a

capsulectomy, which is moving the capsule or shell of the scar

around the implant; an explantation of the silicone implants,

which is removing the current implants; and an augmentation,

which is putting in new implants. When Dr. Marciano made

incisions in each breast to find the capsules, she found the

capsules right beneath the subcutaneous tissue, which is

basically right beneath the skin and above the pectoralis major

muscle. Although Dr. Marciano found the implants which had been

placed by Dr. Labs, above the major pectoralis muscle, she could

not determine where the implants were actually placed by

Dr. Labs at the time he performed the implant exchange on W.S.

13. Dr. Marciano removed the silicone implants, identified

the pectoralis muscle, incised the inferior edge of the

pectoralis muscle, and dissected the plane underneath the

muscle. Dr. Marciano placed new implants, which were 150cc’s,

on both breasts. The new implants were placed entirely

underneath the muscle, and the small opening that was made in

muscle fascia was closed with sutures so that the implants were

in a closed pocket.

14. Capsular contraction, such as W.S. experienced, can

cause the implants to move. Additionally, during the early

stages after an implant has been placed, there is more potential

for the implant to move before the capsule forms. Based on the

evidence presented, the logical inference is that the capsular

contraction caused the implants placed by Dr. Labs to move from

underneath the pectoralis muscle so that the implants came to

rest in a subglandular position as Dr. Marciano found them.

15. There were no medical records admitted in evidence

from the Texas physician who placed the original implants in the

1980’s. Based on what Dr. Labs found when he exchanged the

implants, it is probable that the Texas physician used the dual-

plane method to insert the implants, meaning that a portion of

the implants were subglandular. This scenario comports with one

of the hypotheses set forth by the Department’s expert, who

surmised that, based on the preoperative photographs taken by

Dr. Labs, it appeared that the Texas physician may have placed

the original implants in a subglandular position rather than in

a subpectoral position. If the Texas physician had used a dual-

plane method and placed a small portion of the implants under

the rim of the pectoralis muscle, then a large portion of the

implants would appear to be placed in a subglandular position as

surmised by the Department’s expert; when, in fact, the implants

had been placed subpectorally as that term is commonly

understood by plastic surgeons. Dual-plane placement also

comports with W.S.’s distinct impression that the original

implants had been placed under the muscle.

CONCLUSIONS OF LAW

16. 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. (2008).

17. The Department has the burden of establishing the

allegations in the Administrative Complaint by clear and

convincing evidence. Department of Banking and Finance v.

Osborne Stern and Co. , 429 So. 2d 797 (Fla. 4th DCA 1983). The

Department has alleged that Dr. Labs violated Subsections

provide:

(1) The following acts constitute grounds

for denial of a license or disciplinary

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

* * *

(m) Failing to keep legible, as defined by

department rule in consultation with the

board, medical records that identify the

licensed physician or the physician extender

and supervising physician by name and

professional title who is or are responsible

for rendering, ordering, supervising, or

billing for each diagnostic or treatment

procedure and that justify the course of

treatment of the patient, including, but not

limited to, patient histories; examination

results; test results; records of drugs

prescribed, dispensed, or administered; and

reports of consultations and

hospitalizations.

* * *

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

specified in s. 456.50(2):

1. Committing medical malpractice as

defined in s. 456.50. The board shall give

great weight to the provisions of s. 766.102

when enforcing this paragraph. Medical

malpractice shall not be construed to

require more than one instance, event, or

act.

* * *

Nothing in this paragraph shall be construed

to require that a physician be incompetent

to practice medicine in order to be

disciplined pursuant to this paragraph. A

recommended order by an administrative law

judge or a final order of the board finding

a violation under this paragraph shall

specify whether the licensee was found to

have committed "gross medical malpractice,"

"repeated medical malpractice," or "medical

malpractice," or any combination thereof,

and any publication by the board must so

specify.

