06-000598PL Department Of Health, Board Of Medicine vs. Richard B. Edison, M.D. Status: Closed Recommended Order on Friday, August 25, 2006.

Summary: Petitioner proved that Respondent failed to keep medical records justifying the course of treatment, but not that he failed to meet the applicable standard of care in plastic surgery.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 06 - 0598PL

)

RICHARD B. EDISON, M.D., )

)

Respondent. )

______________________________)

RECOM MENDED ORDER

Robert E. Meale, Administrative Law Judge of the Division

of Administrative Hearings, conducted the final hearing in Fort

Lauderdale, Florida, on July 25 - 26, 2006.

APPEARANCES

For Petitioner: John E. Terrell

Pamela Nel son

Assistant General Counsel

Department of Health

Prosecution Services Unit

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3267

Fo r Respondent: George K. Brew

Lewis W. Harper

Brew & Harper

6817 Southpoint Parkway, Suite 1804

Jacksonville, Florida 32216

STATEMENT OF THE ISS UE

The issue is whether Respondent is guilty of failing to

practice in accordance with the applicable standard of care or

failing to keep adequate medical records and, if so, what

penalty should be imposed.

PRELIMINARY STATEMENT

By Administrative Complai nt dated June 27, 2005, Petitioner

alleged that Respondent performed a abdominoplasty and

liposuction with Level II sedation on S. B. Based on his

findings from a previous office visit, in which S. B. had

displayed high blood pressure, Petitioner had alle gedly referred

her to her primary care physician, who cleared her for surgery

after her blood pressure was less than 150/90. The

Administrative Complaint alleges that S. B.'s blood pressure,

immediately before surgery, was 162/96.

The Administrative Com plaint alleges that earlier lab work

had revealed that S. B. had abnormal prothrombin times, which

are indicative of clotting problems due to liver dysfunction.

The Administrative Complaint alleges that Respondent ordered

S. B. to take vitamin K after exa mining her lab reports.

The Administrative Complaint alleges that Respondent

performed the surgery with a registered nurse who was not a

certified registered nurse anesthesiologist. Under Respondent's

direction, the registered nurse allegedly administere d Versed,

lidocaine with epinephrine, Diprivan, and fentanyl, as well as

nitrous oxide. Respondent allegedly ordered the registered

nurse to administer the Diprivan by drip rather than controlled

infusion, and the medical records allegedly fail to indicat e the

length of the infusion, the details of the doses, and whether a

pump was used, as well as whether S. B. could respond

purposefully to verbal commands or tactile stimulation during

surgery.

The Administrative Complaint alleges that S. B. spent the

ni ght at Respondent's surgical facility where she received

medication to control blood pressure and relieve pain. At about

9:00 a.m. on January 16, 2004, S. B. was allegedly discharged to

go home with her adult daughter. At about 1:00 p.m., the

daughter al legedly checked her mother, found that she had no

complaints, and left S. B. alone while the daughter ran errands.

The Administrative Complaint alleges that the daughter

returned to her mother's home at about 6:00 p.m. and found S. B.

on the floor in full cardiac arrest. Emergency management

services technicians allegedly arrived at the home and found

S. B. unresponsive and apneic, as she laid on the floor in a

fetal position without a pulse. The technicians allegedly

transported S. B. to the hospital, b ut she was dead.

On January 17, 2004, the medical examiner allegedly

conducted an autopsy that revealed the cause of death to be

combined drug overdose (heroin, temazepam, diazepam, methadone,

meperidine (Demerol), and hydrocodone) with contributory cause s

of hypertension, abdominal wall hemorrhage, and liver cirrhosis.

The Administrative Complaint alleges that, based on the

type and quantity of medication administered to S. B., the

sedation was Level III, not Level II. The Administrative

Complaint alleg es that the standard of care precluded delegating

to a registered nurse the administration of Diprivan and Versed

and required the presence of a certified registered nurse

anesthesiologist or a medical doctor anesthesiologist to

administer and monitor the Diprivan and Versed. The

Administrative Complaint alleges that Respondent violated the

standard of care by performing this elective surgery before

S. B.'s blood pressure had been brought under control.

Count One of the Administrative Complaint alleges th at

Respondent violated Section 458.331(1)(t), Florida Statutes, by

failing to practice in accordance with the applicable standard

of care in the following five ways:

a. Ordering the administration of Diprivan

by continuous drip, along with other

anesthesi a medications, without utilizing a

C.R.N.A. or M.D. Anesthesiologist;

b. Performing elective surgery on Patient

S. B. before controlling her hypertension or

waiting for her blood pressure reading to

reach an acceptable level as opined by her

general prac titioner.

c. Failing to perform further evaluations,

tests or treatment prior to surgery after

reviewing abnormal blood and/or prothrombin

time (PT) test results;

d. Failing to obtain a consultation for the

abnormal PT (prothrombin time) test results;

and

e. Administering Lorcet and Tylenol to

Patient S. B., since Tylenol is

contraindicated for patients with liver

problems.

Count Two of the Administrative Complaint alleges that

Respondent violated Section 458.331(1)(m), Florida Statutes, by

failing to keep legible medical records that justify the course

of treatment of S. B. The Administrative Complaint alleges that

Respondent failed to justify the course of S. B.'s treatment by

failing to document three things: whether S. B. had reached the

target ed blood pressure prior to the surgery, why Respondent had

administered vitamin K before surgery, and appropriate plans

concerning prior lab studies.

Count Three of the Administrative Complaint alleges that

Respondent violated Section 458.331(1)(q), Flori da Statutes, by

prescribing or administering a legend drug other than in the

course of his professional practice. The Administrative

Complaint alleges that it is presumed that a physician

prescribes or administers a legend drug other than in the course

of his professional practice when he prescribes or administers

the drug in excessive or inappropriate quantities, without

regard to his intent. The Administrative Complaint alleges that

Respondent prescribed or administered Diprivan excessively or

inappropr iately by continuous drip, along with other anesthesia

drugs, in the absence of a C.R.N.A. or M.D. Anesthesiologist.

