01-003212PL Department Of Health, Board Of Medicine vs. Marc S. Schneider, M.D. Status: Closed Recommended Order on Monday, March 18, 2002.

Summary: Plastic surgeon who performed procedure different than authorized in written consent; did not maintain records justifying difference; and used overly large implants should be fined $5,000, reprimanded, and complete continuing professional education.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 01 - 3212PL

)

MARC S. SCHNEIDER, M.D., )

)

Respondent. )

)

RECOMMENDED O RDER

Administrative Law Judge (ALJ) Daniel Manry conducted the

administrative hearing of this proceeding on December 4 and 5,

2001, in Fort Myers, Florida, on behalf of the Division of

Administrative Hearings (DOAH).

APPEARANCES

For Petitioner: Britt Thomas, Esquire

Agency for Health Care Administration

2727 Mahan Drive

Tallahassee, Florida 32308

For Respondent: Carol A. Lanfi, Esquire

1000 Riverside Avenue, Suite 800

Jacksonville, Florida 32204

Albert Peacock, Esquire

8554 Congressional Drive

Tallahassee, Florida 32312

STATEMENT OF THE ISSUES

The ultimate issues in this case are whether Respondent

violated Section 458.331(1)(m) and (t), Florida St atutes (1997),

respectively, by failing to keep medical records that justify

the course of treatment and by failing to practice medicine with

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

a reasonably prudent similar physician as being ac ceptable under

similar conditions and circumstances; and, if so, what penalty,

if any, should be imposed against Respondent's license to

practice medicine. (All chapter and section references are to

Florida Statutes (1997) unless otherwise stated.)

PRELIM INARY STATEMENT

On July 10, 2000, Petitioner filed an Administrative

Complaint against Respondent. Respondent timely requested an

administrative hearing.

At the hearing, Petitioner presented the testimony of three

witnesses, including one expert, and s ubmitted 12 exhibits for

admission in evidence. Three of the exhibits consisted of the

deposition testimony of three expert witnesses. Respondent

testified in his own behalf, as an expert, and presented the

live testimony of three witnesses, including tw o experts.

Respondent submitted nine exhibits for admission in evidence.

The identity of the witnesses and exhibits in the case and

any attendant rulings are set forth in the four - volume

Transcript of the hearing filed on January 17, 2002. At the

reque st of the parties, the ALJ extended the time for filing the

proposed recommended orders ("PROs"). The four - volume

Transcript was filed January 17, 2002. Petitioner and

Respondent timely filed their respective PROs on February 8,

2002.

FINDINGS OF FACT

1. Petitioner is the state agency responsible for

regulating the practice of medicine in Florida pursuant to

Sections 20.165 and 20.43 and Chapters 455 and 458. Respondent

is licensed as a medical physician in Florida pursuant to

license number ME0050478 . Respondent has been a Board - certified

plastic surgeon at all times material to this proceeding.

2. The Administrative Complaint involves one patient who

undertook elective plastic surgery. The record identifies the

patient as E.O. in order to preserve the patient's

confidentiality. In summary, the Administrative Complaint

alleges that Respondent departed from the acceptable standard of

care by: failing to perform the surgical procedure elected by

E.O.; performing a surgical procedure other than the pr ocedure

E.O. authorized; failing to document a reason for changing the

procedure; failing to advise the patient of the risks associated

with the procedure performed; performing breast augmentation

with implants that were too large; and failing to document a

reason for using the larger implants.

3. On December 31, 1997, E.O. presented to Respondent for

consultation regarding reconstruction of her left breast. At

the time, E.O. was approximately 48 years old.

4. E.O.'s medical history included an abdom inal

hysterectomy, a biopsy of the right breast, two biopsies of the

left breast, and a diagnosis of cancer in the left breast.

A partial mastectomy of the left breast and radiation therapy

resulted in significant scarring.

5. The left breast had a c oncave, depressed area in the

left side. The depressed area extended from the upper part of

the breast, near the outer pectoral muscle, halfway to the

nipple. The nipple on the left breast was pulled to the outside

toward the depressed area. E.O. also s uffered ptosis, i.e., the

appearance of drooping, that was not related to her medical

history.

6. The radiation therapy to the left breast had caused a

burn injury that left internal scar tissue. The scar tissue was

not pliable and was not suitable for m anipulation during plastic

surgery.

