06-003707PL Department Of Health, Board Of Medicine vs. Richard B. Edison, M.D. Status: Closed Recommended Order on Monday, January 7, 2008.

Summary: Petitioner proved that Respondent failed to keep adequate medical records and violated the standard of care regarding the maximum dosage of Lidocaine. Recommended penalty: 90 days` suspension, four years` probation, and a $15,000 fine.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

)

Petitioner, )

)

vs. ) Case No. 06 - 3707PL

)

RICHARD B. EDISON, M.D., )

)

Respondent. )

_________________________________)

RECOMMENDED ORDER

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

on Dec ember 5 through 7, 2006, in Fort Lauderdale, Florida,

before Patricia M. Hart, a duly - designated Administrative Law

Judge of the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Patricia Nelson, Esquire

John E. T errell, Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

For Respondent: George K. Brew, Esquire

Lewis W. Harper, Es quire

Brew & Harper, P.L.

6817 Southpoint Parkway

Jacksonville, Florida 32216

STATEMENT OF THE ISSUE

Whether the Respondent committed the violations alleged in

the Administrative Complain t filed July 7, 2006, and, if so, the

penalty that should be imposed.

PRELIMINARY STATEMENT

In a four - count Administrative Complaint filed July 7,

2006, the Department of Health ("Department") charged Richard

B. Edison, M.D., with the following violations arising out of

Dr. Edison's care and treatment of patient P.L. on July 7, 2005,

as he began to perform breast augmentation surgery:

(1) Section 458.331(1)(t), Florida Statutes (2005), 1

committing medical malpractice by failing "to practice medicine

in acc ordance with the level of care, skill, and treatment

recognized in general law related to" licensure to practice

medicine, § 456.50(1)(g), Florida Statutes;

(2) Section 458.331(1)(m), Florida Statutes, "failing to

keep legible , . . . medical records . . . 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 ";

(3) Sec tion 458.331(1)(q), Florida Statutes,

"[p[ rescribing, dispensing, administering, mixing, or otherwise

preparing a legend drug, including any controlled substance,

other than in the course of the ph ysician's professional

practice"; and

(4) Section 458.331( 1)(w), Florida Statutes, which

prohibits "[d] elegating professional responsibilities to a

person when the licensee delegating such responsibilities knows

or has reason to know that such person is not qualified by

training, experience, or licensure to perfo rm them. "

Dr. Edison timely requested an administrative hearing to

resolve disputed issues of material fact, and the Department

forwarded the matter to the Division of Administrative Hearings

for assignment of an administrative law judge. The case was

ori ginally assigned to Administrative Law Judge Larry J. Sartin

but was transferred to Administrative Law Judge Hart for

hearing. Pursuant to notice, the final hearing was held on

December 5 through 7, 2006.

On November 30, 2006, Dr. Edison filed Respondent' s Motion

for a Determination that Petitioner Participated in the

Proceeding for an Improper Purpose and Determine the Award of

Attorney's Fees and Costs Pursuant to Section 120.595, Florida

Statutes. After discussion during the final hearing, a

telephone conference was held on December 13, 2006, during which

the undersigned requested that the Department file a written

response to the motion and that Dr. Edison file a reply to the

Department's response; the parties filed the requested

submittals on December 19, 2006, and January 6, 2007,

respectively. On February 2, 2007, Dr. Edison filed

Respondent's Motion for Attorney's Fees and Costs Pursuant to

Section 57.105, Florida Statutes, and the Department filed its

response in opposition to the motion on Februa ry 12, 2007.

Finally, on March 9, 2007, Dr. Edison filed a statement of

attorneys' fees and costs incurred by Dr. Edison to date. The

motions for attorneys' fees and costs will be addressed in a

separate order issued contemporaneously with this Recommend ed

Order.

The parties filed a Joint Pre - Hearing Statement on

November 21, 2006. At the hearing, the Department presented the

testimony of patient P.L. and her husband, A.A.; Michelle Hoff,

A.R.N.P., Dr. Edison's nurse; Franklin Segal, M.D., the

Department 's anesthesiology expert; Shana Pender, paramedic;

Holly Schmorr, paramedic; Katherine Rosenblatt, an employee of

the Department; Todd Gardner, M.D., emergency room physician;

Robert Alterbaum, M.D., intensive care physician; and

Marguerite P. Barnett, M.D ., the Department's plastic surgery

expert. Petitioner's Exhibits 1 through 10, 12 through 18, and

20 through 23 were offered and received into evidence.

Dr. Edison testified in his own behalf and presented the

testimony of Samuel Rosenthal, M.D., Dr. Ed ison's expert in

plastic surgery; Liliana Gabor, a surgical technician employed

by Dr. Edison; and Jay Raja, M.D., Dr. Edison's expert in

anesthesiology. Respondent's Exhibits 1 through 5 were offered

and received into evidence.

Official recognition was g ranted, at Dr. Edison's request

and without objection by the Department, to Florida

Administrative Code Rules 64B8 - 9.003 and 9.009, 64B9 - 4.002 and

4.003, and 28 - 105.001; to Sections 120.565, 120.54, 464.001,

.002, and .003, 456.073, and 458.331 , Florida St atutes ; to the

Final Order in Department of Health v. Alton Earl Ingram, M.D. ,

DOAH Case No. 04 - 0709PL (DOH December 16, 2004)(FO No. DOH - 04 -

1585 - FOF - MQA); and copies of written opinions issued by various

Florida appellate courts.

Official recognition was granted, at the Department's

request, of the Final Order entered pursuant to a Consent

Agreement in Agency for Health Care Administration, Board of

Medicine v. Richard B. Edison, M.D. , AHCA Case No. 92 - 13004

(AHCA August 30, 1995)(FO No. AHCA - 95 - 1210); the Recommended

Order in Department of Health, Board of Medicine v. Richard B.

Edison M.D. , DOAH Case No. 05 - 0598PL (DOAH August 25, 2006); the

Final Order in Department of Health, Board of Medicine v.

Richard B. Edison M.D. , DOAH Case No. 05 - 0598PL (DOH Janu ary 4,

2007)(FO No. DOH - 07 - 0026 - FOF - MQA), together with a copy of the

Recommended Order, the exceptions to the Recommended Order filed

by the Department and Dr. Edison, Dr. Edison's response to the

Department's exceptions, and the Administrative Complaint 2 ;

Florida Administrative Code Rules 64B8 - 8.001 and 9.009; the

Recommended Order in Department of Health v. Alton Earl Ingram,

M.D. , DOAH Case No. 04 - 0709PL (DOAH September 24, 2004); and the

Final Order in Department of Health v. Alton Earl Ingram, M.D. ,

D OAH Case No. 04 - 0709PL (DOH December 16, 2004)(FO No. DOH - 04 -

1585 - FOF - MQA).

At the conclusion of the final hearing, the Department was

given leave to file an additional motion for official

recognition, which the Department filed December 18, 2006.

Dr. Edi son objected to the request on the grounds of relevance

and lack of notice and was given the opportunity to file his

objections in writing no later than seven days after the motion

was filed. Dr. Edison did not file written objections, and it

is, therefor e, assumed that he waived the objections raised at

the hearing. Accordingly, as requested by the Department,

official recognition was taken of the Department's Final Order

of Emergency Restriction of License, DOH Case No. 04 - 4940

(DOH June 8, 2005)(FO No. DOH 05 - 0864 - ERO - MQA); the Order of the

First District Court of Appeal in Case No. 1D05 - 2853 (June 20,

2005), granting a stay of the Order of Emergency Restriction of

License; and Edison v. Department of Health , Case No. 1D05 - 2853

(August 30, 2005), in whi ch the court affirmed, per curiam, the

Order of Emergency Restriction of License.