Count Four of the Administrative Complaint alleges that

Respondent violated Section 458.331(1)(w), Florida Statutes, by

delegating profess ional duties to a person whom he knew or had

reason to know was not qualified by training, experience, or

licensure to perform them. In particular, Respondent allegedly

delegated the administration of sedatives or anesthetic agents,

including Diprivan, to a registered nurse, whom he knew or had

reason to know was not licensed as a C.R.N.A.

At the hearing, Petitioner called six witnesses and offered

into evidence 21 exhibits: Petitioner Exhibits 1 - 10, 14, 16 - 20,

and 27 - 31. Respondent called three witness es and offered into

evidence seven exhibits: Respondent Exhibits 1 - 7. All exhibits

were admitted except Petitioner Exhibit 18. Petitioner Exhibit

3 was admitted for penalty, not liability, purposes, and

Petitioner Exhibit 19 and Respondent Exhibits 1 an d 3 were not

admitted for the truth of their contents.

The court reporter filed the transcript on August 11, 2006.

The parties filed their proposed recommended orders on

August 24, 2006.

FINDINGS OF FACT

1. At all material times, Respondent has been a li censed

physician, holding license number ME 44240. He has been

licensed in Florida since 1984. Respondent has practiced

plastic surgery, particularly cosmetic plastic surgery, for the

past 22 years. Respondent is certified by the American Board of

Plast ic Surgery in plastic surgery. He was also certified in

Advanced Cardiac Life Support (ACLS) at the time of the surgery

in question.

2. The Board of Medicine previously disciplined Respondent

by Final Order filed September 1, 1995, pursuant to a Consent

Ag reement into which the parties had entered. The Consent

Agreement arose from allegations that Respondent had failed to

remove a sponge from a breast during breast augmentation

surgery. Respondent did not admit the allegations, but agreed

to pay a $2000 f ine and attend ten hours of continuing medical

education. The Administrative Law Judge admitted this evidence

strictly for the purpose of penalty, not liability.

3. Respondent performs plastic surgery at the Cosmetic

Surgery Center in Fort Lauderdale. The 5000 square - foot

facility contains three examination rooms, two operating rooms,

one recovery room, and an overnight hospital. Another physician

also operates at the Cosmetic Surgery Center, which employs a

wide range of staff, including a patient coordi nator, nurse

practitioner, and a certified register nurse anesthesiologist

(CRNA).

4. In the past, the Cosmetic Surgery Center retained a

CRNA to assist in surgery on an as - needed basis. However, since

mid - 2005, the Cosmetic Surgery Center has regularly employed a

CRNA after the Board of Medicine issued an Order of Emergency

Restriction of License on June 8, 2005. Issued in response to

the incident described below, the emergency order requires,

among other things, that Respondent employ a CRNA or M.D.

an esthesiologist to administer anesthesia at all surgeries,

unless the surgery will involve Level I sedation. The emergency

order also requires Respondent to obtain an unqualified surgical

clearance from every patient's primary care physician.

5. Respondent has performed over 10,000 procedures using

Level II sedation over 25 years. Level II sedation leaves the

patient conscious, but tranquil, and responsive to painful

stimulus or verbal command. Level III sedation leaves the

patient unconscious.

6. This ca se involves a 50 - year - old female, S. B., who

presented to Respondent's office on July 9, 2003, to discuss the

possibility of an abdominoplasty, breast augmentation, and arm

lift. Respondent had previously performed an abdominoplasty,

which is also known a s a tummy tuck, on S. B.'s daughter, who

wanted to make a present of cosmetic surgery for her mother.

After examining S. B., Respondent recommended against any work

on the arms, as the surgical scars would outweigh the benefits

of the surgery for S. B.

7. During this initial office visit, Respondent took a

history from S. B., who had three children and was employed as a

receptionist for a local roofing company. S. B. stated that her

general health was good, and she had never had significant

complications f rom any surgery. She reported that her only

medical problem was hypertension and that she consequently took

clonidine and Lasix. She stated that she had never reacted

badly to general or local anesthesia, did not bruise easily, and

did not bleed excessiv ely from cuts. The form asked the patient

to list intoxicating or mind - altering drugs, and S. B. did not

list any. At no time during the July 9 visit did S. B. express

an intent to proceed with the surgery, and, in fact, she was

undecided at the time and remained so for several months.

8. Respondent next saw S. B. on December 11, 2003, when

she presented at his office for a pre - operative examination.

Respondent again discussed the surgical procedures. During this

visit, S. B.'s blood pressure was 210/112 , which was too high

for Respondent to perform elective surgery. Instead, he

discussed with S. B. the need to control her blood pressure and

learned that she had quit taking her blood pressure medication.

Respondent told S. B. to see her primary care phy sician to

control the blood pressure. Respondent's notes document S. B.'s

blood pressure, the referral, and the purpose of the referral.

9. In anticipation of surgery on December 23, 2003,

Respondent prescribed on December 11, 2003, fifteen 500 - mg

tablets of Duricef, fifteen 10 - mg tablets of Lorcet, and fifteen

30 - mg tablets of Restoril. Duricef is an antibiotic. An

analgesic, Lorcet combines 10 mg of hydrocodone, an opioid, with

acetaminophen. Restoril, or temazepam, is a sedative in the

benzodiazepine family and is similar to Valium. Respondent

typically prescribes these or similar medications, so that his

patients can fill them prior to surgery and take them following

surgery.