7. During E.O.'s initial visit with Respondent on

December 31, 1997, Respondent noted E.O.'s prior medical history

and radiation treatment. He noted the bilateral ptosis and the

left breast deformity.

8. Respond ent recommended bilateral implants for the

purposes of reconstructing the left breast and for achieving

symmetry between the breasts. Respondent and E.O. did not agree

on a plan of treatment during the initial visit but did agree to

a second visit.

9. On January 16, 1998, E.O. presented to Respondent for

her second visit. After further consideration of E.O's case,

Respondent made a specific recommendation of bilateral

augmentation with prostheses, in the form of implants, and a

latissimus dorsi flap (LDF ) procedure to correct the depression

in the left breast. An LDF procedure would have resected, or

removed, the scarring in the left breast and would have replaced

the resulting divot with healthy tissue. Respondent would have

obtained healthy tissue by moving a flap of tissue and muscle

from the patient's back underneath the patient's outer tissue

layers and placing the flap internally in the left breast. E.O.

agreed with Respondent's recommendation.

10. E.O. agreed to the bilateral augmentation beca use

Respondent advised her that an implant in her right breast was

necessary to achieve appropriate symmetry. E.O. did not agree

to the augmentation because she wanted larger breasts.

Respondent assured E.O. that her breast size would increase only

about one - half cup. Respondent's records do not include a

reference to the size of the implants to be used.

11. Respondent indicated he would seek preauthorization

from the insurer for the LDF procedure with prosetheses. The

LDF procedure required E.O. to stay overnight in the hospital

following surgery. Surgery that omitted the LDF procedure could

have been performed in "same - day" surgery. Respondent and E.O.

did not discuss or agree upon any plan of treatment.

12. On January 21, 1998, E.O. presented to Respondent for

a third time. E.O.'s husband, L.O., was also present.

Respondent discussed the LDF procedure with E.O. and L.O.

Respondent stated that he believed the LDF procedure was

necessary to fill - in the left breast after Respondent resected

th e radiated tissue as part of the reconstruction of E.O.'s left

breast. Respondent, E.O., and L.O. did not discuss other

treatment options. On January 21, 1998, Respondent requested

authorization from E.O.'s insuror for breast reconstruction

surgery that included an LDF procedure with the use of a

prosthetic implant.

13. On February 12, 1998, E.O. presented to Respondent for

a fourth time. E.O. had additional questions about the surgery

that included questions regarding the insurance coverage for the

s urgery. E.O. and Respondent did not discuss the LDF procedure

or other treatment options.

14. Respondent scheduled the surgery for February 26,

1998, at the Columbia Regional Medical Center Southwest Hospital

("Columbia" or the "hospital"). On Februar y 24, 1998, E.O.

presented to Columbia for a preoperative workup.

15. At the preoperative workup, E.O. executed a written

informed consent document that authorized Respondent to perform

a, "Lat Flap with implant left Breast and Right endoscope

augmentat ion." Respondent also signed the informed consent.

E.O. did not consent to another procedure different from that

stated in the informed consent. Nor did E.O. and Respondent

agree upon a different procedure.

16. Hospital records, including the Shor t - Stay History and

Physical completed on the day of surgery and signed by

Respondent, show that the procedure to be performed was an LDF

procedure with implants. The hospital records are devoid of any

indication that E.O. did not wish to undergo the LDF p rocedure

or that E.O. expressed any reservations about the procedure.

17. On the morning of February 26, 1998, E.O. fully

expected to undergo the LDF procedure. E.O. presented to

Columbia anticipating an overnight hospitalization that was

consistent with an LDF procedure. E.O. brought with her the

personal belongings she would need for an overnight

hospitalization. The applicable standard of medical care

required Respondent to perform the LDF procedure so long as it

was medically reasonable to do so.

18. On February 26, 1998, Respondent performed surgery on

E.O. that included an implant in each breast. However,

Respondent did not perform the LDF procedure. Rather,

Respondent created breast flaps by incising existing scar tissue

and utilizing the inc ised scar tissue to fill in the depression

in the left breast. Respondent did not resect the scar tissue

and replace it with healthy tissue.