The Department also requested, in the second Petitioner's

Motion for Official Recognition filed December 4, 2006, that

official recognition be taken of the Final Order entere d

February 20, 2002, by the Board of Nursing on the Petition for

Declaratory Statement of Brenda Sammy, R.N., Final Order

No. DOH - 02 - 0365 - DS - MQA. The motion was addressed at the

beginning of the final hearing, which convened on December 5,

2006, and the u ndersigned withheld ruling on this portion of the

Department's motion and requested that the parties file written

arguments. Dr. Edison objected to the Department's request that

official recognition be taken of this order on the grounds that

it was not re levant to any issue in these proceedings, first, on

the ground that declaratory statements, by statute, rule, and

case law, do not bind anyone but the person submitting the

petition for a declaratory statement and, second, on the ground

that the declarator y statement was issued by the Board of

Nursing, which has no jurisdiction over Dr. Edison. The

Department responded that its purpose in requesting official

recognition of the declaratory statement was not to establish a

basis for disciplining Dr. Edison b ut to establish that

Dr. Edison had notice about the dangers of the administration of

Diprivan by registered nurses during office surgery and the

concern in the medical community over this practice.

The Department has the burden of proving that Dr. Edison' s

conduct violated the standard of care applicable to physicians.

The declaratory statement at issue does not tend to prove any

fact material to a determination of the standard of care

applicable to Dr. Edison's use of Diprivan in office surgery. 3

Having carefully considered the arguments of counsel, the

Department's request for official recognition of the Final Order

entered February 20, 2002, by the Board of Nursing on the

Petition for Declaratory Statement of Brenda Sammy, R.N., Final

Order No. DOH - 02 - 0365 - DS - MQA, is denied.

The four - volume transcript of the proceedings was filed

with the Division of Administrative Hearings on December 18,

2006. The parties timely filed proposed findings of fact and

conclusions of law, and Dr. Edison also filed Respond ent's

Closing Argument and Memorandum of Law, all of which have been

considered in the preparation of the Recommended Order.

FINDINGS OF FACT

Based on the oral and documentary evidence presented at the

final hearing and on the entire record of this procee ding, the

following findings of fact are made:

1. The Department is the state agency responsible for the

investigation and prosecution of complaints involving physicians

licensed to practice medicine in Florida. See § 455.225, Fla.

Stat. (2006). The Boa rd is the entity responsible for

regulating the practice of medicine in Florida and for imposing

penalties on physicians found to have violated the provisions of

Section 458.331(1), Florida Statutes. See § 458.331(2), Fla.

Stat. (2006).

2. Dr. Edison is, and was at the times material to this

matter, a physician licensed to practice medicine in Florida,

having been issued license number ME 44240.

3. Dr. Edison received his medical degree from the

University of Massachusetts; did his residency in general

s urgery at the Kaiser Foundation in Los Angeles, California; and

did a residency in plastic surgery, with specialties in

reconstructive surgery and cosmetic surgery.

4. Dr. Edison is certified in plastic surgery by the

American Board of Plastic Surgery and is a lifetime diplomate of

that Board. Dr. Edison was also certified in Advanced Cardiac

Life Support ("ACLS") at the times material to this proceeding.

5. Dr. Edison has been practicing plastic surgery in

Florida for 22 years.

6. Prior to the time mat erial to this proceeding,

Dr. Edison performed approximately 150 - to - 200 breast

augmentation surgeries each year and approximately 100 - to - 150

liposuction procedures each year.

7. Dr. Edison practices at the Cosmetic Surgery Center,

which is an office that contains two operating rooms, a recovery

room, and an overnight recovery facility that is staffed by an

ACLS - certified nurse for patients who undergo procedures such as

stomach tucks or facelifts.

8. Dr. Edison's surgical practice is limited to Level II

o ffice surgery, which is defined in Florida Administrative Code

Rule 64B8 - 9.009, Standard of Care for Office Surgery, in

pertinent part as follows:

(4) Level II Office S urgery.

(a) Scope

1. Level II Office Surgery is that in which

peri - operative medica tion and sedation are

used intravenously, intramuscularly, or

rectally, this making intra and post -

operative monitoring necessary. . . .

2. Level II Office S urgery includes any

surgery in which the patient is placed in a

state which allows the patient to tolerate

unpleasant procedures while maintaining

adequate cardiorespiratory function and the

ability to respond purposefully to verbal

command and/or tactile stimulation.

Patients whose only response is reflex

withdrawal from a painful stimulus are

sedat ed to a greater degree than encompassed

by this definition.

(b) Standards for Level II Office Surgery.

* * *

4. Assistance of Other Personnel Required.

The surgeon must be assisted by a qualified

anesthesia provider as follows: An

Anesthesiologist, Certified Registered Nurse

Anesthetist, or Physician Assistant

qualified as set forth in subparagraph 64B8 -

30.012(2)(b)6., F.A.C., or a registered

nurse may be utilized to assist with the

anesthesia, if the surgeon is ACLS

certified. An assisting anesthes ia provider

cannot function in any other capacity during

the procedure. If additional assistance is

required by the specific procedure or

patient circumstances, such assistance must

be provided by a physician, osteopathic

physician, registered nurse, lice nsed

practical nurse, or operating room

technician. . . .

The level of pain and anxiety management achieved under Level II

sedation is determined by the type of drugs administered and the

dosages in which they are administered.

9. Dr. Edison was ACLS cer tified and was, therefore,

authorized to use the services of a registered nurse to

administer the drugs that bring patients to Level II sedation.

He does not use the services of an anesthesiologist or of a

Certified Registered Nurse Anesthetist in his sur gical facility.

Patient P.L.

10. P.L. first consulted with Dr. Edison on July 5, 2005.

P.L. filled out a portion of a Patient Information form, and

Dr. Edison took a general medical history from P.L., but he did

not weigh P.L. during this initial visit, and the Patient

Information form does not include her blood pressure, height, or

weight. Dr. Edison found P.L. to be a healthy 29 - year - old

female, the mother of three children, who had no known allergy

or adverse reaction to any medication.

11. P.L. wan ted breast implants, and, upon examination,

Dr. Edison found that P.L. would be a good candidate,

anatomically, for the surgery. Dr. Edison spent the majority of

time during this initial consultation talking with P.L. and her

husband, A.A., about the vari ous breast implant options. He

also discussed with them the risks and possible complications of

the surgery.

12. After her visit to Dr. Edison's office on July 5,

2005, P.L. notified Dr. Edison's office that she had decided to

have the surgery. Dr. Edis on had a cancellation on July 7,

2005, and P.L. was scheduled for surgery for 8:00 a.m. on that

date.

13. P.L. returned to Dr. Edison's office on July 6, 2005,

for a pre - operative examination. At that time, Dr. Edison did

an examination during which he c hecked P.L.'s heart, lungs,

blood pressure, and pulse rate, and he noted the results in his

examination notes dated July 6, 2005. He found nothing abnormal

and concluded that P.L. was a 29 - year - old patient in perfect

health, with no known allergy or adver se reaction to any

medication.

14. Dr. Edison also had blood drawn during the July 6,

2005, office visit, which was sent to a laboratory for testing.

The laboratory report was completed at 8:21 a.m. on July 7,

2005, and showed nothing abnormal.

15. P.L. presented herself at Dr. Edison's office on

July 7, 2005, at approximately 8:00 a.m. She was examined by

Dr. Edison at 8:10 a.m., and he stated in his office notes that

she had decided on the 300 cubic centimeter implant. There were

no notations of her vital signs in his office notes.