10. On December 11, 2003, Respondent also ordered pre -

surgical lab work. The lab report, dated December 12, 2003,

states that S. B.'s values were largely normal. However,

S. B.'s prothrombin time (PT), which measures clotting time, was

very slightly elevated. The normal range for this parameter for

this laboratory is 11 - 13 secon ds, and the PT for S. B. was 14.8

seconds. However, the International Normalization Ratio (INR),

which normalizes results among labs and tissue samples, was 1.4,

which is within the normal range, as was the partial

thromboplastin time (PTT), which is anot her measure of clotting

time.

11. S. B.'s red blood cell count was very slightly high

(6.13 as compared to a range of 4.2 - 6.1 units per liter). Also

very slightly low were S. B.'s M.C.V. (79.0 as compared to a

range of 80.0 - 99.0 units), M.C.H. (26.3 as compar ed to a range

of 27.0 - 31.0 units), and M.C.H.C (32.7 as compared to a range of

33.0 - 37.0 units per liter). Very slightly high was S. B.'s

R.D.W. (15.4 as compared to a range of 11.5 - 15.0 percent).

Except for the red blood cell count, the other parameters

pertain to precursors of cells.

12. The next day, Respondent added to the pre - operative

prescriptions two 5 - mg tablets of Mephyton, which is vitamin K.

The medical records contain no discussion of why Respondent

added vitamin K the day after he had ordered t he other pre -

operative medications. Most likely, this information would have

been contained in Respondent's notes, which are in a handwritten

scrawl that is partly illegible. Clearly, though, Respondent's

notes fail to disclose the purpose of ordering Re spondent to

take vitamin K. Respondent testified that he was responding to

the PT value, explaining that he gives vitamin K to patients

with borderline clotting studies, so that the patients will not

experience as much bruising and swelling.

13. More import ant than the records' failure to contain an

explanation for the ordering of vitamin K is their failure to

address the high PT value in Respondent's plan of treatment for

S. B. Even if only borderline high and more suggestive of

problems involving only bru ising and swelling, the PT raised a

clotting issue, which is of obvious importance given the nature

of the contemplated surgery. Respondent's records must address

this issue and the impact, if any, on the contemplated surgery.

14. In retrospect, the PT abno rmality proved irrelevant.

S. B. did not display any clotting problems or excessive

bleeding during the surgery. At the hearing, Respondent

explained the limitations of a PT value, especially when it is

unaccompanied by an abnormal INR, although Responde nt obviously

thought enough of the PT test to order one for S. B. More

cogent is Respondent's explanation at the hearing that the

absence of any reported history of bleeding or bruising

outweighed any concerns raised by a slightly elevated PT value,

but t his persuasive analysis is nowhere to be found in the

medical records.

15. Petitioner argues alternatively, though, that the

slightly elevated PT value should have alerted Respondent to

cirrhosis, which is discussed in more detail below. At the pre -

operativ e stage, at least, the history, findings, and complaints

did not support a diagnosis of cirrhosis. In his pre - operative

physical examination, Respondent found no evidence of jaundice

or edema. S. B.'s anemia had resolved. Her history lacked any

indicati on of liver disease, nor did S. B. complain of any

symptoms consistent with cirrhosis. These facts, as well as the

information supplied by S. B.'s primary care physician,

justified Respondent's failure to explore the possibility of

liver disease prior to proceeding with surgery.

16. Nor did the circumstances impose a duty on Respondent

to include in the medical records a plan of treatment that

addressed the possibility of cirrhosis. The facts reasonably

known to Respondent did not raise the possibility of cir rhosis,

any more than they raised the possibility of heroin use by S. B.

It is thus irrelevant to Respondent's documentation duties,

although not necessarily to her death approximately 30 hours

after the end of the surgery, that S. B. suffered from some

d egree of cirrhosis and used heroin.

17. On December 31, 2003, S. B.'s primary care physician

completed a "Medical Clearance" form, even though Respondent had

not requested a medical clearance, but had required only that

the physician do what was necessary to g et S. B.'s blood

pressure under control. On the form, S. B.'s primary care

physician noted that S. B.'s past history consisted of

hypertension and, in June 2000, anemia. The addition of the

date implied that S. B. no longer suffered from anemia -- a fact

b orne out by her elevated red blood cell count. On the form,

the primary care physician noted that her blood pressure was

160/98 and pulse was 80, changed one of S. B.'s blood pressure

medications, and cleared her for surgery under local and general

anesth esia, "once BP <>

18. Two items on the Medical Clearance form support

Respondent's decision not to investigate the possibility of

liver disease before performing surgery. First, as noted above,

the form indicates that S. B.'s anemia had resolved. It would

be reasonable to assume that S. B.'s primary care physician was

especially attentive to indicators of anemia or liver disease

given this history. Second, the Medical Clearance indicates

that S. B.'s primary care physician had ordered a comprehensive

metabolic panel, which would include tests of liver function.

The absence of any further contact from the primary care

physician implies that the comprehensive metabolic panel

revealed nothing of importance as to liver function, and the

function of the l iver is obviously important -- not its post -

mortem condition.

19. On January 15, 2004, S. B. presented at the Cosmetic

Surgery Center for an abdominoplasty with liposuction to the

waist area. Respondent's scrawled notes do not disclose why he

or S. B. decided not to proceed with the breast augmentation.

20. In the pre - operative evaluation, which is initialed by

Respondent, S. B.'s pulse was 95, and her blood pressure was

162/96, with the notation that she was nervous. Her rating on

the American Society of Anest hesiologists (ASA) scale is I,

meaning that she has no disease. Respondent concedes that her

hypertension warranted a II, which means some systemic disease,

but not threatening. However, the mis - rating on the ASA scale

is irrelevant because it did not im pact her treatment or

outcome.

