01-004664PL Department Of Health, Board Of Medicine vs. Steven Pliskow, M.D. Status: Closed Recommended Order on Tuesday, April 30, 2002.

Summary: Department failed to prove physician practiced below accepted standard of care or did not document justification for treatment and dosage of medication. Administrative Complaint should be dismissed.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE )

)

Petitioner, )

vs. ) Case No. 01 - 4664PL

)

STEVEN PLISKOW, M.D., )

)

Respondent. )

_________________________________)

RECOMMENDED ORDER

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

on Feb ruary 6 and 7, 2002, in West Palm Beach, Florida, before

Patricia Hart Malono, a duly - designated Administrative Law Judge

of the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Sarah D. Cyrus, Esquire

Ephraim D . Livingston, Esquire

Agency for Health Care Administration

Post Office Box 14229, Mail Stop 39A

Tallahassee, Florida 32317 - 4229

For Respondent: Alexander Barker, Esquire

Adams, Coogler , Watson, Merkel,

Barry & Kellner, P.A.

1555 Palm Beach Lakes Boulevard

Suite 1600

Post Office Box 2069

West Palm Beach, Florida 33402 - 2069

STA TEMENT OF THE ISSUE

Whether the Respondent committed the violations alleged in

the Administrative Complaint dated October 22, 2001, and, if so,

the penalty that should be imposed.

PRELIMINARY STATEMENT

In a three - count Administrative Complaint dated Octob er 22,

2001, the Department of Health ("Department") charged Steven

Pliskow, M.D., with violations of three provisions of the

Florida Statutes governing the practice of medicine. These

alleged violations involved the treatment provided C.B., a

patient in a weight loss clinic operated in 1996 and 1997 by

Dr. Pliskow and others.

The allegations in the Administrative Complaint are as

follows:

(a) In Count I, the Department charged that Dr. Pliskow

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

prac ticing medicine below the accepted standard of care,

specifically by (1) failing to complete a physical examination

and/or obtain a complete history of C.B. prior to starting her

on a weight loss program; (2) failing to provide adequate

supervision to an A dvanced Registered Nurse Practitioner

("A.R.N.P.") and personally reviewing C.B.'s chart; and

(3) failing to document in C.B.'s medical records justification

for the course of treatment and dosage of medication.

(b) In Count II, the Department charged tha t Dr. Pliskow

had violated Section 458.331(1)(m), Florida Statutes, by failing

to keep written medical records justifying the course of

treatment and dosage of medication provided to C.B.

(c) In Count III, the Department charged that Dr. Pliskow

had viola ted Section 458.331(1)(1)(q), Florida Statutes, by

prescribing a legend drug outside the course of his professional

practice, specifically by failing to document in C.B.'s medical

records her course of treatment and dosage of medication.

Dr. Pliskow timely disputed the facts alleged in the

Administrative Complaint and requested an administrative

hearing. The Department forwarded the matter to the Division of

Administrative Hearings for assignment of an administrative law

judge, and the final hearing was he ld, pursuant to notice, on

February 6 and 7, 2002.

At the hearing, the Department presented the testimony of

Amy Windham, records custodian from Delray Medical Center;

patient C.B.; Ira Fine, M.D., C.B.'s primary care physician; and

Kevin Holthaus, M.D., t he Department's expert witness.

Petitioner's Exhibits 3, 4, and 13 were offered and received

into evidence; Petitioner's Exhibit 12 was offered and rejected,

but was not proffered. Petitioner's Exhibit 3 was received

subject to a hearsay objection, and its use is governed by the

limitation of the use of hearsay evidence in

Section 120.57(1)(c), Florida Statutes (2001).

Dr. Pliskow testified on his own behalf and presented the

testimony of Mark Multach, M.D., his expert witness, and

Kimberly Payne, an A. R.N.P. who worked in the weight loss

clinic. Respondent's Exhibits 1, 4, 5, and 6 were offered and

received into evidence. In addition, prior to the final

hearing, Dr. Pliskow filed Respondent's Request to Take Judicial

Notice, in which he requested that official recognition be taken

of the opinion in Alvarez v. Smith , 714 So. 2d 652 (Fla. 5th DCA

1998); Sections 464.003 and .012, Florida Statutes (1995); and

Rules 64B8 - 35.001 and .002, Florida Administrative Code. The

motion was granted at the hearing, and official recognition has

been taken of these documents.