16. Dr. Edison intended for P.L.'s breast augmentation

surgery to be Level II office surgery, and he noted this on

P.L.'s Immediate Pre - Op Evaluation, which he completed on

July 7, 2005. He also decided to use the transax illary

technique, making incisions under the arms through which to

insert the implants under the muscle in P.L.'s chest.

17. Dr. Edison was assisted during surgery by Michelle

Hoff, an Advanced Registered Nurse Practitioner, who

administered the sedatives and other drugs to P.L. under

Dr. Edison's direction. Dr. Edison was also assisted by Liliana

Gabor, a surgical technician.

18. Ms. Hoff is not a Certified Registered Nurse

Anesthetist, nor has she received any formal training in

administering sedative drugs or anesthesia. She has a

significant amount of experience administering drugs for pain

and anxiety management. Her experience administering drugs to

achieve Level II sedation consists of an externship with

Dr. Edison while working on her master's d egree in nursing and

extensive on - the - job training while working in the operating

room with Dr. Edison, which she has done every day since

beginning to work with Dr. Edison full - time in November 2003.

19. At some point immediately prior to surgery, Dr. Ed ison

asked P.L. her weight, which she reported as 95 pounds, or 43

kilograms, on the morning of surgery. Dr. Edison needed to know

P.L.'s weight in order to calculate the correct dosage of the

drugs she would be given, and he wrote "95 lbs" on the outside

of P.L.'s folder. Dr. Edison noted P.L.'s weight on the outside

of the folder so it would be plainly visible to Ms. Hoff when

she had the chart on the anesthesia stand. 4

20. Dr. Edison did not enter P.L.'s weight in his

examination notes, and the only o ther mention of P.L.'s weight

in the medical records maintained by Dr. Edison is the notation

"<100 lbs"="" on="" a="" sheet="" containing="" the="" contact="" numbers="" for="">

and for her husband, who would be picking her up after surgery.

21. At approximately 8:20 a.m. on J uly 7, 2005, P.L.

walked to the operating room. Working under Dr. Edison's

direction, Ms. Hoff hooked P.L. up to various monitoring

devices, so that her heart, blood pressure, and oxygen

saturation level could be monitored during surgery. Her vital

signs were noted on the anesthesia chart by Ms. Hoff; at

8:20 a.m., P.L.'s heart rate was approximately 104.

22. At 8:20 a.m., Ms. Hoff began to administer drugs to

P.L. to achieve Level II sedation in accordance with directions

from Dr. Edison; she documente d the name of the drugs she

administered, together with the time and dosage administered;

she monitored and documented P.L.'s vital signs, including heart

rate, blood pressure, and oxygen saturation level; and she

maintained anesthesia notes.

23. At 8:20 a.m., Ms. Hoff administered two milligrams of

Valium; one gram of Ancef, and 0.2 milligrams of Robinol at

Dr. Edison's direction.

24. At 8:25 a.m., she administered 10 milligrams of

Ketamine and 10 milligrams of Talwin and started the

administration of Di privan by microdrip at the rate of

approximately 25 micrograms per kilogram of weight per minute.

Ms. Hoff's notes do not indicate the manner in which she

administered the Diprivan, nor the dosage or rate of

administration. Ms. Hoff also administered nit rous oxide and

oxygen at 8:25 a.m., and she noted that Dr. Edison also began

administering local anesthetic by injection at 8:25 a.m.

Ms. Hoff noted that P.L. was responding to verbal stimuli.

25. Ms. Hoff was not involved with the preparation or

adminis tration of local anesthetic to P.L. Dr. Edison prepared

a dilute solution of 70 cubic centimeters of 1% Lidocaine with

epinephrine with 350 cubic centimeters of saline solution and

10 cubic centimeters of 1/2% marcaine. At approximately

8:25 a.m., Dr. Ed ison began injecting the Lidocaine solution,

which totaled approximately 700 milligrams or approximately

14 milligrams of Lidocaine per kilogram of P.L.'s body weight

and 50 milligrams of marcaine, into the tissue surrounding

P.L.'s breasts.

26. At 8:30 a .m., Ms. Hoff, at Dr. Edison's direction,

administered another 10 milligrams of Talwin.

27. At 8:35 a.m., P.L.'s heart rate was 112 beats per

minute and her blood pressure was 142/102. At Dr. Edison's

direction, Ms. Hoff administered 1/4 cubic centimeter of

Labetalol to help control P.L.'s blood pressure. Ms. Hoff noted

that P.L. tolerated the Labetalol well and was responsive to

verbal stimuli.

28. At 8:45 a.m., Ms. Hoff noticed a brief facial twitch

on P.L.'s face, which is an indication of a possible seizure.

At Dr. Edison's direction, she immediately stopped administering

all sedatives, and the surgery was cancelled. At Dr. Edison's

direction, Ms. Hoff administered 2.5 milligrams of Valium to

keep P.L. sedated and to help control the seizure, toget her with

three liters of oxygen by mask.

29. At 8:55 a.m., Ms. Hoff administered another

2.5 milligrams of Valium at Dr. Edison's direction, 5 and she

noted that P.L. 's status was unchanged, by which Ms. Hoff meant

that P.L.'s airway, breathing, and circul ation were maintained,

that her vital signs were stable, and that she remained

responsive to verbal stimuli.

30. Between 8:55 a.m. and 9:15 a.m., P.L.'s status was

unchanged . According to Ms. Hoff's notes, P.L.'s airway,

breathing, circulation, and vital signs were maintained at

normal levels, and she responded well to the Valium and oxygen.

Ms. Hoff observed during this time that P.L. was lethargic and

appeared to be a little more deeply sedated than typical

Level II sedation. P.L. continued breathing on her own and

responding to verbal stimuli.

31. During this interval, Dr. Edison was waiting for P.L.

to come out of sedation, and he intended to send her home and

recommend that she see her doctor about the twitch.

32. Ms. Hoff noticed a second facial twitch between

9:15 a.m. and 9:20 a.m., and Dr. Edison directed Ms. Hoff to

call Emergency Medical Services to transport P.L. to the

hospital. Ms. Hoff continued to monitor P.L.'s airway,

breathing, circulation and vital signs until the Emergency

Medical Services team arrived at 9:30 a.m. During this time ,

Ms. Hoff noted that P.L. responded to verbal stimuli by moving

her head a little bit and attempting to open her eyes.

33. P.L.'s oxygen saturation rate was consistently

maintained at 99% to 100% betwee n 8:20 a.m. and 9:30 a.m., when

Emergency Medical Services arrived. During this time, P.L. was

breathing independently and did not need any assistance with her

airway.

34. Emergency Medical Services received the call from

Dr. Edison's office at 9:21 a.m. and arrived at 9:26 a.m. At

that time, P.L. was receiving oxygen, her airway was normal, and

her perfusion was good. Her blood pressure was 102/68, her

pulse was strong and regular at 120 beats per minute, her

respiratory rate was 20, her respiratory ef fort was normal, and

her breath sounds were clear. She was, however, non - responsive:

She was not able to open her eyes, she had no motor response,

and she was not able to give a verbal response. She appeared to

be having seizure activity in the form of twitching on both

sides of the jaw line.

35. P.L. was transported to Memorial Regional Hospital at

9:31 a.m., and she arrived at the hospital at 9:36 a.m. A

notation on the EMS Report for the incident states that a

"[l]ist of sedation medication [was] gi ven to ER staff."

36. Dr. Todd Gardner was the emergency room physician who

treated P.L. on her arrival at Memorial Regional Hospital. His

diagnosis on admission was status epilepticus and hypoxia.

Status epilepticus is seizures that are unrelenting to normal

therapeutic intervention, and hypoxia is low oxygen level.

