00-004747PL Department Of Health, Board Of Medicine vs. Leland M. Heller, M.D. Status: Closed Recommended Order on Tuesday, June 12, 2001.

Summary: Petitioner failed to prove that Respondent physician failed to practice medicine with requisite level of care, inappropriately prescribed excessive quantities of medications, and failed to keep medical records that justified treatment decisions.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 00-4747PL

)

LELAND M. HELLER, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

The parties having been provided proper notice,

Administrative Law Judge John G. Van Laningham of the Division

of Administrative Hearings convened a formal hearing of this

matter in Okeechobee, Florida, on March 13, 2001. The hearing

was adjourned on March 14, 2001.

APPEARANCES

For Petitioner : Eric S. Scott, Esquire

John E. Terrel, Esquire

Agency for Health Care Administration

Post Office Box 14229

Tallahassee, Florida 32317-4229

For Respondent : Monica L. Felder, Esquire

Sean M. Ellsworth, Esquire

Dresnick, Ellsworth & Felder, P.A.

201 Alhambra Circle, Suite 701

Coral Gables, Florida 33134-5108

STATEMENT OF THE ISSUES

The issues in this case relate to whether Respondent is

guilty of charges that Petitioner has brought against him under

Sections 458.331(1)(t), (q), and (m), Florida Statutes, based on

allegations that in treating a young patient, Respondent failed

to practice medicine with the requisite level of care;

inappropriately prescribed excessive quantities of medications;

and failed to keep medical records that justified his treatment

decisions.

PRELIMINARY STATEMENT

On September 28, 2000, Petitioner Department of Health (the

"Department") filed a three-count Administrative Complaint

against Respondent Leland M. Heller, M.D. ("Dr. Heller"). In

this charging document, the Department accused Dr. Heller of

having committed several offenses which, if proved, would

warrant the suspension or revocation of his medical license, the

imposition of an administrative fine, other discipline such as

probation, or some combination of these or other penalties.

The charges stemmed from Dr. Heller's treatment of a young

child named J.B. during a 36-day period in the autumn of 1998.

Succinctly stated, the Department alleged that in treating this

boy Dr. Heller had failed to practice medicine with the level of

care, skill, and treatment recognized by a reasonably prudent

similar physician as being acceptable under similar conditions

and circumstances; prescribed legend drugs other than in the

course of his professional practice; and failed to keep legible

medical records that justified the course of his treatment of

J.B. Dr. Heller disputed the factual allegations and demanded

an administrative hearing, signing an Election of Rights form on

October 9, 2000.

On November 27, 2000, the Department referred the matter to

the Division of Administrative Hearings for further proceedings.

Thereafter, in due course, a final hearing took place, as

scheduled, on March 13 and 14, 2001.

At hearing, the Department called two witnesses : J.B.'s

kindergarten teacher, Mrs. Glenda McBride; and, as its medical

expert, Morteza Nadjafi, M.D. The Department also proffered

four exhibits, each of which was received into evidence :

Dr. Heller's licensure file (Petitioner's Exhibit 1);

Dr. Heller's license certification (Petitioner's Exhibit 2);

Dr. Nadjafi's curriculum vitae (Petitioner's Exhibit 3); and

Dr. Heller's medical records for J.B. (Petitioner's Exhibit 4).

Dr. Heller presented two expert witnesses through their

videotaped depositions. Each of his four exhibits, all of which

related to these depositions, was admitted into evidence. They

are : the videotape and transcript of the deposition of

Dr. Joseph Talley (Respondent's Exhibit 1); Dr. Talley's

curriculum vitae (Respondent's Exhibit 2); the videotape and

transcript of Dr. David Rooney's deposition (Respondent's

Exhibit 3); and Dr. Rooney's curriculum vitae (Respondent's

Exhibit 4).

At the final hearing, Dr. Heller moved to strike the

testimony of the Department's expert witness, Dr. Nadjafi, on

the ground that, as a board-certified psychiatrist, he is not a

"similar physician" to family practitioner Dr. Heller, and

therefore is legally incompetent to offer an opinion against

Dr. Heller regarding the applicable standard of care under

Section 458.331(1)(t), Florida Statutes. The Administrative Law

Judge denied this motion, reasoning that Dr. Nadjafi's specialty

affected the weight rather than the admissibility of his

testimony, but granted the parties leave to file post-hearing

memorandums on the subject, in view of its significance. Each

side timely submitted a memorandum, and these were carefully

reviewed. Being fully advised, the undersigned is satisfied

that Dr. Nadjafi possessed sufficient expertise in Dr. Heller's

specialty so as to render an opinion on the prevailing standard

of care, see Section 766.102(2)(c )2., Florida Statutes, and thus

there exist no grounds for reconsidering the ruling made at

hearing.