The four - volume transcript of the proceedings was filed

with the Division of Administrative Hearings on February 25,

2002, and the parties timely filed proposed findings of fact and

conclusions of law, which have been considered in the

preparation of this Recommended Order.

FINDINGS OF FACT

Based on the oral and documentary evidence presented at the

final hearing and on the entire record of this proceeding, the

following findings of fact are made:

1. The Department is the state agency responsible for the

investigation and prosecution of complaints involving physicians

licensed to practice medicine in Florida. See Section 455.225,

Florida Statutes. The Board of Medicine is the entity

responsible for regulating the practice of medicine in Florida

and for imposing penalties on physicians found to have violated

the provisions of Section 458.331(1), Florida Statutes.

See Section 458.331(2), Florida Statutes.

2. Dr. Pliskow is, and was at the times m aterial to this

proceeding, a physician licensed to practice medicine in

Florida, having been issued license number ME 0054211, and he is

Board - certified in Obstetrics, Gynecology, and Forensic

Medicine. At the times material to this proceeding, Dr. Plisk ow

practiced obstetrics and gynecology with three other physicians,

Dr. Ackerman, Dr. Herbst, and Dr. Aqua, under the name "Advanced

Women's Healthcare."

3. In 1996, Dr. Pliskow, Dr. Ackerman, and Dr. Herbst

established the Comprehensive Weight Loss & Nut rition Center

("Center") as a separate corporation. Kimberly Payne, an

A.R.N.P., was the administrative director of the Center, and, in

addition to administrative duties, her job responsibilities

included supervision of the nursing staff working in the Ce nter,

direct patient care, and staff training. The four physicians

practicing at Advanced Women's Healthcare were the designated

supervising physicians for staff of the Center.

4. Bariatrics is the subspecialty dealing with the medical

treatment of obe sity, and the four physicians supervising the

Center, as well as Nurse Payne, were members of the American

Society of Bariatric Physicians. As members of this

organization, the physicians and Nurse Payne received two

monthly journals, a biweekly newslette r, a monthly magazine, and

faxes and e - mails containing updates on standard - of - care issues,

medication changes, updates from the Federal Drug

Administration, and suggested treatment changes and

recommendations. The organization also provided educational

p rograms and training opportunities for its members.

5. In accordance with the recommendations of the American

Society of Bariatric Physicians, the Center's weight loss

program included a behavior modification program; a diet

providing between 1200 and 140 0 kilocalories per day; and an

exercise program designed for each of its patients. In

addition, if the patient was an appropriate candidate, the

Center prescribed anorectic medications, including the

combination of the drugs Phentermine and Fenfluramine c ommonly

known as "Phen/Fen."

I. Weight Loss Protocol

6. At the times material to this proceeding, A.R.N.P.s

were allowed under Florida law to practice independently under

the general supervision of a physician who was accessible to

them if they needed a consultation or evaluation of a patient.

See Sections 464.003(3)(c) and 464.012(3), Florida Statutes

(1995); Rule 64B8 - 35.002, Florida Administrative Code. Among

other things, A.R.N.P.s were allowed to perform physical

examinations of patients, to take medical histories, to initiate

treatment programs, to prescribe certain types of drugs, and to

evaluate patients for signs and symptoms of side effects

associated with medications. A.R.N.P.s could not, however,

prescribe drugs that were classified as con trolled substances.

7. Nurse Payne, and another A.R.N.P. subsequently hired to

work at the Center, practiced under the general supervision of

Dr. Pliskow, Dr. Ackerman, Dr. Herbst, and Dr. Aqua and in

accordance with a protocol setting forth the respectiv e duties

of the A.R.N.P.s and of the physicians in the various areas of

practice at Advanced Women's Healthcare. The protocol was filed

with the appropriate state agency.

8. Section Four of the protocol dealt with weight loss.

Pursuant to the general gu idelines, the A.R.N.P.s working at the

Center were "responsible for the assessment and management of

overweight individuals in a comprehensive weight reduction

program including nutritional counseling, exercise management,

and use of anorectic medications when appropriate." Patient

selection criteria were as follows:

A. Any individual who is over their ideal

body weight may participate in the nutrition

and exercise portions of the program.

B. In order to qualify to participate in

the medication portion of the program, the

individual must meet the following criteria:

1. Between the ages of 18 and 65 (any

person between the ages of 61 and 65 must

have medical clearance from their PCP

[primary care physician]).

