07-003396PL Department Of Health, Board Of Medicine vs. James S. Pendergraft, Iv, M.D. Status: Closed Recommended Order on Tuesday, June 8, 2010.

Summary: Petitioner proved a standard of care violation in failing to order lab tests when starting & during admn of anabolic steroids, a medical records violation for failure to document results of lab tests & prescription outside the course of practice.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 07-3396PL

)

JAMES F. PENDERGRAFT, IV, M.D., )

)

Respondent. )

________________________________)

RECOMMENDED ORDER

Robert E. Meale, Administrative Law Judge of the Division

of Administrative Hearings, conducted the final hearing in

Orlando, Florida, on January 11-13, 2010.

APPEARANCES

For Petitioner: Gregg S. Marr

Assistant General Counsel

Department of Health

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399-3265

For Respondent: Kenneth J. Metzger

Metzger & Associates, P.A.

1637 Metropolitan Boulevard, Suite C-2

Tallahassee, Florida 32308

Sharon B. Roberts

Strawn & Monaghan, P.A.

54 Northeast Fourth Avenue

Delray Beach, Florida 33483

STATEMENT OF THE ISSUES

The issues are whether Respondent deviated from the

applicable standard of care, failed to keep medical records

justifying the course of treatment, improperly delegated

professional responsibilities, or prescribed, dispensed or

administered controlled substances other than in the course of

his professional practice; and, if so, what penalty should be

imposed.

PRELIMINARY STATEMENT

By Administrative Complaint dated September 2, 2005,

Petitioner alleged that Respondent is a licensed Florida

physician, holding license number 59702. The Administrative

Complaint alleges that Respondent owned and operated the Orlando

Women's Center, which employed M. W., who was also a patient of

Respondent.

The Administrative Complaint alleges that M. W., who was

not a licensed health care provider, assisted in patient

preparation, administered medications, cleaned equipment,

ordered supplies, and remained overnight with patients to

administer pain medications, such as Demerol, which is a

controlled substance. The Administrative Complaint alleges that

Respondent authorized M. W. to administer pain medications

without his supervision. The Administrative Complaint alleges

that, in 1997, M. W.'s duties expanded to ordering controlled

substances for the Orlando Women's Center using Respondent's

Drug Enforcement Agency registration certificate (DEA number).

The Administrative Complaint alleges that, in November

1998, M. W. informed Respondent that she wanted to become a

wrestler and bodybuilder and asked that he prescribe anabolic

steroids for these purposes. However, the Administrative

Complaint alleges that there was no medical justification for

prescribing anabolic steroids to M. W.

The Administrative Complaint alleges that, in November

1998, Respondent allowed M. W. to use his DEA number to order

anabolic steroids--specifically, Winstrol, depo-testosterone,

and Stanozolol--for her personal use. The Administrative

Complaint alleges that Chapter 893, Florida Statutes, defines an

anabolic steroid as a Schedule III controlled substance and is

any drug or hormonal substance chemically or pharmacologically

related to testosterone that promotes muscle growth.

The Administrative Complaint alleges that Respondent failed

to order laboratory studies, such as liver function tests, to

monitor the effect of the steroids that he authorized for M. W.

Futher, the Administrative Complaint alleges that Respondent

failed to document his monitoring of the effects of the steroids

in his medical records.

The Administrative Complaint alleges that, in March 1999,

M. W. was found unconscious on the floor of the Orlando Women's

Center. She allegedly told Respondent that she had abused

cocaine, a Schedule II controlled substance, and heroin, a

Schedule I controlled substance. Respondent allegedly made no

effort to treat M. W.'s drug addiction or to refer her to an

addiction specialist.

The Administrative Complaint alleges that, in April 1999,

M. W. was again found unconscious on the floor of the Orlando

Women's Center. On August 23, 1999, Respondent allegedly

ordered a drug profile on M. W., which was positive for

benzodiazepines, a group of psychotropic drugs with potent

hypnotic and sedative action used predominantly as anti-anxiety

and sleep-inducing drugs, and cocaine metabolites, a Class II

controlled substance that is a drug of abuse when used for

nonmedical purposes, but is used medically to numb mucous

membranes.

The Administrative Complaint alleges that, on September 22,

1999, M. W. expired from acute pulmonary edema and respiratory

compromise due to acute bronchitis with persistent airway

obstruction. The medical examiner allegedly stated that her

death was due to natural causes.

These paragraphs of the Administrative Complaint are

realleged in each of the four counts of the pleading.

Count One of the Administrative Complaint alleges that

Section 458.331(1)(t), Florida Statutes, authorizes discipline

for failing to practice medicine with that level of skill, care,

and treatment that is recognized by a reasonably prudent similar

physician as being acceptable under similar conditions and

circumstances (Standard of Care). Count One alleges that

Respondent violated the Standard of Care by:

a. Prescribing anabolic steroids for M. W.

when there were no medical indications to

justify giving these drugs.

b. Failing to order laboratory tests for

M. W. to monitor the effects of the

prescribed anabolic steroids.

c. Failing to treat M. W.'s known drug

addiction or to refer her to an addiction

specialist.

d. Employing M. W. in a position that gave

her full access to narcotics to maintain her

drug addiction.

e. Allowing M. W., an unlicensed

practitioner, to administer narcotics to

patients without supervision.

f. Allowing M. W. to use Respondent's DEA

number to order controlled substances.

g. Maintaining inadequate medical records

that would justify the course of treatment.