* * *

(bb) Leaving a foreign body in a patient,

such as a sponge, clamp, forceps, surgical

needle, or other paraphernalia commonly used

in surgical, examination, or other

diagnostic procedures. For the purposes of

this paragraph, it shall be legally presumed

that retention of a foreign body is not in

the best interest of the patient and is not

within the standard of care of the

profession, regardless of the intent of the

professional.

18. Subsection 456.50(1)(g), Florida Statutes, defines

“medical malpractice” as follows:

(g) [T]he failure to practice medicine in

accordance with the level of care, skill,

and treatment recognized in general law

related to health care licensure. Only for

the purpose of finding repeated medical

malpractice pursuant to this section, any

similar wrongful act, neglect, or default

committed in another state or country which,

if committed in this state, would have been

considered medical malpractice as defined in

this paragraph, shall be considered medical

malpractice if the standard of care and

burden of proof applied in the other state

or country equaled or exceeded that used in

this state.

19. In the Administrative Complaint, the Department

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

Statutes, in the following ways:

(a) By failing to perform a subpectoral

implant as requested by Patient W.S.; or

(b) By failing to document the reason for

placing the implants in a subglandular

position and not in a subpectoral position

as requested by Patient W.S.

20. The Petitioner has failed to establish by clear and

convincing evidence that Dr. Labs placed the implants in a

subglandular position. The implants were placed using a dual-

plane method, in which a portion, albeit small, was inserted

underneath the muscle. Based on the testimony of the experts

who testified, as well as the testimony of Dr. Labs and

Dr. Marciano, the use of a dual-plane method constitutes a

subpectoral placement.

21. Dr. Marciano found the implants which had been placed

by Dr. Labs in a subglandular position, but she could not say

that Dr. Labs placed the implants in a subglandular position.

The grade IV capsular contracture which W.S. experienced could

easily have caused the small portion of the implants that were

under the muscle to move to a subglandular position.

22. Petitioner has failed to establish by clear and

convincing evidence that Dr. Labs failed to document why he

placed the implants in a subglandular position. The evidence

does not establish that he placed the implants in a subglandular

position. Thus, Petitioner has failed to establish by clear

and convincing evidence that Dr. Labs violated Subsection

458.331(1)(t), Florida Statutes.

23. In the Administrative Complaint, the Department

alleged that Dr. Labs violated Subsection 458.331(1)(m), Florida

Statutes, “by failing to document the justification for the

decision to place the implants in a subglandular position on

[W.S.] instead of in a subpectoral position as discussed with

[W.S.].” In the Administrative Complaint, the Department

alleged that Dr. Labs violated Subsection 456.072(1)(bb),

Florida Statutes, “by placing the silicone implants for Patient

W.S. in a subglandular position instead of the subpectoral

position Patient W.S. requested.” The Department has failed to

establish by clear and convincing evidence that Dr. Labs placed

the implants in a subglandular position; therefore, the

Department has failed to establish that Dr. Labs violated either

Subsection 458.331(1)(m), Florida Statutes, or Subsection

456.072(1)(bb), 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. Labs did not violate Subsections 458.331(1)(m),

458.331(1)(t), or 456.072(1)(bb), Florida Statutes, and

dismissing the Administrative Complaint.

DONE AND ENTERED this 14th day of October, 2009, 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]

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 14th day of October, 2009.

ENDNOTES

1/ Unless otherwise indicated, all references to the Florida

Statutes are to the 2005 version.

2/ Capsular contracture is a potential complication that can

occur with any breast augmentation and usually occurs in a

progressive manner. The more surgery that has been done to the

breast, the greater the risk that capsular contracture can

occur. The grading of the contracture means the degree of the

stiffness and the degree of the thickness of the capsule and

contracture. Grade IV is the greatest degree of scarring.

3/ Transcript Volume I, page 55.

COPIES FURNISHED :

Louis J. La Cava, Esquire

Stephens, Lynn, Klein, La Cava,

Hoffman & Puya, P.A.

101 East Kennedy Boulevard, Suite 2500

Tampa, Florida 33602

Shirley L. Bates, Esquire

Diane K. Kiesling, 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.