21. The pre - operative evaluation contains two other

notations of interest. First, Respondent planned for S. B. to

remain overnight at the Cosmetic Surgery Center, rather than to

discharge her to home on the day of the surgery or transfer her

to a hospital. Thus, her remaining at the facility the night of

the surgery did not suggest an unusually difficult surgery or

recovery. Second, Respondent found S. B. fit for surgery under

I.V. sedation in the office, rather than local or general

anesthesia.

22. Obviously, the pre - operative evaluation reports a

blood pressure in excess of the maximum listed in the medical

clearance that Respondent had received from S. B.'s primary care

physician. Respondent's medical records fail to address t his

discrepancy and the broader issue of S. B.'s blood pressure,

which was about the same as it was when she visited her primary

care physician, but considerably lower than when she last

visited Respondent. Respondent could and did reasonably

exercise his own medical judgment and proceed with surgery

despite a blood pressure in excess of the maximum on the medical

clearance, but given this recommendation, S. B.'s extremely

elevated blood pressure a month earlier, the challenges of

maintaining reasonable bl ood pressure levels intra - and post -

operatively, and S. B.'s hypertensive condition, Respondent was

required to document his reasoning for proceeding with surgery

despite the relatively high blood pressure.

23. At hearing, Respondent offered a persuasive

exp lanation of why he proceeded to perform the surgery despite a

blood pressure reading over 150/90. Attributing the elevated

blood pressure (and pulse) to adrenalin - producing anxiety, not

hypertension, Respondent decided that he would be able to

control S. B.'s blood pressure adequately during surgery with

sedatives and blood pressure medication. Considerable evidence

indicates that S. B. was a very nervous patient. S. B.'s pulse

was also quite rapid on both visits. As was the case with the

PT value, it i s easier to credit Respondent's reasoning given

hindsight, as he successfully controlled S. B.'s blood pressure

during surgery.

24. During surgery, Respondent's nurse practitioner,

Michelle Huff, monitored heart function by an EKG, blood

oxygenation and puls e by a disposable pulse oximeter, blood

pressure, and respiration. During the surgery, Respondent was

also assisted by Tiffany Archilla, a certified surgical

technologist.

25. At Respondent's direction and under his supervision,

Nurse Hoff, administered the f ollowing drugs immediately before

and during surgery: Diprivan, which is an anesthetic whose

specific effect depends on rate of administration; Versed, which

is a sedative; Robinul, which controls nausea; Ancef, which is

an antibiotic; fentanyl, which is an analgesic and anesthetic;

and labetalol, which controls blood pressure. Nurse Huff also

administered oxygen and nitrous oxide, which is an anesthetic.

26. Nurse Huff had been working at the Cosmetic Surgery

Center for only two months at the time of S. B.'s surgery.

Nurse Huff is not a CRNA, but is an advanced registered nurse

practitioner and has been a registered nurse for 14 years. At

the time of the hearing, she had been employed for three years

at the Cosmetic Surgery Center, where she also had comple ted an

internship. She estimates that she has participated in over

1000 surgical procedures involving Level II sedation.

27. At 8:40 a.m., Nurse Huff administered 2.5 mg of

Versed, 0.2 mg of Robinul, and 1.0 g of Ancef. At 8:45 a.m.,

Nurse Huff started the o xygen, nitrous oxide, and Diprivan drip.

The oxygen was in a two - liter bottle, and the nitrous oxide was

in a four - liter bottle.

28. The Diprivan was 500 mg in a 500 cc solution. During

the surgery, Nurse Huff administered all of this Diprivan, as

well as all of another 200 mg of Diprivan in a 250 cc solution,

given S. B.'s resistance to sedation. In most cases, and

probably in this one, Respondent uses a microchamber, which

releases microdrips at the rate of 60 drops per minute.

Respondent does not admin ister Diprivan by means of an infusion

pump, which would offer more precise control of the rate of

infusion. The records do not indicate the rate of

administration of the Diprivan. However, Respondent rarely

finds it necessary to discontinue Diprivan dur ing surgery, and

its clinical effect wears off after only about three minutes

following its discontinuation, so the patient arouses quickly

after Diprivan is stopped. Thus, the failure to record the rate

of administration of the Diprivan is immaterial.

29. At 8:45 a.m., Nurse Huff also administered 100 mg of

fentanyl, which was followed by 50 mg doses at 8:50 a.m., 8:55

a.m., 9:05 a.m., 9:35 a.m., 9:45 a.m., 10:05 a.m., and 10:10

a.m. S. B. thus received a total of 450 mg of fentanyl.

30. The surgery commenced at 9:30 a.m. At the start of

surgery, Respondent administered subcutaneously at the surgical

site 150 cc of one percent lidocaine, which is a local

anesthetic, with epinephrine at 1/200,000. The epinephrine

prevents the body from quickly absorbing the lido caine.

31. S. B.'s blood pressure had varied between 8:40 a.m.

and 9:30 a.m. It started at 164/97, but was 135/85 15 minutes

later. Her blood pressure remained at 145/85 from 9:00 a.m. to

9:10 a.m. At the time of surgery, S. B.'s blood pressure was

162/88 . In response to the start of surgery and reflective of

S. B.'s level of anxiety, her blood pressure surged to 180/95 at

9:45 a.m., and Respondent directed Nurse Huff to administer 2.5

mg of labetalol at this time. S. B.'s blood pressure reached

190/80 a t 10:00 a.m., five minutes after Nurse Huff had

administered another 2.5 mg of labetalol. By 10:10 a.m.,

S. B.'s blood pressure was down to 125/75, where it remained for

the remainder of the surgery.