2. Minimum of 20% over ideal body

weight.

3. No present history of heart disease,

uncontrolled hypertension, cardiac

arrhythmia, glaucoma, uncontrolled diabetes,

hyperthyroidism, psychotic illness, drug or

alcohol abuse, pregnancy, breastfeeding, or

impending surgery requiring genera l

anesthesia.

4. Any deviation from these criteria

requires collaboration with physician.

9. The following was the General Condition of the weight

loss protocol:

The A.R.N.P. should consult with the

physician on all patients exhibiting

abnormal fin dings which might affect their

weight loss management and refer for

physician evaluation as needed.

II. Patient C.B.

10. Patient C.B. learned of the Center's weight loss

program from her daughter, who had participated in the program

and taken weight l oss medication. C.B. had an initial

consultation at the Center on October 23, 1996. At the time, as

recorded on the Center's Weight Reduction Intake Form, C.B. was

62 years of age, her weight was 165 pounds, her height was five

feet and four inches, she had a medium frame, her blood pressure

was 138/82, and her pulse was 72 beats per minute. The intake

form also included her body measurements as of October 23, 1996.

11. As part of the initial consultation, C.B. completed

the Center's Weight Reduction Pr ogram Questionnaire, in which

she stated that she considered her ideal weight to be 135

pounds, that her biggest obstacle to losing weight was staying

on a diet, and that she was interested in using medication in

her weight loss program. C.B. indicated th at she had no

limitations on exercise and played tennis regularly. She

disclosed her current medications, and she indicated that she

did not then, nor had she ever, had the following conditions:

heart disease, irregular heartbeat, high blood pressure,

gla ucoma, diabetes, psychotic illness, or alcohol or drug abuse.

12. Nurse Payne reviewed the Weight Reduction Program

Questionnaire with C.B. and completed the intake form. She

noted on the intake form that C.B.'s ideal weight was between

120 and 135 pound s, that her weight goal was 135 pounds, and

that her body mass index ("BMI") was 28. 1 Nurse Payne reviewed

with C.B. the information C.B. provided on the questionnaire,

including her medical history, current medications, and drug

allergies, and Nurse Payn e noted on the intake form that C.B.

reported arthritis as her only significant medical history.

13. Nurse Payne and C.B. discussed the 1200 - calorie

exchange diet that was part of the program, and Nurse Payne

developed an exercise plan for C.B. that inclu ded walking in the

pool twice each week and incorporated C.B.'s usual routine of

playing tennis three times each week. Nurse Payne noted on the

intake form that Dr. Ira Fine was C.B.'s primary care physician.

14. Nurse Payne also discussed medication opt ions with

C.B., including the benefits and risks of medications. The

intake form included a printed section on medications, in which

the first entry was "Pondimin 2 20 mg. po bid and Phentermine 37.5

mg. po qd" and the second entry was "Other." Nurse Payn e

indicated on the intake form that C.B. would be started on

"Phen/Fen pending medical clearance [by] Dr. Fine & EKG."

Nurse Payne also advised C.B. that she would need to obtain

medical clearance from Dr. Fine before medication would be

prescribed.

15. During the initial consultation on October 23, 1996,

Nurse Payne provided C.B. with a Consent for Diet Program form

and discussed with C.B. in detail the information in the consent

form. The consent form contained descriptions of both

Phentermine and Fenf luramine, together with the

contraindications to their use, and Nurse Payne provided C.B.

with an excerpt from the Physician's Desk Reference for

Phentermine and the packet insert for Pondimin. 3 C.B. signed the

consent form on October 23, 1996.

16. A blo od specimen was drawn from C.B. on October 23,

1996, and Nurse Payne scheduled C.B. for an EKG on October 26,

1996. Nurse Payne telephoned Dr. Fine's office on October 25,

1996, and spoke with "Betty" about medical clearance for C.B. to

participate in the weight loss program; she specifically told

Dr. Fine's office the program would include the use of Phen/Fen.

Nurse Payne was later advised by Dr. Fine's office that Dr. Fine

had medically cleared C.B. to participate in the Center's weight

loss program. 4

1 7. Once medical clearance was obtained for a patient and

the results of the blood work and EKG were received, the

standard procedure at the Center was for the A.R.N.P. to present

the patient's chart to one of the supervising physicians. 5 The

physician wo uld review the test results and the patient's

medical history and determine whether it was appropriate to

prescribe medications for the patient. If so, the physician

wrote the prescriptions, which were then given to the patient.