The Transcript of the final hearing was filed with the

Division on April 24, 2001. The parties timely filed proposed

recommended orders that were considered thoughtfully in the

preparation of this Recommended Order.

FINDINGS OF FACT

The evidence presented at final hearing established the

facts that follow.

1. Dr. Heller is a Florida-licensed physician who holds

license number ME 0036675. A family practitioner in the small,

rural community of Okeechobee, Florida, Dr. Heller is board-

certified by the American Board of Family Practice.

I. Dr. Heller's Treatment of J.B.

2. On Monday, August 31, 1998, a mother brought her son

J.B., then age five, to Dr. Heller's office. This visit was the

first of six to Dr. Heller that J.B. and his mother would make

over the next six weeks; five of those visits would take place

in the 17 days from August 31 to September 16, 1998. This case

is about Dr. Heller's treatment of J.B.

A. First Week

3. In taking J.B.'s medical history on August 31, 1998,

Dr. Heller learned that from before the age of two the boy had

presented behavioral problems and been difficult to control.

When he was three years old, J.B. had been treated at a

psychiatric hospital. Now J.B. was having difficulty paying

attention in school, experiencing mood swings, and becoming

easily irritated; he had been violent at home, too.

4. Dr. Heller discussed with J.B.'s mother the medications

J.B. was currently taking, as well as the medications that J.B.

had tried in the past, to determine whether those medications

had been effective in controlling J.B.'s behavior. Dr. Heller

learned that J.B. was currently taking ten milligrams of

Adderall in the morning. 1 He noted that although the Adderall

was not particularly effective, J.B.'s behavior worsened when

the Adderall wore off. Additionally, J.B.'s mother had stopped

giving her son his afternoon dose of Adderall because the

medicine apparently suppressed his appetite, and he would not

eat when taking it. J.B.'s mother also informed Dr. Heller that

J.B. had taken Risperdal in the past, and this drug had helped a

great deal. 2 She believed he had taken 0.5 milligrams of

Risperdal twice a day. J.B. had never taken Prozac. 3

5. During the visit, Dr. Heller talked with J.B. and

observed his behavior. Pertinent parts of this discussion and

evaluation are included in the doctor's notes. Dr. Heller

recorded that J.B. was thin and extremely hyperactive. The

child would not sit still for any length of time. J.B. also had

difficulty speaking clearly, and his mother confirmed that he

had speech and language delays. Dr. Heller wrote that J.B.'s

reaction to any criticism was to want to hit someone.

6. After interviewing J.B.'s mother and examining J.B.,

Dr. Heller diagnosed J.B. preliminarily with several behavioral

and mental health problems, namely, attention-deficit

hyperactivity disorder ("ADHD"), problems with violence,

depression, rejection sensitivity, and possible dysthymia. He

believed that J.B. might be bipolar and had concerns about the

patient's low weight, which appeared to have been caused by

Adderall. He thought that the boy might have some combination

of hearing, speech, and language problems as well.

7. To control J.B.'s violent behavior, Dr. Heller started

J.B. on 0.5 milligrams of Risperdal, twice a day, the same dose

his mother recalled he had taken previously. Although Risperdal

is often used as an anti-psychotic agent, it is also helpful in

controlling violent behavior.

8. Dr. Heller continued J.B. on the same amount of

Adderall that the boy was already taking, to improve his

attention in class; prescribed Prozac for J.B., ten milligrams

daily for five days to be followed by ten milligrams daily for

five more days, to treat the child's depression and mood swings;

and instructed J.B.'s mother to bring the boy back after eight

days for another examination.

9. On Wednesday, September 2, 1998, J.B. developed a mild

dystonic reaction for which he was treated with Benadryl at a

local hospital's emergency room and sent home. An unwanted but

tolerable side effect of certain drugs, a dystonic reaction is

an involuntary, potentially dangerous, sometimes painful

contraction of the muscles, usually affecting the upper neck but

occasionally striking other parts of the body. Risperdal most

likely had caused J.B.'s reaction.

10. Based on the symptoms commonly associated with

dystonic reactions——not to mention that J.B. was taken to the

emergency room——the event must have frightened the boy and his

family. There is no evidence, however, that J.B. was either in

pain or in danger from this distressing side effect. When

Dr. Heller was informed that day of his patient's condition and

emergency treatment therefor, he scheduled an office visit with

the child for the next day.

11. On September 3, 1998, J.B.'s mother brought J.B. to

Dr. Heller's office as recommended to discuss the dystonic

reaction. Despite Risperdal's side effect, the drug was working

well, J.B.'s mother reported, and the patient " look[ed] much

better" to Dr. Heller. He also noted that the "[c ]hild like[d]

taking Prozac, [which was] helping him a lot." Dr. Heller

decided to continue the boy on these medicines plus the Adderall

at the same dosages, and to add Cogentin, 0.5 milligrams twice a

day, to control the dystonic reactions. 4

12. Later that afternoon, J.B. returned to Dr. Heller's

office complaining of weakness and nosebleeds. In response,

Dr. Heller reduced J.B.'s morning dose of Risperdal to 0.25

milligrams and prescribed neosynephrine for the nose bleeds.