Count Two alleges that Section 458.331(1)(m), Florida

Statutes, authorizes discipline for failing to keep legible

medical records justifying the course of treatment, including

patient histories, examination results, test results, records of

drugs prescribed, dispensed or administered, and reports of

consultations or hospitalizations. Count Two alleges that

Respondent committed a medical records violation by failing to

justify the course of treatment when he did not adequately

document the monitoring of the effects of the anabolic steroids.

Count Three alleges that Section 458.331(1)(w), Florida

Statutes, authorizes discipline for delegating professional

responsibilities to a person the licensee knows or has reason to

know is not qualified by training, experience, or licensure to

perform them. Count Three alleges that Respondent violated this

provision by: a) allowing M. W. to administer controlled drugs

and narcotics to patients and b) allowing M. W., who had a known

drug addiction, to use Respondent's DEA number to order

controlled substances.

Count Four alleges that Section 458.331(1)(q), Florida

Statutes, authorizes discipline for prescribing, dispensing,

administering, mixing, or otherwise preparing a legend drug,

including any controlled substance, other than in the course of

the physician's practice. Count Four alleges that Respondent

violated this provision by prescribing or allowing to be

purchased, with his DEA number, anabolic steroids for M. W.

without a medical indication or justification.

By Motion to Amend Administrative Complaint filed

August 20, 2009, Petitioner requested leave to amend paragraph

7, above, of Count One, which alleges medical records as a

Standard of Care violation, to add a reference to Florida

Administrative Code Rule 64B8-9.003. By Order entered

September 3, 2009, this request was granted.

Petitioner transmitted the file to the Division of

Administrative Hearings on July 23, 2007. The case was first

set for hearing on January 7-11, 2008. The hearing was

repeatedly continued, most often due to problems in obtaining

discovery from the Drug Enforcement Administration (DEA). 1 Prior

to the assignment of the case to the undersigned Administrative

Law Judge in late October 2009, the case had been assigned to

three Administrative Law Judges, two of whom had disqualified

themselves.

At the hearing, ruling on Respondent's Motion to Dismiss

filed December 30, 2009, the Administrative Law Judge struck

paragraph g, above, of Count One, based on Board of Dentistry v.

Barr , 954 So. 2d 668 (Fla. 1st DCA 2007), and limited paragraphs

d, e, and f, above, of Count One to alleged breaches of the

Standard of Care with respect to the practice of medicine as to

M. W., as a patient, based on the final order in DOAH Case No.

08-4197PL (requirement of a DEA registration to prescribe

certain medications is not a standard-of-care requirement).

These matters are discussed in the conclusions of law.

Petitioner voluntarily dismissed paragraph b of Count Three at

the start of the hearing.

At the hearing, Petitioner called seven witnesses and

offered into evidence seven exhibits: Petitioner Exhibits 1-3,

5, 9, and 11-12. Petitioner Exhibit 1 is limited to pages 4-6

and A and B. Petitioner Exhibit 9 is admitted for penalty, not

liability. Respondent called seven witnesses and offered into

evidence eight exhibits: Respondent Exhibits 1-4, 7, and 8.

Respondent Exhibit 7 is the following pages of Petitioner

Exhibit 1: 11-20 and 22-32. Respondent Exhibit 8 is Petitioner

Exhibits 7 and 8. All exhibits were admitted.

The parties received the Transcript prior to its filing

with the Division of Administrative Hearings. The parties filed

their Proposed Recommended Orders on March 22, 2010, and the

court reporter filed the transcript on March 31, 2010.

FINDINGS OF FACT

1. Respondent is a licensed physician in Florida, holding

license number 59702. He has been licensed in Florida since

1991. Respondent is Board-certified in obstetrics and

gynecology. His last certification was in November 2009.

2. Respondent received his bachelor of science degree from

the University of North Carolina at Chapel Hill in 1978. He

received his doctor of medicine degree from Meharry Medical

College in Nashville in 1982. He performed a surgical

internship from 1982-83 with the Madigan Army Medical Center in

Tacoma, an obstetrics and gynecology residency from 1987-91 at

the Harbor Hospital Center in Baltimore, and a maternal fetal

medicine fellowship from 1991-93 at the University of South

Florida.

3. During the residency, Respondent completed a six-week

rotation in the mental evaluation, diagnosis, and treatment of

transgendered patients. The training took place on the campus

of Johns Hopkins University, which was one of the first medical

schools to offer training in the diagnosis and treatment of

transgendered patients. During this rotation, Respondent

assumed responsibility for the care of about 30 patients, a

little over half transitioning from female to male.

4. From 1991-93, Respondent performed obstetrics and

gynecology at several medical facilities in Florida, Maine, and

Missouri. From 1993-96, Respondent was the Chief of

Perinatology, Healthy Start Program, at the D.C. General

Hospital/Howard University in Washington.

5. In 1996, Respondent started the Orlando Women's Center

(OWC) in Orlando, which he still owns and operates. He opened a

second women's clinic in Orlando the following year. Respondent

also participated in the starting of women's clinics in Ocala in

1998, Fort Lauderdale in April 1999, and Tampa in October 1999.

6. In October 1996, about six months after opening, OWC

hired M. W. as a medical assistant. She had nearly completed

the coursework to become a licensed practical nurse, but at no

time material to this case was she ever a licensed health care

provider. M. W. was employed by OWC until 1999.

7. M. W. was a diligent employee. Her initial duties were

answering the telephone and working in the lab. However, her

enthusiasm, intelligence, dedication, and discretion earned

M. W. a promotion. In January 1997, Respondent promoted M. W.

to a trusted position in which she would care for patients

undergoing abortions during the second trimester of pregnancy.