Dr. Gardner did not attribute a cause to the status epilepticus.

37. Dr. Gardner's intake notes reflect that, prior to

presenting at the emergency room, P.L. had received Ketamine,

Labetal ol to lower her blood pressure, and Valium to relieve the

seizures. Nothing on the intake sheet indicates that P.L. had

received Lidocaine, and there is no list of the medications

given by Dr. Edison in the hospital file.

38. Dr. Gardner intubated P.L. a t 10:02 a.m. and placed

her on a ventilator in the emergency room because she was unable

to breathe on her own. He also treated her with Valium,

Dilantin, and Diprivan, which is used to sedate patients in the

intensive care unit.

39. Dr. Robert Alterbaum , an internist specializing in

pulmonary medicine and critical care, provided care to P.L. in

the intensive care unit of Memorial Regional Hospital.

40. P.L.'s chest X - ray was abnormal and showed

pneumonitis, or an inflammation of the lungs, caused by flu id

being aspirated into the lungs.

41. Based on the emergency room chart, Dr. Alterbaum

diagnosed P.L. with status epilepticus, or seizures, related to

the administration of Ketamine during the pre - operative

procedure for breast augmentation surgery. The re was no

objective medical evidence to support Dr. Alterbaum's conclusion

that Ketamine was the cause of the seizures; he reached this

conclusion because Ketamine was the only medication noted on the

chart as having been administered to P.L. Dr. Alterbau m was not

aware that P.L. had also received Lidocaine; had he been aware

of this, it might have been information he would have considered

in reaching his conclusion regarding the cause of P.L.'s

seizures. 6

42. P.L. was discharged from Memorial Regional Ho spital on

July 12, 2005. She had difficulty walking at first, but has

fully recovered except that she sometimes experiences a little

memory loss.

Drugs administered to P.L.

Valium

43. Valium is a benzodiazopene used to control anxiety,

and the standard dosage ranges from two to 20 milligrams for

conscious sedation. Valium is a controlled substance.

Ancef

44. Ancef is an antibiotic.

Ketamine

45. Ketamine is a disassociative non - barbiturate analgesic

used for sedation and general anesthesia; the maximum dosage is

4.5 milligrams per kilogram of body weight. Ketamine causes a

large amount of secretions, and its effects last only five to

10 minutes. Ketamine is a controlled substance.

Robinol

46. Robinol is an anticholinergic medication used to

prevent b radycardia, a heart rate of less than 60 beats per

minute, and to help dry out secretions in mucous membranes.

Robinol is contraindicated for a patient with tachycardia, or a

heart rate of more than 100 beats per minute, however, because

it could make the patient's heart rate increase. In a healthy

29 year - old patient such as P.L., however, it was not a

violation of the standard of care to administer 0.2 milligrams

of Robinol to P.L. even though her heart rate was 104 beats per

minute at the time it was a dministered; a healthy 29 - year - old

patient could easily sustain a heart rate of 140 beats per

minute without ill effects.

47. Dr. Edison administered Robinol to P.L. as a drying

agent, to control secretions brought on by the use of Ketamine.

Although oth er drugs can be used to control these secretions,

Robinol is the best drug for this purpose and the one most

commonly used.

48. Dr. Edison had ample justification for using Robinol

under the circumstances, and he did not violate the standard of

care by or dering Ms. Hoff to administer the drug even though

P.L.'s heart rate slightly exceeded 100 beats per minute.

Talwin

49. Talwin is an opiate analgesic that is used to control

pain, and the standard dosage is 30 milligrams. Talwin is a

controlled substance .

Nitrous oxide

50. Nitrous oxide is an anesthetic gas that is used for

analgesia and sedation; it was administered to P.L. by nasal

cannula, which delivers a relatively small amount of gas.

Diprivan

51. Diprivan is a sedative hypnotic medication used b oth

for intravenous sedation and for general anesthesia; the package

insert recommends a dosage from 100 to 150 micrograms per

kilogram of body weight per minute. Diprivan's clinical effects

wear off approximately three minutes after its administration is

discontinued.

52. The total dose of Diprivan administered to P.L.,

25 milligrams, was included in Dr. Edison's medical records, but

the manner of administering the Diprivan and the rate of

infusion are not recorded.

53. Diprivan, together with other sed ative drugs, may be

administered in Florida by a registered nurse at the direction

and under the supervision of a surgeon during Level II office

surgery. 7 Dr. Edison did not deviate from the standard of care

in Florida by delegating responsibility to Ms. Hoff, an Advanced

Registered Nurse Practitioner, for administering the various

drugs to P.L., under his direction and supervision. Based on

her training and experience, Ms. Hoff was qualified to

administer these drugs to P.L. to achieve Level II sedation

under Dr. Edison's direction and supervision.

54. The combination of sedative drugs Dr. Edison ordered

administered to P.L., specifically Diprivan, Ketamine, Talwin,

Valium, and nitrous oxide, was appropriate to induce Level II

sedation in P.L., and the d osage of each of the drugs

administered to P.L. was well below the maximum dosage

recommended for each of the drugs. These drugs work

synergistically, however, and, depending on the patient and the

circumstances, the same combination of sedative drugs cou ld

induce Level III sedation.

55. Florida Administrative Code Rule 64B8 - 9.009 defines

Level III office surgery and sets forth the standards that must

be met, in pertinent part, as follows:

(6) Level III Office Surgery.

(a) Scope.

1. Level III Office Surgery is that

surgery which involves, or reasonable should

require, the use of a general anesthesia or

major conduction anesthesia and pre -

operative sedation. This includes the use

of:

a. Intravenous sedation beyond that

defined for Level II Office Surgery;

b. General Anesthesia: loss of

consciousness and loss of vital reflexes

with probable requirement of external

support of pulmonary or cardiac functions:

or

c. Major conduction anesthesia.

* * *

(b) Standards for Level III Office Surgery.

I n addition to the standards for Level II

Office Surgery, the surgeon must comply with

the following:

* * *

4. Assistance of Other Personnel Required.

An Anesthesiologist, Certified Registered

Nurse Anesthetist, or Physician Assistant

qualified as set f orth in subparagraph 64B8 -

30.012(2)(b)6., F.A.C., must administer the

general or regional anesthesia and an M.D.,

D.O., Registered Nurse, Licensed Practical

Nurse, Physician Assistant, or Operating

Room Technician must assist with the

surgery. . . .

56. One difference between Level II and Level III sedation

is the degree of alertness of the patient. At Level II

sedation, the patient must be able to respond to verbal and/or

tactile stimuli. If a patient's only response is a reflex ive

withdrawal from a pa in stimulus, the patient is sedated beyond

Level II. A primary indication that a patient has slipped from

Level II to Level III sedation is the loss of the ability to

breathe without assistance, and the patient's airway must be

partially or totally manage d. In Level II sedation, the need

for management of the airway is minimal compared to that

required at Level III sedation.

57. P.L.'s blood pressure, pulse rate, oxygenation, and

mental state were consistent with Level II sedation until P.L.

had her firs t seizure and all medications , except for the one -

half therapeutic dose of Valium, were discontinued. She

remained responsive to verbal stimuli after the second

2.5 milligram dose of Valium was given to control the seizure

activity, even though she was mo re lethargic than normal under

Level II sedation. P.L. was non - responsive when examined by

Emergency Medical Services personnel, but she was breathing

independently and was not at Level III sedation. Her lack of

response was more likely than not the resu lt of the seizures,

after which a patient can go into a postictal state, or a trance

of sleepiness. 8

58. Dr. Edison did not violate the standard of care for

office surgery in ordering the amounts and combination of drugs

used to sedate P.L. because P.L. d id not reach Level III

sedation. In accordance with the standard of care for Level II

office surgery, Ms. Hoff, as a registered nurse, was qualified

to administer anesthesia to P.L., including Diprivan, Ketamine,

and the other sedative drugs used in P.L.' s surgery, at the

direction and under the supervision of Dr. Edison.