32. S. B.'s other vitals remained good during the surgery.

Oxygenation saturation remained over 96 percent, mostly 97 and

98 percent. Respiration remained around 18. Pulse ran in

proportion to blood pressure, but settled within the range of

80 - 90 once S. B.'s blood pressure stabilized at 10:10 a.m.

33. Blood loss was minimal during the surgery. Typically,

a patient may lose 200 - 300 cc of blood, but S. B. lost only

150 cc. Proceeding conservatively, Respondent did not try to

tighten the muscle wall, as he found, once he had made the

incisions, that S. B. did not r equire this procedure. The

liposuction removed 200 cc, including 150 cc of fat.

34. Anesthesia ended at 11:05 a.m., and surgery ended at

11:10 a.m. During the surgery, S. B. had received 2000 cc of

fluids. At all times, S. B. remained active and alert.

E videncing S. B.'s level of alertness during surgery was her

high oxygen levels at all times during surgery and the necessity

of additional Diprivan.

35. At 11:20 a.m., S. B. was transported by stretcher from

the operating room to the recovery room. At this time, her

oxygen level was 98 percent, her blood pressure was 179/97, her

pulse was 96, and her respiration was 16. At 11:30 a.m., S. B.

received 2.5 mg of labetalol. At 11:35 a.m., S. B. was

complaining of anxiety, so she received 2.5 mg of Valium.

36. At 11:40 a.m., a nurse emptied her Foley catheter of

1600 cc of clear yellow urine. At this time, S. B.'s blood

pressure was 184/105, her pulse was 95, her respiration was 16,

and her oxygen level was 96 percent. She received another 2.5

mg of labetalol. At 11:45 a.m., S. B. received another 2.5 mg

of Valium.

37. At 12:15 p.m., S. B.'s blood pressure was 164/92, and

she received clonidine 0.1 mg to reduce her blood pressure.

Fifteen minutes later, S. B.'s blood pressure dropped to 143/88.

She fell asleep at 1:00 p.m., but awoke an hour later,

complaining of pain. She then received 75 mg of Demerol with

6.25 mg of Phenergan, which controls nausea.

38. At 2:30 p.m., S. B. complained again of pain. Her

blood pressure had risen to 189/78, so she received another

cl onidine 0.1 mg. Fifteen minutes later, a nurse emptied

S. B.'s Foley catheter of 1400 cc of clear urine. S. B.'s blood

pressure was 170/100, and the nurse notified Respondent of this

reading. The nurse gave S. B. 10 mg of Procardia, which reduces

high b lood pressure. At 3:00 p.m., S. B. received 2.5 mg of

labetalol and 2.5 mg of Versed.

39. Fifteen minutes later, S. B. was transferred by

stretcher to the overnight room with a blood pressure of 141/60,

pulse of 96, and respiration of 16. By 3:45 p.m., S. B.'s blood

pressure was 125/59, and she was asleep. Thirty minutes later,

S. B. was watching television, and her blood pressure was

141/78.

40. After complaining of pain, S. B. received 100 mg of

Demerol with 12.5 mg of Phenergan at 4:50 p.m. At 5:10 p.m.,

S . B.'s blood pressure rose to 163/94, and her pulse was 108.

She received another 10 mg of Procardia at this time. At 6:00

p.m., S. B.'s blood pressure was down to 142/88. Two hours

later, after she complained of insomnia, S. B. received 30 mg of

Restor il.

41. At 9:15 p.m., S. B. complained of abdominal pain. She

received 100 mg of Demerol and 25 mg of Phenergan. At 11:30

p.m., S. B. received 30 mg of Restoril for insomnia and 10 mg of

Lorcet for pain.

42. At 1:20 a.m. on January 16, S. B. was sleepy. Two

h ours later, her blood pressure was 148/70. At 5:30 a.m., after

an uneventful night, S. B. complained of abdominal pain and

received another 10 mg of Lorcet. At 7:00 a.m., her intravenous

line was discontinued. Alert and oriented, S. B. walked in the

hal l and received another clonidine 0.1 mg. A nurse emptied her

Foley catheter of 400 cc of urine and removed the Foley

catheter. At discharge at 8:00 a.m., Respondent examined the

wound and found no evidence of bleeding, as he changed the

dressing. At thi s time, S. B.'s blood pressure was 147/70 and

pulse was 108. S. B. was transported by wheelchair to her

daughter's car.

43. S. B. and her daughter arrived at S. B.'s home at

about 9:00 a.m. on January 16, 2004. After spending the morning

with her mother, th e daughter left the home and returned at 1:00

p.m. Having forgotten the house key, the daughter knocked on

the door, and S. B. had to crawl to the door due to her lack of

strength. The daughter assisted her mother to bed. Mid -

afternoon, the daughter lef t her mother to run some errands.

When the daughter returned home shortly before 6:00 p.m., she

found her mother unresponsive and curled into a fetal position

on the floor with blood present on the bed sheets and nightshirt

that she was wearing. The dau ghter immediately called 911 and

requested an ambulance.

44. The emergency management technicians (EMTs) arrived at

S. B.'s home at 6:23 p.m. and found her as her daughter had

found her. S. B. was in full cardiac arrest. The EMTs found

S. B. cold to the touc h with fixed and dilated pupils. They

found a "small amount" of blood oozing from the staples in the

lower stomach. The two surgical drains in the upper stomach

contained no discharge. Blood had soaked the bandage and run

down both legs to thigh level. The EMTs estimated blood loss at

about 500 cc. The EMTs also found the Restoril and Lorcet in

the doses that Respondent had prescribed pre - operatively. The

EMTs attempted unsuccessfully to resuscitate S. B. and

transported her to the hospital where she was pronounced dead on

arrival at 6:35 p.m.