8. Working conditions required M. W. to be on-call nearly

all of the time, as certain patients demanded to be admitted

during nights or weekends to preserve confidentiality. The work

was stressful because some patients bore fetuses with

abnormalities, and protestors regularly demonstrated outside the

clinic. M. W.'s new duties allowed Respondent himself to

observe her work and determine that M. W. had the psychological

stability to perform her job well.

9. M. W. demonstrated her trustworthiness by dealing with

patients' valuables, opening and closing the clinic, ordering

supplies and stocking five surgical rooms, and drawing

controlled substances for administration by Respondent. At the

end of 1997, Respondent promoted M. W. to ordering and stocking

the clinic's medical supplies, which include controlled

substances. For Schedule II drugs, which includes narcotics,

and Schedule III drugs, which includes steroids, M. W. had to

fill out a DEA Form 222, using Respondent's DEA number to place

the order.

10. When OWC received Schedule III drugs, M. W. matched

the order with the shipment. She then recorded the information

in the OWC drug log. M. W. would place the drugs in a locked

cabinet, if they were not needed for immediate use in the

clinic.

11. After nearly one year of ordering supplies, toward the

end of 1998, M. W. approached Respondent to discuss a personal

matter. At this point, the material disputes between the

parties emerge. Respondent testified that M. W. discussed with

him the possibility of undergoing transgender therapy, as well

as treatment for an injured shoulder. According to Petitioner,

M. W. discussed with Respondent the possibility of using

anabolic steroids to improve her bodybuilding and weightlifting.

The parties do not dispute that M. W. had participated in

bodybuilding and weightlifting for several years prior to her

employment with OWC. The Administrative Law Judge credits

Petitioner's version of the purpose of treatment.

12. Respondent testified that M. W. told him that she had

thought about changing genders for several years. She did not

like or want her breasts. She did not like the shape of her

hips and thighs. She had decided that she did not want children

and did not want to undergo menstruation. Although M. W. may

have told Respondent that she did not like her body shape, she

did not tell him that she wanted to change into a man.

13. As discussed below, M. W. is not available to confirm

or deny Respondent's version of events, and Respondent does not

have any medical records documenting his care and treatment of

M. W. Assigning a secondary reason for the treatment--healing a

long-injured shoulder--is an awkward fit with Respondent's

version of events, given the unlikelihood that someone

considering a decision as major as changing genders would bother

assigning a secondary reason for the decision. This secondary

reason for the treatment is a better fit with Petitioner's

version of events, although treatment of an injured shoulder

was, at most, a very minor factor in the steroid treatment

because the reconstructed medical records, discussed below,

mention strength and bodybuilding, not recovery from a shoulder

injury.

14. The most important reason to credit Petitioner's

version of the purpose of the steroid treatment over

Respondent's version is that Petitioner's version conforms to

Respondent's initial description of the purpose of the

treatment. In other words, this is not a case of Respondent's

word against contrary inferences drawn by Petitioner; this is a

case of Respondent's later word against Respondent's earlier

word.

15. The parties do not dispute that, after the initial

meeting to discuss the personal matter, Respondent agreed to

allow M. W. to order anabolic steroids using his DEA number and

at the discounted price charged to OWC. The drugs that

Respondent expressly allowed M. W. to order--and which he

prescribed for her--were Winstrol and, a short while later,

depo-testosterone. Respondent prescribed for M. W. Winstrol

orally at the rate of 2 mg per day, increasing to 10 mg per day

at the end of six weeks, and depo-testosterone by intramuscular

injection, which Respondent administered initially at the rate

of 50 mg every two weeks, increasing to 200 mg every two weeks.

16. The parties do not contest that, in early summer 2009,

M. W. ordered through OWC sufficient Winstrol and Deca-Durabolin

for her weightlifting father and brother, with whom she lived,

to complete one six-week bodybuilding cycle each with these two

anabolic steroids. For her brother, the evidence establishes

that M. W. ordered through OWC additional Winstrol and

sufficient depo-testosterone for him to complete a second six-

week cycle. The evidence is undisputed that M. W. administered

the injections of Deca-Durabolin and depo-testosterone to her

brother, Deca-Durabolin to her father, and Deca-Durabolin to

herself. M. W. probably took additional Winstrol at home. The

evidence is also clear that, in addition to ordering the

Winstrol and depo-testosterone in quantities in excess of the

amount that she was authorized to order and Deca-Durabolin

without any authority whatsoever, M. W. also ordered--without

authorization--Xanax, an anti-anxiety drug, and Soma, a muscle

relaxant, possibly for her own use. Petitioner contends that

Respondent knew or reasonably should have known of these

unauthorized orders, but the evidence that Respondent knew is

nonexistent, and the evidence that he should have known is

insubstantial.

17. There is little, if any, dispute that, unknown to

Respondent, M. W. was using cocaine and heroin--by her own

admission since early 1998. In late July 1999, Respondent was

informed that M. W. had passed out at work. When Respondent

spoke with her about this incident, M. W. admitted to the use of

cocaine and heroin, most recently a couple of weeks earlier.

Respondent immediately withdrew his authorization of M. W. to

order supplies and medications for OWC and immediately

discontinued further steroid treatment.

18. Acting as M. W.'s employer, not physician, Respondent

ordered M. W. to submit to a drug screen for Demerol, which had

been missing from OWC, 2 Valium, and cocaine. Three weeks later,

he received the results, which were positive for cocaine. After

giving M. W. an opportunity to discontinue illegal drug use,

Respondent ordered M. W. to submit to another drug screen for

Demerol, Valium, fentanyl, cocaine, and heroin, and the report,

received in late August, was positive for cocaine and Valium.