Neither Dr. Pliskow nor N urse Payne can recall specifically that

this procedure was followed in C.B.'s case, but there is nothing

in the record to indicate a deviation from this procedure with

respect to C.B.

18. C.B. was cleared for participation in the weight loss

program and f or the use of Phen/Fen based the results of her

blood work and her EKG and on the criteria set out in the weight

loss protocol: Her primary care physician had given medical

clearance; her weight was 20 percent above her ideal body

weight; and she had repo rted no present history of the

conditions identified in paragraph II.B.3 of the protocol. Her

blood pressure and pulse were normal. The results of her EKG

showed no significant abnormality, and there was nothing in the

results of the blood work done on O ctober 23, 1996, that would

prevent C.B. from participating in the weight loss program or

from taking Phen/Fen.

19. C.B.'s initial prescriptions for Phen/Fen were written

on October 28, 1996 and, as noted in her chart, were for

Pondimin in the dosage of " 20 mg. [milligrams] po [orally] bid

[twice daily]" and for Phentermine in the dosage of "37.5 mg.

[milligrams] po [orally] qd [daily]." 6 The medications and

dosage prescribed for C.B. remained the same throughout the time

she participated in the Center's weight loss program, and no

further notations regarding dosage was included in her chart.

20. C.B. initially visited the Center each week; in late

November 1996, the frequency of her visits was decreased to once

every two weeks, and then, in early Februar y 1997, to once every

four weeks. At each visit, a member of the nursing staff at the

Center would note C.B.'s blood pressure, pulse, and weight on

the progress forms in her chart, together with the amount of

weight lost since her last visit. The chart a lso contained the

notes of Nurse Payne or the other A.R.N.P. working at the Center

reporting on C.B.'s success in staying on the diet and exercise

plans; noting that her medication was "P/F"; and summarizing

C.B.'s general progress, anything unusual she re ported, and the

plan she would follow until the next visit. C.B. also completed

at each visit a Follow - Up Questionnaire in which she was asked

to report whether, since her last visit, she had experienced

chest pain, shortness of breath, dizziness, light - h eadedness,

visual problems, palpitations, abdominal pain, bowel changes,

fatigue, difficulty sleeping, depression, irritability,

difficulty concentrating, memory loss, tremors, or increased

appetite.

21. The Center's standard procedure was for the A.R.N.P .

meeting with the patient to discuss the answers in the

questionnaire with the patient and to question the patient

regarding any problems he or she might be having with the

program. Once the A.R.N.P. had examined the patient and

completed the patient's p rogress report, the A.R.N.P. would take

the chart to the supervising physician, who would review the

chart and write the prescriptions for Phen/Fen. None of the

prescriptions for Phen/Fen dispensed at the Center were

pre - signed.

22. Patients in the weig ht loss program received new

prescriptions for Phen/Fen at each visit to the Center. Because

Phentermine and Fenfluramine are controlled substances, there

could be no refills on a prescription, so the prescriptions were

written for a sufficient number of pills to last until the

patient's next visit to the Center. Although the prescriptions

were written and signed by one of the supervising physicians,

the physicians did not sign the patient's chart.

23. After the supervising physician wrote the

prescripti ons, the A.R.N.P. would take the prescriptions to the

patient, who could have them filled at the pharmacy in the

offices of Advanced Women's Healthcare or at a pharmacy

elsewhere. There is nothing in the record to indicate that this

practice was not follo wed with respect to the prescriptions

issued to C.B. 7

24. On November 4, 1996, her first visit after beginning

the program, C.B. reported one episode of light - headedness.

Otherwise, C.B. reported none of the symptoms identified in the

questionnaire and r eported no problems with the program. Had

C.B. reported experiencing anything abnormal, Nurse Payne would

have called in one of the physicians supervising the Center for

a consultation.

25. C.B. participated in the Center's weight loss program

through Ap ril 7, 1997, which was the date of her last visit.