19. Immediately after the surgery, Respondent advised

L.O., without explanation, that Respondent did not perfor m the

LDF procedure and that E.O. was doing well. Columbia discharged

E.O. on the same day of surgery. During the trip home in their

car, L.O. advised E.O. that Respondent did not perform the LDF

procedure. E.O. was surprised but groggy from medication.

20. No medical reason prevented Respondent from performing

the LDF procedure. Respondent encountered no difficulties or

complications during surgery that precluded the LDF procedure.

Moreover, there were medical reasons not to incise the scar

tissue and use it to fill in the depression in the left breast.

Irradiated scar tissue is not well vascularized, is not pliable,

and is not easy to manipulate.

21. The only reason that Respondent offered for failing to

perform the LDF procedure was that E.O. e xpressed concern over

the procedure. Respondent testified that E.O. expressed her

concern to Respondent when Respondent was in the holding area

marking E.O.'s breasts for surgery. The holding area is an area

that is physically separate from the operating room.

22. E.O. did not expressly ask Respondent not to perform

the LDF procedure. Rather, Respondent inferred that E.O. did

not want him to perform the LDF procedure. As Respondent

testified during cross examination:

Q. And you had a conversation wi th her

wherein she expressed some concern about the

latissimus dorsi flap procedure; is that

correct?

A. The tenor of her conversation indicated

some concern. She did not say to me please

don't do it, but the tenor of her

conversation was that there was concern when

I was marking her for it.

Transcript ( TR ) at 624.

23. Respondent claims that the conversation with E.O.

occurred when Respondent was in the holding area marking E.O.

for surgery. Respondent's testimony during cross examination is

illus trative.

Q. And your testimony is that, is the

holding area an area different than the

actual operating room.

A. Yes.

* * *

Q. I would like for you to look to the

first line of this operative report, under

procedures. It says the patient was brought

to the operating room, and marked in the

sitting position, then laid supine.

A. Yes.

Q. Doesn't that note say that you did not

mark this patient in the holding area, but

you marked her in the operating room?

A. It sure does.

Q. And are you telling me today that this

is in error?

A. That is absolutely in error. I have

never marked a patient in the operating

room.

TR at 625.

24. Respondent's claim that he had a conversation with

E.O. in the holding area before surger y is refuted by E.O. The

testimony of E.O. concerning this factual issue is credible and

persuasive. The testimony of E.O. is consistent with the

operative report stating that E.O. was marked in the operating

room rather than in the holding area.

25. Respondent did not see E.O. in the holding area prior

to surgery and did not have a conversation with E.O. in which

E.O. expressed some concern over the LDF procedure. E.O.

received preoperative medication in the holding area and was not

capable of carryi ng on a conversation with Respondent in the

operating room and was not capable of making an informed consent

to a different procedure. If it were determined that Respondent

had a conversation with E.O. in the holding area while marking

her for surgery, th ere was ample time to amend the informed

consent document to reflect a different treatment plan agreed to

by E.O. and Respondent.

26. The actual surgery performed by Respondent was a

procedure that was different from the LDF procedure authorized

by E.O. The actual surgical procedure performed by Respondent

was not a lesser included procedure of the LDF procedure.

27. The applicable standard of care would have required

Respondent to amend the informed consent document under the

facts and circumstances testified to by Respondent. An informed

consent should include all anticipated treatment options. The

informed consent signed by E.O. and Respondent did not include

any options to the LDF procedure.

28. Even if it were determined that the actual proced ure

performed is a lesser included procedure of the LDF procedure,

E.O. did not consent to the lesser included procedure. The

performance of a lesser included procedure for which E.O. was

not informed and to which E.O. did not consent departs from the

app licable standard of care.

29. The procedure performed by Respondent during surgery

increased the risk of failure and the need for subsequent

surgery by using scar tissue rather than resecting the scar

tissue and using healthy tissue to fill in the left br east.

Respondent failed to inform E.O. of the increased risk of the

procedure actually utilized by Respondent.

30. Respondent failed to practice medicine with the level

of care, skill, and treatment recognized by a reasonably prudent

similar physician as acceptable under similar conditions and

circumstances. First, Respondent failed to perform the

procedure that E.O. authorized. Second, Respondent performed a

procedure that placed implants in E.O.'s irradiated left breast

without resecting the irradia ted scar tissue. Third, Respondent

failed to inform E.O. of the increased risk associated with the

procedure Respondent utilized during surgery. Finally,

Respondent failed to document in the records a reason or

rationale for performing a surgical procedu re other than the LDF

procedure authorized by the patient.