Dosage of Lidocaine

59. As stated above, Dr. Edison injected a dilute solution

of Lidocaine with epinephrine and marcaine into the tissue

around P.L.'s breasts between 8:25 a.m. and 8:4 5 a.m., before

P.L. had her first seizure at 8:45 a.m. Lidocaine is a local

anesthetic used to numb nerves and tissue. In breast

augmentation surgery Dr. Edison always uses Lidocaine with

epinephrine because epinephrine is a vasoconstrictor that causes

i ntense vasoconstriction, or closing of the small blood vessels,

which slows the rate of absorption of the Lidocaine and

virtually eliminates bleeding at the site of surgery. Marcaine

is also a local anesthetic similar to Lidocaine, but it is slow

to take effect and lasts four to six hours and helps control

pain after surgery is completed. Marcaine is commonly used with

Lidocaine.

60. It is Dr. Edison's practice to perform breast

augmentation surgery using the tumescent infiltration technique

to infuse a relatively large volume of dilute Lidocaine solution

into the breast area as a local anesthetic. Dr. Edison uses

this tumescent infiltration technique in breast augmentation

surgery because he can deliver a large volume of Lidocaine that

is evenly distrib uted throughout the breast area, which results

in more effective pain reduction.

61. The injection technique Dr. Edison uses for tumescent

infiltration in the breast area is very specific, and it takes

between 20 and 30 minutes to complete the injections. The

needle cannot penetrate close to the pectoral muscle, especially

in a woman as small as P.L., because of the danger of puncturing

a lung. Dr. Edison injects the solution under pressure into the

subcutaneous tissue between the breast and the pectoral muscle.

62. Lidocaine is absorbed faster in areas that are highly

vascular. The tissue in the aerolar space between the breast

and the pectoral muscle does not contain many blood vessels, so

Lidocaine injected in this tissue is absorbed more slowly than

it would be if injected into highly vascular tissue. In

Dr. Edison's experience, because the epinephrine in the

Lidocaine solution causes intense vasoconstriction in the tissue

surrounding the injection sites, the Lidocaine stays in place

and numbs the a rea in which the surgery is to be performed. The

Lidocaine solution is absorbed slowly over approximately

24 hours, and the peak serum concentration of Lidocaine occurs

approximately 10 to 12 hours after it is administered.

63. In this case, Dr. Edison p repared approximately

400 cubic centimeters of solution, which contained

700 milligrams of Lidocaine and 50 milligrams of marcaine,

together with a small, non - therapeutic dose of epinephrine.

According to his surgical notes, Dr. Edison began the injection s

of Lidocaine at 8:25 a.m. and had completed the injections by

the time P.L. had the first seizure at 8:45 a.m., although it is

his recollection that he had not used all of the Lidocaine

solution he had prepared. Dr. Edison did not, however, record

in th e medical records the amount of Lidocaine solution he

injected, and any remaining solution was discarded without being

measured, so he does not know the dosage of Lidocaine P.L.

actually received. Had he injected all of the solution, P.L.

would have recei ved approximately 14 milligrams of Lidocaine per

kilogram of body weight.

64. According to the package insert that accompanies a

bottle of Lidocaine, the maximum dosage of Lidocaine without

epinephrine is five milligrams per kilogram of body weight, and

t he maximum dosage of Lidocaine with epinephrine is seven

milligrams per kilogram of body weight. There is nothing in

Dr. Edison's medical records to indicate that the Lidocaine he

used in P.L.'s surgery included epinephrine or that he

calculated the amoun t of Lidocaine to administer to P.L. based

on her body weight

65. Using the maximum dosage specified on the package

insert, the maximum dosage of Lidocaine without epinephrine for

P.L. would have been 215 milligrams, and the maximum dosage of

Lidocaine wi th epinephrine would have been 301 milligrams, using

the traditional method of administering the drug. Based on the

standard established by the package insert, Dr. Edison exceeded

the maximum dosage of Lidocaine with epinephrine injected into

P.L. by appr oximately 400 milligrams, which constituted a toxic

dose of Lidocaine when measured by the maximum dosage stated on

the package insert.

66. The maximum dosage of Lidocaine with epinephrine

stated on the package insert is routinely exceeded by surgeons

per forming liposuction, which involves suctioning fatty tissue.

The tumescent infiltration technique using Lidocaine with

epinephrine in a dilute solution is commonly used with

liposuction, and Florida Administrative Code Rule 64B8 -

9.009(2)(d), which sets ou t the standards of care for office

surgery, specifically provides that a "maximum of fifty (50)

mg/kg of Lidocaine can be injected for tumescent liposuction in

the office setting." Large dosages of Lidocaine can be safely

used in liposuction because Lidoc aine is metabolized more slowly

by fatty tissue than by muscle or skin, and approximately 20% of

the Lidocaine solution is suctioned out of the body with the fat

that is aspirated during liposuction. As a result, it is

possible to administer what would ot herwise be toxic doses of

Lidocaine under the maximum dosages specified in the package

insert.

67. Dr. Edison has used the tumescent infiltration

technique many times in performing breast augmentations without

his patients' suffering any ill effects. The re is, however, no

rule in Florida equivalent to that relating to liposuction that

permits the use of high dosages of Lidocaine as local anesthetic

in breast augmentation surgery. Furthermore, Dr. Edison has

failed to submit persuasive evidence of a stand ard of care in

Florida among plastic surgeons that would permit the use of

dosages of Lidocaine with epinephrine in excess of the

seven milligrams per kilogram specified on the package insert

for breast augmentation surgery. 9

68. Dr. Edison violated the s tandard of care by injecting

approximately of 700 milligrams of Lidocaine with epinephrine

into the tissue surrounding P.L.'s breasts when the maximum

allowable dosage, according to the insert packaged with the drug

and based on P.L.'s weight, was approxim ately 300 milligrams.

Dr. Edison's previous disciplin e 10

69. Dr. Edison was charged in an Administrative Complaint

dated February 21, 1995, with having committed medical

malpractice in violation of Section 458.331(1)(t), Florida

Statutes. He executed a C onsent Agreement in which he neither

admitted nor denied the factual allegations in the complaint but

agreed that, if proven, the facts would constitute a violation

of Section 458.331(1)(t), Florida Statutes. The Agency for

Health Care Administration ente red a Final Order dated

August 20, 1995, adopting the Consent Agreement in relevant

part. This Final Order does not establish that Dr. Edison

committed a violation of Section 458.331(1)(t), Florida

Statutes.

70. In a Final Order entered January 4, 2007, the Board

adopted the recommended disposition in the Recommended Order in

Department of Health, Board of Medicine v. Richard B. Edison,

M.D. , DOAH Case No. 06 - 0598PL (Recommended Order August 25,

2006), that Dr. Edison be found guilty of a single violation of

Section 458.331(1)(m), Florida Statutes.

CONCLUSIONS OF LAW

71. The Division of Administrative Hearings has

jurisdiction over the subject matter of this proceeding and of

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

456.073(5), Fl orida Statutes (2006).