19. On September 22, 1999, M. W. was found dead in her

home by her father. The first law enforcement officers

responding to the 911 call reported that they had found a

lifeless male dressed in woman's panties; this mistaken

observation was based on M. W.'s muscularization and shadowy

presence of facial hair. A homicide detective conducting an

initial investigation found large quantities of syringes and

prescription drugs, mostly steroids, in M. W.'s bedroom. He

also found shipping labels and receipts with the names of OWC

and Respondent.

20. The parties have stipulated that the death was

unrelated to steroid use. M. W.'s death was classified as a

natural death. She was 30 years old.

21. In resolving the major factual dispute--i.e., the

purpose of the treatment--the Administrative Law Judge has

assigned considerable weight to Respondent's earlier responses

to law enforcement and regulatory inquiries. In these

responses, Respondent never mentioned transgender treatment or

gender identity disorder, but instead admitted that the

treatment was to enhance athletic performance and to facilitate

bodybuilding.

22. In a written reconstruction of the medical records

done prior to the commencement of this case, Respondent stated

that he was "unable to locate [M. W.'s] chart so I will

reconstruct her chart from memory. Last time chart was seen was

June [19]99 which was given to [her]."

23. The reconstructed chart shows three office visits:

November 7, 1998, March 20, 1999, and June 26, 1999. None of

the reconstructed notes mentions anything about lab work being

ordered, the results of any lab work, or anything about an

injured shoulder and whether it was healing.

24. The entry for November 7 starts: "[Patient] request

being placed on testosterone for body building. States she

. . . is considering Pro-Wrestling." The notes indicate blood

pressure of 118 over 64, pulse of 72, and nothing remarkable

from a basic physical examination. The notes state: "Wants to

body build; requests steroids." The notes report that

Respondent prescribed Winstrol in 2 mg doses and explained the

side effects, and Respondent was going to allow M. W. to order

her steroid medication from the clinic's vendors. This entry

concludes with a note for a followup visit in three months.

25. The entry for March 20, 1999, states that M. W. had no

complaints, reported getting stronger, and was happy with

"bench," meaning bench-pressing, a form of weightlifting. This

note states that M. W. denied experiencing any side-effects and

wanted to add a second steroid: "Request to add Depo-

Testosterone."

26. The entry for June 26, 1999, notes that M. W. "feels

good about herself and her outlook on life is much improved" and

is "continuing to [increase] strength [with] weights." This

note contains findings of a physical exam, including blood

pressure of 124 over 78 and pulse of 72, and the note concludes

that M. W. was doing well and Respondent planned to continue the

same steroid regime.

27. The other time that Respondent discussed the purpose

of the treatment was when he was interviewed by a law

enforcement officer on March 10, 2000, in the presence of

Respondent's attorney. Respondent did not say anything about

transgender treatment or gender identity disorder, and he was

evasive when asked if he were M. W.'s physician. When asked if

M. W. were ever a patient or just an employee, Respondent

responded by referring to the incident when she passed out at

work: "She now when you say she would ah the only time when she

and I were upstairs that day. . . . And when she had the

overdose." The law enforcement officer asked, "And that's like

in August [1999]?" Respondent replied, "Yeah. . . . The

question was and I and I still haven't been able to define that

because she asked me not to tell anybody about her problem with

her drug habits and this type of scenario. So the question is

whether or not she was a, whether or not honestly she was a

patient of mine at that particular point in time." 3

28. Shortly after this exchange, the law enforcement

officer asked Respondent if the steroids that Respondent allowed

M. W. to order through the OWC were for competitive purposes,

such as weightlifting. Respondent replied, "we had a discussion

about her wanting to . . . make it so that her, that she could

work out harder because she was having some problems with her

shoulders and these type of things . . . .." 4

29. These reconstructed records and statements to a law

enforcement officer were not casual statements uttered in an

informal setting. This was information that Respondent provided

to assist in the investigation of the circumstances surrounding

the death of this 30-year-old woman. Except for mention of a

shoulder injury in the last-cited statement--an effort by

Respondent to convert the treatment objective from pure

enhancement of athletic performance to a mix of enhancement of

athletic performance and therapy for some undiagnosed shoulder

injury--the information consistently implies that the treatment

objective was to improve M. W.'s efforts in bodybuilding and

weightlifting. And the mention of the shoulder injury suggests

only that its healing was subordinate to the weightlifting and

bodybuilding. The failure of the reconstructed records to

contain any diagnostic information or progress reports on the

injured shoulder precludes a finding that the treatment

objective was to heal a shoulder injury.

30. Respondent testified about the importance of

confidentiality for his patients, especially M. W., as she was

undergoing "gender transformation." But patient confidentiality

is not an end in itself; it is a means to assuring that the

patient will trust the physician with all relevant information

necessary for diagnosis and treatment. Respondent implied that

the requirement of patient confidentiality somehow trumped the

duty not to affirmatively frustrate investigations into the

death of his employee and patient. This makes no sense.

Respondent's strained "explanation" for creating a misleading

set of medical records yields to the simpler explanation that

Respondent told the truth in these reconstructed records and in

the police interview: Respondent was treating M. W. with

steroids for bodybuilding and wrestling, not for gender

transformation and not for an injured shoulder.

31. These findings are supported by the fact that the

first drug that Respondent prescribed M. W. was Winstrol. The

anabolic effect of a steroid promotes muscularization, and the

androgenic effect of a steroid promotes masculinization.

Because Winstrol produces more anabolic than androgenic effect,

it was long favored by females who wanted to produce muscle

mass, such as for bodybuilding, without masculinization.