C.B. lost weight on the Center's program at a slow but steady

rate, usually between one and four pounds between visits, until,

on April 7, 1997, she weighed 141 pounds. C.B.'s treatment with

Phen/Fen end ed before May 1997, when the Florida Board of

Medicine published stricter limitations on the use of these

medications. 8

26. Although Dr. Pliskow was not present in the office on

October 28, 1996, when C.B.'s first prescriptions for Phen/Fen

were written, he was present in the office during four of C.B.'s

ten visits to the Center. Because at least one other physician

was also present in the office during these four visits,

Dr. Pliskow may or may not have reviewed C.B.'s chart and

written her prescriptions. 9

III. Summary

27. The evidence presented by the Department is not

sufficient to support a finding that Dr. Pliskow practiced

medicine below the level of care considered acceptable by a

reasonably prudent physician under similar circumstances or to

supp ort a finding that Dr. Pliskow failed to document in C.B.'s

medical records justification for the course of her treatment in

the weight loss program and the dosage of the medications

prescribed for her.

28. The evidence is not sufficient to establish clea rly

and convincingly that the prevailing standard of care required

the physician supervising the Center's A.R.N.P.s personally to

perform a physical examination of C.B. prior to her being

cleared for receiving medication as part of her weight loss

program or personally to obtain C.B.'s medical history. Rather,

it was appropriate for Nurse Payne and the other A.R.N.P.

working at the Center to perform physical examinations and to

take medical histories of persons seeking to participate in the

Center's weight loss program.

29. In addition, the evidence is not sufficient to

establish clearly and convincingly that it was inconsistent with

the prevailing standard of care for the Center's supervising

physicians to rely on C.B.'s primary care physician to provide

medical clearance for her to participate in the weight loss

program. Dr. Fine was familiar with C.B.'s overall medical

condition as a result of his examination of her on September 12,

1996, and he was, therefore, competent to assess the overall

risks of h er participation in a weight loss program

incorporating the use of anorectic medications. Furthermore,

the evidence fails to establish that it was inconsistent with

the prevailing standard of care to rely on the verbal medical

clearance conveyed to Nurse Payne through Dr. Fine's office;

rather, the persuasive evidence suggests that it was the normal

practice for clearance to be given in this manner. 10 And,

significantly, Dr. Fine's medical clearance was not the only

basis for C.B.'s clearance to take anore ctic medications:

C.B.'s vital signs were recorded on the intake form by the

Center's nursing staff, and Nurse Payne compiled C.B.'s medical

history from C.B.'s answers to questions on the Weight Loss

Program Questionnaire and from discussions with C.B; a n EKG and

extensive blood work were ordered for C.B., and a physician

reviewed C.B.'s chart and the results of these tests before

writing C.B. prescriptions for anorectic medications. 11

30. The evidence is not sufficient to establish that the

physicians pr acticing at Advanced Women's Healthcare failed to

provide the appropriate level of supervision to the A.R.N.P.s

who worked in the Center. A.R.N.P.s are independent

practitioners, and they are subject only to the general

supervision of a physician. The ev idence failed to establish

that the prevailing standard of care for physicians supervising

A.R.N.P.s required anything more than that the physician be

available for consultation. At least one physician was

available in the Advanced Women's Healthcare offi ces at all

times for consultation and/or patient evaluation if an A.R.N.P.

working at the Center determined that a patient was experiencing

any complications or if a patient reported any unusual symptoms.

31. The evidence is not sufficient to establish cl early

and convincingly that the type and scope of information

collected during C.B.'s regular visits to the Center and the

on - going care provided to C.B. were not appropriate under the

prevailing standard of care for monitoring patients on weight

loss pro grams such as C.B.'s. The prescriptions for C.B.'s

weight loss medications were written by a physician at each of

C.B.'s visits, but only after the physician reviewed her chart,

which included the A.R.N.P.'s progress notes and C.B.'s answers

on the Follow - Up Questionnaires she completed at each visit, to

determine whether it was appropriate to continue C.B. on

anorectic medications. 12 The evidence also fails to establish

that the prevailing standard of care required a supervising

physician to sign a chart prepared by an A.R.N.P. to indicate

that it had been reviewed. 13

32. The evidence is not sufficient to establish that C.B.

was not an appropriate candidate for a weight loss program using

Phen/Fen under the prevailing standard of care in 1996 and early

199 7. 14 Adequate justification for the treatment of C.B. with

anorectic medications was included in C.B.'s medical records:

She was considered obese by 1996 standards because her weight of

165 pounds was more than 20 percent higher than her ideal body

weight of 120 - to - 135 pounds and because her BMI was 28 and she

wanted to lose weight. In addition, nothing in the medical

history C.B. provided to Nurse Payne or in her tests results

indicated that she would be an inappropriate candidate for

anorectic medicatio ns, and she reported no complications during

her follow - up visits. 15

33. The evidence is not sufficient to establish clearly

and convincingly that the dosages of Phen/Fen prescribed for

C.B. were inappropriate or excessive under the prevailing

standard of care in 1996 and early 1997. Rather, the dosages

prescribed for C.B. were in the lower range of dosages

recommended at the time by the American Society of Bariatric

Physicians and in the medical literature in general for the use

of Phentermine and Fenflur amine in combination. 16 The dosage of

both medications was printed on the intake form completed during

C.B.'s initial visit to the Center, and the dosages did not

change during the time C.B. participated in the Center's weight

loss program; in accordance w ith normal practice, no further

notations were made regarding dosages in C.B.'s chart. New

prescriptions were written each time C.B. visited the Center,

and no refills were permitted, which is also in accordance with

the standard practice in dispensing co ntrolled substances.

CONCLUSIONS OF LAW

34. The Division of Administrative Hearings has

jurisdiction over the subject matter of this proceeding and of

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

and Section 456.073(6), Florida Statute s (2001).

35. In its Administrative Complaint, the Department has

charged Dr. Pliskow with having violated three provisions of

Section 458.331(1), Florida Statutes, as follows:

(m) Failing to keep legible . . . medical

records that . . . justify the cour se 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, dispen sing, 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, di spensing, 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 pr ofessional

practice, without regard to his or her

intent.

* * *

(t) . . . [T]he 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 co nditions

and circumstances. . . .

36. The Department seeks to impose penalties against

Dr. Pliskow that include suspension or revocation of his license

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

Department has the burden of proving by clear and convincing

evidence that Dr. Pliskow committed the violations alleged in

the Administrative Complaint. Department of Banking and

Finance, Division of Securities and Investor Protection v.

Osborne Stern and Co. , 670 So. 2d 932 (Fla. 1996); and Ferris v.

Turlington , 510 So. 2d 292 (Fla. 1987).

37. In Evans Packing Co. v. Department of Agriculture and

Consumer Services , 550 So. 2d 112, 116, n. 5 (Fla. 1st DCA

1989), the court defined clear and convincing evidence as

follows:

[C]lear and convin cing evidence requires

that the evidence must be found to be

credible; the facts to which the witnesses

testify must be distinctly remembered; the

evidence must be precise and explicit and

the witnesses must be lacking in confusion

as to the facts in issue . The evidence must

be of such weight that it produces in the

mind of the trier of fact the firm belief or

conviction, without hesitancy, as to the

truth of the allegations sought to be

established. Slomowitz v. Walker , 429 So.

2d 797, 800 (Fla. 4th DCA 1983).

See also Walker v. Florida Department of Business and

Professional Regulation , 705 So. 2d 652, 655 (Fla. 5th DCA

1998)(Sharp, J., dissenting).

38. The Department specifically alleged in its

Administrative Complaint that the basis for the charge th at

Dr. Pliskow violated Section 458.331(1)(m), Florida Statutes,

was his failure "to document justification for the course of

treatment and the dosage of Patient C.B.'s medication in the

medical records." On the basis of the findings of fact herein,

the D epartment failed to prove by clear and convincing evidence

that Dr. Pliskow violated Section 458.331(1)(m), Florida

Statutes, as charged in the Administrative Complaint. The

medical records kept by the Center include all of the

information necessary to ju stify placing C.B. on Phen/Fen as

part of her weight loss program in 1996 and early 1997. In

addition, the medical records kept by the Center for C.B.

identified the medication prescribed for her, as well as the

dosages initially prescribed on October 28, 1996, which is

sufficient since there was no change in the dosages prescribed.

39. The Department specifically alleged in its

Administrative Complaint that the basis for the charge that

Dr. Pliskow violated Section 458.331(1)(q), Florida Statutes,

was hi s failure "to document justification for the course of

treatment and the dosage of C.B.'s medication in the medical

records." Based on the findings of fact herein and for the

reasons stated in the immediately preceding paragraph, the

Department failed to prove by clear and convincing evidence that

Dr. Pliskow violated Section 458.331(1)(q), Florida Statutes, as

charged in the Administrative Complaint.