72. Section 458.331(1), Florida Statutes, authorizes the

Board to impose penalties ranging from the issuance of a letter

of concern to revocation of a physician's license to practice

medicine in Florida if a physician commits one or more acts

specified therein. In its Administrative Complaint, the

Department has alleged that Dr. Edison violated Sections

458.331(1)(m), (q), (t), and (w), Florida Statutes, which

provide that the following acts constitute grounds for

disciplinary actio n by the Board:

(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; record s of drugs

prescribed, dispensed, or administered; and

reports of consultations and

hospitalizations.

* * *

(q) Prescribing, dispensing,

administering, mixing, or otherwise

preparing a legend drug, including any

controlled substance, other than in the

course of the physician's professional

practice. For the purposes of this

paragraph, it shall be legally presumed that

prescribing, dispensing, administering,

mixing, or otherwise preparing legend drugs,

including all controlled substances,

inappropriate ly or in excessive or

inappropriate quantities is not in the best

interest of the patient and is not in the

course of the physician's professional

practice, without regard to his or her

intent

* * *

(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.

2. Committing gross medical malpractice.

3. Committing repeated medical malpractice

as defined in s. 456.50. A person found by

the board to have committed repeated medical

malpractice based on s. 456.50 may not be

licensed or continue to be l icensed by this

state to provide health care services as a

medical doctor in this state.

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.

* * *

(w) Delegating professional

responsibilities to a person when the

licensee delegating such responsibilities

knows or has reason to know that such person

is not qualified by training, experience, or

licensure to perform them.

73. Section 456.50(1), Florida Statutes, defines "medical

malpractice" as follows:

g) "Medical malpractice" means the failure

to practice medicine in accordance with the

level of c are, 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 countr y 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.

Burden and Standard of Proof

74. The Department seeks to impose penalties against

Dr. Edison that include suspension or revocation of his license

and/or the imposition of an administrative fine. Therefore, the

Department has t he burden of proving the violations 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); and Section 120.57(1)(h), Florida Statutes

("Findings of fact shall be based on a preponderance of the

evidence, except in penal or li censure disciplinary proceedings

or except as otherwise provided by statute.").

75. "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 l acking

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)(S harp, J., dissenting).

Count One: Section 458.331(1)(t), Florida Statutes; The

Standard of Care .

76. The Administrative Complaint alleges that Dr. Edison

violated the standard of care in his treatment of P.L. by:

a. ordering a dose of Lidocaine for Pat ient

P.L. that was not measured based on the

patient's weight;

b. ordering a toxic dose of Lidocaine for

Patient P.L.;

c. ordering anesthesia for, and performing

surgery on, Patient P.L. without performing

an appropriate history and physical

examinatio n;

d. ordering Ms. Hoff [a registered nurse]

to administer Diprivan, Ketamine and other

anesthesia agents when that was outside the

scope of her practice;

e. performing surgery while utilizing

Diprivan, Ketamine and other anesthesia

agents without havi ng a Certified Registered

Nurse Anesthetist or M.D. Anesthesiologist

monitoring the administration of the

Diprivan, Ketamine and other anesthesia

agents;

f. ordering an amount and type of

anesthetic drugs that produced a Level III

office surgery;

g. or dering Robinol when Patient P.L.'s

heart rate was already above normal.

77. Based on the findings of fact herein, the Department

has failed to prove the violations alleged in paragraphs c., d.,

e., f., and g. by clear and convincing evidence.

78. Specif ically with respect to paragraphs d. and e., the

Board has rejected the position of the Department that the

delegation of responsibility to administer sedative drugs ,

including Diprivan, to put a patient in Level II sedation to a

registered nurse working u nder the direction and supervision of

a surgeon c onstitute s a per se violation of the stan dard of care

for office surgery as contrary to Florida Administrative Code

Rule 64B8 - 9.004(4)(b)4. and the ruling in Ortiz v. Department of

Health, Board of Medicine , 882 So. 2d 402, 405 - 06 (Fla. 1st DCA

2004). See Final Order in Department of Health, Board of

Medicine v. Richard B. Edison M.D. , DOAH Case No. 05 - 0598PL

(DOH January 4, 2007)(FO No. DOH - 07 - 0026 - FOF - MQA) at

paragraphs 1 and 4 and Petitioner's Exceptions to the

Recommended Order in Department of Health, Board of Medicine v.

Richard B. Edison M.D. , DOAH Case No. 05 - 0598PL (DOAH August 25,

2006) at paragraphs 4 through 8 and 14 through 18.

79. With respect to paragraphs c., f., and g., based on

the findings of fact herein, the Department did not prove by

clear and convincing evidence that Dr. Edison failed to note

P.L.'s weight in his medical record; the Department did not

prove by clear and convincing evidence that P.L. slipped into

Level III sedation at an y time, either before or after the

sedative drugs were discontinued; and the Department did not

prove by clear and convincing evidence that administering a

small dose of Robinol to P.L. as a drying agent when her heart

rate was four beats per minute above "normal" violated a

standard of care under the circumstances.

80. Based on the findings of fact herein, the Department

did prove by clear and convincing evidence that Dr. Edison

violated the applicable standard of care by failing to calculate

the dose of Lidocaine to be administered to P.L. based on her

weight and by administering a toxic dose of Lidocaine to P.L.

The Department has, therefore, proven that Dr. Edison committed

medical malpractice as defined in Section 456.50(1)(g), Florida

Statutes, in vi olation of Section 458.331(1)(t)1., Florida

Statutes.

Count Two: Section 458.331(1)(m), Florida Statutes; Medical

Records

81. The Administrative Complaint alleges that Dr. Edison's

medical records were inadequate in violation of Section

458.331(1)(m), Fl orida Statutes, with regard to his treatment of

P.L. In particular, the Department alleged that Dr. Edison

violated Section 458.331(1)(m) by:

a. failing to document Patient P.L.'s

weight in the record;

b. failing to document any reason for

administerin g 70 cc or 700 mg of Lidocaine;

c. failing to document the dosing amounts

of the infusion of the Diprivan or whether

any type of pump was used.

82. Based on the findings of fact herein, the Department

did not prove by clear and convincing evidence that Dr. Edison

failed to document P.L.'s body weight in his medical records.

P.L.'s body weight was recorded on the outside cover of her

folder, and this was sufficient documentation for the purposes

of calculating the dosages of drugs that were to be admini stered

to P.L. under the circumstances of this case.

83. Based on the findings of fact herein, the Department

did prove by clear and convincing evidence that Dr. Edison

failed to document the rate of infusion of Diprivan or the

method of infusion of the D iprivan. The only information in the

medical records relating to the dose of Diprivan given to P.L.

was the notation that 25 milligrams of Diprivan were

administered. This information is insufficient to satisfy the

requirements of Section 458.331(1)(m), Florida Statutes, that

the medical records document the course of treatment.

Count Three: Section 458.331(1)(q), Florida Statutes; Legend

Drugs .

84. The Administrative Complaint alleges that Dr. Edison

violated Section 458.331(1)(q), Florida Statutes, w ith regard to

his treatment of P.L. by

a. ordering the excessive or inappropriate

administration of Diprivan by continuous

drip, along with other anesthesia drugs,

without having a C.R.N.A. or

Anesthesiologist present;

b. ordering an excessive amount of

Lidocaine for Patient P.L.;

c. ordering Robinol when Patient P.L.'s

heart rate was already above normal.

85. Based on the findings of fact herein, the Department

did not prove these allegations by clear and convincing

evidence. There is no evidence t hat the amount of Diprivan

administered to P.L. was excessive, and there is no evidence

that either Lidocaine or Robinol are legend drugs. The

Department, therefore, failed to prove that Dr. Edison violated

Section 458.331(1)(q), Florida Statutes.

Count F our: Section 458.331(1)(w), Florida Statutes; Improper

Delegation of Authority .