B. Second Week

13. Informed by telephone a few days later, on Sunday,

September 6, 1998, that J.B.'s nosebleeds had re-occurred,

Dr. Heller again advised using neosynephrine and applying

pressure——neither of which had yet been tried.

14. Dr. Heller saw J.B. in his office the following

Wednesday, September 9, 1998. He observed that the child seemed

better behaved and had shown some improvement on Risperdal.

During this visit, J.B.'s mother suggested that her son try

Ritalin instead of Adderall, telling Dr. Heller that J.B. had

done better with Ritalin in the past. Acting on this

information, Dr. Heller prescribed slow-release Ritalin, 20

milligrams twice a day, in the place of Adderall. Because J.B.

had not suffered another dystonic reaction——evidently the

Cogentin was doing its job——Dr. Heller continued J.B. on

Cogentin at 0.5 milligrams, twice a day, and instructed the boy

to resume taking the originally-prescribed amount of Risperdal :

0.5 milligrams twice a day. He also directed that J.B.'s Prozac

be increased to 20 milligrams daily. Dr. Heller asked J.B.'s

mother to bring him back to the office in two weeks.

C. Third Week

15. Five days later, on Monday, September 14, 1998,

Dr. Heller saw J.B. again. His mother reported that J.B. was

doing much better in school——apparently the Ritalin was

helping——but he remained angry with and "hateful” to her at

home. J.B. himself told Dr. Heller that his mother

" irritate[d]” him. Armed with this data, Dr. Heller increased

J.B.'s evening dose of Risperdal from 0.5 milligrams to 1.5

milligrams, continuing him on 0.5 milligrams of the drug in the

morning. Dr. Heller also increased J.B.'s morning dose of

Ritalin from 20 milligrams to 40 milligrams, while keeping the

second dose constant at 20 milligrams. He continued J.B. on the

same dosages of Prozac and Cogentin. Finally, Dr. Heller

recommended family counseling and requested to see the boy again

in two days.

16. When Dr. Heller next examined J.B. on Wednesday,

September 16, 1998, the patient's mother reported that J.B. was

doing better in school on the higher morning dose of Ritalin but

was still having problems at home. Dr. Heller observed that the

boy was poorly behaved but under control. He decided to stay

the course and continue J.B. on the present combination of

medicines, at existing dosages, with instructions to return

after one month.

D. Fourth and Fifth Weeks

17. J.B. was not brought to Dr. Heller's office during the

weeks of September 20 and September 27, 1998.

E. Sixth Week

18. Dr. Heller saw J.B. again on Monday, October 5, 1998.

At this time, J.B. was reportedly doing well in school but not

at home, where, according to his mother, J.B. expressed "[l ]ots

of anger towards [his] father"——to the point that she feared the

father's visit at Christmas. J.B. had stopped taking his

evening dose of Risperdal. The boy was still having some

nosebleeds, and he had a rapid heartbeat. His psychological and

behavioral problems continued, although his violent behavior was

under control.

19. J.B.'s mother gave Dr. Heller a note from Mrs. Glenda

McBride, J.B.'s teacher, in which Mrs. McBride had conveyed her

concerns about J.B.'s failure to eat at school and his

depressive behavior. To stimulate J.B.'s appetite, Dr. Heller

prescribed Sinequan——which is an antidepressant that, as a side

effect, can increase the user's appetite——at a dose of 25

milligrams, twice a day. He asked to see J.B. in three weeks.

20. As it happened, however, the October 5, 1998, visit

was J.B.'s last to Dr. Heller's office. Around that time, the

Florida Department of Children and Families ("DCF") became

involved, apparently at the instance of J.B.'s older brother, a

prison inmate who had accused their mother of overmedicating the

boy. The record is empty of substantial competent evidence

concerning DCF's investigation, findings, or interventions, if

any. What is clear, however, is that J.B.'s physician-patient

relationship with Dr. Heller abruptly ended.

21. At hearing, J.B.'s kindergarten teacher recounted an

out-of-court statement by the boy's mother informing her that

J.B. had been taken off all medications except Ritalin effective

October 6, 1998. After that date, according to Mrs. McBride,

the child improved visibly in the classroom, where she had the

opportunity to observe him until the end of January 1999, when

J.B. moved away. The trier accepts Mrs. McBride's testimony as

far as it goes——which is not as far as the Department would take

it.