Initiating treatment with Winstrol and following with depo-

testosterone is a conventional example of the cyclical use of

steroids for muscularization, not masculinization.

32. One of Respondent's expert witnesses made an

interesting observation based on the misidentification of the

gender of the body of M. W. by the first responders. He

testified that, if Respondent had been ordering the anabolic

steroids for weightlifting and bodybuilding, M. W. must have

been seriously dissatisfied with the masculinization that she

had undergone. However, this observation overlooks the fact

that M. W., without Respondent's knowledge, had administered to

herself unknown quantities of the prescribed anabolic steroids

and Deca-Durabolin. Like Winstrol, Deca-Durabolin is more

anabolic, or muscle-making, than androgenic, or masculinizing--

which is consistent with M. W.'s intent to enhance her athletic

performance and bodybuilding, not change her gender. Although

the first responders observed some facial hair, in addition to

muscularization, nothing in the record suggests that M. W. could

take all of these anabolic steroids in unknown quantities

without experiencing some masculinization, or that she expected

no such masculinization side effects. Under these

circumstances, M. W. could not legitimately have confronted

Respondent over the incidental masculinization that she had

experienced, while self-administered steroids whose main effect

was muscularization, without running the risk that he would

detect her unauthorized ordering of steroids.

33. As noted above, there are no available medical

records. Respondent testified that he gave M. W.'s medical

chart and drug log "VIP" treatment to preserve confidentiality:

Respondent allowed M. W. to keep her medical records and the

drug log pertaining to her medications. Each time M. W.

presented to Respondent, such as for an injection, she brought

with her these files, according to Respondent. Petitioner

contends that these records never existed, and, therefore,

Respondent failed to document that he monitored the effects of

the anabolic steroids that he ordered for M. W. The

Administrative Law Judge credits Petitioner's version of the

situation regarding medical records.

34. At the hearing, Respondent characterized as a mere

"sampling" the medical records that he had initially called a

reconstruction. He implied that the reconstructed medical

records were illustrative of what the records originally

contained. This probably explains how he could reconstruct

blood pressure readings of 118 over 64 and 126 over 78 taken six

and nearly twelve months prior to the reconstruction of the

records. Likely, he recalled that the values were normal and

inserted these readings merely to illustrate his recollection.

35. However, as noted above, these reconstructed records

are significant for their omission of any similar illustrative

reconstructions of an SBC for blood chemistry, SMAC 18 for

electrolytes and kidney and liver function, and lipids for

cholesterol and triglycerides. This lab work is essential, at

the start of a course of treatment with anabolic steroids and

periodically during treatment, to ensure the safety of any

patient, especially when orally ingested anabolics--here,

Winstrol--are administered, due to the possibility of liver

damage. Respondent testified at the hearing that the lab

results were normal, but, unlike his addition of illustrative,

normal values for blood pressure and pulse, Respondent never

added illustrative, normal values for this lab work. This is

because he never ordered such lab work.

36. These lab tests are common in a variety of

circumstances, so they did not require the "VIP treatment" that

Respondent claimed was required for the transgender treatment

plan. However, Respondent never produced medical records or

even lab paperwork, such as test results or invoices,

documenting that these tests had been done. Also, if such

records had existed and Respondent had allowed M. W. to keep

them, one obvious place for them would have been in M. W.'s room

at her home, but Respondent never sent anyone there to look for

them after her death.

37. As to the Standard of Care allegations, Petitioner has

thus proved first, that Respondent prescribed steroids for M. W.

both for muscle building (not to treat an injured muscle) and

for enhancement of athletic performance; and, second, that

Respondent did not order lab work to monitor the effects of the

steroids that he prescribed for M. W.

38. The evidence fails to establish that Respondent ever

undertook the treatment of M. W.'s drug addiction (despite his

statement to the contrary, which has been discredited). The

evidence fails to establish the circumstances out of which a

duty to treat could have arisen, especially within the brief

time frame between Respondent's discovery of her drug problems

and her death.

39. Any evidence relevant to the remaining allegations

within Count One involves the employer-employee relationship,

not the physician-patient relationship, between Respondent and

M. W.

40. As to the medical records violation, Petitioner has

proved that Respondent's medical records failed to adequately

document the monitoring of the effects of anabolic steroids that

Respondent prescribed for M. W. The evidence establishes the

necessity of lab work, at the start and during steroid

treatment, to ensure the safety of the patient. Without this

lab work, documented in the medical records, the course of

steroid treatment is not justified.

41. The evidence fails to establish that Respondent

delegated responsibilities to a person whom Respondent knew or

reasonably should have known was not qualified by training,

experience, or licensure to administered controlled substances

to patients. Drug addiction is not a deficit in training,

experience, or licensure. Even if drug addiction fell within

one of these statutory categories, the evidence fails to

establish any improprieties in M. W.'s administration of

controlled substances to patients, and, even if the evidence

proved such improprieties, the evidence fails to establish that

Respondent knew of M. W.'s drug addiction at a point to have

timely relieved her of her duties, or that Respondent reasonably

should have known of M. W.'s drug addiction in time to do

anything about it. To the contrary, Respondent's termination of

these responsibilities of M. W. appears to have been timely.

42. Petitioner has proved that Respondent prescribed and

administered controlled substances--i.e., anabolic steroids--for

muscle building, not the treatment of an injured muscle, and for

enhanced athletic performance.

43. Respondent has previously been disciplined. By Final

Order entered on December 18, 2007, in DOAH Case No. 06-4288PL,

the Board of Medicine imposed one year's suspension, a $10,000

fine, and three years' probation for failing to perform a third-

trimester abortion in a hospital and failing to obtain the

written certifications of two physicians of the necessity for

the procedure; committing an associated medical-records

violation; and committing a Standard of Care violation for

failing to perform a third-trimester abortion in a hospital.