86. The Administrative Complaint alleges that Dr. Edison

delegated professional responsibilities to a

person when he knew or had reason to know

that such person was not qual ified by

training, experience, or licensure to

perform them, in that the Respondent

delegated the administration of sedatives

and/or anesthetic agents, including

Diprivan, during Patient P.L.'s procedure to

a registered nurse, whom he knew or had

reason to know was not licensed as a

Certified Registered Nurse Anesthetist or

M.D. Anesthesiologist.

This charge duplicates the charges set forth in paragraphs d.

and e. of Count One. The Department has failed to prove this

violation by clear and convincing evid ence for the same reasons

set forth above in paragraph 78 .

Penalty

87. The Board's disciplinary guidelines are found in

Florida Administrative Code Rule 64B8 - 8.001.

88. Florida Administrative Code Rule 64B8 - 8.001(2)(m)

provides that the permissible pena lties for a violation of

Section 458.331(1)(m), Florida Statutes, range from a reprimand

to two years' suspension followed by probation and an

administrative fine ranging from $1,000.00 to $10,000.00. The

permissible penalties for a second violation of

Se ction 458.331(1)(m), Florida Statutes, range from probation to

suspension followed by probation and an administrative fine

ranging from $5,000.00 to $10,000.00.

89. Florida Administrative Code Rule 64B8 - 8.001(2)(t)

provides that the permissible penalties for a violation of

Section 458.331(1)(t)1., Florida Statutes, range from one year's

probation to revocation and an administrative fine ranging from

$1,000.00 to $10,000.00.

90. Florida Administrative Code Rule 64B8 - 8.001(3) permits

consideration of aggrav ating and mitigating factors in

determining the appropriate penalty. In this case, there are

several aggravating factors that must be considered. First,

Dr. Edison's violation of the standard of care relating to the

maximum dosage of Lidocaine with epine phrine exposed P.L. to

potential injury even though there was not sufficient persuasive

evidence to establish that P.L.'s seizures resulted from the

administration of 700 milligrams of Lidocaine with epinephrine.

Second, the Department has established tha t Dr. Edison committed

two statutory violations in his treatment of P.L. Third,

Dr. Edison has previously been disciplined for the failure to

maintain adequate me dical records. I t is also noted that

Dr. Edison has practiced plastic surgery in Florida for 22 years

and has had two disciplinary actions filed against him. 11

Dr. Edison's Motion for Attorneys' Fees and Costs pursuant to

Section 120.595(1), Florida Statutes .

91. On November 30, 2006, Dr. Edison filed Respondent' s

Motion for a Determination that Petitioner Participated in the

Proceeding for an Improper Purpose and Determine the Award of

Costs and Attorney' s Fees Pursuant to Section 120.595, Florida

Statutes . In the motion, Dr. Edison argues that the Department

participated in this proceeding for an improper purpose by

filing and prosecuting an Administrative Complaint against

Dr. Edison which included charges that the Department knew or

should have known had been rejected by the Board.

92. Section 120.595, Florida Statutes, provides in

pertinent part:

1) CHALLENGES TO AGENCY ACTION PURSUANT TO

SECTION 120.57(1). --

(a) The provisions of this subsection are

supplemental to, and do not abrogate, other

provisions allowing the award of fees or

costs in administrative proceedings.

(b) The final o rder in a proceeding

pursuant to s. 120.57(1) shall award

reasonable costs and a reasonable attorney's

fee to the prevailing party only where the

nonprevailing adverse party has been

determined by the administrative law judge

to have participated in the pr oceeding for

an improper purpose.

(c) In proceedings pursuant to

s. 120.57(1), and upon motion, the

administrative law judge shall determine

whether any party participated in the

proceeding for an improper purpose as

defined by this subsection. In makin g such

determination, the administrative law judge

shall consider whether the nonprevailing

adverse party has participated in two or

more other such proceedings involving the

same prevailing party and the same project

as an adverse party and in which such two or

more proceedings the nonprevailing adverse

party did not establish either the factual

or legal merits of its position, and shall

consider whether the factual or legal

position asserted in the instant proceeding

would have been cognizable in the prev ious

proceedings. In such event, it shall be

rebuttably presumed that the nonprevailing

adverse party participated in the pending

proceeding for an improper purpose.

(d) In any proceeding in which the

administrative law judge determines that a

party par ticipated in the proceeding for an

improper purpose, the recommended order

shall so designate and shall determine the

award of costs and attorney's fees.

(e) For the purpose of this subsection:

1. "Improper purpose" means participation

in a proceeding pursuant to s. 120.57(1)

primarily to harass or to cause unnecessary

delay or for frivolous purpose or to

needlessly increase the cost of litigation,

licensing, or securing the approval of an

activity.

2. "Costs" has the same meaning as the

costs allowed in civil actions in this state

as provided in chapter 57.

3. "Nonprevailing adverse party" means a

party that has failed to have substantially

changed the outcome of the proposed or final

agency action which is the subject of a

proceeding. In the event that a proceeding

results in any substantial modification or

condition intended to resolve the matters

raised in a party's petition, it shall be

determined that the party having raised the

issue addressed is not a nonprevailing

adverse party. The recomme nded order shall

state whether the change is substantial for

purposes of this subsection. In no event

shall the term "nonprevailing party" or

"prevailing party" be deemed to include any

party that has intervened in a previously

existing proceeding to supp ort the position

of an agency.

93. This statutory provision is, on its face, not

applicable in the instant case to support an award of attorneys'

fees and costs to Dr. Edison against the Department even if the

Board rejects the recommended disposition an d finds in its final

order that Dr. Edison is the prevailing party.

94. Section 120.595(1)(b), Florida Statutes, authorizes

the award of fees and costs to the prevailing party when the

"nonprevailing adverse party" is found to have "participated in

the pr oceeding for an improper purpose." "Nonprevailing adverse

party" is defined in Section 120.595(1)(e)3., Florida Statutes,

as "a party that has failed to have substantially changed the

outcome of the proposed or final agency action which is the

subject of a proceeding."

95. The "proposed agency action" that is the subject of

this proceeding is the Department's attempt to discipline

Dr. Edison's license to practice medicine for the violations

alleged in the Administrative Complaint. The Department does

not seek to substantially change the outcome of its proposed

agency action, and it is, therefore, not possible for the

Department to be a "nonprevailing adverse party" against which

an award of attorneys' fees and costs may be assessed in this

case.

96. Even though Section 120.57(1)(d), Florida Statutes,

provides that "a party" can be found to have participated in the

proceeding for an improper purpose, the fact remains that, under

the statute, the award of fees and costs can only be made

against a "nonprevai ling adverse party." It is, therefore,

unnecessary under the circumstances for the undersigned to make

a determination of whether the Department participated in this

proceeding for an improper purpose.

97. For these reasons, the R espondent' s Motion for a

Determination that Petitioner Participated in the Proceeding for

an Improper Purpose and Determine the Award of Costs and

Attorney' s Fees Pursuant to Section 120.595, Florida Statutes ,

is denied.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is RECOMMENDED that the Board of Medicine enter a final

order

1. Dismissing Counts Three and Four of the Administrative

Complaint;

2. Finding Dr. Edison guilty of a single violation of

Section 458.331(1)(m), Florida Statutes, and of two violations

of Section 458.331(1)(t)1., Florida Statutes;

3. Suspending Dr. Edison's license for a period of

90 days, followed by four years' probation under such terms as

shall be imposed by the Board; and

4. Imposing an administrative fine in the amount of

$15,000.00.

DONE AND ENTERED this 1st day of May, 2007, in Tallahassee,

Leon County, Florida.