22. Specifically, neither Mrs. McBride's testimony nor any

other evidence clearly and convincingly establishes that

Dr. Heller's treatment of J.B. either failed, was deleterious,

or would not have brought about an improvement in J.B.'s

condition similar to that witnessed by Mrs. McBride if J.B. had

remained in Dr. Heller's care beyond October 5, 1998. For one

thing, Mrs. McBride's second-hand testimony regarding the

purported change in J.B.'s mix of medicines as of October 6,

1998, is not, by itself, clear and convincing evidence of that

fact; and, there was no persuasive direct evidence—— e.g. the

testimony of J.B.'s next treating physician——to corroborate her

account or to explain what subsequent care and treatment, if

any, were rendered. For another, there are any number of

reasons unrelated to medical care that could have caused or

contributed to J.B.'s improvement which are not excluded by or

inconsistent with the evidence in the record. 5 In sum, the trier

expressly does not find, and affirmatively rejects any

inference, that DCF "rescued" J.B. from Dr. Heller.

II. The Charges

23. In Count One of its Administrative Complaint, the

Department accused Dr. Heller of failing to practice medicine

with the requisite degree of care and skill, in violation of

Section 458.331(1)(t), Florida Statutes, in four specific

respects: (a) inappropriately prescribing excessive doses of

medicine to J.B.; (b) failing to take a baseline

electrocardiogram ("EKG”) for J.B.; (c) failing to consult a

family therapist or counselor for J.B.; and (d) failing to note

in J.B.'s medical records information regarding the mental

status examination of J.B. or any observations of his behavior

in the office. At hearing, however, the Department withdrew the

allegation that Dr. Heller had negligently failed to order an

EKG. Further, the Department's own expert testified that

Dr. Heller's alleged failure to consult with a family therapist

was not a breach of the standard of care; needless to say,

Dr. Heller's experts agreed. Thus, the alleged negligent acts

described in (a) and (d) above are the ones that remain in

dispute. 6

24. In Count Two, the Department charged Dr. Heller with

prescribing legend drugs other than in the course of his

professional practice, in violation of Section 458.331(1)(q),

Florida Statutes, based on the following allegations:

a. On or about August 31 and September 9,

1998, [Dr. Heller] ordered an automatic 10

mg. increase in Patient J.B.'s Prosac [sic]

prescription without allowing an appropriate

amount of time for the medicine to take

effect

b. On or about September 14, 1998, [Dr.

Heller] increased Patient J.B.'s morning

dose of Ritalin from 20 mg. to 40 mg. in one

jump;

c. From on or about August 31, 1998 to on

or about September 14, 1998, [Dr. Heller]

increased Patient J.B.'s dose of Risperdal

to a total of 2 mg. a day despite the fact

that Patient J.B. suffered an earlier

dystonic reaction;

d. On or about October 5, 1998, [Dr.

Heller] prescribed Sinnequan [sic] to

Patient J.B. in an effort to increase his

appetite despite the fact that Patient J.B.

was already suffering from the side effects

of his other medications;

e. From on or about August 31, 1998 to on

or about October 8, 1998, [Dr. Heller]

prescribed excessive doses of multiple

medications without regard for the

interactions and side effects of the high

doses on Patient J.B.

At hearing, the Department withdrew the allegation, set forth in

(a) above, regarding the purportedly excessive increase in

J.B.'s Prozac.

25. The Department alleged in Count Three of its

Administrative Complaint that Dr. Heller had violated Section

458.331(1)(m), Florida Statutes, by failing to keep medical

records that justified the following alleged misconduct:

(a) his prescribing of excessive doses and multiple medications

to J.B.; (b) his failure to take a baseline EKG for J.B.; (c)

his failure to consult a family therapist; and (d) his failure

to note in J.B.'s medical records information regarding the

mental status examination of J.B. or any observations of the

patient's behavior in the office. For the reasons set forth in

paragraph 23 above, the records dispute has boiled down to the

alleged deficiencies described in the foregoing clauses (a) and

(d).

III. The Standard of Care

26. At hearing, the Department agreed that the standard of

care against which Dr. Heller's conduct must be measured is that

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

reasonably prudent family practitioner as being acceptable under

similar conditions and circumstances. The Department disavowed

any intent to hold Dr. Heller to the standard of care governing

psychiatrists .

27. In its proposed recommended order, however, the

Department has asserted that Dr. Heller provided psychiatric

treatment to J.B., and that, consequently, a board-certified

child psychiatrist should be considered a "similar health care

provider.” This contention is somewhat, if not entirely,

inconsistent with the stipulation at hearing regarding the

applicable standard of care ; at the very least, it muddies the

water.