Respondent's acts and omissions occurred in 2005. The Fifth

District Court of Appeal affirmed the Final Order in Pendergraft

v. Department of Health, Board of Medicine , 19 So. 3d 392 (Fla.

5th DCA 2009).

44. By Final Order entered on January 28, 2010, in DOAH

Case No. 08-4197PL, the Board of Medicine imposed two years'

suspension, a $20,000 fine, and three years' probation for

committing a Standard of Care violation for failing to a advise

subsequent treating physicians that he had removed a portion of

a patient's fetus and an associated medical-records violation.

Respondent's acts and omissions occurred in 2006.

45. Although Respondent has been disciplined prior to this

recommended order, the acts and omissions in this case took

place several years prior to the acts and omissions in the two

cases described immediately above.

CONCLUSIONS OF LAW

46. The Division of Administrative Hearings has

Fla. Stat. (2009).

47. Petitioner must prove the material 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).

48. Section 458.331(1), Florida Statutes (1998), provides,

in relevant part:

(1) The following acts shall constitute

grounds for which the disciplinary actions

specified in subsection (2) may be taken:

* * *

(m) Failing to keep legible, as defined

by department rule in consultation with the

board, medical records that identify the

licensed physician or the physician extender

and supervising physician by name and

professional title who is or are responsible

for rendering, ordering, supervising, or

billing for each diagnostic or treatment

procedure and that justify the course of

treatment of the patient, including, but not

limited to, patient histories; examination

results; test results; records of drugs

prescribed, dispensed, or administered; and

reports of consultations and

hospitalizations.

* * *

(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 which is

recognized by a reasonably prudent similar

physician as being acceptable under similar

conditions and circumstances. . . . As used

in this paragraph, "gross malpractice" or

"the failure to practice medicine with that

level of care, skill, and treatment which is

recognized by a reasonably prudent similar

physician as being acceptable under similar

conditions and circumstances," shall not be

construed 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 disciplined pursuant

to this paragraph.

* * *

(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.

* * *

(ee) Prescribing, ordering, dispensing,

administering, supplying, selling, or giving

growth hormones, testosterone or its

analogs, human chorionic gonadotropin (HCG),

or other hormones for the purpose of muscle

building or to enhance athletic performance.

For the purposes of this subsection, the

term "muscle building" does not include the

treatment of injured muscle. . . .

49. As noted above, the Administrative Law Judge limited

the Standard of Care allegations in two respects. First, the

allegation in paragraph g of Count One attempts to recast a

medical records violation as a Standard of Care violation. This

interpretation of these two statutory subsections was rejected,

in the context of the practice of dentistry, in Barr

v. Department of Health, Board of Dentistry , 954 So. 2d 668

(Fla. 1st DCA 2007).

50. Second, the Administrative Law Judge limited the scope

of proof that would be admissible to prove the allegations in

paragraphs d, e, and f of Count One because a Standard of Care

violation applies only to the practice of medicine and not to

other acts and omissions of the licensee. Section 458.305(3),

Florida Statutes (1998), provides: "'Practice of medicine'

means the diagnosis, treatment, operation, or prescription for

any human disease, pain, injury, deformity, or other physical or

mental condition." In this case, the evidence supporting these

three paragraphs of Count One pertained exclusively to

Respondent's employment or managerial practices involving M. W.

as an employee, not the practice of medicine with respect to

M. W. as a patient, so Petitioner has failed to prove the

Standard of Care violations alleged in these three paragraphs.

51. As to paragraph a of Count One, Petitioner has proved

that Respondent prescribed anabolic steroids to M. W. without

medical indication. Section 458.331(1)(ee) prohibits the use of

anabolic steroids to build muscle, except to treat injured

muscle, or to enhance athletic performance. Any prescription of

anabolic steroids in violation of this statute thus cannot be

medically indicated. The exception applies to building muscle,

not athletic performance. To the extent that M. W. sought

anabolic steroids for weightlifting, which is athletic

performance, not muscle building, the injured-muscle exception

is unavailable to Respondent. However, as noted in the findings

of fact, Petitioner proved that Respondent did not prescribe

anabolic steroids to heal an injured muscle.

52. The problem with paragraph a of Count One is that is

it mispleaded, under Barr . The prescription of anabolic

steroids under these circumstances violates Section

458.331(1)(ee), so it does not constitute a Standard of Care

violation under the reasoning of Barr .

53. As to paragraph b of Count One, Petitioner has proved

that the failure to order lab work to monitor the effects of the

anabolic steroids is a Standard of Care violation. Respondent

testified that he ordered the lab work, and he was treating

M. W. for gender identity disorder. The Administrative Law

Judge is free to disbelieve unrebutted testimony of a physician.

Fox v. Department of Health , 994 So. 2d 416 (Fla. 1st DCA 2008)

(dictum). But see Reich v. Department of Health , 973 So. 2d

1233 (Fla. 4th DCA 2008) (Administrative Law Judge's

discrediting of physician's testimony describing additional

medical records reversed due to lack of competent substantial

evidence). In this case, as noted above, Respondent himself

provided contrary evidence, prior to the commencement of this

case, that is consistent with Petitioner's version of events.

54. The failure to order lab work is distinct from the

medical records violation discussed below because a practitioner

could order the lab work, but fail to document it. In this

case, though, where the physician fails to order and document

the lab work, there is considerable overlap between the

offenses, which must be considered when determining the

appropriate penalty.