31. Prior to surgery, Respondent agreed to use the

smallest implants possible. During surgery, Respondent placed

very large implants in E.O.'s breasts. Respondent used a 480 cc

implant in the left breast and a 460 cc implant in the right

breast. Respondent used the large implant in the left breast,

rather than the LDF, in an attempt to stretch the tissue,

including the scar tissue, and to fill in the depression in the

left breast. Respondent used the large implant in the right

breast for symmetry.

32. E.O. did not consent to the use of large implants in

either breast. Rather, E.O. authorized the smallest implants

possible. Respondent utilized implants that increased E.O.'s

cup size from a small C cup to a DD cup.

33. The weight and volume of the large implants stretched

E.O.'s skin and exacerbated her ptosis. After surgery, E.O.'s

clothes did not fit. A DD cup size was sometimes too small.

34. An accepted method of determining the effect of

implants is to sit the patient up on the operating table prior

to completing surgery. Respondent did not sit E.O. up on the

operating table to view the effect of the implants. Respondent

had a complete range of implant types and sizes available for

use during surgery.

35. Respondent failed to practice medicine with the level

of care, skill, and treatment recognized by a reasonably prudent

similar physician as acceptable under similar conditions and

circumstances. Respondent utilized implants that were not

authorized by E.O. by placing overly large implants in E.O.'s

breasts. Respondent failed to utilize the implants authorized

by E.O. by failing to use the smallest implants possible.

Respondent failed to document in the records a reason or

rationale for using implants other than those authorized by E.O.

36. Respondent's failure to practice medicine in

accordance with the applicable standard of care caused

substantial harm to E.O. At the first postoperative visit on

March 2, 1998, E.O. a sked Respondent why he did not perform the

LDF procedure. Respondent stated that he had determined that

E.O. could do without the LDF procedure.

37. E.O. also expressed concern over the large size of her

breasts. Respondent explained that the large si ze was

attributable to swelling and that it would take several months

for the swelling to dissipate. Until that time, it was

impossible to assess the final result.

38. During subsequent visits on March 11 and 18 and on

April 3, 1998, E.O. expressed con cern over the size and

appearance of her breasts. However, she continued to trust

Respondent and to accept his assurances that she needed to be

patient and allow the swelling to go down before forming any

final opinions regarding the outcome of the surger y.

39. During a visit on May 1, 1998, Respondent examined

E.O. and acknowledged that the procedure actually performed on

February 26, 1998, did not produce the desired result. The

implant and incised scar tissue had not stretched and filled in

the left breast. Respondent advised E.O. that she needed the

LDF procedure.

47. E.O. elected for Dr. Brueck to perform reconstruction

surgery on her. However, problems with insurance coverage

delayed the surgery until July 11, 2000. The surgery included

bila teral reconstruction with bilateral implant and mastopexy.

E.O.'s breast size was a B cup after surgery. E.O. was very

pleased with the results of the surgery.

CONCLUSIONS OF LAW

48. DOAH has jurisdiction over the parties and the subject

matter. The parties received adequate notice of the

administrative hearing. Section 120.57(1).

49. The burden of proof is on Petitioner. Petitioner must

show by clear and convincing evidence that Respondent committed

the violations alleged in Administrative Complai nt and the

reasonableness of any proposed penalty. Department of Banking

and Finance, Division of Securities and Investor Protection vs.

Osborne Stern and Company , 670 So. 2d 932, 935 (Fla. 1996);

State ex rel. Vining v. Florida Real Estate Commission , 28 1 So.

2d 487 (Fla. 1973); Ferris v. Turlington , 510 So. 2d 292 (Fla.

1st DCA 1987).

50. Petitioner satisfied its burden of proof. Clear and

convincing evidence has both qualitative and quantitative

requirements. The factual testimony of E.O., the testim ony of

Petitioner's experts, and the records submitted in the case

satisfy both the qualitative and quantitative requirements for

clear and convincing evidence.

51. The factfinder in this case determined that the

factual testimony of E.O. was credible and persuasive. She

distinctly remembered the material facts to which she testified.