45. The medical examiner conducted an autopsy on

January 17, 2004, at which time blood and urine samples were

taken for toxicological analysis. The toxicology report notes

that a gas chromatography/mass spectrometry procedure revealed

the presence of 6 - MAM, which is a metabolite of heroin and

demonstrates conclusively that S. B. consumed heroin or, much

less likely, 6 - MAM; morphine, which is another indicator of

heroin, at a concentration of 0.22mg/L; methadone at a

concentration of less than 0.05 mg/L; meperidine, which is

Demerol (a narcotic analgesic) at a near - toxic concentration of

0.98 mg/L; diazepam, which is Valium, at a concentration of less

than 0.05 mg/L; nordiazepam, which is a metabolite of Valium, at

a c oncentration of less than 0.05 mg/L; temazepam, which is, as

noted above, Restoril or another metabolite of diazepam, at a

concentration of 0.29 mg/L; and hydrocodone, which is one of the

two ingredients, as noted above, of Lorcet, at a concentration

of 0. 05 mg/L.

46. A drug's half - life is the amount of time for its

potency to be reduced by half. Three to four half - lives are

required for the complete elimination of a drug. Because

various conditions can affect the half - lives of drugs, such as

liver disease a s to drugs eliminated substantially through

metabolism by the liver, half - lives are stated as average

ranges. Relevant half - lives are: Demerol -- 2 - 24 hours;

diazepam -- 21 - 37 hours; hydrocodone -- 3.4 - 8.8 hours; and

temazepam -- 3 - 13 hours. Diprivan and fentan yl have very short

half - lives and were not detected by the toxicologist. The half -

life of 6 - MAM is also very short, about 6 - 25 minutes, leading

the toxicologist who performed the report for the medical

examiner to testify that S. B. had consumed heroin no t more than

two hours before her death.

47. The same toxicologist testified that the detected

concentration of Demerol was six times the therapeutic level.

(This testimony is credited over the testimony of the Deputy

Chief Medical Examiner that the concentrat ion of 0.98 mg/L is

only twice the therapeutic level.) Given a half - life of 2 - 24

hours, all that can be said with certainty is that S. B.

suffered even greater concentrations of Demerol -- possibly much

greater -- prior to the near - toxic concentration found b y the

toxicologist.

48. Undoubtedly, the heroin and methadone that S. B.

consumed were not prescribed by Respondent. Undoubtedly, S. B.

had access to Demerol that Respondent had not administered.

Respondent could not have reasonably have anticipated, based on

the circumstances, that S. B. would consume heroin, methadone,

and toxic or near - toxic amounts of Demerol, in addition to her

prescribed medications, within 12 hours of her release from the

Cosmetic Surgery Center. Just as an illegal drug user has the

right to treatment in accordance with the applicable standard of

care, so a physician has a right to expect behavior on the part

of his patient that is at least consistent with the instinct of

self - preservation.

49. The autopsy determined that S. B. died of a combined

drug overdose of heroin, temazepam, Valium, methadone, Demerol,

and hydrocodone. Contributing causes of death were

hypertension, abdominal wall hemorrhage, and cirrhosis. As to

the hypertension, the autopsy report states that S. B. suffered

from mild arteriosclerotic cardiovascular disease. As to the

abdominal wall hemorrhage, the autopsy report states that S. B.

was in status -- post - tummy tuck and liposuction. As to the

cirrhosis, the autopsy report states that S. B. suffered from

severe fatty metamorphosis of the liver. The autopsy report

concludes that the manner of death was an accident.

50. Of the drugs that combined to kill S. B., Respondent

clearly did not administer or prescribe the heroin or methadone.

Although Respondent administered Deme rol at the dosages of 75 mg

at 2:00 p.m. 100 mg at 4:50 p.m., and 100 mg at 9:15 p.m., all

on January 15, the near - toxic Demerol found in S. B. at the time

of her death was not due to these doses, but due, at least in

large part, to Demerol that S. B. obta ined from other sources.

51. The hydrocodone and temazepam were probably derived,

at least in part, from the Lorcet and Restoril that Respondent

prescribed for post - operative use. Unfortunately, the record

does not reveal how many pills of each that the EMTs found at

the S. B.'s home, so it is impossible even to infer how much of

each medication that S. B. took while at home during the

afternoon of January 16 immediately preceding her death. Not

much hydrocodone was found in S. B., and the 10 mg of Lorcet

giv en at 11:30 p.m. on January 15 and 10 mg of Lorcet given at

5:30 a.m. on January 16 would have been nearly eliminated by the

time of S. B.'s death, given the short half - life of hydrocodone.

Considerably more temazepam was found in S. B., but the 30 mg of

Restoril given at 8:00 p.m. and 30 mg of Restoril given at

11:30 p.m. would have been nearly eliminated by the time of

S. B.'s death, given the short half - life of temazepam.

52. Clearly, in the two or three hours before she died,

S. B. took heroin, methadone, and Demerol. Clearly, the

fentanyl that she had last received at 10:10 a.m. on the prior

day and the Diprivan that she had last received at 11:05 a.m. on

the prior day had long cleared her system before she took the

heroin, methadone, and Demerol. S. B. accidentally took her own

life by taking these three drugs.

53. The record does not suggest that hemorrhaging from the

surgical site was due to some failure on Respondent's part.

Instead, it appears more likely that falling from the bed or

possibly convulsing from the drug overdose, S. B. may have

reopened the incision site.

54. The record does not suggest that cirrhosis materially

extended the half - lives of any medications that Respondent

administered. S. B. efficiently eliminated the Valium that

Respondent admi nistered. The record does not explain why she

would not as efficiently eliminate other drugs metabolized

primarily by the liver.

55. The record does not suggest that Respondent's

management of S. B.'s hypertension intra - and post - operatively

had any bearing o n her demise. Her blood pressure stabilized

late in the afternoon of January 15, and nothing in the record

suggests that anything that transpired on that day concerning

S. B.'s hypertension caused an acute crisis that resulted in her

death.