55. As to paragraph c of Count One, the evidence has

failed to prove that Respondent violated the Standard of Care by

failing to treat M. W.'s drug addiction for the reasons stated

above.

56. As to Count Two, Petitioner has proved a medical

records violation because Respondent failed to document

adequately the effects of the anabolic steroids--specifically,

by failing to document the results of the lab work that must be

performed when administering anabolic steroids under these

circumstances. This is a failure to justify the course of the

steroid treatment that Respondent pursued with M. W.

57. As to Count Three, the evidence fails to establish an

improper delegation of professional responsibilities to M. W.

for the reasons stated above.

58. As to Count Four, Petitioner has proved that

Respondent prescribed and administered anabolic steroids without

medical indication because he did so for building muscles and

enhancing athletic performance. The question is whether

Respondent prescribed and administered these controlled

substances other than in the course of his professional

practice.

59. As Respondent contends, Rogers v. Department of

Health , 920 So. 2d 27 (Fla. 1st DCA 2005), requires an element

of illicitness for a determination that the prescription or

administration is not in the course of the physician's

professional practice. Section 458.331(1)(ee) supplies this

element. The holding in Barr does not require a contrary

result. Here, Section 458.331(1)(ee) has supplied the element

of illicitness necessary to find a violation of Section

458.331(1)(q). The illicit nature of an act or omission may be

derived from any statute, so this situation is different from

merely recasting a medical record violation as Standard of Care

violation, at least where Petitioner has not pleaded a Section

458.331(1)(ee) violation.

60. Section 458.331(2), Florida Statutes (1998), states:

When the board finds any person guilty of

any of the grounds set forth in subsection

(1), . . . it may enter an order imposing

one or more of the following penalties:

* * *

(b) Revocation or suspension of a license.

(c) Restriction of practice.

(d) Imposition of an administrative fine

not to exceed $5,000 for each count or

separate offense.

(e) Issuance of a reprimand.

(f) Placement of the physician on probation

for a period of time and subject to such

conditions as the board may specify,

including, but not limited to, requiring the

physician to submit to treatment, to attend

continuing education courses, to submit to

reexamination, or to work under the

supervision of another physician.

(g) Issuance of a letter of concern.

(h) Corrective action.

(i) Refund of fees billed to and collected

from the patient.

In determining what action is appropriate,

the board must first consider what sanctions

are necessary to protect the public or to

compensate the patient. Only after those

sanctions have been imposed may the

disciplining authority consider and include

in the order requirements designed to

rehabilitate the physician. All costs

associated with compliance with orders

issued under this subsection are the

obligation of the physician.

61. Legislation raising the maximum fine from $5000 to

$10,000, became effective July 1, 1999. 5 However, absent an

explicit provision in the new legislation for retroactive

application, courts will not retroactively apply a new penalty.

McGann v. Florida Elections Commission , 803 So. 2d 763 (Fla. 1st

DCA 2001). Thus, in this case, the statute authorizes a fine of

no more than $5000 per count or offense.

62. As in effect from May 14, 1998, through December 26,

1999, Florida Administrative Code Rule 64B8-8.001 provides:

(1) Purpose. Pursuant to Section 2, Chapter

86-90, Laws of Florida, the Board provides

within this rule disciplinary guidelines

which shall be imposed upon . . . licensees

whom it regulates under Chapter 458, F.S.

The purpose of this rule is to notify . . .

licensees of the ranges of penalties which

will routinely be imposed unless the Board

finds it necessary to deviate from the

guidelines for the stated reasons given

within this rule. The ranges of penalties

provided below are based upon a single count

violation of each provision listed; multiple

counts of the violated provisions or a

combination of the violations may result in

a higher penalty than that for a single,

isolated violation. Each range includes the

lowest and highest penalty and all penalties

falling between. The purposes of the

imposition of discipline are to punish the

. . . licensees for violations and to deter

them from future violations; to offer

opportunities for rehabilitation, when

appropriate; and to deter other . . .

licensees from violations.

63. Former Florida Administrative Code Rule

64B8-8.001(2)(m) punishes a medical records violation with a

reprimand to two years' suspension followed by probation and a

fine of $250-$5000. Former Florida Administrative Code Rule

64B8-8.001(2)(q) punishes inappropriate prescribing with one

year's probation to revocation and a fine of $250-$5000. Former

Florida Administrative Code Rule 64B8-8.001(2)(t)3. punishes a

Standard of Care violation with two years' probation to

revocation and a fine of $250-$5000.

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

establishes various aggravating and mitigating circumstances,

such as the degree of exposure of the patient or public to

injury or death, the legal status of the licensee at the time of

the offenses, the number of counts or separate offenses proved,

the number of times the same offenses have been committed by the

licensee previously, the licensee's disciplinary history, and

any pecuniary benefit inuring to the licensee.

65. Based on Respondent's entire disciplinary record,

these are his first offenses. At least six years after these

offenses, Respondent committed the acts and omissions in 2005

and 2006 that resulted in the disciplinary proceedings described

above. To treat the 1998 and 1999 offenses as subsequent

offenses strains the notion of notice mentioned in the above-

cited portion of Former Rule 64B8-8.001(1). Petitioner selected

the order in which to prosecute these three cases, and its

choice does not transform the acts and omissions of 1998 and

1999 into a third offense. Cf. Department of Public Safety v.

Mitchell , 152 So. 2d 764 (Fla. 3d DCA 1963). A disciplinary

rule must be construed against the agency due to the penal

nature of the disciplinary proceeding. Colbert v. Department of

Health , 890 So. 2d 1165 (Fla. 2004). However, the language of

the rule permits consideration of Respondent's disciplinary

history, as distinguished from the number of times he has

committed the same offenses, as an aggravating factor, so the

other discipline is an aggravating factor, even though the

present offenses must be considered a first offense.