Her testimony concerning the material facts was precise,

explicit, and lacked confusion.

52. Respondent attempted to discredit E.O.'s testimony by

relying on the absence o f any notation in his records that E.O.

was unhappy with her surgery and by relying on records

indicating that the initial consultation was for implants rather

than for breast reconstruction. However, Respondent does not

rely on the operative report that shows that E.O. was marked in

the operating room rather than in the holding area as asserted

by Respondent. Such inconsistencies are neither credible nor

persuasive to the trier of fact.

53. Respondent also seeks to discredit the testimony of

Dr. Bruec k on the grounds that Dr. Brueck is a subsequent

treating physician with an interest in the outcome of his

treatment of E.O. In addition, Respondent relies on an alleged

business dispute between Respondent and Dr. Brueck that preceded

the surgery performe d by Respondent. See , e.g. , Robinson v.

Board of Dentistry , 447 So. 2d 930, 931 - 932 (Fla. 3d DCA

1984)(holding that the testimony of one interested witness does

not rise to the level of clear and convincing evidence).

54. The holding in Robinson does not render the testimony

of an interested witness inadmissible. It affects only the

weight to be afforded such testimony.

55. The issue surrounding the testimony of Dr. Brueck is

one of credibility rather than admissibility. Martuccio v.

Department of Professional Regulation, Board of Optometry , 622

So.2d 607, 609 (Fla. 1st DCA 1993). The trier fact in this case

determined the testimony of Dr. Brueck to be credible and

consistent with the testimony of another board - certified plastic

surgeon present ed by Petitioner. Even if the testimony of

Dr. Brueck were disregarded, the testimony of the other three

board - certified plastic surgeons presented by Petitioner

satisfies the requirements of the clear and convincing standard.

56. During the administra tive hearing, the ALJ requested

the parties to brief the issue of whether the assertion by

Respondent that E.O. consented to the procedure performed on

February 26, 1998, during a conversation in the holding area is

in the nature of an affirmative defense for which Respondent

bears the burden of proof. The issue is moot because the clear

and convincing evidence shows that E.O. gave no consent.

57. Petitioner showed by clear and convincing evidence

that Respondent failed to practice medicine with the level of

care, skill, and treatment recognized by a reasonably prudent

similar physician as acceptable under similar conditions and

circumstances. Respondent failed to perform the procedure that

E.O. authorized; performed a different procedure that placed

impl ants in E.O.'s irradiated left breast without resecting the

irradiated scar tissue; failed to inform E.O. of the increased

risk associated with the different procedure; and placed overly

large implants in E.O.'s breasts. In addition, Respondent

failed to document in the records a reason or rationale for

performing a surgical procedure other than the LDF procedure

authorized by the patient and for using implants larger than

those authorized by E.O.

58. Respondent caused significant harm to E.O. Respon dent

failed to correct the disfigurement of the left breast and

exacerbated the ptosis that E.O. sought to correct. Respondent

caused E.O. to undergo a second surgical procedure as well as

pain, embarrassment, and discomfort from February 26, 1998,

until July 11, 2000.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions

of Law, it is

RECOMMENDED, in accordance with the terms of Petitioner's

PRO, that Petitioner enter a Final Order finding Respondent

guilty of violating Section 458.3 31(1)(m) and (t); issuing a

written reprimand; imposing a fine of $5,000; and requiring

Respondent to complete, within one year, 20 hours of continuing

professional education above and beyond that required to

maintain licensure.

DONE AND ENTERED this 18th day of March, 2002, in

Tallahassee, Leon County, Florida.

___________________________________

DANIEL MANRY

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 96 75 SUNCOM 278 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 18th day of March, 2002.

COPIES FURNISHED :

William W. Large, General Counsel

Department of Health

4052 Bald Cypres s Way, Bin A02

Tallahassee, Florida 32399 - 1701

Britt Thomas, Esquire

Agency for Health Care Administration

2727 Mahan Drive

Tallahassee, Florida 32308

Carol A. Lanfi, Esquire

1000 Riverside Avenue, Suite 800

Jacksonville, Florida 32204

Albert Peacoc k, Esquire

8554 Congressional Drive

Tallahassee, Florida 32312

Tanya Williams, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

R. S. Power, Agency Clerk

Department of Health

40 52 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.