28. The greater weight of the evidence shows that mental

illnesses and behavioral problems such as J.B.'s are conditions

that reasonably fall within the discipline of family practice,

and that specialists such as Dr. Heller may appropriately

diagnose and treat the mentally ill without thereby engaging in

the specialized practice of psychiatry. 7 As a matter of fact,

therefore, the relevant standard of care in this case is that

applicable to small-town family practitioners.

29. The evidence regarding the appropriate standard of

care is in conflict. The Department's expert, Dr. Morteza

Nadjafi, is a board-certified child psychiatrist who practices

in the large city of Orlando, Florida. Based primarily on the

medical records that Dr. Heller prepared and without having

discussed the case with Dr. Heller himself, Dr. Nadjafi found

much to criticize in Dr. Heller's treatment of J.B. Broadly

speaking, it is Dr. Nadjafi's opinion that, in caring for——and

in documenting his treatment of——J.B., Dr. Heller repeatedly

fell short of the minimal standard of care for any physician,

irrespective of specialty.

30. On the other hand, Dr. Heller's experts opined that

Respondent treated J.B. with the requisite level of care

expected of a reasonably prudent family practitioner. They

were : Dr. Joseph Talley, author of a textbook entitled Family

Practitioner's Guide to the Treatment of Depressive Illnesses

that was favorably reviewed in the New England Journal of

Medicine , a board-certified family practitioner who regularly

treats mentally ill patients in the small North Carolina town

where he works; and Dr. David Rooney, a board-certified

psychiatrist who presently specializes in treating adults and

geriatric patients, whose background includes a one-year, post-

graduate internship in family practice that was followed by

about a year's employment as a family practitioner in a rural

community in Iowa.

31. As the trier of fact and arbiter of credibility, the

Administrative Law Judge must resolve the evidential conflict

regarding the acceptable degree of care and Dr. Heller's failure

or success in practicing with it. Accordingly, the trier has

carefully considered the substance and foundations of the

several experts' opinions as well as their respective demeanors,

testimonial inconsistencies, and possible biases, ultimately

determining the appropriate weight to be given each witness's

testimony. On balance, all factors considered, the trier

believes that Dr. Heller's witnesses painted a more accurate

picture of the relevant standard of care. 8 Of the three experts,

Dr. Talley's testimony was the most persuasive because his

specialty, community, and practice are the most similar to

Dr. Heller's.

IV. Ultimate Factual Determinations

32. In treating J.B., Dr. Heller did not fail 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. To the

contrary, Dr. Heller's care and treatment of a difficult patient

more likely than not exceeded the relevant standard of care and

probably reflected above-average skill for a family practitioner

in a small town where there is (according to the Department's

expert) no local psychiatrist.

33. The Department failed to adduce clear and convincing

evidence that Dr. Heller prescribed drugs to J.B.

inappropriately or in excessive or inappropriate quantities,

either negligently in violation of the applicable standard of

care or (it follows from the foregoing) in amounts that no

reasonable physician could justify as medically appropriate. If

the Department had proved the latter clearly and convincingly,

then the trier would have been allowed to presume that the

doctor had prescribed drugs outside the course of his medical

practice in violation of Section 458.331(1)(q), Florida

Statutes. As it is, however, the greater weight of the evidence

shows that Dr. Heller prescribed drugs for J.B. in appropriate

quantities, for medically justifiable purposes. Further, the

evidence is overwhelming——indeed, is clear and convincing——that

Dr. Heller's treatment of J.B. took place in the course of his

professional practice.

34. Dr. Heller's medical records pertaining to J.B. were

legible; they properly identified the responsible physician

(Dr. Helle r) by name and professional title; and, as a

preponderance of evidence demonstrates, they justified the

course of treatment that Dr. Heller rendered to J.B. Dr. Heller

not only exercised reasonable care under the circumstances in

preparing these records, but also he obeyed the statutory

directives regarding record-keeping set forth in Section

458.331(1)(m), Florida Statutes. The Department's evidence to

the contrary is not clear and convincing.

CONCLUSIONS OF LAW

35. The Division of Administrative Hearings has personal

and subject matter jurisdiction in this proceeding pursuant to

Sections 120.569 and 120.57(1), Florida Statutes.

36. Section 458.331(1), Florida Statutes, sets forth the

acts that constitute grounds for which doctors may be

disciplined. Among the described offenses are the following:

(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. The board

shall give great weight to the provisions of

s. 766.102 when enforcing this paragraph.

As used in this paragraph, "repeated

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 $25,000 each to the claimant in

a judgment or settlement and which incidents

involved 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 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.

Section 458.331(1), Florida Statutes.

37. If the Board of Medicine finds a physician guilty of

any of the statutorily proscribed acts, including those

mentioned above, it may enter an order imposing one or more of

the following penalties:

(a ) Refusal to certify, or certification

with restrictions, to the department an

application for licensure, certification, or

registration.