40. The Department specifically alleged in its

Administrative Complaint that the basis for the charge tha t

Dr. Pliskow violated Section 458.331(1)(q), Florida Statutes,

was his failure "to complete a physical examination and/or

obtain a complete history of Patient C.B. prior to starting her

on a weight loss regime"; "to provide adequate supervision of

the A.R .N.P. and personally reviewed [sic] Patient C.B.'s

chart"; and "to document justification for the course of

treatment and the dosage of Patient C.B.'s medication in the

medical records." Based on the findings of fact herein, the

Department failed to prove by clear and convincing evidence that

Dr. Pliskow violated Section 458.331(1)(t), Florida Statutes, as

charged in the Administrative Complaint. As set forth in

paragraph 38, above, the medical records of the Center included

sufficient information to just ify C.B.'s treatment and

medication dosages. The prevailing standard of care did not

require the supervising physician of an A.R.N.P. personally to

perform a physical examination of C.B. or personally to compile

her medical history. Finally, Nurse Payne and the other

A.R.N.P. at the Center were adequately supervised in a manner

consistent with the prevailing standard of care, with the

requirements of the protocol for the Center on file with the

Department, and with the parameters within which A.R.N.P.s

pr acticed in Florida, as set forth in Sections 464.003 and .012,

Florida Statutes (1995); and in Rules 64B8 - 35.001 and .002,

Florida Administrative Code.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

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

order dismissing in its entirety the Administrative Complaint

against Steven Pliskow, M.D.

DONE AND ENTERED this 30th day of April, 2002, in

Tallahassee, Leon County, Florida.

________________ ___________________

PATRICIA HART MALONO

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 (850) 921 - 6847

www.doah.state .fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 30th day of April, 2002.

ENDNOTES

1 / Ideal weight range and BMI were calculated using a chart

produced by the Americ an Society of Bariatric Physicians.

2 / Pondimin is a brand name of Fenfluramine.

3 / The package insert contains the same information found in the

Physician's Desk Reference.

4 / Dr. Fine did a comprehensive routine physical examination of

C.B. on Sept ember 12, 1996, during her first visit to his

office. This examination included taking a medical history of

her and her family, a social history, a review of her current

medications, and a examination of all of her organ systems. The

only abnormality Dr. Fine discovered during his examination was

a mild to moderate systolic heart murmur, which he rated as a

"one - to - two over six" murmur.

Dr. Fine did not perform a special examination in late

October 1996 for the purpose of clearing C.B. for a weight loss

program. In Dr. Fine's opinion, however, based on his

examination in September 1996, there was no medical reason she

could not participate in a weight loss program involving the use

of Phen/Fen. Dr. Fine noted that, at the time, the medical

professi on was not aware of any problems with prescribing

Phen/Fen as part of a weight loss program.

5 / The supervising physicians at any given time were those

present in the offices of Advanced Women's Healthcare, which

were next door to the Center's offices.

6 / Dr. Pliskow was in surgery and not in the Advanced Women's

Healthcare offices on the morning of October 28, 1996, when C.B.

received her first prescription for Phen/Fen.

7 / C.B. testified that either Nurse Payne or the other A.R.N.P.

working at the C enter provided the prescriptions to her.

C.B. does not know who filled out the prescriptions and signed

them, but she testified that the prescriptions were signed by a

medical doctor.

8 / Fenfluramine was removed from the market in late 1997.

9 / Dr. Pl iskow cannot recall specifically reviewing C.B.'s chart

or writing prescriptions for her during the time she was a

patient at the Center. It was not his practice to initial the

charts of the Center's patients when he reviewed them, nor did

he note the med ication and dosage prescribed on the chart unless

the medication or dosage was changed. Dr. Pliskow testified

that he attempted to obtain the prescriptions themselves from

the pharmacy that operated on the Center's premises to verify

the identity of the p hysician(s) who signed the prescriptions

and the dosage prescribed, but the pharmacy refused to release

the records.

10 / Dr. Fine could not recall ever having sent a copy of his

medical records to another physician in the context of clearing

a patient for a medical procedure, and both he and Dr. Multach

testified that they were not aware of any requirement that a

primary care physician do so.