66. Although M. W.'s drug addiction and death cannot be

linked in any way to the acts and omissions of Respondent, the

potential for injury to M. W. was at least moderate when

Respondent prescribed anabolic steroids for bodybuilding and

weightlifting without ordering lab work. On these facts, as

noted above, the failure to document the lab results is

essentially duplicative of the Standard of Care violation

arising from the failure to order these tests, so, in

determining an appropriate penalty, Respondent is essentially

guilty only of a Standard of Care violation and a violation of

the inappropriate prescription of steroids.

67. If this were a case in which increasingly serious

discipline had failed to produce corrective behavior, the

Administrative Law Judge would recommend revocation, but a less

harsh penalty is indicated due to the first-offense status of

these acts and omissions. On the other hand, the risk of injury

and, somewhat contradictorily, the disciplinary history require

a significant penalty.

RECOMMENDATION

It is

RECOMMENDED that the Board of Medicine enter a Final Order

finding Respondent guilty of violations of Section

458.331(1)(m), (t), and (q), Florida Statutes (1998), and

suspending his license for one year followed by three years'

probation, imposing a fine of $10,000, and assessing costs as

provided by law.

DONE AND ENTERED this 8th day of June, 2010, in

Tallahassee, Leon County, Florida.

___________________________________

ROBERT E. MEALE

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

[phone] SUNCOM 278-9675

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 8th day of June, 2010.

ENDNOTES

1 . After setting the case for final hearing January 7-11, 2008,

the first Administrative Law Judge disqualified herself by Order

entered December 7, 2007. On December 27, 2007, the new

Administrative Law Judge granted a motion for continuance filed

by Respondent, and reset the hearing for April 22-25, 2008. On

April 1, 2008, Respondent filed a Motion to Continue Formal

Hearing due to the need for more time for discovery, and

Petitioner supported the motion. On April 3, 2008, the second

Administrative Law Judge abated the case.

Based on joint status reports filed May 2, 2008, and June 27,

2008, the Administrative Law Judge extended the abatement. By

joint status report filed October 2, 2008, Petitioner objected

to Respondent's claim that the abatement needed to be extended a

third time. After a conference call, the Administrative Law

Judge extended the abatement 30 days. On November 7, 2008, the

parties filed another joint status report, disagreeing again on

whether the case was ready to be set for hearing. After a

conference call, the Administrative Law Judge extended the

abatement about five weeks and transferred the case to a third

Administrative Law Judge.

On December 12, 2008, the parties filed a joint status report,

in which Petitioner reported that the prior delays were due to

the inability of the parties to obtain the cooperation of the

U.S. Department of Justice, Drug Enforcement Administration,

which had recently responded to a subpoena. Respondent claimed

that the case was not ready for hearing because the Drug

Enforcement Administration had not agreed to a deposition of any

of its agents or investigators.

After a conference call on January 12, 2009, the Administrative Law Judge scheduled the case for final hearing on

June 16-19, 2009. On May 28, 2009, Petitioner filed a Motion to

Reschedule Final Hearing, and Respondent joined in the motion.

After a conference call on June 1, 2009, the Administrative Law

Judge continued the hearing to September 15-18, 2009. On

September 1, 2009, Respondent filed a Motion for Brief

Continuance, based on problems in arranging a deposition of a

Drug Enforcement Administration agent. On September 2, 2009,

the Administrative Law Judge conducted a conference call, and,

the next day, issued an Order continuing the final hearing to

December 8-11, 2009.

On October 26, 2009, Respondent filed a Motion to Disqualify the Administrative Law Judge on the ground that he had issued a

recommended order on September 21, 2009, in a different

disciplinary case involving Respondent and had rejected certain

testimony of Respondent as not credible. On the same day, the

Administrative Law Judge granted the motion and the undersigned

Administrative Law Judge was assigned the case at that time.

On November 20, 2009, Respondent filed an Unopposed Motion for

Continuance due to discovery problems. After a conference call

on November 23, 2009, the Administrative Law Judge issued an

Order Granting Continuance on November 24, 2009, and reset the

final hearing for January 11-15, 2010.

2 . By stipulation, there is no evidence that M. W. took the

Demerol from OWC.

3 . Petitioner Exhibit 5, p. 71.

4 . Petitioner Exhibit 5, p. 72.

5 . Chap. 99-397, Laws of Fla. § 99. This provision became

effective July 1, 1999. Chap. 99-397 Laws of Fla. § 208.

COPIES FURNISHED:

R. S. Power, Agency Clerk

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399-1701

Josefina M. Tamayo, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399-1701

Dr. Ana M. Viamonte Ros, Secretary

State Surgeon General

Department of Health

4052 Bald Cypress Way, Bin A00

Tallahassee, Florida 32399-1701

Larry McPherson, Jr., Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399

Kenneth J. Metzger

Metzger & Associates, P.A.

1637 Metropolitan Boulevard, Suite C-2

Tallahassee, Florida 32308

Sharon B. Roberts, Esquire

Strawn & Monaghan, P.A.

54 Northeast Fourth Avenue

Delray Beach, Florida 33483

Kathryn L. Kasprzak, Esquire

2826 Osprey Creek Lane

Orlando, Florida 32825

Greg S. Marr, Esquire

Assistant General Counsel

Department of Health

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399-3265

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

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

to this Recommended Order should be filed with the agency that

will issue the Final Order in this case.