(b ) Revocation or suspension of a

license.

(c ) Restriction of practice.

(d ) Imposition of an administrative fine

not to exceed $10,000 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.

(j ) Imposition of an administrative fine

in accordance with s. 381.0261 for

violations regarding patient rights.

Section 458.331(2), Florida Statutes.

38. A proceeding to suspend, revoke, or impose other

discipline upon a professional license is penal in nature.

State ex rel. Vining v. Florida Real Estate Commission , 281 So.

2d 487, 491 (Fla. 1973). Accordingly, to impose discipline, the

Department must prove the charges against Dr. Heller by clear

and convincing evidence. Department of Banking and Finance,

Div. of Securities and Investor Protection v. Osborne Stern &

Co. , 670 So. 2d 932, 935-36 (Fla. 1996)(citing Ferris v.

Turlington , 510 So. 2d 292, 294-95 (Fla. 1987)) ; Nair v.

Department of Business & Professional Regulation , 654 So. 2d

205, 207 (Fla. 1st DCA 1995).

39. In Slomowitz v. Walker , 429 So. 2d 797, 800 (Fla.

4th DCA 1983), the Court of Appeal, Fourth District, canvassed

the cases to develop a "workable definition of clear and

convincing evidence" and found that of necessity such a

definition would need to contain "both qualitative and

quantitative standards." The court held that

clear and convincing evidence requires that

the evidence must be found to be credible;

the facts to which the witnesses testify

must be distinctly remembered; the testimony

must be precise and explicit and the

witnesses must be lacking confusion as to

the facts in issue. The evidence must be of

such weight that it produces in the mind of

the trier of fact a firm belief or

conviction, without hesitancy, as to the

truth of the allegations sought to be

established.

Id. The Florida Supreme Court later adopted the fourth

district's description of the clear and convincing evidence

standard of proof. Inquiry Concerning a Judge No. 93-62 , 645

So. 2d 398, 404 (Fla. 1994). The First District Court of Appeal

also has followed the Slomowitz test, adding the interpretive

comment that "[a ]lthough this standard of proof may be met where

the evidence is in conflict, . . . it seems to preclude evidence

that is ambiguous." Westinghouse Electric Corp., Inc. v. Shuler

Brothers, Inc. , 590 So. 2d 986, 988 (Fla. 1st DCA 1991), rev .

denied , 599 So. 2d 1279 (1992)(citation omitted).

40. Whether Dr. Heller failed to practice medicine with

reasonable skill and safety and committed the other wrongful

acts of which he stands accused are questions of fact for the

trier to resolve——not issues of law. See Hoover v. Agency for

Health Care Administration , 676 So. 2d 1380, 1384 (Fla. 3d DCA

1996). As set forth in the preceding Findings of Fact, the

trier has determined as matter of ultimate fact that the

Department failed to establish, by the requisite level of proof,

that Dr. Heller is guilty as charged.

41. There is one legal issue that merits further

discussion. Based on the same alleged over-prescribing of drugs

to J.B., the Department accused Dr. Heller of professional

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

Statutes, and also of prescribing legend drugs "other than in

the course of [his] professional practice," in violation of

Section 458.331(1)(q). Given the identity of the conduct

underlying both charges, it is important to point out that

Section 458.331(1)(q) does not target "mere" negligence but

rather proscribes a different form of misconduct.

42. The wrongdoing that Section 458.331(1)(q) seeks to

prevent, it bears repeating, is "prescribing . . . a legend drug

. . . other than in the course of the physician's professional

practice ." (Emphasis added). The underlined language is the

gravamen of the offense. 9 To establish guilt, the Department

must prove that the accused doctor was not practicing medicine

when he prescribed the drugs in question but instead was engaged

in an illicit (and probably oftentimes criminal) activity, e.g.

selling narcotics to a "patient" who was not really sick but

wanted the drugs for recreational purposes. No other subpart of

Section 458.331(1), it may be seen, generally proscribes this

type of physician misbehavior. 10

43. To help the Department prove this offense, the

legislature has provided a presumption, which arises when the

Department demonstrates that the accused doctor prescribed drugs

"inappropriately or in excessive or inappropriate quantities[.]"

Section 458.331(1)(q), Florida Statutes. In that event, it may

be "legally presumed" that the doctor was not acting in the

course of his or her professional practice, "without regard to

his or her intent." Id.

44. From the plain language of Section 458.331(1)(q),

considered as a whole, it is clear that the terms

"inappropriate" and "excessive," taken in context, do not refer

to simple breaches of ordinary and reasonable care. Such

negligence is the province of Section 458.331(1)(t).