56. As to Count I, Respondent did not depart from the

applicable standard of care. S. B. never fell below Level II

sedation; she was always responsive to pain and attempts to

communicate. S. B. proved difficult to sedate even to Level II.

On these facts, it is impossi ble to find even that it was

reasonably likely, at the outset of the procedure, that S. B.

would reach Level III sedation.

57. Additionally, as to Count I, Respondent competently

managed S. B.'s hypertension intra - and post - operatively. Based

on the circums tances, Respondent correctly determined that the

slight elevation of PT would not interfere with clotting or

endanger the patient's safety and correctly determined that the

other five slight abnormalities in the lab report were

immaterial to patient safety in the contemplated surgical

procedure. Respondent was thus not required to obtain

additional tests or to obtain a consultation for the slight PT

abnormality. Based on the physical examination and lab results,

including those ordered by the primary care physician,

insufficient evidence of liver abnormality existed to preclude

the administration of the acetaminophen contained in Lorcet.

Further, the standard of care does not preclude the prescription

of acetaminophen to all patients with any kind of live r disease.

58. As to Count II, Respondent's medical records fail to

document adequately why he proceeded to operate despite S. B.'s

failure, pre - operatively, to reach a blood pressure of less than

150/90, why he administered vitamin K pre - operatively, and, mo st

importantly, how he had assimilated the PT abnormality in his

treatment plan for S. B. As noted above, at hearing, Respondent

amply supplied all of this information -- the problem is that he

never bothered to do so in the medical records. Although these

deficiencies in medical records did not contribute in any way to

S. B.'s death, they are material failures to justify the course

of treatment. In contrast to the detailed records of Nurse Huff

intra - operatively and the post - operative records prepared by

nurses, Respondent's notes, and thus the records themselves, do

not approach the minimum level of detail necessary to justify

the course of treatment in this case.

59. As to Count III, Respondent did not administer or

cause to be administered excessive or inap propriate quantities

of Diprivan.

60. As to Count IV, Respondent did not improperly delegate

professional duties, with respect to the administration of

Diprivan, to a registered nurse who was not a CRNA. At all

times, Respondent adequately supervised and moni tored the

administration of this short - acting sedative.

61. The record does not support Respondent's claim of

prejudice resulting from any delay in the prosecution of this

case. Any claim of prejudice due to delay is undermined by

Respondent's failure to dema nd an immediate hearing due to the

imposition of an emergency restriction on his license.

CONCLUSIONS OF LAW

62. The Division of Administrative Hearings has

jurisdiction over the subject matter. §§ 120.569 and 120.57(1),

Fla. Stat. (2003).

63. Respondent's Motio n for Recommended Order of Dismissal

is denied because the Division of Administrative Hearings lacks

the authority to dismiss the case for prosecutorial delay, and

Respondent failed to prove any prejudice from any prosecutorial

delay. Given the findings a nd conclusions that Respondent is

guilty only of the charges concerning the inadequacy of his

medical records, any claim of prejudice would necessarily fail,

as the records are in the exact same condition as they were at

the time of the incident, and no pa ssage of time or testimony

could alter this fact.

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

Board of Medicine to discipline Respondent for:

(m) Failing to keep legible, as defined by

department rule in consultation with the

board, medical recor ds 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 justif y 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.

* * *

(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,

inappropriately 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) Gross or repeated malpractice or the

failure to practice medicine with that level

of care, skill, and treatment whic h is

recognized by a reasonably prudent similar

physician as being acceptable under similar

conditions and circumstances. The board

shall give great weight to the provisions of

s. 766.102 when enforcing this paragraph. As

used in this paragraph, "repeate d

malpractice" includes, but is not limited to,

three or more claims for medical malpractice

within the previous 5 - year period resulting

in indemnities being paid in excess of

$50,000 each to the claimant in a judgment or

settlement and which incidents inv olved

negligent conduct by the physician. As used

in this paragraph, "gross malpractice" or

"the failure to practice medicine with that

level of care, skill, and treatment which is

recognized by a reasonably prudent similar

physician as being acceptable u nder similar

conditions and circumstances," shall not be

construed so as to require more than one

instance, event, or act. Nothing in this

paragraph shall be construed to require that

a physician be incompetent to practice

medicine in order to be discipli ned 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

malpractice," "repeated malprac tice," or

"failure to practice medicine with that level

of care, skill, and treatment which is

recognized as being acceptable under similar

conditions and circumstances," 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.

65. Florida Administrative Code Rule 64B8 - 9.009(4) and (5)

provides:

(4) Level II Office Surgery.

(a) Scope.

* * *

2. Level II Office surgery includes

any surgery in which the patient is placed

in a state which allow s 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

st imulus are sedated to a greater degree

than encompassed by this definition.

(b) Standards for Level II Office

Surgery.

ansfer Agreement Required. The

physician must have a transfer agreement

with a licensed hospital within reasonable

proxi mity if the physician does not have

staff privileges to perform the same

procedure as that being performed in the

out - patient setting at a licensed hospital

within reasonable proximity. “Reasonable

proximity” is defined as not to exceed

thirty (30) minute s transport time to the

hospital.

* * *

4. Assistance of Other Personnel

Required. The surgeon must be assisted by a

qualified anesthesia provider as follows:

An Anesthesiologist, Certified Registered

Nurse Anesthesis t, 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. . . .

* * *

(6) Level III O ffice Surgery.

(a) Scope.