S

___________________________________

PATRICIA M. HART

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florid a 32399 - 3060

(850) 488 - 9675 SUNCOM 278 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 1st day of May, 2007.

ENDNOTES

1 / All references to the Florida Statutes shall be to the 2005

edition, except where noted otherwise.

2 / Official recognition was granted at the hearing even though

the Final Order was not entered until after the hearing had been

closed; the hearing before the Board of Medicine occurred

December 1, 2006.

3 / See Ehrhardt, C.W., Florida Evidence , § 201.1; Wilson v.

State , 666 So. 2d 979, 980 (Fla. 1st DCA 1996).

4 / The Department argues that Dr. Edison's testimony that he

entere d P.L.'s weight on the outside of the folder containing

her chart is not credible because he did not provide a copy of

the outside of the folder with the medical records he produced

during the investigation of the charges against him and because

he did not mention the entry or provide a copy of the outside of

the folder until his deposition. Having considered the evidence

and the argument of the Department, it is concluded that

Dr. Edison's testimony is persuasive, and the inference

suggested by the Depart ment is rejected.

5 / The normal dosage of Valium for controlling seizures is

five milligrams, but Dr. Edison decided to administer this

dosage in two increments.

6 / Dr. Franklin Segal, the Department's expert anesthesiologist,

testified that he would a ttribute P.L.'s seizures to a toxic

dose of Lidocaine. According to Dr. Segal, using an amount of

Lidocaine with epinephrine in excess of the maximum dosage

increases the risk that the patient will suffer neurotoxicity,

which is the most common response t o a toxic dose of Lidocaine.

The symptoms of neurotoxicity are progressive and begin with

numbness around the face and mouth and progress to light -

headedness, ringing in the ears, twitching, convulsions, and

seizures, with the patient eventually becoming unconscious and

going into respiratory arrest. P.L.'s symptoms included

twitching and losing consciousness. The evidence is not,

however, sufficient to establish that P.L. experienced

respiratory failure as a result of a neurotoxic response to an

overdos e of Lidocaine. As previously noted, the records of the

emergency treatment P.L. received at Memorial Regional Hospital

indicated that P.L. was intubated in the emergency room because

she had aspirated fluid into her lungs. In addition,

Dr. Alterbaum att ributed the cause of the seizures to a reaction

to Ketamine, and, although his conclusion might have changed had

he known at the time about the dosage of Lidocaine administered

to P.L., the cause of the seizures cannot now be established

with any acceptabl e degree of certainty. In any event, the

cause of P.L.'s seizures is not relevant to the charges in the

Administrative Complaint.

7 / See Final Order in Department of Health, Board of Medicine v.

Richard B. Edison M.D. , DOAH Case No. 05 - 0598PL (DOH Janua ry 4,

2007)(FO No. DOH - 07 - 0026 - FOF - MQA) at paragraphs 1 and 4 and

Petitioner's Exceptions to the Recommended Order in Department

of Health, Board of Medicine v. Richard B. Edison M.D. , DOAH

Case No. 05 - 0598PL (DOAH August 25, 2006) at paragraphs

4 through 8 and 14 through 18. It is also noted that the Final

Order in Department of Health v. Alton Earl Ingram, M.D. , DOAH

Case No. 04 - 0709PL (DOH December 16, 2004)(FO No. DOH - 04 - 1585 -

FOF - MQA) accepted Dr. Ingram's voluntary relinquishment of his

license to pra ctice medicine in lieu of consideration of the

Recommended Order entered in that case. Even though the

Recommended Order was attached to and made a part of the Final

Order, it was not adopted by the Board and, therefore, has no

force or effect with respec t to the facts found therein or the

conclusions of law. See § 120.52(7), Fla. Stat. (2006)("Final

order" means a written final decision which results from a

proceeding under . . . s. 120.57 . . . and includes final agency

actions which are affirmative, ne gative, injunctive, or

declaratory in form. A final order includes all materials

explicitly adopted in it . . . .")(Emphasis supplied.)

8 / Dr. Franklin Segal, the Department's anesthesiology expert,

testified that P.L. never reached Level III sedation.

Transcript of the proceedings, volume 2, pages 200 - 01.

Dr. Segal also testified that P.L. was at Level III sedation

when Emergency Medical Services arrived. Id. at pages 240 - 41.

Careful consideration was given to this testimony and to the

testimony and questions on pages 237 - 40 of the transcript, which

preceded Dr. Segal's statement that P.L. was at Level III

sedation. Dr. Segal, on page 238, attributed P.L.'s greater

degree of sedation, as described by Ms. Hoff, to her seizure.

In addition, the hypoth etical question that prompted Dr. Segal's

response was premised on facts not in evidence, specifically, it

was not established in the record that, at the time the

Emergency Medical Services personnel recorded that P.L. was

unresponsive, her lack of respons e was "due to the medications

and the Lidocaine that triggered the seizure." Accordingly,

Dr. Segal's statement that P.L. was at Level III sedation is

found to be not credible in light of all of the evidence.

9 / Through the testimony of its expert witne ss in plastic

surgery, Dr. Marguerite Barnett, the Department established that

the approved maximum dosage of Lidocaine with epinephrine, as

specified in the insert included with the product, is

seven milligrams per kilogram of body weight and that deviati on

from this maximum dosage violated the standard of care in

Florida for plastic surgeons performing breast augmentation

surgery. Dr. Samuel Rosenthal, Dr. Edison's expert witness in

plastic surgery, testified about his own practice, in which he

uses a di lute solution of Lidocaine with epinephrine at a dosage

of approximately 20 milligrams per kilogram of body weight when

performing breast augmentation surgery; he does not, however,

use the tumescent infiltration technique used by Dr. Edison

because he bel ieves that it is not possible to use this

technique in breast augmentation surgery because of the

relatively small area in which the solution can be infiltrated.

Dr. Rosenthal testified that he was familiar with the

practice of other plastic surgeons performing breast

augmentation surgery and that Dr. Edison's use of Lidocaine was

consistent with the standard of care. He did not, however,

define in his testimony the standard of care in Florida

regarding the maximum dosage of Lidocaine with epinephrin e that

is used in breast augmentation surgery. His only reference was

to a 1999 journal article reporting on a Norwegian study of

10 women who received dosages of Lidocaine with epinephrine of

up to 20 milligrams per kilogram of body weight. The

observat ion is made in the article that 20 milligrams per

kilogram of body weight of Lidocaine with epinephrine had

routinely been used for over 20 years in Norway for breast

augmentation surgery and that clinical experience had shown that

it was a safe dosage. T he authors of the article concluded

that, based on the scientific evidence collected in their study,

this dosage was safe and produced no toxicity when administered

as described in the study. The results of this study do not,

however, establish the standa rd of care among plastic surgeons

performing breast augmentation surgery in Florida.

10 / Previous discipline is not considered for purposes of

determining liability but only for purposes of determining

penalty.

11 / The Order of Emergency Restriction of D r. Edison's license

filed on June 8, 2005, in the context of the Administrative

Complaint filed against Dr. Edison that was resolved by the

Board's Final Order in DOAH Case No. 06 - 0598PL, has not been

considered disciplinary action for the purpose of aggra vating

and mitigating factors.

COPIES FURNISHED:

Lewis W. Harper, Esquire

Brew and Harper, PL

6817 Southpoint Parkway, Suite 1804

Jacksonville, Florida 32216

Patr icia Nelson, Esquire

Department of Health

4052 Bald Cypress Way, Bin C65

Tallahassee, Florida 32399

Josefina M. Tamayo, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

Dr. Ana M. Viamonte Ros, Sec retary

Department of Health

4052 Bald Cypress Way, Bin A00

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 EXCEP TIONS

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.