45. Supporting this interpretation is the common sense

observation that there is no logical connection between an ill-

advised prescription resulting from negligence and the

conclusion that the negligent physician was operating outside

the course of his medical practice . It is an undeniable and

commonly-known fact of the human condition that all doctors make

a mistake now and again, and some doctors' mistakes

unfortunately cause harm, for which the law provides redress.

But reasonable people do not ordinarily conclude that a

negligent doctor must have made his mistake other than in the

course of his medical practice. To the contrary, the natural

and normal assumption when contemplating medical malpractice is

that the wrong occurred while the doctor was practicing

medicine. (Conversely, it is counterintuitive to conceive of a

doctor's dispensing drugs outside the course of his medical

practice as a form of professional negligence; this is a

wrongful act, to be sure, deserving of censure and sanction

without question, but not one commonly thought of as

malpractice.)

46. Further, if the terms "inappropriate" and "excessive"

were construed to embrace all prescription practices that fall

short of that which reasonable care requires under the

circumstances, then the presumption of guilt effectively would

re-define and become the offense, and Sections 458.331(1)(q) and

458.331(1)(t) would be practically indistinguishable. Because

the legislature presumably did not intend that Section

458.331(1)(q) be subsumed by Section 458.331(1)(t)——which would

make the former redundant——it follows that the presumption of

guilt should not arise from proof of mere negligence.

47. The Department has proposed a novel solution to the

redundancy problem. It contends that whether a prescription is

inappropriate or excessive should be determined based on a

universal standard of care——the same for all doctors, regardless

of specialty. 11 This would, of course, distinguish Section

458.331(1)(q) from Section 458.331(1)(t), but in a potentially

anomalous way. A doctor could be deemed to have exercised

reasonable care in compliance with Section 458.331(1)(t) but be

found in violation of the "universal" standard under Section

458.331(1)(q) and punished for prescribing outside the course of

his medical practice! That cannot have been the legislature's

intent.

48. To have relevant meaning in reference to the offense

of prescribing drugs outside the scope of a medical practice,

then, the words "inappropriate" and "excessive" should be

understood to connote prescription practices that are an abuse

of professional discretion, that is, so far beyond the pale that

no reasonable physician could justify them. Put another way, if

reasonable physicians can disagree about whether the

prescription in question was inappropriate or excessive, then

the presumption is not warranted, and the Department must prove

a charge under Section 458.331(1)(q) with other evidence that

the doctor was acting outside the course of his professional

practice. 12

49. Here, the Department failed to prove, clearly and

convincingly, either a "universal" standard of care respecting

the prescriptions at issue (assuming for argument's sake that

such is relevant, as the Department urges) or that Dr. Heller's

treatment decisions were an untenable abuse of professional

judgment. Further, at any rate, as set forth above, the trier

has determined based on the totality of the evidence that

Dr. Helle r in fact treated J.B. in the course of his

professional practice.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, the Department having failed to prove the charges brought

against Dr. Heller by clear and convincing evidence, it is

RECOMMENDED that the Board of Medicine enter a final order

dismissing the Administrative Complaint.

DONE AND ENTERED this 12th day of June, 2001, in

Tallahassee, Leon County, Florida.

___________________________________

JOHN G. VAN LANINGHAM

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488- 9675 SUNCOM 278-9675

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 12th day of June, 2001.

ENDNOTES

1 / Adderall is a stimulant used to treat attention deficit

disorder and hyperactivity. It is a legend drug as defined by

Section 465.003(7), Florida Statutes. This medicine's side

effects include facial tics and a decrease in appetite.

2 / Risperdal is a legend drug as defined by Section 465.003(7),

Florida Statutes. Risperdal contains risperdone and is an anti-

psychotic medication that is used for aggressive behavior,

hallucinations, delusions, and schizophrenia. The side effects

of Risperdal are akathisia (a severe state of restlessness and

agitation), dystonic reaction (a form of muscle contraction),

and Parkinsonism (a level of stiffness where one has a "mask”

face and cannot smile or show expression).

3 / Prozac is a legend drug as defined by Section 465.003(7),

Florida Statutes. Prozac is classified as a serotonin uptake

inhibitor and is used for treatment of depression, anxiety,

panic attacks, obsessive-compulsive disorder, and behavior

disturbances. The side effects of Prozac are sleepiness,

sedation, dry mouth, decrease in appetite, nausea, potential

vomiting, and tremors.

4 / Cogentin is a legend drug as defined by Section 465.003(7),

Florida Statutes, that is given to counteract a number of side

effects collectively referred to as "extrapyramidal” symptoms,

one of which is dystonic reaction. Side effects of this

medicine are increased temperature and dry mouth.

5 / For example, if DCF removed J.B. from his mother's custody

and placed him with another family member or in foster care, or

provided some other assistance to J.B.'s mother that improved

the family's home life, this might have accounted for the

child’s improvement at school. The record does not tell the

whole story, and hence the evidence is inconclusive.