1. Level III Office Surgery is that

surgery which involves, or reasonably 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. In addition to the standards for

Level II Office Surgery, the surgeon must

comply with the following:

* * *

4. A ssistance of Other Personnel

Required. An Anesthesiologist, Certified

Registered Nurse Anesthetist, or Physician

Assistant qualified as set forth in

subparagraph 64B8 - 30.012(2)(c)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. The anesthesia

provider cannot function in any other

capacity during the procedure. . . .

66. Petitioner must prove the materia l allegations by

clear and convincing evidence. Department of Banking and

Finance v. Osborne Stern and Company, Inc. , 670 So. 2d 932 (Fla.

1996) and Ferris v. Turlington , 510 So. 2d 292 (Fla. 1987).

67. Count I alleges that Respondent departed from the

appl icable standard of care. One basis for this allegation is

that he administered or caused the administration of Diprivan

without a CRNA. In this allegation, Petitioner relies on the

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

DOAH Case Nos. 04 - 0709PL and 04 - 0901PL. These cases are

distinguishable in one important respect: both patients in

Ingram clearly slipped into Level III sedation during their

operations, as they were not responsive to verbal and tactile

stimuli during parts of th eir surgeries. In one case, the

patient's oxygen saturation rate dropped to 78 percent, and, in

the other case, the patient's oxygen saturation rate was not

measurable, under circumstances that permit no inference but

that the patient slipped into Level I II sedation. Nor does the

Ingram Final Order take issue to the following statement in the

Recommended Order adopted by the Final Order: "Diprivan, when

properly controlled, can be used to achieve Level II

anesthesia." (Recommended Order, page 17.)

68. Duri ng her surgery, S. B. never slipped below Level II

sedation. Respondent was ACLS certified, so he was permitted by

rule to employ a registered nurse as his required assistant,

rather than a CRNA. It is well - established that penal statutes

are construed i n favor of licensees. See , e.g. , Djokic v.

Department of Business and Professional Regulation , 875 So. 2d

693, 695 (Fla. 4th DCA 2004). The facts of this case do not

support the effort by Petitioner to prohibit, by order rather

than rule, the skilled use of Diprivan in office surgery using

Level II sedation.

69. For the reasons set forth in the Findings of Fact,

Petitioner likewise failed to prove the remaining bases for its

allegations that Respondent departed from the applicable

standard of care.

70. Count II alleges that Respondent failed to keep

medical records justifying the course of treatment. For the

reasons set forth in the Findings of Fact, Petitioner proved

these allegations.

71. Count III alleges that Respondent administered

Diprivan excessively or inappropriately. Respondent effectively

monitored the rate of administration of Diprivan, which

generally was dripped without interruption during the entire

procedure.

72. Count IV alleges that Respondent improperly delegated

professional duties to a person unqualified to perform them.

This allegation essentially restates the allegation that

Respondent was required to use a CRNA, not a registered nurse,

because he was proceeding with Level III sedation. However, as

noted above, Petitioner failed to prove t hese allegations.

73. Section 458.331(2), Florida Statutes, provides that

the Board of Medicine may impose such penalties as are

authorized by Section 456.072, Florida Statutes. Section

456.072(2)(b), Florida Statutes, authorizes suspension or

revocation. Se ction 456.072(2)(e), Florida Statutes, authorizes

an administrative fine of up to $10,000 per offense or count.

Section 456.072(2)(f), Florida Statutes, authorizes probation

for a period of time selected by the Board and upon such

conditions, such as cont inuing education, as the Board may

specify.

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

provides that, for a second offense, the penalty guidelines for

failing to keep appropriate medical records range from probation

to suspension and an administrati ve fine of $5000 to $10,000.

In mitigation, Respondent's reasoning in support of his

treatment plan was sound and all of his assumptions proved

correct. Although maintaining S. B.'s blood pressure within

reasonable limits demanded close attention and con siderable

effort, Respondent and his staff succeeded in meeting this

challenge. Respondent's failures regarding medical records did

not contribute to the death of S. B.; if they had, the

recommendation would have exceeded the maximum penalties in the

guid elines.

75. The disciplinary guidelines take into account the

prior discipline by treating this violation as a second offense,

so the prior discipline is not an aggravating circumstance.

However, aggravating circumstances exist. Three separate bases

suppor t Petitioner's claim of inadequate medical records. As to

these three matters, Respondent's records are silent, betraying

either a dangerous ignorance of the purpose of medical records

or a casual disregard for the importance of the requirements

concernin g medical records.

RECOMMENDATION

It is

RECOMMENDED that the Board of Medicine enter a Final Order

dismissing Counts I, III, and IV of the Administrative

Complaint, finding Respondent guilty of a single violation of

Section 458.331(1)(m), Florida Statu tes, suspending his license

for 30 days, placing his license on probation for two years,

requiring him to complete successfully continuing medical

education on medical records, and imposing an administrative

fine of $10,000.

DONE AND ENTERED this 25th day of August, 2006, in

Tallahassee, Leon County, Florida.

S

___________________________________

ROBERT E. MEALE

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675 SUNC OM 278 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 25th day of August, 2006.

COPIES FURNISHED:

Larry McPherson, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way, BIN A02

Tallahassee, Florida 32399 - 1701

Timothy M. Cerio, General Counsel

Department of Health

4052 B ald Cypress Way, Bin AO2

Tallahassee, Florida 32399 - 1701

John E. Terrel

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

Lewis W. Harper

Brew and Harper, PL

6817 Southpoint Parkway, Suite 1804

Jacksonville, Florida 32216

George Kellen Brew

Brew and Harper, P.L.

6817 Southpoint Parkway, Suite 1804

Jacksonville, Florida 32216

Patricia Nelson

Department of Health

4052 Bald Cypress Way, Bin C65

Tallahassee, Florida 32399

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All pa rties have the right to submit written exceptions within

15 days from the date of this recommended order. Any exceptions

to this recommended order must be filed with the agency that

will issue the final order in this case.