11 / The results of C.B.'s EKG and blood work were not among the

documents the Department provided its expert witne ss,

Dr. Holthaus. Consequently, Dr. Holthaus's opinion that

Dr. Pliskow failed to do an adequate physical examination before

clearing C.B. for the use of anorectic medications was based, at

least in part, on his incorrect assumption that C.B. had had no

E KG or blood work done as part of her evaluation at the Center.

His opinion on this point is, therefore, not credited.

12 / Dr. Holthaus testified that "an encounter" with a patient

taking anorectic medications should minimally include an

extensive examina tion into the patient's cardiovascular,

gastrointestinal, neurological, and psychological status; renal

function; electrolyte level; and orthostatic changes.

Dr. Holthaus did not state that such an examination was the

prevailing standard of care at the ti mes material to this

proceeding, and it must be inferred from the context of his

testimony that he was expressing his opinion and beliefs and

describing the manner in which he conducted his practice, rather

than describing the objective standard of care ac ceptable to a

reasonably prudent physician under circumstances similar to

those in which C.B. was treated at the Center.

13 / Dr. Holthaus first testified that the standard of care for

supervising A.R.N.P.s required the supervising physician to sign

the ch art. Dr. Holthaus later conceded that the chart prepared

by a physician's assistant had to be reviewed and signed but

that this was not a requirement for charts prepared by an

A.R.N.P.

14 / Dr. Holthaus first testified that C.B. was not an

appropriate can didate for anorectic medications because her BMI

was not sufficiently high; he later testified that she was

marginally qualified as a candidate because her weight was more

than 20 percent over her ideal body weight; and he finally

conceded that C.B. did qu alify under the guidelines in place at

the time she participated in the Center's weight loss program.

Although C.B. may not have qualified for the use of anorectic

medications under the stricter standards published by the

Florida Medical Association, thes e standards were not published

until after C.B. stopped participating in the Center's program.

15 / C.B. testified that she was not aware that she had a heart

murmur until after she stopped visiting the Center and so did

not include this in her medical his tory. In Dr. Holthaus's

opinion, C.B. was a high - risk patient for anorectic medications

because a patient with a heart murmur "by definition may have

some abnormality within their heart," and the use of anorectic

medications could potentially cause "cardi ovascular stress."

Dr. Pliskow, Dr. Fine, and Dr. Multach each testified that a

"one - to - two over six" heart murmur, which is by definition one

that is barely audible, would not preclude C.B. from

participating in the medication portion of the Center's wei ght

loss program. According to Dr. Multach, Dr. Pliskow's expert

witness, in 1996 there were no known adverse effects of Phen/Fen

on the heart, and Dr. Fine did not consider C.B.'s heart murmur

an impediment to her participation in the weight loss program .

The testimony of Dr. Multach, Dr. Pliskow, and Dr. Fine on this

point is credited as more persuasive than that of Dr. Holthaus.

Dr. Holthaus testified that he believes that C.B.'s age of

62 years placed her at a high risk for the use of anorectic

medications, but he did not explain the basis for this opinion.

Moreover, he did not opine that her age disqualified her from

taking such medications.

Dr. Holthaus's testimony that the results of C.B.'s EKG

indicated an abnormality is not credited. Dr. Holthaus examined

the EKG results for the first time at the hearing, and his

description of the perceived abnormality was vague and

inconclusive. Both Dr. Pliskow and Dr. Multach testified that

there were no significant abnormalities shown on the res ults of

C.B.'s EKG, and their opinions are credited as more persuasive

than the opinion of Dr. Holthaus.

16 / Dr. Holthaus initially testified that the dosages of

Phen/Fen prescribed for C.B. at the Center were excessive given

her age and what he considere d her marginal qualification for

anorectic medication. He did not, however, identify what he

considered to be the appropriate dosages, and, later in his

testimony, he conceded that the dosages prescribed for C.B. were

not greater than the dosages consider ed appropriate under the

prevailing standard of care.

COPIES FURNISHED:

Alexander Barker, Esquire

Adams, Co ogler, Watson, Merkel, Barry & Kellner, P.A.

1555 Palm Beach Lakes Boulevard, Suite 1600

Post Office Box 2069

West Palm Beach, Florida 33402 - 2069

Sarah D. Cyrus, Esquire

Agency for Health Care Administration

Post Office Box 14229, Mail Stop 39A

Tallahass ee, Florida 32317 - 4229

William W. Large, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

Mr. R. S. Power, Agency Clerk

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1 701

Ms. Tanya Williams, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from th e 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.