6 / The alleged negligent act described in clause (d) is repeated

in Count Three of the Administrative Complaint as a basis for

the records charge brought under Section 458.331(1)(m), Florida

Statutes. See paragraph 25, infra . Interestingly, the

Department argues in its proposed recommended order, as it did

at hearing, that violations of Section 458.331(1)(m) are not to

be determined with reference to the standard of reasonable care

that obtains in the application of Section 458.331(1)(t) because

"the standard of care for medical records is the same for all

physicians.” If this were true, then a particular doctor,

preparing a medical record with all the skill and care that

Section 458.331(1)(t) requires, could nevertheless violate the

(presumably) stricter standard imposed by Section 458.331(1)(m).

This apparent anomaly is readily resolved. The Department is

partially correct: the standard of care applicable under

Section 458.331(t) is irrelevant to Section 458.331(m). Where

the Department has erred is in urging that a "standard of care”

analysis is necessary in the application of Section 458.331(m).

The record-keeping offense plainly is not a "standard of care”

violation but rather a failure to follow a fairly specific

statutory mandate. Indeed, expert testimony should not be

needed in most instances to establish the violation, except to

explain medical terms of art.

All that being said, the Department's decision to charge

Dr. Heller with malpractice under Section 458.331(1)(t) based in

part on purported record-keeping deficiencies was a questionable

strategy but of little moment here, since the Department failed

to prove that Dr. Heller negligently prepared his medical

records.

7 / Moreover, the Department did not charge Dr. Heller with

"performing professional responsibilities which the licensee

knows or has reason to know that he or she is not competent to

perform," in violation of Section 458.331(1)(v), Florida

Statutes.

8 / As an aside, it should be noted that Dr. Heller did not have

the burden to establish the applicable standard of care,

although he did so by the greater weight of the evidence.

Rather, because the Department must prove its case by clear and

convincing evidence, Dr. Heller needed only to raise in the mind

of the fact-finder, by evidence or argument, such doubt about

the weight of the Department's proof as to produce a hesitance

concerning the truth of the allegations sought to be

established. In other words, to determine that the Department's

proof was less than clear and convincing would not have required

the trier to find, as it has, that Dr. Heller's experts, more

likely than not, articulated the correct standard of care.

Indeed, the Department's heavy burden is such that, in a given

case, the trier could find that the Department has proved the

relevant standard of care by a preponderance of the evidence and

yet determine that the Department has failed to establish the

doctor’s alleged negligence. This point is made here solely to

emphasize that in this case the trier is more than merely

hesitant about the truth of the Department's allegations——which

would have been sufficient to recommend disposition in favor of

Dr. Heller——but instead deems Dr. Heller's version of the truth

likely to be correct.

9 / The Department's rule establishing disciplinary guidelines,

which informs licensees of the ranges of penalties that will

routinely be imposed for the various statutory violations,

summarizes the act prohibited by Section 458.331(q), Florida

Statutes, as "[i ]nappropriate or excessive prescribing." See

Rule 64B8-8.001(2), Florida Administrative Code. This is not

the offense, however, as the plain language of the statute makes

clear. In this instance, the following caveat, stated in the

rule, must be taken seriously: "The verbal identification of

offenses are descriptive only; the full language of each

statutory provision cited must be consulted in order to

determine the conduct included." Rule 64B8-8.001(2), Florida

Administrative Code.

10 / Several subparts aim to curtail the prescription of specific

drugs. See Sections 458.331(1)(bb), (cc), (ee), and (ff),

Florida Statutes.

11 / The Department's argument here is similar to its contention

regarding the standard of care it urges should govern record-

keeping violations. See note 6, supra .

12 / Because the presumption is not the offense, and since the

presumption appears to be rebuttable (for the statute does not

expressly make it conclusive), a doctor who has issued an

indefensible prescription might still be able to disprove the

presumed fact by demonstrating that his egregious error

nevertheless occurred during the course and within the scope of

his professional practice.

COPIES FURNISHED:

Sean M. Ellsworth, Esquire

Dresnick, Ellsworth & Felder, P.A.

201 Alhambra Circle, Suite 701

Coral Gables, Florida 33134-5108

Eric S. Scott, Esquire

Agency for Health Care Administration

Post Office Box 14229

Tallahassee, Florida 32317-4229

Tanya Williams, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399-1701

Theodore M. Henderson, Agency Clerk

Department of Health

4052 Bald Cypress Way

Bin A02

Tallahassee, Florida 32399-1701

William W. Large, General Counsel

Department of Health

4052 Bald Cypress Way

Bin A02

Tallahassee, Florida 32399-1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this R ecommended O rder. Any exceptions

to this R ecommended O rder should be filed with the agency that

will issue the F inal O rder in this case.